LANTUS 100IU/mL insulin glargine (rbe) 100IU/mL 10mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Insulin glargine, Quantity: 3.6378 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Insulin glargine

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: zinc chloride; polysorbate 20; metacresol; glycerol; hydrochloric acid; water for injections; sodium hydroxide

Administration route:

Subcutaneous

Therapeutic indications:

Insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

Product summary:

Visual Identification: Clear colourless solution.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-05-24

Patient Information leaflet

LANTUS
®
1
LANTUS
®
_(LANT-US) _
_insulin glargine (in-sue-lin glar-jeen) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lantus.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or diabetes educator.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Lantus 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 THE MEDICINE.
You may need to read it again.
WHAT LANTUS IS USED
FOR
Lantus is used to reduce high blood
sugar (glucose) levels in people with
diabetes mellitus.
Lantus is a modified insulin that is
very similar to human insulin. It is a
substitute for the insulin produced by
the pancreas.
Lantus is a long-acting insulin. Your
doctor may tell you to use a rapid-
acting human insulin or oral diabetes
medication in combination with
Lantus.
Lantus is not addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LANTUS HAS
BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE LANTUS
_WHEN YOU MUST NOT USE _
_LANTUS _
DO NOT USE LANTUS:
−
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing insulin
•
any of the ingredients contained
in Lantus listed at the end of this
leaflet
Some of the symptoms of an allergic
reaction may include:
•
redness, swelling, rash and
itching at the injection site
•
rash, itching or hives on the skin
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
−
IF YOU ARE EXPERIENCING LOW
BLOOD SUGAR LEVELS
(HYPOGLYCAEMIA - A "HYPO").
If you have a lot of hypos discuss
appropriate treatment with your
doctor.
−
AFTER THE EXPIRY DATE PRINTED ON
THE PACK OR IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF
TAMPERING.
If you use Lantus after the expiry
date has passed, it may not work as
well. If it has expired or is damaged,
return it to your pharmacist

Summary of Product characteristics

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Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION – LANTUS/LANTUS
SOLOSTAR (INSULIN GLARGINE)
1
NAME OF THE MEDICINE
Insulin glargine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 3 mL cartridges contain 100 IU/mL (3.6378 mg/mL) insulin glargine.
The 10 mL vials contain 100 IU/mL (3.6378 mg/mL) insulin glargine.
3
PHARMACEUTICAL FORM
Lantus is a sterile clear to colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Insulin glargine is an insulin analogue indicated for once-daily
subcutaneous administration
in the treatment of type 1 diabetes mellitus in adults and children
and type 2 diabetes mellitus
in adults who require insulin for the control of hyperglycaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Lantus is an insulin analogue, equipotent to human insulin, with a
peakless glucose lowering
profile and a prolonged duration of action that permits once daily
dosing.
Lantus is for individual patient use only.
DOSAGE
Lantus is given subcutaneously once a day. It may be administered at
any time during the
day, however, at the same time every day.
Lantus is not intended for intravenous administration.
Blood glucose monitoring is recommended for all individuals with
diabetes. The desired
blood glucose levels as well as the doses and timing of any
antidiabetic medication, including
Lantus, must be determined and adjusted individually. In a clinical
study in insulin-naïve
patients with type 2 diabetes, Lantus was started at a dose of 10.8 ±
4.9 IU (mean ± SD;
median dose 10 IU) Lantus once daily and subsequently adjusted
individually
lantus-ccdsv20-piv18-29nov21
Page 2 of 25
Dose adjustment may also be required, for example, if the patient’s
weight or lifestyle
change, change in timing of insulin dose or other circumstances arise
that increase
susceptibility to hypo- or hyperglycaemia. Any change of insulin dose
should be made
cautiously and only under medical supervision.
_DOSAGE IN PAEDIATRICS _
Lantus can be safely administered to paediatric patients >6