Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ketamine hydrochloride, Quantity: 57.67 mg/mL (Equivalent: ketamine, Qty 50 mg/mL)
Interpharma Pty Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; water for injections; sodium hydroxide
Intravenous, Intravenous Infusion, Intramuscular
2 mL
(S8) Controlled Drug
KETAMINE INTERPHARMA? is recommended:,1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. KETAMINE INTERPHARMA ? 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 solution, free from visible particles.; 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
Registered
2019-12-16
KETAMINE INTERPHARMA CMI V1.0 Page 1 KETAMINE INTERPHARMA KETAMINE HYDROCHLORIDE _ (KEY-TAR-MEAN) _ _ _ _ _ CONSUMER MEDICINE INFORMATION _Date of Dispensing _ _Consumer Name _ _Pharmacist Name _ _Consumer Address _ _Pharmacist Address_ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about KETAMINE INTERPHARMA. 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 Injection 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 INTERPHARMA IS USED FOR KETAMINE INTERPHARMA is used to make the body insensitive to surgical treatment. It may be used in combination with other medicines to induce anaesthesia (an-es- these-ee- ya). This medicine belongs to a group of medicines called anaesthetics (an-es-thet-icks). 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 INTERPHARMA 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 INTERPHARMA INJECTION _WHEN YOU MUST NOT _ _BE GIVEN IT _ YOU MUST NOT BE GIVEN KETAMINE INTERPHARMA INJECTION 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 hiv Read the complete document
Ketamine Interpharma V1.2 Dec 2019 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – KETAMINE INTERPHARMA 10 MG/ML AND 50 MG/ML AMPOULES (KETAMINE HYDROCHLORIDE 1. NAME OF THE MEDICINE Ketamine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION KETAMINE INTERPHARMA is formulated as an acid (pH 3.5 to 5.5) solution for intravenous or intramuscular injection in concentrations containing the equivalent of 10 mg or 50 mg ketamine base per millilitre. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM KETAMINE INTERPHARMA is a clear, colourless solution for intravenous or intramuscular injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KETAMINE INTERPHARMA is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. KETAMINE INTERPHARMA 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 KETAMINE INJECTION IS FOR SINGLE USE IN ONE PATIENT ONLY. DISCARD ANY RESIDUE. ALL DOSES ARE GIVEN IN TERMS OF KETAMINE BASE. PRE-OPERATIVE PREPARATION 1. While vomiting has been reported following KETAMINE INTERPHARMA 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 Ketamine Interpharma V1.2 Dec 2019 Page 2 of 14 considered. KETAMINE INTERPHARMA 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 risks. 2. Atropine, hyoscine or other 'drying' agents should be given at an appropriate interval prior to induction. DOSAGE As with other general anaestheti Read the complete document