natgillin/translations-raw huggingface dataset:
For more information about treatment with Truberzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Truberzi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In the first study effectiveness was shown in 29% (125 out of 426) of patients taking Truberzi 100 mg twice a day compared with 19% (81 out of 427) in patients taking placebo.
V prvi študiji se je učinkovitost pokazala pri 29 % (125 od 426) bolnikov, ki so prejemali zdravilo Truberzi 100 mg dvakrat dnevno, v primerjavi z 19 % (81 od 427) bolnikov, ki so prejemali placebo.
Truberzi must not be given to patients with liver disorders, those at risk of pancreatitis (such as those who have had problems with their pancreas or who drink alcohol excessively), patients whose gall bladders have been removed or who have disorders affecting secretion of bile into the gut, and those who have had severe or long-term constipation or blocked bowel.
Zdravila Truberzi ne smejo jemati bolniki z boleznimi jeter, tveganjem za pankreatitis (npr. bolniki, ki so imeli težave s trebušno slinavko ali ki uživajo preveč alkohola), bolniki, ki so jim odstranili žolčnik ali imajo motnje z izločanjem žolča v črevesje, in bolniki s hudo ali dolgotrajno zaprtostjo ali zaporo v črevesju.
It is used for the treatment of adults who have irritable bowel syndrome with diarrhoea.
Uporablja se za zdravljenje odraslih, ki imajo sindrom razdražljivega črevesja z drisko.
Truberzi was evaluated in two main studies involving over 2,400 patients with irritable bowel syndrome with diarrhoea.
Zdravilo Truberzi so ocenjevali v dveh glavnih študijah, ki sta vključevali več kot 2 400 bolnikov s sindromom razdražljivega črevesja z drisko.
In the second study symptoms improved in 33% (125 out of 382) of patients taking Truberzi 100 mg twice a day compared with 20% (77 out of 382) of patients taking placebo.
V drugi študiji so se simptomi izboljšali pri 33 % (125 od 382) bolnikov, ki so prejemali zdravilo Truberzi 100 mg dvakrat dnevno, v primerjavi z 20 % (77 od 382) bolnikov, ki so prejemali placebo.
The most common side effects with Truberzi (which may affect more than 5 in 100 people) are constipation, nausea (feeling sick) and abdominal pain.
Najpogostejši neželeni učinki zdravila Truberzi (ki se lahko pojavijo pri več kot 5 bolnikih od 100) so zaprtost, navzeja (slabost) in bolečine v trebuhu.
Serious side effects include pancreatitis (inflammation of the pancreas) and sphincter of Oddi spasm (a painful condition in which bile and digestive juices are blocked from flowing into the gut).
Resni neželeni učinki vključujejo pankreatitis (vnetje trebušne slinavke) in spazem Oddijevega sfinktra (boleče stanje, kadar je blokiran pretok žolča in prebavnih sokov v črevesje).
Eluxadoline, the active substance in Truberzi, is an opioid receptor agonist.
Eluksadolin, zdravilna učinkovina v zdravilu Truberzi, je agonist opioidnih receptorjev.
For practical information about using Truberzi, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Truberzi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
In both studies Truberzi was compared with placebo (a dummy treatment) over 26 weeks of treatment during which patients kept a daily record of their irritable bowel syndrome symptoms.
V obeh študijah so zdravilo Truberzi primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju več kot 26 tednov, v katerem so bolniki, ki so se zdravili, dnevno vodili evidenco svojih simptomov razdražljivega črevesja.
Truberzi is a medicine that acts on the digestive system.
Truberzi je zdravilo, ki deluje na prebavni sistem.
For the full list of all side effects of Truberzi, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Truberzi glejte navodilo za uporabo.
Irritable bowel syndrome is a long-term disorder of the gut with pain or discomfort in the abdomen (belly), bloating and altered bowel habit.
Sindrom razdražljivega črevesja je dolgotrajna črevesna bolezen z bolečinami ali neprijetnim občutkom v trebuhu, napihnjenostjo in spremenjenim odvajanjem blata.
