NOVORAPID FLEXPEN INJECTION 100 uml

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Insulin Aspart

Dostopno od:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Koda artikla:

A10AB05

Odmerek:

100 u/ml

Farmacevtska oblika:

INJECTION

Sestava:

Insulin Aspart 100 u/ml

Pot uporabe:

INTRAVENOUS, SUBCUTANEOUS

Tip zastaranja:

Prescription Only

Izdeluje:

Novo Nordisk A/S

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2003-02-06

Navodilo za uporabo

1
NOVORAPID
®
 FLEXPEN
®

100 U/ml solution for injection in pre-filled pen. 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 ml of the solution contains 100 U of insulin aspart
 (equivalent to 3.5 mg). 
1 pre-filled pen contains 3 ml equivalent to 300 U. 
Insulin aspart is produced by recombinant DNA technology
in _Saccharomyces cerevisiae._ 

PHARMACEUTICAL FORM 
Clear, colourless, aqueous solution for injection in pre-filled
pen. FlexPen
®
. 

THERAPEUTIC INDICATIONS 
Treatment of diabetes mellitus in adults, adolescents and children
aged 2 years and above.  

POSOLOGY  
NovoRapid
®
 is a rapid-acting insulin analogue. NovoRapid
®
 dosage is individual and determined in 
accordance with the needs of the patient. It should normally be
used in combination with intermediate-
acting or long-acting insulin given at least once a day. Blood
glucose monitoring and insulin dose 
adjustment are recommended to achieve optimal glycaemic control. 
The individual insulin requirement in adults and children is
usually between 0.5 and 1.0 U/kg/day. In a 
basal-bolus treatment regimen, 50 - 70% of this requirement may be
provided by NovoRapid
®
 and the 
remainder by intermediate-acting or long-acting insulin.
Adjustment of dosage may be necessary if 
patients undertake increased physical activity, change their usual
diet or during concomitant illness. 
NovoRapid
®
 has a faster onset and a shorter duration of action than soluble
human insulin. 
Due to the faster onset of action, NovoRapid
®
 should generally be given immediately before a meal. 
When necessary NovoRapid
®
 can be given soon after a meal. 
Due to the shorter duration, NovoRapid
®
 has a lower risk of causing nocturnal hypoglycaemic 
episodes. 

SPECIAL POPULATIONS 
As with all insulin products, in elderly patients and patients with
renal or hepatic impairment, glucose 
monitoring should be intensified and the insulin aspart dosage
adjusted on an

Lastnosti izdelka

NOVORAPID
® FLEXPEN
®
100 U/ml solution for injection in pre-filled pen.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains 100 U of insulin aspart* (equivalent to
3.5 mg).
1 pre-filled pen contains 3 ml equivalent to 300 U.
*Insulin aspart is produced by recombinant DNA technology in
_Saccharomyces cerevisiae_
.
PHARMACEUTICAL FORM
Clear, colourless, aqueous solution for injection in pre-filled pen.
FlexPen
®
.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
aged 2 years and above.
POSOLOGY
NovoRapid
®
is a rapid-acting insulin analogue. NovoRapid
®
dosage is individual and determined in
accordance with the needs of the patient. It should normally be used
in combination with intermediate-
acting or long-acting insulin given at least once a day. Blood glucose
monitoring and insulin dose
adjustment are recommended to achieve optimal glycaemic control.
The individual insulin requirement in adults and children is usually
between 0.5 and 1.0 U/kg/day. In a
basal-bolus treatment regimen, 50–70% of this requirement may be
provided by NovoRapid
®
and the
remainder by intermediate-acting or long-acting insulin. Adjustment of
dosage may be necessary if patients
undertake increased physical activity, change their usual diet or
during concomitant illness. NovoRapid
®
has a faster onset and a shorter duration of action than soluble human
insulin. Due to the faster onset of
action, NovoRapid
®
should generally be given immediately before a meal.
When necessary NovoRapid
®
can be given soon after a meal. Due to the shorter duration, NovoRapid
®
has
a lower risk of causing nocturnal hypoglycaemic episodes.
SPECIAL POPULATIONS
As with all insulin products, in elderly patients and patients with
renal or hepatic impairment, glucose
monitoring should be intensified and the insulin aspart dosage
adjusted on an individual basis.
PAEDIATRIC POPULATION
NovoRapid
®
can be used in children aged 2 year and above in preference to soluble
human insulin when a
rapid