Pancef tablets film-coated

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

cefixime (cefixime trihydrate)

Tilgængelig fra:

Alkaloid AD Skopje

ATC-kode:

J01DD08

INN (International Name):

cefixime (cefixime trihydrate)

Dosering:

400mg

Lægemiddelform:

tablets film-coated

Enheder i pakken:

(5/1x5/) in blister, (7/1x7/) in blister, (10/2x5/) in blister

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2022-11-03

Produktets egenskaber

PANCEF
400 mg film-coated tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PANCEF

400 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg cefixime (in a form of
cefixime trihydrate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
*
Film-coated tablets.
White to slightly cream, oblong, biconvex, film coated tablets with
bisection line on one side
of the tablet.
The tablet can be divided into two equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pancef is indicated for the treatment of infections caused by
microorganisms susceptible to
cefixime, as follows:

acute upper respiratory tract infections (pharyngo-tonsillitis,
sinusitis);

otitis media acuta;

lower respiratory tract infections (acute bronchitis, acute
exacerbation of chronic bronchitis,
tracheobronchitis, pneumonia);

uncomplicated and complicated urinary tract infections, including
acute pyelonephritis;

uncomplicated gonorrhea (cervical/urethral);
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
ADULTS AND CHILDREN (WEIGHING MORE THAN 50 KG OR OLDER THAN 10 YЕАRS
OF AGE).
The recommended dosage is 400 mg daily, administered as single oral
dose or divided in two
equal oral doses of 200 mg every 12 hours.
PANCEF
400 mg film-coated tablets
Summary of Product Characteristics
2
For the treatment of uncomplicated cervical/urethral gonococcal
infection, a single one day oral
dose of 400 mg is recommended.
For the treatment of lower urinary infections in women a single dose
of 400 mg or 3 day
treatment is recommended.
OLDER PEOPLE
Older people may be given the same dose as recommended for adults.
Renal function should
be assessed and dosage should be adjusted in in cases with severe
renal impairment (See
“Dosage in patients with renal Impairment”).
DOSAGE IN PATIENTS WITH RENA