Glaritus contains insulin glargine an insulin analogue with a prolonged duration of action. It should be administered once daily at any time but at the same time each day.
The dosage and timing of dose of Glaritus should be individually adjusted. In patients with type 2 diabetes, Glaritus can also be given together with orally antidiabetic medicinal products.
Change-over to Glaritus: When changing from a treatment regimen with an intermediate- or another long-acting insulin to a regimen with Glaritus, the amount and timing of the short acting insulin or fast-acting insulin analogue or of the dose of any oral antidiabetic drugs may need to be adjusted.
Switch from twice daily NPH insulin to Glaritus: To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from twice-daily NPH insulin to once-daily Glaritus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Switch from insulin glargine 300 unit/mL to Glaritus: Glaritus (100 IU/mL) and insulin glargine 300 U/mL are not bioequivalent and are not directly interchangeable. When switching from once daily insulin glargine 300 units/mL to once daily Glaritus, the dose should be reduced (approximately by 20%) to reduce the risk of hypoglycaemia.
During the first week the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter. As with all insulin analogues, this is particularly true for patients which, due to antibodies to human insulin, need high insulin doses and may experience an improved insulin response with insulin glargine.
With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dosage regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo-or hyperglycaemia.
Method of administration: Glaritus is administered by subcutaneous tissue injection.
Glaritus is not intended for intravenous administration. The prolonged duration of action of insulin glargine is dependent on injection into the subcutaneous space. 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 Glaritus. Injection sites must be rotated within a given injection area from one injection to the next.
Mixing, diluting: Glaritus must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Glaritus solution for injection in dispopen: Glaritus 100 IU/mL in dispopen is only suitable for subcutaneous injections.
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