HUMULIN R

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

INSULIN, REGULAR/SOLUBLE

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

INSULIN, REGULAR/SOLUBLE

Unit dalam pakej:

10ml mL

Dikeluarkan oleh:

ELI LILLY & CO

Risalah maklumat

HUMULIN
® R
Regular human insulin, soluble (100 IU/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
-
_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 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 R
•
If your blood sugar levels are well
controlled by your current insulin
therapy,
you
may
not
feel
the
warning
symptoms
when
your
blood

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 .