LEQVIO Solution for injection (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Leqvio 284 mg solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
Each pre-filled syringe contains inclisiran sodium equivalent to 284 mg inclisiran in 1.5 ml solution. Each ml contains inclisiran sodium equivalent to 189 mg inclisiran. For the full list of excipients, ...
3. Pharmaceutical form
Solution for injection (injection). The solution is clear, colourless to pale yellow, and essentially free of particulates.
4.1. Therapeutic indications
Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other ...
4.2. Posology and method of administration
Posology The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months. Missed doses If a planned dose is missed by ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Haemodialysis The effect of haemodialysis on inclisiran pharmacokinetics has not been studied. Considering that inclisiran is eliminated renally, haemodialysis should not be performed for at least 72 hours ...
4.5. Interaction with other medicinal products and other forms of interaction
Inclisiran is not a substrate for common drug transporters and, although in vitro studies were not conducted, it is not anticipated to be a substrate for cytochrome P450. Inclisiran is not an inhibitor ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of inclisiran in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ...
4.7. Effects on ability to drive and use machines
Leqvio has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The only adverse reactions associated with inclisiran were adverse reactions at the injection site (8.2%). Tabulated list of adverse reactions Adverse reactions are presented ...
4.9. Overdose
No clinically relevant adverse reactions were observed in healthy volunteers who received inclisiran at doses up to three times the therapeutic dose. No specific treatment for inclisiran overdose is available. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> lipid modifying agents, other lipid modifying agents <b>ATC code:</b> C10AX16 Mechanism of action Inclisiran is a cholesterol-lowering, double-stranded, small interfering ...
5.2. Pharmacokinetic properties
Absorption Following single subcutaneous administration, systemic exposure to inclisiran increased approximately dose-proportionally over a range from 24 mg to 756 mg. At the recommended dosing regimen ...
5.3. Preclinical safety data
In repeated dose toxicology studies conducted in rats and monkeys the no observed adverse effect levels (NOAEL) were identified as the highest doses administered subcutaneously which produced exposures ...
6.1. List of excipients
Water for injections Sodium hydroxide (for pH adjustment) Concentrated phosphoric acid (for pH adjustment)
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions. Do not freeze.
6.5. Nature and contents of container
1.5 ml solution in a pre-filled syringe (Type I glass) with plunger stopper (bromobutyl, fluorotec coated rubber) with needle and rigid needle shield. Pack size of one pre-filled syringe.
6.6. Special precautions for disposal and other handling
Leqvio should be inspected visually prior to administration. The solution should be clear, colourless to pale yellow and essentially free of particulates. If the solution contains visible particulate matter, ...
7. Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
8. Marketing authorization number(s)
EU/1/20/1494/001
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