SYLVANT Powder for concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
SYLVANT 100 mg powder for concentrate for solution for infusion. SYLVANT 400 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
SYLVANT 100 mg powder for concentrate for solution for infusion: Each single-use vial contains 100 mg siltuximab powder for concentrate for solution for infusion. After reconstitution the solution contains ...
Pharmaceutical form
Powder for concentrate for solution for infusion (powder for concentrate). The product is a freeze-dried white powder.
Therapeutic indications
SYLVANT is indicated for the treatment of adult patients with multicentric Castlemans disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Posology and method of administration
This medicinal product should be administered by qualified healthcare professionals and under appropriate medical supervision. Posology The recommended dose is 11 mg/kg siltuximab given over 1 hour as ...
Contraindications
Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Concurrent active serious ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. In non-clinical studies, interleukin-6 (IL-6) is known to decrease the activity of cytochrome P450 (CYP450). Binding bioactive IL-6 by siltuximab may result ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential must use effective contraception during and up to 3 months after treatment (see section 4.5). Pregnancy There are no data from the use of ...
Effects on ability to drive and use machines
Siltuximab has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Infections (including upper respiratory tract infections), pruritus, rash, arthralgia, and diarrhoea were the most common adverse reactions, occurring in >20% of siltuximab-treated ...
Overdose
No case of overdose has been reported in clinical trials. In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppresants, interleukin inhibitors ATC code: L04AC11 Mechanism of action Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes ...
Pharmacokinetic properties
Following the first administration of siltuximab (doses ranging from 0.9 to 15 mg/kg), the area under the concentration-time curve (AUC) and maximal serum concentration (Cmax) increased in a dose-proportional ...
Preclinical safety data
The repeat-dose toxicology studies conducted in young cynomolgus monkeys at doses of 9.2 and 46 mg/kg/week (up to 22-fold greater exposure than in patients receiving 11 mg/kg every 3 weeks) with siltuximab ...
List of excipients
Histidine Histidine hydrochloride monohydrate Polysorbate 80 Sucrose
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Unopened vial: 3 years. After reconstitution and dilution: Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6). From a microbiological point ...
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 reconstitution and dilution of the medicinal product, see section ...
Nature and contents of container
SYLVANT 100 mg powder for concentrate for solution for infusion: 8 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of siltuximab. Pack size ...
Special precautions for disposal and other handling
This medicinal product is for single use only. Use aseptic technique. Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed. The recommended needle ...
Marketing authorization holder
EUSA Pharma (Netherlands) B.V., Johannes Vermeerplein 11, 1071 DV, Amsterdam, Netherlands
Marketing authorization number(s)
SYLVANT 100 mg powder for concentrate for solution for infusion: EU/1/14/928/001 SYLVANT 400 mg powder for concentrate for solution for infusion: EU/1/14/928/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 May 2014 Date of latest renewal: 2 April 2019
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