Ketalar 10mg/ml Solution for Injection/Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketamine hydrochloride

Available from:

Pfizer Healthcare Ireland

ATC code:

N01AX; N01AX03

INN (International Name):

Ketamine hydrochloride

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

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

Therapeutic area:

Other general anesthetics; ketamine

Authorization status:

Marketed

Authorization date:

1980-04-01

Patient Information leaflet

Page 1 of 10
2023-0086367
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KETALAR
® 10 MG/ML SOLUTION FOR INJECTION / INFUSION
KETALAR
® 50 MG/ML SOLUTION FOR INJECTION / INFUSION
KETAMINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
If you have been given Ketalar in an emergency you will not have had a
chance to read this
leaflet. Your doctor or anaesthetist will have considered the
important safety information in this
leaflet, but your urgent need for treatment may have been more
important than some of the usual
precautions.
•
If you are discharged on the same day as the operation, you should be
accompanied by another
adult.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.4.
_ _
WHAT IS IN THIS LEAFLET
1.
WHAT KETALAR INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KETALAR INJECTION
3.
HOW KETALAR INJECTION IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE KETALAR INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT KETALAR INJECTION IS AND WHAT IT IS USED FOR
▪
This medicine contains ketamine hydrochloride which belongs to a group
of medicines called
anaesthetic agents, which are used to put you to sleep during an
operation. Ketalar may be
used in both routine and emergency surgery.
▪
Ketalar is used in adults, the elderly and children.
▪
Ketalar can be given alone or in combination with other anaesthetic
agents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KETALAR INJECTION
DO NOT TAKE KETALAR:
•
if you are allergic (hypersensitivity) to ketamine hydrochloride or
any of the other ingredients of
this medicine (listed in section 6).
•
if you are suffering from any condition in which an increase in blood
pressure may be harmful to
you or have suffe

Summary of Product characteristics

Health Products Regulatory Authority
20 February 2024
CRN00D6VD
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ketalar 10mg/ml Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketamine hydrochloride equivalent to 10 mg ketamine base per ml.
A 20 ml solution contains ketamine hydrochloride equivalent to 200 mg
ketamine base.
Excipient with known effect:
Ketalar 10mg/ml contains 53 mg of sodium per 20 ml of solution.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
A clear, colourless, aqueous solution for injection or infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ketamine is indicated in children and in adults.
1. As an anaesthetic agent for short diagnostic and surgical
procedures which do not require skeletal muscle relaxation.
2. For the induction of anaesthesia prior to the administration of
other general anaesthetic agents.
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.
NOTE: Ketamine should be used only with caution in surgical procedures
involving pharynx, larynx or trachea as it increases
salivary and tracheo-bronchial secretions and does not reliably
suppress pharyngeal or laryngeal reflexes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous infusion, intravenous injection or intramuscular
injection.
NOTE: ALL DOSES ARE GIVEN IN TERMS OF KETAMINE BASE
Ketalar is not indicated nor recommended for long term use (see
sections 4.1 and 4.4).
_Adults, elderly (over 65 years) and children_
Health Products Regulatory Authority
20 February 2024
CRN00D6VD
Page 2 of 11
For surgery in elderly patients