How does Truberzi work?
Kako zdravilo Truberzi deluje?
How is Truberzi used?
Kako se zdravilo Truberzi uporablja?
Truberzi can only be obtained with a prescription.
Predpisovanje in izdaja zdravila je le na recept.
Truberzi contains the active substance eluxadoline.
Zdravilo Truberzi vsebuje zdravilno učinkovino eluksadolin.
• Risk management plan:
• Načrt za obvladovanje tveganja:
Efficacy data demonstrated an effect from 35 days after treatment.
Podatki o učinkovitosti dokazujejo učinek po 35 dneh po zdravljenju.
The first report shall be submitted 6 months after Day 0, and subsequently at 6-month intervals, until otherwise agreed by the CVMP.
Prvo poročilo je treba predložiti šest mesecev po 0. dnevu, nato pa v šestmesečnih presledkih, dokler ni drugače dogovorjeno z odborom CVMP.
Each vial contains:
Vsaka viala vsebuje:
Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Swirl gently before use in order to ensure the contents are well mixed.
Pred uporabo ga nežno sukajte, da se vsebina dobro premeša.
MARKETING AUTHORISATION NUMBER(S) EU/2/18/226/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/18/226/001
Substantial improvement was shown in the next 48 hours and complete remission in the following two weeks.
V naslednjih 48 urah se je pokazalo pomembno izboljšanje, v naslednjih dveh tednih pa popolna remisija.
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.
Če opazite kakršne koli neželene učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
The onset of efficacy may be gradual.
Nastop učinka je lahko postopen.
The product must be handled and injected following sterile techniques and in a clean environment.
Z zdravilom je treba ravnati in ga injicirati s sterilnimi tehnikami in v čistem okolju.
The marketing authorisation holder shall perform the required pharmacovigilance activities and interventions as detailed in the agreed risk management plan and any agreed subsequent updates of the risk management plan.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem načrtu za obvladovanje tveganja, in vseh nadaljnjih sprejetih posodobitvah načrta za obvladovanje tveganja.
Do not use this veterinary medicinal product after the expiry date which is stated on the vial label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na oznaki viale.
Use a 20G needle.
Uporabite iglo velikosti 20 G.
MARKETING AUTHORISATION NUMBER(S) EU/2/18/226/001 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2019
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/18/226/001 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 19/06/2019
The starting date of the reporting scheme (Day 0) shall be the date of first release of a batch that has been tested with the updated and validated potency assay.
Datum začetka sheme poročanja (0. dan) je dan prve sprostitve serije, testirane s posodobljenim in validiranim testom jakosti.
In one case, symptomatic treatment (NSAID) was required.
V enem primeru je bilo potrebno simptomatsko zdravljenje (NSAID).
Pharmacotherapeutic group: Not yet assigned ATCvet code: Not yet assigned
FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: še ni bila dodeljena Oznaka ATC vet: še ni bila dodeljena
The safety of the veterinary medicinal product has only been investigated in horses at least two years old.
Varnost zdravila za uporabo v veterinarski medicini so proučevali samo pri konjih, starih vsaj dve leti.
In 5/6 horses, the adverse reactions were mild and resolved spontaneously within 28 days.
Pri 5/6 konjev so bili neželeni učinki blagi in so spontano minili v 28 dneh.
No efficacy data are available regarding the treatment in more than one arthritic joint at the same time.
Podatki o učinkovitosti pri zdravljenju več kot enega artritičnega sklepa hkrati niso na voljo.
Store and transport refrigerated (2 °C - 8 °C).
Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
Shelf life after first opening the immediate packaging: Use immediately.
Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
Correct placement of the needle is crucial to avoid accidental injection into blood vessels and an associated risk of thrombosis.
Pravilna vstavitev igle je ključnega pomena za preprečitev nenamernega injiciranja v krvne žile in s tem povezanega tveganja tromboze.
