natgillin/translations-raw huggingface dataset:
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Detaljne informacije o ovom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.
Special caution should be taken to avoid accidental self-injection, as toxicology studies in laboratory animals showed cardiovascular effects after intramuscular administration of tildipirosin.
Toksikološkim ispitivanjima u laboratoriju, životinje su pokazale kardiovaskularne učinke nakon intramuskularne primjene tildipirosina.
Citric acid monohydrate Propylene glycol Water for injections
Propilen glikol Voda za injekcije
Pathomorphological injection site reactions resolved completely within 21 days.
Patomorfološka reakcija na mjestu ubrizgavanja završila je unutar 21 dana.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Cattle
POJEDINOSTI KOJE SE POJAVLJUJU NA SREDNJEM PAKIRANJU Goveda
In vitro, the effect of tildipirosin is bactericidal against M. haemolytica and H. somni, and bacteriostatic against P. multocida.
In vitro, učinak tildipirosina je bakteriocidni na Mannheimia haemolytica i Histophilus somni, a bakteriostatski na P. multocida..
Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.
Za liječenje i metafilaksu dišnih bolesti svinja (DBS) povezanih s Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica i Haemophilus parasuis osjetljivih na tildipirosin.
Do not administer simultaneously with other macrolides or lincosamides (see section 12).
Ne primjenjivati istodobno s drugim makrolidima ili linkozamidima ( vidi odjeljak 12).
If clinical signs of respiratory disease persist or increase, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.
Ako klinički znakovi dišnih bolesti opstanu ili se povećaju, liječenje se mora promijeniti koristeći drugi antibiotik i nastaviti se dok ne nestanu klinički znakovi.
Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only.
Primijeniti 4 mg tildipirosina/kg tjelesne mase (ekvivalent 1 ml/45 kg tjelesne mase), samo jednom.
During clinical trials, pain on injection and injection site swellings were seen very commonly in treated pigs.
U kliničkim ispitivanjima, bolnost i otok na mjestu injiciranja su vrlo česti u tretiranih svinja.
Pathomorphological injection site reactions will largely resolve within 35 days.
Patomorfološke reakcije na mjestu injiciranja nestat će najdulje unutar 35 dana.
4.10 Overdose (symptoms, emergency procedures, antidotes)
4.10 Predoziranje (simptomi, postupci u slučaju nužde, protuotrovi)
INDICATION
OZNAČAVANJE
Manufacturer for the batch release: Intervet International GmbH Feldstrasse 1 a
Nositelj odobrenja za proizvodnju za puštanje proizvodne serije: Intervet International GmbH
Vial (100 ml, 250 ml)
Bočica(100 ml, 250 ml)
If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.
Ako klinički znakovi dišnih bolesti i dalje traju ili se pojačavaju, ili se vrate, liječenje treba promijeniti koristeći drugi antibiotik i nastaviti sve dok ne nestanu klinički znakovi.
Meat and offal: 9 days.
Meso i jestive iznutrice: 9 dana.
Type I amber glass vial with chlorobutyl rubber stopper and an aluminium cap.
Jantarna staklena bočica tip I, s klorobutilnim gumenim čepom i aluminijskom kapicom.
Zone diameter (mm) MIC breakpoint (µg/ml) S
Sastav diska Zona dijametra (mm) MIC granična vrijednost (µg/ml)
In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg bodyweight (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg bodyweight group and 2 piglets from the 20 mg/kg bodyweight group following the first or second injection.
U prasadi intramuskularna primjena tildipirosina (u tri navrata u razmaku od 4 dana) u dozi od 8, 12 i 20 mg/kg tjelesne mase (2, 3 i 5 puta preporučena klinička doza) rezultirala je privremenim blago potištenim ponašanjem kod jednog praseta iz skupine od 8 i od 12 mg/kg tjelesne mase, u dva praseta iz skupine od 20 mg/kg tjelesne mase nakon prve ili druge aplikacije.
OTHER INFORMATION Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml.
15. OSTALE INFORMACIJE Kutija sadrži jednu bočicu od 20 ml, 50 ml, 100 ml i 250 ml.
Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/10 kg body weight) once only.
Primijeniti 4 mg tildipirosina/kg tjelesne mase (ekvivalent 1ml/10 kg tjelesne mase), samo jednom.
