NINLARO Hard capsule (2019)
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Περιεχόμενα
Name of the medicinal product
NINLARO 2.3 mg hard capsules. NINLARO 3 mg hard capsules. NINLARO 4 mg hard capsules.
Qualitative and quantitative composition
NINLARO 2.3 mg hard capsules: Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate). NINLARO 3 mg hard capsules: Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate). ...
Pharmaceutical form
Hard capsule. NINLARO 2.3 mg hard capsules: Light pink, size 4 gelatin hard capsule, marked Takeda on the cap and 2.3 mg on the body with black ink. NINLARO 3 mg hard capsules: Light grey, size 4 gelatin ...
Therapeutic indications
NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Posology and method of administration
Treatment must be initiated and monitored under the supervision of a physician experienced in the management of multiple myeloma. Posology The recommended starting dose of ixazomib is 4 mg administered ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal ...
Special warnings and precautions for use
As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional special warnings and precautions for use. Thrombocytopenia ...
Interaction with other medicinal products and other forms of interaction
Pharmacokinetic interactions CYP inhibitors Co-administration of ixazomib with clarithromycin, a strong CYP3A inhibitor, did not result in a clinically meaningful change in the systemic exposure of ixazomib. ...
Fertility, pregnancy and lactation
As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional information on fertility, pregnancy and lactation. Women of ...
Effects on ability to drive and use machines
Ixazomib has minor influence on the ability to drive or use machines. Fatigue and dizziness have been observed in clinical trials. Patients should be advised not to drive or operate machines if they experience ...
Undesirable effects
As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional undesirable effects. Summary of the safety profile The data ...
Overdose
There is no known specific antidote for ixazomib overdose. Clinical data is limited but doses up to 12 mg have been reported in the randomised controlled trial. In the event of an overdose, monitor the ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents ATC code: L01XX50 Mechanism of action Ixazomib citrate, a prodrug, is a substance that rapidly hydrolyses under physiological ...
Pharmacokinetic properties
Absorption After oral administration, peak plasma concentrations of ixazomib were achieved at approximately one hour after dosing. The mean absolute oral bioavailability is 58%. Ixazomib AUC increases ...
Preclinical safety data
Mutagenicity Ixazomib was not mutagenic in a bacterial reverse mutation assay (Ames assay) or clastogenic in a bone marrow micronucleus assay in mice. Ixazomib was positive in an in vitro clastogenicity ...
List of excipients
NINLARO 2.3 mg hard capsules Capsule contents: Microcrystalline cellulose Magnesium stearate Talc Capsule shell: Gelatin Titanium dioxide (E171) Red iron oxide (E172) Printing ink: Shellac Propylene glycol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C. Do not freeze. Store in the original package in order to protect from moisture.
Nature and contents of container
PVC-Aluminium/Aluminium blister sealed inside a wallet pack containing one capsule. Three single blister wallet packs are packaged in one carton.
Marketing authorization holder
Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark
Marketing authorization number(s)
EU/1/16/1094/001 EU/1/16/1094/002 EU/1/16/1094/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 November 2016 Date of Last Renewal: 16 September 2019
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