NOVOMIX 50 FLEXPEN

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

INSULIN ASPART

متاح من:

NOVO NORDISK LTD., ISRAEL

ATC رمز:

A10AB05

الشكل الصيدلاني:

SUSPENSION FOR INJECTION

تركيب:

INSULIN ASPART 100 U/ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NOVO NORDISK A/S, DENMARK

المجموعة العلاجية:

INSULIN ASPART

المجال العلاجي:

INSULIN ASPART

الخصائص العلاجية:

NovoMix 50 is indicated for treatment of diabetes mellitus in adults.

تاريخ الترخيص:

2013-05-31

نشرة المعلومات

1
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
NOVOMIX
® 50 FLEXPEN
100 UNITS/ML
SUSPENSION FOR INJECTION IN A PRE-FILLED PEN
ACTIVE INGREDIENTS: 50% soluble insulin aspart and 50% insulin aspart
crystallized with
protamine.
INACTIVE INGREDIENTS AND ALLERGENS IN THE MEDICINE: See section 2
under “Important
information
about
some
of
this
medicine’s
ingredients”
and
section
6
–
“Further
Information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours..
1.
WHAT IS THIS MEDICINE INTENDED FOR?
NovoMix 50 is used to treat diabetes in adults.
THERAPEUTIC GROUP: Diabetes medicines. Insulins and analogs for
injection, with a
combination of an intermediate-acting or long-acting insulin with
rapid-acting insulin.
NovoMix 50 is a modern insulin (insulin analog) with both a
rapid-acting and an
intermediate-acting effect, in the ratio 50/50. Modern insulin
products are improved
versions of human insulin.
Diabetes is a disease where your body does not produce enough insulin
to control the
level of your blood sugar. NovoMix 50 may be used in combination with
metformin.
NovoMix 50 is used to reduce the high blood sugar level in patients
with diabetes
mellitus (diabetes).
NovoMix 50 will start to lower your blood sugar 10–20 minutes after
you inject it; the
maximum effect occurs between 1 and 4 hours after the injection, and
the effect lasts for
up to 14-24 hours.
2.
BEFORE USING THIS MEDICINE
2
DO NOT USE THIS MEDICINE:

If you are sensitive (allergic) to insulin aspart or to any of the
other ingredients in
this medicine (see section 6, "Further information").

If you suspect hypog

خصائص المنتج

NovoMix 50 FP IL SPC DEC-2020
1
1.
NAME OF THE MEDICINAL PRODUCT
NovoMix® 50 FlexPen®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the suspension contains 100 units soluble insulin
aspart*/protamine-crystallised
insulin aspart* in the ratio 50/50 (equivalent to 3.5 mg). 1
pre-filled pen contains 3 ml
equivalent to 300 units.
*Insulin aspart is produced in
_Saccharomyces cerevisiae_
by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
The suspension is cloudy, white and aqueous.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NovoMix 50 is indicated for treatment of diabetes mellitus in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The potency of insulin analogues, including insulin aspart, is
expressed in units, whereas the
potency of human insulin is expressed in international units.
NovoMix 50 dosing is individual and determined in accordance with the
needs of the patient.
Blood glucose monitoring and insulin dose adjustments are recommended
to achieve optimal
glycaemic control.
The individual insulin requirement is usually between 0.5 and 1.0
unit/kg/day. NovoMix 50
may fully or partially meet this requirement.
In patients with type 2 diabetes,
_ _
NovoMix 50 can be given as monotherapy or in combination
with metformin when the blood glucose is inadequately controlled with
metformin alone.
Adjustment of dose may be necessary if patients undertake increased
physical activity, change
their usual diet or during concomitant illness.
NovoMix 50 FP IL SPC DEC-2020
2
SPECIAL POPULATIONS
In elderly patients (≥65 years old) and in patients with hepatic or
renal impairment, glucose
monitoring should be intensified and the insulin aspart dose adjusted
on an individual basis.
Renal or hepatic impairment may reduce the patient’s insulin
requirements.
_Paediatric population_
The safety and efficacy of NovoMix 50 in children below 18 years of
age have not been
established. No data are available.
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