Emnorm

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Metformin hydrochloride 850mg;  ;  ; Metformin hydrochloride 850mg

Доступна з:

Ipca Pharma (NZ) Pty Limited

ІПН (Міжнародна Ім'я):

Metformin hydrochloride 850 mg

Дозування:

850 mg

Фармацевтична форма:

Film coated tablet

Склад:

Active: Metformin hydrochloride 850mg     Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000 Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Sodium starch glycolate Titanium dioxide Active: Metformin hydrochloride 850mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000 Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Sodium starch glycolate Titanium dioxide

Одиниць в упаковці:

Blister pack, PVC/PVdC/Al, 14 tablets

Клас:

Prescription

Тип рецепту:

Prescription

Виробник:

Ipca Laboratories Limited

Терапевтичні свідчення:

· Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. · Metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents.

Огляд продуктів:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 14 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 84 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 250 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Дата Авторизація:

2005-03-03

Характеристики продукта

NEW ZEALAND DATA SHEET
EMNORM
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1
1
EMNORM (500MG, 850MG AND 1000MG TABLETS)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metformin hydrochloride 500mg
Metformin hydrochloride 850mg
Metformin hydrochloride 1000mg
EXCIPIENT OF KNOWN EFFECT
PROPYLENE GLYCOL
This excipient may cause skin irritation.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Emnorm 500 mg: White coloured, film coated, round, biconvex tablets
with ‘500’ debossing
Emnorm 850 mg: White coloured, film coated, round, biconvex tablets
with ‘850’ debossing
Emnorm 1000mg
White to off white, oval shaped, biconvex, film coated tablets
debossed with '10' and
'00' on either side of deep notch on one side and breakline on other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when
dietary management and exercise alone does not result in adequate
glycaemic control.
•
Metformin may be used as initial treatment or in sulfonylurea failures
either alone or in
combination with a sulfonylurea and other oral agents.
•
Adjuvant therapy in insulin dependent diabetes especially if
overweight.
4.2
DOSE AND METHOD OF ADMINISTRATION
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. RISK FACTORS
INCLUDE RENAL IMPAIRMENT, OLD AGE AND DOSES OF METFORMIN ABOVE 2 G PER
DAY
(SEE SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
It is important that the tablets are taken in divided doses with
meals.
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS IN
ADULTS WITH NORMAL RENAL
FUNCTION
Initially 500 mg should be taken once or twice a day and, if
necessary, increased over a few weeks
up to a maximum of 1 g three times per day. The dose should be
titrated with gradual dose
increments until the desired effect is obtained. 500 mg three times a
day is often sufficient to obtain
diabetic control. Control may be attained within a few days