Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Sucralfate
Chugai Pharma France
A02BX; A02BX02
Sucralfate
1 g/5ml
Oral suspension
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); sucralfate
Not marketed
2000-03-31
1.3.1 Spc, Labelling and Package Leaflet - UK and IE proposed leaflet INN_: _lenograstim _ _ Proposed – Dec 2018 CONFIDENTIAL Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GRANOCYTE 13 MILLION IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION IN A PRE- FILLED SYRINGE GRANOCYTE 34 MILLION IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION IN A PRE- FILLED SYRINGE Lenograstim READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again • If you have any further questions ask your doctor or pharmacist • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Granocyte is and what it is used for 2. What you need to know before you take Granocyte 3. How to take Granocyte 4. Possible side effects 5. How to store Granocyte 6. Contents of the pack and other information 1. WHAT GRANOCYTE IS AND WHAT IT IS USED FOR The name of your medicine is Granocyte, powder and solvent for injection/infusion (called Granocyte in this leaflet). Granocyte contains a medicine called lenograstim. This belongs to a group of medicines called cytokines. Granocyte works by helping your body to make more of the blood cells which fight infection. • These blood cells are made in your bone marrow. • Granocyte encourages your bone marrow to make more cells called ‘blood stem cells’. • It then helps turn these young blood cells into fully working blood cells. • In particular, it helps produce more white blood cells called neutrophils. Neutrophils are important in fighting infections. GRANOCYTE IS USED: • AFTER CANCER TREATMENT, IF THE LEVEL OF YOUR WHITE BLOOD CELLS IS TOO LOW (CALLED ‘NEUTROPENIA’) Some tre Preberite celoten dokument
Health Products Regulatory Authority 22 March 2019 CRN008QYF Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Antepsin 1g/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml dose contains 1 gram sucralfate. Each 5ml dose also contains sodium propyl hydroxybenzoate (E217) 2.0mg and sodium methyl hydroxybenzoate (E219) 3.75mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension White to off-white viscous suspension with an odour of aniseed/caramel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antepsin is indicated in adults and adolescents over 14 years old for the treatment of duodenal ulcer, gastric ulcer, chronic gastritis, and the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Antepsin must not be administered intravenously. _Duodenal ulcer, gastric ulcer, chronic gastritis:_ Adults: The usual dose is 2 grams twice daily to be taken on rising and at bedtime, or 1 gram 4 times a day to be taken 1 hour before meals and at bedtime. Maximum daily dose: 8 grams. Four to six weeks treatment is usually needed for ulcer healing, but up to twelve weeks may be necessary in resistant cases. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Antepsin. Paediatric population: The safety and efficacy of Antepsin in children under 14 years of age has not been established. Currently available data are described in section 5.1 but no recommendation on posology can be made. Elderly: see below _Prophylaxis of gastrointestinal haemorrhage from stress ulceration:_ Adults: The usual dose is 1 gram six times a day.A maximum dose of 8 grams daily should not be exceeded.Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Antepsin. Paediatric population The safety and efficacy of Antepsin in children under 14 years of age has no Preberite celoten dokument