Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
PROMETHAZINE HYDROCHLORIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
PROMETHAZINE HYDROCHLORIDE
2.5 %w/v
Solution for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING THIS MEDICINE • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What Phenergan Injection is and what it is used for 2. Before you are given Phenergan Injection 3. How Phenergan Injection is given 4. Possible side effects 5. How to store Phenergan Injection 6. Further Information 1. WHAT PHENERGAN INJECTION IS AND WHAT IT IS USED FOR Phenergan Injection contains a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed. WHAT PHENERGAN INJECTION IS USED FOR • To treat allergic conditions such as hay fever or rashes (like nettle rash or hives). • As a sedative. This is a medicine given to reduce awareness or make you feel relaxed and at ease • To help you feel more relaxed before an operation • To treat adults with difficulty sleeping (insomnia) 2. BEFORE YOU ARE GIVEN PHENERGAN INJECTION DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF: • The person taking the medicine is under 2 years of age • You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Phenergan Injection (listed in Section 6 below) The signs of an allergic reaction include: a rash, swallowing Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenergan 2.5% w/v Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml ampoule contains Promethazine Hydrochloride 25 mg. Excipients: Contains Sodium Sulphite (E221) 0.5mg and Sodium Metabisulphite (E223) 0.7mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection Clear, bright, almost colourless, solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of allergic conditions and reactions. As an antiemetic. As a tranquilliser. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Intramuscular or Intravenous. INTRAMUSCULAR: ADULTS: The usual daily dose is 25-50 mg by deep intramuscular injection. A maximum dose of 100mg parenterally should not be exceeded. CHILDREN: Children 5-10 years only: 6.25 - 12.5 mg daily be deep intramuscular injection. ELDERLY: No specific dosage recommendations. INTRAVENOUS: ADULTS ONLY: In an emergency, the usual dose is 25-50mg after dilution to 10 times the volume with water for injection. A maximum dose of 100mg parenterally should not be exceeded. ELDERLY: No specific dosage recommendations. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/03/2014_ _CRN 2144304_ _page number: 1_ 4.3 CONTRAINDICATIONS Phenergan should not be used in patients in pre-coma states, in a coma or suffering from CNS depression of any cause. It must not be given to neonates or premature infants. Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients. Phenergan should be avoided in patients with blood dycrasias and in patients taking monoamine oxidase inhibitors up to 14 days Citiți documentul complet