natgillin/translations-raw huggingface dataset:
Subcutaneous use
stekleničko s (govedo)
50 ml
50 odmerki Ni smiselno (ovce)
50 ml
s 50 odmerki Ni smiselno (ovce)
Box of 10 bottles of 50 doses each
EU/ 2/ 09/ 094/ 005
N/ A (Cattle), N/ A (Sheep)
Steklenička
1/ 2 EU/ 2/ 09/ 094/ 005
Škatla z 1 Ni smiselno
Cattle, Sheep
tipa I s
Type I glass bottle with a chlorobutyl rubber stopper and aluminium cap
klorobutilno gumijasto zaporko
10 ml
10 odmerki Ni smiselno (ovce)
BTVPUR AlSap 8, suspension for injection.
BTVPUR AlSap 8 suspenzija za injiciranje.
Active substances:. Bluetongue virus serotype 8 antigen (*) equivalent to titre prior to inactivation (log10)
Virus modrega jezika, serotip 8, antigen ………………………………………………. ≥ 7. 1 CCID50 * (*) Ekvivalent titru pred inaktivacijo (log 10)
Adjuvants:.
Dodatki:.
Aluminium hydroxide 2.7 mg.
Aluminijev hidroksid ………………………………………………………………………… 2. 7 mg.
Saponin 30 HU**(**) Haemolytic units
Saponin ……………………………………………………………………………………… 30 HU ** (**) Hemolizne enote
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8. *(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ ml, indicating no infectious virus transmission )”
Aktivna imunizacija ovac in goveda proti virusu modrega jezika, serotip 8, za preprečitev viremije * in zmanjšanje kliničnih znakov. * (pod stopnjo detekcije z validirano metodo RT- PCR pri 3. 14log10 RNA kopijah/ ml, ni prenosa virusa)
The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.
Trajanje imunosti še ni dokončno ugotovljeno niti pri govedu niti pri ovcah, dosedanji rezultati študij, ki še potekajo pa dokazujejo, da traja imunost pri ovcah vsaj 6 mesecev po osnovnem cepljenju.
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days) A transient increase in body temperature, normally not exceeding an average of 1.1°C, may occur within 24 hours after vaccination.
Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1. 1 °C.
Safety throughout pregnancy in cows is not yet fully established however interim results demonstrate safety in at least the last trimester of pregnancy in cows.
Pri kravah varnost uporabe med brejostjo še ni bila dokončno potrjena, vendar vmesni rezultati študij, ki še potekajo, dokazujejo varnost vsaj v zadnjem trimesečju brejosti.
In this category of animals the vaccine should be used only according to the benefit/ risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/ tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
Avoid bubble formation, as this can be irritating at the site of injection.
Izogibajte se nastanku zračnih mehurčkov saj le- ti lahko povzročijo draženje na mestu dajanja.
• Primary vaccination In sheep
• Osnovno cepljenje Ovce
- One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals
- Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2. 5 meseca
born to immune sheep).
starosti pri mladičih imunih ovc).
- 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals
- Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2. 5 meseca
born to immune cattle).
starosti pri mladičih imunih krav).
- 2nd injection: after 3-4 weeks
- Drugi odmerek: po 3- 4 tednih
3 • Revaccination As the duration of immunity is not yet fully established in cattle or sheep, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
• Ponovno cepljenje Ker trajanje imunosti pri govedu in ovcah še ni dokončno ugotovljeno, se je potrebno za vsak program ponovnega cepljenja dogovoriti s pristojnimi nacionalnimi organi ali odgovornim veterinarjem, upoštevajoč pri tem epidemiološko situacijo.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
3 4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine.
Drugi učinki, razen tistih ki so navedeni v poglavju 4. 6, niso bili opaženi po dajanju dvakratnega odmerka cepiva.
4.11 Withdrawal period
4. 11 Karenca
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08 (cattle).
Farmakoterapevtska skupina: cepivo proti virusu modrega jezika; oznaka ATC vet QI04AA02 (ovce) in QI02AA08 (govedo).