Growing-finishing Finishing/sows/boars
Tovna prasad/krmače/nerast
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
Needle diameter (mm)
Promjer igle ( mm)
Vial (20 ml, 50 ml)
Bočica (20 ml, 50 ml)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pigs
OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Svinje
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Cattle
OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Govedo
MARKETING AUTHORISATION NUMBERS EU/2/11/124/005-008
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/124/005-008
The mean total excretion of the total dose administered within 14 days was about 17% in urine and 57% in faeces.
Prosječno izlučivanje ukupne doze primijenjene unutar 14 dana bilo je 17%
Read the package leaflet before use.
Prije upotrebe pročitati uputu.
Not for use in animals from which milk is produced for human consumption.
Ne primjenjivati kod životinja čije je mlijeko namijenjeno za ljudsku uporabu
6.4 Special precautions for storage
6.4 Posebne mjere opreza za čuvanje
200 μg/kg 2000 μg/kg 3000 μg/kg
μg/kg μg/kg μg/kg μg/kg mišić koža +
MANUFACTURER'S BATCH NUMBER Batch:
17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cattle
PODACI NA VANJSKOM PAKOVANJU Govedo
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Učestalost štetnih nuspojava je definirana sljedećim pravilom: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojave za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Učestalost štetnih nuspojava je definirana sljedećim pravilom: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pigs
PODACI NA VANJSKOM PAKOVANJU Svinje
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
13. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, ako ih ima
To ensure correct dose, body weight should be determined as accurately as possible to avoid underdosing.
Da bi se osigurala ispravna doza, tjelesna težina mora se odrediti što preciznije da bi se izbjegla preniska doza.
NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Zuprevo 180 mg/ml otopina za injekcije za govedo
PHARMACEUTICAL FORM Solution for injection.
Otopina za injekciju.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
12. POSEBNE MJERE OPREZA PRI ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Interakcija s drugim veterinarsko medicinskim proizvodima i drugi oblici interakcija Postoji križna rezistencija s drugim makrolidima.
MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/001-004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/124/001-004
To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Da bi se osigurala ispravna doza, tjelesna masa trebala bi se što točnije definirati radi izbjegavanja subdoziranja.
PHARMACEUTICAL FORM Solution for injection
Otopina za injekciju
Intervet International B. V. Wim de Körverstraat 35
Intervet International BV
SPECIAL STORAGE PRECAUTIONS
11. POSEBNE MJERE OPREZA ZA ČUVANJE
MARKETING AUTHORISATION NUMBERS
BROJ PROIZVODNE SERIJE
PACKAGE LEAFLET FOR: ZUPREVO 180 mg/ml solution for injection for cattle
UPUTA O VMP: Zuprevo 180 mg/ml injekcijska otopina za govedo
Do not use after the expiry date which is stated on the vial after EXP.
Ne primjenjivati poslije isteka roka valjanosti naznačenog na bočici.
QUANTITY OF THE ACTIVE SUBSTANCE 40 mg/ml of tildipirosin
40 mg/ml Tildipirosina
QUANTITY OF THE ACTIVE SUBSTANCE(S) 180 mg/ml of tildipirosin
180 mg/ml Tildipirosin
NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs tildipirosin
Zuprevo 40 mg/ml otopina za injekciju za svinje Tildiprosin
MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/007
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/124/007
For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.
Za liječenje dišnih bolesti goveda povezanih s Mannheimia haemolytica, Pasteurella multocida i
The following tildipirosin breakpoints have been established for swine respiratory disease (according to CLSI Guideline VET02 A3):
Kod respiratornih bolesti svinja ustanovljena je granična vrijednost tildipirosina (prema CLSI
PACKAGE LEAFLET FOR: ZUPREVO 40 mg/ml solution for injection for pigs
ZUPREVO 40 mg/ml otopina za injekciju, za svinje
EXPIRY DATE
EXP.
Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the veterinary medicinal product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.
Metafilaksa implicira da se klinički zdrave životinje, koje su u bliskom kontaktu s bolesnim životinjama
Meat and offal: 47 days
Meso i jestive iznutrice: 47 dana.
MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/003
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/124/003
NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin
ZUPREVO 180 mg/ml otopina za injekciju za goveda Tildipirosin
Withdrawal period: Meat and offal: 47 days.
Karencija: Meso i jestive iznutrice: 47 dana.
NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs
UPUTA O VMP Zuprevo 40 mg/ml injekcijska otopina za svinje
STATEMENT OF ACTIVE AND OTHER SUBSTANCES 40 mg/ml of tildipirosin
40 mg/ml Tildiprosin
METHOD AND ROUTE OF ADMINISTRATION Subcutaneous injection
subkutana injekcija
Do not use after the expiry date stated on the vial after EXP.
