KYTRIL granisetron (as hydrochloride) 3mg/ 3mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

granisetron hydrochloride, Quantity: 1.12 mg/mL (Equivalent: granisetron, Qty 1 mg/mL)

Available from:

Atnahs Pharma Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; citric acid monohydrate; sodium chloride; water for injections; sodium hydroxide

Administration route:

Intravenous

Units in package:

1 x 3mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults: KYTRIL (tablets and injection) is indicated for use in adults for: The prevention of nausea and vomiting induced by cytotoxic chemotherapy; The prevention of nausea and vomiting induced by radiotherapy. KYTRIL (injection) is also indicated for use in the treatment of nausea and vomiting induced by cytotoxic chemotherapy; and prevention and treatment of post-operative nausea and vomiting.,Paediatric: KYTRIL injection is indicated for the prevention of nausea and vomiting induced by cytotoxic chemotherapy..

Product summary:

Visual Identification: Clear, colourless liquid.; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2003-12-02

Patient Information leaflet

KYTRIL
® INJECTION
_PRONOUNCED (KAI-TRIL)_
_contains the active ingredient granisetron hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KYTRIL ampoules
for injection. It does not contain all
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 being given KYTRIL
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT KYTRIL IS USED
FOR
KYTRIL contains the active
ingredient granisetron.
KYTRIL belongs to a group of
medicines called anti-emetics.
KYTRIL is given to stop you feeling
sick (nauseous) or being sick
(vomiting). It is especially useful
when you need to have medical
treatment that may cause you to feel
or be sick, for example,
chemotherapy, radiotherapy or
surgery.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY KYTRIL HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
BEFORE YOU ARE GIVEN
KYTRIL
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN KYTRIL IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
granisetron
•
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 breathing
difficulty; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN KYTRIL, TALK TO
YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF:
•
YOU HAVE ALLERGIES TO ANY OTHER
MEDICINES, FOODS, PRESERVATIVES
OR DYES.
•
YOU HAVE HAD AN ALLERGIC
REACTION WITH OTHER MEDICINES
USED TO PREVENT OR TREAT NAUSEA
AND VOMITING, SUCH AS
ONDANSETRON AND TROPISETRON.
You may have

Summary of Product characteristics

Kytril® PI
1
AUSTRALIAN PRODUCT INFORMATION - KYTRIL
®
(GRANISETRON HYDROCHLORIDE)
1. NAME OF THE MEDICINE
Granisetron hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
KYTRIL INJECTIONS:
KYTRIL injection is available as an ampoule containing granisetron
hydrochloride, equivalent to 3 mg of
granisetron free base in 3 mL; and equivalent to 1 mg of granisetron
free base in 1 mL.
KYTRIL TABLETS:
KYTRIL tablets contain granisetron hydrochloride (equivalent to 2 mg
of granisetron free base).
KYTRIL tablets do not contain sucrose, gluten, tartrazine, or azo
dyes.
EXCIPIENTS WITH KNOWN EFFECT: contains sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
KYTRIL tablet: white to almost white, triangular biconvex, film-coated
tablet, debossed with "K2" on one face.
KYTRIL injection: sterile clear, colourless solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS:
KYTRIL (tablets and injection) is indicated for use in adults for:
The prevention of nausea and vomiting induced by cytotoxic
chemotherapy;
The prevention of nausea and vomiting induced by radiotherapy.
KYTRIL (injection) is also indicated for use in the treatment of
nausea and vomiting induced by cytotoxic
chemotherapy; and prevention and treatment of post-operative nausea
and vomiting.
PAEDIATRIC:
KYTRIL injection is indicated for the prevention of nausea and
vomiting induced by cytotoxic chemotherapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Standard Dosage by presentation and indication for adult and
paediatric patients are shown below.
INDICATION: CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV)
_ADULTS _
_Oral Administration _
_Prevention of nausea and vomiting in adults _
The dose of KYTRIL is 2 mg once a day for up to one week following
chemotherapy. The first dose of
KYTRIL should be administered within 1 hour before the start of
chemotherapy.
_Treatment of established nausea and vomiting in adults _
There is insufficient information to recommend the oral adm