Unimedic Pharma

Solution for injection 0.1 mg / ml 
(Clear, colorless solution)


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 Ampoule 10 x 10 milliliters (Prescription) 

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Leaflet: Information for the user

Adrenaline Martindale Pharma

0.1 mg / ml injection solution 
adrenaline

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.

In this leaflet you will find information about: 
1. What Adrenalin Martindale Pharma is and what it is used for 
2. What you need to know before you use Adrenalin Martindale Pharma 
3. How to take Adrenalin Martindale Pharma 
4. Possible side effects 
5. How to take Adrenalin Martindale Pharma to be stored 
6. Contents of the packaging and other information 

What Adrenaline Martindale Pharma is and what it is used for

Adrenaline Martindale Pharma is used in cardiopulmonary resuscitation and in the treatment of sudden life-threatening allergic reactions ( acute anaphylaxis ).

Adrenaline contained in Adrenaline Martindale Pharma 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.

2. What you need to know before using Adrenalin Martindale Pharma

Do not use Adrenaline Martindale Pharma

  • 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

Talk to your doctor, pharmacist, or nurse before giving Adrenalin Martindale Pharma.

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 pectoris, heart muscle disease, arrhythmias, lung 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.

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

Other medicines and Adrenaline Martindale Pharma

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

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

  • beta-blockers (eg pindolol and propranolol) may cause a rise in blood pressure and a decrease in heart rate
  • medicines for general anesthesia as concomitant use of certain medicines for general anesthesia may increase the risk of arrhythmias
  • medicines that may increase the risk of heart rhythm disorders (eg digitalis and quinidine )
  • certain antidepressants (eg protriptyline, maprotiline), as the effect of adrenaline, maybe enhanced
  • insulin or diabetes medications are taken by mouth, as adrenaline increases blood sugar levels.

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, pharmacist, or nurse for advice before taking this medicine.

Experience from use in pregnant women is limited.

Adrenaline passes into the breast milk. Breast-feeding should be avoided in women receiving adrenaline.

Animal studies are lacking in terms of effects on fertility.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 Martindale Pharma contains sodium metabisulfite and sodium

Sodium metabisulphite can in rare cases cause severe hypersensitivity reactions and bronchospasm.

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

How to take Adrenaline Martindale Pharma

Adrenaline Martindale Pharma is given by a doctor or nurse.

Dosage and route of administration

Dose one is determined by the doctor who adjusts it individually for you.

Cardiac arrest (cardiopulmonary resuscitation)

For adults and children over 12 years of age, 1 mg is given as an intravenous bolus dose every 3-5 minutes.

For children under 12 years of age, 0.01 mg/kg is given as an intravenous bolus dose. The maximum single dose is 1 mg.

For neonates, 0.01-0.03 mg/kg is given as an intravenous bolus dose.

Life-threatening allergic reactions

Intramuscular administration (ie injection into a muscle) of 1 mg/ml adrenaline solution is preferred for the treatment of anaphylactic shock.

It is unlikely that you will receive too much of this medicine as it is only given by a doctor or pharmacist 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, pulmonary edema, irregular heartbeat, heart failure.

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 more than 1 in 100 people)

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

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 Adrenalin Martindale Pharma

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

For single use only.

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

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. 1 ml solution contains adrenaline tartrate corresponding to 0.1 mg adrenaline
  • The other ingredients are sodium chloride, citric acid monohydrate, sodium citrate, sodium metabisulfite (E223), hydrochloric acid (for pH adjustment ), and water for injections.

What the medicine looks like and the contents of the pack

Adrenaline Martindale Pharma is a clear and colorless solution.

Pack size: 10 x 10 ml glass ampoules (type I).

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Ethypharm

194 Bureaux de la Colline

Building D

92213 Saint-Cloud Cedex

France

Manufacturer

Martindale Pharmaceuticals Limited, Bampton Road,

Harold Hill, Essex, RM3 8UG, UK and Northern Ireland.

This leaflet was last modified on 07/03/2020

The following information is intended for healthcare professionals only:

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) 2015.

Adults and children over 12 years

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.

Children under 12 years

0.01 mg/kg as an intravenous bolus dose. The maximum single dose is 1 mg.

Newborns

0.01-0.03 mg/kg as an intravenous bolus dose. Administration via an umbilical venous catheter is recommended.

Acute anaphylaxis

Always check that the correct strength of adrenaline solution is used in the treatment of anaphylaxis.

On equipment for the treatment of anaphylactic shock, 0.1 mg/ml, and 1 mg/ml adrenaline solution must be very clearly distinguished.

Intramuscular administration of 1 mg/ml adrenaline solution is preferred for the treatment of anaphylactic shock. It is also important not to waste time trying to find an intravenous infarction if intramuscular injection can still be successful.

In the treatment of anaphylaxis, adrenaline for intravenous administration should only be used by experienced personnel under the observation of heart rate and blood pressure. In adults, 0.1 mg/ml adrenaline solution is given as a 0.05 mg iv bolus dose and titrated by increasing with a bolus dose of 0.05 mg according to the response.

Incompatibilities

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

Adrenaline can be mixed with 0.9% sodium chloride for injection but is incompatible with 5% sodium chloride for injection. The stability of adrenaline in 5% dextrose injection decreases when the pH exceeds 5.5.

Muhammad Nadeem

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