FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not mix Zometa reconstituted solution with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Slovenian: Ne mešajte rekonstituirane raztopine zdravila Zometa z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
English: Efficacy results are provided in Table 3.
Slovenian: Rezultate učinkovitosti kaže preglednica 3.
English: BPI mean change from baseline
Slovenian: BPI: povprečne spremembe od izhodišča
English: The other ingredients are mannitol, sodium citrate and water for injections.
Slovenian: - Druge sestavine zdravila so manitol, natrijev citrat in voda za injiciranje.
English: Very common (may affect more than 1 in 10 people): Low level of phosphate in the blood.
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): huda okvara ledvic (običajno jo ugotovi zdravnik z določenimi specifičnimi krvnimi preiskavami), nizka raven kalcija v krvi.
English: You must not be given Zometa if you are breast-feeding.
Slovenian: Če dojite, vam ne smejo dati zdravila Zometa.
English: Respiratory, thoracic and mediastinal disorders Common:
Slovenian: tahikardija Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
English: Multipack comprising ten packs, each containing one vial and one ampoule of solvent 5 ml.
Slovenian: prašek in vehikel za raztopino za infundiranje zavoj z več ovojninami obsega deset ovojnin, od katerih vsaka vsebuje eno vialo in eno ampulo vehikla po 5 ml.
English: Zometa 4 mg/100 ml solution for infusion zoledronic acid
Slovenian: Zometa 4 mg/100 ml raztopina za infundiranje zoledronska kislina
English: Patients must be maintained well hydrated prior to and following administration of Zometa.
Slovenian: Bolniki morajo biti pred dajanjem zdravila Zometa in po njem dobro hidrirani.
English: Table 4 Efficacy results (breast cancer and multiple myeloma patients)
Slovenian: Preglednica 4 Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom)
English: FOLDING BOX - OUTER CONTAINER OF MULTIPACK (WITH BLUE BOX)
Slovenian: ŠKATLA - ZUNANJI VSEBNIK SKUPNEGA PAKIRANJA (Z "BLUE BOX" PODATKI)
English: Do not mix Zometa concentrate with calcium-containing or other divalent cationcontaining solutions such as lactated Ringer's solution.
Slovenian: Ne mešajte koncentrata zdravila Zometa z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
English: As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije).
English: Stable for 24 hours at 2C - 8C after further dilution in 100 ml physiological saline or 5% w/v glucose solution.
Slovenian: Po dodatnem razredčenju v 100 ml fiziološke raztopine ali 5-% m/v raztopine glukoze stabilno 24 ur pri 2 °C - 8 °C.
English: Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zometa therapy.
Slovenian: Pred začetkom zdravljenja z zdravilom Zometa je treba izmeriti vrednost kalcija v serumu in odpraviti morebitno hipokalciemijo.
English: There was no accumulation of zoledronic acid in plasma after multiple doses given every 28 days.
Slovenian: Po več odmerkih, danih vsakih 28 dni, se zoledronska kislina ni kopičila v plazmi.
English: Skin and subcutaneous tissue disorders Uncommon:
Slovenian: Bolezni kože in podkožja občasni:
English: This medicinal product must not be allowed to come into contact with any calcium-containing solutions and it must not be mixed or given intravenously with any other medicinal product in the same infusion line.
Slovenian: Prav tako zdravila ne smemo mešati ali dajati intravensko skupaj z drugimi zdravili z istim infuzijskim sistemom.
English: There have been very rare cases of drowsiness and sleepiness with the use of Zometa.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ob uporabi zdravila Zometa v zelo redkih primerih prišlo do dremavosti in zaspanosti.
English: Zometa 4 mg powder and solvent for solution for infusion
Slovenian: Zometa 4 mg prašek in vehikel za raztopino za infundiranje
English: Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Slovenian: Če ste noseči ali če dojite, se posvetujte z zdravnikom, preden vzamete katerokoli zdravilo.
English: The adverse reactions ranked under headings of frequency, are presented in Table 7.
Slovenian: V preglednici 7 so prikazani neželeni učinki, razvrščeni po pogostnosti.
English: Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Slovenian: O zlomih dolgih kosti spodnjih okončin so pri bolnikih s hudo obliko osteogenesis imperfecta, ki so prejemali zoledronsko kislino, poročali v približno 24 % (zlom stegnenice) in v 14 % (zlom golenice) v primerjavi z enakovrednimi bolniki, ki so prejemali pamidronat, pri katerih so o zlomu stegnenice poročali v 12 %, o zlomu golenice pa v 5 %.
