Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ketamine hydrochloride, Quantity: 115.34 mg/mL (Equivalent: ketamine, Qty 100 mg/mL)
Baxter Healthcare Pty Ltd
Ketamine hydrochloride
Injection, solution
Excipient Ingredients: water for injections; nitrogen
Intravenous, Intramuscular
2 mL per ampoule, 25 ampoules, 2 ml per ampoule, 5 ampoules, 2 mL per ampoule, 10 ampoules
(S8) Controlled Drug
KETAMINE-BAXTER is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine-Claris is best suited for short procedures and it can be used with additional doses, for longer procedures; 2. for the induction of anaesthesia prior to the administration of other general anaesthetic agents; 3. to supplement low-potency agents, such as nitrous oxide.
Visual Identification: Clear, colourless to slightly yellow solution essentially free from visible particle matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-02-04
KETAMINE-CLARIS _Ketamine(as hydrochloride) 200 mg/2 mL solution for injection _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ketamine-Claris. 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 being given Ketamine-Claris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again WHAT KETAMINE-CLARIS IS USED FOR Ketamine-Claris is used to make the body insensitive to surgical treatment. It may be used in combination with other medicines to induce anaesthesia. This medicine 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 it for another reason. This medicine is addictive. Individuals with a history of drug abuse of dependence may develop ketamine dependence and tolerance, however, addiction is unlikely to occur when ketamine as hydrochloride is used as prescribed for anaesthesia. It is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN KETAMINE-CLARIS _WHEN YOU MUST NOT BE GIVEN IT _ YOU MUST NOT BE GIVEN KETAMINE-CLARIS IF YOU HAVE AN ALLERGY TO: • any medicine containing ketamine • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue 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 ANY OF THE FOLLOWING MEDICAL CONDITIONS: • poorly controlled blood pressure • severe heart disease • heart failure • a recent history of stroke • rec Read the complete document
KETAMINE-BAXTER (Ketamine) Version 2.0 1 of 15 AUSTRALIAN PRODUCT INFORMATION KETAMINE - BAXTER (KETAMINE HYDROCHLORIDE) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Ketamine Hydrochloride. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: Ketamine (as the hydrochloride) 200 mg/2 mL List of excipients: water for injections and nitrogen. 3. PHARMACEUTICAL FORM Solution for Injection. Clear, colourless to slightly yellow solution essentially free from visible particle matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ketamine-Baxter is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine-Baxter is best suited for short procedures and it can be used with additional doses, for longer procedures; 2. for the induction of anaesthesia prior to the administration of other general anaesthetic agents; 3. to supplement low-potency agents, such as nitrous oxide. 4.2 DOSE AND METHOD OF ADMINISTRATION PRE-OPERATIVE PREPARATION 1. 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-Baxter is recommended for use in the patient whose stomach is not empty only when, in the judgement of the medical practitioner, the benefits of the drug outweigh the possible ATTACHMENT 2B KETAMINE-BAXTER (Ketamine) Version 2.0 2 of 15 risks. 2. Atropine, hyoscine or other 'drying' agents should be given at an appropriate interval prior to induction. DOSAGE As with other general anaesthetic agents, the individual response to Ketamine-Baxter is somewhat varied depending on the dose, route of administration and age of patient, so that the dosage recommended cannot be absolutely determined in a fixed manner. The drug should be titrated against the patient's requirements. ONSET A Read the complete document