Lantus 100unitsml solution for injection 3ml cartridges

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Insulin glargine

Mevcut itibaren:

Sanofi

ATC kodu:

A10AE04

INN (International Adı):

Insulin glargine

Doz:

100unit/1ml

Farmasötik formu:

Solution for injection

Uygulama yolu:

Subcutaneous

Sınıf:

No Controlled Drug Status

Reçete türü:

VMP not recommended to prescribe - brands not bioequivalent

Ürün özeti:

BNF: 06010102; GTIN: 5013011005082

Bilgilendirme broşürü

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. THE INSTRUCTIONS
FOR USING THE INSULIN PEN ARE PROVIDED
WITH YOUR INSULIN PEN. REFER TO THEM
BEFORE USING YOUR MEDICINE.
– Keep this leaflet. You may need to
read it again.
– If you have any further questions, ask
your doctor, pharmacist or nurse.
– This medicine has been prescribed for
you only. Do not pass it on to others.
It may harm them, even if their signs
of illness are the same as yours.
– If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.
541502
SAP-NR. (DMC): 541502
SCHRIFTGRÖSSE: 9,5 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 296 MM
ERSTELLT AM: 17. APRIL 2018 / VERSION: 1 / MAC
541502
PACKAGE LEAFLET:
INFORMATION FOR THE USER
LANTUS®
100 UNITS/ML
SOLUTION FOR INJECTION
IN A CARTRIDGE
insulin glargine
WHAT IS IN THIS LEAFLET:
1. What Lantus is and what it is used for
2. What you need to know before you use
Lantus
3. How to use Lantus
4. Possible side effects
5. How to store Lantus
6. Contents of the pack and other information
1. WHAT LANTUS IS AND WHAT IT IS USED FOR
Lantus contains insulin glargine. This is a
modified insulin, very similar to human
insulin.
Lantus is used to treat diabetes mellitus in
adults, adolescents and children aged 2 years
and above. Diabetes mellitus is a disease
where your body does not produce enough
insulin to control the level of blood sugar.
Insulin glargine has a long and steady blood-
sugar-lowering action.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE LANTUS
DO NOT USE LANTUS
If you are allergic to insulin glargine or any
of the other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Lantus in cartridges is only suitable for
injecting just under the skin using a reusable
pen (see also section 3). Speak to your doctor
if you need to inject your insulin by another
method.
Talk to your doctor, pharmacist or nurse

Ürün özellikleri

OBJECT 1
LANTUS 100 UNITS/ML SOLUTION FOR INJECTION IN A
CARTRIDGE
Summary of Product Characteristics Updated 06-Apr-2018 | SANOFI
1. Name of the medicinal product
Lantus 100 units/ml solution for injection in a vial
Lantus 100 units/ml solution for injection in a cartridge
Lantus SoloStar 100 units/ml solution for injection in a pre-filled
pen
2. Qualitative and quantitative composition
Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg).
Lantus 100 units/ml solution for injection in a vial
Each vial contains 5 ml of solution for injection, equivalent to 500
units, or 10 ml of solution for
injection, equivalent to 1000 units.
Lantus 100 units/ml solution for injection in a cartridge, Lantus
SoloStar 100 units/ml solution for
injection in a pre-filled pen
Each cartridge or pen contains 3 ml of solution for injection,
equivalent to 300 units.
*Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of diabetes mellitus in adults, adolescents and children
aged 2 years and above.
4.2 Posology and method of administration
Posology
Lantus contains insulin glargine, an insulin analogue, and has a
prolonged duration of action.
Lantus should be administered once daily at any time but at the same
time each day.
The dose regimen (dose and timing) should be individually adjusted. In
patients with type 2 diabetes
mellitus, Lantus can also be given together with orally active
antidiabetic medicinal products.
The potency of this medicinal product is stated in units. These units
are exclusive to Lantus and are not
the same as IU or the units used to express the potency of other
insulin analogues (see section 5.1).
_Special population _
_Elderly population (≥65 years old)_
In the elderly, progressive deterioration of renal function may lead
to a steady decrease in insulin
requirements.
_Renal impairmen