País: Israel
Idioma: inglés
Fuente: Ministry of Health
INSULIN ASPART
NOVO NORDISK LTD., ISRAEL
A10AD05
SUSPENSION FOR INJECTION
INSULIN ASPART 100 U/ML
S.C
Required
NOVO NORDISK A/S, DENMARK
INSULIN ASPART
INSULIN ASPART
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.
2022-11-30
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 Leer el documento completo
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 Leer el documento completo