PRALUENT Solution for injection (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Praluent 75 mg solution for injection in pre-filled pen. Praluent 150 mg solution for injection in pre-filled pen. Praluent 75 mg solution for injection in pre-filled syringe. Praluent 150 mg solution ...
Qualitative and quantitative composition
<u>Praluent 75 mg solution for injection in pre-filled pen:</u> Each single-use pre-filled pen contains 75 mg alirocumab in 1 ml solution. <u>Praluent 75 mg solution for injection in pre-filled syringe: ...
Pharmaceutical form
Solution for injection (injection). Clear, colourless to pale yellow solution. pH: 5.7-6.3 Osmolality: Praluent 75 mg solution for injection: 293-439 mOsm/kg Praluent 150 mg solution for injection: 383-434 ...
Therapeutic indications
Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to ...
Posology and method of administration
Posology Prior to initiating Praluent secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g. nephrotic syndrome, hypothyroidism) should be excluded. The usual starting dose for Praluent is 75 ...
Contraindications
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 name and the batch number of the administered product should be clearly recorded. Allergic reactions General allergic ...
Interaction with other medicinal products and other forms of interaction
Effects of alirocumab on other medicinal products Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Praluent in pregnant women. Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier (see section 5.3). Animal studies ...
Effects on ability to drive and use machines
Praluent has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common adverse reactions, at recommended doses, are local injection site reactions (6.1%), upper respiratory tract signs and symptoms (2.0%), and pruritus (1.1%). ...
Overdose
There is no specific treatment for alirocumab overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> lipid modifying agents, other lipid modifying agents <b>ATC code:</b> C10AX14 Mechanism of action Alirocumab is a fully human IgG1 monoclonal antibody that binds with ...
Pharmacokinetic properties
Absorption After subcutaneous administration of 50 mg to 300 mg alirocumab, median times to maximum serum concentration (t<sub>max</sub>) were 3-7 days. The pharmacokinetics of alirocumab after single ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on evaluations of safety pharmacology, and repeated dose toxicity. Reproductive toxicology studies in rats and monkeys indicated that alirocumab, ...
List of excipients
Histidine Sucrose Polysorbate 20 Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
<u>Praluent 75 mg solution for injection in pre-filled pen:</u> 3 years. <u>Praluent 75 mg solution for injection in pre-filled syringe:</u> 3 years. <u>Praluent 150 mg solution for injection in pre-filled ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Praluent can be stored outside the refrigerator (below 25°C) protected from light for a single period not exceeding 30 days. After removal from the ...
Nature and contents of container
1 ml solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber soft needle shield, and an ethylene tetrafluoroethylene-coated bromobutyl ...
Special precautions for disposal and other handling
The solution should be clear, colourless to pale yellow. If the solution is discoloured or contains visible particulate matter, the solution should not be used. After use, place the pre-filled pen/pre-filled ...
Marketing authorization holder
Marketing Authorisation Holder: sanofi-aventis groupe, 54, rue La Boétie, F – 75008 Paris, France
Marketing authorization number(s)
EU/1/15/1031/001 EU/1/15/1031/002 EU/1/15/1031/003 EU/1/15/1031/004 EU/1/15/1031/005 EU/1/15/1031/006 EU/1/15/1031/007 EU/1/15/1031/008 EU/1/15/1031/009 EU/1/15/1031/010 EU/1/15/1031/011 EU/1/15/1031/012 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 September 2015 Date of latest renewal: 2 June 2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
