natgillin/translations-raw huggingface dataset:
Co-administration of darunavir with low dose ritonavir and alfuzosin is contraindicated (see section 4.3).
Sočasna uporaba darunavirja z majhnim odmerkom ritonavirja in alfuzosina je kontraindicirana (glejte poglavje 4.3).
Darunavir co-administered with low dose ritonavir and rilpivirine can be used without dose adjustments.
Darunavir z majhnim odmerkom ritonavirja se lahko uporablja z rilpivirinom brez prilagajanja odmerkov.
The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 14 treatmentexperienced paediatric patients, aged 3 to < 6 years and weighing at least 15 kg to < 20 kg, showed that weight-based dosages resulted in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 600/100 mg twice daily (see section 4.2).
Pri 14 pediatričnih bolnikih (starih od 3 do <6 let in s telesno maso najmanj 15 kg do < 20 kg), predhodno zdravljenih s protiretrovirusnimi zdravili, so farmakokinetični podatki darunavirja v kombinaciji z ritonavirjem dvakrat na dan pokazali, da je bila na osnovi telesne mase določenih odmerkov, izpostavljenost darunavirju primerljiva izpostavljenosti pri odraslih, ki so dvakrat na dan prejemali 600 mg/100 mg odmerek kombinacije darunavirja/ritonavirja (glejte poglavje 4.2).
Boosted darunavir is expected to increase these antipsychotic plasma concentrations.
Pričakovati je, da okrepljeni darunavir zveča plazemske koncentracije teh antipsihotikov.
A once daily dose regimen of darunavir taken with ritonavir taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Bolniki, predhodno zdravljeni s protiretrovirusnimi zdravili, in ki nimajo z rezistenco na darunavir povezanih mutacij (DRV-RAM - Resistance-Associated Mutations)*in imajo < 100.000 kopij/ml HIV-1 RNK v plazmi ter število CD4+ celic ≥ 100 celic x 10
Otherc mean CD4+ cell count change from baseline (x 10
Povprečna sprememba št. CD4+ celic glede na začetek (x 10
An increase of systemic exposure to darunavir was observed when darunavir co-administered with 100 mg ritonavir was co-administered with rifabutin (150 mg once every other day).
Pri sočasni uporabi darunavirj s 100 mg ritonavirja in rifabutina (150 mg rifabutina enkrat vsak drugi dan) so opažali zvečanje sistemske izpostavljenosti darunavirju.
Boosted darunavir is expected to increase these antiarrhythmic plasma concentrations.
Pričakovati je, da okrepljeni darunavir zvečuje plazemsko koncentracijo navedenih antiaritmikov.
It is not recommended to combine darunavir co-administered with low dose ritonavir with saquinavir.
Kombiniranje darunavirja z majhnim odmerkom ritonavirja in sakvinavirja ni priporočljivo.
Darunavir Mylan 400 mg film-coated tablets Each film-coated tablet contains 400 mg of darunavir.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Darunavir Mylan 400 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 400 mg darunavirja.
Systemic dexamethasone should be used with caution when combined with darunavir co-administered with low dose ritonavir.
Pri sočasni uporabi sistemskega deksametazona in darunavirja skupaj z majhnim odmerkom ritonavirja je potrebna previdnost.
Darunavir Mylan 400 mg film-coated tablets are white to off-white, oval shaped with two curved sides, marked with M on one side and DV4 on the other side.
Zdravilo Darunavir Mylan 400 mg filmsko obložene tablete so bele do belkaste, ovalne, na obeh straneh izbočene, filmsko obložene tablete z vtisnjeno oznako M na eni strani in DV4 na drugi tablete.
CD4+ cell count mean change from baseline b a
Št celic CD4+ povprečna sprememba glede na začetne vrednosti b a
Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either: - 600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) together with 100 milligram ritonavir twice daily.
