HorStem

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

equine umbilical cord mesenchymal stem cells

MAH:

EquiCord S.L.

ATC_code:

QM09AX

INN:

equine umbilical cord mesenchymal stem cells

therapeutic_group:

Horses

therapeutic_area:

Other drugs for disorders of the musculo-skeletal system

therapeutic_indication:

Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.

leaflet_short:

Revision: 3

authorization_status:

Authorised

authorization_date:

2019-06-19

PIL

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: [phone]
E-mail: [e-mail]
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

SPC

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