País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
equine umbilical cord mesenchymal stem cells
EquiCord S.L.
QM09AX
equine umbilical cord mesenchymal stem cells
Horses
Other drugs for disorders of the musculo-skeletal system
Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
Revision: 3
Authorised
2019-06-19
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: HORSTEM SUSPENSION FOR INJECTION FOR HORSES 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT EquiCord S.L. 103-D Loeches Polígono Industrial Ventorro del Cano Alcorcón 28925 Madrid Spain Phone: +34 (0) 914856756 E-mail: horstem@equicord.com 2. NAME OF THE VETERINARY MEDICINAL PRODUCT HorStem suspension for injection for horses 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each vial contains: Active Substance: 15x10 6 Equine umbilical cord mesenchymal stem cells Excipient: Adenosine Dextran-40 Lactobionic acid HEPES N-(2-hydroxyethyl) piperazine-N´-(2-ethanesulfonic acid) Sodium hydroxide L- Glutathione Potassium chloride Potassium bicarbonate Potassium phosphate Dextrose Sucrose Mannitol Calcium chloride Magnesium chloride Potassium hydroxide Sodium hydroxide Trolox (6-hydroxyl-2,5,7,8- tetramethylchroman-2-carboxylic acid) Water for injections Suspension for injection. Cloudy colourless suspension. 4. INDICATION 17 Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses. 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 6. ADVERSE REACTIONS Very common Acute synovitis with an acute onset of severe lameness, joint effusion and pain on palpation was reported 24 hours after administration of the veterinary medicinal product. Substantial improvement was shown in the next 48 hours and complete remission in the following two weeks. In case of severe inflammation, administration of symptomatic treatment with Non- Steroidal Anti-Inflammatory Drugs (NSAIDs) could be necessary. Common Moderate joint effusion with no associated lameness has been observed 24 hours after HorStem administration. Complete remission was observed over the following two weeks without any symptomatic treatment. An increase in mild lameness was observed 24 hours after HorSte Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HorStem suspension for injection for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml dose contains: ACTIVE SUBSTANCE: Equine umbilical cord mesenchymal stem cells (EUC-MSCs) 15x10 6 Excipients: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Cloudy colourless suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The veterinary medicinal product was demonstrated to be efficacious in horses affected by osteoarthritis in the metacarpo-phalangeal joint, distal interphalangeal joint, and tarsometatarsal/ distal intertarsal joint. No efficacy data are available regarding the treatment of other joints. No efficacy data are available regarding the treatment in more than one arthritic joint at the same time. The onset of efficacy may be gradual. Efficacy data demonstrated an effect from 35 days after treatment. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Correct placement of the needle is crucial to avoid accidental injection into blood vessels and an associated risk of thrombosis. 3 The safety of the veterinary medicinal product has only been investigated in horses at least two years old. Special precautions to be taken by the person administering the veterinary medicinal product to animals Care should be taken to avoid accidental self-injection. Wash hands after use. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Very common: Acute synovitis with an acute onset of severe lameness, jo Llegiu el document complet