Other products
Arti-Cell Forte
Active substance
ATC code
Species
Horses
Indications
Reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses.
Dose to be administered and administration route
Intra-articular use.
Recommended dosage:
A single intra-articular injection of 1 dose (2 ml) per animal.
Preparation of the suspension for injection:
The veterinary product must be administered intra-articularly by a veterinary surgeon taking special precautions to ensure sterility of the injection process. The product must be manipulated and injected using sterile techniques and in a clean environment.
The product needs to be administered immediately after thawing to prevent significant cell death.
Using appropriate gloves, remove the two vials (one vial of cells (1 ml) and one vial of EAP (1 ml)) from the freezer/liquid nitrogen and thaw immediately at 25 °C – 37 °C, e.g. in a water bath, until the contents in each are completely thawed (approximately 5 minutes).
If any cell clusters are visible in either of the vials after thawing, gently shake the vial concerned until the suspension is clear and colourless (stem cell suspension) or clear and yellow (equine allogeneic plasma suspension: the solvent).
Remove the cap of the vial that thawed first and aspirate the suspension in a syringe, then remove the cap of the other (thawed) vial and aspirate the suspension in the same syringe. Then mix both the suspensions in the same syringe to produce one dose of the product (2 ml).
Use a needle with a diameter greater than or equal to 22G in order to prevent cell damage.
Adverse reactions
Horses:
|
Very common (>1 animal / 10 animals treated): |
Lameness1,2 Injection site reaction1 (e.g. joint swelling3, injection site warmth2) |
1 Occurring in the first week after use of the product.
2 Mild
3 Mild to moderate
In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Arti-Cell Forte suspension for injection for horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
Active substance:
Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells:
1.4 – 2.5 x 106
Excipients:
|
Qualitative composition of excipients and other constituents |
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product |
|
Dimethyl sulfoxide |
|
|
Dulbecco’s Modified Eagle Medium Low Glucose |
|
|
Solvent: |
|
|
Equine allogeneic plasma (EAP) |
1 ml |
Stem cells: clear colourless suspension.
Solvent: clear yellow suspension.
3. CLINICAL INFORMATION
3.1 Target species
Horses
3.2 Indications for use for each target species
Reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses.
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
3.4 Special warnings
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 nonsteroidal anti-inflammatory drug (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.
3.5 Special precautions for use
Special precautions for safe use in the target species:
In order to avoid thrombosis in small vessels when administering intra-articular injections, the correct placement of the needle is critical.
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 should take place in a well-ventilated area. Before withdrawing the vials from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn.
In case of accidental self-injection this product can cause pain, local inflammatory reactions and swelling at the site of injection, which may persist for several weeks and possibly cause fever. Seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment: Not applicable.
3.6 Adverse events
Horses:
|
Very common (>1 animal / 10 animals treated): |
Lameness1,2
Injection site reaction1 (e.g. joint swelling3, injection site warmth2) |
1 Occurring in the first week after use of the product.
2 Mild
3 Mild to moderate
In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
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.
3.8 Interaction with other medicinal products and other forms of interaction
No data available.
Do not administer simultaneously with any other intra-articular veterinary medicinal product.
3.9 Administration routes and dosage
Intra-articular use.
Recommended dosage:
A single intra-articular injection of 1 dose (2 ml) per animal.
Preparation of the suspension for injection:
The veterinary product must be administered intra-articularly by a veterinary surgeon taking special precautions to ensure sterility of the injection process. The product must be manipulated and injected using sterile techniques and in a clean environment.
The product needs to be administered immediately after thawing to prevent significant cell death.
Using appropriate gloves, remove the two vials (one vial of cells (1 ml) and one vial of EAP (1 ml)) from the freezer/liquid nitrogen and thaw immediately at 25 °C – 37 °C, e.g. in a water bath, until the contents in each are completely thawed (approximately 5 minutes).
If any cell clusters are visible in either of the vials after thawing, gently shake the vial concerned until the suspension is clear and colourless (stem cell suspension) or clear and yellow (equine allogeneic plasma suspension: the solvent).
