Mylan

Solution for injection 1 mg / ml 
(Solution for injection)

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.

– 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 Mylan is and what it is used for 
2. What you need to know before you receive Adrenaline Mylan 
3. How to take Adrenaline Mylan 
4. Possible side effects 
5. How to store Adrenaline Mylan 
6. Package contents and other information 

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

Adrenaline Mylan is used in emergency care in connection with asthma, cardiopulmonary resuscitation (cardiac arrest), and allergic reactions ( hypersensitivity reactions and anaphylactic shock ).

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

What You Need to Know Before You Get Adrenaline Mylan

Do not use Adrenaline Mylan

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

Warnings and cautions

Due to the increased risk of adverse reactions following the use of adrenaline, special care should be taken in patients with

  • cardiovascular diseases (such as angina, myocardial infarction, arrhythmias, pulmonary heart disease, atherosclerosis, and high blood pressure )
  • overactive thyroid function
  • adrenal tumor
  • narrow-angle glaucoma ( glaucoma – increased eye pressure)
  • severe renal impairment
  • enlarged prostate that causes urine to remain in the bladder
  • the increased amount of calcium in the blood
  • decreased amount of potassium in the blood
  • diabetes
  • Parkinson’s disease

Special care should also be taken in elderly and pregnant patients.

Other drugs and Adrenaline Mylan

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

This is especially important if you use any of the following:

  • beta-blockers (eg pindolol and propranolol), as concomitant use may cause high blood pressure and decreased heart rate
  • anesthetics (eg ethyl chloride, halothane, enflurane, trichloroethylene, and chloroform), as concomitant use of certain anesthetics, may increase the risk of arrhythmias
  • medicines that may increase the risk of heart rhythm disorders (eg digitalis and quinidine )
  • certain antidepressants
  • such as tricyclic and tetracyclic antidepressants or monoamine oxidase inhibitors ( MAOIs ) (eg clomipramine, amitriptyline, maprotiline, and moclobemide), as the effect of adrenaline may be enhanced
  • insulin or diabetes medications are taken by mouth, as adrenaline increases blood sugar levels
  • medicines for Parkinson’s disease such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa as the effect of adrenaline may be enhanced
  • drugs that make it easier to breathe, used against asthma (theophylline), as the effect of adrenaline can be enhanced
  • medicines used in connection with childbirth ( oxytocin ), as the effect of adrenaline can be enhanced
  • drugs for thyroid disease (eg levothyroxine), as the effect of adrenaline, maybefp enhanced
  • drugs used to treat allergies such as diphenhydramine or chlorpheniramine ( antihistamines ), as the effect of adrenaline may be enhanced
  • drugs that act on the nervous system (parasympatholytics, eg atropine), as the effect of adrenaline may be enhanced 

Adrenaline Mylan and alcohol

Tell your doctor if you drink alcohol as the effect of adrenaline can be amplified.

Pregnancy and breastfeeding

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 taking this medicine.

Experience from use in pregnant women is limited.

There is no information on whether adrenaline passes into breast milk.

Adrenaline Mylan contains sodium metabisulfite and sodium

This medicine contains sodium metabisulphite 0.1 mg / ml. Sodium metabisulfite can in rare cases cause severe hypersensitivity reactions and convulsions in the trachea of ​​sensitive individuals, especially those with previously known asthma.

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

How to take Adrenaline Mylan

Adrenaline Mylan is used in connection with emergency medical care and is given to you by medical staff.

Your doctor will decide which dose is right for you.

It is unlikely that you will receive too much of this medicine as it is only given by a doctor or nurse.

Overdose of adrenaline can cause anxiety, anxiety, tremors, headaches, increased heart rate, palpitations, pallor, cold sweats, nausea, vomiting. At high doses, you can see dilation of the pupils, high blood pressure, irregular heartbeat, heart failure, pulmonary edema.

If you have any further questions on the use of this product, 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 common side effects of adrenaline are effects on the circulation and side effects on the central nervous system. About 1/3 of patients suffer from side effects.

Common side effects (may affect up to 1 in 10 people)

  • Headache, dizziness.
  • Fast heart rate, high blood pressure (in high doses ), heart rhythm disturbances.
  • Anxiety, trembling.

Has been reported (occurs in an unknown number of users)

  • Temporary cardiac muscle weakness ( cardiomyopathy ).
  • Palpitation
  • Ventricular fibrillation (heart rhythm disturbance)
  • Angina (chest pain of varying intensity )
  • Pallor
  • Difficulty breathing
  • Nausea, vomiting
  • Sweating
  • Impotence
  • Accidental injections can lead to injury at the injection site, such as bruising, bleeding, discoloration, reddening of the skin, or skeletal damage.

