Actrapid® 100 IUml Solution for Injection

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

INSULIN,NEUTRAL

Sẵn có từ:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Tên quốc tế):

INSULIN,NEUTRAL

Các đơn vị trong gói:

3ml x 5 Units; 3ml x 5 Units

Sản xuất bởi:

Novo Nordisk Producao Farmaceutica do Brasil Ltda

Tờ rơi thông tin

ACTRAPID
®
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
100 IU/ml
Solution for injection in cartridge, Penfill
®
Insulin human (rDNA)
_ _
_____________________________________________________________________
1
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
CARTRIDGE
OR
THE
DEVICE
CONTAINING THE CARTRIDGE IS DROPPED,
DAMAGED OR CRUSHED.
►
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.
►
ALWAYS
CHECK
the
cartridge,
including the rubber stopper. Do not
use it if any damage is seen or if there
is a gap between the rubber stopper
and the white label band. Take it back
to your pharmacy. See your delivery
system manual for further instructions.
►
ALWAYS USE A NEW NEEDLE
for each
injection to prev

Đặc tính sản phẩm

Actrapid
®
FlexPen
®
Professional leaflet EN-May-2021_site Brazil
Based on EU text: 20200603_EN_06946_APID_30-2
1
ACTRAPID
®
FlexPen
®
100 IU/ml
Solution 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.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen.
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 a