Imlygic

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

talimogene laherparepvec

זמין מ:

Amgen Europe B.V.

קוד ATC:

L01XX51

INN (שם בינלאומי):

talimogene laherparepvec

קבוצה תרפויטית:

Antineoplastic agents

איזור תרפויטי:

Melanoma

סממני תרפויטית:

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.

leaflet_short:

Revision: 13

מצב אישור:

Authorised

תאריך אישור:

2015-12-16

עלון מידע

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMLYGIC 10
6 PLAQUE FORMING UNITS (PFU)/ML SOLUTION FOR INJECTION
IMLYGIC 10
8 PLAQUE FORMING UNITS (PFU)/ML SOLUTION FOR INJECTION
talimogene laherparepvec
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your healthcare professional
(doctor or nurse).
-
If you get any side effects, talk to your healthcare professional.
This includes any possible side
effects not listed in this leaflet. See section 4.
-
Your doctor will give you a Patient Alert Card. Read it carefully and
follow the instructions on
it.
-
Always show the Patient Alert Card to your doctor or nurse when you
see them or if you go to
hospital.
WHAT IS IN THIS LEAFLET
1.
What Imlygic is and what it is used for
2.
What you need to know before and during Imlygic treatment
3.
How Imlygic is given
4.
Possible side effects
5.
How Imlygic is stored
6.
Contents of the pack and other information
1.
WHAT IMLYGIC IS AND WHAT IT IS USED FOR
Imlygic is used to treat adult patients with a type of skin cancer
called melanoma that has spread in the
skin or to the lymph nodes, when surgery is not an option.
The active ingredient of Imlygic is talimogene laherparepvec. This is
a weakened form of herpes
simplex virus type-1 (HSV-1), which is commonly called the cold sore
virus. To get Imlygic from
HSV-1, the virus has been changed so that it multiplies more
effectively in tumours than in normal
cells. This leads to destruction of infected tumour cells. This
medicine also works by helping your
immune system to recognise and destroy tumours throughout your body.
2.
WHAT YOU NEED TO KNOW BEFORE AND DURING IMLYGIC TREATMENT
_ _
YOU WILL NOT BE GIVEN IMLYGIC:
-
if you are allergic to talimogene laherparepvec or any of the other
ingredients of this medicine
(listed in section 6).
-
if your healthcare professional has told you that you have a

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
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 x 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 x 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.
3
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 with talimoge