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 Mylan

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 after EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light.

Store at 2 ° C – 8 ° C (in a refrigerator).

Shelf life 12 months at a maximum of 25 ºC when stored in emergency bags.

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 tartrate. 1 ml contains adrenaline tartrate corresponding to 1 mg adrenaline.
  • The other ingredients are sodium chloride, sodium metabisulfite (E223), disodium edetate, hydrochloric acid to pH 3.0-3.8, water for injections.

Adrenaline Mylan solution for injection has a pH of about 3.5.

What the medicine looks like and the contents of the pack

10 x 1 ml, glass ampoule is.

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

This leaflet was last modified on July 6, 2020

The following information is intended for medical or healthcare professionals only

Dosage

Adults

Individual dosage

Bronchial asthma mainly in seizures:

0.3-0.5 mg intramuscularly (on the outside of the thigh). If necessary, the injection can be repeated at intervals of 5-10 minutes until relief is obtained. In case of concomitant cardiovascular disease only with great caution.

Cardiac arrest (cardiopulmonary resuscitation):

Adrenaline should be dosed and administered according to current treatment recommendations. The following dosage of adrenaline is based on the recommendations of the ERC (European Resuscitation Council) 2010.

1 mg as an intravenous bolus dose every 3-5 minutes.

If the drug is injected through a peripheral venous catheter, the drug must be flushed with at least 20 ml of 0.9% sodium chloride before injection (to facilitate entry into the central circulation).

If venous access is not available, the intraosseous administration is recommended.

Hypersensitivity s

Urticaria and Quincke’s edema:

0.3-0.5 mg intramuscularly (not in the affected area). Repeat as needed.

The asthmatic reaction in allergic hypersensitivity reactions: 

0.5-0.8 mg intramuscularly, preferably in repeated divided doses if the condition is not alarming. In case of a more severe reaction, 0.1-0.25 mg is given intravenously, preferably after dilution. This dose can be repeated every 10 to 20 minutes if the need arises.

Anaphylactic shock:

Intramuscular administration is preferred in the treatment of anaphylaxis. Intravenous administration is generally more appropriate in intensive care units or emergency rooms.

Adrenaline 1 mg / ml is not suitable for iv administration . If adrenaline 0.1 mg / ml is not available, 1 mg / ml must be diluted to 0.1 mg / ml before iv administration . Administration iv must be done with extreme caution and should be performed by specialists experienced in the iv administration of adrenaline.

If IV entry is absent: 0.5 mg of adrenaline is given directly intramuscularly.

If IV entry is present or if there is no improvement: Solution diluted to 0.1 mg/ml: 1 ml 1 mg/ml solution (1 mg adrenaline ) is mixed with 9 ml of isotonic sodium chloride in the syringe.

Diluted solution (0.1 mg / ml) is given 2-3 ml intravenously (0.2-0.3 mg adrenaline ), observing heart rate and blood pressure . Repeat after 2 minutes if no improvement.

Anaphylactic reaction under anesthesia:

Adrenaline is given intravenously under anesthesia after dilution to a maximum of 0.1 mg/ml solution.

Hypotension or unconsciousness: Adrenaline is given intravenously in case of unconsciousness and hypotension if repeated doses of Adrenaline intramuscularly have not been effective. Adrenaline is given intravenously after dilution to a maximum of 0.1 mg/ml solution, 1 (-3) ml, slowly (5-10 minutes) under ECG monitoring. Repeated doses in the lower dose range are preferred.

Pediatric population

Cardiac arrest (cardiopulmonary resuscitation):

  • Children over 12 years of age: 1 mg as an intravenous bolus dose every 3-5 minutes.
  • Children under 12 years of age: 0.01 mg/kg as an intravenous bolus dose. The maximum single dose is 1 mg.
  • Newborns: 0.01-0.03 mg / kg as intravenous bolus dose . Administration via an umbilical venous catheter is recommended.

If the drug is injected through a peripheral venous catheter, the drug must be flushed with at least 20 ml of 0.9% sodium chloride before injection (to facilitate entry into the central circulation). If venous access is not available, the intraosseous administration is recommended.

Anaphylaxis:

Age Dosage adrenaline 1 mg / ml
Over 12 years 0.5 mg im (0.5 ml)
6 – 12 years 0.3 mg im (0.3 ml)
6 months – 6 years 0.15 mg im (0.15 ml)
For 6 months 0.01 mg / kg im (0.01ml / 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 of the syringe should be used.

Incompatibilities

Can be diluted with isotonic sodium chloride solution or glucose solution.

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

Muhammad Nadeem

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