PALONOSETRON 0,25 TEVA Solution for injection

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Teva Pharmaceuticals (Pty) Ltd

Dosage:

Not Indicated

Pharmaceutical form:

Solution for injection

Composition:

Each vial of 5 ml of solution contains PALONOSETRON (AS HYDROCHLORIDE) 0,25 mg

Authorization status:

Registered

Authorization date:

2022-05-07

Patient Information leaflet

TEVA PHARMACEUTICALS (PTY) LTD
Product name: Palonosetron 0,25 Teva
Dosage form and strength: Solution for injection; Each vial contains
0,25 mg
Palonosetron (as HCl) per 5 ml
1.3.2
Page 1 of 7
PATIENT INFORMATION LEAFLET:
SCHEDULING STATUS:
PALONOSETRON 0,25 TEVA (solution for injection)
Palonosetron (as hydrochloride)
Each 5 ml vial contains less than 1 mmol sodium (23 mg)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
PALONOSETRON 0,25 TEVA:
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
WHAT IS IN THIS LEAFLET:
1. WHAT PALONOSETRON 0,25 TEVA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PALONOSETRON 0,25 TEVA
3. HOW TO USE PALONOSETRON 0,25 TEVA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PALONOSETRON 0,25 TEVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT PALONOSETRON 0,25 TEVA IS AND WHAT IT IS USED FOR:
PALONOSETRON 0,25 TEVA belongs to a group of medicines known as
serotonin
(5-HT
3
) antagonists.
These have the ability to block the action of the chemical, serotonin,
which can cause nausea and vomiting.
PALONOSETRON 0,25 TEVA is indicated for the prevention of acute nausea
and vomiting associated with moderately
or highly emetogenic cancer chemotherapy.
S4
TEVA PHARMACEUTICALS (PTY) LTD
Product name: Palonosetron 0,25 Teva
Dosage form and strength: Solution for injection; Each vial contains
0,25 mg
Palonosetron (as HCl) per 5 ml
1.3.2
Page 2 of 7
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALONOSETRON 0,25 TEVA:
_DO NOT TAKE _PALONOSETRON 0,25 TEVA:
If you are allergic to palonosetron or any of the other ingredients of
PALONOSETRON 0,25 TEVA (listed in SECTION 6).
_WARNINGS AND PRECAUTIONS: _
Talk to your doctor, pharmacist or nurse before using PALONOSETRON
0,25 TEVA:
-
If you have acute bowel obstruction or a history of repeated
constipation.
-
If you are using PALONOSETRON 0,25 TEVA in addition to other medicines
that may induce an abnormal
heart rhythm

Summary of Product characteristics

TEVA PHARMACEUTICALS (PTY) LTD
Product name: Palonosetron 0,25 Teva
Dosage form and strength: Solution for injection; Each vial contains
0,25 mg
Palonosetron (as HCl) per 5 ml
PAGE 1 OF 13
1.3.1.1
APPROVED PROFESSIONAL INFORMATION
S4
1. NAME OF THE MEDICINAL PRODUCT:
PALONOSETRON 0,25 TEVA (solution for injection)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ml of solution contains 0,05 mg palonosetron (as hydrochloride).
Each vial of 5 ml of solution contains 0,25 mg palonosetron (as
hydrochloride).
Excipients with known effect:
Each vial contains less than 1 mmol sodium (23 mg) (see SECTION 4.4).
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM:
Sterile, clear solution in a 10 ml single use glass vial.
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
PALONOSETRON 0,25 TEVA is indicated for the prevention of acute nausea
and vomiting associated with
moderately or highly emetogenic cancer chemotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
_USE IN ADULTS: _
0,25 mg PALONOSETRON 0,25 TEVA administered as a single intravenous
bolus approximately 30 minutes
before the start of chemotherapy. PALONOSETRON 0,25 TEVA should be
injected over 30 seconds.
Repeated dosing of PALONOSETRON 0,25 TEVA within a seven day interval
is not recommended.
TEVA PHARMACEUTICALS (PTY) LTD
Product name: Palonosetron 0,25 Teva
Dosage form and strength: Solution for injection; Each vial contains
0,25 mg
Palonosetron (as HCl) per 5 ml
PAGE 2 OF 13
1.3.1.1
The efficacy of PALONOSETRON 0,25 TEVA in the prevention of nausea and
vomiting induced by highly
emetogenic chemotherapy may be enhanced by the addition of a
corticosteroid administered prior to
chemotherapy.
Special populations:
_USE IN ELDERLY: _
No dosage adjustment is necessary in the elderly.
_ _
_USE IN PATIENTS WITH RENAL IMPAIRMENT: _
No dosage adjustment is necessary for patients with impaired renal
function.
No data is available for patients with end stage renal disease
undergoing haemodialysis.
_USE IN PATIENTS WITH HEPATIC IMPAIRMENT: _
No