Zondan tablets film-coated

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

ondansetron (ondansetron hydrochloride dihydrate)

Mevcut itibaren:

Incepta Pharmaceuticals Limited

ATC kodu:

A04AA01

INN (International Adı):

ondansetron (ondansetron hydrochloride dihydrate)

Doz:

8mg

Farmasötik formu:

tablets film-coated

Paketteki üniteler:

(30/3x10/) in blister

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2018-07-11

Bilgilendirme broşürü

INCEPTA PHARMACEUTICALS LTD. DHAKA, BANGLADESH
_ZONDAN TABLETS _
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZONDAN
®
, 8MG FILM-COATED TABLETS_ _
_ONDANSETRON 8 MG _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Zondan Tablets are and what they are used for
2.
What you need to know before you take Zondan Tablets
3.
How to take Zondan Tablets
4.
Possible side effects
5.
How to store Zondan Tablets
6.
Contents of the pack and other information
The name of your medicine is Zondan Tablets Film-Coated Tablets 8 mg
(also referred to as
Ondansetron Tablets throughout this leaflet).
1. WHAT ZONDAN TABLETS ARE AND WHAT THEY ARE USED FOR
Zondan tablets contain a medicine called ondansetron. This belongs to
a group of medicines
called anti-emetics.
Zondan tablets are used for:
•
preventing nausea and vomiting caused by chemotherapy (in adults and
children) or
radiotherapy for cancer (adults only)
•
preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these
uses.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZONDAN TABLETS
DO NOT TAKE ZONDAN TABLETS
•
If you are taking apomorphine (used to treat Parkinson's disease).
•
If you are allergic (hypersensitive) to ondansetron or any of the
other ingredients in
Zondan tablets (listed in Section 6). INCEPTA PHARMACEUTICALS LTD. DHAKA, BANGLADESH
_ZONDAN TABLETS _
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Ürün özellikleri

INCEPTA PHARMACEUTICALS LTD
_ZONDAN TABLETS _
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THE SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zondan®, 8mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8mg of ondansetron (as hydrochloride dihydrate).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film coated tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Ondansetron hydrochloride is indicated for the management of nausea
and vomiting induced by
cytotoxic chemotherapy and radiotherapy.
Ondansetron Hydrochloride is indicated for the prevention of
post-operative nausea and vomiting
(PONV). For treatment of established PONV, administration by injection
is recommended.
Paediatric Population
Ondansetron hydrochloride is indicated for the management of
chemotherapy-induced nausea and
vomiting (CINV) in children aged ≥6 months.
No studies have been conducted on the use of orally administered
ondansetron in the prevention and
treatment of PONV in children aged ≥1 month, administration by IV
injection is recommended for
this purpose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING.
_ADULTS:_
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The selection of dose
regimen should be determined
by the severity of the emetogenic challenge.
_Emetogenic chemotherapy and radiotherapy_: Ondansetron hydrochloride
can be given either by
rectal, oral (tablets or syrup), intravenous or intramuscular
administration.
For oral administration: 8mg taken 1 to 2 hours before chemotherapy or
radiation treatment, followed
by 8 mg every 12 hours for a maximum of 5 days to protect against
delayed or prolonged emesis.
For highly emetogenic chemotherapy: a single dose of up to 24 mg
ondansetron hydrochloride taken
with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before
chem