Valcyte 450mg tablets film-coated

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

valganciclovir (valganciclovir hydrochloride)

זמין מ:

F. Hoffmann-La Roche Ltd

קוד ATC:

J05AB14

INN (שם בינלאומי):

valganciclovir (valganciclovir hydrochloride)

כמות:

450mg

טופס פרצבטיות:

tablets film-coated

יחידות באריזה:

(60) plastic container

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2015-03-19

עלון מידע

VALCYTE
®
Valganciclovir
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antiviral
ATC code: J05AB14
1.2
TYPE OF DOSAGE FORM
Film-coated tablet
Powder for oral solution
1.3
ROUTE OF ADMINISTRATION
Oral
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
valganciclovir (as valganciclovir hydrochloride).
Film-coated tablets: 450 mg.
Powder for oral solution: 50 mg/ml.
_Excipients:_
Tablet:
_Tablet core_
: povidone, crospovidone, microcrystalline cellulose, stearic
acid powder.
_Tablet coat_
: hydroxypropyl methylcellulose, titanium dioxide (E171),
polyethylene glycol, red iron oxide (E172), polysorbate.
Powder:
1 ml of reconstituted solution contains 50 mg valganciclovir
(as hydrochloride).
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Valcyte is indicated for the treatment of cytomegalovirus (CMV)
retinitis in adult patients with acquired immunodeficiency
syndrome (AIDS).
Valcyte is indicated for the prevention of CMV disease in adult and
pediatric solid organ transplant (SOT) patients who are at risk.
2.2
DOSAGE AND ADMINISTRATION
Caution – Strict adherence to dosage recommendations is essential to
avoid overdose.
STANDARD DOSAGE
Valcyte is administered orally, and should be taken with food (see
sections 3.2.1 Absorption and 3.2.5 Pharmacokinetics in Special
Populations).
Valcyte is rapidly and extensively converted into the active
ingredient
ganciclovir. The bioavailability of ganciclovir from Valcyte is up to
10-fold higher than from oral ganciclovir.
The dosage and administration of Valcyte tablets or powder for oral
solution as described below should be closely followed (see sections
2.4 Warnings and Precautions and 2.7 Overdose).
The ganciclovir systemic exposure following administration of 900 mg
Valcyte powder for oral solution is equivalent to a 900 mg Valcyte
dose
administered as two 450 mg tablets.
An oral dosing dispenser with 25 mg graduations up to 500 mg is
provided with the powder for oral solution. It is recom

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Valcyte 450 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 496.3 mg of valganciclovir
hydrochloride equivalent to 450 mg of
valganciclovir (as free base).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Pink, convex oval film-coated tablets, with “VGC” embossed on one
side and “450” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Valcyte is indicated for the induction and maintenance treatment of
cytomegalovirus (CMV) retinitis
in adult patients with acquired immunodeficiency syndrome (AIDS).
Valcyte is indicated for the prevention of CMV disease in CMV-negative
adults and children (aged
from birth to 18 years) who have received a solid organ transplant
from a CMV-positive donor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CAUTION – STRICT ADHERENCE TO DOSAGE RECOMMENDATIONS IS ESSENTIAL TO
AVOID OVERDOSE (SEE
SECTIONS 4.4_ _AND 4.9).
Valganciclovir is rapidly and extensively metabolised to ganciclovir
after oral dosing. Oral
valganciclovir 900 mg b.i.d. is therapeutically equivalent to
intravenous ganciclovir 5 mg/kg b.i.d.
TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS
_Adult patients _
_Induction treatment of CMV retinitis _
_ _
For patients with active CMV retinitis, the recommended dose is 900 mg
valganciclovir (two Valcyte
450 mg tablets) twice a day for 21 days and, whenever possible, taken
with food. Prolonged induction
treatment may increase the risk of bone marrow toxicity (see section
4.4).
_Maintenance treatment of CMV retinitis: _
Following induction treatment, or in patients with inactive CMV
retinitis, the recommended dose is
900mg valganciclovir (two Valcyte 450 mg tablets) once daily and,
whenever possible, taken with
food. Patients whose retinitis worsens may repeat induction treatment;
however, consideration should
be given to the possibility of vi