Silicon antifoam Phosphate buffer Glycine Buffer
Silikon (proti penjenju) Fosfatni pufer Glicerinski pufer
Shelf life of the veterinary medicinal product as package for sale:
12 mesecev.
1 year Shelf life after first opening the immediate packaging: immediately after broaching
Rok uporabnosti po prvem odpiranju stične ovojnine: takoj po prvem odpiranju
Store and transport refrigerated (2°C – 8°C) Do not freeze Protect from light
Zdravilo ne sme zmrzniti.
Polypropylene bottle of 50 or 100 ml with butyl elastomere closure Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml)
Škatla z 10 plastenkami s 50 odmerki (10 x 50 ml).
4 Type I glass bottle of 10 ml with butyl elastomere closure Box of 1 bottle of 10 doses (1 x 10 ml)
Škatlica z 1 stekleničko z 10 odmerki (1 x 10 ml).
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
4 6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
MERIAL 29, avenue Tony Garnier 69007 Lyon FRANCE
MERIAL 29, avenue Tony Garnier 69007 Lyon FRANCIJA
17/ 03/ 2009
{DD/ MM/ LLLL}
03/ 2009
{MM/ LLLL}
The import, sale, supply and/ or use of BTVPUR AlSap 8 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba BTVPUR AlSap 8 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use BTVPUR AlSap 8 must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati BTVPUR AlSap 8, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred vnosom/ uvozom, prodajo, oskrbo in/ ali uporabo.
MANUFACTUREROF THE BIOLOGICAL ACTIVE SUBSTANCEAND MANUFACTURING AUTHORISATION HOLDERRESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN( ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Velika Britanija
MERIAL Laboratory of Lyon Porte des Alpes Rue de l’ Aviation, 69800 Saint-Priest France
MERIAL Laboratory of Lyon Porte des Alpes Rue de l’ Aviation, 69800 Saint- Priest Francija
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/ 82/ ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik tega dovoljenja za promet mora obvestiti Evropsko skupnost o marketinških aktivnostih vezanih na to zdravilo za uporabo v veterinarski medicini.
The following substances are included in Annex II of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Naslednje substance so vključene v Dodatek II Uredbe Sveta (ES) No 2377/ 90 kot je navedeno v tabeli:
Animal species
Marker ostanek
Aluminium hydroxide Saponin
Aluminijev hidroksid
All All
Vse
EC 2796/ 95 EC 1433/ 96
EC 2796/ 95
The Applicant is required to submit in 6 months following the authorisation of the product, an action plan together with timelines for all points that require resolution in order for the authorisation to revert to normal status.
Predlagatelj je dolžan v 6 mesecih po odobritvi dovoljenja za promet predložiti načrt ukrepov s časovnimi okvirji za vsa vprašanja, ki jih je še potrebno rešiti, da dobi dovoljenje za promet normalni status.
The above information will be evaluated and approved by the CVMP and will form part of the subsequent annual reassessment.
Predloženi podatki bodo ocenjeni in potrjeni s strani CVMP in bodo del letne ponovne ocene.
For the first and subsequent annual reassessments the Marketing Authorisation Holder should provide annually an updated risk assessment on the continuous use of the vaccine taking into account the continued need for the vaccine, its history of use over the previous twelve months and progress made in addressing the items that require resolution in order for the authorisation to revert to normal status.
Za prvo in nadaljnja letna ponovna ocenjevanja mora imetnik dovoljenja za promet letno predložiti posodobljeno oceno tveganja stalne uporabe cepiva, upoštevajoč pri tem nadaljnje potrebe po cepivu, uporabo cepiva v preteklih 12 mesecih in napredek pri razreševanju vprašanj, ki jih je še potrebno rešiti, da dobi dovoljenje za promet normalni status.
The Applicant is required to submit 6-monthly Periodic Update Safety reports starting once the MA has been approved and, in addition to the legal requirements applicable to reporting of suspected adverse reactions, the Applicant is required to specifically monitor and evaluate the following suspected adverse reactions in the PSURs: abortions, spontaneous death, effects on milk production, local reactions, pyrexia, lethargy and hypersensitivity reactions, including severe allergic reactions.
