Enterofuryl suspension oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

nifuroxazide

Available from:

Bosnalijek d.d.

ATC code:

A07AX03

INN (International Name):

nifuroxazide

Dosage:

200mg/5ml

Pharmaceutical form:

suspension oral

Units in package:

90ml suspension in 125ml glass bottle and plastic measuring spoon (2,5ml/5ml)

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-01-11

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
ENTEROFURYL
®
200 mg/5 ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of ENTEROFURYL
®
suspension contains:
Nifuroxazide
200.00 mg
See section 6.1. for excipients.
3.
PHARMACEUTICAL FORM
Oral suspension.
A dense, yellow suspension, with odour of banana.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Acute bacterial diarrhea without of aggravation of the general
condition, fever, intoxication signs.
4.2.DOSAGE AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
The medicine is intended for oral administration.
For dosing use the measuring spoon of 5,0 ml having grading for 2,5
ml.
Shake suspension thoroughly before use.
_DOSAGE _
Children from 1 to 6 months of age: 100 mg of nifuroxazide (2,5 ml of
suspension) 2 - 3 times a
day with dosing interval of 8 – 12 h.
Children from 6 months to 3 years of age: 100 mg of nifuroxazide (2,5
ml of suspension) 3 times
a day with dosing interval of 8 h.
Children from 3 to 6 years of age: 200 mg of nifuroxazide (5,0 ml of
suspension) 3 times a day
with dosing interval of 8 h.
Children from 6 to 18 years of age: 200 mg of nifuroxazide (5,0 ml of
suspension) 3 – 4 times a
day with dosing interval of 6 - 8 h.
Adults: 200 mg of nifuroxazide (5,0 ml of suspension) 4 times a day
with dosing interval of 6 h.
The duration of treatment is 5 – 7 days but not more than 7 days.
If no improvement occurs within the first 3 days of treatment, the
patient should consult a doctor.
4.3. CONTRAINDICATIONS

Hypersensitivity to nifuroxazide, nitrofuran derivatives and other
ingredients of the product;

Intolerance
to
fructose,
glucose-galactose
malabsorption
or
saccharose-isomaltase
insufficiency;

Neonates up to one month, prematurity.
4.4.SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In
diarrhea
treatment
rehydration
therapy
(oral
or
intravenous)
should
be
conducted
simultaneously with nifuroxazide therapy based on the patient’s
condition and the intensity of
diarrhea. Treatment of diarrhea in children under 3 years of