SEMGLEE insulin glargine (rDNA) 100 IU/mL, 3 mL solution for injection injector pen

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

Insulin glargine, Quantity: 100 U/mL

Saatavilla:

Maxx Pharma Pty Ltd

Lääkemuoto:

Injection, solution

Koostumus:

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

Antoreitti:

Subcutaneous

Kpl paketissa:

5 pens with 1 x 3mL cartridge each, 1 pen with 1 x 3mL cartridge

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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.

Tuoteyhteenveto:

Visual Identification: Clear, colourless solution, free from particles.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2018-03-28

Pakkausseloste

SEMGLEE
®
_contains the active ingredient insulin glargine (in-sue-lin
glar-jeen)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Semglee.
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 Semglee
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 SEMGLEE IS USED
FOR
Semglee is used to reduce high blood
sugar (glucose) levels in people with
diabetes mellitus.
Semglee is a modified insulin that is
very similar to human insulin. It is a
substitute for the insulin produced by
the pancreas.
Semglee is a long-acting insulin.
Other names for this insulin include
insulin glargine and Lantus. Your
doctor may tell you to use a rapid-
acting human insulin or oral diabetes
medication in combination with
Semglee.
Semglee is not addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SEMGLEE HAS
BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE
SEMGLEE
_WHEN YOU MUST NOT USE_
_SEMGLEE_
DO NOT USE SEMGLEE:
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing insulin
•
any of the ingredients contained
in Semglee 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 Semglee after the expiry
date has passed, it may not work as
wel

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
SEMGLEE
_Insulin glargine solution for injection _
1
NAME OF THE MEDICINE
Insulin glargine
SEMGLEE is a biosimilar medicine to Lantus. The comparability of
SEMGLEE to Lantus has been
demonstrated with regard to physiochemical characteristics, efficacy
and safety outcomes. The evidence for
comparability supports the use of SEMGLEE for the listed indications.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEMGLEE [insulin glargine injection {rDNA origin}] is a recombinant
human insulin analogue produced by
DNA technology.
The SEMGLEE injector pen provides insulin glargine for subcutaneous
injection.
The 3 mL cartridge inside the injector pen contains 100 IU/mL (3.64
mg/mL) of insulin glargine as the active
ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
SEMGLEE is a sterile, clear, colourless solution free from particles.
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
SEMGLEE 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.
SEMGLEE is for individual patient use only.
SEMGLEE is given subcutaneously once a day. It may be administered at
any time during the day, however,
at the same time every day.
SEMGLEE is not intended for intravenous administration.
The desired blood glucose levels as well as the doses and timing of
any antidiabetic medication, including
SEMGLEE, must be determined and adjusted individually. In a clinical
study in insulin- naïve patients with
type 2 diabetes, insulin glargine was started at a dose of 10.8 ±4.9
IU (mean ±SD; median dose 10 IU) insulin
glargine once daily and subsequently a