HUMULIN 3070 - 100UML

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

MIXED INSULIN REGULAR/ISOPHANE (HUMAN)

MAH:

ZUELLIG PHARMA SDN BHD

INN:

MIXED INSULIN REGULAR/ISOPHANE (HUMAN)

units_in_package:

10ml mL

manufactured_by:

ELI LILLY & CO

PIL

HUMULIN
® 30/70
Mixed Human Insulin (30% regular, 70% isophane)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Humulin 30/70 is used for
2.
How Humulin 30/70 works
3.
Before you use Humulin 30/70
4.
How to use Humulin 30/70
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Humulin
30/70
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HUMULIN 30/70
IS USED FOR
Humulin
30/70
contains
the
active
substance human insulin, which is used to
treat diabetes.
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 30/70 WORKS
You
get diabetes if your pancreas does
not make enough insulin to control the level
of glucose in your blood (blood sugar).
Humulin 30/70 is used to control glucose in
the long term. It is a premixed suspension
of rapid and long acting insulin. Its action
is
prolonged
by
the
inclusion
of
protamine sulphate in the suspension.
BEFORE YOU USE HUMULIN 30/70
-
_When you must not use it _
Do not use Humulin 30/70 if you are
allergic (hypersensitive) to human insulin
or
any
of
the
other
ingredients
of
Humulin 30/70.
-
_Before you start to use it _
DO NOT USE HUMULIN 30/70 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 or 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-
feeding,
you
may
need
to
alter
your
insulin intake or diet.
TAKE SPECIAL CARE WITH HUMULIN 30/70
•
If your blood sugar levels are well
controlled
by
y

SPC

Humulin N 3070 and R vial PI_ UK SPC 6 Apr 2016_ 25 Oct 2016_v1
1. NAME OF THE MEDICINAL PRODUCT
Humulin ®
R
(Regular human insulin [ reco mbinant DNA origin])
Humulin ®
N
(NPH human insulin [ reco mbinant DNA origin])
Isophane suspension
Humulin ®
30/70
( 30% Regular human insulin inject ion USP [ recombinant DNA origin])
and
(70% NPH hu ma n insulin isophane suspensio n [recombinant DNA origin] )
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
HUM ULIN R : A sterile, clear colorless, aqueous solution of huma n insulin (DNA ) adjusted to a pH
of 7.0 to 7.8. Contains m -Cres ol 0.25% added during manufacture as a pres ervative.
HUM ULIN N : A sterile suspension of a white, crystalline precipitate of isopha ne huma n insulin
(DNA) in an isotonic phosphate buffer adjusted to a pH of 6.9 to 7.5. Contains m -Cresol 0.16% and
phenol 0.065% added during ma nufacture as a preser vative.
HUMULIN 30/70: A sterile suspension of human insulin in the proportion of 30% soluble insulin and
70% isophane insulin. Contains m -Cresol 0.16% and phenol 0.065% added during manufacture as a
pres ervative.
3. PHARMACEUTICAL FORM
Humulin R
A solution for injection in a vial.
Humulin N
A suspension for injection in a vial.
Humulin 30/70
A suspension for injection in a vial. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications
For the treatment of patients with diabetes mellitus for whom diet and/or oral agents are not
sufficient. 4.2 Posology and method of ad ministration
Posology
T he dosage should be det er mined by the physician, according to the requirement of the patient. Paediatric population
No data are available .