TRICEF 100MG/5ML POWDER FOR ORAL SUSPENSION

Country: Cyprus

Language: Greek

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Active ingredient:

CEFIXIME

Available from:

BIAL-PORTELA & CA, SA (0000003750) A AV. DA SIDERURGIA NACIONAL, S. MAMEDE DO CORONADO, 4745-457

ATC code:

J01DD08

INN (International Name):

CEFIXIME

Dosage:

100MG/5ML

Pharmaceutical form:

POWDER FOR ORAL SUSPENSION

Composition:

CEFIXIME (0079350371) 100MG

Administration route:

ORAL USE

Prescription type:

Εθνική Διαδικασία

Therapeutic area:

CEFIXIME

Product summary:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 BOTTLE X 60ML (200036402) 60 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
TRICEF, 100 mg/5ml, powder for oral suspension.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of oral suspension contains 100 mg cefixime.
Excipient with known effect:
Sucrose – 505.022 mg/mL
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for oral suspension.
White to pale cream powder with strawberry odor.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Tricef is indicated for the treatment of the following infections
caused by susceptible
agents (see section 4.4 and 5.1):
-
Acute otitis media
-
Upper respiratory tract infections (pharyngitis, tonsillitis,
sinusitis)
-
Lower respiratory tract infections ( acute exacerbations of chronic
bronchitis,
community acquired pneumonia);
-
Urinary tract infections (acute cystitis, uncomplicated acute
pyelonephritis);
- Uncomplicated gonococcal cervicitis and urethritis.
Consideration should be given to national and/or local guidelines on
the appropriate use
of antibiotics.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The usual recommended posology is 8 mg/kg, single dose.
In terms of the pharmaceutical form, the dosage is generally as
follows:
- _Children aged 2-4 years_: 1 measuring spoon every 24h; ½ measuring
spoon every 12
hours.
- _Children aged 5-8 years_: 2 measuring spoons every 24h; 1 measuring
spoon every 12
hours.
- _Children aged 9-12 years_: 3 measuring spoons every 24h; 1½
measuring spoon every
12 hours.
- _Patients with renal impairment_: The medicine may be administered
to patients with
impaired renal function.
1
Doses indicated above may be given in patients with creatinine
clearance of 20 mL/min
or above. . In patients whose creatinine clearance is less than 20
mL/min, it is
recommended not to exceed a daily dose of 200 mg. This dose should
also not be
exceeded in patients undergoing chronic peritoneal dialysis or
hemodialysis, since
cefixime is slowly removed from circulation by dialysis.
In patients with impaired liver function, there is an i