Ketamine 500mg/10ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketamine hydrochloride

Available from:

hameln pharma Ltd

ATC code:

N01AX03

INN (International Name):

Ketamine hydrochloride

Dosage:

50mg/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: 5016386009914

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KETAMINE 50 MG/ML INJECTION
Ketamine hydrochloride
1. WHAT KETAMINE 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. Ketamine may be
used in both routine and emergency surgery.
Ketamine
is
used
in
adults,
the
elderly
and
children. Ketamine can be given alone or in
combination with other anaesthetic agents.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN KETAMINE
DO NOT USE KETAMINE:
•
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 increase in blood
pressure
•
if you have been pregnant and during your
pregnancy you have suffered from a condition
called
eclampsia
or
pre-eclampsia
which
causes an increase in your blood pressure
•
if
you
have
recently
suffered
a
stroke
or
serious head or brain injury
•
if you have severe heart disease
•
if you are pregnant, trying to become pregnant
or breast-feeding. However, Ketamine may
safely be used in caesarean section surgery
or vaginal delivery.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Ketamine
if you:
•
drink large amounts of alcohol
•
have a history of drug abuse or addiction
•
have a history of or have current mental health
problems
•
have a chest infection or problems breathing
•
have problems with your liver
•
have increased pressure in the eye (glaucoma)
•
have an inherited disease that affects the
blood (porphyria)
•
have ever had seizures
•
are receiving treatment for your thyroid gland
•
have had any injury to your head or abnormal
growth in the brain
If before your operation the pressure in your
spinal cord is raised, your anaesthetist will pay
special atten

Summary of Product characteristics

OBJECT 1
KETAMINE 50 MG/ML INJECTION
Summary of Product Characteristics Updated 20-Mar-2018 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Ketamine 50 mg/ml Injection
2. Qualitative and quantitative composition
Each 1 ml of solution contains:
Ketamine hydrochloride equivalent to 50 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
Ketamine is indicated in children and in adults.
Ketamine is recommended:
As an anaesthetic agent for diagnostic and surgical procedures. When
used by intravenous or
intramuscular injection, Ketamine is best suited for short procedures.
With additional doses, or by
intravenous infusion, Ketamine 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