Imunorix

Pajjiż: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

pidotimod

Disponibbli minn:

Doppel Farmaceutici S.R.L.

INN (Isem Internazzjonali):

pidotimod

Dożaġġ:

400mg/7ml

Għamla farmaċewtika:

solution oral

Tip ta 'preskrizzjoni:

Prescription

Karatteristiċi tal-prodott

SUMMARY OF MEDICINAL PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
IMUNORIX
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IMUNORIXoral solution
Onesingle-dose vialcontains: pidotimod 400 mg
3.
PHARMACEUTICAL FORM
Oral solution
_ _
4.
CLINICAL INFORMATION
4.1 THERAPEUTIC INDICATIONS
Immunostimulant therapy of infections of respiratory and urinary tract
infections in
subjects affected with cell-mediated immunosuppression in the complex
therapy.
_ _
_ _
4.2 POSOLOGYAND METHOD OF ADMINISTRATION
ADULTS:
800 mg (2 vials)twice a day for 15 days outside meals. Duration of
therapyis
determined by the doctor.
CHILDRENFROM THREE YEARS
400 mg (1 vial) twice daily for 15 daysoutside meals.
Duration of therapyis determined by the doctor.
The daily dose should not exceed 800 mg for children older than 3
years, and 1600
mg for an adult.
4.3 CONTRAINDICATIONS
Hypersensitivity to pidotimod, or to any of the excipients of the
product.
Children up to 3 years.
_ _
4.5 INTERACTION WITH OTHERDRUGSAND OTHER FORMSOF INTERACTION
Theproductmayinterferewith
drugs
which
block
or
stimulate
the
activity
of
lymphocytesor have an activity on immune system.
4.6 PREGNANCY AND LACTATION
_Pregnancy: _
There are no or limited amount of data (less than 300 pregnancy
outcomes) from the
use of pidotimod in pregnant women. Animal studies do not indicate
direct or indirect
harmful effects with respect to reproductive toxicity (see section
5.3).
SUMMARY OF MEDICINAL PRODUCT CHARACTERISTICS
2
As a precautionary measure, it is preferable to avoid the use of
IMUNORIX during
the first of Pregnancy and Lactation.
4.7 EFFECTSON ABILITY TO DRIVE AND USE MACHINES
Theproductdoes not interfere with the ability to drive and use
machines.
4.8 UNDESIDERABLEEFFECTS
Allergic reactions
4.9 OVERDOSE
No case of overdose or abuse of the product has been reported.
5.
PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Immunostimulants, ATC code: L03A X05
Stimulates
and
regulates
cell-mediated
and
humoral
immunity
in
conditions
of
im