Insuman Basal 100unitsml suspension for injection 5ml vials

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:

Valid as a prescribable product

Product summary:

BNF: 06010102; GTIN: 5013841202132

Patient Information leaflet

541557
541557
SAP-NR. (DMC): 541557
SCHRIFTGRÖSSE: 9,5 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 296 MM
ERSTELLT AM: 07. MAI 2018 / VERSION: 3 / MAC
541557
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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Insuman Basal is and what it is used
for
2. What you need to know before you use
Insuman Basal
3. How to use Insuman Basal
4. Possible side effects
5. How to store Insuman Basal
6. Contents of the pack and other
information
1. WHAT INSUMAN BASAL IS AND WHAT IT
IS USED FOR
Insuman Basal contains the active substance
insulin human which is made by a
biotechnology process and is identical with
the body's own insulin.
Insuman Basal is an insulin preparation with
a gradual onset and long duration of action.
The insulin is present as tiny crystals of
insulin protamine.
Insuman Basal is used to reduce high blood
sugar in patients with diabetes mellitus who
need treatment with insulin. Diabetes
mellitus is a disease where your body does
not produce enough insulin to control the
level of blood sugar.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE INSUMAN BASAL
DO NOT USE INSUMAN BASAL
If you are allergic to insulin 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 Insuman Basal.
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 me

Summary of Product characteristics

INSUMAN BASAL 100 IU/ML SUSPENSION FOR INJECTION
IN A VIAL
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_
SoloStar de