HUMULIN N

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

INSULIN,ISOPHANE (NPH)

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

INSULIN,ISOPHANE (NPH)

Unit dalam pakej:

10ml mL

Dikeluarkan oleh:

ELI LILLY & CO

Risalah maklumat

HUMULIN N
®
NPH human insulin isophane (100 IU/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
-
_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 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 N
•
If your blood sugar levels are well
controlled by your current insulin
therapy,
you
may
not
feel
the
warning

Ciri produk

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 .