ADRENALINA 0.5 MG/ML Инъекционный раствор

Содержание инструкции

1. ADRENALINA S.A.L.F. 0.5 mg/ml injectable solution, 1 mg/ml injectable solution
   1. What is ADRENALINA S.A.L.F. and what is it used for
   2. What you need to know before using ADRENALINA S.A.L.F.
   3. How to use ADRENALINA S.A.L.F.
   4. Possible side effects
   5. How to store ADRENALINA S.A.L.F.
   6. Package Contents and Other Information

ADRENALINA S.A.L.F. 0.5 mg/ml injectable solution, 1 mg/ml injectable solution

Adrenalina

Generic medicine

Read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ADRENALINA S.A.L.F. and what is it used for

ADRENALINA S.A.L.F. contains the active ingredient adrenaline, which belongs to a group of medicines
called adrenergic and dopaminergic agents.
ADRENALINA S.A.L.F. can be used in emergency situations to treat anaphylactic shock,
a sudden allergic reaction, potentially life-threatening, and angioedema, characterized by swelling of the face,
lips, tongue, and difficulty breathing, caused by insect bites or stings, foods, drugs or other substances.

2. What you need to know before using ADRENALINA S.A.L.F.

Do not use ADRENALINA S.A.L.F.

• if you are allergic to adrenaline or to any of the other ingredients of this medicine (listed in section 6);
• if you have collapse, due to severe circulatory problems (shock);
• if you suffer from heart diseases (organic cardiac pathologies) such as an enlarged heart (cardiac hypertrophy) or irregular heartbeats (arrhythmias);
• if you have brain damage (organic cerebral damage);
• if you suffer from problems with blood circulation to the brain (cerebral arteriosclerosis);
• if you have an eye disease due to high pressure in the eye (closed-angle glaucoma).

Adrenaline should not be administered during general anesthesia with chloroform, trichloroethylene or
cyclopropane and should be used with caution with other halogenated anesthetics (e.g. halothane).
Adrenaline should not be injected into certain areas, such as fingers and tongue, during local anesthesia because it can
cause damage and death of tissues (necrosis), due to reduced blood supply in these areas.
Adrenaline should not be used during the second stage of labour (See section “Pregnancy and
breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before you are given ADRENALINA S.A.L.F.
This medicine should be administered to you with great care in the following cases:

• if you are elderly;
• if you suffer from diabetes;
• if you suffer from heart and blood circulation problems;
• if you are allergic to some substances similar to adrenaline called sympathomimetic amines.

Injection into the buttocks should be avoided as it can cause tissue damage and death.
Prolonged use of this medicine can cause an alteration in blood pH (metabolic acidosis).
For athletes, the use of this medicine without actual therapeutic need constitutes doping
and may result in positive doping tests.

Other medicines and ADRENALINA S.A.L.F.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Adrenaline should not be administered together with the following medicines:

• other substances similar to adrenaline (sympathomimetic agents), because they can cause an increase in the activity and toxicity of adrenaline;
• alpha and beta-blockers used to lower blood pressure, such as propranolol, fentolamine and medicines used for migraine (dihydroergotoxine) because they can reduce the effect of adrenaline;
• medicines used during anesthesia such as cyclopropane and halothane (halogenated anesthetics) (see section “ Do not use ADRENALINA S.A.L.F.”) and medicines used to treat irregular heartbeat (cardiac glycosides), especially at high doses, because they can cause heart rhythm disturbances (arrhythmias, tachycardia, fibrillation);
• medicines for depression such as tricyclic antidepressants (e.g. imipramine), some antihistamines, used for allergies (e.g. diphenhydramine, tripelennamine and deschlorpheniramine) and thyroid hormones, because they can enhance the effects of adrenaline;
• insulin and other medicines used to lower blood sugar levels, because an increase in the dose of these medicines may be necessary;
• clonidine, a medicine used for high blood pressure, doxapram, a medicine used for breathing difficulties and oxytocin, used during childbirth, because they can cause an increase in blood pressure (hypertension);
• dopexamine, a medicine used to improve heart function and entacapone, a medicine used for Parkinson's disease, because they can increase the action of adrenaline;
• medicines used for mental disorders (antipsychotics), because they can decrease the effects of the medicine;
• medicines used to treat headaches (ergotamine and methysergide), because if used together with adrenaline, they can increase the risk of poisoning, due to the active ingredient of these medicines (ergotism).

