Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Ketamine hydrochloride 1.153 mg/mL equivalent to 1 mg/mL ketamine;
Biomed Limited
Ketamine hydrochloride 1.153 mg/mL (equivalent to 1 mg/mL ketamine)
1 mg/mL
Solution for infusion
Active: Ketamine hydrochloride 1.153 mg/mL equivalent to 1 mg/mL ketamine Excipient: Sodium chloride Water for injection
Bag, plastic, Propyflex non-PVC flexible, 100 mL
Class C4 Controlled Drug
Class C4 Controlled Drug
CU Chemie Uetikon GmbH
Ketamine infusion is recommended: 1. 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; 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: Bag, plastic, flexible non-PVC polypropylene IV bag with foil overwrap - 100 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze.
2011-01-31
NEW ZEALAND DATA SHEET KETAMINE (BIOMED) Page 1 1. PRODUCT NAME_ _ Ketamine 100 mg per 100 mL Ketamine 100 mg per 10 mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each 100 mL of Ketamine 100 mg per 100 mL contains ketamine hydrochloride equivalent to 100 mg ketamine base. Each 10 mL of Ketamine 100 mg per 10 mL contains ketamine hydrochloride equivalent to 100 mg ketamine base. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM_ _ A clear, colourless isotonic solution for injection or infusion. It contains no preservative. It is formulated as an acid (pH 3.5 to 5.5) solution. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ketamine is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine is best suited for short procedures. It can be used for longer procedures with additional doses; 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 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. _ _ DOSE As with other general anaesthetic agents, the individual response to ketamine 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 th Կարդացեք ամբողջական փաստաթուղթը