Bricanyl 500micrograms/1ml solution for injection ampoules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Terbutaline sulfate

זמין מ:

AstraZeneca UK Ltd

קוד ATC:

R03CC03

INN (שם בינלאומי):

Terbutaline sulfate

כמות:

500microgram/1ml

טופס פרצבטיות:

Solution for injection

מסלול נתינה (של תרופות):

Subcutaneous; Intravenous; Intramuscular

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 03010101; GTIN: 5014162002548

עלון מידע

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRICANYL
 INJECTION 0.5 MG/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 or nurse.

If you get any of the side effects, talk to your doctor 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 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 section 6).
DO NOT USE BRICANYL INJECTION (IN THE TREATMENT OF PREMATURE LABOUR):

If you are less than 22 weeks pregnant.

If you suffer from or have a known r

מאפייני מוצר

OBJECT 1
BRICANYL INJECTION, 0.5 MG/ML, SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 02-May-2017 | AstraZeneca
UK Limited
1. Name of the medicinal product
Bricanyl Injection, 0.5 mg/ml, solution for injection or infusion.
2. Qualitative and quantitative composition
1 ml solution for injection contains 0.5mg of 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
_CHILDREN 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
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 f