Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorphenamine maleate
Wockhardt UK Ltd
R06AB04
Chlorphenamine maleate
10mg/1ml
Solution for injection
Subcutaneous; Intramuscular; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5012727912707
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Regulatory text amends PACKAGE LEAFLET: INFORMATION FOR THE USER CHLORPHENAMINE 10MG/ML SOLUTION FOR INJECTION CHLORPHENAMINE MALEATE (REFERRED TO AS CHLORPHENAMINE THROUGHOUT THIS LEAFLET) 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. • 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 Chlorphenamine is and what it is used for 2. What you need to know before you are given Chlorphenamine 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 YOU ARE GIVEN CHLORPHENAMINE YOU MUST NOT BE GIVEN CHLORPHENAMINE IF YOU: • are ALLERGIC to chlorphenamine or any of the other ingredients of this medicine (listed in section 6) • 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 before you are given Chlorphenamine if you: • are being treated for an OVERACTIVE THYROID or ENLARGED PROSTATE GLAND • have EPILEPSY, GLAUCOMA, VERY HIGH BLOOD PRESSURE, HEART, LIVER, ASTHMA or CHEST DISEASES. OTHER MEDICINES AND C Przeczytaj cały dokument
OBJECT 1 CHLORPHENAMINE MALEATE 10MG/ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 10-Nov-2017 | Wockhardt UK Ltd 1. Name of the medicinal product Chlorphenamine 10mg/ml Solution for injection 2. Qualitative and quantitative composition Each 1ml of solution contains 10mg of chlorphenamine maleate. Excipient with known effect: Each 1 ml of solution contains 0.13mmol (3.1mg) of sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection Clear, colourless sterile solution for injection. The pH of the solution is 4.0 5.2 and the osmolality is 261 319 mOsm/Kg. 4. Clinical particulars 4.1 Therapeutic indications Chlorphenamine injection is indicated for acute urticaria, control of allergic reactions to insect bites and stings, angioneurotic oedema, drug and serum reactions, desensitisation reactions, hayfever, vasomotor rhinitis, severe pruritus of non-specific origin. 4.2 Posology and method of administration Adults: The usual dose of chlorphenamine injection for adults is 10mg to 20mg, but not more than 40mg should be given within a 24-hour period. The injection may be given by the subcutaneous, intramuscular or intravenous route. When a rapid effect is desired, as in anaphylactic reactions, the intravenous route is recommended in addition to emergency therapy with adrenaline (epinephrine), corticosteroids, oxygen and supportive therapy as required. In this case chlorphenamine injection should be injected slowly over a period of one minute, using the smallest adequate syringe. Any drowsiness, giddiness or hypotension which may follow is usually transitory. In the event of a blood transfusion reaction, a dose of 10mg to 20mg of chlorphenamine injection should be given by the subcutaneous route. This can be repeated to a total of 40mg within a 24-hour period, or oral forms of chlorphenamine may be given until the symptoms subside. Chlorphenamine injection may be helpful in the prevention of delayed reactions to penicillin and other drugs when give Przeczytaj cały dokument