Odmerek za odrasle, ki ste že prejemali protiretrovirusno zdravljenje (to bo določil vaš zdravnik) Odmerek je lahko: - 800 miligramov darunavirja (dve tableti po 400 miligramov darunavirja ali ena tableta po 800 miligramov darunavirja) skupaj s 150 miligrami kobicistata ali s 100 miligrami ritonavirja enkrat na dan. ALI - 600 miligramov darunavirja (dve tableti zdravila po 300 miligramov darunavirja ali ena tableta po 600 miligramov darunavirja) skupaj s 100 miligrami ritonavirja dvakrat na dan.
Once daily dosing Weight
Odmerjanje dvakrat na dan telesna masa:
Darunavir Mylan 600 mg film-coated tablets EU/1/16/1140/030
Darunavir Mylan 300 mg filmsko obložene tablete EU/1/16/1140/030
No adjustment of methadone dosage is required when initiating coadministration with boosted darunavir.
Ob uvedbi sočasnega zdravljenja z okrepljenim darunavirjem prilagajanje odmerka metadona ni potrebno.
Darunavir is expected to increase these antiarrhythmic plasma concentrations.
Pričakovati je, da darunavir zvečuje plazemsko koncentracijo navedenih antiaritmikov.
The Summary of Product Characteristics of cobicistat or ritonavir as appropriate, must therefore be consulted prior to initiation of therapy with darunavir.
Pred uvedbo terapije z darunavirjem morate zato prebrati tudi Povzetek glavnih značilnosti zdravila za kobicistat ali ritonavir.
Manufacturers
Starostniki
Based on pharmacokinetic modeling, this dosage reduction of 75% is also applicable if patients
Na osnovi podatkov pridobljenih s farmakokinetičnim modeliranjem, je 75 % zmanjšanje odmerka priporočljivo tudi, če bolniki prejemajo rifabutin v odmerkih različnih od 300 mg/dan.
Darunavir co-administered with low dose ritonavir can be coadministered with proton pump inhibitors without dose adjustments.
Darunavir z majhnim odmerkom ritonavirja lahko uporabljamo sočasno z zaviralci protonske črpalke, brez prilagajanja odmerka.
Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Lurazidon, pimozid, kvetiapin ali sertindol zdravljenje psihiatričnih motenj alkaloidi ergot (ergotamin, dihidroergotamin, ergometrin in metilergonovin)
Concomitant use of boosted darunavir with lovastatin and simvastatin is therefore contraindicated (see section
Zato je sočasna uporaba okrepljenega darunavirja z lovastatinom in simvastatinom kontraindicirana (glejte poglavje 4.3).
Last Observation Carried Forward imputation c
Preskušanje z uporabo darunavirja, označenega s
excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails - muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis
včasih tudi ponoči - koprivnica, zelo otečena koža in druga tkiva (najpogosteje ustnic ali oči), ekcem, prekomerno potenje, nočno potenje, izguba las, akne, koža, ki se lušči, obarvanje nohtov - bolečina v mišicah, krči ali šibkost v mišicah, bolečine v okončinah, osteoporoza
Darunavir co-administered with low dose ritonavir and nevirapine can be used without dose adjustments.
Darunavir z majhnim odmerkom ritonavirja se lahko kombinira z nevirapinom brez prilagajanja odmerkov.
Darunavir given with low dose ritonavir may be considered as an alternative.
Kot alternativno zdravljenje se lahko uporabi darunavir z majhnim odmerkom ritonavirja.
Darunavir/ritonavir 600/100 mg twice daily + OBR N=298
Izid darunavir/ritonavir 600 mg/100 mg dvakrat na dan + OBR N=298
When administration of pravastatin and boosted darunavir is required, it is recommended to start with the lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety.
Če je potrebna sočasna uporaba pravastatina in okrepljenega darunavirja, je priporočljivo, da zdravljenje začnete z najmanjšim možnim odmerkom pravastatina, ki ga nato, ob spremljanju varnosti, zvečujete do kliničnega učinka.
Imputations according to the TLOVR algorithm.
Pripisane vrednosti, izračunane z uporabo algoritma TLOVR.
patients receiving the combination with darunavir co-administered with ritonavir.
Pri nekaterih bolnikih so poročali o omotici med zdravljenjem s shemami, ki so vključevale darunavir z majhnim odmerkom ritonavirja.
ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg) In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Pri bolnikih, predhodno zdravljenih z ART, ki nimajo DRV-RAM * in imajo plazemsko koncentracijo HIV-1 RNK < 100,000 kopij/ml in število CD4+ celic ≥ 100 celic x 10
Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child's doctor will determine this) - The usual dose of darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily.
Odmerek za odrasle, ki še niso jemali protiretrovirusnih zdravil (to bo določil zdravnik) Običajni odmerek darunavirja je 800 miligramov (dve 400-miligramski tableti darunavirja ali ena 800-miligramska tableta darunavirja) enkrat na dan.
The concomitant use with boosted darunavir may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Bolnike je treba spremljati zaradi tveganja za dolgotrajno ali zakasnjeno depresijo dihanja.
Medicinal products that affect darunavir exposure (ritonavir as pharmacoenhancer)
Zdravila, ki vplivajo na izpostavljenost darunavirju (farmakokinetični ojačevalec je ritonavir) Darunavir in ritonavir se presnavljata s CYP3A.
Co-administration of boosted darunavir and alfuzosin is contraindicated (see section 4.3).
Sočasno dajanje okrepljenega darunavirja in alfuzosina je kontraindicirano (glejte poglavje 4.3).
Concomitant use of darunavir with low dose ritonavir and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids)
Sočasna uporaba darunavirja skupaj z majhnim odmerkom ritonavirja in kortikosteroidov, ki se presnavljajo s CYP3A (npr. flutikazonpropionat ali drugi inhalacijsko ali intranazalno dani kortikosteroidi), lahko poveča tveganje za razvoj sistemskih učinkov kortikosteroidov, vključno s Cushingovim sindromom in supresijo nadledvične žleze.
≥ 15 kg-< 30 kg 600 mg darunavir/100 mg ritonavir once daily
96. tedenb izidi darunavir/ ritonavir 800 mg/100 mg enkrat na dan
If you notice within 12 hours, you must take the tablets immediately.
Če ste pozabili vzeti zdravilo Darunavir Mylan Če to opazite v 12 urah, morate vzeti tablete takoj.
It is not recommended to coadminister darunavir with low dose ritonavir and boceprevir.
Sočasna uporaba darunavirja z majhnim odmerkom ritonavirja in z boceprevirjem ni priporočljiva.
Co administration of darunavir coadministered with cobicistat and bosentan is not recommended.
Sočasna uporaba darunavirja s kobicistatom in bosentanom ni priporočljiva.
No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of darunavir/ ritonavir 800/100 mg once daily was 162.5 weeks.
Povprečno je zdravljenje z darunavirjem/ritonavirjem 800 mg/100 mg enkrat na dan trajalo 162,5 tednov.
Darunavir Mylan 800 mg film-coated tablets PVC/PE/PVDC-Al blister pack containing 30 tablets and 30x1 tablets.
PVC/PE/PVdC-aluminijevi pretisni omoti s po 30 filmsko obloženimi tabletami in 30 x1 filmsko obloženo tableto.
HIV-1 RNA < 50 copies/mla mean HIV-1 RNA log change from baseline (log10 copies/ml)
HIV-1 RNK < 50 kopij/mla povprečna logaritemska sprememba koncentracije HIV-1 RNA od izhodišča (log10 kopij/ml) povprečna sprememba števila celic CD4+ od izhodiščab a pripisane vrednosti po algoritmu TLOVR
You will require a different dose of darunavir which cannot be administered with these 600 milligram tablets.
Odmerek za odrasle, ki še niso jemali protiretrovirusnih zdravil (to bo določil zdravnik) Potrebovali boste odmerek, ki se ga ne da doseči s 600-miligramskimi tabletami darunavirja.
Date of first authorisation: 13/04/2000 Date of last renewal: 22/03/2010
Datum pridobitve prvega dovoljenja za promet: 13/04/2000 Datum zadnjega podaljšanja dovoljenja za promet: 22/03/2010
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite kakršnekoli resne ali druge stranske učinke, ki niso omenjeni v teh navodilih, obvestite svojega veterinarja.
