Insuman Comb 15 100unitsml suspension for injection 3ml cartridges

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Insulin soluble human; Insulin isophane human

Available from:

Sanofi

ATC code:

A10AD01

INN (International Name):

Insulin soluble human; Insulin isophane human

Dosage:

15unit/1ml ; 85unit/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: 5000283654285

Patient Information leaflet

541552
541552
SAP-NR. (DMC): 541552
SCHRIFTGRÖSSE: 9 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE FORMAT: 420 X 296 MM
ERSTELLT AM: 03. MAI 2018 / VERSION: 3 / MAC
541552
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 Comb 15 is and what it is
used for
2. What you need to know before you use
Insuman Comb 15
3. How to use Insuman Comb 15
4. Possible side effects
5. How to store Insuman Comb 15
6. Contents of the pack and other information
1. WHAT INSUMAN COMB 15 IS AND
WHAT IT IS USED FOR
Insuman Comb 15 contains the active
substance insulin human which is made by a
biotechnology process and is identical with the
body's own insulin.
Insuman Comb 15 is an insulin preparation with
a gradual onset and long duration of action.
Insuman Comb 15 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 COMB 15
DO NOT USE INSUMAN COMB 15
If you are allergic to insulin or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Insuman Comb 15 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
an

Summary of Product characteristics

OBJECT 1
INSUMAN COMB 15 100 IU/ML SUSPENSION FOR
INJECTION IN A CARTRIDGE
Summary of Product Characteristics Updated 13-Apr-2018 | SANOFI
1. Name of the medicinal product
Insuman Comb 15 100 IU/ml suspension for injection in a cartridge
2. Qualitative and quantitative composition
Insuman Comb 15 100 IU/ml in a cartridge
Each ml contains 100 IU insulin human (equivalent to 3.5 mg).
Each cartridge 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 Comb 15 is a biphasic isophane insulin suspension consisting
of 15% dissolved insulin and 85%
crystalline protamine 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
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 Comb 15 is injected subcutaneously 30 to 45
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 _