HUMULIN R 100IU/ML 3ML CARTRIDGES
Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIL active_ingredient:
INSULIN, REGULAR/SOLUBLE
MAH:
ZUELLIG PHARMA SDN BHD
INN:
INSULIN, REGULAR/SOLUBLE
units_in_package:
3ml5Units mL
manufactured_by:
LILLY FRANCE S.A.S.
PIL
HUMULIN R
® CARTRIDGE
Human Insulin, soluble (100IU/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Humulin R is used for
2.
How Humulin R works
3.
Before you use Humulin R
4.
How to use Humulin R
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Humulin R
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HUMULIN R
IS USED FOR
Humulin
R
contains
the
active
substance human insulin, which is used
to treat diabetes.
Your
doctor
may
tell
you
to
use
Humulin R as well as a longer-acting
insulin. Each kind of insulin comes with
its own patient information leaflet to tell
you about it. Do not change your insulin
unless your doctor tells you to. Be very
careful if you do change insulin. Each
type of insulin has a different colour
and symbol on the pack and the vial so
that you can easily tell the difference.
HOW HUMULIN R WORKS
You get diabetes if your pancreas does
not make enough insulin to control the
level of glucose in your blood (blood
sugar). Humulin R is used to control
glucose in the long term. Humulin R is
a rapidly acting insulin preparation.
BEFORE YOU USE HUMULIN R
_HUMULIN _
_R _
_IN _
_CARTRIDGES _
_IS _
_ONLY _
_SUITABLE _
_FOR _
_INJECTING _
_JUST _
_UNDER _
_THE _
_SKIN USING A REUSABLE PEN. SPEAK TO _
_YOUR DOCTOR IF YOU NEED TO INJECT YOUR _
_INSULIN BY ANOTHER METHOD. _
-
_When you must not use it _
Do
not
use
Humulin
R
if
you
are
allergic
(hypersensitive)
to
human
insulin or any of the other ingredients of
Humulin R.
_ _
_ _
-
_Before you start to use it _
DO NOT USE HUMULIN R IF YOU THINK
HYPOGLYCAEMIA (LOW BLOOD SUGAR) IS
STARTING.
Further in this leaflet it tells
you
how
to
deal
with
mild
hypoglycaemia.
If
you
are
pregnant of
lactating,
ask
your doctor or diabetes specialist nurse
for advice before taking any medicine.
The amount of insulin you need usually
falls during the first three months of
pregnancy
and
increases
for
the
remaining six months. If you are breast-
feedin
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SPC
Humulin N 3070 and R cartridges PI_UK SPC 20 Jul 2016_09 Jan 2017_v1
1.
NAME OF THE MEDICINAL PRODUCT
Humulin N 100 IU/ml suspension for injection in cartridge
Humulin 30/70 100 IU/ml suspension for injection in cartridge
Humulin R 100 IU/ml solution for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU human insulin (produced in
_E. coli _
by recombinant DNA technology).
Humulin N
One cartridge contains 3 ml equivalent to 300 IU of isophane insulin.
Humulin 30/70
One cartridge contains 3 ml equivalent to 300 IU of biphasic isophane
insulin – 30 % soluble insulin /
70 % isophane insulin.
Humulin R
One cartridge contains 3 ml equivalent to 300 IU of soluble insulin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Humulin N
A suspension for injection in a cartridge.
Humulin N is a sterile suspension of a white, crystalline precipitate
of isophane human insulin in an
isotonic phosphate buffer.
Humulin 30/70
A suspension for injection in a cartridge.
Humulin 30/70 is a sterile suspension of human insulin in the
proportion of 30 % soluble insulin to 70
% isophane insulin.
Humulin R
A solution for injection in a cartridge.
Humulin R is a sterile, clear, colourless, aqueous solution of human
insulin.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of patients with diabetes mellitus who require
insulin for the maintenance of
glucose homeostasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be determined by the physician, according to the
requirement of the
patient.
_Paediatric population _
No data are available
Humulin N, 3070 and R cartridges PI_EUSPC 12 Aug 2020_19 Nov 2020
Method of administration
Subcutaneous administration should be in the upper arms, thighs,
buttocks or abdomen. Use of
injection sites should be rotated so that the same site is not used
more than approximately once a
month in order to reduce the risk of lipodystrophy and cutaneous
amyloidosis (see section 4.4 and 4.8).
Care should be taken wh
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