Pancef powder for oral suspension

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cefixime (cefixime trihydrate)

Available from:

Alkaloid AD Skopje

ATC code:

J01DD08

INN (International Name):

cefixime (cefixime trihydrate)

Dosage:

100mg/5ml

Pharmaceutical form:

powder for oral suspension

Units in package:

53g powder in 100ml glass bottle and 5ml measuring spoon

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-03

Summary of Product characteristics

PANCEF
100 mg/5 ml powder for oral suspension
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PANCEF
100 mg/5 ml powder for oral suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml (1 graduated spoon) of prepared suspension contains 111.9 mg of
cefixime trihydrate,
corresponding to 100 mg of cefixime.).
Excipients with known effect:
Sucrose 2.517 g/5 ml
Sodium benzoate (E 211) 2.5 mg/5 ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
* Powder for oral suspension.
Almost white to pale yellow powder.
The reconstituted suspension appears as almost white to pale yellow
viscous liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pancef is indicated for the treatment of infections caused by
microorganisms sensitive 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.
PANCEF
100 mg/5 ml powder for oral suspension
Summary of Product Characteristics
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Paediatric population
_ _
_Children below 10 years old or_ _weighing less than 50 kg: _8 mg/kg
daily administered as a
single oral dose, or divided in two equal doses of (4 mg/kg every 12
hours).
As a general guide for prescribing in children the following daily
doses in terms of volume of
oral suspension are suggested:
6 months up to 1 year: 2.5 ml to 5.0 ml daily.
Children 1-4 years: 5 ml daily
Children 5-10 years: 10 ml daily
The safety and efficacy of cefixime has not been established in
children under 6 months.
_Children weighing more than 50 kg or older than 10 years_ should be
tr