Cedax

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ceftibuten

Available from:

Merck Sharp & Dohme Corp.13900 North West 57th Court

INN (International Name):

ceftibuten

Dosage:

36mg/ml

Pharmaceutical form:

powder for oral suspension

Prescription type:

Prescription

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CEDAX 400 mg hard capsules
CEDAX 36 mg/ml powder for oral suspension - bottle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEDAX 400 MG HARD CAPSULES
Each capsule contains:
_Active ingredient_
: Ceftibuten 400 mg
CEDAX 36 MG/ML GRANULES FOR ORAL SUSPENSION
5 ml of suspension contain:
_Active ingredient_
: Ceftibuten 180 mg
For the excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules. Powder for oral suspension.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
CEDAX is indicated for the treatment of infections caused by
susceptible pathogens, and espe-
cially:
•
UPPER RESPIRATORY TRACT INFECTIONS
: pharyngitis, tonsillitis, sinusitis, otitis media.
•
LOWER RESPIRATORY TRACT INFECTIONS
: bronchitis, primary community-acquired pneumonia,
broncho-pneumonia.
•
URINARY TRACT INFECTIONS
: acute and chronic pyelitis, cystopyelitis, cystitis, urethritis. As
a
drug of second choice in uncomplicated acute gonococcal urethritis.
•
ENTERITIS AND GASTROENTERITIS
in children, both complicated and uncomplicated infections
caused by
_Salmonella, Shigella_
or
_E. coli_
. Cedax has not demonstrated activity against spe-
cies of
_Campylobacter_
or
_Yersinia_
.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
_Lower respiratory tract infections_
: Pneumonia: 200 mg twice a day; acute bacterial sinusitis
and acute exacerbations of chronic bronchitis: 400 mg once a day.
_Upper respiratory tract infections_
: 400 mg once a day.
_Urinary tract infections_
: 400 mg once a day.
CHILDREN AGED 6 MONTHS AND OVER:
_Uncomplicated lower respiratory tract infections_
: 9.0 mg/kg once a day.
_Upper respiratory tract infections_
(e.g. otitis media): 9.0 mg/kg once a day.
_Urinary tract infections_
: 9.0 mg/kg once a day.
The maximum daily dose in children should not exceed 400 mg/day.
CEDAX oral suspension can be taken one to two hours before or after
meals.
CEDAX capsules may be taken without regard to food.
4.3.
CONTRAINDICATIONS
Hypersensitivi