Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Ketamine hydrochloride 115.34 mg/mL equivalent to Ketamine 100 mg/mL
Baxter Healthcare Ltd
Ketamine hydrochloride 115.34 mg/mL (equivalent to Ketamine 100 mg/mL)
100 mg/mL
Solution for injection
Active: Ketamine hydrochloride 115.34 mg/mL equivalent to Ketamine 100 mg/mL Excipient: Nitrogen Water for injection
Class C4 Controlled Drug
Supriya Lifescience Ltd
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.
Package - Contents - Shelf Life: Ampoule, glass, Type I glass, 2mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Type I glass, 2mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Type I glass, 2mL - 25 dose units - 36 months from date of manufacture stored at or below 30°C protect from light
2015-03-26
NEW ZEALAND DATA SHEET KETAMINE-BAXTER Data Sheet 13 February 2023 Page 1 of 12 Baxter Healthcare Ltd 1 PRODUCT NAME KETAMINE-BAXTER (100mg/mL) ketamine hydrochloride, solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _ACTIVE INGREDIENT _ Ketamine hydrochloride (115.34mg/mL equivalent to Ketamine 100mg/mL). Each 2mL ampoule contains 200mg ketamine (as the hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection, intravenous or intramuscular. _APPEARANCE _ A clear, colourless to slightly yellow solution essentially free from particles. Formulated as an acid solution KETAMINE-BAXTER has a pH of 3.5 – 5.5. 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 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 r Leggi il documento completo