Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
KETAMINE
hameln pharma r&d gmbh
KETAMINE
10 Mg/Ml
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-10-20
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ketamine 10 mg/ml, solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Ketamine 10.0 mg (as hydrochloride) Each 5 ml and 20 ml ampoule contains 50 mg and 200 mg ketamine, respectively. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection. The medicinal product is a clear and colourless, aqueous solution for injection or infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. As the sole anaesthetic agent for short diagnostic and surgical procedures which do not require skeletal muscle relaxation. 2. Induction of general anaesthesia prior to administration of other anaesthetics. 3. To supplement other anaesthetic agents. Specific areas of application or types of procedures: 1. When the intramuscular route of administration is more convenient. 2. Debridement, painful dressings, and skin grafting in burned patients, as well as other superficial surgical procedures. 3. For certain neurological, radiodiagnostic and therapeutic procedures in children to abolish movement. 4. When airway control is difficult. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For intravenous infusion, intravenous injection or intramuscular injection in adults, elderly (> 65 years) and children. For surgery in elderly patients ketamine has been shown to be suitable either alone or supplemented with other anaesthetic agents. NOTE: All doses are given in terms of ketamine base. As with other general anaesthetic agents, the individual response to ketamine is somewhat varied depending on the dose, route of administration, age of patient, and concomitant use of other agents, so that dosage recommendations cannot be absolutely fixed. The dose should be titrated against the patient’s requirements. The intravenous dose should be administered ove Prečítajte si celý dokument