![]() ![]() Monitor your dog during the healing process and contact your veterinarian if you notice excessive pain, lameness, tiredness, refusal to eat for more than one day, repeated vomiting or diarrhea, trouble breathing, changes to the treated tumor site (including increased or excessive swelling and bruising, extensive wound formation, increased irritation) or any other symptoms that concern you. Ensure your dog receives their prescribed medications to decrease the potential for severe, life-threatening adverse reactions. Thoroughly wash your skin that comes in contact with the treated tumor site, wound, or wound discharge. Wear disposable gloves when cleaning the treated tumor site to avoid contact with any residual drug. For full prescribing information, contact VIRBAC at 1-80 or view the Product Insert. Formation of wounds, possibly extensive, is an intended and likely response to treatment with STELFONTA along with associated swelling, bruising and pain these wounds are expected to heal. Appropriate pre- and post-treatment medications must be given, including a corticosteroid plus blocking agents for both H1 and H2 receptors, in order to decrease the potential for severe systemic adverse reactions, including death, from mast cell degranulation. To decrease the risk of accidental self-injection, sedation of the dog may be necessary. In dogs, do not inject STELFONTA into subcutaneous mast cell tumors located above the elbow or hock. Treatment with STELFONTA has been associated with cellulitis and severe tissue sloughing extending away from the treated site resulting in extensive wounds that require additional treatment and prolonged recovery times (see Warnings, Precautions and Adverse Events).Īccidental self-injection of STELFONTA ® may cause severe wound formation.This may result in accumulation of necrotic debris in the subcutaneous space increasing the risk of systemic adverse reactions, including death, from mast cell degranulation (see Contraindications, Warnings and Adverse Events). Do not inject STELFONTA into subcutaneous mast cell tumors located above the elbow or hock (e.g.famotidine) when treating with STELFONTA to decrease the potential for severe systemic adverse reactions, including death, from mast cell degranulation (see Contraindications and Dosage and Administration). diphenhydramine), and an H2 receptor blocking agent (e.g. prednisone or prednisolone), an H1 receptor blocking agent (e.g. Always administer a corticosteroid (e.g.To decrease the risk of accidental self-injection, sedation of the dog may be necessary (see Dosage and Administration, Human Warnings and Adverse Reactions). Accidental self-injection of STEL FONTA ® may cause severe wound formation.WARNING: SEVERE WOUND FORMATION IN HUMANS EXTENSIVE WOUND FORMATION, MAST CELL DEGRANULATION, AND DEATH IN DOGS DUE TO MAST CELL DEGRANULATION Where possible, patients were assessed at 12 months for tumor recurrence.įor information on contraindications and warnings, Patients that achieved a complete response at Day 28 in either phase were followed for 12 weeks after the final treatment. All patients in both the STEL FONTA ® treated and the control group received concurrent medications. Patients in the STEL FONTA ® treated or the control group that did not achieve a complete response at Day 28 were eligible to receive a second treatment or a first treatment if the patient was in the original control group. Dogs in the STEL FONTA ® group were treated once at the start of the study, in addition to receiving concurrent medications. Effectiveness was evaluated using response evaluation criteria in solid tumors (RECIST), where complete response was defined as complete removal of the tumor. Study design: A multi-center, randomized, controlled, investigator- and owner-masked clinical study in 123 client-owned dogs with MCT measuring ≤10cm3. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |