Cymevene

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Ganciclovir sodium 543mg equivalent to 500 mg ganciclovir

Fáanlegur frá:

Pharmaco (NZ) Ltd

INN (Alþjóðlegt nafn):

Ganciclovir sodium 543 mg (= 500 mg ganciclovir)

Skammtar:

500 mg

Lyfjaform:

Powder for infusion

Samsetning:

Active: Ganciclovir sodium 543mg equivalent to 500 mg ganciclovir

Einingar í pakka:

Vial, glass, 5 dose units

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Corden Pharma Colorado Inc

Ábendingar:

Iindicated for the prophylaxis of CMV infection and disease following bone marrow and solid organ transplantation in patients at risk of CMV disease.

Vörulýsing:

Package - Contents - Shelf Life: Vial, glass, - 5 dose units - 36 months from date of manufacture stored at or below 30°C 12 hours reconstituted stored at or below 25°C

Leyfisdagur:

1990-06-21

Upplýsingar fylgiseðill

CYMEVENE
®
_contains the active ingredient_
_ganciclovir _
Cymevene
®
181205
1
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cymevene.
It does not contain all 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 risks of you being given
Cymevene injection against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CYMEVENE IS
USED FOR
Cymevene contains the active
ingredient ganciclovir.
Cymevene belongs to a class of
medicines used to treat viral
infections. It works by stopping
certain viruses from growing in the
body.
Cymevene acts against a certain
type of herpes virus called
_cytomegalovirus_
or CMV. CMV
causes infections mainly in people
with poor immunity. Poor
immunity can be caused by
HIV/AIDS or some transplant
medications.
Cymevene helps control CMV eye
infections in AIDS patients and in
other patients who have poor
immunity, which if left untreated
can cause blindness. Cymevene is
not a cure for CMV eye infections
and is not effective against any
underlying HIV infection.
Cymevene may also be used to treat
CMV lung infections in bone
marrow transplant patients.
Cymevene may also be used to
prevent CMV infection and disease
in patients following bone marrow
or solid organ transplantation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CYMEVENE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor, however, may have
prescribed Cymevene for another
purpose.
Cymevene is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
CYMEVENE
Animal and other laboratory studies
have shown Cymevene has caused
infertility, birth defects and cancer.
It is possible that these effects may
also occur in humans.
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT USE CYMEVENE IF
1. YOU HAVE HAD

Vara einkenni

NEW ZEALAND DATA SHEET
Cymevene
®
DS 181120
1
1.
PRODUCT NAME
Cymevene
®
500 mg powder for intravenous infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of ganciclovir (as ganciclovir sodium).
After reconstitution with 10 mL of water for injections, each mL
provides 50 mg of
ganciclovir.
Cymevene is available as the sterile lyophilised powder containing
ganciclovir sodium 543
mg equivalent to ganciclovir 500 mg and sodium 43 mg (2 mEq).
Excipients with known effect: approximately 43 mg (2 mEq) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for infusion)
White to off-white solid cake.
Ganciclovir, when formulated as monosodium salt in the intravenous
(IV) dosage form, is a
white to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cymevene (ganciclovir) administered as the
IV infusion is indicated for the palliative
treatment of confirmed sight-threatening cytomegalovirus (CMV) disease
in AIDS and other
severely immunocompromised individuals. It is indicated for the
treatment of confirmed
CMV pneumonitis in bone marrow transplant patients. It is also
indicated for the prophylaxis
of CMV infection and disease following bone marrow and solid organ
transplantation in
patients at risk of CMV disease.
_NOTE:_
Cymevene (ganciclovir) is not indicated for congenital or neonatal CMV
disease; nor
for the treatment of CMV infection in non-immunocompromised
individuals.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
Cymevene
must
be
reconstituted
and
diluted
under
the
supervision
of
a
healthcare
professional and administered as an intravenous infusion (see section
4.2).
Caution: Cymevene must only be administered by IV infusion over 1
hour, preferably via a
plastic
cannula,
into
a
vein
with
adequate
blood
flow
(intramuscular
or
subcutaneous
injection may result in severe tissue irritation due to the high pH
(~11) of ganciclovir
NEW ZEALAND DATA SHEET
Cymevene
®
DS 181120
2
s