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

Active substance: EPHEDRINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript


Noir  Caractères

Package leaflet : Information for the user

Gris  Découpe

Ephedrine Hydrochloride 3 mg/ml

□ Validation
Date :
Nom :
Signature :

□ Correction

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, 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 to treat low blood pressure that can occur
during spinal or epidural 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 heart condition, including
angina;

• you suffer from weakness in a blood vessel wall leading to a bulge
developing (aneurysm);
• you have a 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 gland);
• you are about to have an operation which requires that you are
given an anaesthetic;
• you are currently taking or have taken within the last 14 days any
monoamine oxidase inhibitor medicine used to treat depression.
Other medicines and Ephedrine Injection
Tell your doctor if you are using, have recently used or might use any
other medicines.
This is especially important for the following medicines:
• methylphenidate, used to treat “attention deficit hyperactivity
disorder” (ADHD);
• indirect stimulators of the sympathetic nervous system such as
phenylpropanolamine or pseudoephedrine (medicines used in
nasal decongestant), phenylephrine ( a medicine used to treat
hypotension);
• direct stimulators of alpha receptors of the sympathetic nervous
system (oral and/or nasal use) that are used to treat hypotension or
nasal congestion, among others;
• 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 medicines used to relieve swelling in a
variety of different conditions;
• medicines for epilepsy;
• doxapram, a medicine used to treat breathing problems;
• oxytocin, a medicine used during labour;
• guanethidine and related medicines, used to treat high blood
pressure;
• Ergot alkaloids, a type of medicines used as vasoconstrictors
(narrowing blood vessels) or for their dopaminergic action
(increasing the dopamine-related activity in the brain).
Pregnancy and breast-feeding: If you are pregnant or breast-feeding,
think you may be pregnant or are planning to have a baby, ask your
doctor, pharmacist or nurse for advice before being given this medicine.
Laboratory Testing: This medicinal product contains an active
ingredient that can induce positive results in anti-doping controls.
Ephedrine Injection contains sodium: 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.

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

Safety information:

Solution for Injection in Pre-filled Syringe

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

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.
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.
Pediatric population
• 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.
• Children over 12 years: The method of administration is the same as for adults.
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 management 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 arrhythmia and may be corrected by infusing potassium chloride in
addition to propranolol and correcting respiratory alkalosis, when present.

AGUETTANT SYSTEM®



Noir  Caractères
Gris  Découpe

□ Validation
Date :
Nom :
Signature :

□ Correction

3. How Ephedrine Injection is given

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.
The recommended doses are
Adults and elderly:
You will be given a slow injection of 3 to 6 mg (maximum 9 mg) into a
vein, repeated if necessary every 3-4 minutes to a maximum of 30 mg.
The total dose must be lower than 150 mg/24 hours.
Use in children and adolescents
• Children under 12 years: Your child will be given a slow injection
of 0.5-0.75 mg/kg or 17-25 mg/m², into a vein, every 3-4 minutes
according the child’s response to treatment.
• Children over 12 years: Your child’s dosage will be calculated
the same as for an adult.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The most serious side effets that will require immediate medicinal
attention from your doctor are:
• abnormal heart rhythm;
• palpitations, high blood pressure, fast heartbeat;
• pain over the heart, slow heartbeat, low blood pressure;
• heart failure (cardiac arrest),
• bleeding in the brain;
• build up of a fluid within the lungs (pulmonary oedema).
• increased pressure in the eye (glaucoma);
• difficulty in passing urine.
Other side effects that you may experience while taking this medicine
are listed below.
Common (may affect up to 1 in 10 people):
• confusion, feeling worried, depression;
• nervousness, irritability, restlessness, weakness, sleeping problems,
headache, sweating;
• shortness of breath;
• nausea, vomiting.
Not known (frequency cannot be estimated from the available
data):
• affects blood clotting;
• allergy;
• change in your personality or the way you feel or think, fear;
• tremor, excessive saliva production;
• reduced appetite;
• a decrease in blood potassium levels, changes in blood glucose
levels.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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 this medicine out of the sight and reach 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 thrown away 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
Marketing Authorisation Holder:
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON - France
Manufacturer:
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON - France
This leaflet was last revised in 08/2014.
Detailed information on this medicine is available on the MHRA website.

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®

Expand view ⇕

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.

Hide
(web4)