Excipients: For the full list of excipients, see section 6.1.
Pomožne snovi: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Adverse reactions in the other horses resolved spontaneously within a maximum of 21 days; lameness lasted for up to three days.
Neželeni učinki pri drugih konjih so minili spontano v največ 21 dneh; šepavost je trajala do tri dni.
The potential of EUC-MSCs to secrete PGE2 with and without stimulation by synovial fluid has been demonstrated in studies in vitro.
Potencial celic EUC-MSC za izločanje PGE2 s ali brez stimulacije s sinovijsko tekočino so dokazali v študijah in vitro.
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.
Drugo dajanje zdravila v priporočenem odmerku zdravim mladim konjem v isti sklep 28 dni po prvem dajanju v priporočenem odmerku je povzročilo povečano pogostost in resnost vnetja, povezanega z zdravljenim sklepom (8/8 konjev), ter povečanje izrazitosti opažene šepavosti (3/8 konjev; do stopnje 4/5 po lestvici šepavosti ameriškega združenja veterinarjev za konje (AAEP)) v primerjavi s prvim zdravljenjem.
METHOD AND ROUTE(S) OF ADMINISTRATION Swirl gently before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo nežno sukajte.
Shelf life of the veterinary medicinal product as packaged for sale: 14 days.
Rok uporabnosti zdravila v pakiranju za prodajo: 14 dni.
E-mail: horstem@equicord.com
E-naslov: horstem@equicord.com
Phone: +34 (0) 914856756
Telefonska številka: +34 (0) 914856756 E-naslov: horstem@equicord.com
Intraarticular placement should be confirmed by the appearance of synovial fluid in the hub of the needle.
Intraartikularno vbrizganje je treba potrditi s pojavom sinovijske tekočine v nastavku igle.
For intraarticular use.
Za intraartikularno uporabo.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 1 ml
Administrative office and manufacturing site: EquiCord-YMAS
Upravni urad in mesto proizvodnje: EquiCord-YMAS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Ne uporabite v primerih preobčutljivosti za učinkovino ali katero koli pomožno snov.
Mesenchymal stem cells have immunomodulatory and anti-inflammatory properties that may be attributed to their paracrine activity, -e.g. prostaglandin (PGE2) secretion, and can possess tissue regenerative properties.
Mezenhimske matične celice imajo imunomodulatorne in protivnetne lastnosti, ki jih lahko pripišemo njihovi parakrini aktivnosti, npr. izločanju prostaglandinov (PGE2); poleg tega imajo lahko regenerativen učinek na tkiva.
EXPIRY DATE EXP: {day/month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {dan/mesec/leto}
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z nobenimi drugimi zdravili za uporabo v veterinarski medicini.
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.
Dokazali so, da je zdravilo za uporabo v veterinarski medicini učinkovito pri konjih z osteoartritisom v metakarpofalangealnem sklepu, distalnem interfalangealnem sklepu in tarzometatarzalnem/distalnem intertarzalnem sklepu.
Trolox (6-hydroxyl-2,5,7,8- tetramethylchroman-2-carboxylic acid) Water for injections
Troloks (6-hidroksil-2,5,7,8-tetrametilkroman-2-karboksilna kislina) voda za injekcije
In order to further support the link between PGE2 production and a clinically-relevant therapeutic effect, the marketing authorisation holder shall conduct and submit an updated and validated potency assay (a product specific in vitro model) to the CVMP/EMA for evaluation before batch release and placing the product on the market.
Za nadaljnjo podporo povezavi med nastajanjem PGE2 in klinično pomembnim terapevtskim učinkom mora imetnik dovoljenja za promet z zdravilom pred sproščanjem serij in dajanjem zdravila na trg izvesti ter odboru CVMP/agenciji EMA v vrednotenje predložiti posodobljen in validiran test jakosti (za zdravilo specifičen model in vitro).
One horse required symptomatic treatment (NSAID) and its lameness resolved by day 14.
