Ventolin Nebules

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Salbutamol sulfate 1 mg/mL (plus 0.2mg/ml overage);  

Disponibil de la:

GlaxoSmithKline NZ Limited

INN (nume internaţional):

Salbutamol sulfate 1 mg/mL (plus 0.2mg/ml overage)

Dozare:

2.5mg/2.5mL

Forma farmaceutică:

Solution for inhalation

Compoziție:

Active: Salbutamol sulfate 1 mg/mL (plus 0.2mg/ml overage)   Excipient: Sodium chloride Sulfuric acid Water for injection

Unități în pachet:

Ampoule, plastic, 4x(5x2.5ml foil pack), 20 dose units

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Cambrex Profarmaco Milano Srl

Indicații terapeutice:

Salbutamol is a selective ?2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them prior to a known trigger. Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failure to respond promptly or fully to such rescue medication signals a need for urgent medical advice and treatment.

Rezumat produs:

Package - Contents - Shelf Life: Ampoule, plastic, 4x(5x2.5ml foil pack) - 20 dose units - 36 months from date of manufacture stored at or below 30°C protect from light 3 months unopened stored at or below 30°C protect from light - Ampoule, plastic, - 30 dose units - 36 months from date of manufacture stored at or below 30°C protect from light 3 months unopened stored at or below 30°C protect from light

Data de autorizare:

1981-08-05

Prospect

VENTOLIN
®
NEBULES
®
1
VENTOLIN
® NEBULES
®
_Salbutamol sulfate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use your medicine.
This leaflet answers some common
questions about Ventolin Nebules. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Ventolin
Nebules against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VENTOLIN
NEBULES ARE USED FOR
Ventolin Nebules help you breathe
more easily. When your chest is tight
or when you are wheezing, Ventolin
opens up the breathing tubes in your
lungs.
Your medicine is known as a
bronchodilator. Because the medicine
in your Ventolin Nebules gives fast
relief from your chest symptoms, it is
often called a 'reliever'. There are
other types of medicines that prevent
wheezing or chest tightness. These
medicines are called 'preventers' and
must be used every day. Your doctor
may tell you to use a 'preventer' in
addition to your Ventolin Nebules.
VENTOLIN NEBULES ARE NOT THE ONLY
FORM OF VENTOLIN AVAILABLE. YOUR
DOCTOR WILL DECIDE WHICH FORM OF
VENTOLIN IS RIGHT FOR YOU.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE
VENTOLIN NEBULES
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VENTOLIN NEBULES IF
YOU HAVE AN ALLERGY TO SALBUTAMOL
SULFATE OR ANY OF THE OTHER
INGREDIENTS IN VENTOLIN NEBULES
(SEE INGREDIENTS).
DO NOT TAKE VENTOLIN NEBULES TO
STOP A MISCARRIAGE OR PREMATURE
LABOUR.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK HAS
PASSED OR IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NO

Caracteristicilor produsului

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ventolin Nebules 2.5 mg/2.5 mL
Ventolin Nebules 5 mg/ 2.5 mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin nebules 2.5mg are a plastic ampoule presentation containing a
sterile,
aqueous colourless solution of salbutamol sulfate in normal saline.
The concentration
of salbutamol is 0.1% (1mg salbutamol, as the sulfate, in 1mL). Each
Nebule contains
2.5mL of solution equivalent to 2.5mg salbutamol.
Ventolin nebules 5.0mg are a plastic ampoule presentation containing a
sterile,
aqueous colourless solution of salbutamol sulfate in normal saline.
The concentration
of salbutamol is 0.2% (2mg salbutamol, as the sulfate, in 1mL). Each
Nebule contains
2.5mL of solution equivalent to 5.0mg salbutamol.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for inhalation.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Salbutamol is a selective beta-
2
adrenoceptor agonist indicated for the treatment or
prevention of bronchospasm. It provides short acting (four hours)
bronchodilation in
reversible airways obstruction due to asthma, chronic bronchitis and
emphysema. For
patients with asthma salbutamol may be used to relieve symptoms when
they occur
and to prevent them prior to a known trigger.
Bronchodilators should not be the only or the main treatment in
patients with persistent
asthma. In patients with persistent asthma unresponsive to salbutamol,
treatment with
inhaled corticosteroids is recommended to achieve and maintain
control. Failing to
respond to treatment with salbutamol may signal a need for urgent
medical advice or
treatment.
4.2 DOSE AND METHOD OF ADMINISTRATION
Method of administration
Salbutamol has a duration of action of 4 to 6 hours in most patients.
2
Ventolin Nebules are intended to be used undiluted. However, if
prolonged delivery
time is desirable (more than 10 minutes) dilution using sterile normal
saline as a diluent
may be required.
Ventolin Nebules are to be used with a nebuliser, under the direction
o