Stelfonta

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

tigilanol tiglate

Available from:

QBiotics Netherlands B.V.

ATC code:

QL01XX

INN (International Name):

tigilanol tiglate

Therapeutic group:

Dogs

Therapeutic area:

tigilanol tiglate

Therapeutic indications:

For the treatment of non-resectable, non-metastatic (WHO staging) subcutaneous mast cell tumours located at or distal to the elbow or the hock, and non-resectable, non metastatic cutaneous mast cell tumours in dogs.

Product summary:

Revision: 1

Authorization status:

Authorised

Authorization date:

2020-01-15

Patient Information leaflet

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
STELFONTA 1 MG/ML SOLUTION FOR INJECTION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
QBiotics Netherlands B.V.
Prinses Margrietplantsoen 33
2595 AM The Hague
Netherlands
Manufacturer responsible for batch release:
Virbac
1
ère
avenue
2065m L I D
06516 Carros
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
STELFONTA 1 mg/ml solution for injection for dogs
Tigilanol tiglate
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
ACTIVE SUBSTANCE:
Tigilanol tiglate
1 mg
4.
INDICATION(S)
For the treatment of non-resectable, non-metastatic (WHO staging)
subcutaneous mast cell tumours
located at or distal to the elbow or the hock, and non-resectable,
non-metastatic cutaneous mast cell
tumours in dogs. Tumours must be less than or equal to 8 cm
3
in volume, and must be accessible to
intratumoral injection.
5.
CONTRAINDICATIONS
In order to minimise product leakage from the tumour surface upon
injection, do not use in mast cell
tumours with a broken surface.
Do not administer the product directly into the surgical margins
following the surgical removal of a
tumour.
6.
ADVERSE REACTIONS
Manipulation of mast cell tumours may cause the tumour cells to
degranulate. Degranulation can
result in swelling and redness at and around the tumour site as well
as systemic clinical signs,
including stomach ulceration and bleeding and potentially
life-threatening complications, including
hypovolemic shock and/or a systemic inflammatory response. In order to
reduce the occurrence of
20
local and systemic adverse events related to mast cell degranulation
and histamine release, all treated
dogs must be provided with concomitant supportive therapies,
consisting of corticosteroids and H1
and H2 receptor blocking agents, both before and after treatment.
Formation of wounds is an intended reaction to treatment and is
expected follo

Summary of Product characteristics

1
ANNEX I
SUMMARY PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
STELFONTA 1 mg/ml solution for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tigilanol tiglate
1 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of non-resectable, non-metastatic (WHO staging)
subcutaneous mast cell tumours
located at or distal to the elbow or the hock, and non-resectable,
non-metastatic cutaneous mast cell
tumours in dogs.
Tumours must be less than or equal to 8 cm
3
in volume, and must be accessible to intratumoral
injection.
4.3
CONTRAINDICATIONS
In order to minimise product leakage from the tumour surface upon
injection, do not use in mast cell
tumours with a broken surface.
Do not administer the product directly into the surgical margins
following the surgical removal of a
tumour.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The effect of STELFONTA on mast cell tumours is restricted to the
location of injection, as it is not
systemically active. STELFONTA should therefore not be used in case of
metastatic disease.
Treatment does not prevent the development of
_de novo_
mast cell tumours.
Treatment causes a change in the tissue architecture. It is therefore
unlikely that an accurate
histological tumour grading can be obtained after treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
3
The product must strictly be administered intratumorally, as other
routes of injections are associated
with adverse reactions. Unintentional intravenous (IV) administration
should be avoided at all times,
since this is expected to cause severe systemic effects. After
injection of tigilanol tiglate into the
subcutaneous tissues, even at low concentrations/doses, treated dogs
exhibited restlessness and
vocalisation, as well as severe lo