Pri enem konju je bilo potrebno simptomatsko zdravljenje (NSAID), njegova šepavost pa je minila do 14. dne.
HEPES N-(2-hydroxyethyl) piperazine-N´-(2-ethanesulfonic acid) Sodium hydroxide
HEPES N-(2-hidroksietil) piperazin-N´-(2-etansulfonska kislina) natrijev hidroksid
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: http://www.ema.europa.eu/
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
To what extent EUC-MSCs from this product persist after intraarticular administration to horses is not known as no proprietary biodistribution studies have been conducted with HorStem.
Do katere mere se celice EUC-MSC iz tega zdravila ohranijo po intraartikularnem dajanju konjem, ni znano, saj z zdravilom HorStem niso bile izvedene lastniške študije o biološki porazdelitvi.
These pharmacodynamic properties may be also relevant for equine umbilical cord derived MSCs (EUC-MSCs) but have not been demonstrated in proprietary studies conducted with the product.
Te farmakodinamične lastnosti so lahko pomembne tudi pri konjskih mezenhimskih matičnih celicah, pridobljenih iz popkovnice (EUC-MSC), vendar tega v lastniških študijah z zdravilom niso dokazali.
Cyclic olefin vial closed with a bromobutyl rubber stopper and a flip off aluminium cap.
Viala iz cikličnega olefina, zaprta z bromobutilnim gumijastim zamaškom in aluminijastim dvižnim pokrovčkom.
Pack size: Cardboard box with 1 vial containing 1 ml.
Velikost pakiranja: kartonska škatla z 1 vialo z 1 ml.
Intraarticular use.
Intraartikularna uporaba.
No efficacy data are available regarding the treatment of other joints.
Podatki o učinkovitosti pri zdravljenju drugih sklepov niso na voljo.
Intraarticular administration of a 2x dose (30x106/2ml) 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.
Intraartikularno dajanje dvakratnega odmerka (30 x 106/2 ml) zdravila HorStem zdravim konjem, starim štiri leta in več, je pri 5/6 živali povzročilo šepavost, pri vseh živalih pa znake vnetja.
Complete remission was observed over the following two weeks without any symptomatic treatment.
V naslednjih dveh tednih so brez simptomatskega zdravljenja opazili popolno remisijo.
PACKAGE SIZE One 1 ml vial.
VELIKOST PAKIRANJA Ena 1-ml viala.
Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
Zmanjšanje šepavosti, povezane z blago do zmerno degenerativno boleznijo sklepov (osteoartritisom) pri konjih.
Incompatibilities:
Glavne inkompatibilnosti:
Special warnings for each target species:
POSEBNA OPOZORILA Posebna opozorila za vsako ciljno živalsko vrsto:
The veterinary product must be administered intraarticularly, only by a veterinary surgeon, taking special precautions to ensure the sterility of the injection process.
Način uporabe Zdravilo za uporabo v veterinarski medicini mora intraartikularno dati izključno veterinar in pri tem upoštevati previdnostne ukrepe za zagotavljanje sterilnosti postopka injiciranja.
NAME OF THE VETERINARY MEDICINAL PRODUCT HorStem suspension for injection for horses
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI HorStem suspenzija za injiciranje za konje
4.2 Indications for use, specifying the target species Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zmanjšanje šepavosti, povezane z blago do zmerno degenerativno boleznijo sklepov (osteoartritisom) pri konjih.
TARGET SPECIES Horses
CILJNE ŽIVALSKE VRSTE Konji
In case of severe inflammation, administration of symptomatic treatment with NonSteroidal Anti-Inflammatory Drugs (NSAIDs) could be necessary.
V primeru hudega vnetja je morda potrebno simptomatsko zdravljenje z nesteroidnimi protivnetnimi zdravili (NSAID).
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, including isolated reports)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali)
Complete remission was observed within 3 days, without any symptomatic treatment.
V naslednjih treh dneh so brez simptomatskega zdravljenja opazili popolno remisijo.
