Mixtard 30 100 IUml Suspension for Injection in Vial

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:

1 vial Vials

Dikeluarkan oleh:

Novo Nordisk Production SAS

Risalah maklumat

MIXTARD
®
30
_Consumer Medication Information Leaflet (RiMUP) _
100 IU/ml
Suspension for injection in vial
Insulin human (rDNA) (30% dissolved insulin and 70% isophane insulin)
1
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 _
_ _
►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 PROTECTIVE CAP IS LOOSE OR
MISSING.
Each
vial
has
a
protective,
tamper-proof
plastic
cap. If it is not in perfect condition
when you get the vial, return the
vial to your pharmacy.
►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.
►REMOVE THE PROTECTIVE CAP.
_- 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 if you are

Ciri produk

Mixtard
®
30 vial 100 IU/ml Professional leaflet EN-Jul-2021_site France
Based on EU text: 20200603_EN_06970_MIXT_32-2
1
100 IU/ml
MIXTARD
® 30
Suspension for injection in vial.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin human, rDNA (produced by recombinant DNA technology in
_Saccharomyces cerevisiae_
).
1 ml contains 100 IU of insulin human.
1 vial contains 10 ml equivalent to 1,000 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 vial.
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.
ADMINISTRATION
For subcutaneous use. Insulin suspen