Remove the cap of the vial that thawed first and aspirate the suspension in a syringe, then remove the cap of the other (thawed) vial and aspirate the suspension in the same syringe. Then mix both the suspensions in the same syringe to produce one dose of the product (2 ml).
Use a needle with a diameter greater than or equal to 22G in order to prevent cell damage.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No data available.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Zero days.
4. PHARMACOLOGICAL INFORMATION
4.1 ATCvet code:
QM09AX90
4.2 Pharmacodynamics
This product contains chondrogenic induced equine mesenchymal stem cells and equine allogeneic plasma (EAP). The addition of the EAP to the stem cells after thawing and just before injection of the product increases the viability of the stem cells.
The chondrogenic induction of the mesenchymal stem cells aims to activate chondroprotective mechanisms, such as the production of extracellular matrix. In an experimental model of osteoarthritis in horses these effects were reflected through parameters related to cartilage turnover.
4.3 Pharmacokinetics
After injection of the product the stem cells do not migrate or distribute from the treated joint and synovia to tissues surrounding the synovial space.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
5.2 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after reconstitution according to directions: use immediately.
5.3 Special precautions for storage
Store and transport frozen (–90 °C to –70 °C) or in liquid nitrogen.
5.4 Nature and composition of immediate packaging
Each pack (polycarbonate container) contains a single dose of the product: one vial of chondrogenic induced mesenchymal stem cell suspension and one vial of equine allogeneic plasma (EAP) suspension (solvent).
Nature of vials: cyclo-olefin co-polymer (COC) vial with a thermoplastic elastomer (TPE) stopper and a high-density polyethylene (HDPE) cap.
5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
6. NAME OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
7. MARKETING AUTHORISATION NUMBER(S)
EU/2/18/228/001
8. DATE OF FIRST AUTHORISATION
Date of first authorisation: 29/03/2019
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
{MM/YYYY}
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Detailed information on this veterinary medicinal product is available in the Union Product Database(https://medicines.health.europa.eu/veterinary).
ANNEX II OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
None.
ANNEX III
LABELLING AND PACKAGE LEAFLET
A. LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Polycarbonate container (2 vials of 1 ml)
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Arti-Cell Forte suspension for injection
|
2. |
STATEMENT OF ACTIVE SUBSTANCES |
Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells:
1.4 – 2.5 x 106
|
3. |
PACKAGE SIZE |
1 ml vial of stem cells
1 ml solvent vial of equine allogeneic plasma
|
4. |
TARGET SPECIES |
Horses
|
5. |
INDICATIONS |
|
6. |
ROUTES OF ADMINISTRATION |
Intra-articular use.
|
7. |
WITHDRAWAL PERIODS |
Withdrawal period: Zero days.
|
8. |
EXPIRY DATE |
Exp. {mm/yyyy}
Once reconstituted use immediately.
|
9. |
SPECIAL STORAGE PRECAUTIONS |
Store and transport frozen (–90 °C to –70 °C) or in liquid nitrogen.
|
10. |
THE WORDS “READ THE PACKAGE LEAFLET BEFORE USE” |
Read the package leaflet before use.
|
11. |
THE WORDS “FOR ANIMAL TREATMENT ONLY” |
For animal treatment only.
|
12. |
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” |
Keep out of the sight and reach of children.
|
13. |
NAME OF THE MARKETING AUTHORISATION HOLDER |
Boehringer Ingelheim Vetmedica GmbH
|
14. |
MARKETING AUTHORISATION NUMBERS |
EU/2/18/228/001
|
15. |
BATCH NUMBER |
Lot {number}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1 ml vial containing the stem cell suspension
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Arti-Cell Forte
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
1 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
Once reconstituted use immediately.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1 ml vial containing the solvent
|
1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
Solvent for Arti-Cell Forte
|
2. |
QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES |
1 ml
|
3. |
BATCH NUMBER |
Lot {number}
|
4. |
EXPIRY DATE |
Exp. {mm/yyyy}
B. PACKAGE LEAFLET
PACKAGE LEAFLET 1. Name of the veterinary medicinal product
Arti-Cell Forte suspension for injection for horses
2. Composition
Each dose of 2 ml contains:
Active substance:
Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells:
1.4 – 2.5 x 106
Solvent: Equine allogeneic plasma (EAP), 1 ml
Stem cells: clear colourless suspension.
