Comparing the efficacy and safety of extended (3 h) and intermittent infusion (0.5 h) of beta-lactams (cefepime, ceftriaxone, meropenem, piperacillin/tazobactam) in critically ill paediatric patients (PEBBLE)

2024-518115-19-02 Protocol PEBBLE Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol PEBBLE

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 110
Countries 1
Sites 2

suspected or proven infection

The objective of the study is to investigate the probability of target attainment of beta-lactams (100% fT>MIC, primary outcome) administering extended versus short-term intermittent infusion.

Key facts

Sponsor
Semmelweis University
Participant type
Pediatric, Patients
Age range
0-17 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial)
2025-07-24
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Semmelweis University

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Safety, Pharmacokinetic, Therapy

The objective of the study is to investigate the probability of target attainment of beta-lactams (100% fT>MIC, primary outcome) administering extended versus short-term intermittent infusion.

Secondary objectives 13

  1. achieving a higher target (100% fT>4xMIC)
  2. all-cause mortality
  3. adverse events
  4. clinical response
  5. clinical success
  6. duration of the antibiotic
  7. length of stay in the Paediatric Intensive Care Unit or in the Neonatal Intensive Care Unit (PICU or NICU)
  8. length of hospital stay (LOS)
  9. C-reactive protein (CRP) normalisation
  10. Procalcitonin (PCT) normalisation
  11. White blood cells (WBC) normalisation
  12. Microbiological eradication rate
  13. treatment failure

Conditions and MedDRA coding

suspected or proven infection

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 comparing the efficacy and safety of extended (3 h) and intermittent infusion (0.5 h) of β-lactams
Two intervention groups will be compared in a partially blind, open-label, randomised, parallel-group, superiority study design.
 Randomised Controlled Single [{"id":142507,"code":4,"name":"Analyst"}] extended infusion: 3 hours
short intermittent infusion: 0.5 hour

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2024-518115-19-01 A single-centre, partially blind, randomised, parallel-group, two-arms, superiority study to compare the efficacy and safety of extended (3 h) and intermittent infusion (0.5 h) of β-lactams (cefepime, ceftazidime, ceftriaxone, meropenem, piperacillin/tazobactam) in critically ill paediatric patients (PEBBLE) Semmelweis University
2024-518115-19-00 A single-centre, partially blind, randomised, parallel-group, two-arms, superiority study to compare the efficacy and safety of extended (3 h) and intermittent infusion (0.5 h) of β-lactams (cefepime, ceftazidime, ceftriaxone, meropenem, piperacillin/tazobactam) in critically ill paediatric patients Semmelweis University

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. paediatric patients (0-17 years of age) with suspected or proven bacterial infection being treated in a PICU or NICU and diagnosed with sepsis, i.e. a total Phoenix Sepsis Score≥2 points
  2. receiving β-lactams including meropenem, piperacillin/ tazobactam, cefepime, ceftazidime, ceftriaxone
  3. start of the same β-lactam therapy within the previous 24 hours or the start of a new β-lactam therapy because of clinical deterioration
  4. patients with normal or decreased estimated glomerular filtration rate (eGFR) if a dosage adjustment is not needed (in the case of meropenem, cefepime, ceftazidime and piperacillin/tazobactam eGFR>50 ml/min/1.73m2, in the case of ceftriaxone eGFR>10 mL/minute/1.73m2)
  5. ongoing infection is likely with or without culture positivity or confirmed infection: culture (haemoculture, cerebrospinal fluid, urine, from trachea, from wound, etc.) positivity, excluding contamination
  6. written informed consent by parent or guardian

Exclusion criteria 9

  1. ≥18 years of age
  2. palliative patients
  3. patients enrolled in other medication studies
  4. patients with decreased renal function if dosage adjustment is needed (in the case of meropenem, cefepime, ceftazidime and piperacillin/tazobactam eGFR<50 ml/min/1.73m2, in the case of ceftriaxone eGFR<10 mL/minute/1.73m2)
  5. patients with Therapeutic Plasma Exchange (TPE)
  6. patients with extracorporeal therapy (continuous kidney replacement therapy [CKRT] or extracorporeal membrane oxygenation [ECMO])
  7. β-lactam allergy
  8. discontinued beta-lactam treatment within 3 days after randomisation
  9. referral from another institution or department with the same ongoing antibiotic treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The proportion of patients achieving the therapeutic and optimal exposure when the plasma concentrations are above the MIC for 100% of the dosing interval. Trough plasma concentration levels will be measured.