Predlagatelj mora pri pripravi PSUR posebno pozorno spremljati in ocenjevati naslednje možne neželene učinke: abortuse, pogine, vplive na proizvodnjo mleka, lokalne reakcije, povišano telesno temperaturo, letargičnost in reakcije hipersenzitivnosti vključno z alergičnimi reakcijami.
The frequency of submissions of PSUR reports will be assessed at the annual reassessment of the product.
Pogostnost predaje PSUR bo ocenjena ob letni ponovni oceni tega zdravila za uporabo v veterinarski medicini.
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10 PODATKI NA ZUNANJI OVOJNINI PODATKI NA STIČNI OZ.
Each dose of 1ml of vaccine contains:
Vsak odmerek (1ml) cepiva vsebuje: antigen BTV8 ≥ 7. 1 CCID50 *
BTV8 antigen ≥ 7.1 CCID50* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
1 odmerek (*) (*) glejte navodilo za uporabo
Sheepand cattle
Ovce in govedo.
Active immunisation of sheep and cattle to prevent, viraemia and clinical signs caused by the bluetongue virus serotype 8.
Aktivna imunizacija ovc in goveda proti virusu modrega jezika, serotip 8, za preprečitev viremije in kliničnih znakov.
Subcutaneous use Read the package leaflet before use.
Pred uporabo preberite navodilo za uporabo.
Withdrawal period: zero days
Nič dni.
EXP {month/ year} Shelf life after first opening the immediate packaging: immediately after broaching
EXP {mesec/ leto} Rok uporabnosti po prvem odpiranju stične ovojnine: takoj po prvem odpiranju.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO “ SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
For animal treatment only – to be supplied only on veterinary prescription
Samo za živali - na veterinarski recept.
EU/ 2/ 09/ 094/ 001 EU/ 2/ 09/ 094/ 002
EU/ 2/ 09/ 094/ 001 EU/ 2/ 09/ 094/ 002 EU/ 2/ 09/ 094/ 003
12 EU/ 2/ 09/ 094/ 003 EU/ 2/ 09/ 094/ 004 EU/ 2/ 09/ 094/ 005
12 EU/ 2/ 09/ 094/ 004 EU/ 2/ 09/ 094/ 005
BTV 8 antigen.................................................................................................................. ...≥ 7.1 CCID50
Antigen BTV8 …………………………………………… ≥ 7. 1 CCID50
ROUTE(S) OF ADMINISTRATION
POT( I) UPORABE ZDRAVILA
EXP {month/ year} Once broached, use immediately
EXP {mesec/ leto} Po odprtju uporabite takoj.
14 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
PRIMARNI OVOJNINI
Each dose of 1ml of vaccine contains Bluetongue virus serotype 8 antigen............... ...≥ 7.1 CCID50
Vsak odmerek (1ml) cepiva vsebuje: virus modrega jezika, serotip 8, antigen ……………………………………… ≥ 7. 1 CCID50
Read package leaflet before use
Pred uporabo preberite navodilo za uporabo.
Active immunisation of sheep and cattle to prevent viraemia and clinical signs caused by the bluetongue virus serotype 8.
Aktivna imunizacija ovc in goveda proti virusu modrega jezika, serotip 8, za preprečitev viremije in zmanjšanje kliničnih znakov.
Do not freeze Protect from light.
Zaščitite pred svetlobo.
17 PACKAGE LEAFLET FOR:
17 NAVODILO ZA UPORABO
MERIAL 29 avenue Tony Garnier 69007 Lyon, France
MERIAL 29 avenue Tony Garnier 69007 Lyon, Francija
BTVPUR AlSap 8 suspension for injection
BTVPUR AlSap 8suspenzija za injiciranje
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGEIH SESTAVIN
Each dose of 1 ml of vaccine contains:
Vsak odmerek (1ml) cepiva vsebuje:
Bluetongue virus serotype 8 antigen ....................................................................≥ 7.1 CCID50* Aluminium hydroxide ........................................................................................................2.7 mg
Virus modrega jezika, serotip 8, antigen ……………………………………………... … ≥ 7. 1 CCID50 * Aluminijev hidroksid ……………………………………………………………………………... 2. 7 mg Saponin ………………………………………………………………………………………… 30 HU ** (*) Ekvivalent titru pred inaktivacijo (log10) (**) Hemolizne enote
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8 (BTV 8). *below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission
Aktivna imunizacija ovac in goveda proti virusu modrega jezika, serotip 8 (BTV8), za preprečitev viremije * in zmanjšanje kliničnih znakov. * pod stopnjo detekcije z validirano metodo RT- PCR pri 3. 14log10 RNA kopijah/ ml, ni prenosa virusa
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days).
Po cepljenju se lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 32 cm2),
A transient increase in body temperature, normally not exceeding an average of 1.1°C, may occur within 24 hours after vaccination.
Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1. 1 °C.
- 2nd injection: after 3-4 weeks.
- Drugi odmerek: po 3- 4 tednih
• Revaccination As the duration of immunity is not yet fully established in cattle or sheep, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Ker trajanje imunosti pri govedu in ovcah še ni dokončno ugotovljeno, se je potrebno za vsak program ponovnega cepljenja dogovoriti s pristojnim nacionalnim organom ali odgovornim veterinarjem, upoštevajoč pri tem epidemiološko situacijo.
Store and transport refrigerated (2 °C – 8 °C).
Zdravilo ne sme zmrzniti.
19 Shelf life after first opening the immediate packaging: immediately after broaching Do not use after the expiry date (EXP) which is stated on the carton and the label.
19 Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
SPECIAL WARNINGS
POSEBNO( A) OPOZORILO( A)
Safety throughout pregnancy in cows is not yet fully established however interim results demonstrate safety in at least the last trimester of pregnancy in cows.
Pri kravah varnost uporabe v brejosti še ni bila dokončno potrjena, vendar vmesni rezultati študij, ki še potekajo, dokazujejo varnost vsaj v zadnjem trimesečju brejosti.
In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/ tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami kompetentnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
No adverse reactions except those mentioned in section ‘adverse reaction’ were observed after the administration of a double-dose of vaccine.
Drugi učinki, razen tistih, ki so navedeni v poglavju neželeni učinki, niso bili opaženi po dajanju dvojnega odmerka cepiva.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu /.
The vaccine contains inactivated bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants.
Cepivo vsebuje inaktiviran virus modrega jezika, serotip 8, z aluminijevim hidroksidom in saponini kot adjuvansoma.
20 Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Škatla z 10 plastenkami s 100 odmerki (1 x 100 ml).
EMEA/ V/ C/ 0106 EMEA/ CVMP/ 254129/ 2006
EMEA/ V/ C/ 0106 EMEA/ CVMP/ 343602/ 2006
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) CERENIA
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
This document cannot replace a face- to-face discussion with your veterinarian.
Pojasnjuje, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil opravljene raziskave, na podlagi česar je oblikoval priporočila glede uporabe zdravila Ta dokument ne more nadomestiti osebnega pogovora z veterinarjem.
Cerenia contains the active substance maropitant and is available as tablet or as solution for injection.
Zdravilo Cerenia vsebuje zdravilno učinkovino maropitant, na razpolago pa je v obliki tablet ali kot raztopina za injiciranje.
The tablets are pale-orange and have a score line on both sides so that they can be halved.
Tablete so bledo oranžne barve in imajo zarezo na obeh straneh, tako da jih je mogoče razpoloviti.
Each tablet is marked with the Pfizer logo on one side and with the letters “ MPT” and the quantity of maropitant on the other side.
Vsaka tableta je na eni strani označena z logom družbe Pfizer, na drugi strani pa s črkami “ MPT ” in številkami, ki označujejo količino maropitanta.
The solution for injection is clear and colourless to light yellow.
Raztopina za injiciranje je bistra in brezbarvna do svetlo rumena.
Cerenia is an anti-emetic, this means that it stops vomiting.
Zdravilo Cerenia je antiemetik, kar pomeni, da preprečuje bruhanje.
It is used in dogs to prevent vomiting such as vomiting caused by chemotherapy (medicines used for the treatment of cancer, some of which are known to cause vomiting).
Uporablja se pri psih za preprečevanje bruhanja kot je na primer bruhanje, povzročeno s kemoterapijo (zdravila, ki se uporabljajo za zdravljenje rakavih obolenj, pri čemer je za nekatera izmed njih znano, da povzročajo bruhanje).
In combination with supportive measures such as other veterinary treatment or a special diet, Cerenia can also be used in the treatment of vomiting (either as injection or as injection followed by tablets).
V kombinaciji s podpornimi ukrepi, kot so drugo veterinarsko zdravljenje ali posebna dieta, se zdravilo Cerenia lahko uporablja tudi pri zdravljenju bruhanja (bodisi kot injekcija, ali pa kot injekcija, ki ji sledi uporaba tablet).
For these purposes, Cerenia can be given for up to five days.
Za te namene se lahko zdravilo Cerenia daje do pet dni.
Cerenia tablets can also be used in a higher dosage for a maximum of two days to prevent vomiting due to motion (travel) sickness when a dog tends to vomit when travelling by car.
Tablete Cerenia se največ dva dneva lahko uporabljajo tudi v večjih odmerkih za preprečevanje bruhanja, ki je posledica slabosti zaradi vožnje, ko so psi nagnjeni k bruhanju, kadar se prevažajo z avtomobilom.
Cerenia blocks a neurokinin 1 (NK1) receptor, which acts in the central nervous system.
Zdravilo Cerenia zavre neurokinin 1 (NK1) receptor, ki je dejaven v osrednjem živčnem sistemu.
It prevents a peptide (“ Substance P”) from binding to the NK1 receptors, which is involved in causing vomiting.
Preprečuje, da bi se peptid (“ substanca P ”), ki sodeluje pri povzročanju bruhanja, vezal na NK1 receptorje.
By stopping “ Substance P”, Cerenia acts as an anti-emetic.
Z zavrtjem “ substance P ” zdravilo Cerenia deluje kot antiemetik.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged additional treatment.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Cerenia raziskano?
Dogs were treated with either 1 mg/ kg (injection) or 2 mg/ kg (tablet) once daily up to 5 days.
Pse so zdravili bodisi z dajanjem odmerkov 1 mg/ kg (injekcije) ali 2 mg/ kg (tablete), enkrat dnevno v obdobju do 5 dni.
In order to study the effect of Cerenia in motion sickness, dogs known to vomit when travelling were taken on car journeys lasting several hours for up to 2 days.
Da bi lahko preučevali učinek zdravila Cerenia pri slabosti zaradi vožnje, so pse, za katere je bilo znano, da med potovanji bruhajo, vzeli na večurne vožnje z avtomobilom v obdobju do 2 dni.
The animals received either Cerenia tablets at a dose of 8 mg/ kg bodyweight or a placebo of up to 2 days.
Živali so prejemale bodisi tablete zdravila Cerenia v odmerku 8 mg/ kg telesne mase ali pa placebo v obdobju do 2 dni.
What benefit has Cerenia shown during the studies?
Kakšne koristi je zdravilo Cerenia izkazalo v raziskavah?
The results of the studies showed that Cerenia was more effective than the placebo: less vomiting was seen in dogs that received the medicine than in dogs that received a placebo, both in the treatment or in the prevention of vomiting.
Rezultati raziskav so pokazali, da je bilo zdravilo Cerenia bolj učinkovito kot pa placebo: pri psih, ki so prejeli zdravilo, so ugotovili manj bruhanja kot pri psih, ki so prejeli placebo, in sicer tako pri zdravljenju kot pri preprečevanju bruhanja.