Unimedic Pharma

Solution for injection 1 mg / ml 
(Clear, colorless, sterile solution)

Due to your condition, it may be difficult for you to read this leaflet before you receive Adrenaline Ethypharm

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or nurse.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Adrenalin Ethypharm is and what it is used for 
2. What you need to know before you use Adrenalin Ethypharm 
3. How to use Adrenalin Ethypharm 
4. Possible side effects 
5. How to store Adrenaline Ethypharm 6. Contents of the pack 
and other information 

What Adrenaline Ethypharm is and what it is used for

Adrenaline belongs to a group of drugs called sympathomimetics. Adrenaline is used as a treatment in acute cases of severe allergic reactions.

Adrenaline contained in Adrenaline Ethypharm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Adrenaline Ethypharm

Do not use Adrenaline Ethypharm

  • if you are allergic to adrenaline or any of the other ingredients of this medicine (listed in section 6).
  • Adrenaline should not be used in fingers, toes, ears, nose, genitals, or tail as the blood flow to these body parts may be insufficient.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving Adrenaline Ethypharm if:

  • you are older
  • you have a heart problem, especially if it affects your heart rate or if you have chest pain
  • you have problems with the brain e.g. stroke, brain damage, or vascular disease
  • you have an overactive thyroid, diabetes, or glaucoma (high pressure in the eye)
  • you have pheochromocytoma (a tumor on the adrenal gland)
  • you have low potassium levels or high calcium levels in your blood
  • you have a tumor in the prostate gland or a kidney disease
  • you are in shock or have lost large amounts of blood
  • you will undergo surgery under anesthesia
  • you have high blood pressure
  • you have atherosclerosis, which means narrowing and hardening of the body’s blood vessels (your doctor can consult you about this)

Talk to your doctor before receiving this medicine if any of these apply to you.

Other medicines and Adrenaline Ethypharm

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

A large number of drugs can affect the effect of Adrenaline Ethypharm. These medicines include:

  • monoamine oxidase inhibitors ( MAOIs ) or tricyclic antidepressants such as imipramine, amitriptyline, used to treat depression
  • cardiac glycosides, e.g. digoxin, which is used for heart failure
  • guanethidine is used for rapid blood pressure control
  • diuretics ( diuretics ), e.g. hydrochlorothiazide , furosemide
  • anesthetic drugs that are inhaled e.g. halothane
  • drugs to raise or lower blood pressure, such as beta-blockers, e.g. propranolol, atenolol,
  • bisoprolol, phentolamine
  • drugs for diabetes such as insulin or oral hypoglycaemic agents (eg glipizide)
  • aminophylline and theophylline (medicines used to treat asthma )
  • corticosteroids (medicines to treat inflammatory conditions in the body such as asthma or rheumatoid arthritis )
  • antihistamine s (e.g. diphenhydramine) for the treatment of allergy s
  • drugs for the treatment of mental illness, e.g. chlorpromazine, penicillin, or fluphenazine
  • drugs for the treatment of underactive thyroid gland
  • oxytocin (used to initiate labor in full-term pregnancy and to control postpartum hemorrhage)
  • medicines for coughs and colds ( sympathomimetics ).

If you are already taking any of these medicines, talk to your doctor before taking Adrenaline Ethypharm.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Adrenaline should only be used during pregnancy and breastfeeding when doctors consider it absolutely necessary.

Driving and using machines

You should not drive or use machines if you are affected by the administration of Adrenaline Ethypharm.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Adrenaline Ethypharm contains excipients

This medicine contains sodium metabisulphite which may cause allergic reactions

( hypersensitivity reactions ) which may lead to difficulty breathing or collapse in some individuals. Individuals who have previously had asthma or allergies are more likely to experience these problems.

This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’.

3. How to use Adrenaline Ethypharm

You will receive Adrenaline Ethypharm injected into a muscle ( intramuscularly – im) but may also in some cases be injected diluted into a vein ( intravenous -iv).

