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

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Insulin glargine

Dostupné z:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC kód:

A10AE04

Dávkovanie:

100 iu/ml

Forma lieku:

INJECTION, SOLUTION

Zloženie:

Insulin glargine 100 iu/ml

Spôsob podávania:

SUBCUTANEOUS

Typ predpisu:

Prescription Only

Výrobca:

SANOFI-AVENTIS DEUTSCHLAND GMBH

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2008-03-18

Príbalový leták

1 

1.4.3 Proposed clean PI Lantus SoloStar  

1. 
NAME OF THE MEDICINAL PRODUCT 
Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each ml contains 100 units insulin glargine (equivalent to 3.64 mg). Each pen contains 3 ml of solution for 
injection, equivalent to 300 units. 
Insulin glargine is produced by recombinant DNA technology in _Escherichia coli_.
For the full list of 
excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 
  Solution for injection in a pre-filled pen SoloStar. 
  Lantus is a clear colourless solution. 

4. 
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 
  For the 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 
Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. 
Lantus should be administered once daily at any time but at the same time each day. 

The Lantus dose regimen (dose and timing) should be individually adjusted. In patients with type 2 
diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products. 
The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are 
not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). 

Special population 
_Elderly population (_
_≥65 years old)_ 
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin 
requirements. 

_Renal impairment_ 
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin

Súhrn charakteristických

1
SG/
L
AN SOLO/1120/CCDS V20
1.
NAME OF THE MEDICINAL PRODUCT
Lantus SoloStar 100 units/ml solution for injection in a pre-filled
pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units insulin glargine*(equivalent to 3.64 mg).
Each
pen contains 3 ml of solution for injection, equivalent to 300 units.
*Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in a pre-filled pen SoloStar.
Lantus is a clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the 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
Lantus contains insulin glargine, an insulin analogue, and has a
prolonged duration of action. Lantus
should be administered once daily at any time but at the same time
each day.
The Lantus dose regimen (dose and timing) should be individually
adjusted. In patients with type 2
diabetes mellitus, Lantus can also be given together with orally
active antidiabetic medicinal products.
The potency of this medicinal product is stated in units. These units
are exclusive to Lantus and are
not the same as IU or the units used to express the potency of other
insulin analogues (see section 5.1).
_Special population _
_Elderly population (≥65 years old) _
In the elderly, progressive deterioration of renal function may lead
to a steady decrease in insulin
requirements.
_Renal impairment _
In patients with renal impairment, insulin requirements may be
diminished due to reduced insulin
metabolism.
_Hepatic impairment _
In patients with hepatic impairment, insulin requirements may be
diminished due to reduced capacity
for gluconeogenesis and reduced insulin metabolism.
_Children _
In children, efficacy and safety of Lantus have only been demonstrated
when given in the evening.
Due to limited experience, the efficacy and safety o