ISOPRENALINE HYDROCHLORIDE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ISOPRENALINE HYDROCHLORIDE
Available from:
International Medication Systems
Dosage:
20 Microgram/ML
Pharmaceutical form:
Solution for Inj/Inf
Authorization date:
1977-09-08
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoprenaline Minijet , solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoprenaline Hydrochloride 20 micrograms per ml.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
The container is specially designed for use with the IMS Minijet injector supplied.
The product may also be diluted (see 6.6).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short term, emergency treatment of heart block, severe bradycardia and the temporary control of Stokes-Adams
syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Widely ranging doses have been used successfully. The dose/infusion rate should be adjusted according to response.
ECG should be monitored during treatment.
_Adults_: initial bolus of 20mcg then subsequent doses of 10-200mcg by intravenous injection.
or
0.5-10mcg/minute by intravenous infusion.
_Children_: initial bolus of 10mcg then subsequent doses of 5-100mcg by intravenous injection.
or
0.25-5mcg/minute by intravenous infusion.
4.3 CONTRAINDICATIONS
Contraindications are relative, as Isoprenaline is only intended for short term emergency treatment. Known
hypersensitivity, recent myocardial infarction, pre-existing tachyarrhythmias.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Isoprenaline should be administered with caution in elderly patients, patients with diabetes or hyperthyroidism or who
are otherwise hyper-responsive to sympathomimetic drugs, and patients suffering from cardiovascular disease such as
ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disease including arteriosclerosis, those on
digitalis, hypertension or aneurysms. Anginal pain may be precipitated.
IRISH MEDICINES BOARD
___________________________________________________________
Read the complete document
