KETAMINE PANPHARMA 50MG1ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

KETAMINE AS HYDROCHLORIDE

Available from:

PHARMALOGIC LTD

ATC code:

N01AX03

Pharmaceutical form:

SOLUTION FOR INJECTION / INFUSION

Composition:

KETAMINE AS HYDROCHLORIDE 50 MG / 1 ML

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

PANPHARMA GMBH, GERMANY

Therapeutic area:

KETAMINE

Therapeutic indications:

As the sole anaesthetic agent for diagnostic and surgical procedures. When used by intravenous or intramuscular injection, Ketamin is best suited for short procedures. With additional doses, or by intravenous infusion, Ketamin 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 procedure: 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 movement 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 reduction, manipulation 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 risk of an attack of bronchospasm developing or in the presence of bronchospasm

Authorization date:

2022-12-31

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Ketamine Panpharma 50 mg/ml
Solution for injection/Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 10 ml solution for injection contains 500 mg ketamine (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for I.M, I.V use
Clear colorless solution
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As the sole anesthetic agent for diagnostic and surgical procedures.
When used by
intravenous or intramuscular injection, ketamine is best suited for
short
procedures. With additional doses, or by intravenous infusion,
ketamine 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.
Anesthesia in poor-risk patients with depression of vital functions or
where
depression of vital functions must be avoided, if at all possible.
Orthopedic 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.
Anesthesia in the asthmatic patient, either to minimize the risks of
an attack of
bronchospasm developing, or in the presence of bronchospasm where
anesthesia cannot