Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
OBETICHOLIC ACID
NEOPHARM LTD, ISRAEL
A05AA04
FILM COATED TABLETS
OBETICHOLIC ACID 10 MG
PER OS
Required
ADVANZ PHARMA LIMITED, IRELAND
OBETICHOLIC ACID
OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
2023-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS ’ REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied upon a physician's prescription only OCALIVA ® 5 MG OCALIVA ® 10 MG FILM-COATED TABLETS FILM-COATED TABLETS COMPOSITION: COMPOSITION: THE ACTIVE INGREDIENT AND ITS QUANTITY: THE ACTIVE INGREDIENT AND ITS QUANTITY: Each film-coated tablet contains: Each film-coated tablet contains: obeticholic acid 5 mg obeticholic acid 10 mg For the list of excipients, please see section 6. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to the physician or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if you think that their illness is similar to yours. This medicine is intended for the treatment of adults over the age of 18 years. 1. WHAT IS THE MEDICINE INTENDED FOR? Ocaliva is intended for treatment of adult patients with a type of liver disease known as primary biliary cholangitis (also known as primary biliary cirrhosis), either by itself or together with another medicine, ursodeoxycholic acid. THERAPEUTIC GROUP: Bile and liver therapy, bile acids and derivatives OCALIVA contains the active substance obeticholic acid (farnesoid X-receptor agonist) which helps to improve how your liver works by reducing the production and build up of bile in the liver and also reducing inflammation. 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF: - You are hypersensitive (allergic) to the active ingredient (obeticholic acid) or to any of the other ingredients of this medicine (_see section 6_). - You have primary biliary cholangitis with liver cirrhosis with symptoms such as fluid in the belly or confusion (decompensated liver cirrhosis). - You have a complete blockage of the biliary tract (liver, gallbladder and bile ducts). SPECIAL WARNINGS REGARDING THE USE OF OCALIVA • Your doctor may need to inte Belgenin tamamını okuyun
Page 1 of 11 1. NAME OF THE MEDICINAL PRODUCT OCALIVA ® 5 mg OCALIVA ® 10 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION OCALIVA 5 mg film-coated tablets Each film-coated tablet contains 5 mg of obeticholic acid. OCALIVA 10 mg film-coated tablets Each film-coated tablet contains 10 mg of obeticholic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet OCALIVA 5 mg film-coated tablets Off white to yellow, round tablet debossed with ‘INT’ on one side and ‘5’ on the other side. OCALIVA 10 mg film-coated tablets Off white to yellow, triangular tablet, debossed with ‘INT’ on one side and ‘10’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Prior to initiation of treatment with obeticholic acid the patient’s hepatic status must be known. Whether the patient has decompensated cirrhosis (including Child-Pugh Class B or C) or has had a prior decompensation event should be determined prior to initiation of treatment because obeticholic acid is contraindicated in these patients (see sections 4.3 and 4.4)_. _ The starting dose of obeticholic acid is 5 mg once daily for the first 6 months. Limited data is available on Ocaliva as monotherapy. After the first 6 months, for patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin and who are tolerating obeticholic acid, increase to a maximum dose of 10 mg once daily. Page 2 of 11 No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid. _Management and dose adjustment for severe pruritus _ Management strategies include the addition of bile acid binding resins or antihistamines. For patients experiencing seve Belgenin tamamını okuyun