NOVOMIX 70 FLEXPEN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INSULIN ASPART

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

A10AB05

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

INSULIN ASPART 100 U/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic area:

INSULIN ASPART

Therapeutic indications:

NovoMix 70 is indicated for treatment of diabetes mellitus in adults.

Authorization date:

2013-05-31

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
)
ךיראת
:
7
102/
20
1
9
/
תילגנאב רישכת םש
םושירה רפסמו
:
00
-
31774
-
76
-
138
–
0 FLEXPEN
7
NOVOMIX
םושירה לעב םש
:
מ"עב קסידרונ ובונ
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
קט טס
יחכונ
שדח טסקט
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE &
ADMINISTRATION
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS FOR
USE
N/A
AVOIDANCE OF ACCIDENTAL MIX-UPS/MEDICATION ERRORS
Patients must be instructed to always check the insulin label
before each injection to avoid accidental mix-ups between
NovoMix and other insulin products.
INTERACTION WITH OTHER
MEDICAMENTS AND OTHER
FORMS OF INTERACTION
FERTILITY,
PREGNANCY AND
LACTATION
ADVERSE EVENTS ב"צמ
נמוסמ ובש ,ןולעה
תו
ורמחהה ת
שקובמה תו
בוהצ עקר לע
.
ונמוס תורמחה רדגב םניאש םייוניש
)ןולעב(
םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש
עבצב
.טסקטה םוקימב

Summary of Product characteristics

NovoMix 70 FP IL SPC DEC-2020
1
1.
NAME OF THE MEDICINAL PRODUCT
NovoMix® 70 FlexPen®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the suspension contains 100 units soluble insulin
aspart*/protamine-crystallised
insulin aspart* in the ratio 70/30 (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 70 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 70 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 70
may fully or partially meet this requirement.
In patients with type 2 diabetes, NovoMix 70 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.
SPECIAL POPULATIONS
NovoMix 70 FP IL SPC DEC-2020
2
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 70 in children below 18 years of
age have not been
established. No data are available.
TRANSFER FROM OTHER INSULIN