Ephedrine 30mg/10ml solution for injection pre-filled syringes

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Ephedrine hydrochloride

Disponível em:

Aguettant Ltd

Código ATC:

C01CA26

DCI (Denominação Comum Internacional):

Ephedrine hydrochloride

Dosagem:

3mg/1ml

Forma farmacêutica:

Solution for injection

Via de administração:

Intravenous

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02070200; GTIN: 5060238380034 5060238380027 3700567703969

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPHEDRINE HYDROCHLORIDE 3MG/ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
EPHEDRINE HYDROCHLORIDE
(REFERRED TO AS “EPHEDRINE INJECTION” IN THIS LEAFLET)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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 Ephedrine Injection is and what it is used for
2.
What you need to know before you are given Ephedrine Injection
3.
How Ephedrine Injection is given
4.
Possible side effects
5.
How to store Ephedrine Injection
6.
Contents of the pack and other information
1.
WHAT EPHEDRINE INJECTION IS AND WHAT IT IS USED FOR
This medicine is used to treat low blood pressure that can occur
during spinal or epidural
anaesthesia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN EPHEDRINE INJECTION
DO NOT USE EPHEDRINE INJECTION IF:
-
you are allergic to ephedrine hydrochloride or to any of the other
ingredients of this
medicine (listed in section 6).
-
you
are
taking
another
indirect
sympathomimetic
agent
such
as
phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used to
RELIEVE
BLOCKED NOSE) or methylphenidate (medicine used to TREAT “ATTENTION
DEFICIT
HYPERACTIVITY DISORDER (ADHD)”),
-
you are taking an alpha sympathomimetic agent (medicines used to TREAT
LOW BLOOD
PRESSURE),
-
you are taking or have taken in the last 14 days a non-selective
monoamine oxidase
inhibitor (medicines used to TREAT DEPRESSION).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Ephedrine Injection if:
-
you are a diabetic;
-
you suffer from heart dise

Características técnicas

OBJECT 1
EPHEDRINE HYDROCHLORIDE 3 MG/ML SOLUTION FOR
INJECTION IN PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 02-Nov-2015 | Aguettant Ltd
1. Name of the medicinal product
Ephedrine Hydrochloride 3 mg/ml solution for injection in pre-filled
syringe
2. Qualitative and quantitative composition
Each ml of Solution for Injection contains 3 mg ephedrine
hydrochloride, corresponding to 2.46 mg
ephedrine.
Each 10 ml pre-filled syringe contains 30 mg ephedrine hydrochloride,
corresponding to 24.6 mg
ephedrine.
Excipient with known effect:
This medicinal product contains sodium.
Each ml of Solution for Injection contains 3.32 mg equivalent to 0.144
mmol of sodium.
Each 10 ml pre-filled syringe contains 33.2 mg equivalent to 1.44 mmol
of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, colourless liquid
pH = 4.5 to 5.5
Osmolality: between 270 – 300 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of hypotension from spinal or epidural anaesthesia.
4.2 Posology and method of administration
POSOLOGY
ADULTS
Slow intravenous injection of 3 to 6 mg (maximum 9 mg), repeated as
needed every 3-4 min to a
maximum of 30 mg. A lack of efficacy after 30 mg should lead to
reconsideration of the choice of the
therapeutic agent.
The dose administered for 24 hours must not exceed 150 mg.
PAEDIATRIC POPULATION
Ephedrine Hydrochloride 3 mg/ml solution for Injection in Prefilled
Syringe is generally not
recommended for use in children due to insufficient data on efficacy,
safety and dosage
recommendations.
• Children under 12 years
The safety and efficacy of Ephedrine in paediatric patients under 12
years have not been established. No
data are available.
• Children over 12 years
The posology and method of administration is the same as for adults.
PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT
There are no dose adjustment recommended for patients with renal or
hepatic impairment.
OLDER PEOPLE
As for adults.
METHOD OF ADMINISTRATION
Ephedrine