Bricanyl 500 micrograms/ml solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terbutaline sulfate

Available from:

AstraZeneca AB

ATC code:

R03CC; R03CC03

INN (International Name):

Terbutaline sulfate

Dosage:

500 microgram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Selective beta-2-adrenoreceptor agonists; terbutaline

Authorization status:

Not marketed

Authorization date:

1999-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRICANYL
 500 MICROGRAMS/ML, SOLUTION FOR INJECTION OR INFUSION
terbutaline sulfate
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 further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Bricanyl Injection is and what it is used for
2. What you need to know before you use Bricanyl Injection
3. How to use Bricanyl Injection
4. Possible side effects
5. How to store Bricanyl Injection
6. Contents of the pack and other information
1.
WHAT BRICANYL INJECTION IS AND WHAT IT IS USED FOR
Bricanyl Injection contains a medicine called terbutaline sulfate.
This belongs to a group of
medicines called beta-agonists. These work by relaxing certain
muscles. For example, they
open up the airways in the lungs or relax the muscles of the womb
(uterus) during pregnancy.

Bricanyl Injection is used for breathing disorders such as asthma. It
helps to relieve
tightening of the chest and difficulty breathing (bronchospasm).

Bricanyl Injection is also used in women who have unexpectedly gone
into early labour
(premature labour) between the 22
nd
and 37
th
week of gestation, to provide a short delay in
the early delivery of the baby. You will receive Bricanyl Injection
for a maximum of 48
hours. This will give your doctor or midwife time to take extra
measures that will improve
the health of your baby.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRICANYL INJECTION
DO NOT USE BRICANYL INJECTION:

If you are allergic to terbutaline sulfate or any of the other
ingredients of this medicine
(listed in Secti

Summary of Product characteristics

Health Products Regulatory Authority
03 November 2020
CRN009Z4Q
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bricanyl 500 micrograms/ml solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 500 micrograms Terbutaline sulfate.
Excipient(s) with known effect: 1 ml also contains sodium (<1
mmol/ml), as sodium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
A clear aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bronchodilation
Terbutaline is a selective beta
2
-adrenergic agonist recommended for the relief of bronchospasm in
bronchial asthma and other
bronchopulmonary disorders in which bronchospasm is a complicating
factor.
For the short term management of uncomplicated premature labour
To arrest labour between 22 and 37 weeks of gestation in patients with
no medical or obstetric contraindication to tocolytic
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage should be individualised.
FOR BRONCHODILATION
When a rapid therapeutic response is required, Bricanyl can be
administered by any of the three standard parenteral routes:
subcutaneous, intramuscular, or i.v. bolus. The preferred routes will
usually be subcutaneous or intramuscular. When given as
an i.v. bolus the injection must be made slowly noting patient
response.
Adults
0.5 -1 ml (0.25 - 0.5 mg) up to four times a day.
Paediatric population
2 -15 years: 0.01 mg/kg body weight to a maximum of 0.3 mg total.
Age
Average
weight
mg
ml
kg
(lb)
terbutaline
volume
<3
10
(22)
0.1
0.2
3
15
(33)
0.15
0.3
6
20
(44)
0.2
0.4
8
25
(55)
0.25
0.5
10+
30+
(66+)
0.3
0.6
Health Products Regulatory Authority
03 November 2020
CRN009Z4Q
Page 2 of 10
By infusion
3 - 5 ml (1.5 - 2.5 mg) in 500 ml 5% dextrose, saline or
dextrose/saline given by continuous intravenous infusion at a rate of
10
- 20 drops (0.5 - 1 ml) per minute for 8 to 10 hours. A corresponding
reduction in dosage should be made for chil