Posology : מינונים

4.2   Posology and method of administration

The pre-filled syringe of SAYANA® should be vigorously shaken just before use to ensure that the dose being given represents a uniform suspension. The treatment should be initiated by a doctor or healthcare assistant and administered as a subcutaneous injection (SC) into the anterior thigh or 
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abdomen. The medication should be injected slowly until the syringe is empty, which should take about 5-7 seconds. For instructions on how to prepare SAYANA® before administration, and how to administer SAYANA®, see section 5.4.


Adults
First Injection: To provide contraceptive cover in the first cycle of use, an injection of 104 mg SC should be given during the first five days of a normal menstrual cycle. If the injection is carried out according to these instructions, no additional contraceptive measure is required.

Further Doses: The second and subsequent injections should be given at 13-week intervals, as long as the injection is given no later than seven days after this time, no additional contraceptive measures (e.g., barrier) are required. If the interval from the preceding injection is greater than 14 weeks (13 weeks plus 7 days) for any reason, then pregnancy should be excluded before the next injection is given. The efficacy of SAYANA® depends on adherence to the recommended dosage schedule of administration.

Post Partum: If the patient is not breast-feeding, the injection should be given within 5 days post partum (to increase assurance that the patient is not pregnant). If the injection is to be given at another time, then pregnancy should be excluded.

If the patient is breast-feeding, the injection should be given no sooner than six weeks post partum, when the infant's enzyme system is more developed (see section 4.6).

There is evidence that women prescribed SAYANA® in the immediate puerperium can experience prolonged and heavy bleeding. Because of this, the drug should be used with caution in the puerperium. Women who are considering use of the product immediately following delivery or termination should be advised that the risk of heavy or prolonged bleeding may be increased. Doctors are reminded that in the non-breast-feeding, post partum patient, ovulation may occur as early as week 4.

Switching from other Methods of Contraception: When switching from other contraception methods, SAYANA® should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods (e.g., patients switching from oral contraceptives should have their first injection of SAYANA® within 7 days after their last active pill).

Hepatic impairment: The effect of hepatic disease on the pharmacokinetics of SAYANA® is unknown. As SAYANA® largely undergoes hepatic elimination, it may be poorly metabolised in patients with severe liver insufficiency (see section 4.3 Contraindications).

Renal impairment: The effect of renal disease on the pharmacokinetics of SAYANA® is unknown.
No dosage adjustment should be necessary in women with renal insufficiency, since SAYANA ® is almost exclusively eliminated by hepatic metabolism.

Paediatric Population
SAYANA® is not indicated before menarche (see section 4.1 Therapeutic Indications). Data in adolescent females (12-18 years) is available for IM administration of MPA (see section 4.4 Special Warnings and Precautions for Use and section 5.1 Pharmacodynamic properties). Other than concerns about loss of BMD, the safety and effectiveness of SAYANA® is expected to be the same for adolescents after menarche and adult females.