Insuman Basal 100unitsml suspension for injection 3ml cartridges

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Insulin isophane human

Available from:

Sanofi

ATC code:

A10AC01

INN (International Name):

Insulin isophane human

Dosage:

100unit/1ml

Pharmaceutical form:

Suspension for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

VMP not recommended to prescribe - patient training required

Product summary:

BNF: 06010102; GTIN: 5013841202149

Patient Information leaflet

541554
541554
SAP-NR. (DMC): 541554
SCHRIFTGRÖSSE: 9 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE FORMAT: 420 X 296 MM
ERSTELLT AM: 18. APRIL 2018 / VERSION: 1 / MAC
541554
PACKAGE LEAFLET:
INFORMATION FOR THE USER
INSUMAN® BASAL
100 IU/ML
SUSPENSION FOR INJECTION
IN A CARTRIDGE
insulin human
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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
Follow closely the instructions for dose,
monitoring (blood and urine tests), diet and
physical activity (physical work and exercise) as
discussed with your doctor.
If you are allergic to this medicine or to animal
insulins, talk to your doctor.
Special patient groups
If you have liver or kidneys problems or if you
are elderly, speak to your doctor as you may
need a lower dose.
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:
– If you are ill or have a major injury then your
blood sug

Summary of Product characteristics

INSUMAN BASAL 100 IU/ML SUSPENSION FOR INJECTION
IN A CARTRIDGE
Summary of Product Characteristics Updated 27-Jul-2017 | SANOFI
1. Name of the medicinal product
Insuman Basal 100 IU/ml suspension for injection in a vial
Insuman Basal 100 IU/ml suspension for injection in a cartridge
Insuman Basal SoloStar 100 IU/ml suspension for injection in a
pre-filled pen
2. Qualitative and quantitative composition
Insuman Basal 100 IU/ml in a vial
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each vial contains 5 ml of suspension for injection, equivalent to 500
IU insulin, or 10 ml of suspension
for injection, equivalent to 1000 IU insulin.
Insuman Basal 100 IU/ml in a cartridge, Insuman Basal SoloStar 100
IU/ml in a pre-filled pen
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each cartridge or pen contains 3 ml of suspension for injection,
equivalent to 300 IU insulin.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin
*
.
Insuman Basal is an isophane insulin suspension.
*
Human insulin is produced by recombinant DNA technology in
_Escherichia coli_.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection.
After resuspension, milky-white suspension.
4. Clinical particulars
4.1 Therapeutic indications
Diabetes mellitus where treatment with insulin is required.
4.2 Posology and method of administration
Posology
The desired blood glucose levels, the insulin preparations to be used
and the insulin dose regimen (doses
and timings) must be determined individually and adjusted to suit the
patient's diet, physical activity and
life-style.
_Daily doses and timing of administration _
There are no fixed rules for insulin dose regimen. However, the
average insulin requirement is often 0.5
to 1.0 IU per kg body weight per day. The basal metabolic requirement
is 40% to 60% of the total daily
requirement. Insuman Basal is injected subcutaneously 45 to 60 minutes
before a meal.
_Insuman Basal SoloStar 100 IU/ml in a pre-filled pen_
SoloSt