IMLYGIC 10^ 6 PFUML

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

TALIMOGENE LAHERPAREPVEC

Saatavilla:

AMGEN EUROPE B.V.

ATC-koodi:

L01XX51

Lääkemuoto:

SOLUTION FOR INJECTION

Koostumus:

TALIMOGENE LAHERPAREPVEC 10^6 PFU / 1 ML

Antoreitti:

INTRA-LESIONAL

Prescription tyyppi:

Required

Valmistaja:

AMGEN EUROPE B.V., NETHERLANDS

Terapeuttinen alue:

TALIMOGENE LAHERPAREPVEC

Käyttöaiheet:

Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic ( stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.

Valtuutus päivämäärä:

2018-02-12

Pakkausseloste

טסוגוא
9
201
PFU/ML
8
, 10
6
IMLYGIC 10
SOLUTION FOR INJECTION
,ה/דבכנ ת/חקור ,ה/דבכנ ה/אפור
לע ךעידוהל תשקבמ ,םושירה תלעב ,יו יב
הפוריא ן'גמא
ולעב םינוכדע
אפורל ן
רישכתל
קי'גיילמיא
6
10
,
8
10
.
.דבלב תורמחהה תונייוצמ וז העדוהב
:תורשואמה תויוותהה
Imlygic is indicated for the treatment of adults with unresectable
melanoma that is
regionally or distantly metastatic (stage IIIB, IIIC and IVM1a) with
no bone, brain,
lung or other visceral disease.
ןוכדע
:אפורל ןולעב
5.2
PHARMACOKINETIC PROPERTIES
Biodistribution (within the body) and viral shedding
(excretion/secretion)
Pharmacokinetic properties updated to include information based on the
final results
from study 20120324.
תופורתה רגאמב םוסרפל חלשנ ןכדועמה
אפורל ןולעה
ב
ולבקל ןתינו ,תואירבה דרשמ רתא
םג
לע
-
ץיפמל הינפ ידי
ה
תרבח ,הפורתה לש ימוקמ
ןוסידמ
.המראפ
:תוחוקל תורש
[e-mail]
-
Medison
ןופלט
:
*5634
רבב
הכ
,
רוד ןב לגיס
הנוממ תחקור

Valmisteyhteenveto

1
_ _
_Revised in December 2020._
1.
NAME OF THE MEDICINAL PRODUCT
Imlygic
_ _
10
6
plaque forming units (PFU)/mL solution for injection
Imlygic
_ _
10
8
plaque forming units (PFU)/mL solution for injection
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Talimogene laherparepvec is an attenuated herpes simplex virus type-1
(HSV-1) derived by functional
deletion of 2 genes
(
ICP34.5 and ICP47) and insertion of coding sequence for human
granulocyte
macrophage colony-stimulating factor (GM-CSF) (see section 5.1).
_ _
Talimogene laherparepvec is produced in Vero cells by recombinant DNA
_ _
technology.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imlygic
_ _
10
6
plaque forming units (PFU)/mL solution for injection
Each vial contains 1 mL deliverable volume of Imlygic at a nominal
concentration of 1 × 10
6
(1 million) plaque forming units (PFU)/mL.
Imlygic
_ _
10
8
plaque forming units (PFU)/mL solution for injection
Each vial contains 1 mL deliverable volume of Imlygic at a nominal
concentration of 1 × 10
8
(100 million) plaque forming units (PFU)/mL.
Excipient with known effect
Each 1 mL vial contains 7.7 mg sodium and 20 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Imlygic
_ _
10
6
plaque forming units (PFU)/mL solution for injection
Clear to semi-translucent liquid following thaw from its frozen state.
It may contain white, visible, variously shaped, virus-containing
particles.
Imlygic
_ _
10
8
plaque forming units (PFU)/mL solution for injection
Semi-translucent to opaque liquid following thaw from its frozen
state.
It may contain white, visible, variously shaped, virus-containing
particles.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imlygic is indicated for the treatment of adults with unresectable
melanoma that is regionally or
distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain,
lung or other visceral disease
(see sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment