NOVOMIX 30 FLEXPEN 100 UI/ML Suspension injectable

Pays: Tunisie

Langue: français

Source: Ministère de la Santé, Direction de l'inspection Pharmaceutique

Ingrédients actifs:

INSULINE ANALOGUE

Disponible depuis:

NOVO NORDISK A/S Bagsvaerd

DCI (Dénomination commune internationale):

INSULINE ANALOGUE

Dosage:

100 UI/ML

forme pharmaceutique:

Suspension injectable

Unités en paquet:

B/5/stylos pré-remplies/3 ML

classe:

C

Groupe thérapeutique:

MEDICAMENT UTILISE DANS LE TRAITEMENT DU DIABETE

Domaine thérapeutique:

APPAREIL DIGESTIF ET METABOLISME

indications thérapeutiques:

Traitement du diabète de l'adulte, de l'adolescent et de l'enfant de 10 à 17 ans.

Descriptif du produit:

Classement VEIC: Vital

Date de l'autorisation:

2007-02-28

Notice patient

NovoMix® 30
FlexPen®
– Adjustment of dosage may be necessary if
patients undertake increased physical activity,
change their usual diet or during concomitant
illness.
The following titration guideline is recommended
for dose adjustments:
PRE-MEAL BLOOD GLUCOSE LEVEL
NOVOMIX® 30
DOSE
ADJUSTMENT
<4.4 mmol/l
<80 mg/dl
-2 U
4.4–6.1 mmol/l
80–110 mg/dl
0
6.2–7.8 mmol/l
111–140 mg/dl
+2 U
7.9–10 mmol/l
141–180 mg/dl
+4 U
>10 mmol/l
>180 mg/dl
+6 U
In patients with type 2 diabetes, a dose reduction of
20% is recommended for patients with an HbA
1c
less than 8% when a GLP-1 receptor agonist is
added to NovoMix® 30, to minimise the risk of
hypoglycaemia. For patients with an HbA
1c
higher
than 8% a dose reduction should be considered.
Subsequently, dosage should be adjusted
individually.
SPECIAL POPULATIONS
As with all insulin products, in special populations,
glucose monitoring should be intensified and the
insulin aspart dosage adjusted on an individual
basis.
Elderly: NovoMix® 30 can be used in elderly patients;
however there is limited experience with the use of
NovoMix® 30 in combination with OADs in patients
older than 75 years.
Renal and hepatic impairment: Renal or hepatic
impairment may reduce the patient’s insulin
requirements.
Paediatric population: NovoMix® 30 can be used in
children and adolescents aged 10 years and above
when premixed insulin is preferred. Limited clinical
data exist for children aged 6 to 9 years (see
_Pharmacodynamic properties_).
No data are available for NovoMix® 30 in children
below 6 years of age.
METHOD OF ADMINISTRATION
NovoMix® 30 is for subcutaneous administration
only. NovoMix® 30 must not be administered
intravenously as it may result in severe
hypoglycaemia. Intramuscular administration
should be avoided. NovoMix® 30 is not to be
used in insulin infusion pumps.
NovoMix® 30 is administered subcutaneously by
injection in the thigh or in the abdominal wall. If
convenient, the gluteal or deltoid region may be
used. Injection sites should always be rotated