Adrenaline should NOT be injected in areas such as fingers, toes, ears, nose, genitals, or tail as blood flow in these areas may become insufficient. If repeated injections required, your doctor will change the injection site. Adrenaline will be given by trained healthcare professionals. The doctor decides what dose and in what way the medicine should be given depending on what is most appropriate in your particular case based on your age and your general condition.

Adults

The most common dose is 0.5 ml. If necessary, this dose can be repeated several times at 5-minute intervals

Older

No specific dosing information available for injection of adrenaline in the elderly. However, adrenaline should be used with great caution in these patients.

Use for children and adolescents

The following dosage of Adrenaline Ethypharm is recommended:

Age Dose
Over 12 years 0.5 mg im (0.5 ml 1 mg / ml solution for injection )0.3 mg im (0.3 ml 1 mg / ml solution for injection ) if the child is small or pre-pubertal
6-12 years 0.3 mg im (0.3 ml 1 mg / ml solution for injection )
6 months – 6 years 0.15 mg im (0.15 ml 1 mg / ml solution for injection )
For 6 months 0.01 mg / kg im (0.01 ml / kg 1 mg / ml solution for injection )

If necessary, these doses can be repeated several times at 5-15 minute intervals, depending on blood pressure, heart rate, and respiratory function.

A small volume of the syringe should be used.

If you use more Adrenaline Ethypharm than you should 

As an injection is given when you are in hospital, it is unlikely that you have received too little or too much medicine, contact a doctor or nurse if you feel worried.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following side effects, stop taking this medicine and contact your doctor immediately:

  • allergic reactions, although severe allergic reactions are rare
  • sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially all over the body)

The following side effects have also been reported (affects an unknown number of users):

  • headache
  • dizziness
  • the feeling of anxiety, fear, or restlessness
  • tremors
  • insomnia, confusion, irritability
  • deviant mood or behavior
  • dry mouth or excessive salivation
  • weakness or sweating
  • altered heart rhythm or heart rate
  • palpitations (rapid or irregular heartbeat), tachycardia (abnormally high heart rate at rest), angina (chest pain of varying intensity )
  • high blood pressure
  • cold arms or legs
  • shortness of breath
  • decreased appetite, nausea, or vomiting
  • Repeated injections can damage tissue at the injection site
  • difficulty or inability to empty the bladder
  • metabolic acidosis (an imbalance of certain components in the blood) may occur
  • bleeding in the head
  • paralysis in one half of the body
  • elevated blood sugar levels
  • breakdown of fat in the body
  • decreased potassium levels in the blood
  • accumulation of fluid in the lungs
  • chest pain ( acute angina)
  • heart attack ( acute myocardial infarction)
  • pallor
  • fainting
  • enlargement of pupil one

Adrenaline may increase stiffness and tremor ( tremor ) in patients with Parkinson’s syndrome.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Adrenaline Ethypharm

Keep this medicine out of the sight and reach of children.

Your doctor or nurse will check that the expiry date stated on the label has not expired before you receive Adrenaline Ethypharm. The expiration date is the last day of the specified month.

Keep the vial are in the outer carton. Sensitive to light. Do not store above 25 ° C and do not freeze.

You should not receive Adrenaline Ethypharm if you notice that it has already been used or if it appears to have been damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is adrenaline as adrenaline tartrate 1 mg/ml.
  • The other ingredients are sodium chloride, sodium metabisulfite, and water for injections.

Hydrochloric acid or sodium hydroxide may be added to adjust the acid content ( pH).

What the medicine looks like and the contents of the pack

Adrenaline Ehtypharm is a clear, colorless solution, whose packs of 10 glass ampoules contain 0.5, 1, 2, 5, or 10 ml each.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Ethypharm

194 Bureaux de la Colline

Saint- Cloud CEDEX

France

Manufacturer

Macarthys Laboratories Limited,

Bampton Road,

Harold Hill,

Romford,

Essex, RM38UG

UK

This leaflet was last modified on 5 April 2019

Other sources of information

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Unimedic Pharma AB

medinfo@unimedicpharma.se

+ 46 (0) 10-130 99 50

The following information is intended for healthcare professionals only:

Preparation and handling

Do not use Adrenaline Ethypharm 1 mg/ml solution for injection if you notice that it is discolored.

