APIDRA SOLOSTAR 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN [SIN13432P]

Product Info

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

[SIN13432P]

4.1 Therapeutic indications
Treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required.

4.2 Posology and method of administration
Posology
The potency of this preparation is stated in units. These units are exclusive to Apidra 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).
Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents.
The dose of Apidra should be individually adjusted.

Method of administration
Apidra SoloStar 100 Units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe, intravenous injection or infusion pump 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).

Subcutaneous use
Apidra should be given by subcutaneous injection shortly (0–15 min) before or soon after meals or by continuous subcutaneous pump infusion.
Apidra should be administered subcutaneously in the abdominal wall, thigh or deltoid or by continuous infusion in the abdominal wall. Injection sites and infusion sites within an injection area (abdomen, thigh or deltoid) should be rotated 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). The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables. Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Care should be taken to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated to use proper injection techniques.

Mixing with insulins
When administered as a subcutaneous injection, Apidra must not be mixed with other medicinal products except NPH human insulin.

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).

Special populations
Renal impairment
The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment. However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function. In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.

Elderly
Limited pharmacokinetic data are available in elderly patients with diabetes mellitus. Deterioration of renal function may lead to a decrease in insulin requirements.

Paediatric population
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.

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.
Hypoglycaemia.