VENTOLIN INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SALBUTAMOL AS SULFATE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

R03CC02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SALBUTAMOL AS SULFATE 0.5 MG/ML

Administration route:

I.M, I.V, S.C

Prescription type:

Required

Manufactured by:

GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY

Therapeutic group:

SALBUTAMOL

Therapeutic area:

SALBUTAMOL

Therapeutic indications:

Ventolin Injection is indicated in adults.Ventolin Injection provides short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. It is indicated for the relief of severe bronchospasm.

Authorization date:

2023-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Ventolin Injection
Solution for injection
Each 1 ml ampoule contains the active ingredient:
salbutamol (as sulfate) 0.5 mg
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 Injection is indicated in adults and is used for the relief
of severe
bronchospasm.
Ventolin Injection provides short-acting (4-6 hour) bronchodilation
with a fast
onset (within 5 minutes) in reversible airways obstruction.
Therapeutic group: selective beta-2 adrenoceptor agonist.
Ventolin Injection contains the active ingredient salbutamol, which
belongs to a
group of medicines called bronchodilators.
• Bronchodilators help the airways in your lungs to stay open. This
makes it
easier for air to get in and out.
• They help to relieve chest tightness, wheezing and cough.
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).
Do not use Ventolin Injection if you think what is described above
applies to
you. If you are not sure, consult your physician or pharmacist before
using
Ventolin Injection.
Special warnings regarding use of the medicine
Before the treatment with Ventolin Injection, tell the physician if:
• you have high blood pressure.
• you are diabetic.
• you have an overacti

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin Injection is presented as ampoules of 1 ml, each containing
500
micrograms (0.5mg) salbutamol as salbutamol sulfate BP in a sterile
isotonic
solution.
3.
PHARMACEUTICAL FORM
A colourless to pale straw coloured solution for injection.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Ventolin Injection is indicated in adults.
Ventolin Injection provides short-acting (4-6 hour) bronchodilation
with a fast
onset (within 5 minutes) in reversible airways obstruction. It is
indicated for the
relief of severe bronchospasm.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Ventolin Injection may be administered by the subcutaneous,
intramuscular or
intravenous route, under the direction of a physician.
Adults:_ _
_ _
_Subcutaneous route:_ 500 micrograms (8 micrograms/kg body weight) and
repeated every four hours as required.
_ _
_Intramuscular route:_ 500 micrograms (8 micrograms/kg body weight)
and
repeated every four hours as required.
Slow intravenous injection:
250 micrograms (4 micrograms/kg body weight) injected slowly. If
necessary the
dose may be repeated.
The use of Ventolin Injection 500 micrograms in 1ml (500
micrograms/ml, for
intravenenous administration may be facilitated by dilution to 10 ml
with Water
for Injection (final concentration of 50 micrograms/ml) and 5 mls of
the diluted
preparation (250 micrograms/5 ml) administered by slow intravenous
injection
.
_ _
2
_Paediatric Population _
At present there is insufficient evidence to recommend a dosage
regimen for routine
use in children.
Instructions to open the ampoule
Ampoules are equipped with the OPC (One Point Cut) opening system and
must
be opened using the following instructions:
hold with one hand the bottom part of the ampoule as indicated in
Picture 1 put
the other hand on the top of the ampoule positioning the thumb above
the coloured
point and press as indicated in Picture 2
Picture 1
Picture 2
4.3.
CONTRA-INDI