STELFONTA

Nazione: Australia

Lingua: inglese

Fonte: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Principio attivo:

TIGILANOL TIGLATE

Commercializzato da:

QBIOTICS GROUP LIMITED

Forma farmaceutica:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composizione:

TIGILANOL TIGLATE ESTER Active 1.0 mg/ml

Confezione:

2 mL

Classe:

VM - Veterinary Medicine

Area terapeutica:

ANTI-NEOPLASTIC AGENT

Dettagli prodotto:

Poison schedule: 4; Withholding period: ; Host/pest details: DOG - OLDER THAN 12 MONTHS: [CUTANEOUS MAST CELL TUMOURS – NON-METATSTATIC., SUBCUTANEOUS MAST CELL TUMOURS - LOCATED AT OR DISTAL TO THE ELBOW OR THE HOCK]

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2023-07-01

Foglio illustrativo

Product Name:
APVMA Approval No:
Stelfonta
88412/121236
Label Name:
STELFONTA
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
Constituent
Statements:
Tigilanol tiglate 1 mg/mL
Claims:
For the treatment of non-metastatic (WHO staging):
1. cutaneous mast cell tumours (located anywhere on the body, legs or
head in dogs), and
2. non-metastatic subcutaneous mast cell tumours located at or distal
to the elbow or hock
in dogs.
Tumours may be of any cytological grade, must be less than or equal to
10 cm
3
in volume,
and must be accessible to intratumoral injection.
Net Contents:
2 mL
Directions for Use:
Restraints:
DO NOT ADMINISTER by intravenous, intramuscular or subcutaneous
injection.
Contraindications:
Precautions:
The safety of STELFONTA
®
has not been established in dogs that are less than 12
months of age, are pregnant, lactating, or intended for breeding. The
use of STELFONTA
®
is not recommended in these cases.
Provide all patients with essential concomitant medications before and
after treatment to
minimise the risk of degranulation associated with any manipulation of
a mast cell tumour. RLP APPROVED
Owners should be advised to check for signs of potential mast cell
degranulation reactions.
These include vomiting, anorexia, severe pain, lethargy, inappetence
or extensive swelling.
If signs of degranulation are observed the treating veterinarian
should be contacted such
that appropriate treatment can be started immediately.
Special care should be taken when treating tumours in mucocutaneous
locations. Treating
tumours on the eyelids, vulva, preputial opening, anus and mouth can
lead to loss of tissue
in these areas that can affect the functionality of the treated site.
The product is an irritant,
use of the product in the proximity of sensitive tissues, in
particular the eye, should be
avoided.
Side Effects:
Treatment with STELFONTA
®
induces substantial local inflammatory reaction for
approximately 7 days. Com