Ketamine 500mg/10ml solution for injection vials

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Ketamine hydrochloride

Tillgänglig från:

Panpharma UK Ltd

ATC-kod:

N01AX03

INN (International namn):

Ketamine hydrochloride

Dos:

50mg/1ml

Läkemedelsform:

Solution for injection

Administreringssätt:

Intramuscular; Intravenous

Klass:

Schedule 2 (CD)

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 15010100; GTIN: 3391135500013

Bipacksedel

KETAMINE
SOLUTION FOR INJECTION
50 MG/ML
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 Ketamine in an emergency, you might not have
had a chance to read this leaflet. Your doctor or anaesthetist would
have considered the important safety
information in this leaflet, but your urgent need for treatment might
have been more important than some of the usual precautions.
–
If you are discharged from the hospital 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, pharmacist or
nurse.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ketamine is and what it is used for
2.
What you need to know before you are given Ketamine
3.
How Ketamine is given
4.
Possible side effects
5.
How to store Ketamine
6.
Contents of the pack and other information
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, 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
KETAMINE MUST NOT BE GIVEN:
–
if you are allergic (hypersensitive) 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 of 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 : h

Produktens egenskaper

OBJECT 1
KETAMINE 50MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 16-Feb-2017 | Panpharma UK
Ltd
1. Name of the medicinal product
Ketamine 50 mg/ml, solution for injection
2. Qualitative and quantitative composition
Each 1 ml of solution contains:
Ketamine 50mg/ml solution for injection: 57.7 mg of ketamine
hydrochloride equivalent to 50 mg
ketamine base per ml.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
A clear solution for injection or infusion.
4. Clinical particulars
4.1 Therapeutic indications
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.
Caesarian section; as an induction agent in the absence of elevat