Solvent: clear yellow suspension.
3. Target species
Horses.
4. Indications for use
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. Special warnings
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 a nonsteroidal anti-inflammatory drug (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 intra-articular injection.
Special precautions for safe use in the target species:
In order to avoid thrombosis in small vessels when administering intraarticular injections, the correct placement of the needle is critical.
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 should take place in a well-ventilated area. Before withdrawing the vials from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn.
In case of accidental self-injection this product can cause pain, local inflammatory reactions and swelling at the site of injection, which may persist for several weeks and possibly cause fever. 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 interaction: No data available.
Do not administer simultaneously with any other intra-articular veterinary medicinal product.
Overdose:
No data available.
Major incompatibilities:
In the absence of incompatibility studies, this veterinary product must not be mixed with other veterinary medicinal products.
7. Adverse events
Horses:
Very common (> 1 animal / 10 animals treated): Lameness1,2,
Injection site reaction1 (e.g. joint swelling3, injection site warmth2)
1 Occurring in the first week after use of the product.
2 Mild
3 Mild to moderate
In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte.
Reporting adverse events is important. It allows continuous safety monitoring of a product. 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 contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorisation holder or the local representative of the marketing authorisation holder using the contact details at the end of this leaflet, or via your national reporting system: {national system details}.
8. Dosage for each species, routes and method of administration
For intra-articular use.
Recommended dosage:
Single administration of 1 dose (equivalent to 2 ml) per animal.
9. Advice on correct administration
Preparation of the suspension for injection:
The veterinary product must be administered intra-articularly by a veterinary surgeon taking special precautions to ensure sterility of the injection process. The product must be manipulated and injected using sterile techniques and in a clean environment.
The following information is intended for the veterinary surgeon only:
The product needs to be administered immediately after thawing to prevent significant cell death.
Using appropriate gloves, remove the two vials (one vial of cells (1 ml) and one vial of EAP (1ml)) from the freezer/liquid nitrogen and thaw immediately at 25 °C – 37 °C, e.g. in a water bath, until the contents in each are completely thawed (approximately 5 minutes).
If any cell clusters are visible in either of the vials after thawing, gently shake the vial concerned until the suspension is clear and colourless (stem cell suspension) or clear and yellow (equine allogeneic plasma suspension: the solvent).
Remove the cap of the vial that thawed first and aspirate the suspension in a syringe, then remove the cap of the other (thawed) vial and aspirate the suspension in the same syringe. Then mix both the suspensions in the same syringe to produce one dose of the product (2 ml).
Use a needle with a diameter greater than or equal to 22G in order to prevent cell damage.
10. Withdrawal periods
Zero days.
11. Special storage precautions
Keep out of the sight and reach of children.
Store and transport frozen (–90 °C to –70 °C) or in liquid nitrogen.
Do not use this veterinary medicinal product after the expiry date which is stated on the labels after Exp. The expiry date refers to the last day of that month.
Shelf life after reconstitution according to directions: use immediately.
12. Special precautions for disposal
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
13. Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription.
14. Marketing authorisation numbers and pack sizes
EU/2/18/228/001
Each pack (polycarbonate container) contains a single dose of the product: one vial of stem cell suspension and one vial of EAP suspension.
15. Date on which the package leaflet was last revised
{MM/YYYY}
Detailed information on this veterinary medicinal product is available in theUnion Product Database (https://medicines.health.europa.eu/veterinary).