English: The withdrawn amount of reconstituted solution must be diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Slovenian: Odvzeto količino rekonstituirane raztopine morate razredčiti v 100 ml sterilne 0,9-odstotne m/v raztopine natrijevega klorida ali 5-odstotne m/v raztopine glukoze.
English: Immune system disorders Uncommon:
Slovenian: Bolezni imunskega sistema občasni:
English: Patients were evenly distributed between zoledronic acid-treated and placebo groups.
Slovenian: V obe skupini, zdravljeni bodisi z zoledronsko kislino bodisi s placebom, so bile bolnice razporejene enakomerno.
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Slovenian: Da ne bi prišlo do možnih inkompatibilnost, mora biti infuzijska raztopina, ki se uporablja za razredčenje, bodisi 0,9-odstotna m/v raztopina natrijevega klorida bodisi 5odstotna m/v raztopina glukoze.
English: Thrombocytopenia, leukopenia
Slovenian: trombocitopenija, levkopenija redki:
English: General disorders and administration site conditions Common:
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti:
English: NA Not Applicable
Slovenian: NR ni bil dosežen;
English: From a microbiological point of view, the diluted solution for infusion should be used immediately.
Slovenian: - Z mikrobiološkega stališča je razredčeno raztopino za infundiranje najbolje uporabiti takoj.
English: Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): glavobol in gripi podoben sindrom, ki ga sestavljajo zvišana telesna temperatura, utrujenost, šibkost, zaspanost, mrazenje in bolečine v kosteh, sklepih in/ali mišicah.
English: The adverse reactions ranked under headings of frequency, are presented in Table 6.
Slovenian: V preglednici 6 so prikazani neželeni učinki, razvrščeni po pogostnosti.
English: Placeb o zoledronic acid 4 mg
Slovenian: zdravljenje kosti z obsevanjem zoledronska kislina 4 mg
English: Urticaria.
Slovenian: Dojenje
English: Withdraw an appropriate volume of the reconstituted solution (4 mg/5 ml) as needed: - 4.4 ml for 3.5 mg dose
Slovenian: Odvzemite ustrezni volumen rekonstituirane raztopine (4 mg/5 ml), kot sledi: - 4,4 ml za odmerek 3,5 mg
English: High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation, abdominal pain, dry mouth.
Slovenian: zamegljen vid, solzenje oči, občutljivost oči na svetlobo, nenaden občutek hladu z izgubo zavesti, mlahavost ali kolaps (padec zaradi nenadnega znižanja krvnega tlaka), oteženo dihanje s piskanjem ali kašljem, koprivnica.
English: Zometa 4 mg powder for solution for infusion zoledronic acid
Slovenian: Zometa 4 mg prašek za raztopino za infundiranje zoledronska kislina
English: Unit packs containing 1 bottle.
Slovenian: Posamezno pakiranje vsebuje 1 plastenko.
English: To avoid potential incompatibilities, Zometa concentrate is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Slovenian: Da se izognete možnim nezdružljivostim, razredčite koncentrat zdravila Zometa z 0,9-odstotno m/v raztopino natrijevega klorida ali 5-odstotno m/v raztopino glukoze.
English: Fractures*
Slovenian: zlomi*
English: This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Zdravila ne smemo mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: Zometa reconstituted solution must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Rekonstituirane raztopine zdravila Zometa se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: Solution for infusion
Slovenian: voda za injekcije
English: FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AND 4 AMPOULES AS UNIT PACK (INCLUDING BLUE BOX
Slovenian: ŠKATLA ZA 4 VIALE IN 4 AMPULE KOT ENOTA PAKIRANJA (VKLJUČENI PODATKI ZA “BLUE BOX”)
English: Very rare (may affect up to 1 in 10,000 people):
Slovenian: Čimprej povejte zdravniku za kateregakoli od naslednjih neželenih učinkov: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
English: Zometa concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Koncentrata zdravila Zometa se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: After dilution: From a microbiological point of view, the diluted solution for infusion should be used immediately.
Slovenian: Po redčenju: z mikrobiološkega stališča je razredčeno raztopino za infundiranje najbolje uporabiti takoj.
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving Zometa.
Slovenian: O osteonekrozi čeljustnic so občasno poročali pri bolnikih, ki so prejemali zdravilo Zometa v kliničnih preskušanjih ali so se z njim zdravili po začetku trženja zdravila.
English: White to off-white powder and clear, colourless solvent.
