Ephedrine Hydrochloride 3 mg/ml solution for injection in pre-filled syringe

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ephedrine hydrochloride

Tilgjengelig fra:

Laboratoire AGUETTANT

ATC-kode:

C01CA26

INN (International Name):

Ephedrine hydrochloride

Dosering :

3 milligram(s)/millilitre

Legemiddelform:

Solution for injection in pre-filled syringe

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

ephedrine

Autorisasjon status:

Marketed

Autorisasjon dato:

2018-12-21

Informasjon til brukeren

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 for the management of low blood pressure induced
by 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 disease or any other

Preparatomtale

Health Products Regulatory Authority
22 February 2023
CRN00DFQR
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SUMMARY OF PRODUCT CHARACTERISTICS
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 3.39 mg equivalent to 0.15
mmol of sodium.
Each 10 ml pre-filled syringe contains 33.9 mg equivalent to 1.5 mmol
of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (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, epidural and general
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.
_Elderly_
Health Products Regulatory Authority
22 February 2023
CRN00DFQR
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