VALOID cyclizine lactate 50 mg/1 mL injection ampoule

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

cyclizine lactate, Quantity: 50 mg/mL

Διαθέσιμο από:

Amdipharm Mercury Australia Pty Ltd

INN (Διεθνής Όνομα):

cyclizine lactate

Φαρμακοτεχνική μορφή:

Injection

Σύνθεση:

Excipient Ingredients: lactic acid; water for injections

Οδός χορήγησης:

Intravenous

Μονάδες σε πακέτο:

5 ampoules/carton

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Valoid is indicated for the prevention of nausea and vomiting in the post operative period

Περίληψη προϊόντος:

Visual Identification: clear, colourless to pale yellow solution in a clear glass, 1 mL ampoule; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2012-06-19

Φύλλο οδηγιών χρήσης

VALOID
®
_cyclizine lactate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VALOID injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of giving you VALOID
injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT VALOID IS USED
FOR
VALOID is used to prevent nausea
and vomiting in the post-operative
period. It belongs to a group of
medicines called anti-emetics.
The exact mechanism by which it
works is not known.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN CHOSEN FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
VALOID is not recommended for
use in children. Children may be
more sensitive than adults to some of
the side effects of VALOID.
BEFORE YOU ARE GIVEN
VALOID
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN VALOID:
•
after a heart attack
•
if you have severe heart failure
(disease of the heart with
shortness of breath, and swelling
of the feet or legs due to fluid
build-up)
•
if you are drunk
•
if you have an allergy to any
medicine containing cyclizine or
to any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
difficulty passing urine or
symptoms due to an enlarged
prostate
•
liver disease
�

Αρχείο Π.Χ.Π.

VALOID
®
1
AUSTRALIAN PRODUCT INFORMATION
VALOID
®
CYCLIZINE LACTATE
INJECTION
1
NAME OF THE MEDICINE
Cyclizine lactate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule contains 50 mg cyclizine lactate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
VALOID injection is a clear, colourless solution for injection
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VALOID is indicated for the prevention of nausea and vomiting in the
post-operative period.
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment with VALOID should commence within the first 24 hours of
surgery and should
not continue beyond 48 hours.
There are no data on the use of VALOID in the treatment of established
post-operative
nausea and vomiting.
Route of Administration: intravenous
ADULTS
50 mg intravenously up to three times daily.
When used intravenously, VALOID should be injected slowly into the
bloodstream, with
only minimal withdrawal of blood into the syringe.
For the prevention of postoperative nausea and vomiting, administer
the first dose by slow
intravenous injection 20 minutes before the anticipated end of
surgery.
VALOID
®
2
ELDERLY
There have been no specific studies of VALOID Injection in the
elderly. Experience has
indicated that normal adult dosage is appropriate.
4.3 CONTRAINDICATIONS
VALOID should not be given to individuals with known hypersensitivity
to cyclizine or to
any of the excipients.
VALOID should not be given to patients who have severe heart failure
or acute myocardial
infarction. In such patients, cyclizine may cause a fall in cardiac
output associated with
increases in heart rate, mean arterial pressure and pulmonary wedge
pressure.
VALOID should not be given to patients who have acute alcohol
intoxication. The anti-
emetic properties of cyclizine may increase the toxicity of alcohol.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
ANTICHOLINERGIC EFFECTS
Cyclizine has anticholinergic effects and may precipitate pre-existing
conditions that are
likely to be exacerb