Mixtard® 30 FlexPen® 100 IUml Suspension for Injection in Pre-filled Pen

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Insulin human

Boleh didapati daripada:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Insulin human

Unit dalam pakej:

3 ml x 5 Units

Dikeluarkan oleh:

Novo Nordisk Production SAS

Risalah maklumat

MIXTARD
® 30
100 IU/ml
Suspension for injection
Pre-filled pen, FlexPen
®
Insulin human (rDNA) (30% dissolved insulin and 70% isophane insulin)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
WHAT IS IN THIS LEAFLET
1.
What Mixtard
®
is used for
2.
How Mixtard
®
works
3.
Before you use Mixtard
®
4.
How to use Mixtard
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Mixtard
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT MIXTARD
® IS USED FOR
MIXTARD
® IS HUMAN INSULIN USED TO
TREAT DIABETES.
Diabetes mellitus is a
disease
where
your
body
does
not
produce enough insulin to control the
level of your blood sugar.
2. HOW MIXTARD
® WORKS
Mixtard
®
is a mixture of fast-acting
insulin and long-acting insulin. This
means that it will start to lower your
blood sugar about ½ hour after you
take it, and the effect will last for
approximately 24 hours.
3. BEFORE YOU USE MIXTARD
®
_- WHEN YOU MUST NOT USE IT _
_ _
DO NOT USE MIXTARD
®
►
IN INSULIN INFUSION PUMPS.
►
IF
YOU
ARE
ALLERGIC
(HYPERSENSITIVE)
to human insulin or
any
of
the
other
ingredients
in
Mixtard
®
(see
section
8.
_Product _
_description_
).
►
IF
YOU
SUSPECT
HYPOGLYCAEMIA
(low blood sugar) is starting (see
section 4.
_How to use Mixtard_
_®_
).
►
IF
THE
FLEXPEN
®
IS
DROPPED,
DAMAGED OR CRUSHED.
►
IF IT HAS NOT BEEN STORED CORRECTLY
or
been
frozen
(see
section
7.
_Storage and Disposal of Mixtard_
_®_
).
►
IF THE RESUSPENDED INSULIN DOES
NOT APPEAR UNIFORMLY WHITE AND
CLOUDY.
_- BEFORE YOU START TO USE IT _
_ _
►
CHECK THE LABEL TO MAKE SURE
it is
the right type of insulin.
►
ALWAYS USE A NEW
needle for each
injection to prevent contamination.
►
NEEDLES AND MIXTARD
® FLEXPEN
®
MUST NOT BE SHARED.
_- TAKING OTHER MEDICINES _
_ _
Some
medicines
affect
the
way
glucose works in your body and this
may
influence
your
insulin
dose.
Listed below are the most common
medicines
which
may
affect
your
insulin
treatment.
Tell
your
doctor,
nurse or pharmacist

Ciri produk

Mixtard
®
30 FlexPen
®
Professional leaflet EN-Jul-2021_site France_8-XXXX-XX-XXX-X
Based on EU text: 20200603_EN_06970_MIXT_32-2
1
MIXTARD
® 30
FlexPen
®
100 IU/ml
Suspension for injection in pre-filled pen.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin human, rDNA (produced by recombinant DNA technology in
_Saccharomyces cerevisiae_
).
1 ml contains 100 IU of insulin human.
1 pre-filled pen contains 3 ml equivalent to 300 IU.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin.
Mixtard
®
is a mixture of dissolved insulin and isophane (NPH) insulin.
Mixtard
®
30 consists of 30% dissolved insulin and 70% isophane insulin.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled pen.
Cloudy, white, aqueous suspension.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus.
POSOLOGY AND METHOD OF ADMINISTRATION
Mixtard
®
is a dual-acting insulin. It is a biphasic formulation containing both
fast-acting and long-acting
insulin.
Premixed insulin products are usually given once or twice daily when a
rapid initial effect together with a
more prolonged effect is desired.
DOSAGE
Dosage is individual and determined in accordance with the needs of
the patient. The individual insulin
requirement is usually between 0.3 and 1.0 IU/kg/day. The daily
insulin requirement may be higher in
patients with insulin resistance (e.g. during puberty or due to
obesity) and lower in patients with residual,
endogenous insulin production.
An injection should be followed within 30 minutes by a meal or snack
containing carbohydrates.
DOSAGE ADJUSTMENT
Concomitant illness, especially infections and feverish conditions,
usually increases the patient's insulin
requirement. Concomitant diseases in the kidney, liver or affecting
the adrenal, pituitary or thyroid gland can
require changes in the insulin dose. Adjustment of dosage may also be
necessary if patients change physical
activity or their usual diet. Dosage adjustment may be necessary when
transferring patients from one insulin
preparation to another.
A