Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
FLUPENTIXOL DECANOATE
Lundbeck Limited
FLUPENTIXOL DECANOATE
40/2 Mg/Ml
Solution for Injection
Withdrawn
2008-10-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Depixol 40mg/2ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2ml ampoule contains 40mg (2% w/v) cis (z)-flupentixol decanoate (equivalent to 20mg/ml). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, yellowish, sterile oily solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The management of schizophrenia and allied paranoid psychoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ROUTE OF ADMINISTRATION: _Deep intramuscular injection into the upper outer buttock or lateral thigh. Dosage and dosage interval should be adjusted according to the patients’ symptoms and response to treatment. _NOTE: _As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur. _Adults: _The usual dose is between 20 to 40 mg every two to four weeks. Larger doses may be used if necessary, distributed between two injection sites. In patients who have not previously received depot neuroleptics, treatment is usually started with a small dose (e.g. 20 mg) to assess tolerability. An interval of at least one-week should be allowed before the second injection is given at a dose consistent with the patients’ condition. Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse. The appropriate presentation of Depixol should be selected to achieve an injection volume, which does not exceed 2 ml. Volumes greater than 2 ml should be distributed between two injection sites. When transferring patients from oral to depot neurolep Lestu allt skjalið