ICLUSIG Film-coated tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Iclusig 15 mg film-coated tablets. Iclusig 30 mg film-coated tablets. Iclusig 45 mg film-coated tablets.
Qualitative and quantitative composition
Iclusig 15 mg film-coated tablets: Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride). Excipients with known effect: Each film-coated tablet contains 40 mg of lactose monohydrate. ...
Pharmaceutical form
Film-coated tablet (tablet). Iclusig 15 mg film-coated tablets: White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with A5 debossed on one side. Iclusig 30 mg film-coated ...
Therapeutic indications
Iclusig is indicated in adult patients with: chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib ...
Posology and method of administration
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. Haematologic support such as platelet transfusion and haematopoietic growth factors can ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Important adverse reactions Myelosuppression Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and ...
Interaction with other medicinal products and other forms of interaction
Substances that may increase ponatinib serum concentrations CYP3A inhibitors Ponatinib is metabolized by CYP3A4. Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole ...
Pregnancy and lactation
Women of childbearing potential / Contraception in males and females Women of childbearing age being treated with Iclusig should be advised not to become pregnant and men being treated with Iclusig should ...
Effects on ability to drive and use machines
Iclusig has minor influence on the ability to drive and use machines. Adverse reactions such as lethargy, dizziness, and vision blurred have been associated with Iclusig. Therefore, caution should be recommended ...
Undesirable effects
Summary of the safety profile The adverse reactions described in this section were identified in a single-arm, open-label, international, multicenter trial in 449 CML and Ph+ ALL patients who were resistant ...
Overdose
Isolated reports of unintentional overdose with Iclusig were reported in clinical trials. Single doses of 165 mg and an estimated 540 mg in two patients did not result in any clinically significant adverse ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors ATC code: L01XE24 Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, ...
Pharmacokinetic properties
Absorption Peak concentrations of ponatinib are observed approximately 4 hours after oral administration. Within the range of clinically relevant doses evaluated in patients (15 mg to 60 mg), ponatinib ...
Preclinical safety data
Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity studies. Ponatinib did not exhibit genotoxic properties when ...
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Colloidal anhydrous silica Magnesium stearate Tablet coating: Talc Macrogol 4000 Poly(vinyl alcohol) Titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in the original container in order to protect from light. The bottle contains one sealed canister containing a molecular sieve desiccant. Keep the canister in the bottle.
Nature and contents of container
Iclusig 15 mg film-coated tablets: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30, 60 or 180 film-coated tablets, together with one plastic canister containing a ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
Marketing authorization number(s)
Iclusig 15 mg film-coated tablets: EU/1/13/839/001 EU/1/13/839/002 EU/1/13/839/005 Iclusig 30 mg film-coated tablets: EU/1/13/839/006 Iclusig 45 mg film-coated tablets: EU/1/13/839/003 EU/1/13/839/004 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 1 July 2013 Date of latest renewal: 8 February 2018
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