Repeated topical administration may cause necrosis at the injection site.

The best site for intramuscular injection is anterolateral in the middle third of the thigh. The needle used for injection must be long enough to ensure that the adrenaline reaches the muscle.

Intramuscular injection in fingers, toes, ears, nose, genitals, or tail should be avoided due to the risk of tissue necrosis.

Prolonged administration may cause metabolic acidosis, renal necrosis, or tachyphylaxis.

The use of adrenaline should be avoided or avoided with extreme caution in patients under anesthesia with halothane or other halogenated anesthetics, due to the risk of causing ventricular fibrillation.

Do not mix with other drugs unless compatibility has been confirmed.

Adrenaline should not be used during the expulsion phase of labor.

Accidental intravascular injection may result in cerebral hemorrhage due to the sudden rise in blood pressure.

Start monitoring the patient as soon as possible (heart rate, blood pressure, ECG, pulse oximetry) to assess the response to adrenaline.

Incompatibilities

Adrenaline is rapidly denatured by oxidizing agents and alkalis including sodium bicarbonate, halogens, nitrates, nitrites, and salts of iron, copper, and zinc.

Dosage and route of administration

Adrenaline Ethypharm 1 mg/ml solution for injection is intended for intramuscular administration.

Administering not adrenaline Ethypharm 1 mg/ml injection solution intravenously.

Intravenous administration of adrenaline for the treatment of anaphylaxis requires an adrenaline solution of 0.1 mg/ml.

Intramuscular administration is generally preferred in the initial treatment of anaphylaxis and intravenous administration is generally more appropriate in intensive care units or emergency rooms. Adrenaline Ethypharm 1 mg/ml solution for injection is not suitable for intravenous administration. If Adrenaline 0.1 mg / ml is not available, Adrenaline Ethypharm 1 mg / ml solution for injection should be diluted to 0.1 mg / ml solution (ie a 1:10 dilution) before administration . Intravenous administration of adrenaline should be done with great caution and by specialists with experience of intravenous use of adrenaline.

Acute anaphylaxis

The intramuscular route of administration is preferred for most individuals requiring treatment with adrenaline for acute anaphylaxis.

The most common dose for adults is 0.5 mg (0.5 ml adrenaline 1 mg / ml). If necessary, this dose can be repeated several times at 5-minute intervals, depending on blood pressure, heart rate, and respiratory function.

Older:

No specific dosing information available for injection of adrenaline in the elderly. However, adrenaline should be used with great caution in these patients, as they may be more susceptible to cardiovascular side effects from adrenaline.

Pediatric population

The following dosage of Adrenaline Ethypharm is recommended:

Age Dose
Over 12 years 0.5 mg im (0.5 ml 1 mg / ml solution for injection )0.3 mg im (0.3 ml 1 mg / ml solution for injection ) if the child is small or pre-pubertal
6-12 years 0.3 mg im (0.3 ml 1 mg / ml solution for injection )
6 months – 6 years 0.15 mg im (0.15 ml 1 mg / ml solution for injection )
For 6 months 0.01 mg / kg im (0.01 ml / kg 1 mg / ml solution for injection )

If necessary, these doses can be repeated several times at 5-15 minute intervals, depending on blood pressure, heart rate, and respiratory function.

A small volume of the syringe should be used.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

Overdose

Sign

Overdose of Adrenaline Ethypharm may cause severe hypertension. It can result in cerebral, cardiovascular, or vascular effects, which can be fatal (cerebral hemorrhage, dysrhythmias such as transient bradycardia followed by tachycardia which may lead to arrhythmia, myocardial necrosis, acute pulmonary edema, renal failure ).

Treatment

The effects of adrenaline can be counteracted, depending on the patient’s condition, by administering fast-acting vasodilators, fast-acting alpha-receptor blockers (eg phentolamine), or beta-blockers, e.g. propranolol. Due to the short half-life of adrenaline, treatment with these drugs may not be necessary. If prolonged hypotension occurs, administration of an additional vasodilator such as norepinephrine may be required.

Muhammad Nadeem

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