KETAMINE 10 Mg/Ml Solution for Inj/Inf

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

KETAMINE

Tersedia dari:

hameln pharma r&d gmbh

INN (Nama Internasional):

KETAMINE

Dosis:

10 Mg/Ml

Bentuk farmasi:

Solution for Inj/Inf

Jenis Resep:

Product subject to prescription which may not be renewed (A)

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2010-10-20

Karakteristik produk

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ketamine 10 mg/ml, solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Ketamine 10.0 mg (as hydrochloride)
Each 5 ml and 20 ml ampoule contains 50 mg and 200 mg ketamine,
respectively.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The medicinal product is a clear and colourless,
aqueous solution for injection or infusion.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
1.
As the sole anaesthetic agent for short diagnostic and
surgical procedures which do not require skeletal muscle 
relaxation.
2.
Induction of general anaesthesia prior to administration
of other anaesthetics.
3.
To supplement other anaesthetic agents.
Specific areas of application or types of procedures:
1. When the intramuscular route of administration
is more convenient.
2. Debridement, painful dressings, and skin grafting in burned
patients, as well as other superficial surgical 
procedures.
3. For certain neurological, radiodiagnostic and
therapeutic procedures in children to abolish movement.
4. When airway control is difficult.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For intravenous infusion, intravenous injection
or intramuscular injection in adults, elderly (> 65 years) and
children. 
For surgery in elderly patients ketamine has been shown to
be suitable either alone or supplemented with other 
anaesthetic agents. 
NOTE: All doses are given in terms of ketamine base.
As with other general anaesthetic agents,
the individual response to ketamine is somewhat varied depending
on the 
dose, route of administration, age of patient, and
concomitant use of other agents, so
that dosage recommendations 
cannot be absolutely fixed. The dose should be titrated
against the patient’s requirements.
The intravenous dose should 
be administered ove