Isonly

Italy
Brand name Isonly
Form solution for infusion, concentrate
Active substance / Dosage
ISOPRENALINE HYDROCHLORIDE
Prescription type Prescription only
ATC code
C01CA02
Registration number 050062
Manufacturer S.A.L.F. SPA LABORATORIO FARMACOLOGICO

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

Isonly 1mg/5 ml, concentrate for solution for infusion
isoprenaline hydrochloride
Please read all of this leaflet carefully before you start using this medicine because 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 other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effects, including any 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 ISONLY IS AND WHAT IT IS USED FOR

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

  • slow heart rate in patients awaiting implantation of a temporary or permanent device
  • sudden fainting with loss of consciousness caused by a slow heart rate (Stokes-Adams syndrome)

2. WHAT YOU SHOULD KNOW BEFORE USING ISONLY

Do not use Isonly

  • if you are allergic to 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 (ischaemic heart disease)); you may experience excessive increase in heart rate
  • if you have a faster than normal heart rate
  • if you have a stressed heart (atrial or ventricular hyperexcitability)
  • if you have taken an excessive dose of digoxin (digitalis), a medicine used to treat cardiac arrhythmia and heart failure
  • if you are experiencing a heart attack (myocardial infarction)
  • if you have acute heart failure (acute coronary insufficiency)
  • if you have chest pain (angina pectoris) and irregular heartbeat (ventricular arrhythmia) requiring treatment

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

  • if you have heart problems
  • if you have diabetes
  • if you are taking digoxin (digitalis) (another medicine affecting the heart)
  • if you have an overactive thyroid gland. Administration of this preparation must be avoided in cases of uncontrolled hyperthyroidism.
  • if you have seizure disorders.
  • if you have previously experienced a reaction to a medicine belonging to the sympathomimetic amine group.
  • During treatment with this medicine, you will be monitored by ECG and your dose may be adjusted.
  • If you are being treated for shock, Isonly may be used only after blood volume has been restored.
  • Exercise particular caution if doses are high enough to result in a heart rate exceeding 130 beats/minute. Consult your doctor, pharmacist, or nurse before using Isonly.

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

  • other central nervous system or cardiac stimulants.
  • adrenaline.
  • digitalis.
  • monoamine oxidase inhibitors (MAOIs).
  • antidepressants (e.g. imipramine).
  • sulfates, such as salicylamide.
  • entacapone.
  • doxapram.
  • ergotamine.
  • sympathomimetic vasoconstrictors (oxytocin).

Isonly must not be administered in combination with anaesthetics based on chloroform, cyclopropane, halothane, or
any other halogenated anaesthetic.
Pregnancy, breastfeeding and fertility
If you are pregnant, this medicine may be used only if your doctor considers it
absolutely necessary.
Administration of Isonly during breastfeeding is not recommended.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
please consult your doctor before taking this medicine.

3. HOW TO USE ISONLY

This medicinal product will be administered to you by intravenous infusion by a specialist doctor. The medicinal product will be diluted in 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 any change in colour before use. If visible particulate matter or a change in colour is observed, the medicinal product must not be used.
The recommended initial dose is 0.01 microgram/kg/min. The dose may be increased by 0.01 microgram/kg/min up to a maximum of 0.15 microgram/kg/min. The infusion rate should be adjusted according to the patient's heart rate.
Isonly must never, under any circumstances, be administered simultaneously with adrenaline. However, if both medicinal products are required, they may be administered alternately, with an interval of 4 hours between administrations.
If you use more Isonly than you should
Symptoms of overdose include nausea, headache, excessively high heart rate, and accelerated heart rate.
If you use more Isonly than you should, contact your doctor or nurse immediately.
If necessary, plasma or whole blood transfusion may be performed.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Isonly may cause increased heart rate, heart rhythm disturbances, nausea, chest pain, headache, restlessness, tremors, dizziness, feeling of weakness, and sweating.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or nurse. You can also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide 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 the refrigerator (2°C - 8°C). Do not use this medicine after the expiry date stated on the carton 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, chemical and physical stability during use has been demonstrated for 48 hours at 25°C and at 2-8°C.
From a microbiological point of view, diluted solutions should be used immediately. If not used immediately, the times and conditions of storage 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 was carried out under controlled and validated aseptic conditions.
Do not freeze.

6. PACKAGING CONTENTS AND OTHER

INFORMATION
What Isonly contains

  • The active substance is isoprenaline hydrochloride.
  • The other components 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 contents of the pack
Isonly is a clear, colourless or pale yellow injectable solution in a 5 ml vial.
Pack: 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 Farmacologico
Via Giuseppe Mazzini 9
24069 Cenate Sotto (BG),
Italy