Hypnomidate 20mg/10ml solution for injection ampoules

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Etomidate

Disponible des:

Piramal Critical Care Ltd

Codi ATC:

N01AX07

Designació comuna internacional (DCI):

Etomidate

Dosis:

2mg/1ml

formulario farmacéutico:

Solution for injection

Vía de administración:

Intravenous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 15010100; GTIN: 5012674037140

Informació per a l'usuari

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYPNOMIDATE
®
Etomidate
Hypnomidate is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again

If you have any further questions, ask your doctor or nurse

This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours

If you get side effects and they become serious or if you notice any
side
effects not listed in this leaflet, please tell your doctor or nurse
IN THIS LEAFLET
1. What Hypnomidate is and what it is used for
2. Before you are given Hypnomidate
3. How Hypnomidate is given
4. Possible side effects
5. How Hypnomidate is stored
6. Further information
1. WHAT HYPNOMIDATE IS AND WHAT IT IS USED FOR
Hypnomidate contains a medicine called etomidate. It is used as a
general
anaesthetic.
2. BEFORE YOU ARE GIVEN HYPNOMIDATE
DO NOT HAVE HYPNOMIDATE IF:

You are allergic to anything in Hypnomidate (listed in section 6
below)
If you are not sure if this applies to you, talk to your doctor or
nurse before
having Hypnomidate.
TAKE SPECIAL CARE WITH HYPNOMIDATE
Check with your doctor or nurse before being given this medicine if
you have
ever had:

Problems with your liver

Low blood pressure

Long-term treatment with strong painkillers

Problems with your drinking (alcoholism)

Problems with your adrenal glands not working properly
Also tell your doctor if you are suffering from a serious infection in
your blood
(sepsis).
Your doctor will carefully monitor the amount of Hypnomidate they give
you or
you may need other medication. If you are not sure if any of the above
applies
to you, talk to your doctor or nurse before having Hypnomidate.
- 2 -
Before your anaesthetic, you will normally be given another medicine,
known as
a 'pre-med'. This will probably make you feel drowsy and will also
help stop any
uncontrollable muscle twitches which can occur.
SPECIAL MONITORING
Hypnomidate

Fitxa tècnica

OBJECT 1
HYPNOMIDATE 2 MG/ML INJECTION
Summary of Product Characteristics Updated 08-Jan-2016 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Hypnomidate 2 mg/ml Injection
2. Qualitative and quantitative composition
Each ml of Hypnomidate contains etomidate 2 mg.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Hypnomidate is an intravenous induction agent of anaesthesia.
4.2 Posology and method of administration
For intravenous administration.
Hypnomidate should be injected slowly by the intravenous route.
The product must only be used by physicians trained in endotracheal
intubation. Equipment for artificial
respiration must be available.
It is recommended to wear gloves while opening the ampoule. In the
case of any accidental dermal
exposure, rinse the affected area with water. Avoid use of soap,
alcohol and other cleaning materials that
may cause chemical or physical abrasions to the skin.
_Adults and children:_
A dose of 0.3 mg/kg bodyweight given intravenously at induction of
anaesthesia, gives sleep lasting from
4 to 5 minutes.
Dosage should be adjusted to the individual patient response and to
clinical effects.
In children under 15 years the dosage may need to be increased: a
supplementary dose of up to 30% of
the normal dose for adults is sometimes necessary to obtain the same
depth and duration of sleep as
obtained in adults.
_Elderly:_
A dose of 0.15-0.2 mg/kg bodyweight should be given and the dose
should be further adjusted according
to the individual patient response and to clinical effects (see
Section 4.4 Special Warnings and
Precautions for Use).
Since Hypnomidate has no analgesic action, appropriate analgesics
should be used in procedures
involving painful stimuli.
Hypnosis can be prolonged by additional injections of Hypnomidate.
Do not exceed a total dose of 30 ml (3 ampoules).
Hypnomidate may be diluted with sodium chloride infusion BP or
dextrose infusion BP but it is not
compatible with compound sodium lactate infusion BP (Hartmann's
so