COMPETACT 15 MG 850 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

METFORMIN HYDROCHLORIDE; PIOGLITAZONE AS HYDROCHLORIDE

可用日期:

ABIC MARKETING LTD, ISRAEL

ATC代码:

A10BA02

药物剂型:

FILM COATED TABLETS

组成:

METFORMIN HYDROCHLORIDE 850 MG; PIOGLITAZONE AS HYDROCHLORIDE 15 MG

给药途径:

PER OS

处方类型:

Required

厂商:

TAKEDA PHARMA A/S, DENMARK

治疗领域:

METFORMIN

疗效迹象:

Competact is indicated as second line treatment of type 2 diabetes mellitus adult patients,particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

授权日期:

2019-11-12

资料单张

•
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رثكأ ةبيرق نايحأ يف( ،لقلأا ىلع ،ةنسلا
يف ةرم بيبطلا كنم بلطي فوس
.داتعملاك نلامعت كاتيلك تناك اذإ
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قيرط نع رخآ صخش علتبا اذإ وأ أطخلا قيرط
نع ةطرفم ةعرج تلوانت اذإ
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لوانتو ،ةيسنملا ةعرجلا ىطخت ،ةعرج
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产品特点

Competact 15mg/850mg MF 05/2019 Certification
COMPETACT 15 MG/850 MG
Film-coated tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Competact 15 mg/850 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850
mg of metformin
hydrochloride.
Excipient with known effect:
Each tablet contains
3.3-5
mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The tablets are white to off-white, oblong, convex, film-coated,
embossed ‘15 / 850’ on one face
and ‘4833M’ on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Competact is indicated as second line treatment of type 2 diabetes
mellitus adult patients,
particularly overweight patients, who are unable to achieve sufficient
glycaemic control at their
maximally tolerated dose of oral metformin alone.
After initiation of therapy with pioglitazone, patients should be
reviewed after 3 to 6 months to
assess adequacy of response to treatment (e.g. reduction in HbA
1c
). In patients who fail to show
an adequate response, pioglitazone should be discontinued. In light of
potential risks with
prolonged therapy, prescribers should confirm at subsequent routine
reviews that the benefit of
pioglitazone is maintained (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Adults with normal renal function (GFR ≥ 90 mL/min) _
The
recommended
dose
of
Competact
is
30 mg/day
pioglitazone
plus
1,700 mg/day
of
metformin hydrochloride (this dose is achievable with one tablet of
Competact 15 mg/850 mg,
taken twice a day).
Competact 15mg/850mg MF 05/2019 Notification
2
Dose titration with pioglitazone (added to the optimal dose of
metformin) should be considered
before the patient is switched to Competact.
When clinically appropriate, direct change from metformin monotherapy
to Competact may be
considered.
_Special populations _
_ _
_Elderly _
As metformin is excreted via the kidney, and