FOSCAVIR 24 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FOSCARNET TRISODIUM HEXAHYDRATE

Available from:

MEGAPHARM LTD

ATC code:

J05AD01

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

FOSCARNET TRISODIUM HEXAHYDRATE 24 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI AUSTRIA GmbH

Therapeutic group:

FOSCARNET

Therapeutic area:

FOSCARNET

Therapeutic indications:

Treatment of CMV retinitis in patients with aquired immunodeficiency syndrome (AIDS).

Authorization date:

2015-11-30

Patient Information leaflet

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
ןכדועמ(
05.2013
) :ךיראת
08 רבמטפס
2014 :םושירה רפסמו תילגנאב רישכת םש
FOSCAVIR 24MG/ML NO. 068-16-28118 :םושירה לעב םש
מ"עב הרביל-םראפ-וא-קט
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
תפסוה BLACK BOX
WARNING
RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF
FOSCAVIR. FREQUENT
MONITORING OF SERUM CREATININE, WITH DOSE
ADJUSTMENT FOR
CHANGES IN RENAL FUNCTION, AND ADEQUATE
HYDRATION WITH
ADMINISTRATION OF FOSCAVIR IS IMPERATIVE. (See
ADMINISTRATION s ection
;
Hydration
(.
SEIZURES, RELATED TO ALTERATIONS IN PLASMA
MINERALS AND
ELECTROLYTES, HAVE BEEN ASSOCIATED WITH
FOSCAVIR TREATMENT
.
THEREFORE, PATIENTS MUST BE CAREFULLY
MONITORED FOR SUCH
CHANGES AND THEIR POTENTIAL SEQUELAE.
MINERAL AND ELECTROLYTE
SUPPLEMENTATION MAY BE REQUIRED
.
FOSCAVIR IS INDICATED FOR USE ONLY IN
IMMUNOCOMPROMISED PATIENTS
WITH CMV RETINITIS (See INDICATIONS s ection)
CONTRAINDICATIONS
POSOLOGY, DOSAGE
& ADMINISTRATION
SPECIAL WARNINGS
AND SPECIAL
PRECAUTIONS FOR USE
-
Due to the sodium content of Foscavir )240
micromoles )5.5 mg( of sodium per ml(, it’s use
should be avoided when a saline load cannot be
tolerated )e.g. in cardiomyopathy(. This should also
be taken into consideration by patients on a
controlled sodium diet.
Seizures, related to alterations in plasma minerals
and electrolytes, have been associated with Foscavir
treatment. Therefore, patients must be carefully
monitored for such changes and their potential
sequelae. Mineral and electrolyte supplementation
may be required.
Should patients experience extremity paresthesia or
nausea, it is recommended to reduce the speed of
infusion.
INTERACTION WITH
OTHER MEDICAMENTS
AND OTHER FORMS OF
INTERACTION
Since Foscavir can impair renal
function, additive toxicity may occur
when used in combination with other
nephrotoxic drugs such as
amin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FOSCAVIR 24MG/ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Foscarnet trisodium hexahydrate 24mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for intravenous Infusion (I.V)
Clear and colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of CMV retinitis in patients with acquired immunodeficiency
syndrome
(AIDS).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Foscarnet should be administered by the
intravenous route
only, either by a central venous line or in a peripheral vein.
When peripheral veins are used, the solution of foscarnet 24mg/ml must
be diluted.
Individually dispensed doses of foscarnet should be aseptically
transferred and diluted
with equal parts of 0.9% sodium chloride (9mg/ml) or 5% dextrose
(50mg/ml) by the
hospital pharmacy. The diluted solutions should be used as soon as
possible after
preparation but can be stored for up to 24 hours if kept refrigerated.
The solution of foscarnet 24mg/ml may be given without dilution via a
central vein.
WARNING
Renal impairment is the major toxicity of Foscavir 24mg/ml. Frequent
monitoring of
serum creatinine, with dose adjustment for changes in renal function,
and adequate
hydration with administration of Foscavir 24mg/ml is imperative (see
administration
section: Hydration).
Seizures, related to alterations in plasma minerals and electrolytes,
have been
associated with Foscavir 24mg/ml treatment. Therefore, patients must
be carefully
monitored for such changes and their potential sequelae. Mineral and
electrolyte
supplementation may be required. Foscavir 24mg/ml is indicated for use
only in
immunocompromised patients with CMV retinitis (see Indications
section).
Adults: Induction therapy for CMV retinitis: Foscavir 24mg/ml is
administered over 2-
3 weeks depending on the clinical response, as intermittent infusions
every 8 hours at
a
dose
of
60mg/kg
in
patients
with
normal
renal
function.
Dosage
must
b