KETALAR Solution for injection or infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Ketalar 10 mg/ml Injection.
Qualitative and quantitative composition
Each 1 ml of solution contains: ketamine hydrochloride equivalent to 10 mg ketamine base per ml. Excipient(s) with known effect: Each 1 ml contains 2.6 mg of sodium. For the full list of excipients see ...
Pharmaceutical form
Solution for Injection or Infusion. A clear solution for injection or infusion.
Therapeutic indications
Ketamine is indicated in children and in adults. Ketalar is recommended: As an anaesthetic agent for diagnostic and surgical procedures. When used by intravenous or intramuscular injection, Ketalar is ...
Posology and method of administration
For intravenous infusion, intravenous injection or intramuscular injection. NOTE: All doses are given in terms of ketamine base Adults, elderly (over 65 years) and children For surgery in elderly patients ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ketalar is contra-indicated in persons in whom an elevation of blood pressure would constitute a serious hazard ...
Special warnings and precautions for use
To be used only in hospitals by or under the supervision of experienced medically qualified anaesthetists except under emergency conditions. As with any general anaesthetic agent, resuscitative equipment ...
Interaction with other medicinal products and other forms of interaction
Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketalar. Ketalar is chemically incompatible with barbiturates and diazepam because of precipitate formation. ...
Fertility, pregnancy and lactation
Pregnancy Ketalar crosses the placenta. This should be borne in mind during operative obstetric procedures in pregnancy. No controlled clinical studies in pregnancy have been conducted. The use in pregnancy ...
Effects on ability to drive and use machines
Patients should be cautioned that driving a car, operating hazardous machinery or engaging in hazardous activities should not be undertaken for 24 hours or more after anaesthesia. This medicine can impair ...
Undesirable effects
The following Adverse Events have been reported: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Not known (frequency cannot be estimated from the available data) ...
Overdose
Respiratory depression can result from an overdosage of ketamine hydrochloride. Supportive ventilation should be employed. Mechanical support of respiration that will maintain adequate blood oxygen saturation ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other general anaesthetics ATC Code: N01AX03 Ketamine is a rapidly acting general anaesthetic for intravenous or intramuscular use with a distinct pharmacological action. Ketamine ...
Pharmacokinetic properties
Absorption Ketamine is rapidly absorbed following intra-muscular administration. Distribution Ketamine is rapidly distributed into perfused tissues including brain and placenta. Animal studies have shown ...
Preclinical safety data
Animal research has shown that ketamine can induce NMDA antagonist-induced neuronal cell death in juvenile animals (apoptosis) when administered in high doses, for prolonged periods, or both. In some cases ...
List of excipients
Sodium chloride Benzethonium chloride Water for injections
Incompatibilities
Ketalar is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.
Shelf life
Shelf life: 5 years. For single use only. Discard any unused product at the end of each operating session. After dilution the solutions should be used immediately.
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
Nature and contents of container
20 ml white neutral glass vial with rubber closure and aluminium flip-off cap containing 20ml of solution as 10 mg ketamine base per ml.
Special precautions for disposal and other handling
For single use only. Discard any unused product at the end of each operating session. See section 4.2.
Marketing authorization holder
Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0529
Date of first authorization / renewal of the authorization
1<sup>st</sup> July 2003
Date of revision of the text
01/2019
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