Posology : מינונים

4.2   Posology and method of administration
Posology
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Rosetemib S.K.

Rosetemib S.K is not suitable for initial therapy.
When Rosetemib S.K is indicated for patients not controlled by statin alone, the dose of Rosetemib S.K should be individualized according to the target lipid levels and the patient's response.

When Rosetemib S.K is indicated for patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate product, treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.
Patient should use the strength corresponding to their previous treatment.
The recommended dose is one Rosetemib S.K tablet daily.

Co-administration with bile acid sequestrants
Dosing of Rosetemib S.K should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant (see section 4.5).

Paediatric population
The safety and efficacy of Rosetemib S.K in children below the age of 18 years have not yet been established. Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

Elderly
A start dose of 5 mg rosuvastatin is recommended in patients >70 years (see section 4.4).
The combination is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.

Hepatic impairment
No dosage adjustment is required in patients with mild hepatic impairment (Child Pugh score 5 to 6). Treatment with Rosetemib S.K is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score>9) liver dysfunction (see sections 4.4 and 5.2).
Rosetemib S.K is contraindicated in patients with active liver disease (see section 4.3).

Renal impairment
No dose adjustment is necessary in patients with mild renal impairment.
The recommended start dose is rosuvastatin 5 mg in patients with moderate renal impairment (creatinine clearance <60 ml/min).

The 40 mg/10 mg dose is contraindicated in patients with moderate renal impairment. The use of Rosetemib S.K in patients with severe renal impairment is contraindicated for all doses (see sections 4.3 and 5.2).

Race
Increased systemic exposure of rosuvastatin has been seen in Asian subjects (see sections 4.4 and 5.2). The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Rosetemib S.K 40 mg/10 mg film-coated tablets are contraindicated in these patients (see sections 4.3 and 5.2).

Genetic polymorphisms
Specific types of genetic polymorphisms are known that can lead to increased rosuvastatin exposure (see section 5.2). For patients who are known to have such specific types of polymorphisms, a lower daily dose of Rosetemib S.K is recommended.

Dosage in patients with pre-disposing factors to myopathy
The recommended start dose is rosuvastatin 5 mg in patients with pre-disposing factors to myopathy (see section 4.4). The fixed dose combination is not suitable for initial therapy.
Monocomponent preparations should be used to start the treatment or to modify the dose.
Rosetemib S.K 40 mg/10 mg film-coated tablets are contraindicated in some of these patients (see section 4.3).

Concomitant therapy
Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Rosetemib S.K is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir; see sections 4.4 and 4.5).

Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Rosetemib S.K therapy. In situations where co-administration of these medicinal products with Rosetemib S.K is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered (see section 4.5).

Method of administration
Route of administration is oral. Rosetemib S.K can be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water.