KETALAR INJECTION 10 MGML

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

KETAMINE AS HYDROCHLORIDE

Saatavilla:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-koodi:

N01AX03

Lääkemuoto:

SOLUTION FOR INJECTION / INFUSION

Koostumus:

KETAMINE AS HYDROCHLORIDE 10 MG/ML

Antoreitti:

I.M, I.V

Prescription tyyppi:

Required

Valmistaja:

SIEGFRIED HAMELN GMBH, GERMANY

Terapeuttinen ryhmä:

KETAMINE

Terapeuttinen alue:

KETAMINE

Käyttöaiheet:

As the sole anaesthetic agent for diagnostic and surgical procedures. When used by intravenous or intramuscular injection, Ketalar is best suited for short procedures. With additional doses, or by intravenous infusion, Ketalar 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 where anaesthesia cannot be delayed.

Valtuutus päivämäärä:

2023-05-31

Pakkausseloste

1
רזייפ
יא ףא יפ
מ"עב לארשי הקיטבצמרפ
רקנש 'חר
9
.ד.ת ,
12133
לארשי ,חותיפ הילצרה
46725
:לט
972-9-9700500
:סקפ
972-9-9700501
רבוטקוא
2018
,ה/דבכנ ת/חקור ,ה/אפור
ולעב ןוכדע לע ךעידוהל וננוצרב
ן
אפורל
(אפורל ןולע תנוכתמב ןכרצל ןולע)
לש
רישכתה
:םי
KETALAR INJECTION 10MG/ML
KETALAR 50MG/ML INJECTION :ליעפה ביכרמה
Ketamine (as hydrochloride) 10mg/mL
Ketamine (as hydrochloride) 50mg/ml
INDICATED FOR:
As the sole anaesthetic agent for diagnostic and surgical procedures.
When used by intravenous or intramuscular injection, Ketalar is best
suited for short procedures. With
additional doses, or by intravenous infusion, Ketalar 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

Valmisteyhteenveto

Ketalar LPD CC 271122
2019-0048486
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ketalar
®
Injection 10 mg/ml
Ketalar
®
50 mg/ml Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains:
Ketalar
®
Injection 10 mg/ml
ketamine (as hydrochloride) equivalent to 10 mg ketamine base per ml.
Excipient with known effect: Ketalar
®
Injection 10 mg/ml contains 53 mg of sodium
per 20 ml of solution.
Ketalar
®
50 mg/ml Injection
ketamine (as 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 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, Ketalar
®
is best suited for short procedures.
With additional doses, or by intravenous infusion, Ketalar
®
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.
Ketalar LPD CC 271122
2019-0048486
Page 2 of 12
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,
fem