Adrenaline should not be used to treat circulatory collapse or low blood pressure
caused by phenothiazines, (antipsychotic medicines), as it causes a further lowering of blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before this medicine is given to you.
Adrenaline should not be administered during labour because it inhibits uterine contractions and can
delay the second stage of labour.
This medicine should not be administered during pregnancy unless absolutely necessary and under
direct medical supervision as it can cause problems for the fetus.
Avoid breastfeeding if you are given this medicine, because adrenaline passes into breast milk.

Driving and operating machinery
There is no data available to establish the effect of the medicine on the ability to drive and operate
machinery.

ADRENALINA S.A.L.F. contains sodium and sodium metabisulfite
This medicine contains less than 1 mmol (less than 23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.
This medicine contains sodium metabisulfite which rarely can cause severe hypersensitivity reactions and
bronchospasm.

3. How to use ADRENALINA S.A.L.F.

Use this medicine always following the instructions of your doctor or pharmacist. If you have doubts, consult your doctor
or pharmacist.
ADRENALINA S.A.L.F. must not be injected into the gluteus.
The recommended dose is 0.5 – 1 mg by injection into the muscle (intramuscular), to be repeated every 10
minutes until improvement is achieved. During treatment, blood pressure and heart rate must be monitored.
In more severe cases, administration into a vein slowly (intravenous infusion) of 0.5
mg at an infusion rate of 100 micrograms per minute may be necessary, after appropriate dilution 1:10,000 (e.g.,
dilution 1:10 ml in the case of a syringe).

Use in prepubertal or growth-retarded adolescents
Use in children (under 12 years of age)

• Up to 6 months: the recommended dose is 50 micrograms for intramuscular administration.
• From 6 months to 6 years: the recommended dose is 120 micrograms for intramuscular administration for robust children and 60 micrograms for underweight children.
• From 6 years to 12 years: the recommended dose is 250 micrograms for intramuscular administration.

In more severe cases, administration into a vein (intravenous infusion) slowly at a
dose of 10 micrograms per kg of body weight may be necessary, after appropriate dilution 1:10,000 (e.g., dilution
1:10 ml in the case of a syringe).

If you use more ADRENALINA S.A.L.F. than you should
In case of overdose or accidental injection of adrenaline, immediately inform your doctor or go to the
nearest hospital.
Symptoms of an overdose may include: a significant increase in blood pressure that can lead to bleeding
at the level of the brain vessels (cerebrovascular hemorrhages) or another district and to
movement difficulties (hemiplegia), especially in the elderly, alteration of the heartbeat (bradycardia,
tachycardia, potentially fatal arrhythmias), kidney function problems, alteration of blood pH
(metabolic acidosis), fluid accumulation in the lungs (pulmonary edema).
Treatment involves the administration of medicines that counteract the effects of adrenaline. An alpha blocker, such as fentolamine, is administered, followed by a beta blocker, such as propranolol. In case
of a significant increase in pressure, some medicines such as sodium nitroprusside and
nitrites can also be administered to return blood pressure to normal values.
If you have any doubts about the use of this medicine, consult 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 may occur:

Not known(the frequency of the side effects cannot be estimated from the available data)

• heart problems, such as changes in heart rate (potentially life-threatening heart rhythm disturbances, palpitations, tachycardia);
• stiffness, tremor, agitation, weakness, worsening or appearance of psychomotor agitation;
• headache, dizziness, lightheadedness, excitability;
• nervousness, insomnia, disorientation, loss, panic, hallucinations;
• psychiatric problems and tendencies to harm oneself or others (suicidal or homicidal tendencies);
• nausea, vomiting;
• excessive sweating and paleness;
• difficulty breathing or absence of breathing (apnea).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at 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 S.A.L.F.

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 pack after “Expiry”.
The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Store at a temperature below 25°C. Do not freeze.
The solution must be clear, colourless or slightly yellow and free from visible particles. The vial is
for single and uninterrupted administration and any remaining solution cannot be used.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

WhatADRENALINA S.A.L.F. contains
ADRENALINA S.A.L.F. 0.5 mg/ml injectable solution

• The active ingredient is adrenaline. Each vial contains 0.5 mg of adrenaline.
• The other ingredients are: sodium chloride, sodium metabisulfite, hydrochloric acid, water for injections.

ADRENALINA S.A.L.F. 1 mg/ml injectable solution

• The active ingredient is adrenaline. Each vial contains 1 mg of adrenaline.
• The other ingredients are: sodium chloride, sodium metabisulfite, hydrochloric acid, water for injections.

Description of the appearance of ADRENALINA S.A.L.F. and package contents
Pack of 5 vials of 1 ml injectable solution.

Marketing Authorisation Holder and manufacturer
S.A.L.F. S.p.A. Pharmaceutical Laboratory
Via Marconi, 2
24069 Cenate Sotto (BG)
Italy