Secondary endpoints 13

  1. The proportion of patients achieving PK/PD index: 100% fT>4xMIC (Ctrough >4xMIC)
  2. CRP normalisation (days, <10 mg/L)
  3. PCT normalisation (days, <0.5)
  4. WBC normalisation (days, <10000 /µl)
  5. All-cause mortality (within 30 days or until hospital discharge)
  6. Adverse events (every day)
  7. Microbiological eradication rate (in different time points: 1st day, 2nd day, 3rd day, 5th day)
  8. Clinical response (resolution or improvement or failure)
  9. Clinical success (Time in days when clinical succes or resolution is achieved)
  10. Treatment failure (Number of patients, for whom the β-lactam antibiotic had to be stopped due to the clinical deterioration and/or antibiotic resistance.)
  11. Duration of the antibiotic (days)
  12. Length of PICU/NICU stay (days)
  13. Length of hospital stay (LOS) (days)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 65

Meropenem Kalceks 500 mg por oldatos injekcióhoz vagy infúzióhoz

PRD10209456 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24185/01
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Sandoz 4 g/0,5 g por oldatos infúzióhoz

PRD8950540 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-21315/09
MA holder
SANDOZ HUNGÁRIA KFT
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Pharmacenter 500 mg por oldatos injekcióhoz vagy infúzióhoz

PRD8905623 · Product

Active substance
Meropenem Anhydrous
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-23864/01
MA holder
PHARMACENTER EUROPE KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Kalceks 4 g/0,5 g por oldatos infúzióhoz

PRD10209486 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-24184/04
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kalceks 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10209458 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24185/03
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Sandoz 4 g/0,5 g por oldatos infúzióhoz

PRD919746 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-21315/07
MA holder
SANDOZ HUNGÁRIA KFT
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Qilu 500 mg por oldatos injekcióhoz/infúzióhoz

PRD10138994 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24169/01
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Qilu 1 g por oldatos injekcióhoz/infúzióhoz

PRD10139010 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24169/04
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Sandoz 4 g/0,5 g por oldatos infúzióhoz

PRD919747 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-21315/08
MA holder
SANDOZ HUNGÁRIA KFT
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Sandoz 4 g/0,5 g por oldatos infúzióhoz

PRD919744 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-21315/05
MA holder
SANDOZ HUNGÁRIA KFT
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Kalceks 4 g/0,5 g por oldatos infúzióhoz

PRD10209485 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-24184/03
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kalceks 500 mg por oldatos injekcióhoz vagy infúzióhoz

PRD10209457 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24185/02
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Kabi 4 g/0,5 g por oldatos infúzióhoz

PRD2857475 · Product

Active substance
Piperacillin Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-20979/09
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kalceks 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10209459 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24185/04
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Steriscience 1000 mg por oldatos injekciohoz vagy infuziohoz

PRD10079109 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24048/03
MA holder
STERISCIENCE B.V.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Steriscience 500 mg por oldatos injekciohoz vagy infuziohoz

PRD10079066 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24048/01
MA holder
STERISCIENCE B.V.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Qilu 1 g por oldatos injekcióhoz/infúzióhoz

PRD10139008 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24169/03
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Qilu 1 g por oldatos injekcióhoz/infúzióhoz

PRD10139010 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24169/04
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Sandoz 4 g/0,5 g por oldatos infúzióhoz

PRD919745 · Product

Active substance
Piperacillin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-21315/06
MA holder
SANDOZ HUNGÁRIA KFT
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon MIP 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD2743981 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 kg kilogram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-22387/01
MA holder
MIP PHARMA GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon MIP 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD3430883 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-22387/02
MA holder
MIP PHARMA GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kabi 500 mg por oldatos injekcióhoz vagy infúzióhoz

PRD2054474 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-21722/01
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD2054451 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-21722/07
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon MIP 2 g por oldatos infúzióhoz

PRD3430982 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-22387/06
MA holder
MIP PHARMA GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Kalceks 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10198519 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24174/01
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefepim AptaPharma 2 g por oldatos injekcióhoz vagy infúzióhoz

PRD10371891 · Product

Active substance
Cefepime Dihydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
150 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — -
Marketing authorisation
OGYI-T-24228/04
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem AptaPharma 500 mg por oldatos injekcióhoz vagy infúzióhoz