Odlaganje: prije upotrebe pročitati uputu o VMP.
Muscle Fat
masno tkivo jetra bubreg
Both are antihypertensive medicines that have been available separately in the European Union (EU) since the mid1990s.
Obje su antihipertenzivni lijekovi koji su u Europskoj uniji (EU) dostupni zasebno od sredine 1990-ih.
It is a ‘generic medicine'.
Riječ je o „generičkom lijeku”.
One tablet is taken daily by mouth with water.
Uzima se jedna tableta na dan s nešto vode.
It blocks special channels on the surface of cells through which calcium normally enters the cells.
Blokira posebne kanale na površini stanica kroz koje kalcij normalno ulazi u stanice.
Amlodipine is a calcium channel blocker.
Amlodipin je blokator kalcijevih kanala.
By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Snižavanjem krvnog tlaka smanjuju se rizici povezani s visokim krvnim tlakom, kao što je mogućnost moždanog udara.
The full EPAR for Amlodipine/Valsartan Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Amlodipin/Valsartan Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
They work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Djeluju na sličan način kako bi smanjili krvni tlak opuštanjem krvnih žila.
Amlodipine/Valsartan Mylan is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).
Amlodipin/Valsartan Mylan dostupan je u obliku tableta (5 mg amlodipina i 80 mg valsartana; 5 mg amlodipina i 160 mg valsartana; 10 mg amlodipina i 160 mg valsartana).
It is recommended that the patient takes amlodipine and valsartan as separate tablets or capsules before switching to the combination tablet.
Preporuča se da bolesnici uzimaju amlodipin i valsartan u odvojenim tabletama ili kapsulama prije prelaska na kombiniranu tabletu.
This means that Amlodipine/Valsartan Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exforge.
To znači da je Amlodipin/Valsartan Mylan sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Exforge.
Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Valsartan je „antagonist receptora angiotenzina II”, što znači da blokira djelovanje hormona angiotenzina II u tijelu.
The strength of the tablet to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Jačina tablete koja se uzima ovisi o dozama amlodipina ili valsartana koje je bolesnik uzimao prije.
When calcium enters the cells in the muscles of blood vessel walls, this causes contraction.
Ulazak kalcija u stanice u mišićima stjenki krvnih žila uzrokuje kontrakciju.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Amlodipine/Valsartan Mylan has been shown to have comparable quality and to be bioequivalent/be comparable to Exforge.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Amlodipin/Valsartan Mylan posjeduje usporedivu kvalitetu te je bioekvivalentan/usporediv s lijekom Exforge.
Amlodipine/Valsartan Mylan amlodipine / valsartan
Amlodipin/Valsartan Mylan amlodipin/valsartan
By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen.
Blokiranjem receptora na koje se angiotenzin II inače veže valsartan sprečava djelovanje tog hormona, čime omogućava širenje krvnih žila.
By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Smanjujući protok kalcija u stanicama, amlodipin sprečava kontrakciju stanica te na taj način omogućava opuštanje krvnih žila.
Because Amlodipine/Valsartan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je lijek Amlodipin/Valsartan Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
This is a summary of the European public assessment report (EPAR) for Amlodipine/Valsartan Mylan.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Amlodipin/Valsartan Mylan.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Amlodipine/Valsartan Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Amlodipin/Valsartan Mylan nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
For more information about treatment with Amlodipine/Valsartan Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Amlodipin/Valsartan Mylan pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
What measures are being taken to ensure the safe and effective use of Amlodipine/Valsartan Mylan?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Amlodipin/Valsartan Mylan?
The Committee recommended that Amlodipine/Valsartan Mylan be approved for use in the EU.
Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Amlodipin/Valsartan Mylan u EU-u.
Amlodipine/Valsartan Mylan is a medicine used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Amlodipin/Valsartan Mylan lijek je koji se primjenjuje u bolesnika s esencijalnom hipertenzijom (visokim krvnim tlakom) koja se ne može odgovarajuće kontrolirati samo amlodipinom ili valsartanom. „Esencijalna” znači da ne postoji očiti uzrok hipertenzije.
Because Amlodipine/Valsartan Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exforge.
Budući da je Amlodipin/Valsartan Mylan generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Exforge.
Other information about Amlodipine/Valsartan Mylan
Ostale informacije o lijeku Amlodipin/Valsartan Mylan
A risk management plan has been developed to ensure that Amlodipine/Valsartan Mylan is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Amlodipin/Valsartan Mylan.
