Metformin

Երկիր: Հայաստան

Լեզու: անգլերեն

Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ակտիվ բաղադրիչ:

metformin (metformin hydrochloride)

Հասանելի է:

Arpimed LLC

INN (Միջազգային անվանումը):

metformin (metformin hydrochloride)

Դոզան:

1000mg

Դեղագործական ձեւ:

tablets

Ռեկվիզորի տեսակը:

Prescription

Ապրանքի հատկությունները

SUMMARY PRODUCT CHARACTERISTIC (SPC)
METFORMIN
500 MG AND 1000 MG TABLETS
1.1 BRAND NAME – METFORMIN
1.2 INTERNATIONAL NON-PROPERTY NAME - METFORMIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Metformin 500 mg tablet contains:
_ACTIVE INGREDIENT:_ metformin hydrochloride - 500 mg (equivalent to
390 mg metformin)
_For a full list of excipients, see section 6.1. _
Each Metformin 1000 mg tablet contains:
_ACTIVE INGREDIENT:_ metformin hydrochloride - 1000 mg (equivalent to
780 mg metformin).
_For a full list of excipients, see section 6.1. _
3. PHARMACEUTICAL FORM
_Metformin, 500 mg tablets _
White biconvex tablets.
_Metformin, 1000 mg tablets _
White oval biconvex one-side scored tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus, particularly in overweight
patients, when dietary management
and exercise alone does not result in adequate glycaemic control.
• In adults, Metformin may be used as monotherapy or in combination
with other oral antidiabetic
agents or with insulin.
• In children from 10 years of age and adolescents, Metformin may be
used as monotherapy or in
combination with insulin.
A reduction of diabetic complications has been shown in overweight
type 2 diabetic adult patients
treated with metformin as first-line therapy after diet failure (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_Adults with normal renal function (GFR≥ 90 mL/min)_
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS
The usual starting dose is 500 mg metformin hydrochloride 2 or 3 times
daily given during or after
meals.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A slow
increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of metformin hydrochloride is 3 g daily,
taken as 3 divided doses
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and initiate
metformin at the dose indicated above.
COMBINATION WITH INSULIN
M