FOSCAVIR INFUSION 24 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

FOSCARNET TRISODIUM HEXAHYDRATE

Available from:

LINK HEALTHCARE SINGAPORE PTE LTD

ATC code:

J05AD01

Dosage:

24 mg/ml

Pharmaceutical form:

INJECTION

Composition:

FOSCARNET TRISODIUM HEXAHYDRATE 24 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Fresenius Kabi Austria GmbH

Authorization status:

ACTIVE

Authorization date:

1995-06-29

Patient Information leaflet

 
FOSCAVIR

 Infusion 24 mg/ml 
Solution for infusion 
COMPOSITION  
Solution for intravenous infusion. 
1
ml contains 24 mg (80 μmol) foscarnet trisodium hexahydrate*,
hydrochloride acid q.s. and 
water for injection q.s. The solution is sterile, clear and
isotonic with a pH of 7.4. 
*foscanet sodium (rINN) or trisodium phosphonoformate hexahydrate or phosphonoformic 
acid trisodium salt hexahydrate. 
DESCRIPTION 
Antiviral and pharmacological properties 
Foscarnet is an antiviral agent with a broad antiviral
spectrum which inhibits all known human 
viruses of the herpes group, herpes simplex virus type 1 and
2, human herpes virus 6, varicella 
zoster virus, Epstein-Barr virus and cytomegalovirus (CMV) and
some retroviruses, including 
human
immunodeficiency virus (HIV) at concentrations not affecting normal cell growth. 
Foscarnet also inhibits the viral
DNA polymerase from hepatitis B virus. Foscarnet exerts its 
antiviral activity by a direct inhibition of viral
specific DNA polymerase and reverse 
transcriptase.  
The mean FOSCAVIR 50% inhibition value (ID50) for more than
one hundred clinical CMV 
isolates is approximately 270 μmol/l,
while a reversible inhibition of normal cell growth was 
observed at about 1000 μmol/l. 
In several animal species foscarnet is rapidly cleared from the
blood and other soft tissues 
after intravenous administration.  
The most pronounced effects noted
during general toxicity studies performed with Foscavir 
are perturbation of some serum electrolytes, and kidney and
bone changes. 
An observed reduction
of serum electrolytes such as calcium and magnesium can be
explained 
by the property of Foscavir to form chelate with
divalent metal ions. The reduction of ionized 
calcium and magnesium is, most probably, the explanation to
seizures/convulsions seen 
during and shortly aft

Summary of Product characteristics

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FOSCAVIR

INFUSION 24 MG/ML
Solution for infusion
COMPOSITION
Solution for intravenous infusion.
1 ml contains 24 mg (80 μmol) foscarnet trisodium hexahydrate*,
hydrochloride acid (E507)
q.s. and water for injection q.s. The solution is sterile, clear and
isotonic with a pH of 7.4.
*foscarnet sodium (rINN) or trisodium phosphonoformate hexahydrate or
phosphonoformic
acid trisodium salt hexahydrate.
DESCRIPTION
ANTIVIRAL AND PHARMACOLOGICAL PROPERTIES
Foscarnet is an antiviral agent with a broad antiviral spectrum which
inhibits all known human
viruses of the herpes group, herpes simplex virus type 1 and 2, human
herpes virus 6, varicella
zoster virus, Epstein-Barr virus and cytomegalovirus (CMV) and some
retroviruses, including
human immunodeficiency virus (HIV) at concentrations not affecting
normal cell growth.
Foscarnet also inhibits the viral DNA polymerase from hepatitis B
virus. Foscarnet exerts its
antiviral activity by a direct inhibition of viral specific DNA
polymerase and reverse
transcriptase.
The mean Foscavir 50% inhibition value (IC
50
) for more than one hundred clinical CMV
isolates is approximately 270 μmol/l, while a reversible inhibition
of normal cell growth was
observed at about 1000 μmol/l.
In several animal species foscarnet is rapidly cleared from the blood
and other soft tissues after
intravenous administration.
The most pronounced effects noted during general toxicity studies
performed with Foscavir are
perturbation of some serum electrolytes, and kidney and bone changes.
An observed reduction of serum electrolytes such as calcium and
magnesium can be explained
by the property of Foscavir to form chelate with divalent metal ions.
The reduction of ionized
calcium and magnesium is, most probably, the explanation to
seizures/convulsions seen during
and shortly after the infusion of high doses of Foscavir. This
reduction may also have a bearing
on heart function (e.g. ECG) although the toxicological studies
performed did not disclose any
such effects. The rate of infusion