국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Lactulose
Pinewood Laboratories Ltd
A06AD; A06AD11
Lactulose
3.35 g/5ml
Oral solution
Product not subject to medical prescription
Osmotically acting laxatives; lactulose
Not marketed
1996-05-07
FOR THE RELIEF OF CONSTIPATION 500 ML BALLYMACARBRY, CO. TIPPERARY. LACTULOSE SOLUTION BP 3.35 G/5 ML ORAL SOLUTION P PATIENT Adults & adolescents Children, 7 - 14 years Children, 1 - 6 years Infants under 1 year STARTING DOSE DAILY 15 - 45 ml 15 ml 5 - 10 ml Up to 5 ml FOR ORAL ADMINISTRATION. EACH 5 ML OF LAXOSE™ CONTAINS: 3.35 g of Lactulose. Also includes Lactose, Galactose and Fructose. CONSTIPATION: HEPATIC ENCEPHALOPATHY (hepatic coma): Initially 30 - 45 ml three to four times daily. Read the package leaftlet before use. Use as directed by your doctor or pharmacist. The action of Laxose may take 2 - 3 days to show results hence it is important to take the medicine regularly as directed. Keep out of the sight and reach of children. Do not store above 25˚C. Do not freeze. PA Holder: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PA 281/79/1 23LL05176PW FOR THE RELIEF OF CONSTIPATION 500 ML BALLYMACARBRY, CO. TIPPERARY. LACTULOSE SOLUTION BP 3.35 G/5 ML ORAL SOLUTION P PATIENT Adults & adolescents Children, 7 - 14 years Children, 1 - 6 years Infants under 1 year STARTING DOSE DAILY 15 - 45 ml 15 ml 5 - 10 ml Up to 5 ml FOR ORAL ADMINISTRATION. EACH 5 ML OF LAXOSE™ CONTAINS: 3.35 g of Lactulose. Also includes Lactose, Galactose and Fructose. CONSTIPATION: HEPATIC ENCEPHALOPATHY (hepatic coma): Initially 30 - 45 ml three to four times daily. Read the package leaftlet before use. Use as directed by your doctor or pharmacist. The action of Laxose may take 2 - 3 days to show results hence it is important to take the medicine regularly as directed. Keep out of the sight and reach of children. Do not store above 25˚C. Do not freeze. PA Holder: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PA 281/79/1 23LL05176PW 25˚C. Do not freeze. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OT 전체 문서 읽기
Health Products Regulatory Authority 09 June 2022 CRN00CY5T Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Laxose (Lactulose Solution BP) 3.35g/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of solution contains 3.35 g lactulose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear to almost clear pale yellow oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of hepatic encephalopathy (HE). In the treatment of constipation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The lactulose solution may be administered diluted or undiluted. A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time. The posology should be adjusted according to the individual needs of the patient. In case of a single daily dose, this should be taken at the same time e.g. during breakfast. During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5 – 2 litres, equal to 6-8 glasses) during the day. DOSING IN CONSTIPATION Lactulose may be given as a single daily dose or in two divided doses. After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs. Starting dose daily Maintenance dose daily Adults and adolescents 15 - 45 ml 15 – 30 ml Children (7-14 years) 15 ml 10 – 15 ml Children (1-6 years) 5 - 10 ml 5 – 10 ml Infants under 1 year Up to 5 ml Up to 5 ml Health Products Regulatory Authority 09 June 2022 CRN00CY5T Page 2 of 6 DOSING IN HEPATIC ENCEPHALOPATHY HE (FOR ADULTS ONLY) Starting Dose Maintenance Dose 3 to 4 times daily 30-45 ml Starting dose may be adjusted to the maintenance dose to achieve 2 – 3 soft stools per day PAEDIATRIC POPULATION The safety and efficacy in children (newborn to 18 years of age) with HE have not been established. No data is available. ELDERLY PATIENTS A 전체 문서 읽기