VENTOLIN RESPIRATOR SOLUTION

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

SALBUTAMOL AS SULFATE

Dostopno od:

GLAXO SMITH KLINE (ISRAEL) LTD

Koda artikla:

R03AC

Farmacevtska oblika:

SOLUTION FOR NEBULISATION

Sestava:

SALBUTAMOL AS SULFATE 5 MG/ML

Pot uporabe:

INHALATION WITH NEBULISER

Tip zastaranja:

Required

Izdeluje:

GLAXO OPERATIONS (UK) LIMITED

Terapevtska skupina:

SELECTIVE BETA-2 ADRENORECEPTOR AGONISTS

Terapevtske indikacije:

Ventolin Respirator Solution is indicated in adults, adolescents and children.Ventolin Respirator Solution is indicated as a rescue treatment of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma.

Datum dovoljenje:

2021-12-31

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician’s prescription
only
Ventolin Respirator Solution
Active substance: Salbutamol (as Sulfate) 5 mg/ml
For the list of the inactive and allergenic ingredients in the
medicine, see section 2
– "Important information about some of the ingredients in the
medicine" and section
6 – "Additional information".
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Ventolin Respirator Solution is used to treat severe attacks of asthma
and other
forms of bronchospasm.
Therapeutic group:
Fast-acting bronchodilators, short-acting selective agonist to beta-2
receptors.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
• if you are sensitive (allergic) to salbutamol sulfate or to any of
the additional
ingredients contained in this medicine (listed in section 6).
•
non-I.V. formulations of salbutamol must not be used to arrest
uncomplicated
premature labour or threatened abortion.
Special warnings regarding use of the medicine
Before the treatment with Ventolin Respirator Solution, tell the
physician if:
•
your asthma is active (for example, you have frequent flare-ups or
symptoms or
limited physical ability). Your physician may start or increase a
medicine to control
your asthma, such as an inhaled corticosteroid.
•
you have high blood pressure.
•
you are diabetic.
•
you have an overactive thyroid gland.
•
you have a history of heart problems such as an irregular or fast
heartbeat or
angina.
•
you use another nebuliser solution, e.g., ipratropium bromide; make
sure that the
mist does not get in your eyes. This can be prevented b

Lastnosti izdelka

1
_ _
VENTOLIN RESPIRATOR SOLUTION
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Respirator Solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aqueous, colourless to light yellow solution, pH 3.5, providing 0.5%
w/v
(5mg/ml) of salbutamol (as Salbutamol Sulfate BP).
Excipients with known effect:
Benzalkonium chloride solution (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for nebulisation.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin Respirator Solution is indicated in adults, adolescents and
children
(for paediatric population see Section 4.2).
Ventolin Respirator Solution is indicated as a rescue treatment of
chronic
bronchospasm unresponsive to conventional therapy, and in the
treatment of
acute severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ventolin Respirator Solution is for inhalation use only, to be
breathed in
through the mouth, under the direction of a physician, using a
suitable
nebuliser. The solution should not be injected or swallowed. Ventolin
Respirator Solution may be administered intermittently or
continuously.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Private purchase of nebuliser devices for use at home to deliver
rescue therapy
for the acute treatment of asthma in children and adolescents is not
recommended.
The treating physician can initiate and clinically manage use of
nebulisers and
associated nebulised medicines at home for acute treatment of asthma
in
children and adolescents.
2
Children should be trained in the correct use of their device to
deliver rescue
therapy and use should be supervised by a responsible adult.
Urgent medical assistance should be sought if worsening asthma
symptoms
are not relieved by rescue medicines, even if there is short-term
recovery
following use of prescribed nebulised medication.
Intermittent administration
_Adults: _Ventolin Respirator solution 0.5 ml (2.5 mg of salbutamol)
should be
diluted to a final volume of 2 ml with sterile normal saline. This m