16. Contact details
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
Local representatives and contact details to report suspected adverse reactions:
België/Belgique/Belgien
Boehringer Ingelheim Animal
Health Belgium SA
Avenue Arnaud Fraiteurlaan 15-23,
1050 Bruxelles/Brussel/Brüssel
Tél/Tel: + 32 2 773 34 56
|
Република България Boehringer Ingelheim RCV GmbH & Co KG Dr. Boehringer Gasse 5-11 A-1121 Виена Австрия/Austria Tel: +359 2 958 79 98
|
Luxembourg/Luxemburg Boehringer Ingelheim Animal Health Belgium SA Avenue Arnaud Fraiteurlaan 15-23, 1050 Bruxelles/Brussel/Brüssel Tél/Tel: + 32 2 773 34 56
|
|
Česká republika Boehringer Ingelheim spol. s r.o. Purkyňova 2121/3 CZ - 110 00, Praha 1 Tel: +420 234 655 111
|
Magyarország Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelep Lechner Ö. Fasor 10. H-1095 Budapest Tel: +36 1 299 8900 |
Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Dr. Boehringer Gasse 5-11
A-1121 Vīne, Austrija
Tel: +370 5 2595942
Danmark
Boehringer Ingelheim Animal Health Nordics
A/S
Weidekampsgade 14
DK-2300 København S
Tlf: + 45 3915 8888
Malta
Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim/Rhein, il-Ġermanja
Tel: +353 1 291 3985
Deutschland
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Tel: 0800 290 0 270
Nederland
Boehringer Ingelheim Animal Health
Netherlands bv
Basisweg 10
1043 AP Amsterdam
|
|
|
Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Dr. Boehringer Gasse 5-11 A-1121 Viin, Austria Tel: +372 612 8000
|
Norge Boehringer Ingelheim Animal Health Nordics A/S Weidekampsgade 14 DK-2300 København S Tlf: +47 66 85 05 70
|
|
Ελλάδα Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim/Rhein Γερμανία/Germany Tηλ: +30 2108906300 |
Österreich Boehringer Ingelheim RCV GmbH & Co KG Dr. Boehringer Gasse 5-11 A-1121 Wien Tel: +43 1 80105-6880
|
|
España Boehringer Ingelheim Animal Health España, S.A.U. Prat de la Riba, 50 08174 Sant Cugat del Vallès (Barcelona) Tel: +34 93 404 51 00
|
Polska Boehringer Ingelheim Sp. z o.o. ul. Józefa Piusa Dziekonskiego 3 00-728 Warszawa Tel.: + 48 22 699 0 699
|
|
France Boehringer Ingelheim Animal Health France, SCS 29, avenue Tony Garnier 69007 Lyon Tél : +33 4 72 72 30 00
|
Portugal Boehringer Ingelheim Animal Health Portugal, Unipessoal, Lda. Avenida de Pádua, 11 1800-294 Lisboa Tel: +35121 313 5300
|
|
Hrvatska Boehringer Ingelheim RCV GmbH & Co KG Dr. Boehringer Gasse 5-11 A-1121 Beč, Austrija Tel: +385 1 2444 600
|
România Boehringer Ingelheim RCV GmbH & Co KG Sucursala Bucureşti Dr. Boehringer Gasse 5-11 A-1121 Viena, Austria Tel: +40 21 302 28 00
|
|
Ireland Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim/Rhein, Germany Tel: +353 1 291 3985
|
Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana Dr. Boehringer Gasse 5-11 A-1121 Dunaj, Avstrija Tel: +386 1 586 40 00 |
Tel: +31 20 799 6950
Ísland
Vistor
Hörgatún 2
210 Garðabær
Sími: + 354 535 7000 Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG, o.z.
Dr. Boehringer Gasse 5-11
A-1121 Viedeň, Rakúsko
Tel: +421 2 5810 1211
Italia
Boehringer Ingelheim Animal Health Italia S.p.A.
Via Vezza d'Oglio, 3
20139 Milano
Tel: +39 02 53551
Suomi/Finland
Vetcare Oy
PL/PB 99
24101 Salo
Puh/Tel: + 358 201443360
Sverige
Κύπρος
Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim/Rhein
Γερμανία/Germany
Tηλ: +30 2108906300
Boehringer Ingelheim Animal Health Nordics
A/S
Weidekampsgade 14
DK-2300 København S
Tel: +46 (0)40-23 34 00
Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiāle
Dr. Boehringer Gasse 5-11
A-1121 Viena, Austrija Tel: +371 67 240 011 United Kingdom (Northern Ireland)
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim/Rhein, Germany
Tel: +353 1 291 3985
| Art. Nr. | 04491/5062 |
|---|---|
| GTIN | • • • • • • • • • 0404 |
