ADRENALINA 1 mg /10 Ml Injectable Solution In Pre-Filled Syringe

Зміст інструкції

1. Adrenalina Aguettant 1 mg/10 ml (1:10.000) injectable solution in pre-filled syringe
   1. What Adrenalina injectable is and what it is used for
   2. What you need to know before you use Adrenalina injectable
   3. How to use Adrenalina injectable
   4. Possible side effects
   5. How to store Adrenalina iniettabile
   6. Contents of the pack and other information

Adrenalina Aguettant 1 mg/10 ml (1:10.000) injectable solution in pre-filled syringe

Adrenalina

Read this leaflet carefullybefore using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Adrenalina injectable belongs to a group of medicines called adrenergic and dopaminergic agents.

This medicine is used for:

• Treatment of cardiac arrest (sudden loss of cardiac function, breathing and consciousness),
• Treatment of acute anaphylaxis in adults (severe shock or collapse determined by a severe allergic reaction).

2. What you need to know before you use Adrenalina injectable

Adrenalina injectable must not be administered:

• if you are allergic (hypersensitive) to any of the other ingredients of this medicine (listed in section 6) when an alternative presentation of Adrenalina or an alternative vasoconstrictor is available.

Warnings and precautions
Adrenalina injectable is indicated for emergency treatments. After administration, continuous medical supervision is required.

Precautions for use
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The risk of undesirable effects increases if you:

• have a medical history of hyperthyroidism (thyroid disease),
• have severe renal insufficiency,
• suffer from hypercalcemia (increased concentration of calcium in the blood),
• suffer from hypokalaemia (decreased concentration of potassium in the blood),
• have diabetes mellitus,
• have a heart condition or high blood pressure,
• have brain damage or hardening of the arteries in the brain,
• have glaucoma (increased pressure in the eye),
• have prostate disorders,
• are an elderly patient,
• are pregnant.

Other medicines and Adrenalina injectable
Tell your doctor if you are taking, have recently taken or might take any other medicine.
Medicines that may interact with Adrenalina injectable include:

• volatile halogenated anesthetics (gases used during anesthesia);
• some antidepressants;
• medicines to treat high blood pressure, heart problems;
• medicines to treat diabetes.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or are breastfeeding with breast milk, ask your doctor, pharmacist or nurse for advice before using this medicine.

Driving and operating machinery
The use of Adrenalina injectable does not affect the ability to drive or operate machinery.

Adrenalina injectable contains sodium
This medicine contains 35.4 mg of sodium (the main component of table salt) per pre-filled syringe. This is equivalent to 1.77% of the maximum daily intake recommended with the diet of an adult.

3. How to use Adrenalina injectable

Adrenalina injectable is administered by a doctor, nurse or paramedic personnel.
They will decide the correct dosage and when and how it should be administered.
In case of potentially life-threatening allergic reactions (acute anaphylaxis):

Adultswill receive a dose of 0.05 mg (0.5 ml of Adrenalina 1:10,000 solution) in
repeatedly until the desired result is achieved.
In case of cardiac arrest:

Adults:1 mg (10 ml of Adrenalina 1:10,000 solution) is administered intravenously or into a
bone every 3-5 minutes until the heart begins to beat.
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Children over 5 kg:10 micrograms/kg (0.1 ml/kg of Adrenalina 1:10,000 solution) is
administered into a vein or a bone every 3-5 minutes until the heart begins to beat.
This medicine is not indicated for administration at doses less than 0.5 ml and therefore
should not be used in newborns and children with a body weight less than 5 kg.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:

• anxiety;
• dyspnea (difficulty breathing);
• nervousness;
• fear;
• sweating;
• palpitations (irregular or fast heartbeat);
• tachycardia (increased heart rate);
• pallor;
• tremors;
• weakness;
• dizziness;
• headache;
• nausea;
• vomiting;
• feeling of coldness in the extremities;
• hallucinations;
• syncope;
• hyperglycemia (high blood sugar levels);
• hypokalemia (low potassium levels in the blood);
• metabolic acidosis (increased blood acidity);
• mydriasis (pupil dilation).

With high dosages or for patients with sensitivity to adrenaline the side effects are:

• cardiac arrhythmia (irregular/cardiac arrest beats),
• hypertension (with risk of cerebral hemorrhage),
• vasoconstriction (narrowing of blood vessels for example cutaneous, in the extremities or in the kidneys),
• acute angina attacks,
• risk of acute myocardial infarction.

