KETAMINE PROPHARM 10 MGML

দেশ: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

KETAMINE AS HYDROCHLORIDE

থেকে পাওয়া:

PROPHARM LTD

এটিসি কোড:

N01AX03

ফার্মাসিউটিকাল ফর্ম:

SOLUTION FOR INJECTION / INFUSION

রচনা:

KETAMINE AS HYDROCHLORIDE 10 MG/ML

প্রশাসন রুট:

I.V, I.M

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

LABORATOIRE RENAUDIN, FRANCE

থেরাপিউটিক এলাকা:

KETAMINE

থেরাপিউটিক ইঙ্গিত:

* As the sole anaesthetic agent for diagnostic and surgical procedures.When used by intravenous or intramuscular injection, Ketamine Propharm 10mg/ml is best suited for short procedures. With additional doses, or by intravenous infusion, Ketamine Propharm 10mg/ml 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.

অনুমোদন তারিখ:

2023-03-20

পণ্য বৈশিষ্ট্য

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ketamine Propharm 10 mg/ml
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains:
ketamine (as hydrochloride) equivalent to 10 mg ketamine base per ml.
Excipient with known effect: sodium.
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
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 Propharm is best
suited for short
procedures. With additional doses, or by intravenous infusion,
Ketamine Propharm
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.
Page 2 of 12
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 risks of
an attack of