NOVOMIX 30 FLEXPEN

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

INSULIN ASPART

Dostopno od:

NOVO NORDISK LTD., ISRAEL

Koda artikla:

A10AD05

Farmacevtska oblika:

SUSPENSION FOR INJECTION

Sestava:

INSULIN ASPART 100 U/ML

Pot uporabe:

S.C

Tip zastaranja:

Required

Izdeluje:

NOVO NORDISK A/S, DENMARK

Terapevtska skupina:

INSULIN ASPART

Terapevtsko območje:

INSULIN ASPART

Terapevtske indikacije:

NovoMix® 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above. משטר מינון : 7/8/2019Posology and method of administrationPosologyThe 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 and/or GLP-1 receptor agonists . 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).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 units4.4–6.1 mmol/l 80–110 mg/dl 06.2–7.8 mmol/l 111–140 mg/dl +2 units7.9–10 mmol/l 141–180 mg/dl +4 units>10 mmol/l >180 mg/dl +6 unitsThe lowest of the three previous days’ pre-meal blood glucose levels should be used. The dose should not be increased if hypoglycaemia occurred within these days. Dose adjustments can be made once a week until target HbA1c is reached. Pre-meal blood glucose levels should be used to evaluate the adequacy of the preceding dose.In patients with type 2 diabetes, a dose reduction of 20% is recommended for patients with an HbA1c less than 8% when a GLP-1 receptor agonist is added to NovoMix 30, to minimise the risk of hypoglycaemia. For patients with an HbA1c higher than 8% a dose reduction should be considered. Subsequently, dosage should be adjusted individually.

Datum dovoljenje:

2022-11-30

Navodilo za uporabo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
NOVOMIX
® 30 FLEXPEN 100 UNITS/ML
SUSPENSION FOR INJECTION IN A PRE-FILLED INJECTION PEN
ACTIVE INGREDIENTS: 30% soluble insulin aspart and 70% insulin aspart
protamine
crystallized.
INACTIVE INGREDIENTS AND ALLERGENS IN THIS MEDICINE: See section 2
under ‘Important
information about some of this medicine’s ingredients’ and section
6 ‘Additional
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 for 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 30 is used to treat diabetes in adults, adolescents, and
children aged 10 years
and older.
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 30 is a modern insulin (insulin analog) with both a
rapid-acting and an
intermediate-acting effect, in the ratio 30/70. Modern insulin
products are improved
versions of human insulin.
NovoMix 30 is used to reduce high blood sugar level in adults,
adolescents and children
aged 10 years and above who have diabetes. Diabetes is a disease where
your body
does not produce enough insulin to control the level of your blood
sugar.
NovoMix 30 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 24 hours.
NovoMix 30 can be used in combination with tablets for treatment of
diabetes
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE:

if you are sensitive (allergic) to insulin aspart or any of the other
ingredients

Lastnosti izdelka

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