ONDANSETRON TABLETS VIATRIS ondansetron (as hydrochloride dihydrate) 8 mg film-coated tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

ondansetron hydrochloride dihydrate, Quantity: 10 mg (Equivalent: ondansetron, Qty 8 mg)

Dostupné z:

Dr Reddys Laboratories Australia Pty Ltd

INN (Medzinárodný Name):

Ondansetron hydrochloride dihydrate

Forma lieku:

Tablet, film coated

Zloženie:

Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400

Spôsob podávania:

Oral

Počet v balení:

10 tablet, 6 tablet, 4 tablet

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Prehľad produktov:

Visual Identification: Dark yellow, oval, biconvex, film coated tablets embossed 'OND' on one side and '8' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2017-08-09

Príbalový leták

Ondansetron Mylan CMI v1
Page 1 of 4
CONSUMER MEDICINE INFORMATION
ONDANSETRON MYLAN TABLETS
_Ondansetron hydrochloride dihydrate _
WHAT IS IN THIS LEAFLET?
Please read this leaflet
carefully before you use
Ondansetron Mylan tablets.
This leaflet answers some
common questions about
Ondansetron Mylan
tablets. 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 expected
benefits of you taking
Ondansetron Mylan tablets
against the risks this
medicine could 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 ARE ONDANSETRON
MYLAN TABLETS USED FOR?
Ondansetron Mylan tablets
contain a medicine called
ondansetron. This belongs to
a group of medicines called
serotonin receptor‐3
antagonists.
Ondansetron Mylan
tablets are used to help
stop the nausea (sick
feeling) and vomiting
which can occur after
medical treatments.
Ondansetron Mylan tablets
should only be used to treat
the nausea and vomiting for
which they have been
prescribed.
Your doctor may have
prescribed Ondansetron
Mylan tablets for another
reason. If you want more
information, ask your
doctor.
Ondansetron Mylan tablets
are not addictive.
BEFORE YOU TAKE
ONDANSETRON MYLAN
TABLETS
_DO NOT TAKE IF:_
You must not take
Ondansetron Mylan tablets if:
•
YOU ARE TAKING
APOMORPHINE (USED TO
TREAT PARKINSON’S
DISEASE)
•
YOU HAVE EVER HAD AN
ALLERGIC REACTION TO
ONDANSETRON OR ANY OF
THE INGREDIENTS LISTED
TOWARD THE END OF THIS
LEAFLET. (SEE
"INGREDIENTS")
•
YOU ARE PREGNANT,
TRYING TO BECOME
PREGNANT OR BREAST
FEEDING, UNLESS YOUR
DOCTOR SAYS IT IS SAFE.
•
THE EXPIRY DATE (EXP)
PRINTED ON THE PACK HAS
PASSED.
•
THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING
_TELL YOUR DOCTOR IF:_
You must tell your doctor if:
•
YOU ARE ALLERGIC TO FOODS,
DYES, PRESERVATIVES OR ANY
OTHER MEDICINES.
•
YOU HAVE HAD TO

Súhrn charakteristických

AUSTRALIAN PRODUCT INFORMATION – ONDANSETRON MYLAN
(ONDANSETRON HYDROCHLORIDE DIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate
2
& 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Ondansetron hydrochloride dihydrate is a white to off white powder
with a melting point of
177°C. It is sparingly soluble in water and in alcohol, soluble in
methanol and slightly soluble in
methylene chloride. It is soluble in saline (0.9% w/v) to about 8
mg/mL. The pKa of
ondansetron hydrochloride dihydrate as determined by a solubility
procedure is 7.4. The
distribution coefficient between n-octanol and water is pH dependent
with log D = 2.2 at a pH of
10.6 and log D = 0.6 at a pH of 5.95.
EXCIPIENTS WITH KNOWN EFFECT: Contains sugars (as lactose)
Ondansetron Mylan 4 mg and 8 mg tablets contain the following
excipients: Lactose
monohydrate, microcrystalline cellulose, pregelatinised maize starch,
magnesium stearate,
sodium starch glycollate, colloidal anhydrous silica, Opadry Yellow
03B52375 and Opadry
Yellow 03B52246.
Ondansetron Mylan 4 mg tablets: Light yellow, oval, biconvex, film
coated tablets embossed
‘OND’ on one side and ‘4’ on other side.
Ondansetron Mylan 8 mg tablets: Dark yellow, oval, biconvex, film
coated tablets embossed
‘OND’ on one side and ‘8’ on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prevention and treatment of nausea and vomiting induced by cytotoxic
therapy and
radiotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The route of
administration and dose of
ondansetron should be flexible in the range of 8 to 32 mg a day and
selected as shown below.
The lowest effective dose should be used.
ADULTS. EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY For the control of
chemotherapy or
radiotherapy induced emesis or nausea in adults, two oral doses of 8
mg each at 12 hourly
intervals may be given (tablet