FOSAPREPITANT CIPLA SOLUTION

Ország: Dél-afrikai Köztársaság

Nyelv: angol

Forrás: South African Health Products Regulatory Authority (SAHPRA)

Beszerezhető a:

Cipla Medpro (Pty) Ltd

Adagolás:

150,0 mg

Gyógyszerészeti forma:

SOLUTION

Összetétel:

EACH VIAL CONTAINS FOSAPREPITANT DIMEGLUMINE EQUIVALENG TO FOSAPREPITANT 150,0 mg

Engedélyezési státusz:

Registered

Betegtájékoztató

CIPLA MEDPRO (PTY) LTD FOSAPREPITANT LYOPHILISED POWDER FOR SOLUTION
FOR INFUSION 150 MG/VIAL
Page 1 of 10
PATIENT INFORMATION LEAFLET
FOSAPREPITANT CIPLA
SCHEDULING STATUS
FOSAPREPITANT CIPLA (150 MG LYOPHILISED POWDER FOR SOLUTION FOR
INFUSION)
Fosaprepitant Dimeglumine
Contains Sugar (Lactose Anhydrous 375 mg)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN FOSAPREPITANT
CIPLA
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor, pharmacist, nurse, or
other health care
provider.
WHAT IS IN THIS LEAFLET
1.
What FOSAPREPITANT CIPLA is and what it is used for
2.
What you need to know before you are administered FOSAPREPITANT CIPLA
3.
How to use FOSAPREPITANT CIPLA.
4.
Possible side effects
5.
How to store FOSAPREPITANT CIPLA
6.
Contents of the pack and other information.
1.
WHAT FOSAPREPITANT CIPLA IS AND WHAT IT IS USED FOR
FOSAPREPITANT CIPLA contains the active substance Fosaprepitant
dimeglumine which is
converted to aprepitant in the body. Aprepitant belongs to a group of
medicines called
S4
CIPLA MEDPRO (PTY) LTD FOSAPREPITANT LYOPHILISED POWDER FOR SOLUTION
FOR INFUSION 150 MG/VIAL
Page 2 of 10
"neurokinin 1 (NK
1
) receptor antagonists". The brain has a specific area that controls
nausea
(feeling sick) and vomiting. FOSAPREPITANT CIPLA works by blocking
signals to that area of
the brain, thereby reducing nausea and vomiting.
FOSAPREPITANT CIPLA is used in combination with other medicines to
prevent nausea
(feeling sick) and vomiting caused by chemotherapy (cancer treatment).
Doctor has prescribed FOSAPREPITANT CIPLA for the prevention of nausea
and vomiting
triggered by cancer chemotherapy treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE ADMINISTERED FOSAPREPITANT CIPLA
FOSAPREPITANT CIPLA SHOULD NOT BE ADMINISTERED TO YOU
•
if you are hypersensitive (allergic) to aprepitant, polysorbate 80 or
any other ingredients
other ingredients of FOSAPREPITANT CIPLA (listed in SECTION 6).
•
If you are pregnant or breastfeeding your baby.
•
If you ar

Termékjellemzők

CIPLA MEDPRO (PTY) LTD FOSAPREPITANT LYOPHILISED POWDER FOR SOLUTION
FOR INFUSION 150 MG/VIAL
Page 1 of 21
PROFESSIONAL INFORMATION FOR
FOSAPREPITANT CIPLA
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
FOSAPREPITANT CIPLA Lyophilised powder for Solution for Infusion.
STRENGTH
Each 10 mL vial of FOSAPREPITANT CIPLA contains Fosaprepitant
Dimeglumine 245,3
mg equivalent to Fosaprepitant 150 mg.
PHARMACEUTICAL FORM
Lyophilised cake or powder for solution for Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial of FOSAPREPITANT CIPLA contains Fosaprepitant
dimeglumine 245,3
mg equivalent to Fosaprepitant 150 mg.
When reconstituted (150 mg of Fosaprepitant in 150 mL 0,9 % Sodium
chloride Injection),
yields a final concentration of 1 mg/mL Fosaprepitant solution for
infusion.
Contains Sugar (Lactose Anhydrous 375 mg).
For full list of excipients, see SECTION 6.1
3.
PHARMACEUTICAL FORM
Lyophilised cake or powder for solution for Infusion.
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CIPLA MEDPRO (PTY) LTD FOSAPREPITANT LYOPHILISED POWDER FOR SOLUTION
FOR INFUSION 150 MG/VIAL
Page 2 of 21
BEFORE RECONSTITUTION: White to off white lyophilised cake or powder.
4.
CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS
FOSAPREPITANT CIPLA in combination with other anti-emetic medicines,
is indicated for
the prevention of acute (0 to 24 hours) and delayed (> 24 to 120
hours) nausea and
vomiting associated with initial and repeat courses of:
•
highly emetogenic cancer chemotherapy, see SECTION 4.2.
•
moderately emetogenic cancer chemotherapy, see SECTION 4.2.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
Recommended dosing for the prevention of nausea and vomiting
associated with highly
emetogenic cancer chemotherapy is as follows:
HIGHLY EMETOGENIC CHEMOTHERAPY REGIMEN
Day 1
Day 2
Day 3
Day 4
FOSAPREPITANT
CIPLA
150 mg IV
None
None
None
Dexamethasone**
12 mg orally
8 mg orally
8 mg orally,
twice daily
8 mg orally,
twice daily
5-HT
3
antagonist
See the professional
information for the selected 5-
HT
3
antagonist for appropriate
dosing information
No