Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1361360
Name of medicinal product: AMIKACIN B.BRAUN 5 MG/ML
Active substances:
Estonian, English, Latin
ATC code: J01GB06
Dosage form: solution for infusion
Route of administration: intravenous use
Strengh: 5mg 1ml
Amount in package: 100ml 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: For the treatment of the following severe infections due to bacteria susceptible to amikacin (see section 5.1) when less toxic antimicrobial agents are not effective: - Nosocomial lower respiratory tract infections including severe pneumonia, - Intra-abdominal infections, including peritonitis, - Complicated and recurrent urinary tract infections, - Skin and soft tissue infections including burn-wound infections, - Bacterial endocarditis, - Post-operative intra-abdominal infections. Amikacin 2.5 mg/ml, 5 mg/ml, and 10 mg/ml solution for infusion can also be used in the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infec-tions listed above. Amikacin 2.5 mg/ml, 5 mg/ml, and 10 mg/ml solution for infusion is commonly used in combination with other appropriate antibiotics to cover the bacterial spectrum encountered in the respective infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated October 17, 2023)
Package information leaflet (PIL): EST  (last updated October 17, 2023)
Labelling:  (last updated April 30, 2019)
Last imported to Estonia: December 27, 2021
Marketing authorization holder: B. Braun Melsungen AG 
Marketing authorization number: 727611 
Marketing authorization issued on: February 1, 2011 
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: April 15, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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