Emend IV

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Fosaprepitant dimeglumine 197.5mg ((free acid) (120.8 mg))

Tillgänglig från:

Merck Sharp & Dohme (New Zealand) Limited

INN (International namn):

Fosaprepitant dimeglumine 197.5 mg ((free acid) (120.8 mg))

Dos:

115 mg

Läkemedelsform:

Powder for injection

Sammansättning:

Active: Fosaprepitant dimeglumine 197.5mg ((free acid) (120.8 mg)) Excipient: Disodium edetate Hydrochloric acid Lactose Polysorbate 80 Sodium hydroxide Water for injection

Enheter i paketet:

Vial, glass, Borosilicate Type I with 13 mm latex free rubber stoper, 1 dose unit

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

Laboratoires Merck Sharp & Dohme - Chibret

Produktsammanfattning:

Package - Contents - Shelf Life: Vial, glass, Borosilicate Type I with 13 mm latex free rubber stoper - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at or below 25°C - Vial, glass, Borosilicate Type I with 13 mm latex free rubber stoper - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at or below 25°C

Tillstånd datum:

2006-05-26

Bipacksedel

EMEND IV™ 
_fosaprepitant dimeglumine _
Intravenous 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about EMEND IV.  It does
not contain all the 
available information.  It does not take the place of talking to
your doctor. 

All medicines have risks and benefits.  Your doctor has weighed the
risks of you being 
given EMEND IV against the benefits they expect it will have for
you. 

If you have any concerns about taking this medicine, ask your
doctor. 

Keep this leaflet with the medicine.  You may need to read it
again. 

WHAT EMEND IV IS USED FOR 
Your doctor has prescribed EMEND IV for the prevention of nausea and
vomiting 
associated with your cancer chemotherapy treatment. 

HOW EMEND IV WORKS 
EMEND IV is a member of a class of medicines called neurokinin 1 (NK
1
) receptor 
antagonists that is used ALONG WITH OTHER MEDICINES to prevent and
control 
nausea (sick feeling in the back of throat and stomach) and vomiting
(throwing up) caused 
by your cancer chemotherapy treatment. 

BEFORE YOU ARE GIVEN EMEND IV 
WHEN YOU MUST NOT  BE GIVEN IT 
Do not have EMEND IV if: 
• 
you have an allergy to EMEND IV or any of the ingredients listed at
the end of this 
leaflet 
• 
the packaging is torn or shows signs of tampering 
• 
the expiry date on the pack has passed. 
If you receive this medicine after the expiry date has passed, it may
not work. 

If you are not sure whether you should start EMEND IV, talk to your
doctor. 

EMEND IV has not been adequately studied in children.  Therefore,
EMEND IV should not 
be given to children. 

EMEND IV works equally well in and is equally well-tolerated by older
and younger adult 
patients.  No dosage adjustment is necessary for older patients. 
BEFORE EMEND IV IS STARTED 
Tell your doctor if: 
• 
you are pregnant or intend to become pregnant 
• 
you are breast-feeding or plan to breast-feed 
• 
you have any past or present medical problems 
• 
you have any alle

Produktens egenskaper

NAME OF MEDICINE 
EMEND IV™ 
_fosaprepitant dimeglumine _
Intravenous 
PRESENTATION 
EMEND IV 115 mg is for intravenous use and comes in a 10 mL vial with
a grey butyl 
stopper and aluminium seal with a light blue plastic flip off lid. 

EMEND IV 150 mg is for intravenous use and comes in a 10 mL vial with
a grey butyl 
stopper and aluminium seal with a dark grey plastic flip off lid. 

Each 10 mL vial contains either 115 mg or 150 mg of fosaprepitant
free acid as a white to 
off white lyophilised solid. 

The reconstitution liquid is clear. 

THERAPEUTIC CLASS 
EMEND IV (fosaprepitant dimeglumine, MSD), is a prodrug of aprepitant,
a substance 
P/neurokinin (NK
1
) receptor antagonist. 

INDICATIONS 
EMEND IV, in combination with other antiemetic agents, is indicated
for the prevention of 
acute and delayed nausea and vomiting associated with initial and
repeat courses of: 

• 
highly emetogenic cancer chemotherapy (see Dosage and
Administration) 
• 
moderately emetogenic cancer chemotherapy (see Dosage and
Administration). 

DOSAGE AND ADMINISTRATION 
EMEND IV for intravenous administration is a lyophilised prodrug of
aprepitant (EMEND
®
) 
containing polysorbate 80 (PS80).  EMEND IV is available as a 150 mg
and 115 mg IV for 
infusion. 
EMEND IV 150 MG 
EMEND IV 150 mg is administered on Day 1 only as an infusion OVER 20
– 30 MINUTES 
initiated approximately 30 minutes prior to chemotherapy.  No
capsules of EMEND are 
administered on Days 2 and 3.  EMEND IV should be administered in
conjunction with a 
corticosteroid and a 5-HT
3
 antagonist as specified in the tables below.  The recommended 
dosage of dexamethasone with EMEND IV 150 mg differs from the
recommended dosage 
of dexamethasone with EMEND IV 115 mg on Days 3 and 4. 

Recommended dosing for the prevention of nausea and vomiting
associated with highly 
emetogenic cancer chemotherapy: 

Day 1 
Day 2 
Day 3 
Day 4 
EMEND IV 
150 mg IV 
none 
none 
none 
Dexameth