Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ketamine hydrochloride
Apotex Pty Ltd
Ketamine hydrochloride
Registered
KETAMINE APOTEX _SOLUTION FOR INJECTION_ _Ketamine hydrochloride_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOU. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Ketamine Apotex solution for injection. It contains the active ingredient ketamine hydrochloride. Ketamine is used to make the body insensitive to surgical treatment. It may be used in combination with other medicines to induce anaesthesia. Ketamine belongs to a group of medicines called anaesthetics. It works by stopping the brain from interpreting messages of pain. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. THIS MEDICINE IS ADDICTIVE. Individuals with a history of drug abuse or dependence may develop ketamine dependence and tolerance; however, addiction is unlikely to occur when ketamine is used as prescribed for anaesthesia. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN THIS MEDICINE _WHEN YOU MUST NOT BE GIVEN_ _THIS MEDICINE_ YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • ketamine • any of the ingredients listed at the end of the leaflet Some of the symptoms of an allergic reaction may include: • cough, shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE OR HAVE HAD Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – KETAMINE APOTEX (KETAMINE HYDROCHLORIDE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Ketamine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ketamine solution for injection contains ketamine 200 mg in 2 mL Ketamine Apotex solution for injection is formulated as an acid (pH 3.5 to 5.5) solution for intravenous or intramuscular injection in concentrations containing the equivalent of 100 mg ketamine base per millilitre. EXCIPIENTS WITH KNOWN EFFECT None stated For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection, The solution is clear and colourless to slightly yellow, essentially free from visible particulate matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KETAMINE IS RECOMMENDED: as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine is best suited for short procedures and it can be used with additional doses, for longer procedures; for the induction of anaesthesia prior to the administration of other general anaesthetic agents; to supplement low-potency agents, such as nitrous oxide . 4.2 DOSE AND METHOD OF ADMINISTRATION Ketamine injection is intended for intravenous or intramuscular injection. Ketamine injection is for single use in one patient only. Discard any residue. PRE-OPERATIVE PREPARATION While vomiting has been reported following ketamine administration, airway protection is usually afforded because of active laryngeal-pharyngeal reflexes. However, because these reflexes may also be diminished by supplementary anaesthetics or muscle relaxants, the possibility of aspiration must be considered. Ketamine is recommended for use in the patient whose stomach is not empty only when, in the judgment of the medical practitioner, the benefits of the drug outweigh the possible risks. 2 Atropine, hyoscine or other 'drying' agents should be given at an appropriate interval prior to induction. DOSAGE As with other g Read the complete document