CYMEVENE 500mg (as sodium) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ganciclovir sodium, Quantity: 543 mg (Equivalent: ganciclovir, Qty 500 mg)

Available from:

Pharmaco Australia Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

5 x 500mg vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 12 October 2005: CYMEVENE (ganciclovir) administered as the intravenous 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.

Product summary:

Visual Identification: White to off-white lyophilised powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-06-11

Patient Information leaflet

CYMEVENE
®
CMI
1
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 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 ALLE

Summary of Product characteristics

Cymevene
1
AUSTRALIAN PRODUCT INFORMATION
CYMEVENE
® (GANCICLOVIR)
1
NAME OF THE MEDICINE
Ganciclovir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cymevene vial contains 500 mg of ganciclovir (as ganciclovir
sodium 543 mg equivalent to
ganciclovir 500 mg and sodium 43 mg (2 mEq). ganciclovir sodium).
After reconstitution with 10 mL of water for injections, each mL
provides 50 mg of ganciclovir.
There are no excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Sterile lyophilised powder for intravenous infusion
Ganciclovir, when formulated as monosodium salt in the intravenous
(IV) dosage form, is a white to off-
white lyophilised powder. 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.
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
DOSE
Reconstituted Cymevene sterile powder is for IV administration only.
Intravenous Administration
Cymevene must be reconstituted and diluted under the supervision of a
healthcare professional and
administered as an intravenous infusion (see section 6.6 Special
precautions for disposal and other handling).
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