Adrenaline aguettant

Package leaflet: information for the patient

Adrenalina Aguettant, 1 mg/10 ml, solution for injection in prefilled syringe
Adrenalinum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Adrenalina Aguettant is and what it is used for
2. Important information before using Adrenalina Aguettant
3. How to use Adrenalina Aguettant
4. Possible side effects
5. How to store Adrenalina Aguettant
6. Contents of the pack and other information

1. What Adrenalina Aguettant is and what it is used for

Adrenalina Aguettant, solution for injection in prefilled syringe, contains the active substance adrenaline, belonging to a group of medicines called adrenergic agonists or dopaminergic agents.
This medicine is used:

• In the treatment of cardiac arrest (sudden loss of heart function, breathing, and consciousness).
• In the treatment of acute anaphylactic reaction (severe shock or collapse caused by a serious allergic reaction).

2. Important information before using Adrenalina Aguettant

When not to use Adrenalina Aguettant
Do not use this medicine if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6), unless no alternative form of adrenaline or alternative vasoconstrictor medicine is available.

Warnings and precautions
Adrenalina Aguettant is recommended for emergency treatment. Continuous medical supervision is required after administration of this medicine.

Precautions during use
The risk of adverse effects is increased if the patient has:

• A history of hyperthyroidism (thyroid gland disorder), including past episodes,
• Severe renal insufficiency,
• Hypercalcemia (elevated calcium levels in the blood),
• Hypokalemia (low potassium levels in the blood),
• Diabetes,
• Heart disease or hypertension,
• Brain damage or cerebral arteriosclerosis,
• Glaucoma (increased pressure in the eye),
• Prostate disorders,
• Advanced age,
• Pregnancy.

Adrenalina Aguettant and other medicines
Inform your doctor about all medicines currently used or recently taken, as well as any medicines the patient intends to take.
Medicines that may interact with Adrenalina Aguettant include:

• Halogenated inhalational anesthetics (gases used during anesthesia),
• Certain antidepressants,
• Medicines for hypertension or heart disease,
• Medicines for diabetes.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor, pharmacist, or nurse before using this medicine.

Driving and operating machinery
The use of Adrenalina Aguettant has no influence on the ability to drive or operate machinery.

Adrenalina Aguettant contains sodium
This medicine contains 35.4 mg of sodium (the main component of table salt) per prefilled syringe.
This corresponds to 1.77% of the maximum daily recommended sodium intake in the adult diet.

3. How to use Adrenalina Aguettant

Adrenalina Aguettant is administered by a doctor, nurse, or paramedic. They will determine the appropriate dose, timing, and route of administration for the patient.

In life-threatening allergic reactions (acute anaphylactic reaction):
Recommended dose
Adults: Administer a dose of 0.05 mg (0.5 ml of Adrenalina Aguettant 1:10,000 solution), repeated if necessary until the desired response is achieved.

In cardiac arrest:
Adults: 1 mg (10 ml of Adrenalina Aguettant 1:10,000 solution) administered intravenously or intraosseously every 3–5 minutes until return of spontaneous circulation.
Children with body weight above 5 kg: 10 micrograms/kg body weight (0.1 ml/kg body weight of Adrenalina Aguettant 1:10,000 solution) administered intravenously or intraosseously every 3–5 minutes until return of spontaneous circulation.

This medicine should not be used at doses lower than 0.5 ml; therefore, it should not be used in newborns and infants with body weight less than 5 kg.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported:

• anxiety,
• dyspnoea (difficulty in breathing),
• nervousness,
• restlessness,
• sweating,
• palpitations (irregular or rapid heartbeat),
• tachycardia (increased heart rate),
• pallor,
• seizures,
• weakness,
• dizziness,
• headache,
• nausea,
• vomiting,
• cold extremities,
• hallucinations,
• fainting,
• hyperglycaemia (high blood sugar levels),
• hypokalaemia (low potassium levels in blood),
• metabolic acidosis (increased blood acidity),
• excessive pupil dilation.

Adverse reactions in patients sensitive to adrenaline or after administration of adrenaline in high doses:

• cardiac arrhythmia (irregular heartbeat/cardiac arrest),
• hypertension (with risk of cerebral haemorrhage),
• vasoconstriction (narrowing of blood vessels, e.g. in the skin, limbs or kidneys),
• acute angina attacks,
• risk of acute myocardial infarction.

