KETAMINE - HAMELN 50 MGML INJECTION

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

KETAMINE AS HYDROCHLORIDE

Commercializzato da:

PHARMA MEDIS

Codice ATC:

N01AX03

Forma farmaceutica:

SOLUTION FOR INJECTION / INFUSION

Composizione:

KETAMINE AS HYDROCHLORIDE 50 MG/ML

Via di somministrazione:

I.M, I.V

Tipo di ricetta:

Required

Prodotto da:

SIEGFRIED HAMELN GMBH, GERMANY

Area terapeutica:

KETAMINE

Indicazioni terapeutiche:

As the sole anaesthetic agent for diagnostic and surgical procedures. When used by intravenous or intramuscular injection, Ketamine-Hameln is best suited for short procedures. With additional doses, or by intravenous infusion, Ketamine-Hameln can be used for longer procedures. If skeletal muscle relaxation is desired, a muscle relaxant should be used and respiration should be supported.For the induction of anesthesia prior to the administration of other general anesthetic agents.To supplement other anesthetic agents.Specific areas of application or types of procedures:When the intramuscular route of administration is preferred.Debridement, painful dressings, and skin grafting in burned patients, as well as other superficial surgical procedures.Neurodiagnostic procedures such as pneumoencephalograms, ventriculograms, myelograms, and lumbar punctures.Diagnostic and operative procedures of the eye, ear, nose, and mouth, including dental extractions.Note: Eye movements may persist during ophthalmological procedures. Anaesthesia in poor-risk patients with depression of vital functions or where depression of vital functions must be avoided, if at all possible. Orthopaedic procedures such as closed reductions, manipulations, femoral pinning, amputations, and biopsies. Sigmoidoscopy and minor surgery of the anus and rectum, circumcision and pilonidal sinus. Cardiac catheterization procedures.Caesarian section; as an induction agent in the absence of elevated blood pressure. Anaesthesia in the asthmatic patient, either to minimise the risks of an attack of bronchospasm developing, or in the presence of bronchospasm where anaesthesia cannot be delayed.

Data dell'autorizzazione:

2019-07-31

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ketamine-hameln 50 mg/ml Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains:
Ketamine hydrochloride equivalent to 50 mg ketamine base per ml.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection or Infusion
A clear, colorless, free of visible particles solution for injection
or infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As the sole anaesthetic agent for diagnostic and surgical procedures.
When used by
intravenous or intramuscular injection, Ketamine-hameln is best suited
for short
procedures. With additional doses, or by intravenous infusion,
Ketamine-hameln can
be used for longer procedures. If skeletal muscle relaxation is
desired, a muscle
relaxant should be used and respiration should be supported.
For the induction of anaesthesia prior to the administration of other
general
anaesthetic agents.
To supplement other anaesthetic agents.
Specific areas of application or types of procedures:
When the intramuscular route of administration is preferred.
Debridement, painful dressings, and skin grafting in burned patients,
as well as other
superficial surgical procedures.
Neurodiagnostic procedures such as pneumoencephalograms,
ventriculograms,
myelograms, and lumbar punctures.
Diagnostic and operative procedures of the eye, ear, nose, and mouth,
including
dental extractions.
NOTE:
Eye movements may persist during ophthalmological procedures.
Anaesthesia in poor-risk patients with depression of vital functions
or where
depression of vital functions must be avoided, if at all possible.
Orthopaedic procedures such as closed reductions, manipulations,
femoral pinning,
amputations, and biopsies.
Sigmoidoscopy and minor surgery of the anus and rectum, circumcision
and pilonidal
sinus.
Cardiac catheterization procedures.
Caesarean section; as an induction agent in the absence of elevated
blood pressure.
Anaesthesia in the asthmatic patient, either to minimise the