HUMULIN R biosynthetic human neutral insulin 100IU/mL injection multidose cartridge
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
03-02-2021
Summary of Product characteristics
(SPC)
01-02-2021
Public Assessment Report
(PAR)
01-12-2017
Active ingredient:
insulin, Quantity: 100 IU/mL
Available from:
Eli Lilly Australia Pty Ltd
INN (International Name):
insulin
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: water for injections; sodium hydroxide; metacresol; hydrochloric acid; glycerol
Administration route:
Subcutaneous
Units in package:
5x3mL
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
OTHER CONDITIONS: Refrigerate - do not freeze. INDICATIONS: For the treatment of insulin dependent diabetic patients.
Product summary:
Visual Identification: Clear, sterile, colourless solution.; Container Type: Cartridge; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Registered
Authorization date:
1992-05-11
Patient Information leaflet
HUMULIN
®
_CARTRIDGES_
_Biosynthetic Human Insulin (rbe)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about HUMULIN.
It does not contain all the available
information. It does not take the
place of talking with your doctor or
pharmacist.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine. You can also
download the most up to date leaflet
from www.lilly.com.au. The updated
leaflet may contain important
information about HUMULIN and its
use that you should be aware of.
All medicines have risks and
benefits.
YOUR DOCTOR HAS WEIGHED THE RISKS
OF YOU TAKING HUMULIN AGAINST
THE BENEFITS THEY EXPECT IT WILL HAVE
FOR YOU.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT HUMULIN IS
USED FOR
HUMULIN is used to reduce high
blood sugar (glucose) levels in
patients with diabetes mellitus.
Diabetes is a condition in which your
pancreas does not produce enough
insulin to control your blood sugar
level. Extra insulin is therefore
needed.
There are two types of diabetes
mellitus:
Type 1 diabetes - also called juvenile
onset diabetes.
Type 2 diabetes - also called maturity
onset diabetes.
Patients with type 1 diabetes always
require insulin to control their blood
sugar levels.
Some patients with type 2 diabetes
may also require insulin after initial
treatment with diet, exercise and
tablets.
HUMULIN is identical to the insulin
produced by the pancreas.
There are 3 different types of
HUMULIN cartridges:
•
HUMULIN R
•
HUMULIN NPH
•
HUMULIN 30/70.
Your doctor will tell you the type of
HUMULIN that is best suited to you.
The duration of action of the insulin
you inject will vary according to the
type being used, the dose, injection
site, blood flow, temperature and
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
vDA5.0_Jan21
SUPERSEDES: vA4.0_Mar20
Page 1 of 10
HUMULIN® R (REGULAR – NEUTRAL – SOLUBLE HUMAN INSULIN (RBE)
INJECTION)
HUMULIN®
NPH
(ISOPHANE
–
NPH
–
HUMAN
INSULIN
(RBE)
SUSPENSION)
HUMULIN® 30/70 (30% REGULAR HUMAN INSULIN (RBE) INJECTION
AND 70% ISOPHANE HUMAN INSULIN (RBE) SUSPENSION)
1.
NAME OF THE MEDICINE
Insulin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
There are three different presentations in the HUMULIN range:
HUMULIN R (regular-neutral-soluble) – neutral human insulin of
recombinant DNA origin.
HUMULIN NPH (isophane) – isophane human insulin of recombinant DNA
origin.
HUMULIN
30/70
–
a
mixture
consisting
of
30%
Regular
(neutral
human
insulin
of
recombinant DNA origin) and 70% NPH (isophane human insulin of
recombinant DNA origin.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS
HUMULIN is found to be chemically, physically, biologically and
immunologically equivalent to
pancreatic human insulin, which differs slightly from porcine or
bovine insulin in amino acid
composition.
3.
PHARMACEUTICAL FORM
HUMULIN R: A sterile, clear colourless, aqueous solution of neutral
human insulin (rbe)
adjusted to pH 6.6 to 8.0.
HUMULIN NPH: A sterile suspension of white, crystalline precipitate of
isophane human
insulin (rbe) in an isotonic phosphate buffer adjusted to pH 6.9 to
7.5
HUMULIN 30/70: A sterile mixture of 30% Regular and 70% NPH human
insulin (rbe)
adjusted to pH 6.9 to 7.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HUMULIN is indicated for the treatment of insulin-dependent diabetic
patients.
vA5.0_Jan21
SUPERSEDES: vA4.0_Mar20
Page 2 of 10
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage should be determined by the physician, according to the
requirements of the
patient. During changes to a patient’s insulin regimen, increase the
frequency of glucose
monitoring. Subcutaneous administration, preferably by the patient,
should be in the upper
arms, thighs, buttocks, or abdomen. Use of injection sites should be
rotated so that
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