APIDRA 100 Unitsml Solution for Injection in vial

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Insulin glulisine

זמין מ:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

קוד ATC:

A10AB06

כמות:

3.49 mg

טופס פרצבטיות:

INJECTION, SOLUTION

הרכב:

Insulin glulisine 3.49 mg

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

Prescription Only

תוצרת:

Sanofi-Aventis Deutschland GmbH

מצב אישור:

ACTIVE

תאריך אישור:

2005-05-31

עלון מידע

APIDRA® 100 UNITS/ML 
_Insulin glulisine_ 

Solution for injection in vial  

[Sanofi-Aventis Logo] 

1. NAME OF THE MEDICINAL PRODUCT  
Apidra 100Units/ml, solution for injection in vial.  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml contains 100 Units insulin glulisine (equivalent to 3.49
mg). 
Each vial contains 10
ml of solution for injection, equivalent to 1000 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 vial. 
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 injection to
the next. The rate of absorption, and consequently the 
onset and duration of action, may be affected b

מאפייני מוצר

APIDRA® 100 UNITS/ML
_Insulin glulisine_
Solution for injection in vial
[Sanofi-Aventis Logo]
1. NAME OF THE MEDICINAL PRODUCT
Apidra 100Units/ml, solution for injection in vial.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Each vial contains 10 ml of solution for injection, equivalent to 1000
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 vial.
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 injection to the next. The rate
of absorption, and consequently the
onset and duration of action, may be affected by the injection site,
exercise and other variables.
Subcutaneous injection in the abdominal wall ensures a slightly faster
absorption than other injection sites
(see section 5.2).
Care should be taken to ensure that a blood vessel has not been
ente