ATC vet code: QI06AD
Oznaka ATC vet: QI06AD
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno)
Vaccination of FeLV positive cats is of no benefit.
Cepljenje FeLV pozitivnih mačk ni smiselno.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.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) http://www.ema.europa.eu
F-69800 SAINT PRIEST
F-69800 SAINT PRIEST FRANCIJA
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant or by appropriate channels approved for use by the competent authorities.
Odpadne snovi odstranite s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
V izjemnih primerih se lahko pojavi preobčutljivostna reakcija, ki jo je treba ustrezno simptomatično zdraviti
Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections.
Kalijev dihidrogen fosfat Natrijev dihidrogenfosfat dihidrat Magnezijev klorid heksahidrat Kalcijev klorid dihidrat Voda za injiciranje
first injection: from 8 weeks of age, second injection: 3 to 5 weeks later.
prvi odmerek: od osmega tedna starosti dalje, drugi odmerek: 3 do 5 tednov pozneje.
Use immediately after broaching.
Uporabite takoj po odprtju.
Do not mix with any other vaccine or immunological product except Merial non-adjuvanted vaccine range.
Ne mešajte z nobenim drugim cepivom ali imunološkim zdravilom, razen z Merialovimi neadjuviranimi cepivi.
Duration of immunity:1 year after the last vaccination.
Trajanje imunosti: eno leto po zadnjem cepljenju.
10 x 1-ml suspension (10 doses) 20 x 1-ml suspension (20 doses) 50 x 1-ml suspension (50 doses)
10 x 1 ml suspenzije (10 odmerkov) 20 x 1 ml suspenzije (20 odmerkov) 50 x 1 ml suspenzije (50 odmerkov)
Laboratoire Lyon Gerland 254, rue Marcel Mérieux F-69007 Lyon FRANCE
Laboratoire de Lyon Gerland 254, rue, Marcel Mérieux F-69007 LYON FRANCIJA
Plastic box containing 10, 20 or 50 type I glass bottle with a Butyl elastomer closure and sealed with an aluminium cap.
Plastična škatla z 10, 20 ali 50 stekleničkami iz stekla tipa I z butilelastomerno zaporko, zapečateno z aluminijastim pokrovčkom.
Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCE
Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCIJA
Shelf life of the veterinary medicinal product as packaged for sale: 2 years Use immediately after broaching.
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti Uporabite takoj po odprtju.
Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
V naravi je infektivna le podskupina A. in imunizacija proti podskupini A zagotavlja tudi popolno zaščito proti A, B in C. Po inokulaciji virus izraža zaščitne proteine, vendar se v mački ne množi.
Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Aktivna imunizacija mačk, starih osem tednov ali več, proti mačji levkemiji za zaščito pred perzistentno viremijo in kliničnimi znaki bolezni.
Do not use in pregnant animals.
Ne uporabite pri brejih živalih.
Name and address of the manufacturer of the biological active substance(s)
Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin).
Store and transport refrigerated (2°C - 8°C), Protect from light.
Shranjujte pri temperaturi 2 °C - 8 °C (v hladilniku), zaščiteno pred svetlobo.
No undesirable effect has been observed after the administration of several doses except those mentioned in the “Adverse reactions” section.
Po vnosu večkratnih odmerkov cepiva niso opazili nobenih drugih učinkov razen tistih, navedenih v poglavju »Neželeni učinki«.
Purevax FeLV Suspension for injection
Purevax FeLV suspenzija za injiciranje
EU/2/00/019/005 10 doses: 1-ml suspension (10 bottles) EU/2/00/019/006 20 doses: 1-ml suspension (20 bottles) EU/2/00/019/007 50 doses: 1-ml suspension (50 bottles)
EU/2/00/019/006 20 odmerkov: 1 ml suspenzije (20 stekleničk) EU/2/00/019/007 50 odmerkov: 1 ml suspenzije (50 stekleničk)
Administer one dose of 1ml according to the following schedule: Basic vaccination:
Dajte en odmerek po1 ml po naslednjem razporedu: Osnovno cepljenje:
The vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
Cepni sev je rekombinantni poxvirus kanarčkov, ki izraža env in gag gene FeLV-A.
