Salbutamol 2.5mg/2.5ml nebuliser liquid unit dose vials

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Salbutamol sulfate

Dostępny od:

Arrow Generics Ltd

Kod ATC:

R03AC02

INN (International Nazwa):

Salbutamol sulfate

Dawkowanie:

1mg/1ml

Forma farmaceutyczna:

Nebuliser liquid

Droga podania:

Inhalation

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 03010101; GTIN: 5060034833000

Ulotka dla pacjenta

Salbutamol 2.5mg/2.5ml & 5mg/2.5ml PIL - UK
item no: AAAI7544
print proof no: 2
origination date: 11.02.16
originated by: S.Anson
revision date: 10.03.16
revised by: S.Anson
dimensions: 200 x 280
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 11.02.16
supplier: Laboratoire Unither
technically app. date: 16.02.16
min pt size: 9
TECHNICAL APPROVAL
IN THIS LEAFLET:
1. What Salbutamol Nebuliser Solution is and what it is used for
2. Before you take Salbutamol Nebuliser Solution
3. How to take Salbutamol Nebuliser Solution
4. Possible side effects
5. How to store Salbutamol Nebuliser Solution
6. Further information
_1 WHAT SALBUTAMOL NEBULISER SOLUTION IS AND WHAT IT _
_IS USED FOR_
Salbutamol 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.
Salbutamol Nebuliser Solution helps to make breathing easier in
patients
who have long-standing breathing difficulties. It is also given to
treat
severe attacks of asthma.
_2 BEFORE YOU TAKE SALBUTAMOL NEBULISER SOLUTION_
DO NOT TAKE SALBUTAMOL NEBULISER SOLUTION
• If you are allergic (hypersensitive) to salbutamol
• If you are allergic to any of the other ingredients (see section 6
Further
Information)
Some forms of Salbutamol are used to help control premature labour.
Salbutamol Nebuliser Solution is not to be used for this purpose.
TAKE SPECIAL CARE WITH SALBUTAMOL NEBULISER SOLUTION
Talk to your doctor if any of the following apply to you:
• if you have diabetes
• if you have a heart condition or have recently had a heart attack
• if you have high blood pressure
• if you have an overactive thyroid gland
• if you have a history of heart disease, irregular heartbeat/rhythm
including a very fast pulse or angina
• if you have an aneurysm (a widening of the wall of a blood vessel)
• if you suffer from glaucoma (excessive pressure inside your eyes)
• if you have ever been told that you suffer from ph

Charakterystyka produktu

OBJECT 1
SALBUTAMOL 2.5MG/2.5ML NEBULISER SOLUTION
(ARROW)
Summary of Product Characteristics Updated 09-Jun-2016 | Accord-UK Ltd
1. Name of the medicinal product
Salbutamol 2.5mg/2.5ml Nebuliser Solution
2. Qualitative and quantitative composition
Each ampoule contains 2.5 mg salbutamol (as sulfate).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Nebuliser Solution
A clear, colourless to pale yellow solution in a clear, plastic single
dose ampoule.
4. Clinical particulars
4.1 Therapeutic indications
Salbutamol Nebuliser Solution are indicated in adults, adolescents and
children aged 4 years and above,
see section 4.2.
Salbutamol Nebuliser Solution is indicated for use in the routine
management of chronic bronchospasm
unresponsive to conventional therapy and the treatment of acute severe
asthma.
4.2 Posology and method of administration
Salbutamol Nebuliser Solution should be administered by a suitable
nebuliser, via a face mask or T piece
or via an endotracheal tube.
To open the plastic ampoule, take a strip of ampoules from the foil
pack, remove one ampoule, replacing
the rest back in the foil pack, and replace the foil pack back in the
carton. Hold the ampoule upright and
open it by twisting off the top. Squeeze the liquid into the solution
holder of the machine.
DOSAGE:
_ADULTS _
The usual starting dose is 2.5mg as a single dose. This may be
increased to 5mg. Treatment may be
repeated up to four times a day.
For the treatment of severe airways obstruction in adult hospitalised
patients, higher doses up to 40mg per
day can be given under strict medical supervision.
In domiciliary practice the benefits of increasing the dosage should
be weighed against the risk that a
deterioration in the patient's underlying condition may be masked. In
this case a medical assessment
should be considered and alternative therapy instituted where
indicated.
_PAEDIATRIC POPULATION_
Children aged 12 years and over: Dose as per adult population.
Children aged 4 to 11 years: 2.5mg to 5mg up to four times a day