NOVOMIX® 30 PENFILL® 100 U/ML

NOVO NORDISK A/S (BAGSVÆRD) (BULK PRODUCTION AND PRIMARY PACKAGER) - DENMARKNOVO NORDISK PRODUÇÃO FARMACÊUTICA DO BRASIL LTDA. - BRAZILNOVO NORDISK PRODUCTION SAS (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: May 9, 2018
Approval ID: 07c63682ff5592c5
Company: NOVO NORDISK A/S (BAGSVÆRD) (BULK PRODUCTION AND PRIMARY PACKAGER) - DENMARKNOVO NORDISK PRODUÇÃO FARMACÊUTICA DO BRASIL LTDA. - BRAZILNOVO NORDISK PRODUCTION SAS (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: 07c63682ff5592c5
Drug Name: NOVOMIX® 30 PENFILL® 100 U/ML
Product Name: NOVOMIX® 30 PENFILL® 100 U/ML
Approval Number: SIN15480P
Approval Date: 2018-05-09
Registrant: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Licence Holder: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SUSPENSION
Dosage: Posology 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 drugs and/or GLP-1 receptor agonists. How to start Insulin naïve patients: 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). However, it can also be initiated once daily with 12 units at dinner (evening meal). How to switch When transferring a patient from biphasic human insulin to NovoMix® 30, start with the same dose and regimen. Then titrate according to individual needs (see The following titration guideline). As with all insulin products, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see Transfer from other insulin products – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). How to intensify NovoMix® 30 can be intensified from once daily to twice daily. 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 (50:50). From NovoMix® 30 twice daily to thrice daily: the morning dose can be split into morning and lunchtime doses (thrice daily dosing). How to adjust the dose <ul class="dash"> <li>Adjust the dose of NovoMix® 30 on the basis of the lowest pre-meal blood glucose level from the three previous days.</li> <li>Always change the mealtime dose preceding the measurement.</li> <li>Dose adjustment can be made once a week until target HbA1c is reached.</li> <li>The dose should not be increased if hypoglycaemia occurred within these days.</li> <li>Adjustment of dosage may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.</li> </ul> The following titration guideline is recommended for dose adjustments: <img src="/TGIF/Novomix30Penfill-Table1_161221.png" alt="Novomix 30 Penfill Dosage Table 1" /> 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. Special populations As with all insulin products, in special populations, glucose monitoring should be intensified and the insulin aspart dosage adjusted on an individual basis. Elderly: NovoMix® 30 can be used in elderly patients; however there is limited experience with the use of NovoMix® 30 in combination with OADs in patients older than 75 years. Renal and hepatic impairment: Renal or hepatic impairment may reduce the patient’s insulin requirements. Paediatric population: NovoMix® 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred. Limited clinical data exist for children aged 6 to 9 years (see Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No data are available for NovoMix® 30 in children below 6 years of age. Method of administration NovoMix® 30 is for subcutaneous administration only. NovoMix® 30 must not be administered intravenously as it may result in severe hypoglycaemia. Intramuscular administration should be avoided. NovoMix® 30 is not to be used in insulin infusion pumps. NovoMix® 30 is administered subcutaneously by injection in the thigh or in the abdominal wall. If convenient, the gluteal or deltoid region may be used. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Special warnings and precautions for use and Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). As with all insulin products, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. NovoMix® 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, NovoMix® 30 can be given soon after a meal.
Route Of Administration: SUBCUTANEOUS
Indication Info: Therapeutic indications: Treatment of patients with diabetes mellitus requiring insulin.
Contraindications: Contraindications Hypersensitivity to insulin aspart or any of the excipients (see List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: A10AD05
Atc Item Name: insulin aspart
Pharma Manufacturer Name: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Company Detail Path: /organization/novo-nordisk-pharma-singapore-pte-ltd

Active Ingredients

Insulin Aspart (600nmol)(approx. 3.5mg)

100 U/ ml

INSULIN ASPART (600 NMOL) (APPROX. 3.5 MG)

100 UNITS/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 9, 2018

Approval ID

07c63682ff5592c5

Type

Therapeutic

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