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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1617498
Name of medicinal product: CEFEPIME MIP
Active substances:
Cefepime
Estonian, English, Latin
ATC code: J01DE01
Dosage form: powder for solution for injection/infusion
Route of administration: intramuscular use; intravenous use
Strengh: 2g
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Cefepim MIP is indicated for the treatment of the severe infections listed below caused by cefepime-susceptible pathogens (see sections 4.4 and 5.1). In adults and children over 12 years of age and with a body weight of ? 40 kg: • Pneumonia • Complicated urinary tract infections (including pyelonephritis) • Complicated intra-abdominal infections • Peritonitis associated with dialysis in patients on CAPD In adults: • Acute biliary tract infections In children aged 2 months up to 12 years and with a body weight of ? 40 kg: • Pneumonia • Complicated urinary tract infections (including pyelonephritis) • Bacterial meningitis (see section 4.4) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Cefepime may be used in the empirical treatment of adults, adolescents and children aged 2 months to 12 years with febrile neutropenia that is suspected to be due to a bacterial infection. In patients at high risk of severe infections (e.g. patients with recent bone marrow transplantation, hypotension at presentation, underlying haematological malignancy, or severe or prolonged neutropenia), antimicrobial monotherapy may be inappropriate. No sufficient data exist to support the efficacy of cefepime monotherapy in such patients. A combination therapy with an aminoglycoside or glycopeptide antibiotic may be advisable, taking into consideration the patient's individual risk profile. Cefepime should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum of activity. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated May 31, 2019)
Package information leaflet (PIL): EST  (last updated May 31, 2019)
Labelling:  (last updated May 31, 2019)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: MIP Pharma GmbH 
Marketing authorization number: 861514 
Marketing authorization issued on: January 6, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada
Entry/Changing date: November 16, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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