SIKLOS Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Siklos 100 mg film-coated tablets. Siklos 1000 mg film-coated tablets.
Qualitative and quantitative composition
Siklos 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of hydroxycarbamide. Siklos 1000 mg film-coated tablets: Each film-coated tablet contains 1,000 mg of hydroxycarbamide. For the ...
Pharmaceutical form
Film-coated tablet (tablet). Siklos 100 mg film-coated tablets: Off-white oblong-shaped, film-coated tablet with half-scoring on both sides. The tablet can be divided into two equal parts. Each half of ...
Therapeutic indications
Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic Sickle ...
Posology and method of administration
Treatment with Siklos should be initiated by a physician experienced in the management of Sickle Cell Syndrome. Posology In adults, adolescents and children older than 2 years The posology should be based ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Severe hepatic impairment (Child-Pugh classification C). Severe renal impairment (creatinine clearance <30 ml/min). Toxic ranges of ...
Special warnings and precautions for use
Treatment with Siklos requires close clinical monitoring. The haematological status of the patient, as well as renal and hepatic functions should be determined prior to, and repeatedly during treatment. ...
Interaction with other medicinal products and other forms of interaction
Specific interaction studies have not been performed with hydroxycarbamide. Potentially fatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing age receiving hydroxycarbamide should be advised to avoid becoming pregnant, and to inform the treating physician ...
Effects on ability to drive and use machines
Siklos has minor influence on the ability to drive and use machines. Patients should be advised not to drive or operate machines, if dizziness is experienced while taking Siklos.
Undesirable effects
Summary of the safety profile Specifically, the safety of hydroxycarbamide had been examined retroactively from cohorts of 123 adults over 13 years and 352 children older than 2 years and adolescents up ...
Overdose
Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at doses several times above the therapeutic dose. Soreness, violet erythema, oedema on palms and soles followed by ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents ATC code: L01XX05 Mechanism of action The specific mechanism of action of hydroxycarbamide is not fully understood. One of ...
Pharmacokinetic properties
Absorption After oral administration of 20 mg/kg of hydroxycarbamide, a rapid absorption is observed with peak plasma levels of about 30 mg/L occurring after 0.75 and 1.2 h in children and adult patients ...
Preclinical safety data
In preclinical toxicity studies the most common effects noted included bone marrow depression, lymphoid atrophy and degenerative changes in the epithelium of the small and large intestines. Cardiovascular ...
List of excipients
Sodium stearyl fumarate Silicified microcrystalline cellulose Basic butylated methacrylate copolymer
Incompatibilities
Not applicable.
Shelf life
3 years. In-use: Unused broken tablets must be replaced in the bottle and must be used within three months.
Special precautions for storage
Store below 30°C.
Nature and contents of container
High density polyethylene (HDPE) bottle with polypropylene child-resistant closure with a dessicant unit. Siklos 100 mg film-coated tablets: Pack sizes of 60, 90 or 120 tablets. Not all pack sizes may ...
Special precautions for disposal and other handling
Siklos is a medicinal product that must be handled with care. People who are not taking Siklos and in particular pregnant women should avoid being in contact with hydroxycarbamide. Anyone handling Siklos ...
Marketing authorization holder
Addmedica, 37 rue de Caumartin, 75009 Paris, France, Phone: +33 1 72 69 01 86, Fax: +33 1 73 72 94 13, E-mail: contact@addmedica.com
Marketing authorization number(s)
Siklos 100 mg film-coated tablets: EU/1/07/397/002 EU/1/07/397/003 EU/1/07/397/004 Siklos 1000 mg film-coated tablets: EU/1/07/397/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 29/06/2007 Date of latest renewal: 24/04/2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
