FrostPharma

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

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– 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.

In this leaflet you will find information about: 
1. What adrenaline Bradex is and what it is used for 
2. What you need to know before you use Adrenaline Bradex 
3. How to use Adrenaline Bradex 
4. Possible side effects 
5. How to store Adrenaline Bradex 6. Contents of the pack 
and other information 

1. What Adrenaline Bradex is and what it is used for

Adrenaline belongs to a group of drugs called adrenergic and dopaminergic drugs. Adrenaline Bradex is used in life-threatening acute cases such as severe allergic reactions or cardiac arrest.

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

What you need to know before using Adrenaline Bradex

Do not use Adrenaline Bradex

• if you are allergic to adrenaline or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving Adrenaline Bradex 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 gland, 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 with you about this).

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

Other medicines and Adrenaline Bradex

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

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

• medicines for the treatment of depression, e.g. monoamine oxidase inhibitors ( MAOIs, eg moclobemide) or tricyclic antidepressants (eg imipramine, amitriptyline)

Cardiac glycosides, e.g. digoxin, which is used for heart failure

Guanethidine, used for rapid blood pressure control

• diuretics ( diuretics ), e.g. hydrochlorothiazide , furosemide

• anesthetics e.g. halothane

• medicines to raise or lower blood pressure, e.g. beta-blockers such as propranolol, atenolol, bisoprolol, phentolamine

• medicines for diabetes such as insulin or oral hypoglycaemic agents (eg glipizide)

• aminophylline and theophylline (medicines used to treat asthma )

• corticosteroids (medicines used to treat inflammatory conditions in the body such as asthma or rheumatoid arthritis )

• antihistamine s (e.g. diphenhydramine) for the treatment of allergy s

• medicines 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 Bradex.

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 Bradex should not be used during pregnancy or childbirth.

Adrenaline is excreted in breast milk. If you are breast-feeding, talk to your doctor before taking Adrenaline Bradex. Adrenaline should only be used during pregnancy and breastfeeding when doctors consider it absolutely necessary.

Driving and using machines

This probably does not apply to you because you will not feel good enough to be able to drive or use machines. Talk to your doctor before considering driving or using machines.

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 Bradex contains sodium metabisulfite and sodium chloride

Sodium metabisulfite (a preservative ) can in rare cases cause severe allergic reactions ( hypersensitivity reactions ) and rashes.

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

Adrenaline Bradex can be diluted with sodium chloride 9 mg / ml (0.9%). This should be considered by patients on a low-salt diet.

3. How to use Adrenaline Bradex

Adrenaline can be injected into a muscle ( intramuscularly ) or into the skeleton (intraosseous). It must be diluted before injection into a vein. Adrenaline should not be injected in areas such as fingers, toes, ears, nose, or penis as blood flow in these areas may be insufficient.

The drug is given by trained healthcare professionals. The doctor decides what does 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.

If you use more Adrenaline Bradex than you should  

This is unlikely because the injection is given by a doctor or nurse. Possible signs of overdose may include restlessness, confusion, pallor, abnormally high heart rate at rest ( tachycardia ), low heart rate ( bradycardia ), irregular heartbeat ( cardiac arrhythmia ), and cardiac arrest.

Talk to your doctor if you get any side effects so that he/she can give you appropriate treatment. If you have already left the hospital premises, contact your nearest hospital, doctor, or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

• headache, dizziness

• feeling of anxiety, fear, or restlessness

• tremors

• insomnia, confusion, irritability

• deviant mood or behavior

• dry mouth or excessive salivation

• weakness or sweating

• change in heart rate 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, injuries can also occur in the arms, legs, kidneys, and liver

• difficulty or inability to empty the bladder

• metabolic acidosis (an imbalance of certain components in the blood) may occur

• worsening tremors and worsening stiffness in patients with parkinsonism

• bleeding in the head

• paralysis in one half of the body

• elevated blood sugar levels

• decreased potassium levels in the blood

• accumulation of fluid in the lungs

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Adrenaline Bradex

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

Do not use this medicine after the expiry date which is stated on the carton and ampoule after EXP. The expiration date is the last day of the specified month.

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

For single use only. If only part of the contents of the ampoule is used, discard any remaining solution.

Do not remove an ampoule from the carton before use.

After dilution, the reconstituted solution should be administered as soon as possible but under no circumstances should it be stored for more than 24 hours at 2–8 ° C, 3 hours at 23‑27 ° C when exposed to light, or 6 hours at 23-27 ° C protected from light.

Only clear colorless or pale yellow solution free from particles or precipitates should be used.

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. One ml solution for injection contains 1 mg of adrenaline as adrenaline tartrate.

