SUTENT Hard capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Sutent 12.5 mg hard capsules. Sutent 25 mg hard capsules. Sutent 37.5 mg hard capsules. Sutent 50 mg hard capsules.
Qualitative and quantitative composition
12.5 mg hard capsules: Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib. 25 mg hard capsules: Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib. 37.5 mg ...
Pharmaceutical form
Hard capsule. Sutent 12.5 mg hard capsules: Gelatin capsules with orange cap and orange body, printed with white ink Pfizer on the cap, STN 12.5 mg on the body, and containing yellow to orange granules. ...
Therapeutic indications
Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment ...
Posology and method of administration
Therapy with Sutent should be initiated by a physician experienced in the administration of anticancer agents. Posology For GIST and MRCC, the recommended dose of Sutent is 50 mg taken orally once daily, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Co-administration with potent CYP3A4 inducers should be avoided because it may decrease sunitinib plasma concentration (see sections 4.2 and 4.5). Co-administration with potent CYP3A4 inhibitors should ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Medicinal products that may increase sunitinib plasma concentrations Effect of CYP3A4 inhibitors In healthy volunteers, concomitant administration ...
Fertility, pregnancy and lactation
Contraception in males and females Women of childbearing potential should be advised to use effective contraception and avoid becoming pregnant while receiving treatment with Sutent. Pregnancy There are ...
Effects on ability to drive and use machines
Sutent has minor influence on the ability to drive and use machines. Patients should be advised that they may experience dizziness during treatment with sunitinib.
Undesirable effects
Summary of the safety profile The most serious adverse reactions associated with sunitinib, some fatal, are renal failure, heart failure, pulmonary embolism, gastrointestinal perforation, and haemorrhages ...
Overdose
There is no specific antidote for overdose with Sutent and treatment of overdose should consist of general supportive measures. If indicated, elimination of unabsorbed active substance may be achieved ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE04 Mechanism of action Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, ...
Pharmacokinetic properties
The PK of sunitinib were evaluated in 135 healthy volunteers and 266 patients with solid tumours. The PK were similar in all solid tumours populations tested and in healthy volunteers. In the dosing ranges ...
Preclinical safety data
In rat and monkey repeated-dose toxicity studies up to 9-months duration, the primary target organ effects were identified in the gastrointestinal tract (emesis and diarrhoea in monkeys); adrenal gland ...
List of excipients
12.5 mg hard capsules Capsule content: Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate Capsule shell: Gelatin Red iron oxide (E172) Titanium dioxide (E171) Printing ink: Shellac ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
High-density polyethylene (HDPE) bottle with a polypropylene closure containing 30 hard capsules. Poly(chlorotrifluoroethylene)/PVC transparent perforated unit dose blister with aluminium foil coated with ...
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
Sutent 12.5 mg hard capsules: EU/1/06/347/001 EU/1/06/347/004 Sutent 25 mg hard capsules: EU/1/06/347/002 EU/1/06/347/005 Sutent 37.5 mg hard capsules: EU/1/06/347/007 EU/1/06/347/008 Sutent 50 mg hard ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 July 2006 Date of latest renewal: 9 November 2016
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