Humalog Mix25 pen

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ixtrih issa

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, prefilled disposable Kwikpen 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, prefilled disposable Kwikpen 5x3mL - 15 mL - 36 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 - Cartridge, glass, prefilled disposable pen 5x3mL - 15 mL - 36 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
®
 KWIKPEN 
1 
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 BYETTA 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 
                                
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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 
                                
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