Humulin R

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Insulin, human, recombinant DNA origin 100 [iU]

Available from:

Eli Lilly and Company (NZ) Limited

INN (International Name):

Insulin, human, recombinant DNA origin 100 IU

Dosage:

100 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Insulin, human, recombinant DNA origin 100 [iU] Excipient: Glycerol Hydrochloric acid as 10% solution for pH adjustment Metacresol Sodium hydroxide as 10% solution for pH adjustment Water for injection

Units in package:

Cartridge, glass, 1.5mL x 5 (not marketed), 7.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Eli Lilly and Co Inc

Therapeutic indications:

HUMULIN is indicated for the treatment of insulin-requiring diabetes mellitus.

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, 1.5mL x 5 - 7.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 21 days opened stored at or below 25°C - Cartridge, glass, 3.0mL x 5 - 15 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days opened stored at or below 30°C - Vial, glass, - 10 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days opened stored at or below 30°C

Authorization date:

1986-03-13

Patient Information leaflet

HUMULIN® VIALS
1
HUMULIN
®
_VIALS _
_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 mellitus 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 vials:

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 fl

Summary of Product characteristics

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Page 1 of 10
NEW ZEALAND DATASHEET
1.
PRODUCT NAME
HUMULIN
®
R (Regular), 100 IU/mL, solution for injection
HUMULIN
®
NPH, 100IU/mL, suspension for injection
HUMULIN
®
30/70, 100 IU/mL, suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin human (rbe) recombinant DNA origin solution/suspension for
injection containing
100 IU/mL.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
HUMULIN R (REGULAR)
(also called soluble insulin injection) is a sterile, clear colourless
aqueous solution of human
insulin (rbe) adjusted to a pH range of 7.0 to 7.8. HUMULIN R is a
short-acting insulin
preparation.
HUMULIN NPH
(also called isophane insulin injection) is a sterile suspension of a
white, crystalline
precipitate of isophane human insulin (rbe) in an isotonic phosphate
buffer adjusted to a pH
range of 6.9 to 7.5. HUMULIN N is an intermediate-acting insulin
preparation.
HUMULIN 30/70
(also called biphasic isophane insulin injection) is a mixture of
human insulin (70% isophane
human insulin (rbe), 30% soluble human insulin (rbe)) adjusted to a pH
range of 6.9 to 7.5.
HUMULIN Mixture 70/30 is an intermediate acting insulin preparation.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HUMULIN is indicated for the treatment of insulin-requiring diabetes
mellitus._ _
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage should be determined by the physician, according to the
requirement of the
patient. During changes to a patient’s insulin regimen, increase the
frequency of glucose
monitoring.
HUMULIN R should be given by subcutaneous injection. It may also be
administered
intravenously.
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Page 2 of 10
HUMULIN NPH and HUMULIN 30/70should be given by subcutaneous
injection. These
formulations should not be administered intravenously.
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 a