Apidra SoloStar 100 Unitsml Solution for injection in a pre-filled pen

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Insulin glulisine

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

A10AB06

Dosage:

3.49 mg (100 Units)

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Insulin glulisine 3.49 mg (100 Units)

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Authorization status:

ACTIVE

Authorization date:

2008-03-20

Patient Information leaflet

APIDRA® 100 UNITS/ML SOLUTION FOR INJECTION IN A
PRE-FILLED PEN 
INSULIN GLULISINE 
SOLOSTAR 
[SANOFI-AVENTIS LOGO] 

1. NAME OF THE MEDICINAL PRODUCT 
Apidra SoloStar 100 Units/ml Solution for injection in
a pre-filled pen 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml contains 100
Units insulin glulisine (equivalent to 3.49 mg). 
Each pen contains
3 ml of solution for injection, equivalent to 300 Units. 
Insulin glulisine is produced by recombinant DNA technology in _Escherichia
coli. _
For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 
Solution for injection in a pre-filled pen, SoloStar. 
Clear, colourless, aqueous solution. 

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
Treatment of adults, adolescents and
children of 6 years or above with diabetes mellitus, where 
treatment with insulin is required. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
The potency of this preparation is stated in units. These units are exclusive to Apidra and are 
not  the  same  as  IU  or  the  units  used  to  express  the  potency  of  other  insulin  analogues.  See 
section 5.1 (Pharmacodynamics). 
Apidra should
be given shortly (0-15 min) before or soon after meals. 
Apidra should be used in regimens that include an
intermediate or long acting insulin or basal 
insulin analogue and can be used with
oral hypoglycaemic agents. 
The dosage of Apidra should be individually adjusted. 

Administration 
Apidra should be given by subcutaneous
injection or by continuous subcutaneous pump 
infusion. 
Apidra should be administered subcutaneously in
the abdominal wall, thigh or deltoid or by 
continuous infusion in the abdominal wall. Injection sites and
infusion sites within an injection 
area (abdomen, thigh or deltoid) should be rotated from one
injecti

Summary of Product characteristics

SG/API/1120/CCDSv12
APIDRA® 100 Units/ml solution for injection in a pre-filled pen
Insulin glulisine
SoloStar
[sanofi logo]
1. NAME OF THE MEDICINAL PRODUCT
Apidra SoloStar 100 Units/ml Solution for injection in a pre-filled
pen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Each pen contains 3 ml of solution for injection, equivalent to 300
Units.
Insulin glulisine is produced by recombinant DNA technology in
Escherichia coli.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in a pre-filled pen, SoloStar.
Clear, colourless, aqueous solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of adults, adolescents and children of 6 years or above with
diabetes mellitus, where
treatment with insulin is required.
4.2 Posology and method of administration
Posology
The potency of this preparation is stated in units. These units are
exclusive to Apidra and are
not the same as IU or the units used to express the potency of other
insulin analogues(see
section 5.1).
Apidra should be used in regimens that include an intermediate or long
acting insulin or basal
insulin analogue and can be used with oral hypoglycaemic agents.
The dose of Apidra should be individually adjusted.
Method of administration
Apidra SoloStar 100 Units/ml in pre-filled pen is only suitable for
subcutaneous injections. If
administration by syringe, intravenous injection or infusion pump is
necessary, a vial should be
used (see section 4.4).
Subcutaneous use
Apidra should be given by subcutaneous injection shortly (0-15 min)
before or soon after meals
or by continuous subcutaneous pump infusion.
Apidra should be administered subcutaneously in the abdominal wall,
thigh or deltoid or by
continuous infusion in the abdominal wall. Injection sites and
infusion sites within an injection
area (abdomen, thigh or deltoid) should be rotated from one injection
to the next in order to
reduce the risk of lipodystrophy and cutaneous amyloido