NECARAL 4mg glimepiride tablet 4mg blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

glimepiride, Quantity: 4 mg

Հասանելի է:

Micro Labs Pty Ltd

INN (Միջազգային անվանումը):

Glimepiride

Դեղագործական ձեւ:

Tablet, uncoated

Կազմը:

Excipient Ingredients: sodium lauryl sulfate; magnesium stearate; microcrystalline cellulose; sodium starch glycollate type A; lactose monohydrate; povidone; indigo carmine aluminium lake

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

blister pack of 30's [15's X 2] in Monocarton

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

Indicated as an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.

Ապրանքի ամփոփագիր:

Visual Identification: Light blue coloured capsule shaped uncoated tablet with embossing GM & 4 with score line on one side and score line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Լիազորման կարգավիճակը:

Licence status A

Հաստատման ամսաթիվը:

2016-08-03

Ապրանքի հատկությունները

1
AUSTRALIAN
PRODUCT INFORMATION- NECARAL TABLETS (GLIMEPIRIDE)
1
NAME OF THE MEDICINE
Glimepiride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NECARAL tablets contain 1 mg, 2 mg, 3 mg or 4 mg of glimepiride.
Excipient with known effect:
Contains sugars as lactose monohydrate
For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
NECARAL tablets
•
1.0 mg: Pink coloured capsule shaped tablet with embossing “GM” &
“1” with score line
on one side and score line on the other side.
•
2.0 mg: Pale green coloured capsule shaped tablet with embossing
“GM” & “2” with
score line on one side and score line on the other side.
•
3.0 mg: Pale yellow coloured capsule shaped tablet with embossing
“GM” & “3” with
score line on one side and score line on the other side.
•
4.0 mg: Light blue coloured capsule shaped uncoated tablet with
embossing “GM” & “4”
with score line on one side and score line on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NECARAL is indicated as an adjunct to diet, exercise and weight loss,
to lower the
blood glucose in patients with non-insulin-dependent (type 2) diabetes
mellitus.
4.2 DOSE AND METHOD OF ADMINISTRATION
In the management of type 2 diabetes mellitus, administration of an
oral antidiabetic
agent is not a substitute for appropriate dietary control.
In initiating treatment for type 2 diabetes mellitus, diet should be
emphasised as the
primary form of treatment. Caloric restriction and weight loss are
essential in the
2
obese
diabetic
patient.
Proper
dietary
management
alone
may
be
effective
in
controlling the blood glucose and symptoms of hyperglycaemia. The
importance of
regular physical activity should also be stressed, and cardiovascular
risk factors
should be identified and corrective measures taken where possible.
If this treatment program fails to reduce symptoms and/or blood
glucose, the use of
an oral sulfonylurea should be considered. Use of NECARAL must be
viewed by
both the physician and pati