Medicinal Products

APIDRA OPTISET 100 Units / ml

Generic drug of the therapeutic class: Metabolism and nutrition
Active ingredients: Insulin glulisine
laboratory: Sanofi-Aventis Deut Gmbh

Injectable solution
Box of 5 pre-filled pens of 3 ml
All forms

Indication

Treatment of adult diabetes.

Dosage APIDRA OPTISET 100 Units / ml Solution for injection Box of 5 Pre-filled pens of 3 ml

- The activity of the product is expressed in units. These units are specific to Apidra and do not match the IUs or units used for other insulin analogues. See section on pharmacodynamic properties.
- Apidra should be administered shortly before (0-15 minutes) or just after meals.
- Apidra is used in regimens that associate it with either an intermediate-acting or long-acting human insulin or a long-acting insulin analogue or oral hypoglycemic agents.
- The dosage of Apidra must be adjusted individually.
- Administration:
. Apidra should be administered by subcutaneous injection or continuous subcutaneous infusion with a pump.
. Apidra should be administered by subcutaneous injection into the abdominal wall, thigh or deltoid region or by continuous infusion into the abdominal wall. In the same injection zone (abdomen, thigh or deltoid), injection sites and infusion sites should be varied from one injection to another. The absorption rate, and therefore the onset and duration of action, can be modified by the injection site, physical exercise and other factors. Subcutaneous injection into the abdominal wall results in slightly faster absorption than from other injection sites (see section 5.2).
. You must be careful not to enter a blood vessel. After the injection, do not massage the injection site. Patients need to be educated about the right injection techniques.
- Mix with insulins:
. In the absence of compatibility studies, insulin glulisine should not be mixed with other drugs except with NPH human insulin.
. The Instructions for Use mentioned in the package leaflet must be read carefully before using OptiSet (see section on instructions for use, handling and disposal).
- Special populations:
. Renal insufficiency :
The pharmacokinetic properties of insulin glulisine are generally unchanged in patients with renal impairment. Insulin requirements may, however, be reduced in case of renal insufficiency (see section on pharmacokinetic properties).
. Hepatic insufficiency :
The pharmacokinetic properties of insulin glulisine have not been evaluated in patients with impaired liver function. In patients with hepatic impairment, insulin requirements may be decreased due to reduced gluconeogenesis and reduced insulin metabolism.
. Elderly :
Available pharmacokinetic data for elderly subjects with diabetes are limited. Impaired renal function may cause a decrease in insulin requirements.
. Children and adolescents :
There is insufficient clinical information regarding the use of Apidra in children and adolescents.

Against indications

- Hypersensitivity to insulin glulisine or to any of the excipients.
- Hypoglycemia.
- Children and adolescents: There is insufficient clinical information regarding the use of Apidra in children and adolescents.

Adverse effects Apidra Optiset

- Hypoglycaemia, the most common side effect of any insulin therapy, may occur if the insulin dose is greater than needed.
- The undesirable effects reported during clinical trials are listed below, classified by organ system, in descending order of occurrence frequencies (very common:> 1/10, frequent:> 1/100, 1/1000, 1/10000, <1/1000, very rare: <1/10000).
- Within each frequency group, adverse effects should be presented in descending order of severity.
- Metabolism and nutrition disorders:
Very common : Hypoglycemia.
The symptoms of hypoglycemia usually appear suddenly. They include cold sweats, pallor, fatigue, nervousness or tremor, unusual anxiety, exhaustion or weakness, confusion, difficulty concentrating, drowsiness, intense hunger, blurred vision, headache, nausea and palpitations.
Hypoglycaemia may worsen and lead to loss of consciousness and / or convulsions and may lead to reversible impairment of brain function or even death.
- Skin and subcutaneous tissue disorders:
. Common : Injection site reactions and local hypersensitivity reactions.
Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin. These reactions are usually transient and they usually disappear during treatment.
. Rare : Lipodystrophy.
Lipodystrophy may occur at the injection site if the change of the injection site in the same injection zone is not respected.
- General disorders:
Uncommon : Systemic hypersensitivity reactions.
Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnoea, allergic eczema, and pruritus. Cases of severe generalized allergy, including anaphylactic shock, may be life-threatening.

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