Stelfonta 1 mg/ml Solution for Injection for Dogs

required, based on clinical assessment by the veterinarian. Any bandaging
used must be loose to allow for anticipated local oedema.
Treating tumours in mucocutaneous locations (eyelids, vulva, preputial
opening, anus, mouth) and at the extremities (e.g. paws, tail) could impair
functionality. Additionally, there may be a requirement for some normal tissue
resection or amputation of extremities, due to impairment of circulation caused
by a local inflammatory response.
The product is an irritant; therefore, use of the product in the proximity of
sensitive tissues, in particular the eye, should be avoided.
In order to reduce the occurrence of 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 (see
section 4.9).
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 straight away, so that
appropriate treatment can be started immediately.

Revised: January 2025
AN: 02179/2024
Following treatment, drinking water should always be available.
The safety of the product has not been established in dogs that are less than
12 months of age.
Tumours that lie completely in the subcutaneous tissue with no dermal
involvement may have difficulty in creating an exit site for necrotic tissue
removal. This may necessitate an incision to allow for drainage of necrotic
tissue.
The product is to be administered only by a veterinarian.
ii). Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Special precautions to be taken by the professional user (veterinarian):
Veterinarians should inform the pet owner about the special precautions to be
taken at home.
People with known hypersensitivity to tigilanol tiglate or to propylene glycol
should avoid contact with the product. The product is an irritant and potentially
a skin sensitiser.
Accidental self-injection may result in severe local inflammatory reactions,
including pain, swelling, redness and potential wound formation/necrosis, which
may take several months to resolve. Caution is required during treatment to
avoid self-injection. Dogs undergoing treatment with the product should be
adequately restrained, including by sedation if necessary. Use a Luer lock
syringe to administer the product. In case of accidental self-injection, seek
medical advice immediately and show the package insert to the physician.
Accidental exposure to skin, eye, or by ingestion should be avoided. Leakage
of the product from the site of injection may occur directly after administration.
Personal protective equipment consisting of disposable impervious gloves and
protective eye glasses should be worn when handling the product and/or
touching the site of injection. In case of dermal or ocular exposure, repeatedly
wash the exposed skin or eye with water. If symptoms such as local signs of
redness and swelling occur, or if there has been ingestion, seek the advice of a
physician and show them the package leaflet.
The safety of the veterinary medicinal product has not been established during
pregnancy or lactation. Pregnant women and breastfeeding women should take
care to avoid accidental self-injection, contact with the injection site, leaking
product and tumour debris.

Revised: January 2025
AN: 02179/2024
Special precautions to be taken by the animal owner:
Low levels of tigilanol tiglate residues might be present in the wound debris. In
case of severe leakage of wound debris, which may occur in the first weeks
following administration of the product, the wound should be covered. If
however covering the wound is contraindicated due to its healing, the dog must
be kept away from children. Wound debris should only be handled with
protective equipment (disposable gloves).
In case of any contact with wound debris, the affected area(s) on the person
should be thoroughly washed. Contaminated areas or bedding should be
thoroughly cleaned/washed.
The safety of the veterinary medicinal product has not been established during
pregnancy or lactation. Pregnant women and breastfeeding women should take
care to avoid contact with the injection site, leaking product and tumour debris.
Special precautions for the protection of the environment:
Not applicable.
iii). Other precautions
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
The following adverse reactions can be observed in dogs:
Very common (>1 animal / 10
animals treated):
Pain upon injection/Injection site pain
2, 3
, Wound at injection site/Injection
site reaction NOS
1, 2, 3
, Injection site
swelling
2, 6
Lameness
2, 3
,
Vomiting
,
Tachycardia
Common (1 to 10 animals / 100
animals treated):
Injection site pain
2, 4
, Wound at
injection site/Injection site reaction
NOS
1, 2, 4
, Injection site infection
,
Injection site erythema
2, 3, 6
, Injection
site bruising
2,
, Injection site oedema
2,
, Scar contraction at injection
ite/Application site scar
, Injection
site ulcer
Behavioural disorder NOS
,
Enlarged lymph node (localised)
,
Diarrhoea
, Stomach ulceration
4, 6
,
Haemorrhagic gastritis
4, 6
,
Anaemia
, Neutrophilia
, Increased
band neutrophils
, Hypoalbuminemia

Revised: January 2025
AN: 02179/2024
, Leucocytosis
, Monocytosis
,
Elevated creatine kinase
Lameness
1, 2, 4
,
New neoplastic mass/Neoplasia NOS
,
Tremor
,
Cystitis
,
Tachypnoea
,
Pruritus
,
Lethargy
3,
, Anorexia
, Decreased
appetite
, Weight loss
, Pyrexia
,
Malaise
Uncommon (1 to 10 animals / 1,000
animals treated):
Injection site nodule
, Loss of
essential tissue/Digit amputation,
Limb amputation, Tail amputation
,
Inappropriate Defecation
,
Haemorrhage
,
Compromised circulation/ Circulatory
disorder NOS
, Tachycardia
,
Regurgitation
, Flatulence
, Melaena
,
Cholestasis/Cholecystitis
,
Hyperkalaemia
, Proteinuria
,
Leucocytosis
, Increased band
neutrophils
, Thrombocytopenia
,
Thrombocytosis
, Elevated alanine
aminotransferase (ALT)
3,
,
Elevated serum alkaline phosphatase
(SAP)
, Elevated total bilirubin
,
Elevated gamma-glutamyl transferase
(GGT)
, Elevated triglyceride
,
Elevated blood urea nitrogen (BUN)
,
Somnolence, Neuropathy NOS
,
Seizure
,
Polyuria
, Urinary incontinence
,
Cellulitis
, Skin slough
, Dermatitis
,
Licking
, Macular rash
, Pruritus
,
Anorexia
, Abrasion
, Decreased
appetite
, Dehydration
, Polydipsia
NOS: not otherwise specified
Formation of wounds is an intended reaction to treatment and is expected
following the use of this veterinary medicinal product in all cases. In the pivotal
field study, a maximum wound surface area was observed at 7 days after
treatment for most patients, although in a small number of cases wound size
increased up to 14 days post treatment. Most wounds were completely re-
epithelised within 28 to 42 days of treatment (with individual cases that healed
by day 84. In most cases, the wound area will increase with increasing tumour
size. However, this is not a reliable predictor for wound size or severity, and

Revised: January 2025
AN: 02179/2024
duration of healing. These wounds resolve by second intention healing with
minimal intervention. Wound management measures may be required as
deemed necessary by the responsible veterinarian. The speed of healing is
related to the size of the wound.
Very commonly and/or commonly reported local adverse events, such as pain
upon injection, pain at injection site, injection site bruising/erythema/oedema,
lameness in a treated limb and wound formation, are related to localised
pathology. The wounds may evolve to cover significantly larger areas than the
original size of the tumour.
Reaction of mild to moderate intensity
Reaction of severe intensity
Enlargement of the draining lymph node of mild to moderate intensity can be
observed.
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
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.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated
reports).
Reporting adverse events is important. It allows continuous safety monitoring of
a veterinary medicinal product. Reports should be sent, preferably via a
veterinarian, to either the marketing authorisation holder or its local
representative, or the national competent authority via the national reporting
system. See also the last section of the package leaflet for contact details.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in dogs
during pregnancy or lactation or in dogs intended for breeding. The use of the
veterinary medicinal product is therefore not recommended in these animals.

Revised: January 2025
AN: 02179/2024
4.8 Interaction with other medicinal products and other forms of interaction
None known.
No specific in

[Text truncated]