INSULATARD 100IUML10ML

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

INSULIN (HUMAN MONOCOMPONENT), ISOPHANE

Verfügbar ab:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

INSULIN (HUMAN MONOCOMPONENT), ISOPHANE

Einheiten im Paket:

10ml1Units mL

Hergestellt von:

NOVO NORDISK A/S

Gebrauchsinformation

INSULATARD
®
_Consumer Medication Information Leaflet (RiMUP) _
100 IU/ml
Suspension for injection in vial
Insulin human (rDNA) (isophane insulin)
________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Insulatard
®
is used for
2. How Insulatard
®
works
3. Before you use Insulatard
®
4. How to use Insulatard
®
5. While you are using it
6. Side effects
7. Storage and disposal of
Insulatard
®
8. Product description
9. Manufacturer
10. Product Registration Holder
11. Date of revision
1. WHAT INSULATARD
® IS USED FOR
INSULATARD
® 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 INSULATARD
® WORKS
Insulatard
®
is a long-acting insulin.
This means that it will start to lower
your
blood
sugar
about
1½
hours
after you take it, and the effect will
last
for
approximately
24
hours.
Insulatard
®
is often given alone or in
combination with fast-acting insulin
products.
3. BEFORE YOU USE INSULATARD
®
_- 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
Insulatard
®
(see section 8._ Product _
_description_).
►IF
YOU
SUSPECT
HYPOGLYCAEMIA
(low blood sugar) is starting (see
section 4. _How to use Insulatard_
_®_
).
►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 _
_Insulatard_
_®_
).
►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 t

Fachinformation

Insulatard
®
vial 100 IU/ml Professional leaflet EN-Jun-2021_site Denmark
Based on EU text: 20200603_EN_06969_INS_32-2
1
100 IU/ml
INSULATARD
®
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.
Insulatard
®
is a suspension of isophane (NPH) insulin.
PHARMACEUTICAL FORM
Suspension for injection in vial.
Cloudy, white, aqueous suspension.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus.
POSOLOGY AND METHOD OF ADMINISTRATION
Insulatard® is a long-acting insulin and may be used alone or in
combination with fast or rapid-acting insulin
products.
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.
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 suspensions are never to be administered
intravenously.
Insulatard
®
is administered subcutaneously by injection in the thigh. If
convenient, the abdominal wall, the
gluteal region or the deltoid region may also be used. Injection sites
should always be rotated within the
same region in order to reduce the risk of lipodystrop