YERVOY Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
YERVOY 5 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
Each ml of concentrate contains 5 mg ipilimumab. One 10 ml vial contains 50 mg of ipilimumab. One 40 ml vial contains 200 mg of ipilimumab. Ipilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1κ) ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates and has a pH of 7.0 and an osmolarity ...
Therapeutic indications
Melanoma YERVOY as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older (see section 4.4). YERVOY in combination ...
Posology and method of administration
Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer. Posology YERVOY as monotherapy Melanoma Adults and adolescents 12 years of age and older: The ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Ipilimumab in combination with nivolumab When ipilimumab is administered in combination with nivolumab, refer to the Summary of Product Characteristics for nivolumab prior to initiation of treatment. For ...
Interaction with other medicinal products and other forms of interaction
Ipilimumab is a human monoclonal antibody that is not metabolized by cytochrome P450 enzymes (CYPs) or other drug metabolizing enzymes. A drug-interaction study in adults of ipilimumab administered alone ...
Fertility, pregnancy and lactation
Pregnancy There are no data on the use of ipilimumab in pregnant women. Animal reproduction studies have shown reproductive toxicity (see section 5.3). Human IgG1 crosses the placental barrier. The potential ...
Effects on ability to drive and use machines
YERVOY has minor influence on the ability to drive and use machines. Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or ...
Undesirable effects
Ipilimumab as monotherapy (see section 4.2) a. Summary of safety profile Ipilimumab has been administered to approximately 10,000 patients in a clinical program evaluating its use with various doses and ...
Overdose
The maximum tolerated dose of ipilimumab has not been determined. In clinical trials, patients received up to 20 mg/kg without apparent toxic effects. In case of overdose, patients must be closely monitored ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC11 Mechanism of action Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity. Ipilimumab ...
Pharmacokinetic properties
The pharmacokinetics of ipilimumab was studied in 785 patients with advanced melanoma who received induction doses ranging from 0.3 to 10 mg/kg administered once every 3 weeks for 4 doses. C<sub>max</sub> ...
Preclinical safety data
In intravenous repeat-dose toxicology studies in monkeys, ipilimumab was generally well tolerated. Immune-mediated adverse reactions were observed infrequently (~3%) and included colitis (which resulted ...
List of excipients
Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride) Sodium chloride Mannitol (E421) Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80 Sodium hydroxide (for pH-adjustment) ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life Unopened vial: 3 years. After opening: From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately. The chemical and physical ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light. For storage conditions after first opening or dilution of the medicinal product, see section ...
Nature and contents of container
10 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium). Pack size of 1. 40 ml of concentrate in a vial (Type I glass) with a stopper (coated ...
Special precautions for disposal and other handling
Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Marketing authorization holder
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Marketing authorization number(s)
EU/1/11/698/001-002
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 July 2011 Date of latest renewal: 21 April 2016
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