- Approval Id
- d1cbf34a18d75a42
- Drug Name
- NOVORAPID FLEXPEN INJECTION 100 U/ML
- Product Name
- NOVORAPID FLEXPEN INJECTION 100 U/ML
- Approval Number
- SIN12189P
- Approval Date
- 2003-02-06
- 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
- Dosage
- <p><strong>Posology</strong><br>
NovoRapid® is a rapid‐acting insulin analogue. NovoRapid® dosage is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long‐acting insulin given at least once a day. Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control.<br>
The individual insulin requirement in adults and children is usually between 0.5 and 1.0 units/kg/day. In a basal‐bolus treatment regimen, 50–70% of this requirement may be provided by NovoRapid® and the remainder by intermediate‐acting or long‐acting insulin. Adjustment of dosage may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. NovoRapid® has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, NovoRapid® should generally be given immediately before a meal.<br>
When necessary NovoRapid® can be given soon after a meal. Due to the shorter duration, NovoRapid® has a lower risk of causing nocturnal hypoglycaemic episodes.</p>
<p><strong>Special populations</strong><br>
As with all insulin products, in elderly patients and patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin aspart dosage adjusted on an individual basis.</p>
<p><strong>Paediatric population</strong><br>
NovoRapid® can be used in children aged 2 year and above in preference to soluble human insulin when a rapid onset of action might be beneficial. For example, in the timing of the injections in relation to meals.</p>
<p><strong>Transfer from other insulin products</strong><br>
When transferring from other insulin products, adjustment of the NovoRapid® dose and the dose of the basal insulin may be necessary.</p>
<p><strong>Method of administration</strong><br>
NovoRapid® is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see <em>Special warnings and precautions for use</em> and <em>Undesirable effects</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). As with all insulin products, subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites.<br>
The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. However, the faster onset of action compared to soluble human insulin is maintained regardless of injection site.<br>
NovoRapid® FlexPen® is a pre‐filled pen designed to be used with NovoFine® or NovoTwist® disposable needles up to a length of 8 mm. NovoRapid® FlexPen® is colour‐coded and accompanied by a package leaflet with detailed instructions for use to be followed – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><u>Continuous Subcutaneous Insulin Infusion (CSII):</u><br>
NovoRapid® may be used for Continuous Subcutaneous Insulin Infusion (CSII) in pump systems suitable for insulin infusion. CSII should be administered in the abdominal wall. Infusion sites should be rotated.<br>
When used with an insulin infusion pump, NovoRapid® should not be mixed with any other insulin products.<br>
Patients using CSII should be comprehensively instructed in the use of the pump system and use the correct reservoir and tubing for the pump. The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set. Patients administering NovoRapid® by CSII must have alternative insulin delivery method available in case of pump system failure.</p>
<p><u>Intravenous use:</u><br>
If necessary, NovoRapid® can be administered intravenously by physicians or other healthcare staff if applicable. For intravenous use, infusion systems with NovoRapid® 100 units/ml at concentrations from 0.05 units/ml to 1.0 units/ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose including 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours.<br>
Although stable over time, a certain amount of insulin will be initially adsorbed to the infusion bag. Monitoring of blood glucose is necessary during insulin infusion.</p>
- Route Of Administration
- INTRAVENOUS, SUBCUTANEOUS
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Hypersensitivity to the active substance or any of the excipients.</p>
- Atc Code
- A10AB05
- Atc Item Name
- insulin aspart
- Pharma Manufacturer Name
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
