Ketalar 1g/10ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketamine hydrochloride

Available from:

Pfizer Ltd

ATC code:

N01AX03

INN (International Name):

Ketamine hydrochloride

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010100; GTIN: 5013457011432

Patient Information leaflet

Page 1 of 16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KETALAR
® 10 MG/ML, 50 MG/ML AND 100 MG/ML INJECTION
KETAMINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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._ _
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 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 suffered in the past from a medical condition which may have
been caused/made worse by an
incre

Summary of Product characteristics

KETALAR 100 MG/ML INJECTION
Summary of Product Characteristics Updated 22-Nov-2016 | Pfizer
Limited
1. Name of the medicinal product
Ketalar 100 mg/ml Injection
2. Qualitative and quantitative composition
Each 1 ml of solution contains:
ketamine hydrochloride equivalent to 100 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
Ketalar is recommended:
As an 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.
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.
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,