Repeated local injections can produce necrosis (tissue damage) at the injection sites as a
consequence of vascular constriction (narrowing of blood vessels).

In all cases, following the administration ofAdrenalina iniettabilemedical supervision is
necessary.
Reporting of side effects
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If you experience any side effects, including those not listed in this leaflet, please
tell your doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Adrenalina iniettabile

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. The expiry date refers to the last day of that month. The doctor or nurse will check the
expiry date.
Store in the aluminum pouch to protect the medicine from light and oxygen.
Do not store at a temperature above 25°C.
Do not open the aluminum pouch until use.
After opening, the medicine must be used immediately.
Do not freeze.
Do not use sharp tools to open the pouch.
Adrenalina iniettabile must not be administered if it has been partially used or
shows signs of visible damage.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance of Adrenalina injectable and contents of the pack
Adrenalina injectable is a clear and colourless solution contained in a polypropylene pre-filled syringe of 10 ml. Each syringe is individually packaged in a transparent blister
pack, placed inside an aluminium pouch.
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The pre-filled syringes are available in packs of 1 and 10 syringes.
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
More detailed information on this medicine is available on the website of the Italian Medicines Agency.
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The following information is intended exclusively for healthcare professionals:
Intravenous adrenaline must only be administered by personnel experienced
in the use and titration of vasopressors in normal clinical practice.

Cardiopulmonary resuscitation:
10 ml of adrenaline 1:10,000 solution (1 mg) intravenously or intraosseously, repeated
every 3-5 minutes until spontaneous circulation returns.
Endotracheal use should only be applied as a last option if no other route of
administration is available, at a dose of 20-25 ml of 1:10,000 solution (2-2.5 mg).
In the event of cardiac arrest following cardiac surgery, adrenaline should be
administered intravenously at doses of 0.5 or 1 ml of 1:10,000 solution (50 or 100
micrograms) with great caution and titrated to the effective dose.

Acute anaphylaxis
Titrate using 0.5 ml of a 1:10,000 solution (0.05 mg) in intravenous bolus according
to the response.
Adrenalina Aguettant 1 mg/10 ml (1:10,000) injectable solution in a pre-filled syringe is not
indicated for intramuscular use in acute anaphylaxis. A 1 mg/ml (1:1000) solution should be used for intramuscular
administration.

Paediatric population
This medicine is not indicated for administration at doses less than 0.5 ml and therefore
should not be used in neonates and children with a body weight of less than 5 kg.

Cardiac arrest in children:
Administration by intravenous or intraosseous route (only above 5 kg): 0.1 ml/kg of adrenaline 1:10,000 solution (10 micrograms/kg) up to a single maximum dose of 10 ml of
1:10,000 solution (1 mg), repeated every 3-5 minutes until spontaneous circulation
returns.
Endotracheal use (for any weight) should only be applied as a last option if
no other route of administration is available, at a dose of 1 ml/kg of 1:10,000 solution
(100 micrograms/kg) up to a single maximum dose of 25 ml of 1:10,000 solution (2.5 mg).

Strictly adhere to the following protocol:
The pre-filled syringe is for single use only. Discard the syringe after use. Do
not reuse.
The product must be visually inspected for the presence of particles and
changes in colour before administration. Use only clear and
colourless solution free of particles or precipitate.
The product should not be used if the pouch or blister has been opened or if the tamper-evident seal on the syringe (plastic tab at the base of the end cap) is broken.

• 1) Open the aluminium pouch by tearing it with your hands using the notches. 6 of 7

Do not use sharp instruments to open the pouch.

• 2) Remove the pre-filled syringe from the sterile blister pack.
• 3) Press the plunger to release the cap. The process of

sterilisation may cause the cap to adhere to the body
of the syringe.

• 4) Rotate the end cap to break the seal. Do nottouch the exposed Luer connector to avoidcontamination.

• 5) Check that the syringe seal has been completely removed. If not, reclose the cap and rotate it again.

• 6) Expel the air by gently pushing the plunger.
• 7) Connect the syringe to the vascular access device or needle.

Press the plunger to inject the required volume.
Unused product and waste derived from this medicine must be disposed of in
accordance with local regulations.
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