দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
CHLORPHENAMINE MALEATE
Archimedes Pharma UK Limited
R06AB04
CHLORPHENAMINE MALEATE
10 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Substituted alkylamines
Authorised
1995-06-10
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 nurse. − If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Chlorphenamine is and what it is used for 2. What you need to know before Chlorphenamine is given 3. How Chlorphenamine is given 4. Possible side effects 5. How to store Chlorphenamine 6. Contents of the pack and other information 1. WHAT CHLORPHENAMINE IS AND WHAT IT IS USED FOR Chlorphenamine 10mg/ml Solution for Injection contains the active ingredient chlorphenamine maleate which is an antihistamine. These medicines inhibit the release of histamine into the body that occurs during an allergic reaction. This product relieves some of the main symptoms of a severe allergic reaction. This injection is usually given to you by your doctor or someone else trained to give it to you. 2. WHAT YOU NEED TO KNOW BEFORE CHLORPHENAMINE IS GIVEN YOU MUST NOT BE GIVEN CHLORPHENAMINE IF YOU: • are ALLERGIC to chlorphenamine maleate or any of the other ingredients in the product (_see section 6: Contents of the pack and _ _other information_) • are in a PRE-COMA state • have had monoamine oxidase inhibitor (MAOI) ANTIDEPRESSIVE TREATMENT within the past 14 days. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given this medicine if you: • are being treated for an OVERACTIVE THYROID or ENLARGED PROSTATE GLAND • have EPILEPSY, GLAUCOMA or raised pressure within the eye, very HIGH BLOOD PRESSURE, HEART DISEASE, LIVER DISEASE, ASTHMA or other CHEST DISEASES. Children and the elderly are more likely to experience certain side effects (see section 4: Possible side effects). OTHER MEDICINES AND CHLORPHENAMINE Tell your doctor or pharmacist if you ar সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorphenamine 10mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of solution contains: Chlorphenamine Maleate 10 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for Injection. Clear colourless sterile solution for injections. 4 CLINICAL PARTICULARS Chlorphenamine maleate is a potent antihistamine (H 1 -receptor antagonist). Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine 1 receptor sites on tissues. Chlorphenamine also has anticholinergic activity. 4.1 THERAPEUTIC INDICATIONS In the treatment of acute allergic reactions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intramuscular Subcutaneous Intravenous When administered intravenously the injection should be given slowly over a period of one minute in order to avoid hypotension or central nervous system stimulation. Adults: The usual dose is 10mg to 20mg, with a maximum dose of 40mg in 24 hours. Children: The dose for children should be calculated, based on either the child’s age or their body weight, using the following table: Age Dose 1 month to 1 year 0.25mg/kg 1 to 5 years 2.5mg – 5mg OR 0.20mg/kg 6 to 12 years 5mg – 10mg OR 0.20mg/kg 12 to 18 years 10mg – 20mg OR 0.20mg/kg HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 20/05/2015_ _CRN 2162533_ _page number: 1_ Extra care should be taken when preparing the injection for children under 1 year due to the small volumes that are required. Dilution of chlorphenamine injection with sodium chloride intravenous infusion (0.9% w/v) should facilitate preparation. For example, diluting 0.2ml সম্পূর্ণ নথি পড়ুন