Actrapid 100 IUml Solution for Injection in Vial

Riik: Malaisia

keel: inglise

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

Toimeaine:

Insulin human

Saadav alates:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Rahvusvaheline Nimetus):

Insulin human

Ühikuid pakis:

1 vial Vials

Valmistatud:

Novo Nordisk Production SAS

Infovoldik

ACTRAPID
®
100 IU/ml
Solution for injection in vial
Insulin human (rDNA)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
WHAT IS IN THIS LEAFLET
1.
What Actrapid
®
is used for
2.
How Actrapid
®
works
3.
Before you use Actrapid
®
4.
How to use Actrapid
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Actrapid
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT ACTRAPID
® IS USED FOR
ACTRAPID
® 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 ACTRAPID
® WORKS
Actrapid
®
is
a
fast-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 8 hours. Actrapid
®
is
often
given
in
combination
with
longer-acting insulin products.
3. BEFORE YOU USE ACTRAPID
®
_ _
_- 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
Actrapid
®
(see section 8.
_Product _
_description_
).
►IF
YOU
SUSPECT
HYPOGLYCAEMIA
(low blood sugar) is starting (see
section 4.
_How to use Actrapid_
_®_
)
_. _
►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 _
_Actrapid_
_®_
).
►
IF
THE
INSULIN
DOES
NOT
APPEAR
CLEAR AND COLOURLESS.
_- 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

Toote omadused

Actrapid
®
vial 100 IU/ml Professional leaflet EN-May-2021_site France
Based on EU text: 20200603_EN_06946_APID_30-2
1
100 IU/ml
ACTRAPID
®
Solution 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.
PHARMACEUTICAL FORM
Solution for injection in vial.
Clear, colourless, aqueous solution.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus.
POSOLOGY AND METHOD OF ADMINISTRATION
Actrapid
®
is a fast-acting insulin and may be used in combination with
long-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.
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 or intravenous use.
Actrapid
®
is administered subcutaneously by injection in the abdominal wall. If
convenient, the thigh, 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 lipodystrophy and cutaneous
amyloidosis.
Subcutan