CIPROBID 500 Tablets

Land: Tanzania

Sprog: engelsk

Kilde: Tanzania Medicinces & Medical Devices Authority

Aktiv bestanddel:

Ciprofloxacin Hydrochloride

Tilgængelig fra:

Cadila Healthcare Limited, INDIA

ATC-kode:

Antibacterials for systemic use, quinolone antibac

INN (International Name):

Ciprofloxacin Hydrochloride

Dosering:

500

Lægemiddelform:

Tablets

Fremstillet af:

Pinnacle Life Science Limited, INDIA

Produkt oversigt:

Physical description: White coloured, caplet shaped, biconvex, film coated tablets, plain on both side; Local technical representative: Abacus Pharma Africa Limited (8473)

Autorisation status:

Registered/Compliant

Autorisation dato:

2021-10-09

Produktets egenskaber

PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS)
1.
NAME OF THE MEDICINAL PRODUCT
Strength: 500 mg
Brand Name: CIPROBID 500
INN Name: Ciprofloxacin Tablet USP 500 mg
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
EACH FILM COATED
TABLET CONTAINS
Ciprofloxacin
Hydrochloride USP
Equivalent to Ciprofloxacin
500 mg
Excipients q.s.
Colour- Titanium Dioxide
For full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM:
Form: Tablet
u
DESCRIPTION
:
CIPROBID 500 Tablet is white colored, caplet shaped, biconvex film
coated
tablets, plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Ciprofloxacin tablets are indicated for the treatment of the following
infections.
ADULTS
-
Lower respiratory tract infections due to Gram-negative bacteria
-
exacerbations of chronic obstructive pulmonary disease
-
broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
-
pneumonia
-
Chronic suppurative otitis media
-
Acute exacerbation of chronic sinusitis especially if these are caused
by Gram-
negative bacteria
-
Urinary tract infections & Genital tract infections
-
Infections of the gastro-intestinal tract (e.g. travellers' diarrhoea)
-
Intra-abdominal infections
-
Infections of the skin and soft tissue caused by Gram-negative
bacteria
-
Infections of the bones and joints
-
Inhalation anthrax (post-exposure prophylaxis and curative treatment)
CHILDREN AND ADOLESCENTS
-
Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas
aeruginosa
-
Complicated urinary tract infections and pyelonephritis
- Inhalation anthrax (post-exposure and curative treatment)
Ciprofloxacin may also be used to treat severe infections in children
and
adolescents when it is considered to be necessary.
Treatment should be initiated only by physicians who are experienced
in the
treatment of cystic fibrosis and/or severe infections in children and
adolescents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
Posology
The dosage is determined by the indication, the severity and the site
of the
infection, the suscepti