Lantus 100unitsml solution for injection 10ml vials

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Insulin glargine

Доступно од:

Sanofi

АТЦ код:

A10AE04

INN (Међународно име):

Insulin glargine

Дозирање:

100unit/1ml

Фармацеутски облик:

Solution for injection

Пут администрације:

Subcutaneous

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 06010102; GTIN: 5013011005068

Информативни летак

541579
541579
SAP-NR. (DMC): 541579
SCHRIFTGRÖSSE: 10 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 296 MM
ERSTELLT AM: 03. MAI 2018 / VERSION: 4 / MAC
541579
PACKAGE LEAFLET:
INFORMATION FOR THE USER
LANTUS®
100 UNITS/ML
SOLUTION FOR INJECTION
IN A VIAL
insulin glargine
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
− 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.
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
Talk to your doctor, pharmacist or nurse
before using Lantus.
Follow closely the instructions for
posology, monitoring (blood and urine
tests), diet and physical activity (physical
work and exercise) as discussed with your
doctor.
If your blood sugar is too low (hypoglycaemia),
follow the guidance for hypoglycaemia
(see box at end of this leaflet).
Travel
Before travelling consult your doctor. You
may need to talk about
– the availability of your insul

Карактеристике производа

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