Insuman Comb 25 100unitsml suspension for injection 5ml vials

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:

25unit/1ml ; 75unit/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: 5013841202170

Patient Information leaflet

541560
541560
SAP-NR. (DMC): 541560
SCHRIFTGRÖSSE: 9,5 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 296 MM
ERSTELLT AM: 02. MAI 2018 / VERSION: 2 / MAC
541560
WHAT IS IN THIS LEAFLET
1. What Insuman Comb 25 is and what it is
used for
2. What you need to know before you use
Insuman Comb 25
3. How to use Insuman Comb 25
4. Possible side effects
5. How to store Insuman Comb 25
6. Contents of the pack and other information
1. WHAT INSUMAN COMB 25 IS AND WHAT IT
IS USED FOR
Insuman Comb 25 contains the active
substance insulin human which is made by a
biotechnology process and is identical with
the body’s own insulin.
Insuman Comb 25 is an insulin preparation
with a gradual onset and long duration of
action.
Insuman Comb 25 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 25
DO NOT USE INSUMAN COMB 25
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 Comb 25.
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, injection syringes 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 count

Summary of Product characteristics

INSUMAN COMB 25 100 IU/ML SUSPENSION FOR
INJECTION IN A VIAL
Summary of Product Characteristics Updated 27-Jul-2017 | SANOFI
1. Name of the medicinal product
Insuman Comb 25 100 IU/ml suspension for injection in a vial
Insuman Comb 25 100 IU/ml suspension for injection in a cartridge
Insuman Comb 25 SoloStar 100 IU/ml suspension for injection in a
pre-filled pen
2. Qualitative and quantitative composition
Insuman Comb 25 100 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.
Insuman Comb 25 100 IU/ml in a cartridge, Insuman Comb 25 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 Comb 25 is a biphasic isophane insulin suspension consisting
of 25% dissolved insulin and 75%
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 25 is injected subcutaneously 30 to 45
minutes before a meal.
_Insuman Comb 25 SoloStar 100 IU/ml i