Milgamma solution for i/m injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

thiamine (thiamine hydrochloride), pyridoxine (pyridoxine hydrochloride), cyanocobalamin, lidocaine(lidocaine hydrochloride)

Available from:

Solupharm Pharmazeutische Erzeugnisse GmbH

ATC code:

առկա չէ (A11DB)

INN (International Name):

thiamine (thiamine hydrochloride), pyridoxine (pyridoxine hydrochloride), cyanocobalamin, lidocaine(lidocaine hydrochloride)

Dosage:

100mg/2ml+ 100mg/2ml+ 1mg/2ml+ 20mg/2ml

Pharmaceutical form:

solution for i/m injection

Units in package:

(5) ampoules 2ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-06-10

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Milgamma
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 ml of the injection solution contain:
Thiamine hydrochloride (Vitamin B 1)
Pyridoxine hydrochloride (Vitamin B6)
Cyanocobalamin (Vitamin Bl2)
Lidocaine hydrochloride
100 mg
100 mg
1 mg
20 mg
Excipients:
Contains 40 mg benzyl alcohol in 2 ml solution for injection For the
full list of excipients, see
section 6.1.
_c _
3.
PHARMACEUTICAL FORM
Solution for injection, for intramuscular injection
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Neurological diseases of various origins,
•
neuritides,
•
neuralgias,
•
polyneuropathies (diabetic, alcoholic, etc.),
•
myalgias,
•
radicular syndromes,
•
cervical syndromes,
•
shoulder-arm syndromes,
•
retrobulbar neuritis,
•
herpes zoster,
•
facioplegia (facial paralysis),
•
haematological and neurological symptoms caused by vitamins B
1
, B
6
and B
12
deficiency,
when oral treatment is inappropriate,
•
and as a roborant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
In
severe and acutely painful cases, initially 1 injection (2 ml) daily
in order to quickly achieve a high
blood level. After the acute stage has subsided, and in cases of less
severe diseases, 1 injection 2-3 times a
week.
_Children and adolescents_
There are no adequate studies on the use of Milgamma in children and
adolescents below 18 years of age.
Therefore, Milgamma should not be used in children and adolescents
below 18 years of age.
_Elderly_
On this basis of the available data no restrictions on the use of
Milgamma in elderly at the recommended
dosage are required.
c
page 2 of 6
_Patients with renal impairment_
In
these patients Milgamma can be used in the normal dosage.
_Patients with hepatic impairment_
Pharmacokinetic data and clinical experience on patients with hepatic
impairment are not available.
Safety and efficacy in patients with hepatic impairment have not been
established. Therefore, Milgamma
should not be used in patients w