Attention medical professionals! Changes in the Instructions for the use of Cefepime powder for solution preparation for intravenous and intramuscular administration, manufactured by JSC "Kraspharma," reg. number LSR-005610/09.
01.09.2015
Attention medical professionals! Changes in the Instructions for the use of Cefepime powder for solution preparation for intravenous and intramuscular administration, manufactured by JSC "Kraspharma," reg. number LSR-005610/09.
Based on the recommendations presented in the letter from the Ministry of Health of Russia dated January 29, 2015, No. 20-3/57 "On the need to amend the instructions for the use of medicinal products containing cefepime as the active ingredient" (together with the informational letter from the Federal State Budgetary Institution "NCESMP" of the Ministry of Health of Russia dated January 15, 2015, No. 201), as well as based on the latest clinical application data for the medicinal product Cefepime in powder form for intravenous and intramuscular solution preparation in 0.5 g and 1 g doses, manufactured by JSC "Kraspharma," reg. number LSR-005610/09, changes have been made to the Instructions for use, including the following sections:
The updated Instructions for use, containing the revised information, were approved by the Ministry of Health of the Russian Federation on August 14, 2015.
The main changes are in the "Indications for Use" section.
According to the currently effective Instructions for use (from August 14, 2015), the medicinal product Cefepime in powder form for intravenous and intramuscular solution preparation, manufactured by JSC "Kraspharma," reg. number LSR-005610/09, is used for the treatment of infectious-inflammatory diseases caused by cefepime-sensitive microorganisms in adults:
The new Instructions for use approve the following indications for the use of the medicinal product Cefepime in powder form for intravenous and intramuscular solution preparation, manufactured by JSC "Kraspharma" in children:
Based on the information in the Instructions for Medical Use, the medicinal product Cefepime in powder form for intravenous and intramuscular solution preparation, manufactured by JSC "Kraspharma," is pharmaceutically equivalent to the original cefepime and can be used for the same indications, in the same doses, and for the same duration of treatment. It also has similar side effects and drug interactions to the original cefepime.
- Pharmacodynamics
- Pharmacokinetics
- Indications for use
- Contraindications
- With caution
- Method of administration and dosage
- Side effects
- Drug interactions
- Special instructions
The updated Instructions for use, containing the revised information, were approved by the Ministry of Health of the Russian Federation on August 14, 2015.
The main changes are in the "Indications for Use" section.
According to the currently effective Instructions for use (from August 14, 2015), the medicinal product Cefepime in powder form for intravenous and intramuscular solution preparation, manufactured by JSC "Kraspharma," reg. number LSR-005610/09, is used for the treatment of infectious-inflammatory diseases caused by cefepime-sensitive microorganisms in adults:
- Lower respiratory tract infections, including pneumonia and bronchitis
- Complicated and uncomplicated urinary tract infections, including pyelonephritis and pyelitis
- Skin and soft tissue infections
- Abdominal infections (in combination with metronidazole), including peritonitis and biliary tract infections
- Gynecological infections
- Septicemia
- Febrile neutropenia
- Used for perioperative antibiotic prophylaxis in abdominal surgeries
The new Instructions for use approve the following indications for the use of the medicinal product Cefepime in powder form for intravenous and intramuscular solution preparation, manufactured by JSC "Kraspharma" in children:
- Pneumonia
- Complicated and uncomplicated urinary tract infections, including pyelonephritis and pyelitis
- Skin and soft tissue infections
- Septicemia
- Febrile neutropenia
- Bacterial meningitis
Based on the information in the Instructions for Medical Use, the medicinal product Cefepime in powder form for intravenous and intramuscular solution preparation, manufactured by JSC "Kraspharma," is pharmaceutically equivalent to the original cefepime and can be used for the same indications, in the same doses, and for the same duration of treatment. It also has similar side effects and drug interactions to the original cefepime.
