Insuman Basal 100unitsml suspension for injection 3ml pre-filled SoloStar pen

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: 5000283654650

Patient Information leaflet

LEGENDE / LEGEND
SAP-Nr. / Plant PM code:
541524
Sprachvariante / Country code:
103
Version:
2
Datum / Date:
03.05.2018 UK
Abmessungen / Dimensions:
628 × 296 mm
Schriftgröße / Font size:
9 Pt
Zeilenabstand / Line spacing:
10 Pt
Seite / Page:
1/2
Druckbare Farben / Printing colours
Pantone Reflex Blue C
Technische Information / Technical information
Kontur / Outline
PACKAGE LEAFLET:
INFORMATION FOR THE USER
INSUMAN® BASAL
SOLOSTAR®
100 IU/ML
SUSPENSION FOR INJECTION IN A PRE-FILLED PEN
insulin human
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 sugar level may increase (hyperglycaemia).
– If you are not eating enough, your blood sugar
level may become too low (hypoglycaemia).
In most cases you will need a doctor. MAKE SURE
THAT YOU CONTACT A DOCTOR EARLY.
If you have type 1 diabetes (insulin dependent
diabetes mellitus), do not stop your insulin and
continue to get enough carbohydrates. Always tell
people who are caring for you or treating you that
you require insulin.
Some patients with long-standing type 2 diabetes
mellitus and heart disease or previous stroke
who were treated with pioglitazone and insulin
experienced the development of heart failure.
Inform your doctor as soon as possible if you
experience signs of heart failure such as unusual
shortn

Summary of Product characteristics

INSUMAN BASAL SOLOSTAR 100 IU/ML SUSPENSION FOR
INJECTION IN A PRE FILLED PEN
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-fill