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SANSULIN Log-G contains Insulin Glargine an Insulin analogue with a prolonged duration of action. It should be administered once daily at any time but the same time each day.
The dosage and timing of dose of SANSULIN Log-G should be individually adjusted. In patients with type 2 diabetes mellitus, SANSULIN Log-G can also be given together with orally active antidiabetic medicinal products.
Children: In children efficacy and safety of SANSULIN Log-G have only been demonstrated when given in the evening. Due to limited experience the efficacy and safety of SANSULIN Log-G have not been demonstrated in children below the age of 6 years.
Change-over to SANSULIN Log-G: When changing from a treatment regimen with an intermediate or another long-acting Insulin to a regimen with SANSULIN Log-G, the amount and timing of the short acting Insulin or fast-acting Insulin analogue or of the doses of any oral antidiabetic drug may need to be adjusted.
To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal Insulin regimen from twice daily NPH Insulin to a once daily regimen with SANSULIN Log-G should reduce their daily dose of basal Insulin by 20-30% during the first week of treatment. 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 the patients which, due to antibodies to human Insulin, need high Insulin doses and may experience a markedly 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, changes of timing of Insulin dose or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia.
Administration: SANSULIN Log-G is administered by subcutaneous tissue injection.
SANSULIN Log-G is not intended for be intravenous administration. The prolonged duration of the 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 SANSULIN Log-G.
Injection sites must be rotated within a given injection area from one injection to the next.
SANSULIN Log-G must not be mixed with any another Insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Inspect each cartridge before use. Only use it if the solution is clear, colourless, with no solid particles visible and if it of a water-like consistency.
Cartridge in use or carried as a spare may be kept up to four weeks when stored below 25°C. When in use (in the pen), do not store in a refrigerator and protected from heat and light. After inserting a new cartridge, check to see that the pen is working properly prior to injecting the first dose. See the pen instruction booklet for further details.
Due to limited experience the efficacy and safety of SANSULIN Log-G could not be assessed in the following groups of patients: Patients with impaired liver function or patients with moderate/severe renal impairment.
