VENTOLIN 500microgram/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salbutamol sulfate, Quantity: 0.6 mg/mL (Equivalent: salbutamol, Qty 0.5 mg/mL)

Available from:

GlaxoSmithKline Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sulfuric acid; water for injections

Administration route:

Subcutaneous, Intramuscular, Intravenous

Units in package:

5x1mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 3rd DECEMBER 2002: For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise-induced asthma or in other situations known to induce bronchospasm.

Product summary:

Visual Identification: Clear, colourless to pale, straw-coloured solution.; Container Type: Ampoule; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

VENTOLIN
® INJECTION
_Salbutamol sulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Ventolin Injection. It
does not contain all of 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
Injection 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 IS VENTOLIN
INJECTION USED FOR?
Ventolin Injection helps you to
breathe more easily. When your chest
is tight or when you are wheezing,
Ventolin opens up the breathing
tubes in your lungs.
Ventolin Injection belongs to a group
of medicines called bronchodilators.
Because the medicine in Ventolin
Injection 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 Injection. Ventolin Injection
is not the only form of Ventolin
available. Your doctor will decide
which form of Ventolin is right for
you.
Your doctor may have prescribed
Ventolin Injection for another reason.
Ventolin Injection is not addictive.
BEFORE YOU ARE GIVEN
VENTOLIN INJECTION
_WHEN YOU MUST NOT HAVE IT:_
•
if you have ever had an allergic
reaction to salbutamol sulfate or
any of the ingredients listed
toward the end of this leaflet.
(See "Ingredients")
Some of the symptoms of an allergic
reaction may include:
-
Shortness of breath
-
Wheezing or difficulty in
breathing
-
Swelling of the face, lips, tongue
or other parts of the body
-
Rash, itching or hives on the skin.
•
after the expiry date (EXP)
printed on the pack
•
if the packaging is torn or shows
signs of tampering.
_TELL YOUR DOCTOR IF:_
You must tell y

Summary of Product characteristics

1
PRODUCT INFORMATION
VENTOLIN
SUGAR FREE SYRUP AND INJECTION
NAME OF THE MEDICINE:
Salbutamol Sulphate BP
CHEMICAL NAME
1-(4-hydroxy-3-hydroxymethylphenyl)-2-(t-butylamino)ethanol Sulphate.
STRUCTURE
MOLECULAR FORMULA:
(C
13
H
21
NO
3
)
2
H
2
SO
4
DESCRIPTION:
Salbutamol sulphate is a white or almost white odourless powder. It is
soluble in 4 parts of
water; slightly soluble in 95% alcohol, chloroform and solvent ether.
Ventolin Sugar Free Syrup contains the following excipients: sodium
citrate, citric acid
monohydrate, hypromellose, sodium benzoate, saccharin sodium, sodium
chloride, water –
purified and orange flavouring.
Ventolin Injection contains the following excipients: sodium chloride,
sulfuric acid and water
for injections.
PHARMACOLOGY:
Salbutamol is a relatively selective beta-2 adrenoreceptor stimulant.
It is more specific than
both isoprenaline and orciprenaline for adrenergic beta-2 receptors.
After oral and parenteral administration, stimulation of the beta
receptors in the body, both
beta-1 and beta-2, occurs because (a) beta-2 selectivity is not
absolute, and (b) higher
concentrations of salbutamol occur in the regions of these receptors
with these modes of
administration. This results in the beta-1 effect of cardiac
stimulation, though not so much as
with isoprenaline, and beta-2 effects of peripheral vasodilatation and
hypotension, skeletal
muscle tremor and uterine muscle relaxation.
Metabolic effects such as hyperinsulinaemia and hyperglycaemia also
may occur, although it
is not known whether these effects are mediated by beta-1 or beta-2
receptors. The serum
potassium levels have a tendency to fall.
CHOH.CH
2
.NHC(CH
3
)
3
HOH
2
C
HO
H
2
SO
4
2
2
PHARMACOKINETICS
Peak plasma levels occur at 2 to 4 hours after oral administration of
salbutamol.
The elimination half-life of oral or inhaled salbutamol is between 2.7
and 5 hours.
Salbutamol is not metabolized in the lung but is converted to the
4'-o-sulphate ester in the
liver. Salbutamol is excreted in the urine as free drug and as the
metab