CEFRIM 500 Film Coated Tablet 500 mg

Land: Tansanía

Tungumál: enska

Heimild: Tanzania Medicinces & Medical Devices Authority

Virkt innihaldsefni:

Cefuroxime Axetil

Fáanlegur frá:

ZIM LAboratories Limited, INDIA

INN (Alþjóðlegt nafn):

Cefuroxime Axetil

Skammtar:

500 mg

Lyfjaform:

Film Coated Tablet

Framleitt af:

ZIM LABORATORIES LIMITED, INDIA

Vörulýsing:

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)

Leyfisstaða:

Registered/Compliant

Leyfisdagur:

2019-08-02

Vara einkenni

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