CEFRIM 500 Film Coated Tablet 500 mg

Land: Tanzania

Språk: engelska

Källa: Tanzania Medicinces & Medical Devices Authority

Aktiva substanser:

Cefuroxime Axetil

Tillgänglig från:

ZIM LAboratories Limited, INDIA

INN (International namn):

Cefuroxime Axetil

Dos:

500 mg

Läkemedelsform:

Film Coated Tablet

Tillverkad av:

ZIM LABORATORIES LIMITED, INDIA

Produktsammanfattning:

Physical description: Light red colored, caplet shaped film coated having break line on one side and plain on other side; Local technical representative: Salama Pharmaceuticals Limited (9410)

Bemyndigande status:

Registered/Compliant

Tillstånd datum:

2019-08-02

Produktens egenskaper

Summary of Product Characteristics
1. Name of the medicinal product
CEFRIM 500 (Cefuroxime 500 mg Film Coated Tablet)
2. Qualitative and quantitative composition
Each 500 mg film coated tablet contains NNN mg cefuroxime (as axetil).
For the full list of excipients: see section 6.1.
3. Pharmaceutical form
Film Coated tablets
Light red colored, caplet shaped film coated having break line on one side and plain on other side
4. Clinical particulars
4.1 Therapeutic indications
Cefuroxime axetil is indicated for the treatment of the infections listed below in adults and children
from the age of 3 months (see sections 4.4 and 5.1).
- Acute streptococcal tonsillitis and pharyngitis.
- Acute bacterial sinusitis.
- Acute otitis media.
- Acute exacerbations of chronic bronchitis.
- Cystitis
- Pyelonephritis.
- Uncomplicated skin and soft tissue infections.
- Treatment of early Lyme disease.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology and method of administration
Posology
The usual course of therapy is seven days (may range from five to ten days).
Table 1. Adults and children (≥40 kg)
Indication Dosage
Acute tonsillitis and pharyngitis, acute bacterial
sinusitis
250 mg twice daily
Acute otitis media 500 mg twice daily
Acute exacerbations of chronic bronchitis 500 mg twice daily
Cystitis 250 mg twice daily
Pyelonephritis 250 mg twice daily
Uncomplicated skin and soft tissue infections 250 mg twice daily