The other ingredients are sodium metabisulfite (E223), sodium chloride, water for injections, hydrochloric acid, and sodium hydroxide.

What the medicine looks like and the contents of the pack

Adrenaline Bradex is a clear, colorless, or pale yellow, sterile solution for injection in an amber glass ampoule of glass I.

Adrenaline Bradex is available in packs of 10, 25, and 50 ampoules.

Marketing Authorization Holder and Manufacturer

Holder of approval

BRADEX SA, 27 Asklipiou street, 14568 Kryoneri Greece.

Manufacturer

DEMO SA PHARMACEUTICAL INDUSTRY, 21st km National Road Athens-Lamia, 145 68 Krioneri, Attiki, Greece.

Information is provided by

FrostPharma AB

Berga Backe 2

182 53 Danderyd

This leaflet was last modified on 18/09/2020

The following information is intended for healthcare professionals only:

Only clear colorless or pale yellow solution free from particles or precipitates should be used.

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 of adrenaline into the gluteal muscle should be avoided due to the risk of tissue necrosis.

Prolonged administration may cause metabolic acidosis, renal necrosis, and decreased sensitivity to adrenaline 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.

Adrenaline should not be used together with local anesthesia of peripheral structures e.g. fingers, toes, and earlobes.

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

Dilution

For intravenous administration , Adrenaline Bradex should be diluted to a 0.1 mg / ml solution (a 1:10 dilution of the ampoule contents) with sodium chloride 9 mg / ml (0.9%).

Dosage and route of administration

Adrenaline Bradex is intended for intramuscular and intraosseous use. For intravenous administration only after dilution.

Acute anaphylaxis

The intramuscular route of administration is preferred for most individuals requiring treatment with adrenaline for acute anaphylaxis, in doses listed in Table 1.

The recommended dose of adrenaline is generally 0.01 mg per kg of body weight.

For adults, the usual recommended dose of adrenaline is 0.5 mg.

For children whose weight is not known, the following table, which shows the recommended dose by age, can be used:

Table 1. Dose adrenaline 1 mg/ml as an intramuscular injection for a severe anaphylactic reaction

Age Dose Volume of adrenaline 1 mg / ml
Adults 0.5mg 0.5 ml
Children> 12 years 0.5 mg 0.5 ml
Children 6 – 12 years 0.3 mg 0.3 ml
Children 6 months – 6 years 0.15 mg 0.15 ml
For 6 months 0.01 mg / kg 0.01 ml / kg
If necessary, these doses can be repeated several times at intervals of 5‑15 minutes depending on blood pressure , heart rate and respiratory function.
A small volume syringe should be used.

If the patient is seriously ill and there is reason to suspect inadequate circulation and absorption from the intramuscular injection site, adrenaline may be given as an intravenous injection.

Intravenous adrenaline should only be given by staff experienced in the use and titration of vasopressors from their normal clinical practice (see section 4.4 of the Summary of Product Characteristics). Upon administration of intravenous epinephrine will dose a given after dilution to 0.1 mg/ml solution (i.e. ml of a 1:10 dilution). Dose one should be titrated with bolus doses of 0.05 mg according to the response. Do not give the undiluted 1 mg/ml adrenaline solution intravenously.

If necessary, repeated dosing with adrenaline recommended intravenous infusion, with the rate titrated according to response followed by continued hemodynamic monitoring.

Cardiopulmonary rescue

Adults

1 mg adrenaline administered intravenously or intraosseously, repeated at 3-5 minute intervals until spontaneous circulation returns. If the injection is made through a peripheral inlet, this must be followed by flushing with at least 20 ml of fluid and raising the extremity one for 10–20 seconds to promote the drug’s distribution to the central circulation.

Pediatric population

The recommended intravenous or intraosseous dose of adrenaline in children is 0.01 mg/kg. Depending on the weight, this dose may need to be given as a 0.1 mg/ml solution (ie a 1:10 dilution of the ampoule contents). Subsequent dose s adrenaline is given 3-5 minutes. The maximum single dose is 1 mg.

Disposal

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

Overdose

Sign

Overdose with Adrenaline Bradex leads to restlessness, confusion, pallor, tachycardia, bradycardia, cardiac arrhythmias, and cardiac arrest.

Treatment

Treatment is mainly symptomatic and supportive. Attempts have been made to counteract the astringent and arrhythmogenic effects of adrenaline with an immediate injection of fast-acting alpha-receptor blockers, e.g. phentolamine, followed by a beta-blocker, e.g. propranolol. A fast-acting vasodilator, e.g. glyceryl trinitrate has also been used.

Muhammad Nadeem

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