Granisetron-AFT, granisetron (as hydrochloride) 3 mg/3 mL, concentrated injection, clear type I glass ampoule

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

granisetron hydrochloride, Quantity: 3.36 mg (Equivalent: granisetron, Qty 3 mg)

Διαθέσιμο από:

AFT Pharmaceuticals Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, concentrated

Σύνθεση:

Excipient Ingredients: water for injections; sodium chloride; nitrogen; citric acid monohydrate; sodium citrate dihydrate

Οδός χορήγησης:

Intravenous

Μονάδες σε πακέτο:

5 ampoules, 1 ampoule

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Granisetron injection is indicated in:,Adults: - for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy - for the prevention of nausea and vomiting induced by radiotherapy,Children: - for the prevention of nausea and vomiting induced by cytotoxic chemotherapy

Περίληψη προϊόντος:

Visual Identification: Clear colourless liquid; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2018-05-31

Φύλλο οδηγιών χρήσης

GRANISETRON-AFT*
1
GRANISETRON-AFT*
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GRANISETRON-AFT?
GRANISETRON-AFT contains the active ingredient granisetron.
GRANISETRON-AFT is used to prevent nausea (feeling sick) and
vomiting. It is especially useful when you need to have medical
treatment that may cause you to feel or be sick, for example,
chemotherapy or radiotherapy.
For more information, see Section 1. Why am I using GRANISETRON-AFT?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GRANISETRON-AFT?
Do not use if you have ever had an allergic reaction to
GRANISETRON-AFT or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
GRANISETRON-AFT?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GRANISETRON-AFT and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW IS GRANISETRON-AFT GIVEN?
•
Your doctor will decide how much GRANISETRON-AFT you should receive
and for how long you should receive it.
More instructions can be found in Section 4. How do I use
GRANISETRON-AFT?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING GRANISETRON-AFT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist who treat you that you are
using GRANISETRON-AFT.
•
Keep all of your doctor’s appointments, so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not take any other medicines whether they require a prescription or
not without first telling your
doctor.
DRIVING OR
USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how GRANISETRON-AFT affects
you.
•
GRANISETRON-AFT may ca

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
GRANISETRON-AFT (GRANISETRON HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
GRANISETRON-AFT granisetron (as hydrochloride) 1 mg/mL concentrated
solution for injection.
GRANISETRON-AFT granisetron (as hydrochloride) 3 mg/3 mL concentrated
solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GRANISETRON-AFT 1 mg/mL injection:
Each 1 mL concentrated solution for injection contains 1.12 mg
granisetron hydrochloride, equivalent
to 1 mg granisetron.
GRANISETRON-AFT 3 mg/3 mL injection:
Each 3 mL concentrated solution for injection contains 3.36 mg
granisetron hydrochloride, equivalent
to 3 mg granisetron.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Concentrated solution for injection.
Sterile, clear, colourless solution, practically free of visible
particles.
GRANISETRON-AFT contains no antimicrobial preservative.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
GRANISETRON-AFT, concentrated solution for injection, is indicated in:
ADULTS:
•
for the prevention and treatment of nausea and vomiting induced by
cytotoxic chemotherapy;
•
for the prevention of nausea and vomiting induced by radiotherapy.
PAEDIATRIC PATIENTS:
•
for the prevention of nausea and vomiting induced by cytotoxic
chemotherapy.
4.2.
Dose and method of administration
DOSE
GRANISETRON-AFT
must
be
diluted
in
accordance
with
the
directions
below
before
being
administered.
Page 1 of 14
_CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) _
_Intravenous administration _
_Adults: _
For prevention of nausea and vomiting in adults, a single dose of 3 mg
of GRANISETRON-AFT should
be administered as an intravenous infusion, diluted in 20 – 50 mL
infusion fluid and administered over
5 minutes prior to the start of chemotherapy. The infusion should be
commenced within 30 minutes
before the start of chemotherapy.
Prophylactic
administration
of
GRANISETRON-AFT
should
be
completed
prior
to
the
start
of
chemotherapy.
In clinical trials, the majority of patients have required