Insuman Rapid 100unitsml solution for injection 3ml cartridges

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Insulin soluble human

Available from:

Sanofi

ATC code:

A10AB01

INN (International Name):

Insulin soluble human

Dosage:

100unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

VMP not recommended to prescribe - patient training required

Product summary:

BNF: 06010101; GTIN: 5013841202125

Patient Information leaflet

541561
541561
SAP-NR. (DMC): 541561
SCHRIFTGRÖSSE: 9 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE FORMAT: 420 X 296 MM
ERSTELLT AM: 18. APRIL 2018 / VERSION: 1 / MAC
541561
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.
WHAT IS IN THIS LEAFLET
1. What Insuman Rapid is and what it is used
for
2. What you need to know before you use
Insuman Rapid
3. How to use Insuman Rapid
4. Possible side effects
5. How to store Insuman Rapid
6. Contents of the pack and other information
1. WHAT INSUMAN RAPID IS AND
WHAT IT IS USED FOR
Insuman Rapid contains the active substance
insulin human which is made by a
biotechnology process and is identical with the
body's own insulin.
Insuman Rapid is an insulin solution with a
rapid onset and short duration of action.
Insuman Rapid 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 RAPID
DO NOT USE INSUMAN RAPID
If you are allergic to insulin or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Insuman Rapid 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 you

Summary of Product characteristics

OBJECT 1
INSUMAN RAPID 100 IU/ML SOLUTION FOR INJECTION
IN A CARTRIDGE
Summary of Product Characteristics Updated 13-Apr-2018 | SANOFI
1. Name of the medicinal product
Insuman Rapid 100 IU/ml solution for injection in a cartridge
2. Qualitative and quantitative composition
Insuman Rapid 100 IU/ml in a cartridge
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each cartridge contains 3 ml of solution for injection, equivalent to
300 IU insulin.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin
*
.
Insuman Rapid is a neutral insulin solution (regular insulin).
*
Human insulin 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
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 Rapid is injected subcutaneously 15 to 20 minutes
before a meal.
_Secondary dose adjustment _
Improved metabolic control may result in increased insulin
sensitivity, leading to a reduced insulin
requirement. Dose adjustment may also be required, for example, if
- the patient's weight changes,
- the patient's life-style changes,
- other circumstances arise that may promote an increased
susceptibility to hypo- or hyperglycaemia (see
section 4.4).
_Special populations _
_Elderly population(_
_65 years old)_
≧
In the elderly, progressive deterioration of renal function