REPATHA Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Repatha 140 mg solution for injection in pre-filled syringe. Repatha 140 mg solution for injection in pre-filled pen. Repatha 420 mg solution for injection in cartridge.
Qualitative and quantitative composition
Repatha 140 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution. Repatha 140 mg solution for injection in pre-filled pen: Each pre-filled ...
Pharmaceutical form
Solution for injection (injection). Solution for injection (injection) (SureClick). Solution for injection (injection) (automated mini-doser). The solution is clear to opalescent, colourless to yellowish, ...
Therapeutic indications
Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: ...
Posology and method of administration
Prior to initiating Repatha, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded. Posology Primary hypercholesterolaemia and mixed dyslipidaemia ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Renal impairment There is limited experience with Repatha in patients with severe renal impairment (defined as eGFR <30 mL/min/1.73 m²) (see section 5.2). Repatha should be used with caution in patients ...
Interaction with other medicinal products and other forms of interaction
No formal drug-drug interaction studies have been conducted for Repatha. The pharmacokinetic interaction between statins and evolocumab was evaluated in the Repatha clinical trials. An approximately 20% ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of Repatha in pregnant women. Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity (see section ...
Effects on ability to drive and use machines
Repatha has no known influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions during pivotal trials, at the recommended doses, were nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain ...
Overdose
No adverse effects were observed in animal studies at exposures up to 300-fold higher than those in patients treated with Repatha at 420 mg once monthly. There is no specific treatment for Repatha overdose. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other lipid modifying agents ATC code: C10AX13 Mechanism of action Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein ...
Pharmacokinetic properties
Absorption and distribution Following a single subcutaneous dose of 140 mg or 420 mg Repatha administered to healthy adults, median peak serum concentrations were attained in 3 to 4 days. Administration ...
Preclinical safety data
Evolocumab was not carcinogenic in hamsters at exposures much higher than patients receiving evolocumab at 420 mg once monthly. The mutagenic potential of evolocumab has not been evaluated. In hamsters ...
List of excipients
Proline Glacial acetic acid Polysorbate 80 Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Repatha 140 mg solution for injection in pre-filled syringe: 3 years. Repatha 140 mg solution for injection in pre-filled pen: 3 years. Repatha 420 mg solution for injection in cartridge: 2 years.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Repatha 140 mg solution for injection in pre-filled syringe: Keep in the original carton in order to protect from light. Repatha 140 mg solution for injection ...
Nature and contents of container
Repatha 140 mg solution for injection in pre-filled syringe One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle. The needle cover of the pre-filled ...
Special precautions for disposal and other handling
Before administration, the solution should be inspected. Do not inject the solution if it contains particles, or is cloudy or discoloured. To avoid discomfort at the site of injection, allow the medicine ...
Marketing authorization holder
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Marketing authorization number(s)
Repatha 140 mg solution for injection in pre-filled syringe: EU/1/15/1016/001 1 pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen: EU/1/15/1016/002 1 pre-filled pen EU/1/15/1016/003 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 July 2015
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