VENTOLIN OBSTETRIC 5mg/5mL injection ampoule

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

salbutamol sulfate, Quantity: 1.2 mg/mL (Equivalent: salbutamol, Qty 1 mg/mL)

Dostopno od:

GlaxoSmithKline Australia Pty Ltd

Farmacevtska oblika:

Injection, concentrated

Sestava:

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

Pot uporabe:

Intravenous

Enote v paketu:

5x5mL

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

For the management of uncomplicated premature labour. To arrest labour between 24 and 33 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy. 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.

Povzetek izdelek:

Visual Identification: Clear, colourless to pale, straw-coloured solution.; Container Type: Ampoule; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Registered

Datum dovoljenje:

1991-08-13

Navodilo za uporabo

VENTOLIN
® OBSTETRIC
INJECTION
_Salbutamol sulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ventolin Obstetric
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
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
OBSTETRIC INJECTION IS
USED FOR?
Ventolin Obstetric injection is used
to stop contractions of premature
labour between weeks 24 and 37 of
pregnancy. Your medicine relaxes
the muscles in the uterus and stops
contractions due to labour during this
stage of pregnancy.
Ventolin Obstetric injection may not
be as effective if your 'waters break'
or the neck of the uterus has
widened.
Ventolin Obstetric Injection is not
addictive.
BEFORE YOU ARE GIVEN
VENTOLIN OBSTETRIC
INJECTION
_WHEN YOU MUST NOT HAVE IT:_
•
If you have ever had an allergic
reaction to salbutamol sulphate 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
•
YOU ARE LESS THAN 24 WEEKS
PREGNANT
•
IF YOU HAVE ANY PROBLEM WHERE
IT WOULD NOT BE SAFE TO PROLONG
THE PREGNANCY
•
YOU HAVE ASTHMA
•
IF YOU HAVE A THYROID PROBLEM
ASSOCIATED WITH PREGNANCY
•
YOU HAVE BEEN HAVE OR ARE
HAVING TREATMENT FOR HIGH BLOOD
PRESSURE, INCLUDING HIGH BLOOD
PRESSURE ASSOCIATED WITH
PREGNANCY
•
YOU HAVE PRE-EXISTING HEART
DISEASE OR RAPID HEART BEATS
•
IF YOU HAVE ANY PROBLEM WITH
THE BOWELS
•
YOU HAVE A KIDNEY PROBLEM
•
YOU HAVE DIABETES
•
YOU HAVE EYE PROBLEMS DUE TO
THE CONDITION

Lastnosti izdelka

1
AUSTRALIAN PRODUCT INFORMATION
VENTOLIN OBSTETRIC INJECTION (SALBUTAMOL SULFATE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Salbutamol sulfate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ampoules of 5 mL containing salbutamol sulfate equivalent to 5 mg (1
mg/mL) salbutamol BP
in a sterile isotonic solution.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Concentrated injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the management of uncomplicated premature labour. To arrest labour
between 24 and
33 weeks of gestation in patients with no medical or obstetric
contraindication to tocolytic
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR INTRAVENOUS INFUSION ONLY. FOR OBSTETRIC USE ONLY – DILUTE
BEFORE
USE.
Treatment
with
VENTOLIN
OBSTETRIC
INJECTION
should
only
be
initiated
by
obstetricians/physicians experienced in the use of tocolytic agents.
Ideally, it should be carried
out in facilities adequately equipped to perform continuous monitoring
of maternal and foetal
health status.
VENTOLIN OBSTETRIC INJECTION should not be administered in the same
syringe or
infusion as any other medication.
INFUSION: Use of an infusion pump will facilitate accurate adjustment
and control of salbutamol
infusion.
The infusion should be administered as early as possible after the
diagnosis of premature
labour, and after evaluation of the patient to rule out
contraindications to the use of salbutamol
(See Section 4.3 CONTRAINDICATIONS). This should include an adequate
assessment of
the patient's cardiovascular status with continuous ECG monitoring
throughout treatment (See
Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
2
In premature labour infusion rates of 10-50 micrograms per minute are
usually adequate to
control uterine contractions. The infusion rate required varies
according to the strength and
frequency of contractions. A starting dose of 10 micrograms per minute
is recommended,
increasing the rate at 10-minute int