ISONLY 1 mg /5 Ml Концентрат Для Инфузионного Раствора

Содержание инструкции

1. Isonly 1mg/5 ml, concentrate for solution for
   1. WHAT IS ISONLY AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE ISONLY
   3. HOW TO USE ISONLY
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ISONLY
   6. PACKAGE CONTENTS AND OTHER

FOR THE USER

Isonly 1mg/5 ml, concentrate for solution for

infusion
isoprenaline hydrochloride

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 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 you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT IS ISONLY AND WHAT IT IS USED FOR

This medicine is used as an emergency medicine for the treatment of an abnormally slow heart rhythm.
Isonly is indicated for the treatment of:

• slowing of the heart rhythm in patients awaiting the insertion of a temporary or permanent device
• sudden fainting with loss of consciousness caused by a slowing of the heart rhythm (Stokes-Adams syndrome)

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ISONLY

Do not use Isonly

• if you are allergicto isoprenaline hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking monoamine oxidase inhibitors (MAOIs).
• if your thyroid gland is overactive and you have heart problems (chest pain and shortness of breath (ischemic heart disease); you may experience an excessive increase in heart rate
• if you experience a heart rate faster than normal
• if your heart is stressed (atrial or ventricular excitability)
• if you have taken an excessive dose of digoxin (digitalis), a medicine to treat cardiac arrhythmia and heart failure
• if you experience a heart attack (myocardial infarction)
• if you experience acute heart failure (acute coronary insufficiency)
• if you experience chest pain (angina pectoris) and irregular heartbeat (ventricular arrhythmia) that requires treatment

Warnings and precautions
Talk to your doctor or nurse before using Isonly:

• if you suffer from heart problems
• if you suffer from diabetes
• if you are taking digoxin (digitalis) (another medicine that affects the heart)
• if you have an overactive thyroid gland. Administration of this preparation should be avoided in cases of uncontrolled hyperthyroidism.
• if you suffer from convulsive disorders.
• if you have had a reaction to a drug belonging to the sympathomimetic amines group in the past.
• During treatment with this medicine, you will be monitored by ECG and your dose may be adjusted.
• If you are receiving treatment for shock, Isonly can only be used after blood volume has been restored.
• Pay particular attention if doses are high enough to reach a heart rate greater than 130 beats/minute. Talk to your doctor, pharmacist or nurse before using Isonly.

Other medicines and Isonly
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
This is particularly important if you are taking any of the following medicines:

• other stimulants of the central nervous system or heart.
• adrenaline.
• digitalis.
• monoamine oxidase inhibitors (MAOIs).
• antidepressants (for example imipramine).
• sulfates, for example salicylamide.
• entacapone.
• doxapram.
• ergotamine.
• sympathomimetic vasoconstrictors (oxytocin).

Isonly should not be administered in the presence of chloroform-based anesthetics, cyclopropane, halothane or
any other halogenated anesthetic.

Pregnancy, breastfeeding and fertility
If you are pregnant, this medicine can only be used if your doctor considers it
absolutely necessary.
Administration of Isonly during breastfeeding is not recommended.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.

3. HOW TO USE ISONLY

This medicine will be administered to you by intravenous infusion by a specialist doctor.
The medicine will be diluted in a physiological saline solution or isotonic glucose solution.
It is recommended to gently shake and thoroughly mix the resulting solution and to visually
check for the absence of particulate matter and color change before use. If visible particulate
matter or color change is present, the medicine must not be used.
The recommended initial dose is 0.01 micrograms/kg/minute. The dose may be increased by 0.01
micrograms/kg/minute up to a maximum of 0.15 micrograms/kg/minute. The infusion rate
must be adjusted according to the patient's heart rate.
Isonly must not, under any circumstances, be injected simultaneously with adrenaline. However, if
both medicines are necessary, they can be administered alternately, with an
interval of 4 hours between administrations.

If you use more Isonly than you should
The symptoms of overdose are nausea, headache, a heart rate that is too high, and an acceleration of the
heart rate.
If you use more Isonly than you should, contact your doctor or nurse immediately.
If necessary, a plasma or whole blood transfusion may be performed.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Isonly may cause acceleration of the heart rate, heart rhythm disturbances, nausea, chest pain, headache, restlessness, tremors, dizziness, feeling of weakness and sweating.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
consult your doctor 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 contribute to providing more information on the safety of this medicine.

5. HOW TO STORE ISONLY

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not use this medicine after the expiry date which is
stated on the pack after EXP. The expiry date refers to the last day of that month.
After opening or after dilution with 0.9% sodium chloride solution or 5% glucose solution, the chemical and physical stability during use has been demonstrated for 48 hours at 25°C and 2-8°C.
From a microbiological point of view, diluted solutions should be used immediately. If
not used immediately, - the storage times and conditions during use are the responsibility of the user and must not exceed 24 hours at a temperature of 2°C – 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Do not freeze.

6. PACKAGE CONTENTS AND OTHER

INFORMATION
What Isonly contains

• The active ingredient is isoprenaline hydrochloride.
• The other ingredients are: sodium chloride, EDTA, trisodium citrate dihydrate, citric acid monohydrate, water for injections, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment)

Description of the appearance of Isonly and package contents
Isonly is a transparent and colourless or pale yellow injectable solution in a vial containing
5 ml. Pack of 5 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
S.A.L.F. S.p.A. Laboratorio Farmacologico
Via Guglielmo Marconi 2,
24069 Cenate Sotto (BG),
Italy

Manufacturer:
S.A.L.F. S.p.A. Laboratorio Farmacologica
Via Giuseppe Mazzini 9
24069 Cenate Sotto (BG),
Italy