HUMALOG MIX50 KwikPen Insulin lispro 100IU/mL injection multidose syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Insulin lispro, Quantity: 100 IU/mL

Available from:

Eli Lilly Australia Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; metacresol; Protamine sulfate; dibasic sodium phosphate heptahydrate; phenol; glycerol; zinc oxide; hydrochloric acid

Administration route:

Subcutaneous

Units in package:

5 x syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: For the treatment of patients with Type I (IDDM) and Type II (NIDDM) diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Product summary:

Visual Identification: White suspension.; Container Type: Syringe; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-10-08

Patient Information leaflet

HUMALOG
®
,
HUMALOG
® MIX25 AND
HUMALOG
® MIX50
_KWIKPEN_
_Insulin Lispro (rbe)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about these medicines. It
does not contain all the available
information and does not take the
place of talking with your doctor.
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 HUMALOG and
its use that you should be aware of.
All medicines have risks and
benefits. Your doctor has more
information about these medicines
than is contained in this leaflet. Also,
your doctor has had the benefit of
taking a full and detailed history
from you and is in the best position
to make an expert judgement to meet
your individual needs.
IF YOU HAVE ANY CONCERNS ABOUT
USING THESE MEDICINES, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT THE HUMALOG
INSULINS ARE USED FOR
HUMALOG insulins are used to
reduce high blood sugar (glucose)
levels in insulin dependent diabetic
patients. 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 Insulin
Dependent Diabetes Mellitus
(IDDM). Patients with type 1
diabetes always need insulin to
control their blood sugar levels.
Type 2 diabetes - also called Non
insulin dependent diabetes mellitus
(NIDDM). Some patients with type 2
diabetes may also need insulin after
initial treatment with diet, exercise
and tablets.
HUMALOG insulins are insulin
lispro, which works more quickly
than soluble human insulin because
the insul

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
vA12.0_Dec20
SUPERSEDES: vA11_Aug19
Page 1 of 15
HUMALOG
® [INSULIN LISPRO (RBE)] 10-ML VIAL
HUMALOG
® CARTRIDGE [INSULIN LISPRO (RBE)] 3 ML
HUMALOG
® KWIKPEN
® [INSULIN LISPRO (RBE)] 3 ML
HUMALOG
® MIX25
® CARTRIDGE [25% INSULIN LISPRO (RBE) AND
75% INSULIN LISPRO (RBE) PROTAMINE SUSPENSION] 3 ML
HUMALOG
® MIX25
® KWIKPEN
® [25% INSULIN LISPRO (RBE) AND
75% INSULIN LISPRO (RBE) PROTAMINE SUSPENSION] 3 ML
HUMALOG
® MIX50
® CARTRIDGE [50% INSULIN LISPRO (RBE) AND
50% INSULIN LISPRO (RBE) PROTAMINE SUSPENSION] 3 ML
HUMALOG
® MIX50
® KWIKPEN
® [50% INSULIN LISPRO (RBE) AND
50% INSULIN LISPRO (RBE) PROTAMINE SUSPENSION] 3 ML
1.
NAME OF THE MEDICINE
Insulin lispro (rbe)
2 AND 3.
QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
The HUMALOG range consists of three presentations:
HUMALOG - Insulin lispro solution [recombinant DNA origin] is an
aqueous solution of
insulin lispro ([Lys (B28), Pro (B29)] human insulin analogue,
adjusted to pH 7.0 to 7.8. It
also contains metacresol, glycerol, dibasic sodium phosphate
heptahydrate, zinc oxide and
water for injection. Hydrochloric acid and sodium hydroxide may be
used to adjust pH.
HUMALOG is available as a clear, colourless solution for parenteral
administration in a
concentration of 100 units/mL in 10-mL vials, 3-mL cartridges and 3-mL
prefilled insulin
delivery devices (HUMALOG KwikPen).
HUMALOG MIX25 – 25% insulin lispro and 75% insulin lispro protamine
suspension (NPL)
[recombinant DNA origin] is a mixture of insulin lispro, a
rapid-acting blood glucose lowering
agent and insulin lispro protamine suspension, an intermediate-acting
blood glucose
lowering agent, adjusted to pH 7.0 to 7.8.
vA12.0_Dec20
SUPERSEDES: vA11_Aug19
Page 2 of 15
HUMALOG MIX25 is available as a white suspension for parenteral
administration in a
concentration of 100 units/mL in 3 mL cartridges and 3 mL prefilled
insulin delivery devices
(HUMALOG MIX25 KwikPen).
HUMALOG MIX50 –50% insulin lispro and 50% insulin lispro protamine
suspensi