Patient leaflet - HorStem
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
HorStem suspension for injection for horses
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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:
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
HorStem suspension for injection for horses
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each vial contains:
Active Substance: 15×106 Equine umbilical cord mesenchymal stem cells
Excipient:
Adenosine
Dextran-40
Lactobionic acid
HEPES N-(2-hydroxyethyl) piperazme-N'-(2-ethanesulfomc acid)
Sodium hydroxide
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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.
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4. INDICATION
Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
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5. CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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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 NonSteroidal 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 HorStem administration. Complete remission was observed within 3 days, without any symptomatic treatment.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Horses.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Route of administration:
Intraarticular use.
Dosage
A single intraarticular injection of 1 ml (15×106 equine umbilical cord mesenchymal stem cells) into the affected joint.
Method of administration
The veterinary product must be administered intraarticularly, only by a veterinary surgeon, taking special precautions to ensure the sterility of the injection process. The product must be handled and injected following sterile techniques and in a clean environment.
Swirl gently before use in order to ensure the contents are well mixed.
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9. ADVICE ON CORRECT ADMINISTRATION
Do not apply simultaneously with other intraarticular veterinary medicinal products.
The product should only be administered by a veterinary surgeon.
Use a 20G needle.
Intraarticular placement should be confirmed by the appearance of synovial fluid in the hub of the needle.
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10. WITHDRAWAL PERIOD (S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the vial label.
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12. SPECIAL WARNINGS
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.
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.
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.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interactions
Do not administer simultaneously with any other intraarticular veterinary medicinal product.
Overdose (symptoms, emergency procedures, antidotes):
Intraarticular administration of a 2× dose (30×106/2ml) of HorStem to 4 years old and older healthy horses led to lameness in 5/6 animals and to signs of inflammation in all animals. In 5/6 horses, the adverse reactions were mild and resolved spontaneously within 28 days. One horse required symptomatic treatment (NSAID) and its lameness resolved by day 14.
A second administration of the product at the recommended dose to healthy young horses in the same joint, 28 days after the first administration at the recommended dose, led to an increase in frequency and severity of inflammation related to the treated joint (8/8 horses) and to an increase in the severity of the lameness observed (3/8 horses; up to grade 4/5 according to the American Association of Equine Practitioners lameness scale (AAEP)) compared to the first treatment. In one case, symptomatic treatment (NSAID) was requiredAdverse reactions in the other horses resolved spontaneously within a maximum of 21 days; lameness lasted for up to three days.
Incompatibilities :
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency:
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15. OTHER INFORMATION