Insulatard® 100 IUml Suspension for Injection

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

INSULIN (HUMAN MONOCOMPONENT), ISOPHANE

Dostupné z:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Medzinárodný Name):

INSULIN (HUMAN MONOCOMPONENT), ISOPHANE

Počet v balení:

3ml x 5 Units; 3ml x 5 Units

Výrobca:

Novo Nordisk Producao Farmaceutica do Brasil Ltda

Príbalový leták

INSULATARD
®
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
100 IU/ml
Suspension for injection in cartridge, Penfill
®
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
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 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.
►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 pre

Súhrn charakteristických

Insulatard
®
Penfill
®
Professional leaflet EN-Jun-2021_site Brazil
Based on EU text: 20200603_EN_06969_INS_32-2
1
INSULATARD
®
Penfill
®
100 IU/ml
Suspension for injection in cartridge.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin human, rDNA (produced by recombinant DNA technology in
_Saccharomyces cerevisiae_
).
1 ml contains 100 IU of insulin human.
1 cartridge contains 3 ml equivalent to 300 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 cartridge.
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 ri