Terbutaline 5mg/2ml nebuliser liquid unit dose vials

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Terbutaline sulfate

Disponible depuis:

Arrow Generics Ltd

Code ATC:

R03AC03

DCI (Dénomination commune internationale):

Terbutaline sulfate

Dosage:

2.5mg/1ml

forme pharmaceutique:

Nebuliser liquid

Mode d'administration:

Inhalation

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 03010101; GTIN: 5060034833321

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TERBUTALINE 2.5MG/ML 20 2ML AMPOULES PIL - UK
Black
Profile
BBBA1433
S.Anson
10.11.17
23.11.17
S.Anson
200 x 280
9pts
Laboratoire Unither
10.11.17
23.11.17
3
_1. WHAT TERBUTALINE SULFATE NEBULISER SOLUTION IS AND WHAT IT _
_IS USED FOR_
Terbutaline Sulfate Nebuliser Solution belongs to a group of medicines
called ‘bronchodilators’ which help to open up the air passages in
your
lungs so that you can breathe more easily.
Terbutaline Sulfate Nebuliser Solution helps to make breathing easier
in
patients who have asthma, bronchitis and other chest illnesses.
_2. WHAT YOU NEED TO KNOW BEFORE YOU USE TERBUTALINE SULFATE _
_NEBULISER SOLUTION_
DO NOT USE TERBUTALINE SULFATE NEBULISER SOLUTION:
•
If you are allergic to terbutaline sulfate or any of the other
ingredients
of this medicine (listed in section 6).
•
If you have a heart condition called cardiomyopathy (this is when your
heart does not work properly due to inflammation of the heart
muscles).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Terbutaline Sulfate
Nebuliser Solution if any of the following apply to you:
•
If you have diabetes
•
If you have an overactive thyroid gland
•
If you have a heart condition, abnormal heart rhythm, or disease of
the
heart
•
If you have high blood pressure
•
If you have low levels of potassium in the blood (hypokalaemia).
OTHER MEDICINES AND TERBUTALINE SULFATE NEBULISER SOLUTION
Tell your doctor or pharmacist if you are taking, have recently taken
or
might take any other medicines including:
•
Medicines for treating high b

Résumé des caractéristiques du produit

OBJECT 1
TERBUTALINE SULPHATE 2.5MG/ML NEBULISER
SOLUTION
Summary of Product Characteristics Updated 18-Dec-2017 | Accord-UK Ltd
1. Name of the medicinal product
Terbutaline Sulfate 2.5mg/ml Nebuliser Solution
2. Qualitative and quantitative composition
Each ampoule contains 5mg terbutaline sulfate in 2ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Nebuliser solution.
A clear, colourless to yellow solution contained within clear plastic
single dose ampoules.
4. Clinical particulars
4.1 Therapeutic indications
Terbutaline Sulfate Nebuliser Solution is indicated for the relief of
severe bronchospasm in bronchial
asthma and in chronic bronchitis, emphysema and other bronchopulmonary
disorders in which
bronchospasm is a complicating factor.
4.2 Posology and method of administration
Posology
Dosage:
Adults (including the elderly): One or two ampoules (5 or 10mg), two
to four times daily.
Children (>25kg): One ampoule (5mg), two to four times daily
Children (<25kg): Not recommended
In acute severe asthma, additional doses may be necessary.
In domiciliary practice, the benefits of increasing the dose of
nebulised terbutaline should be considered
against a potential masking of a deterioration in the patients
underlying conditions. In such circumstances,
a medical assessment should be considered, as alternative therapy may
be indicated.
Method of administration
Terbutaline Sulfate Nebuliser Solution should be administered by a
power operated nebuliser via a face
mask or mouth piece. Terbutaline Sulfate has a duration of action of
up to 6 hours.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Terbutaline Sulfate Nebuliser Solution should not be used in patients
with hypertrophic cardiomyopathy
because of the positive inotropic effects of beta
2
-agonists.
4.4 Special warnings and precautions for use
Terbutaline Sulfate Nebuliser Solution is for use with a nebuliser
under the direction of a physician. The
solution must not be inj