Cymevene

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

Ganciclovir sodium

Sẵn có từ:

Roche Products Pty Ltd

Lớp học:

Medicine Registered

Tờ rơi thông tin

CYMEVENE
®

_contains the active ingredient ganciclovir_
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 it 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 AN ALLER

Đặc tính sản phẩm

 
Cymevene
® 
PI 110405 

1 of 25 
CDS 2.0 

NAME OF THE MEDICINE 
CYMEVENE
®

GANCICLOVIR

POWDER FOR INTRAVENOUS INFUSION 

_CAS-82410-32-0 _
N
H
2
N
N
N
O
H N
CH
2
OH
CH
2
OCHCH
2
OH
_ _
DESCRIPTION 
Ganciclovir is a synthetic nucleoside analogue of guanine. 
Its chemical name is 9-(1,3-
dihydroxy-2-propoxymethyl) guanine.   Ganciclovir has also been referred to as DHPG. 
Ganciclovir has a molecular formula of C
9
H
13
N
5
O
4
 and a molecular weight of 255.2. 
Ganciclovir is a polar hydrophilic compound with
a solubility of 2.6 mg/mL in water at 25 ºC 
(Hydrated Phase II polymorph) and  an n-octanol/water partition
coefficient of 0.022.  The 
solubility of ganciclovir is independent of the crystalline phase composition.
 Ganciclovir has 
two dissociation constants: pKa
1 
= 2.2 and pKa
2
 = 9.4.  
Ganciclovir, when formulated as monosodium salt  in
the intravenous  (IV)  dosage form, is a 
white to off-white lyophilised powder with
the molecular formula of C
9
H
12
N
5
Na0
4
 (molecular 
weight is 277.2). The lyophilised powder has an
aqueous solubility of greater than 50 mg/mL at 
25 °C. At physiological pH, ganciclovir sodium exists as the un-ionized
form.  CYMEVENE is 
available as the sterile lyophilised
powder containing ganciclovir sodium 543  mg equivalent 
to ganciclovir 500  mg and sodium 43 mg (2 mEq).  There are
no excipients.   Reconstituted 
CYMEVENE sterile powder is for IV administration only.  
PHARMACOLOGY 
MICROBIOLOGY 
Ganciclovir is a synthetic nucleoside analogue of 2-deoxyguanosine that inhibits replication
of 
herpes viruses both _in vitro_  and  _in vivo_.
 Sensitive human viruses include cytomegalovirus 
 
Cymevene
® 
PI 110405 

2 of 25 
CDS 2.0 

(HCMV), herpes simplex virus-1 and -2 (HSV-1 and HSV-2),
herpes virus type -6, -7