Lantus 100unitsml solution for injection 3ml pre-filled SoloStar pen

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Insulin glargine

Disponibbli minn:

Sanofi

Kodiċi ATC:

A10AE04

INN (Isem Internazzjonali):

Insulin glargine

Dożaġġ:

100unit/1ml

Għamla farmaċewtika:

Solution for injection

Rotta amministrattiva:

Subcutaneous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

VMP not recommended to prescribe - brands not bioequivalent

Sommarju tal-prodott:

BNF: 06010102; GTIN: 5000283652946

Fuljett ta 'informazzjoni

LEGENDE / LEGEND
SAP-Nr. / Plant PM code:
541512
Sprachvariante / Country code:
103
Version:
1
Datum / Date:
13.04.2018 PE
Abmessungen / Dimensions:
628 × 296 mm
Schriftgröße / Font size:
10 Pt
Zeilenabstand / Line spacing:
11 Pt
Seite / Page:
1/2
Druckbare Farben / Printing colours
Pantone Reflex Blue C
Technische Information / Technical information
Kontur / Outline
PACKAGE LEAFLET: INFORMATION FOR THE USER
LANTUS®
SOLOSTAR®
100 UNITS/ML
SOLUTION FOR INJECTION
IN A PRE-FILLED PEN
insulin glargine
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),
injection technique as discussed with your
doctor.
If your blood sugar is too low (hypoglycaemia),
follow the guidance for hypoglycaemia (see
box at the end of this leaflet).
Travel
Before travelling consult your doctor. You may
need to talk about
– the availability of your insulin in the
country you are visiting,
– supplies of insulin, needles etc.,
– correct storage of your insulin while
travelling,
– timing of meals and insulin administration
while travelling,
– the possible effects of changing to different
time zones,
– possible new health risks in the countries to
be visited,
– what you should do in emergency situations
when you feel unwell or become ill.
Illnesses and injuries
In the following situations, the management
of your diabetes may require a lot of care (for
example, adjustment to insulin dose, blood
and urine tests):
– If you are ill or have a major injury then
your blood sugar level may increase
(hyperglycaemia).
– If you are not eating enough your
blood sugar level may become too low
(hypoglycaemia).
In most cases you will need a doctor. MAKE
SURE THAT YOU CONTACT A DOCTOR EARLY.
If you have type 1 diabetes (insulin dependent
diabetes mellitus), do not stop your insulin
and continue to get enough carbohydrates.
Always tell people who are caring for you or
treating you that you requi

Karatteristiċi tal-prodott

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