ONPATTRO Concentrate for solution for infusion (2023)
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Περιεχόμενα
Name of the medicinal product
Onpattro 2 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
Each mL contains patisiran sodium equivalent to 2 mg patisiran. Each vial contains patisiran sodium equivalent to 10 mg patisiran formulated as lipid nanoparticles. Excipients with known effect: Each mL ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). White to off-white, opalescent, homogeneous solution (pH approximately 7).
Therapeutic indications
Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Posology and method of administration
Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis. Posology The recommended dose of Onpattro is 300 micrograms per kg body weight administered ...
Contraindications
Severe hypersensitivity (e.g., anaphylaxis) to the active substance or any of the excipients listed in section 6.1.
Special warnings and precautions for use
Infusion-related reactions IRRs have been observed in patients treated with Onpattro. In patients experiencing an IRR, the majority experienced the first IRR within the first 2 infusions (see section 4.8). ...
Interaction with other medicinal products and other forms of interaction
No formal clinical drug interaction studies have been performed. Onpattro is not expected to be affected by inhibitors or inducers of cytochrome P450 enzymes or to cause drug-drug interactions, except ...
Fertility, pregnancy and lactation
Women of childbearing potential Treatment with Onpattro reduces serum levels of vitamin A. Both too high or too low vitamin A levels may be associated with an increased risk of foetal malformation. Therefore, ...
Effects on ability to drive and use machines
On the basis of the pharmacodynamic and pharmacokinetic profiles, Onpattro is considered to have no or negligible influence on the ability to drive or use machines.
Undesirable effects
Summary of the safety profile The most frequently occurring adverse reactions reported in Onpattro-treated patients were peripheral oedema (29.7%) and infusion-related reactions (18.9%). The only adverse ...
Overdose
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and given symptomatic treatment, as appropriate.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other nervous System Drugs <b>ATC code:</b> N07XX12 Mechanism of action Onpattro contains patisiran, a double-stranded small interfering ribonucleic acid (siRNA) that ...
Pharmacokinetic properties
The pharmacokinetic properties of Onpattro were characterised by measuring the plasma concentrations of patisiran and the lipid components DLin-MC3-DMA and PEG<sub>2000</sub>-C-DMG. Absorption Greater ...
Preclinical safety data
General toxicology Liver and spleen were the primary target organs of toxicity in both rats and monkeys. Intravenous administration of Onpattro led to increases in serum liver markers (ALT, AST, ALP, and/or ...
List of excipients
DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino)butanoate) PEG2000-C-DMG (α-(3'propyl)ω-methoxy,polyoxyethylene) DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine) ...
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life <u>Unopened vials:</u> 3 years. <u>After dilution:</u> Chemical and physical in-use stability has been demonstrated for 16 hours at room temperature (up to 30°C). From a microbiological point ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. If refrigeration is not available, Onpattro can be stored at room temperature up to 25°C for up to 14 days. For storage conditions after dilution of ...
Nature and contents of container
5 mL concentrate in a Type I glass vial with a chlorobutyl stopper and an aluminium flip-off cap. Pack size of 1 vial.
Special precautions for disposal and other handling
This medicinal product is for single-use only. Onpattro must be diluted with sodium chloride 9 mg/mL (0.9%) solution prior to intravenous infusion. The diluted solution for infusion should be prepared ...
Marketing authorization holder
Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
Marketing authorization number(s)
EU/1/18/1320/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 August 2018
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