Ephedrine 30mg/1ml solution for injection ampoules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Ephedrine hydrochloride

Inapatikana kutoka:

Martindale Pharmaceuticals Ltd

ATC kanuni:

C01CA26

INN (Jina la Kimataifa):

Ephedrine hydrochloride

Kipimo:

30mg/1ml

Dawa fomu:

Solution for injection

Njia ya uendeshaji:

Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 02070200; GTIN: 5014124170148

Taarifa za kipeperushi

100MM MEASUREMENT VERIFICATION BAR
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
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 or epidural anaesthesia. It raises blood pressure by
temporarily reducing the blood supply to small blood vessels.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
EPHEDRINE INJECTION
You should not be given Ephedrine Injection if:
• you are allergic to ephedrine hydrochloride or to any of the
other ingredients in 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 suffer from diabetes
• you suffer from heart disease or any other heart conditions,
including angina;
• you suffer from weakness in a blood vessel wall leading to a
bulge developing (aneurysm);
• you have high blood pressure;
• you have a narrowing and/or blockage of blood vessels
(occlusive vascular disorders)
• you have an overactive thyroid gland (hyperthyroidism);
• you know or suspect that you suffer from glaucoma (increased
pressure in your eyes) or prostatic hypertrophy (enlarged
prostate g

Tabia za bidhaa

OBJECT 1
EPHEDRINE HYDROCHLORIDE 30 MG PER 1 ML
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 18-Apr-2017 | Martindale
Pharma
1. Name of the medicinal product
Ephedrine Hydrochloride 30 mg per 1 ml Solution for Injection
2. Qualitative and quantitative composition
Ephedrine Hydrochloride 3% w/v.
Each ml of Solution for Injection contains 30 mg ephedrine
hydrochloride.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Clear, colourless solution for Injection
pH = 5.00 - 7.000
4. Clinical particulars
4.1 Therapeutic indications
Reversal of hypotension from spinal or epidural anaesthesia.
4.2 Posology and method of administration
Posology
_Adults and the elderly _
Up to 30 mg in increments of 3 - 7.5 mg.
After the development of hypotension, by slow intravenous
administration.
_Paediatric Population_
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
Hypersensitivity to Ephedrine Hydrochloride or to any of the
excipients listed in section 6.1
• In combination with other indirect sympathomimetic agents such as
phenylpropanolamine,
phenylephrine, pseudoephedrine and methylphenidate.
• In combination with alpha sympathomimetic agents.
• In combination with non-selective Monoamine Oxidase Inhibitors
(MAOI) or within 14 days of their
withdrawal.
4.4 Special warnings and precautions for use
Warnings
Ephedrine should be used with caution in patients who may be
particularly susceptible to their effects,
particularly those with hyperthyroidism. Great care is also needed in
patients with cardiovascular disease
such as ischaemic heart disease, arrhythmia or tachycardia, occlusive
vascular disorders including
arteriosclerosis, hypertension, or aneurysms. Angina pain may be
precipitated in patients with angina
pectoris.
Care is also required when Ephedrine is given to patients with
diabetes mellitus, closed-angle glaucoma
or prostatic hypertrophy.
Ephedrine should be avoided