PRD5806930 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-23338/02
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Qilu 2 g por oldatos injekcióhoz vagy infúzióhoz

PRD10147734 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24154/05
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Kalceks 2 g por oldatos injekcióhoz vagy inf?zióhoz

PRD10198522 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24174/04
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefepim AptaPharma 2 g por oldatos injekcióhoz vagy infúzióhoz

PRD10371892 · Product

Active substance
Cefepime Dihydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
150 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — -
Marketing authorisation
OGYI-T-24228/05
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kabi 500 mg por oldatos injekcióhoz vagy infúzióhoz

PRD2054475 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-21722/02
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Kalceks 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10198520 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24174/02
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefepim AptaPharma 2 g por oldatos injekcióhoz vagy infúzióhoz

PRD10371893 · Product

Active substance
Cefepime Dihydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
150 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — -
Marketing authorisation
OGYI-T-24228/06
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon AptaPharma 2 g por oldatos injekcióhoz vagy infúzióhoz

PRD9154079 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-23794/03
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD2054450 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-21722/06
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon MIP 2 g por oldatos infúzióhoz

PRD2744216 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-22387/04
MA holder
MIP PHARMA GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon MIP 2 g por oldatos infúzióhoz

PRD3430962 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-22387/05
MA holder
MIP PHARMA GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem AptaPharma 1000 mg por oldatos injekcióhoz vagy infúzióhoz

PRD5806931 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-23338/04
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Qilu 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10147679 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24154/01
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefepim AptaPharma 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10371890 · Product

Active substance
Cefepime Dihydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
150 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — -
Marketing authorisation
OGYI-T-24228/03
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon Kabi 2 g por oldatos infúzióhoz

PRD669084 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-20554/03
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem AptaPharma 500 mg por oldatos injekcióhoz vagy infúzióhoz

PRD5806928 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-23338/01
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD408943 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-20554/01
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon Kabi 2 g por oldatos infúzióhoz

PRD2691538 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-20554/04
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD2054453 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-21722/09
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon AptaPharma 2 g por oldatos injekcióhoz vagy infúzióhoz

PRD8591582 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-23794/02
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon AptaPharma 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD8591581 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-23794/01
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Qilu 2 g por oldatos injekcióhoz vagy infúzióhoz

PRD10147725 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24154/04
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD2054452 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-21722/08
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon MIP 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD3430938 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-22387/03
MA holder
MIP PHARMA GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxon Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD2691537 · Product

Active substance
Ceftriaxone Sodium
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-20554/02
MA holder
FRESENIUS KABI DEUTSCHLAND GMBH
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Qilu 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10147695 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24154/02
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefepim AptaPharma 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10371889 · Product

Active substance
Cefepime Dihydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
150 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — -
Marketing authorisation
OGYI-T-24228/02
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Qilu 2 g por oldatos injekcióhoz vagy infúzióhoz

PRD10147735 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24154/06
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem AptaPharma 1000 mg por oldatos injekcióhoz vagy infúzióhoz

PRD5806929 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-23338/03
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD2054454 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-21722/10
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Kalceks 2 g por oldatos injekcióhoz vagy inf?zióhoz

PRD10198521 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24174/03
MA holder
KALCEKS
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Qilu 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10147704 · Product

Active substance
Ceftriaxone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
100 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DD04 — -
Marketing authorisation
OGYI-T-24154/03
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD2054449 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-21722/05
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefepim AptaPharma 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD10371888 · Product

Active substance
Cefepime Dihydrochloride Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
150 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — -
Marketing authorisation
OGYI-T-24228/01
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem AptaPharma 2000 mg por oldatos infúzióhoz

PRD9781984 · Product

Active substance
Meropenem Trihydrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
2 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-23338/05
MA holder
APTA MEDICA INTERNACIONAL D.O.O.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Kabi 4 g/0,5 g por oldatos infúzióhoz

PRD767286 · Product

Active substance
Piperacillin Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-20979/07
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin/Tazobactam Kabi 4 g/0,5 g por oldatos infúzióhoz

PRD2857474 · Product

Active substance
Piperacillin Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
400 mg/kg milligram(s)/kilogram
Max total dose
16 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
OGYI-T-20979/08
MA holder
FRESENIUS KABI HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Qilu 500 mg por oldatos injekcióhoz/infúzióhoz

PRD10139005 · Product

Active substance
Meropenem
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-24169/02
MA holder
QILU PHARMA SPAIN S.L.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem Pharmacenter 1 g por oldatos injekcióhoz vagy infúzióhoz

PRD8905624 · Product

Active substance
Meropenem Anhydrous
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
120 mg/kg milligram(s)/kilogram
Max total dose
6 g gram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
OGYI-T-23864/02
MA holder
PHARMACENTER EUROPE KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Semmelweis University

13 Total trials 3 Recruiting 1 Ended
Commercial
Sponsor organisation
Semmelweis University
Address
Bokay Janos Utca 53
City
Budapest VIII
Postcode
1083
Country
Hungary

Scientific contact point

Organisation
Semmelweis University
Contact name
Kinga Budai

Public contact point

Organisation
Semmelweis University
Contact name
Kinga Budai

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Hungary Authorised, recruitment pending 110 2
Rest of world — 0 —

Investigational sites

Hungary

2 sites · Authorised, recruitment pending
Semmelweis University
Pediatric Intensive Care Unit, Bokay Janos Utca 53, 1083, Budapest VIII
Semmelweis University
Pediatric Intensive Care Unit, Tuzolto Utca 7-9, 1094, Budapest

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 58 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_ENG_EU CT 2024-518115-19-00 v2 2
Protocol (for publication) D1_Protocol_HU_EU CT 2024-518115-19-00 v2 2
Protocol (for publication) questionnaire-a-form-PEBBLE 1
Protocol (for publication) questionnaire-b-form-PEBBLE 1
Protocol (for publication) questionnaire-c-form-PEBBLE 1
Protocol (for publication) questionnaire-d-form-PEBBLE 1
Recruitment arrangements (for publication) K1_Recruitment_Arrangements_ENG_EU CT 2024-518115-19-00 1
Subject information and informed consent form (for publication) L1_Betegkartya_HU_EU CT 2024-518115-19-00 v2 2
Subject information and informed consent form (for publication) L1_Patient card_ENG_EU CT 2024-518115-19-00 v2 2
Subject information and informed consent form (for publication) L1_SIS_and_ICF_0-6y_ENG_EU CT 2024-518115-19-00 1
Subject information and informed consent form (for publication) L1_SIS_and_ICF_0-6y_HU_EU CT 2024-518115-19-00 1
Subject information and informed consent form (for publication) L1_SIS_and_ICF_12-17y_ENG_EU CT 2024-518115-19-00 1
Subject information and informed consent form (for publication) L1_SIS_and_ICF_12-17y_HU_EU CT 2024-518115-19-00 1
Subject information and informed consent form (for publication) L1_SIS_and_ICF_7-11y_ENG_EU CT 2024-518115-19-00 1
Subject information and informed consent form (for publication) L1_SIS_and_ICF_7-11y_HU_EU CT 2024-518115-19-00 1
Subject information and informed consent form (for publication) L1_SIS_and_ICF_adults_ENG_EU CT 2024-518115-19-00 v2 2
Subject information and informed consent form (for publication) L1_SIS_and_ICF_adults_HU_EU CT 2024-518115-19-00 v2 2
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Cefepim Aptapharma 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Ceftriaxon Aptapharma 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Ceftriaxon Kabi 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Ceftriaxon MIP 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Ceftriaxone Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Ceftriaxone Qilu 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Aptapharma 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Kabi 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Pharmacenter 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Pharmacenter 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Pharmacenter 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Qilu 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Qilu 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Qilu 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Qilu 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Qilu 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Qilu 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Steriscience 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Steriscience 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Meropenem Steriscience 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Kabi 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Kabi 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Kabi 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Kabi 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Kalceks 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Sandoz 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Sandoz 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Sandoz 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Sandoz 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Sandoz 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Piperacillin tazobactam Sandoz 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Zavicefta 1
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_ENG_EU CT 2024-518115-19-00 2
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_HU_EU CT 2024-518115-19-00 2

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-04-30 Hungary Acceptable with conditions
2025-07-21
 2025-07-24
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-08-26 Hungary Acceptable with conditions
2025-07-21
 2025-08-26
3 SUBSTANTIAL MODIFICATION SM-1 2025-08-27 Hungary Acceptable
2025-09-23
 2025-09-29

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