Ephedrine Aguettant 30mg/ml, Solution for injection

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

EPHEDRINE HYDROCHLORIDE

Tilgjengelig fra:

Laboratoire Aguettant 1 Rue Alexander Fleming, 69007 Lyon, France

ATC-kode:

C01CA06

INN (International Name):

EPHEDRINE HYDROCHLORIDE 30 mg/ml

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

EPHEDRINE HYDROCHLORIDE 30 mg/ml

Resept typen:

POM

Terapeutisk område:

CARDIAC THERAPY

Autorisasjon status:

Authorised

Autorisasjon dato:

2006-04-17

Informasjon til brukeren

_T10 - Q11ADOC034 v.04 _
_1_
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAME OF THE MEDICINAL PRODUCT
EPHEDRINE AGUETTANT 30 MG/ML, SOLUTION FOR INJECTION
EPHEDRINE HYDROCHLORIDE
BOX
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 AGUETTANT 30 mg/ml, solution for injection is and
what it is used for
2. What you need to know before you take EPHEDRINE AGUETTANT 30 mg/ml,
solution for injection
3. How to use EPHEDRINE AGUETTANT 30 mg/ml, solution for injection
4. Possible side effects
5. How to store EPHEDRINE AGUETTANT 30 mg/ml, solution for injection
6. Contents of the pack and other information.
1.
WHAT EPHEDRINE AGUETTANT 30 MG/ML, SOLUTION FOR INJECTION IS AND WHAT
IT
IS USED FOR
Pharmacotherapeutic group: Cardiac stimulants, cardiac glycosides
excluded, ATC code: C01CA26.
EPHEDRINE AGUETTANT 30 mg/ml, solution for injection is indicated in
the following cases:

Treatment of hypotension during general anaesthesia and loco-regional
anaesthesia, whether
spinal or epidural and whether for surgical or obstetric procedures,

Preventative treatment of hypotension during spinal anaesthesia for
surgical or obstetric
procedures
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPHEDRINE AGUETTANT 30
MG/ML, SOLUTION FOR INJECTION
NEVER USE EPHEDRINE AGUETTANT 30 MG/ML, SOLUTION FOR INJECTION:

if you are allergic to ephedrine or any of the other ingredients of
this medicine listed in section 6

in combination with other indirect sympathomimetic vasoconstrictors
(such as pseudoephedr

Preparatomtale

_1_
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
EPHEDRINE AGUETTANT 30 MG/ML, SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ephedrine hydrochloride
..................................................................................................................
30 mg
For 1 ml of solution for injection.
1 ml of solution for injection contains 30 mg of ephedrine
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
pH = 5.5 to 7.0
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Treatment of hypotension during general anaesthesia and locoregional
anaesthesia, whether for
surgical or obstetric procedures, and whether spinal or epidural.
•
Preventive
treatment
of
hypotension
during
spinal
anaesthesia
for
surgical
or
obstetric
procedures.
4.2.
DOSAGE AND METHOD OF ADMINISTRATION
DOSAGE
_Adults _
The dose is from 3 to 6 mg, repeated as needed every 5 to 10 min.
The dose for 24 hours must be less than 150 mg.
A lack of efficacy after 30 mg should lead to reconsideration of the
choice of the therapeutic agent.
_Paediatric population_
The administration route is intravenous.
The dose is from 0.1 to 0.2 mg/kg every 4 to 6 hours.
METHOD OF ADMINISTRATION
Ephedrine must be used solely by or under the supervision of the
anaesthetist.
For intravenous use.
Intravenous infusion or IV bolus. The administration route varies
depending on the patient’s condition,
weight and additional therapies.
_2_
_ _
4.3.
CONTRAINDICATIONS
This medicinal product must never be used in the following cases:
•
hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
in combination with other indirect sympathomimetic agents such as
pseudoephedrine,
methylphenidate, bupropion, cafedrine, and theodrenaline.
•
in combination with alpha sympathomimetic agents,
•
in combination with irreversible MAOIs
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SPECIAL WARNINGS
Ephedrine should be use