OCALIVA Film-coated tablet (2023)
Βιβλιογραφική αναφορά
Συγγραφείς
ADVANZ PHARMA Limited
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Περιεχόμενα
Name of the medicinal product
Ocaliva 5 mg film-coated tablets. Ocaliva 10 mg film-coated tablets.
Qualitative and quantitative composition
<u>Ocaliva 5 mg film-coated tablets:</u> Each film-coated tablet contains 5 mg of obeticholic acid. <u>Ocaliva 10 mg film-coated tablets:</u> Each film-coated tablet contains 10 mg of obeticholic acid. ...
Pharmaceutical form
Film-coated tablet. <u>Ocaliva 5 mg film-coated tablets:</u> Yellow, 8 mm round tablet debossed with INT on one side and 5 on the other side. <u>Ocaliva 10 mg film-coated tablets:</u> Yellow, 8 mm × 7 ...
Therapeutic indications
Ocaliva is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable ...
Posology and method of administration
Posology Prior to initiation of treatment with obeticholic acid the patients hepatic status must be known. Whether the patient has decompensated cirrhosis (including Child-Pugh Class B or C) or has had ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event (see section ...
Special warnings and precautions for use
Hepatic adverse events Hepatic failure, sometimes fatal or resulting in liver transplant, has been reported with obeticholic acid treatment in PBC patients with either compensated or decompensated cirrhosis. ...
Interaction with other medicinal products and other forms of interaction
Effect of other medicinal products on obeticholic acid Bile acid binding resins Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may ...
Fertility, pregnancy and lactation
Pregnancy There are no data on the use of obeticholic acid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ...
Effects on ability to drive and use machines
Ocaliva has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%). The most common adverse reaction leading to discontinuation was pruritus. The majority ...
Overdose
The highest single dose exposure of obeticholic acid in healthy volunteers has been at the 500 mg dose. Repeated doses of 250 mg have been administered for 12 consecutive days and some subjects experienced ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Bile and liver therapy, bile acids and derivatives <b>ATC code:</b> A05AA04 Mechanism of action Obeticholic acid is a selective and potent agonist for the farnesoid X ...
Pharmacokinetic properties
Absorption Obeticholic acid is absorbed with peak plasma concentrations (C<sub>max</sub>) occurring at a median time (t<sub>max</sub>) of approximately 2 hours. Co-administration with food does not alter ...
Preclinical safety data
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, reproduction ...
List of excipients
<u>Tablet core:</u> Microcrystalline cellulose (E460) Sodium starch glycolate (Type A) Magnesium stearate <u>Tablet coating:</u> Poly(vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171) ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
High-density polyethylene (HDPE) bottles with a child resistant polypropylene closure and an aluminium foil induction seal. <u>Pack size:</u> 30 or 100 film-coated tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
ADVANZ PHARMA Limited, Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland
Marketing authorization number(s)
EU/1/16/1139/001 EU/1/16/1139/002 EU/1/16/1139/003 EU/1/16/1139/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 December 2016 Date of latest renewal: 09 November 2022
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