Approvals/HSA/LANTUS SOLOSTAR 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Approved

THERAPEUTIC

LANTUS SOLOSTAR 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN

SANOFI-AVENTIS DEUTSCHLAND GMBH (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Mar 18, 2008
Approval ID: 72f6a12a70ce6c69
Company: SANOFI-AVENTIS DEUTSCHLAND GMBH (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: 72f6a12a70ce6c69
Drug Name: LANTUS SOLOSTAR 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN
Product Name: LANTUS SOLOSTAR 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN
Approval Number: SIN13426P
Approval Date: 2008-03-18
Registrant: SANOFI-AVENTIS SINGAPORE PTE. LTD.
Licence Holder: SANOFI-AVENTIS SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: 4.2 Posology and method of administration Posology Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus should be administered once daily at any time but at the same time each day. The Lantus dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as international units or the units used to express the potency of other insulin analogues (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Special population Elderly population (≥65 years old) In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. Renal impairment In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. Hepatic impairment In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. Children In children, efficacy and safety of Lantus have only been demonstrated when given in the evening. Due to limited experience, the efficacy and safety of Lantus have not been demonstrated in children below the age of 6 years. Switch from other insulins to Lantus When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products). Switch from twice daily NPH insulin to Lantus To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20–30% during the first weeks of treatment. Switch from insulin glargine 300 units/ml to Lantus Lantus and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with Lantus should reduce their dose by approximately 20%. During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually. Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter. With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or lifestyle changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Lantus. Method of administration Lantus is administered subcutaneously. Lantus should not be administered intravenously. The prolonged duration of action of Lantus is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia. There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Lantus. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Lantus must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation. Lantus SoloStar 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Before using SoloStar, the instructions for use included in the package leaflet must be read carefully (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: SUBCUTANEOUS
Indication Info: 4.1 Therapeutic indications For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required.
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Atc Code: A10AE04
Atc Item Name: insulin glargine
Pharma Manufacturer Name: SANOFI-AVENTIS SINGAPORE PTE. LTD.
Company Detail Path: /organization/sanofi-aventis-singapore-pte-ltd

Active Ingredients

Insulin glargine

100 iu/ml

Insulin glargine

100 iu/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 18, 2008

Approval ID

72f6a12a70ce6c69

Type

Therapeutic

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