NILEMDO Film-coated tablet (2024)
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Περιεχόμενα
1. Name of the medicinal product
Nilemdo 180 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 180 mg of bempedoic acid. <u>Excipient(s) with known effect:</u> Each 180 mg film-coated tablet contains 28.5 mg of lactose. For the full list of excipients, see section ...
3. Pharmaceutical form
Film-coated tablet. White to off-white, oval, film-coated tablet of approximately 13.97 mm × 6.60 mm × 4.80 mm debossed with 180 on one side and ESP on the other side.
4.1. Therapeutic indications
Hypercholesterolaemia and mixed dyslipidaemia Nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: in ...
4.2. Posology and method of administration
Posology The recommended dose of Nilemdo is one film-coated tablet of 180 mg taken once daily. Concomitant simvastatin therapy When Nilemdo is coadministered with simvastatin, simvastatin dose should be ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6). Breast-feeding (see section 4.6). Concomitant use with simvastatin >40 mg daily ...
4.4. Special warnings and precautions for use
Potential risk of myopathy with concomitant use of statins Bempedoic acid increases plasma concentrations of statins (see section 4.5). Patients receiving Nilemdo as adjunctive therapy to a statin should ...
4.5. Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on bempedoic acid Transporter-mediated drug interactions <em>In vitro</em> drug interaction studies suggest bempedoic acid, as well as its active metabolite and glucuronide ...
4.6. Fertility, pregnancy and lactation
Pregnancy Nilemdo is contraindicated during pregnancy (see section 4.3). There are no or limited amount of data from the use of bempedoic acid in pregnant women. Studies in animals with bempedoic acid ...
4.7. Effects on ability to drive and use machines
Nilemdo has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The safety profile of bempedoic acid has been studied in 4 placebo-controlled phase 3 primary hyperlipidaemia studies (N=3 621) including patients with hypercholesterolemia ...
4.9. Overdose
Doses up to 240 mg/day (1.3 times the approved recommended dose) have been administered in clinical trials with no evidence of dose limiting toxicity. No adverse events were observed in animal studies ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Lipid modifying agents, other lipid modifying agents <b>ATC code:</b> C10AX15 Mechanism of action Bempedoic acid is an adenosine triphosphate citrate lyase (ACL) inhibitor ...
5.2. Pharmacokinetic properties
Absorption Pharmacokinetic data indicate that bempedoic acid is absorbed with a median time to maximum concentration of 3.5 hours when administered as Nilemdo 180 mg tablets. Bempedoic acid pharmacokinetic ...
5.3. Preclinical safety data
The standard battery of genotoxicity studies has not identified any mutagenic or clastogenic potential of bempedoic acid. In full lifetime carcinogenicity studies in rodents, bempedoic acid increased the ...
6.1. List of excipients
<u>Tablet core:</u> Lactose monohydrate Microcrystalline cellulose (E460) Sodium starch glycolate (Type A grade) Hydroxypropyl cellulose (E463) Magnesium stearate (E470b) Silica, colloidal anhydrous (E551) ...
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Polyvinyl chloride (PVC)/aluminum blisters. Pack sizes of 10, 14, 28, 30, 84, 90, 98 or 100 film-coated tablets. Polyvinyl chloride (PVC)/aluminum perforated unit dose blisters. Pack sizes of 10 1, 50 ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
8. Marketing authorization number(s)
EU/1/20/1425/001 011
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01/04/2020
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