OPDIVO Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
OPDIVO 10 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
Each mL of concentrate contains 10 mg of nivolumab. One vial of 4 mL contains 40 mg of nivolumab. One vial of 10 mL contains 100 mg of nivolumab. One vial of 24 mL contains 240 mg of nivolumab. Nivolumab ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to pale yellow liquid that may contain few light particles. The solution has a pH of approximately 6.0 and an ...
Therapeutic indications
Melanoma OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase ...
Posology and method of administration
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. Posology OPDIVO as monotherapy The recommended dose of OPDIVO is either nivolumab 240 mg every 2 weeks or ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
When nivolumab is administered in combination with ipilimumab, refer to the Summary of Product Characteristics for ipilimumab prior to initiation of treatment. Immune-related adverse reactions have occurred ...
Interaction with other medicinal products and other forms of interaction
Nivolumab is a human monoclonal antibody, as such pharmacokinetic interaction studies have not been conducted. As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug ...
Pregnancy and lactation
Pregnancy There are no data on the use of nivolumab in pregnant women. Studies in animals have shown embryofoetal toxicity (see section 5.3). Human IgG4 is known to cross the placental barrier and nivolumab ...
Effects on ability to drive and use machines
Based on its pharmacodynamic properties, nivolumab is unlikely to affect the ability to drive and use machines. Because of potential adverse reactions such as fatigue (see section 4.8), patients should ...
Undesirable effects
Nivolumab as monotherapy (see section 4.2) Summary of the safety profile In the pooled dataset of nivolumab 3 mg/kg as monotherapy across tumour types (n=2578) with minimum follow-up ranging from 2.3 to ...
Overdose
No cases of overdose have been reported in clinical trials. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC17 Mechanism of action Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the ...
Pharmacokinetic properties
The pharmacokinetics (PK) of nivolumab is linear in the dose range of 0.1 to 10 mg/kg. The geometric mean clearance (CL), terminal half-life, and average exposure at steady state at 3 mg/kg every 2 weeks ...
Preclinical safety data
Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to increase foetal loss. The effects of nivolumab on prenatal and postnatal development ...
List of excipients
Sodium citrate dihydrate Sodium chloride Mannitol (E421) Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80 Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. OPDIVO should not be infused concomitantly in the same intravenous line with other medicinal ...
Shelf life
Shelf life Unopened vial: 40 mg/4 mL and 100 mg/10 mL vials: 3 years. 240 mg/24 mL vial: 2 years. After opening: From a microbiological point of view, once opened, the medicinal product should be infused ...
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. The unopened vial can be stored at controlled room temperature up to 25°C with room light ...
Nature and contents of container
4 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a dark blue flip-off seal (aluminium). Pack size of 1 vial. 10 mL of concentrate in a 10 mL vial (Type I glass) ...
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. Preparation and administration Calculating the dose More than one vial ...
Marketing authorization holder
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Marketing authorization number(s)
EU/1/15/1014/001 EU/1/15/1014/002 EU/1/15/1014/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 June 2015
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