NOVOMIX 30 PENFILL

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

INSULIN ASPART

Inapatikana kutoka:

NOVO NORDISK LTD, ISRAEL

ATC kanuni:

A10AB05

Dawa fomu:

SUSPENSION FOR INJECTION

Tungo:

INSULIN ASPART 100 IU/ML

Njia ya uendeshaji:

S.C

Dawa ya aina:

Required

Viwandani na:

NOVO NORDISK A/S, DENMARK

Kundi la matibabu:

INSULIN ASPART

Eneo la matibabu:

INSULIN ASPART

Matibabu dalili:

Treatment of diabetes mellitus.

Idhini ya tarehe:

2011-06-30

Taarifa za kipeperushi

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
:
07/09/2014
םש
רישכת
תילגנאב
רפסמו
םושירה
:
NOVOMIX 30 FLEXPEN – 127- 24-30599-00
NOVOMIX 30 PENFILL – 122- 67-30240-00
םש
לעב
םושירה
:
ובונ
קסידרונ
מ"עב
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE & ADMINISTRATION
SPECIAL WARNINGS AND SPECIAL
PRECAUTIONS FOR USE
-
Insulin antibodies
Insulin administration may cause insulin antibodies to
form. In rare cases, the presence of such insulin
antibodies may necessitate adjustment of the insulin dose
in order to correct a tendency to hyper- or
hypoglycaemia.
INTERACTION WITH OTHER
MEDICAMENTS AND OTHER FORMS
OF INTERACTION
FERTILITY, PREGNANCY AND
LACTATION
ADVERSE EVENTS
ב"צמ
ובש ,ןולעה
נמוסמ
תו
תורמחהה
שקובמה
תו
לע
עקר
בוהצ
.
םייוניש
םניאש
רדגב
תורמחה
ונמוס
)ןולעב(
עבצב
שי .הנוש
ןמסל
קר
ןכות
יתוהמ
אלו
םייוניש
םוקימב
.טסקטה
רבעוה
ראודב
ינורטקלא
ךיראתב
07/09/2014

Tabia za bidhaa

NovoMix 30 FP IL SPC NOV2020
1
1.
NAME OF THE MEDICINAL PRODUCT
NovoMix® 30 FlexPen®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the suspension contains 100 units soluble insulin
aspart*/protamine-crystallised insulin aspart*
in the ratio 30/70 (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 30 is indicated for treatment of diabetes mellitus in adults,
adolescents and children aged
10 years and above.
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® 30 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.
_ _
In patients with type 2 diabetes, NovoMix 30 can be given as
monotherapy. NovoMix 30 can also be
given in combination with oral antidiabetic medicinal products if the
patient's blood glucose is
inadequately controlled with oral antidiabetic medicinal products
alone. For patients with type 2
diabetes, the recommended starting dose of NovoMix 30 is 6 units at
breakfast and 6 units at dinner
(evening meal). NovoMix 30 can also be initiated once daily with 12
units at dinner (evening meal).
When using NovoMix 30 once daily, it is generally recommended to move
to twice daily when
reaching 30 units by splitting the dose into equal breakfast and
dinner doses. If twice daily dosing with
NovoMix® 30 results in recurrent daytime hypoglycaemic episodes, the
morning dose can be split into
morning and lunchtime doses (thrice daily dosing).
NovoMix 30 FP IL SPC NOV2020
2
The following titration