Imlygic 1million plaque forming units1ml solution for injection vials

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Talimogene laherparepvec

Tillgänglig från:

Amgen Ltd

ATC-kod:

L01XX51

INN (International namn):

Talimogene laherparepvec

Dos:

1mega u/1ml

Läkemedelsform:

Solution for injection

Administreringssätt:

Intralesional

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 08010500; GTIN: 8715131010133

Bipacksedel

1
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
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
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.
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. Imlygic
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 severely

Produktens egenskaper

OBJECT 1
IMLYGIC
Summary of Product Characteristics Updated 03-Jul-2018 | Amgen Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 4 mL dose contains approximately 30 mg (1.3 mmol) sodium and 80
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.
4. Clinical particulars
4.1 Therapeutic indicati