Ganciclovir SXP

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Ganciclovir sodium 543mg equivalent to 500 mg ganciclovir

Prieinama:

Southern Cross Pharma NZ Ltd

Dozė:

500 mg

Vaisto forma:

Powder for injection

Sudėtis:

Active: Ganciclovir sodium 543mg equivalent to 500 mg ganciclovir

Recepto tipas:

Prescription

Terapinės indikacijos:

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.

Produkto santrauka:

Package - Contents - Shelf Life: Vial, glass, Type 1 glass Vial with grey chlorobutyl rubber stopper - 5 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Leidimo data:

2019-09-23

Pakuotės lapelis

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 a

Prekės savybės

NEW ZEALAND DATA SHEET
Ganciclovir SXP DS v3 180221
Page 1 of 26
1.
PRODUCT NAME
Ganciclovir SXP 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.
Ganciclovir SXP 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 from
ganciclovir sodium.
Ganciclovir SXP contains no excipients.
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
Ganciclovir SXP 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 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
Ganciclovir
SXP
must
be
reconstituted
and
diluted
under
the
supervision
of
a
healthcare
professional and administered as an intravenous infusion (SEE SECTION
4.2).
Caution: Ganciclovir SXP 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 solu