Foscavir

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Foscarnet sodium hexahydrate 24 mg/mL

Disponível em:

Link Pharmaceuticals Ltd

DCI (Denominação Comum Internacional):

Foscarnet sodium hexahydrate 24 mg/mL

Dosagem:

24 mg/mL

Forma farmacêutica:

Solution for infusion

Composição:

Active: Foscarnet sodium hexahydrate 24 mg/mL

Unidades em pacote:

Bottle, glass, 250 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

PCAS Finland Oy

Indicações terapêuticas:

Treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Treatment of acyclovir resistant herpes simplex virus (HSV) infections in immunocompromised patients. The safety and efficacy of Foscavir for the treatment of other HSV infections (e.g. retinitis, encephalitis); congenital or neonatal disease; or HSV in immunocompetent individuals has not been established.

Resumo do produto:

Package - Contents - Shelf Life: Bottle, glass, - 250 mL - 24 months from date of manufacture stored at or below 25°C

Data de autorização:

1988-06-08

Folheto informativo - Bula

FOSCAVIR
®
INJECTION
1
FOSCAVIR
®
INJECTION
_Foscarnet sodium. _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Foscavir. It does not contain all the
information that is known about
Foscavir.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor will have weighed the
risks of you being given Foscavir
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 WITH THE MEDICINE.
You may need to read it again.
WHAT IS FOSCAVIR
USED FOR
Foscavir is used to treat infections
caused by two viruses,
Cytomegalovirus
(CMV)
and Herpes
simplex.
These viruses infect different parts of
the body and are most serious if your
body's natural defences to fight
disease are low
(immunocompromised).
Your doctor will have explained what
type of infection you have and where
it is.
Foscavir belongs to a group of
medicines called antivirals.
It is injected into the body where it
interferes with the way viral cells
reproduce themselves and stops them
increasing in number.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may prescribe this
medicine for another use.
Foscavir is not addictive.
It is only available with a doctor's
prescription.
There is not enough information to
recommend the use of Foscavir in
children.
BEFORE YOU ARE GIVEN
FOSCAVIR
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE FOSCAVIR IF YOU HAVE AN
ALLERGY TO:
•
foscarnet
•
any of the ingredients listed at the
end of this leaflet.
SOME OF THE SYMPTOMS OF AN ALLERGIC
REACTION MAY INCLUDE:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
or other parts of the body
•
rash, itching or hives of the skin
TELL YOUR DOCTOR BEFORE YOU ARE
GIVEN FOSCAVIR IF YOU ARE PREGNANT,
INTEND TO BECOME PREGNANT, ARE
BREAST-FEEDING OR INTEN

Características técnicas

FOSCAVIR Infusion Data Sheet
Page 1 of 14
NEW ZEALAND DATA SHEET
1. FOSCAVIR®
24 MG/ML SOLUTION FOR INFUSION.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Foscarnet trisodium hexahydrate 24 mg/mL
3. PHARMACEUTICAL FORM
Solution for infusion.
A
clear,
colourless,
particle-free,
sterile,
isotonic
solution
(pH
7.4)
containing
24 mg/mL (80 µmol/mL) foscarnet trisodium hexahydrate, hydrochloric
acid q.s. and
water q.s.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
•
Treatment
of
cytomegalovirus
(CMV)
retinitis
in
patients
with
acquired
immunodeficiency syndrome (AIDS).
•
Treatment of aciclovir resistant HSV infections in immunocompromised
patients. The
safety and efficacy of FOSCAVIR for the treatment of other HSV
infections (e.g.
retinitis, encephalitis); congenital or neonatal disease; or HSV in
immunocompetent
individuals has not been established.
4.2. DOSE AND METHOD OF ADMINISTRATION
Contact with the skin and eyes may cause local irritation and a
burning sensation. If
accidental contact occurs, the exposed area should be rinsed
immediately with cold
water.
METHOD OF ADMINISTRATION
FOSCAVIR
must be given by the intravenous route only, either via a central
venous
line or directly into peripheral veins.
When peripheral veins are used, FOSCAVIR 24 mg/mL must be diluted with
glucose
(dextrose) 5% or normal saline to a concentration of 12 mg/mL
immediately prior to
administration. (See SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE
regarding total daily sodium intake).
FOSCAVIR 24 mg/mL solution may be given without dilution via a central
vein.
CAUTION - DO NOT ADMINISTER FOSCARNET BY RAPID INTRAVENOUS INJECTION.
FOSCAVIR Infusion Data Sheet
Page 2 of 14
ADULTS
CMV RETINITIS
Induction therapy
Foscarnet
can be administered over 2-3 weeks, depending on clinical response, as
intermittent infusions every 8 hours at a dose of 60 mg/kg in patients
with normal renal
function (see dosing chart below). The infusion time should not be
shorter than one
hour for the 60 mg/kg dose.
The dose of foscarnet should be