KETAMINE HYDROCHLORIDE INJECTION USP

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

קנה את זה

הורד מאפייני מוצר (SPC)
19-01-2021

מרכיב פעיל:

KETAMINE HCl 57.7 mg/ml EQV KETAMINE

זמין מ:

DUOPHARMA (SINGAPORE) PTE LTD

קוד ATC:

N01AX03

כמות:

50 mg/ml

טופס פרצבטיות:

INJECTION

הרכב:

KETAMINE HCl 57.7 mg/ml EQV KETAMINE 50 mg/ml

מסלול נתינה (של תרופות):

INTRAVENOUS, INTRAMUSCULAR

סוג מרשם:

Prescription Only

תוצרת:

PANPHARMA GmbH

מצב אישור:

ACTIVE

תאריך אישור:

1991-05-23

מאפייני מוצר

                                PAC3L487-XX / 11.20
COMPOSITION: Each vial with 10 mL solution for injection contains 500
mg ketamine (as ketamine hydrochloride).
Excipients: benzethonium chloride 0.1 mg/mL, water for injections.
INDICATIONS: KETAMINE HYDROCHLORIDE INJECTION USP is recommended:
1.
As the sole anaesthetic agent for diagnostic and surgical procedures
that do not require skeletal muscle relaxation. KETAMINE HYDROCHLORIDE
INJECTION USP is best suited for short procedures but it can be used
with additional doses, for longer procedures;
2.
For the induction of anaesthesia prior to administration of other
general anaesthetic agents;
3.
To supplement low potency agents, such as nitrous oxide;
4.
In obstetrics, for vaginal delivery or in caesarian section. Maternal
side effects of awareness and dreaming can be reduced by the injection
of diazepam
or related drugs after the birth of the infant.
SPECIFIC AREAS OF APPLICATION INCLUDED THE FOLLOWING:
1.
Debridement, painful dressings and skin grafting in burn patients, as
well as other superficial surgical procedures;
2.
Neurodiagnostic, such as pneumoencephalograms, ventriculograms,
myelograms and lumbar punctures;
3.
Diagnostic and operative procedures of the eye, nose and mouth,
including dental extractions;
4.
Diagnostic and operative procedures of the pharynx, larynx or
bronchial tree; Note: Muscle relaxants, with proper attention to
respiration, may be
required (see Precautions)
5.
Sigmoidoscopy and minor surgery of the anus, rectum and circumcision;
6.
Extraperitoneal procedures used in gynaecology, such as dilation and
curettage;
7.
Orthopaedic procedures, such as closed reductions, manipulations,
femoral pinning, amputation and biopsies;
8.
As an anaesthetic in poor-risk patients with depression of vital
functions;
9.
In procedures where the intramuscular route of administration is
preferred;
10. In cardiac catherisation procedures.
PREOPERATIVE PREPARATION:
1.
When vomiting has been reported following KETAMINE HYDROCHLORIDE
INJECTION USP administration, airway protection is usual
                                
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