Arti-Cell Forte
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
25-10-2021
Karatteristiċi tal-prodott
(SPC)
25-10-2021
Rapport ta 'Valutazzjoni Pubblika
(PAR)
07-05-2019
Ingredjent attiv:
chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells
Disponibbli minn:
Boehringer Ingelheim Vetmedica GmbH
Kodiċi ATC:
QM09AX90
INN (Isem Internazzjonali):
chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells
Grupp terapewtiku:
Horses
Żona terapewtika:
Other drugs for disorders of the musculo-skeletal system
Indikazzjonijiet terapewtiċi:
Reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses.
Sommarju tal-prodott:
Revision: 5
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2019-03-29
Fuljett ta 'informazzjoni
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
ARTI-CELL FORTE 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
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Veterinary Medicine Belgium NV
Noorwegenstraat 4
9940 Evergem
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Arti-Cell Forte suspension for injection for horses
Chondrogenic induced equine allogeneic peripheral blood-derived
mesenchymal stem cells
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (2 ml) contains:
ACTIVE SUBSTANCE (1 ML):
1.4–2.5×10
6
Chondrogenic induced equine allogeneic peripheral blood-derived
mesenchymal stem
cells (1 ml)
Colourless and clear suspension.
EXCIPIENTS (1 ML):
Equine allogeneic plasma (1 ml)
Yellow and clear suspension.
4.
INDICATION(S)
Reduction of mild to moderate recurrent lameness associated with
non-septic joint inflammation in
horses.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or any
of the excipients.
6.
ADVERSE REACTIONS
Mild increases in lameness and injection site reactions, such as mild
to moderate increases in joint
swelling and mild increases in temperature at the injection sites,
occurred very commonly in the first
week after use of the product. In the pivotal clinical field study a
single systemic administration of an
NSAID was given concurrently to treatment.
16
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, inclu
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Arti-Cell Forte suspension for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose - contains:
ACTIVE SUBSTANCE (1 ML):
Chondrogenic induced equine allogeneic peripheral blood-derived
mesenchymal stem cells (1 ml)
1.4–2.5×10
6
EXCIPIENTS (1ML):
Equine allogeneic plasma (EAP) 1 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Chondrogenic induced equine allogeneic peripheral blood-derived
mesenchymal stem cell suspension:
clear colourless suspension.
Equine allogeneic plasma suspension (diluent): clear yellow
suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of mild to moderate recurrent lameness associated with
non-septic joint inflammation 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 product has been demonstrated to be efficacious in horses showing
mild to moderate lameness in
the fetlock joint. Efficacy data are not available regarding treatment
of other joints.
The efficacy of the product was demonstrated in a pivotal field trial
after single administration of the
product and concurrent single systemic administration of an NSAID.
According to the benefit-risk
assessment of the responsible veterinarian of the individual case a
single dose systemic NSAID may
be administered on the day of intraarticular injection.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In order to avoid thrombosis in small vessels when administering
intraarticular injections the correct
placement of the needle is critical.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Liquid nitrogen containers should be handled by properly trained
personnel only. The handling of
liquid nitrogen sh
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