The active substance, mesenchymal stem cells, is considered as not falling within the scope of the MRL regulation, as it is covered by the entry for stem cells in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina, mezenhimske matične celice, ne spada v področje uporabe uredbe o vrednostih MRL, saj je vključena v rubriko za matične celice na seznamu snovi, ki ne spadajo v področje uporabe Uredbe (ES)
Cloudy colourless suspension.
Motna brezbarvna suspenzija.
ADVICE ON CORRECT ADMINISTRATION Do not apply simultaneously with other intraarticular veterinary medicinal products.
NASVET O PRAVILNI UPORABI ZDRAVILA Ne dajajte hkrati z drugimi intraartikularnimi zdravili za uporabo v veterinarski medicini.
PACKAGE LEAFLET: HorStem suspension for injection for horses
NAVODILO ZA UPORABO: HorStem suspenzija za injiciranje za konje
A single intraarticular injection of 1 ml (15x106 equine umbilical cord mesenchymal stem cells) into the affected joint.
Ena intraartikularna injekcija z 1 ml (15 x 106 konjskih popkovničnih mezenhimskih matičnih celic) v prizadeti sklep.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Route of administration:
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
ROUTE(S) OF ADMINISTRATION Intraarticular use
POT(I) UPORABE ZDRAVILA Intraartikularna uporaba
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
FOR ANIMAL TREATMENT ONLY For animal treatment only.
SAMO ZA ŽIVALI Samo za živali.
Equine umbilical cord mesenchymal stem cells (EUC-MSCs)
Učinkovina: Konjske popkovnične mezenhimske matične celice (EUC-MSC)
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben, ali pa ne spadajo v področje uporabe
4.7 Use during pregnancy, lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
To be supplied only on veterinary prescription.
Zdravilo sme dati samo veterinar.
An increase in mild lameness was observed 24 hours after HorStem administration.
24 ur po dajanju zdravila HorStem so opazili povečanje blage šepavosti.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml dose contains:
Vsak 1-ml odmerek vsebuje:
Do not administer simultaneously with any other intraarticular veterinary medicinal product.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne dajajte hkrati z nobenim drugim intraartikularnim zdravilom za uporabo v veterinarski medicini.
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.
Zelo pogosti Poročali so, da se je 24 ur po dajanju zdravila za uporabo v veterinarski medicini pojavil akutni sinovitis z akutnim nastopom hude šepavosti, efuzijo sklepa in bolečino ob palpaciji.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne dajajte hkrati z nobenim drugim intraartikularnim zdravilom za uporabo v veterinarski medicini.
Active Substance: 15x106 Equine umbilical cord mesenchymal stem cells
Učinkovina: 15 x 106 konjskih popkovničnih mezenhimskih matičnih celic
QUANTITY OF THE ACTIVE SUBSTANCE(S) 15x106 /ml Equine umbilical cord mesenchymal stem cells
KOLIČINA UČINKOVIN(E) 15 x 106/ml konjskih popkovničnih mezenhimskih matičnih celic
In order to collect further field data, related to both safety and efficacy, from batches that have been released by use of the updated potency assay, the marketing authorisation holder shall conduct and submit the results of a surveillance study.
Imetnik dovoljenja za promet z zdravilom mora izvesti nadzorno študijo in predložiti njene rezultate, da bi zbral več terenskih podatkov, povezanih z varnostjo in učinkovitostjo, iz serij, sproščenih z uporabo posodobljenega testa jakosti.
15x106 /ml Equine umbilical cord mesenchymal stem cells
15 x 106/ml konjskih popkovničnih mezenhimskih matičnih celic
Method of administration:
Pot uporabe zdravila::
Moderate joint effusion with no associated lameness has been observed 24 hours after HorStem administration.
24 ur po dajanju zdravila HorStem so opazili zmerno efuzijo sklepa brez povezane šepavosti.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Da bi se izognili samoinjiciranju, je potrebna previdnost.