Humalog Mix25

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Insulin lispro 100 U/mL (3.5mg; overage 0-3%);  

Disponibbli minn:

Eli Lilly and Company (NZ) Limited

INN (Isem Internazzjonali):

Insulin lispro 100 U/mL (3.5mg; overage 0-3%)

Dożaġġ:

100 U/mL

Għamla farmaċewtika:

Suspension for injection

Kompożizzjoni:

Active: Insulin lispro 100 U/mL (3.5mg; overage 0-3%)   Excipient: Dibasic sodium phosphate heptahydrate Glycerol Hydrochloric acid Metacresol Phenol Protamine sulfate Sodium hydroxide Water for injection Zinc oxide

Unitajiet fil-pakkett:

Cartridge, glass, Type I flint, 5x3mL, 15 mL

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Lilly del Caribe Inc

Indikazzjonijiet terapewtiċi:

For the treatment of patients with Type 1 (IDDM) and Type 2 (NIDDM) diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Cartridge, glass, Type I flint, 5x3mL - 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 protect from light - Vial, glass, multi-dose, Type I flint - 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 protect from light

Data ta 'l-awtorizzazzjoni:

1999-07-01

Fuljett ta 'informazzjoni

HUMALOG® CARTRIDGES
1
HUMALOG
®
,
HUMALOG
® MIX25 AND
HUMALOG
® MIX50
_CARTRIDGES _
_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 hum

Karatteristiċi tal-prodott

NEW ZEALAND DATASHEET
vA13.0_Oct20
SUPERSEDES: vA12.0_Jul20
Page 1 of 14
1.
PRODUCT NAME
HUMALOG
®
100 units/mL, solution for injection in vial
HUMALOG
®
100 units/mL, solution for injection in cartridge
HUMALOG
®
MIX25
®
100 units/mL, suspension for injection in cartridge
HUMALOG
®
MIX50
®
100 units/mL, suspension for injection in cartridge
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 100 units of insulin lispro (rbe).
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.
Hydrochloric acid and sodium hydroxide may be used to adjust pH.
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. Hydrochloric acid and
sodium hydroxide may be
used to adjust pH.
HUMALOG MIX50 – 50% insulin lispro and 50% 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. Hydrochloric acid and
sodium hydroxide may be
used to adjust pH.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
The HUMALOG range consists of three presentations:
HUMALOG is available as a clear, colourless solution for parenteral
administration in a
concentration of 100 units/mL in 10-mL vials and 3-mL cartridges
HUMALOG MIX25 is available as a white suspension for parenteral
administration in a
concentration of 100 units/mL in 3 mL cartridges.
HUMALOG MIX50 is available as a white suspension for parenteral
administration in a
concentration of 100 units/mL in 3-mL cartridges.
HUMALOG is a Lilly human insulin analogue. It differs