Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
tigilanol tiglate
QBiotics Netherlands B.V.
QL01XX
tigilanol tiglate
Dogs
tigilanol tiglate
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.
Revision: 1
Authorised
2020-01-15
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 Belgenin tamamını okuyun
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 Belgenin tamamını okuyun