Slovenian: prašek in vehikel za raztopino za infundiranje bel do sivo bel prašek in bister, brezbarven vehikel
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zometa.
Slovenian: Poročali so tudi o posameznih primerih osteonekroze na drugih lokacijah, vključno s kolkom in stegnenico.
English: Clinical trial results in the treatment of TIH
Slovenian: Rezultati kliničnih preskušanj v zdravljenju tumorsko povzročene hiperkalciemije (TIH)
English: FOLDING BOX - UNIT PACK
Slovenian: ŠKATLA - POSAMIČNO PAKIRANJE
English: Component of a multipack comprising 5 packs, each containing 1 bottle.
Slovenian: raztopina za infundiranje skupno pakiranje s 4 pakiranji, od katerih vsako vsebuje 1 plastenko skupno pakiranje s 5 pakiranji, od katerih vsako vsebuje 1 plastenko
English: One vial with 5 ml concentrate contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala s 5 ml koncentrata vsebuje 4 mg zoledronske kisline, kar ustreza 4,264 mg zoledronske kisline monohidrata.
English: To avoid potential incompatibilities, Zometa reconstituted solution is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Slovenian: Da se izognete možnim nezdružljivostim, razredčite rekonstituirano raztopino zdravila Zometa z 0,9odstotno m/v raztopino natrijevega klorida ali 5-odstotno m/v raztopino glukoze.
English: Placebo zoledronic acid 4 mg
Slovenian: zdravljenje kosti z obsevanjem zoledronska kislina 4 mg placebo zoledronska kislina 4 mg placebo zoledronska kislina 4 mg placebo
English: After first opening, Zometa solution for infusion should preferably be used immediately.
Slovenian: Raztopino za infundiranje Zometa je najbolje uporabiti takoj po prvem odpiranju.
English: AMPOULE LABEL
Slovenian: NALEPKA AMPULE
English: Zometa 4 mg powder and solvent for solution for infusion zoledronic acid
Slovenian: Zometa 4 mg prašek in vehikel za raztopino za infundiranje zoledronska kislina
English: FOLDING BOX FOR 1 VIAL AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AS UNIT PACK (INCLUDING BLUE BOX)
Slovenian: ŠKATLA ZA 4 VIALE KOT ENOTA PAKIRANJA (VKLJUČENI PODATKI ZA “BLUE BOX”)
English: Within three days after Zometa administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Slovenian: Pogosto so poročali o reakciji akutne faze, do katere pride v prvih treh dneh po vnosu zdravila Zometa, simptomi pa vključujejo bolečine v kosteh, zvišano telesno temperaturo, utrujenost, artralgijo, mialgijo, okorelost in artritis, ki povzroči otekline sklepov.
English: Weight increase.
Slovenian: - Navodilo shranite.
English: However, such reports have been infrequent.
Slovenian: Te bolečine so bolnike občasno onesposobile, vendar so o takih primerih poročali le redko.
English: Pruritus, rash (including erythematous and macular rash), increased sweating
Slovenian: srbenje, izpuščaj (z eritematoznim in makularnim izpuščajem vred), povečano potenje
English: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
Slovenian: Pri zdravljenju z difosfonati, še posebej pri dolgotrajnem zdravljenju osteoporoze, so poročali o atipičnih subtrohanternih zlomih stegnenice in zlomih diafize stegnenice.
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zometa or after stopping treatment.
Slovenian: Če se med zdravljenjem ali po zaključku zdravljenja z zdravilom Zometa pojavijo simptomi kot so pojav bolečine, ki je prej ni bilo, poslabšanje obstoječe bolečine ali okornost, takoj obvestite zdravnika.
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Slovenian: Če ste prejeli večji odmerek zdravila Zometa, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
English: As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Slovenian: Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov): zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zometa or after stopping treatment.
Slovenian: Če med zdravljenjem ali po zaključku zdravljenja z zdravilom Zometa pride do navedenih simptomov, takoj obvestite svojega zdravnika in zobozdravnika.
English: Bone pain, myalgia, arthralgia, generalised pain
Slovenian: bolečine v kosteh, mialgija, artralgija, bolečine po celem telesu občasni:
English: Sodium citrate Water for injections
Slovenian: 6.1 Seznam pomožnih snovi manitol natrijev citrat voda za injekcije
English: One vial contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.
Slovenian: Ena viala vsebuje 4 mg zoledronske kisline, kar ustreza 4,264 mg zoledronske kisline monohidrata.