Each dose of 1ml contains:
Vsak odmerek (1ml) vsebuje:
Plastic box containing 10, 20 or 50 bottles Not all pack sizes may be marketed.
Plastična škatla z 10, 20 ali 50 stekleničkami.
Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Imetnik dovoljenja za promet z zdravilom: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Purevax FeLV suspension for injection
Purevax FeLV Suspenzija za injiciranje.
As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Posledica tega je, da cepivo spodbudi imunsko odpornost proti virusu mačje levkemije.
Transient lethargy and hyperthermia may occur for 1 day, exceptionally 2 days.
Lahko se pojavita prehodna letargičnost in povišana temperatura, ki trajata en dan in le izjemoma dva dni.
Onset of immunity:2 weeks after primary vaccination course.
Nastop imunosti: dva tedna po prvem cepljenju.
A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4 weeks
Na mestu injiciranja se lahko pojavi manjši vozlič (< 2cm), ki je prehoden in izgine v enem do štirih tednih
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali -na veterinarski recept.
Potassium chloride Sodium chloride
Kalijev klorid
It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Pred cepljenjem je priporočljivo opraviti test za ugotavljanje prisotnosti antigenov za FeLV.
Manufacturing authorisation holder responsible for batch release MERIAL
Izdelovalec, odgovoren za sprostitev serije: MERIAL
A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4 weeks.
NEŽELENI UČINKI Na mestu injiciranja se lahko pojavi manjši vozlič (<2cm), ki je prehoden in izgine v enem do štirih tednih.
EXP (mm/yy) Use immediately after broaching
EXP {mm/ll} Uporabite takoj po rekonstituciji.
Subcutaneous use
Subkutano dajanje
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je cepivo varno zmešati z Merialovimi neadjuviranimi cepivi za mačke (več kombinacij mačjih cepiv s komponentami proti virusnemu rinotraheitisu, calicivirozi, panleukopenji in klamidiozi) in/ali varno aplicirati isti dan, vendar ne zmešano z Merialovimi adjuviranimi cepivi proti steklini.
FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije (vCP97) ….. ≥ 10 7,2 CCID50
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccines (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and rabies components).
Podatki o varnosti in učinkovitosti cepiva so pokazali, da je cepivo varno aplicirati isti dan vendar ne zmešano z Merialovimi adjuviranimi cepivi (različne kombinacije cepiv s komponentami proti virusnemu rinotraheitisu, calicivirozi, panleukopenji in steklini).
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
4.2 Indications for use,specifying the target species
4.2 Indikacije za uporabo
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in aplicira z Merialovimi neadjuviranimi cepivi (različne kombinacije komponent virusnega rinotraheitisa mačk, kaliciviroze,
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGE(IH) SNOVI
annual
enkrat letno
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDEOSKRBE IN UPORABE
D. STATEMENT OF THE MRLs
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
GLEDE VARNE IN UČINKOVITE UPORABE
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
NAVODILO ZA UPORABO ZA: Purevax FeLV Suspenzija za injiciranje IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA
Keep out of the reach and sight of children.
Zdravilo shranjujte nedosegljivo otrokom.
FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50 (cell culture infective dose 50%)
Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije(vCP97)…..
The recommended starting dose is one capsule three times a day.
Priporočeni začetni odmerek je ena kapsula trikrat na dan.
The full EPAR for Yargesa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Yargesa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Yargesa.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Yargesa.
What measures are being taken to ensure the safe and effective use of Yargesa?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Yargesa?
As a result, glucosylceramide builds up in different parts of the body, such as the spleen, liver and bones.
Glukozilceramid se posledično kopiči v različnih delih telesa, npr. v vranici, jetrih in kosteh.
The Committee recommended that Yargesa be approved for use in the EU.
Priporočil je, da se zdravilo Yargesa odobri za uporabo v EU.
As for every medicine, the company provided studies on the quality of Yargesa.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Yargesa.