OCREVUS Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Ocrevus 300 mg concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30 mg/mL. The final drug concentration after dilution is approximately 1.2 mg/mL. Ocrelizumab is a recombinant humanised anti-CD20 ...
Pharmaceutical form
Concentrate for solution for infusion. Clear to slightly opalescent, and colourless to pale brown solution.
Therapeutic indications
Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1). Ocrevus is indicated ...
Posology and method of administration
Ocrevus treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Current active infection (see section 4.4). Patients in a severely immunocompromised state (see section 4.4). ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-Related Reactions (IRRs) ...
Interaction with other medicinal products and other forms of interaction
No formal drug interaction studies have been performed, as no drug interactions are expected via cytochrome P450 enzymes, other metabolising enzymes or transporters. Vaccinations The safety of immunisation ...
Fertility, pregnancy and lactation
Women of child bearing potential Women of child bearing potential should use contraception while receiving Ocrevus and for 12 months after the last infusion of Ocrevus (see below and section 5.1 and 5.2). ...
Effects on ability to drive and use machines
Ocrevus has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most important and frequently reported adverse drug reactions (ADRs) were IRRs and infections. See section 4.4 and section 4.8 (subsection Description of selected adverse ...
Overdose
There is limited clinical trial experience with doses higher than the approved intravenous dose of Ocrevus. The highest dose tested to date in MS patients is 2000 mg, administered as two 1000 mg intravenous ...
Pharmacodynamic properties
Pharmacotherapeutic group: selective immunosuppressants group ATC code: L04AA36 Mechanism of Action Ocrelizumab is a recombinant humanised monoclonal antibody that selectively targets CD20-expressing B ...
Pharmacokinetic properties
The pharmacokinetics of ocrelizumab in the MS studies were described by a two compartment model with time-dependent clearance, and with PK parameters typical for an IgG1 monoclonal antibody. The overall ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and embryo-foetal development. Neither carcinogenicity nor mutagenicity ...
List of excipients
Sodium acetate trihydrate Glacial acetic acid Trehalose dihydrate Polysorbate 20 Water for injection
Incompatibilities
No incompatibilities between Ocrevus and polyvinyl chloride (PVC) or polyolefin (PO) bags and intravenous administration sets have been observed. Do not use diluents other than the one detailed in section ...
Shelf life
Shelf life Unopened vial: 24 months. Diluted solution for intravenous infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently for 8 hours at room temperature. ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the vials in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
10 mL concentrate in a glass vial. Pack size of 1 or 2 vials. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Instructions for dilution Ocrevus should be prepared by a healthcare professional using aseptic technique. Do not shake the vial. The product is intended for single use only. Do not use the solution if ...
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/17/1231/001 EU/1/17/1231/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 8 January 2018
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