Ganciclovir SXP ganciclovir (as sodium) 500 mg powder for injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

ganciclovir sodium, Quantity: 546 mg (Equivalent: ganciclovir, Qty 500 mg)

Tilgjengelig fra:

Southern Cross Pharma Pty Ltd

INN (International Name):

ganciclovir sodium

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients:

Administreringsrute:

Intravenous, Intravenous Infusion

Enheter i pakken:

5 vials

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

GANCICLOVIR SXP (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: GANCICLOVIR SXP (ganciclovir) is not indicated for congenital or neonatal CMV disease; nor for the treatment of CMV infection in non-immunocompromised individuals.

Produkt oppsummering:

Visual Identification: White, hygroscopic, crystalline powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2017-08-31

Informasjon til brukeren

v2
GANCICLOVIR SXP
_contains the active ingredient ganciclovir _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GANCICLOVIR
SXP.
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
GANCICLOVIR SXP 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 GANCICLOVIR
SXP IS USED FOR
GANCICLOVIR SXP contains the
active ingredient ganciclovir.
GANCICLOVIR SXP belongs to a
class of medicines used to treat viral
infections. It works by stopping
certain viruses from growing in the
body.
GANCICLOVIR SXP 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.
GANCICLOVIR SXP helps control
CMV eye infections in AIDS
patients and in other patients who
have poor immunity, which if left
untreated can cause blindness.
GANCICLOVIR SXP it is not a
cure for CMV eye infections and is
not effective against any underlying
HIV- infection.
GANCICLOVIR SXP may also be
used to treat CMV lung infections in
bone marrow transplant patients.
GANCICLOVIR SXP 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
GANCICLOVIR SXP HAS BEEN
PRESCRIBED FOR YOU.
Your doctor, however, may have
prescribed GANCICLOVIR SXP
for another purpose.
GANCICLOVIR SXP is not
addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
GANCICLOVIR SXP
Animal and other laboratory studies
have shown GANCICLOVIR SXP
has caused infertility, birth defects
and cancer. It is possible that these
effects may als

Preparatomtale

AUSTRALIAN PRODUCT
INFORMATION
GANCICLOVIR SXP
(GANCICLOVIR)
1
NAME OF THE MEDICINE
Ganciclovir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ganciclovir SXP 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 _
Ganciclovir SXP (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: _Ganciclovir SXP (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 Ganciclovir SXP sterile powder is for IV administration
only.
Intravenous Administration
Ganciclovir
SXP
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).
Ganciclovir SXP must only be administered by IV infusion over 1 hour,
preferably via a plastic
cannula into a vein with adequate blood flow