HUMALOG insulin lispro 100IU/mL injection multidose vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

Insulin lispro, Quantity: 100 IU/mL

Disponible des:

Eli Lilly Australia Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

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

Vía de administración:

Intravenous, Subcutaneous

Unidades en paquete:

1 X 10mL vial

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: CLEAR SOLUTION DISPENSED IN CRIMP SEALED CLEAR GLASS VIALS SEALED WITH A RUBBER DISC.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

1996-06-13

Informació per a l'usuari

HUMALOG
® VIALS
_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 this medicine. 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 this medicine 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 THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT HUMALOG IS
USED FOR
HUMALOG 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
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
(NIDDM). Some patients with
type 2 diabetes may also need
insulin after initial treatment with
diet, exercise and tablets.
HUMALOG is insulin lispro, which
works more quickly than soluble
insulin because the insulin molecule
has been changed slightly.
The duration of effect of
HUMALOG varies in each
individ

Fitxa tècnica

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