What is Amlodipine/Valsartan Mylan and what is it used for?
Što je Amlodipin/Valsartan Mylan i za što se koristi?
It is not intended to provide practical advice on how to use Amlodipine/Valsartan Mylan.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Amlodipin/Valsartan Mylan.
Amlodipine/Valsartan Mylan contains two active substances, amlodipine and valsartan.
Amlodipin/Valsartan Mylan sadrži dvije djelatne tvari, amlodipin i valsartan.
What are the benefits and risks of Amlodipine/Valsartan Mylan?
Koje su koristi i rizici lijeka Amlodipin/Valsartan Mylan?
Therefore, the CHMP's view was that, as for Exforge, the benefit outweighs the identified risk.
Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Exforge.
For practical information about using Amlodipine/Valsartan Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Amlodipin/Valsartan Mylan pročitajte u uputi o lijeku ili se obratite svom liječniku ili ljekarniku.
Why is Amlodipine/Valsartan Mylan approved?
Zašto je lijek Amlodipin/Valsartan Mylan odobren?
How is Amlodipine/Valsartan Mylan used?
Kako se Amlodipin/Valsartan Mylan koristi?
How does Amlodipine/Valsartan Mylan work?
Kako djeluje Amlodipin/Valsartan Mylan?
How has Amlodipine/Valsartan Mylan been studied?
Kako je Amlodipin/Valsartan Mylan ispitivan?
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Stranica2/2
Horses were examined at days 14, 35 and 63.
Konji su pregledani 14., 35. i 63. dana.
Substantial improvement occurs in the next 48 hours with complete resolution in the following two weeks.
Znatno poboljšanje nastupa u sljedećih 48 sati, a potpuno povlačenje nuspojava u sljedeća dva tjedna.
Further information on HorStem can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/horstem.
Više informacija o VMP-u HorStem nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/horstem.
Other information about HorStem
Ostale informacije o VMP-u HorStem
Stem cells can develop into other types of cells.
Matične stanice mogu se razviti u druge vrste stanica.
In case of severe inflammation, treatment with an anti-inflammatory medicine (NSAID) might be necessary.
U slučaju teške upale može biti potrebno primijeniti terapiju nesteroidnim protuupalnim lijekovima (NSAID).
Why is HorStem authorised in the EU?
Zašto je HorStem odobren u EU-u?
Hands should be washed after handling the medicine.
Nakon rukovanja VMP-om treba oprati ruke.
It is not clear exactly how HorStem works in horses with osteoarthritis.
Nije poznato na koji način točno djeluje HorStem u konja s osteoartritisom.
What is HorStem and what is it used for?
Što je HorStem i za što se primjenjuje?
This overview was last updated in February 2019.
Pregled informacija posljednji je put ažuriran u 2. 2019.
These properties are expected to play a role in the effect of HorStem.
Očekuje se da ta svojstva imaju ulogu u djelovanju VMP-a HorStem.
Care should be taken to avoid accidental self-injection.
Potrebno je postupati oprezno kako bi se izbjeglo nehotično samoinjiciranje.
Mesenchymal stem cells can have effects on the immune system as well as anti-inflammatory effects and can possess tissue regenerative properties.
Mezenhimske matične stanice mogu djelovati na imunosni sustav te mogu imati protuupalne učinke i sposobnost regeneracije tkiva.
The withdrawal period for meat from horses treated with HorStem is ‘zero' days, which means that there is no mandatory waiting time.
Razdoblje karencije za meso konja liječenih VMP-om HorStem iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.
These are stem cells taken from the umbilical cord of donor horses when a foal is born and grown in a laboratory to increase their numbers.
To su matične stanice iz krvi pupkovine konja donora nakon rođenja ždrebeta, uzgojene u laboratoriju radi povećanja njihova broja.
HorStem received a marketing authorisation valid throughout the EU on 19 June 2019.
Za VMP HorStem izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 19/06/2019.
The European Medicines Agency decided that HorStem's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od VMP-a HorStem nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
U slučaju nehotičnog samoinjiciranja potrebno je odmah potražiti savjet liječnika te mu pokazati uputu o VMP-u ili etiketu.
Twelve HorStem treated horses were successfully treated (success rate 75%) at day 63 compared to only 4 of the control group (success rate 25%).
Liječenje VMP-om HorStem u 12 konja bilo je uspješno (stopa uspješnosti 75 %) 63. dana liječenja u usporedbi s uspješnim liječenjem u samo 4 konja iz kontrolne skupine (stopa uspješnosti 25 %).