Ephedrine Hydrochloride 30mg in 1ml Solution for Injection

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Ephedrine hydrochloride

Доступна з:

Ethypharm

Код атс:

C01CA26

ІПН (Міжнародна Ім'я):

Ephedrine hydrochloride

Дозування:

30 milligram(s)/millilitre

Фармацевтична форма:

Solution for injection

Терапевтична области:

ephedrine

Статус Авторизація:

Marketed

Дата Авторизація:

2004-11-26

інформаційний буклет

Package Leaflet: Information for the user
EPHEDRINE HYDROCHLORIDE 30MG IN 1ML SOLUTION FOR INJECTION
Ephedrine Hydrochloride
(Referred to as Ephedrine Injection in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
nurse.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or nurse.
IN THIS LEAFLET:
1. What Ephedrine Injection is and what it is used for
2. Before Ephedrine Injection is given
3. How Ephedrine Injection is given
4. Possible side effects
5. How to store Ephedrine Injection
6. Further information
This leaflet contains a summary of the information available for this
medicine. You should ask your
doctor or pharmacist if you are unsure about any aspect of this
medicine.
1. WHAT EPHEDRINE INJECTION IS AND WHAT IT IS USED FOR
Ephedrine belongs to a group of medicines called sympathomimetics.
Sympathomimetic drugs affect the
part of your nervous system that works automatically.
Ephedrine Injection is used to relieve low blood pressure during
spinal anaesthesia. It raises blood
pressure by temporarily reducing the blood supply to small blood
vessels.
2. BEFORE YOU ARE GIVEN EPHEDRINE INJECTION
YOU SHOULD NOT BE GIVEN EPHEDRINE INJECTION IF:
• you are allergic (hypersensitive) to ephedrine or to any of the
other ingredients in this medicine, listed in
section 6 of this leaflet
• you suffer from an overactive thyroid gland which can cause
increased appetite, weight loss or sweating
• you suffer from prostate gland enlargement
• you suffer from any heart disease
• you suffer from increased pressure in the eye (glaucoma)
• you suffer from diabetes
• you suffer from blood clots
• you suffer from high blood pressure
• you are taking monoamine oxidase inhibitors (MAOIs) (see Taking
other medicines).
If any of the above applies to you, please tell your doctor.
TAKE SPECI

Характеристики продукта

Health Products Regulatory Authority
10 June 2019
CRN008YGG
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ephedrine Hydrochloride 30mg in 1ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 30mg of ephedrine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear colourless sterile solution for injection
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To reduce hypotension during spinal anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For single patient use only:
Adults and the elderly
Up to 30 mg in increments of 3 - 7.5 mg.
After the development of hypotension, by slow intravenous
administration.
Children
0.5 - 0.75 mg / kg body weight or 17 - 25 mg / m
2
body surface.
After the development of hypotension, by slow intravenous
administration.
4.3 CONTRAINDICATIONS
Patients receiving treatment with monoamine oxidase inhibitors (or
within 2 weeks of their withdrawal). Coronary thrombosis,
diabetes mellitus, ischaemic heart disease, hypertension,
thyrotoxicosis, closed angle glaucoma or, in the case of elderly
patients prostatic hypertrophy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Cardiovacular effects may be seen with sympathomimetic drugs including
Ephedrine Hydrochloride 30 mg in 1 ml Solution for
Injection. There is some evidence from post-marketing data and
published literature of rare occurrences of myocardial
ischaemia associated with beta agonists. Patients with underlying
severe heart disease (e.g. ischaemic heart disease, arrhythmia
or severe heart failure) who are receiving Ephedrine Hydrochloride 30
mg in 1 ml Solution for Injection should be warned to
seek medical advice if they experience chest pain or other symptoms of
worsening heart disease. Attention should be paid to
assessment of symptoms such as dyspnoea and chest pain, as they may be
of either respiratory or cardiac origin.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERAC