EPHEDRINE HYDROCHLORIDE 3 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance: EPHEDRINE HYDROCHLORIDE

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Ephedrine Hydrochloride 3 mg/ml

000000 MM/AA

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 or pharmacist.
• 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 or pharmacist. 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 use Ephedrine Injection
3. How to use Ephedrine Injection
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 product is used to treat low blood pressure that can occur
during spinal or epidural anaesthesia.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
EPHEDRINE INJECTION

Do not use Ephedrine Injection if:
• You know you are allergic (hypersensitive) to the active
substance or to any of the ingredients of Ephedrine Injection
(See section 6, Contents of the pack and other information),
• 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»),
• 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 nonselective monoamine oxidase inhibitor (medicines used to treat
depression).

Take special care with Ephedrine Injection. Tell your doctor if:
• You are a diabetic,
• You suffer from heart disease or any other heart condition,
• 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 gland),
• You are about to have an operation which requires that you be
given an anaesthetic,
• You are currently taking or have taken within the last 14 days
any monoamine oxidase inhibitor drug used to treat depression.
Other medicines and Ephedrine Injection
Tell your doctor if you are taking or have recently taken any other
medicines including medicines obtained without a prescription as
they may interact with Ephedrine Injection.
This is especially important of the following medicines:
• methylphenidate, used to treat “attention deficit hyperactivity
disorder”
• anaesthetics that are inhaled such as halothane
• medicines used to treat depression,
• sibutramine, a medicine used as an appetite suppressant
• linezolid, used to treat infections
• medicines used to treat asthma such as theophylline
• corticosteroids, a type of medicine used to relieve swelling in a
variety of different conditions
• medicines for epilepsy
• doxapram, a drug used to treat breathing problems
• oxytocin, a drug used during labour
• guanethidine and related medicines, used to treat high blood
pressure
• ergot alkaloids, a type of medicine used as vasoconstrictors or
for their dopaminergic action
Pregnancy and breast-feeding
Please tell your doctor if you are pregnant or think you may be
pregnant before you are given this medicine.
If you are breast-feeding, speak to your doctor or pharmacist
before taking this medicine.
Ask your doctor or pharmacist for advice before taking any
medicine.
Laboratory Testing
This medicinal product contains an active ingredient that can
induce positive results in anti-doping controls.

AGUETTANT SYSTEM®
The following information is intended for medical or healthcare professionals only:
This is an extract from the Summary of Product Characteristics to assist in the administration of Ephedrine Injection. When determining
appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics of the product.
Drug name:

Ephedrine Hydrochloride 3 mg/ml
Solution for Injection in Pre-filled Syringe

Safety information:

Ephedrine must be used solely by or under the supervision of the anaesthetist.
For intravenous injection.

Incompatibilities:

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Administration:

The pre-filled syringe contains a ready-to-use solution for injection containing 3 mg ephedrine hydrochloride in each ml of solution.
Adult and children over 12 years
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.
Children under 12 years
The paediatric dose is 0.5 to 0.75 mg/kg or 17-25 mg/m2 every 3-4 minutes according to response.
Elderly
As for adults.

Overdose:

In the event of overdose, the occurrence of nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias,
respiratory depression, convulsions and coma is observed.
The lethal dose in humans is approximately 2 g corresponding to blood concentrations of approximately 3.5 to 20 mg/I.
Treatment
The treatment of ephedrine overdose with this product may require intensive supportive treatment. Slow intravenous injection of
labetalol 50-200 mg may be given with electrocardiograph monitoring for the treatment of supraventricular tachycardia. Marked
hypokalaemia (< 2.8 mmol.l-1) due to compartmental shift of potassium predisposes to cardiac arrhythmias and may be corrected by
infusing potassium chloride in addition to propranolol and correcting respiratory alkalosis, when present.

AGUETTANT SYSTEM®



Important information about some of the ingredients of
Ephedrine Injection: This medicinal product contains 3.32 mg
(0.144 mmol) of sodium per ml of injection (a total of 33.2 mg or
1.44 mmol sodium in 10 ml syringe). This amount must be taken
into consideration by patients on a salt-restricted diet.

3. HOW TO USE EPHEDRINE INJECTION

Your doctor or nurse will administer Ephedrine Injection to you into
a vein (intravenous). Your doctor will decide the correct dosage for
you and when and how the injection should be administered.
Dosage
Adults, elderly and children over 12 years:
You will be given a slow injection into a vein of 3 to 6 mg
(maximum 9 mg), repeated if necessary every 3-4 minutes to a
maximum of 30 mg.
The total dose must be lower than 150 mg/24 hours.
Children under 12 years
Your child will be given a slow injection into a vein of 0.5-0.75 mg/kg
or 17-25 mg/m² every 3-4 minutes according to response.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ephedrine Injection can cause side effects,
although not everybody gets them.
Common (affect less than 1 in 10 patients):
• Confusion, feeling worried, depression
• Nervousness, irritability, restlessness, weakness, sleeping
problems, headache, sweating
• Palpitations, high blood pressure, fast heartbeat
• Shortness of breath
• Nausea, vomiting
Rare (affect less than 1 in 1000 patients):
• Irregular heartbeat
• Difficulty in passing urine
Other side effects (it is not known how often these occur):
• Affects blood clotting
• Allergy
• Change in your personality or the way you feel/think, fear
• Tremor, excessive saliva production
• Increased pressure in the eye (glaucoma)
• Pain over the heart, slow heartbeat, heart failure (cardiac arrest),
low blood pressure
• Bleeding in the brain
• Breathing problems

• Reduced appetite
• A fall in blood potassium levels, changes in blood glucose levels
• Build up of a fluid within the lungs (pulmonary oedema)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme :
Tel: Freephone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information
on the safety of this medicine.

5. HOW TO STORE EPHEDRINE INJECTION
Keep out of the reach and sight of children.

You should not be given this medicine if it has passed the expiry
date shown on the carton and syringe label. Your doctor or nurse
will check this.
Store the blister in the outer carton in order to protect from light.
Any unused product or waste material should be disposed of in
accordance with local requirements.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Ephedrine Injection contains:
• The active ingredient is Ephedrine Hydrochloride. Each ml of
Solution for Injection contains 3 mg ephedrine hydrochloride. Each
10 ml prefilled syringe contains 30 mg ephedrine hydrochloride.
• The other ingredients are Sodium Chloride, Citric acid
monohydrate, sodium citrate and Water for Injections and may
contain hydrochloric acid or sodium hydroxide (for pH adjustments).
What Ephedrine Injection looks like and contents of the pack:
Ephedrine Injection is a clear and colourless liquid. It is supplied
in a 10 ml polypropylene prefilled syringe with a polypropylene
tip cap and tamper proof seal, and is individually packaged in a
transparent blister pack.
The prefilled syringes are available in boxes of 1, 5, 10, 12 and 20
syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON - France
This leaflet was last approved in June 2013.

AGUETTANT SYSTEM®
Instructions for use:
Please prepare the syringe carefully as follows.
The pre-filled syringe is for single patient only.
Discard syringe after use. DO NOT REUSE.
The content of un-opened and un-damaged blister is sterile, and must not be opened until use.
The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from
particles or precipitates should be used.
Do not use the product if the tamper evident seal on syringe is broken.
The external surface of syringe is sterile until blister is opened
1) Withdraw the pre-filled syringe from the sterile blister.




2) Push on the plunger to free the bung




4) Check that the syringe seal has
been completely removed. If not,
replace the cap and twist again.







3) Twist off the end cap to break the
seals.

5) Expel the air by gently pushing
the plunger.

6) Connect the syringe to the IV access. Push the plunger slowly to inject the required volume.
Any unused product or waste material should be disposed of in accordance with local requirements.

Storage and Shelf life:

Do not use this product after the expiry date which is stated on the carton and syringe label. The expiry date refers to the last day of
that month.
After opening: the product must be used immediately.
Store the blister in the outer carton in order to protect from light.

AGUETTANT SYSTEM®

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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