Repeated local injections may lead to necrosis (tissue damage) at injection sites due to vasoconstriction (narrowing of blood vessels).
In all cases, medical supervision is required after administration of Adrenalina Aguettant.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Adrenalina Aguettant

The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month. This should be checked by the doctor or nurse caring for the patient.
Store in the aluminium sachet to protect from light and oxygen.
Do not store above 25°C.
Do not open the aluminium sachet until the time of use.
The product must be used immediately after opening the sachet.
Do not freeze.
Do not use sharp objects to open the sachet.
Do not use this medicine if it appears partially used or shows visible signs of damage.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Adrenalina Aguettant contains
The active substance is adrenaline bitartrate:
Each ml of injection solution contains 0.1 mg adrenaline (as adrenaline bitartrate).
Each 10 ml pre-filled syringe contains 1 mg adrenaline (as adrenaline bitartrate).
The other ingredients are: sodium chloride, hydrochloric acid, sodium hydroxide, water for injections.

What Adrenalina Aguettant looks like and contents of the pack
Adrenalina Aguettant is a clear, colourless solution in a 10 ml polypropylene pre-filled syringe, individually packed in a transparent blister and placed in an aluminium sachet.
Pack sizes available: 1 or 10 pre-filled syringes in a cardboard box.
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
Laboratoire Aguettant
Lieu Dit Chantecaille
07340 Champagne
France

For further information on this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Information intended exclusively for medical professionals:

Intravenous adrenaline should be administered only by individuals experienced in its use and in the adjustment of doses of vasoactive substances that cause vasoconstriction, as part of standard clinical practice.

Cardiopulmonary resuscitation:
10 ml of 1:10,000 solution (1 mg) adrenaline administered intravenously (IV) or intraosseously (IO), repeated every 3–5 minutes until return of spontaneous circulation.
Endotracheal administration (ET) should only be used as a last resort when neither IV nor IO access is available, at a dose of 20 ml to 25 ml of 1:10,000 solution (2 mg to 2.5 mg).
If cardiac arrest occurs during or immediately after cardiac surgery, adrenaline should be administered intravenously with extreme caution, in doses of 0.5 ml or 1 ml of 1:10,000 solution (50 micrograms or 100 micrograms), depending on the observed response.

Acute anaphylactic reaction:
Administer intravenously (as bolus injections) 0.5 ml of 1:10,000 solution (0.05 mg), adjusting the dose according to the treatment response.
Adrenalina Aguettant 1 mg/10 ml (1:10,000) solution for injection in pre-filled syringe is not recommended for intramuscular use in the treatment of acute anaphylactic reaction.
For intramuscular administration, a 1 mg/ml (1:1000) solution should be used.

Paediatric population:
This medicine is not suitable for administration of doses smaller than 0.5 ml; therefore, it should not be used intravenously or intraosseously in neonates and infants with body weight below 0.5 kg.

Cardiac arrest in children:
Intravenous or intraosseous (only in children weighing more than 5 kg): 0.1 ml/kg of 1:10,000 solution (10 micrograms/kg) of adrenaline, up to a maximum single dose of 10 ml of 1:10,000 solution (1 mg), repeated every 3–5 minutes until return of spontaneous circulation.
Endotracheal administration should only be used as a last resort, regardless of the child's weight, when no other route is available, at a dose of 1 ml/kg of 1:10,000 solution (100 micrograms/kg) up to a maximum of 25 ml of 1:10,000 solution (2.5 mg).

The following instructions must be strictly observed:
The pre-filled syringe is intended for single use in one patient only. The syringe must be discarded after use. Do not reuse.
Immediately before administration, the product should be inspected visually for particulate matter and discoloration. Only clear, colourless solutions free from particles or precipitates may be used.
The product must not be used if the sachet or blister pack has been opened or if the tamper-evident feature on the syringe (plastic film at the base of the cap) is damaged.

1. Open the aluminium sachet by hand only, tearing along the perforation(s).
   Do not use sharp objects to open the sachet.
2. Remove the pre-filled syringe from the sterile blister pack.

3. Push the plunger to release the stopper. The sterilization process may cause the stopper to adhere to the syringe.
4. Twist the cap at the tip to break the tamper-evident seal. Do not touch the luer tip of the syringe to avoid contamination.
5. Check whether the syringe tip protector has been completely removed. If not, reattach the cap and twist again.
6. Remove air by gently pressing the plunger.
7. Attach the syringe to an intravenous access device or connect it to a needle.
   Push the plunger to inject the required volume.
   Any unused medicinal product or waste material must be disposed of in accordance with local regulations.