FOSCAVIR foscarnet sodium 6g/250mL injection bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

foscarnet sodium, Quantity: 24 mg/mL

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

Foscarnet sodium

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid

Administration route:

Intravenous

Units in package:

250mL X 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of cytomegalovirus (CMV) retinitis in patients with the acquired immunodeficiency syndrome (AIDS). INDICATIONS AS AT 11 NOVEMBER 1994: For treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS); and treatment of aciclovir resistant herpes simplex virus (HSV) infections (defined by clinical trial or in-vitro resistance) in immunocompromised patients with human immunodeficiency virus (HIV) infection. NOTE: the indication for treatment of aciclovir resistant HSV infections in immunocompromised patients with HIV infections is based primarily on the results of one open label comparative study. This was of patients with HIV infections and herpetic lesions unresponsive to aciclovir administered intravenously for 10 days or more and in-vitro documented resistance to aciclovir. Eight patients were randomised to foscarnet (40mg/kg IV given eight hourly) and 6 were randomised to vidarabine 15mg/kg IV daily. The results showed a significant difference in favour o

Product summary:

Visual Identification: A clear colourless solution.; Container Type: Bottle; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1992-09-29

Patient Information leaflet

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 virus (HSV).
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
FOSCAVIR SHOULD NOT BE GIVEN TO
CHILDREN.
Safety and effectiveness in children
have not been established.

Summary of Product characteristics

FOSCAVIR solution for infusion Product Information – V6
1
AUSTRALIAN PRODUCT INFORMATION -
FOSCAVIR
®
(FOSCARNET SODIUM HEXAHYDRATE) SOLUTION
FOR INJECTION
1. NAME OF THE MEDICINE
Foscarnet sodium hexahydrate.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Intravenous infusion solution containing 6 g foscarnet sodium
hexahydrate (24 mg/mL) in 250 mL.
A clear, sterile, isotonic solution of foscarnet sodium in Water for
Injections, adjusted to pH 7.4 with hydrochloric
acid. No preservatives or buffers are contained in FOSCAVIR.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICLUARS
4.1 THERAPEUTIC INDICATIONS
FOSCAVIR is indicated for:
•
Treatment of cytomegalovirus (CMV) retinitis in patients with the
acquired immunodeficiency syndrome
(AIDS).
•
Treatment of aciclovir resistant herpes simplex virus (HSV) infections
(defined by clinical trial or _in vitro _
resistance) in immunocompromised patients with human immunodeficiency
virus (HIV) infection.
NOTE: The indication for treatment of aciclovir resistant HSV
infections in immunocompromised patients with HIV
infections is based primarily on the results of one open label
comparative study. This was of patients with HIV
infections and herpetic lesions unresponsive to aciclovir administered
intravenously for 10 days or more and i_n vitro _
documented resistance to aciclovir. Eight patients were randomised to
foscarnet (40 mg/kg IV given eight hourly)
and 6 were randomised to vidarabine 15 mg/kg IV daily. The results
showed a significant difference in favour of the
foscarnet treatment group for clinical and virological endpoints,
especially in time to complete healing of lesions and
time to complete loss of pain. In 177 other patients treated with
foscarnet in non-comparative studies, results were
sufficiently similar to support the efficacy of foscarnet in this
indication.
4.2 DOSE AND METHOD OF ADMINISTRATION
CONTACT WITH THE SKIN AND EYES MAY CAUSE LOCAL IRRITATION AND A
BURNING