HUMULIN N 100IU/ML 3ML CARTRIDGES

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

INSULIN,ISOPHANE (NPH)

থেকে পাওয়া:

ZUELLIG PHARMA SDN BHD

INN (International Name):

INSULIN,ISOPHANE (NPH)

প্যাকেজ ইউনিট:

3ml5Units mL

Manufactured by:

LILLY FRANCE S.A.

তথ্য লিফলেট

HUMULIN
®
N CARTRIDGE
Human Insulin, Isophane (100IU/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Humulin N is used for
2.
How Humulin N works
3.
Before you use Humulin N
4.
How to use Humulin N
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Humulin N
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HUMULIN N
IS USED FOR
HUMULIN
N
CONTAINS
HUMAN
INSULIN
AND IS USED TO TREAT DIABETES
Your doctor may tell you to use Humulin
N as well as a fast-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 cartridge so
that you can easily tell the difference.
HOW HUMULIN N WORKS
Humulin N contains the active substance
human
insulin,
which
is
used
to
treat
diabetes.
You
get
diabetes
if
your
pancreas does not make enough insulin
to control the level of glucose in your
blood (blood sugar). Humulin N is used
to control glucose in the long term. Its
action is prolonged by the inclusion of
protamine sulphate in the suspension.
BEFORE YOU USE HUMULIN N
_HUMULIN N 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 N if you are allergic
(hypersensitive) to human insulin or any
of the other ingredients of Humulin N.
_ _
-
_Before you start to use it _
DO NOT USE HUMULIN N IF YOU THINK
HYPOGLYCAEMIA
(LOW
BLOOD
SUGAR)
IS
STARTING.
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-

পণ্য বৈশিষ্ট্য

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