English: Uncommon:
Slovenian: konjunktivitis občasni:
English: Hypocalcaemia-related ADRs
Slovenian: Neželeni učinki zaradi hipokalciemije
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Slovenian: bradikardija, aritmija (zaradi hipokalciemije) Bolezni dihal, prsnega koša in mediastinalnega prostora občasni:
English: One vial with 5 ml concentrate for solution for infusion.
Slovenian: koncentrat za raztopino za infundiranje ena viala po 5 ml koncentrata za raztopino za infundiranje.
English: Atypical fractures of the femur
Slovenian: Atipičen zlom stegnenice
English: 1 bottle contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.
Slovenian: 1 plastenka vsebuje 4 mg zoledronske kisline, kar ustreza 4,264 mg zoledronske kisline monohidrata.
English: Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): počasno bitje srca, zmedenost, redko se lahko pojavijo neobičajni zlomi stegnenice, še posebno pri bolnikih, ki so na dolgotrajnem zdravljenju osteoporoze.
English: One bottle contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.
Slovenian: Ena plastenka vsebuje 4 mg zoledronske kisline, kar ustreza 4,264 mg zoledronske kisline monohidrata.
English: Talk to your doctor before you are given Zometa: if you have or have had a kidney problem.
Slovenian: Opozorila in previdnostni ukrepi Preden vam dajo zdravilo Zometa, se posvetujte z zdravnikom: - če imate ali ste imeli težave z ledvicami, - če imate ali ste imeli bolečino, oteklino ali odrevenelost čeljusti, občutek pritiska v čeljusti ali če se vam maje zob.
English: Withdraw the appropriate volume of the liquid concentrate, as follows: 4.4 ml for 3.5 mg dose
Slovenian: Navodila za pripravo zmanjšanih odmerkov zdravila Zometea: Odvzemite ustrezni volumen tekočega koncentrata, kot sledi: 4,4 ml za odmerek 3,5 mg
English: This summary was last updated in June 2014.
Slovenian: Povzetek je bil nazadnje posodobljen junija 2014.
English: The measure of effectiveness was levels of antibodies before and after vaccination.
Slovenian: Merilo učinkovitosti so bile ravni protiteles pred cepljenjem in po njem.
English: Responses in puppies were lower than adult dogs in some cases, because of antibodies inherited from their mothers.
Slovenian: Odzivi pri pasjih mladičih so bili v določenih primerih slabši kot pri odraslih psih, kar je bila posledica protiteles, ki so jih podedovali od mater.
English: In the future, if the animals are exposed to these viruses or bacteria again the immune system will be able to respond more quickly.
Slovenian: Če so živali kasneje izpostavljene tem virusom ali bakterijam, se lahko imunski sistem nanje hitreje odzove.
English: • leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding,
Slovenian: • leptospirozo, tj. bakterijsko boleznijo, ki se lahko prenaša z okuženim urinom in povzroči krvavitve,
English: In situations where puppies are expected to inherit very high antibody levels from the bitch the vaccination protocol should be planned accordingly.
Slovenian: Kadar je mogoče pričakovati, da bodo mladiči od psice podedovali zelo visoke ravni protiteles, je treba načrtovani protokol cepljenja ustrezno prilagoditi.
English: The dogs were either vaccinated twice with a three or four week interval or they received a single annual booster vaccination.
Slovenian: Psi so bili bodisi cepljeni dvakrat v razmiku od treh do štirih tednov, bodisi so prejeli enkraten letni obnovitveni odmerek cepiva.
English: The effectiveness of Versican Plus Pi/L4 was investigated in a field study involving 129 dogs.
Slovenian: Učinkovitost zdravila Versican Plus Pi/L4 so raziskali v terenski študiji, v katero so vključili 129 psov.
English: The field study showed that after vaccination with Versican Plus Pi/L4 the percentage of dogs with protective levels of antibodies for parainfluenza virus ranged from 73 to 97% and for leptospira 59 to 96%.
Slovenian: Terenska študija je pokazala, da je po cepljenju z zdravilom Versican Plus Pi/L4 zaščitne ravni protiteles proti virusu parainfluence razvilo od 73 do 97 % psov, proti leptospiri pa od 59 do 96 % psov.
English: This will help protect them against kennel cough and leptospirosis.
Slovenian: To pomaga zaščititi pse pred kužnim kašljem in leptospirozo.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega samoinjiciranja zdravila se je treba takoj posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali ovojnino.
English: hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation).
Slovenian: hepatitis (vnetje jeter) in zlatenico ali nefritis (vnetje ledvic).
English: The vaccine is given to puppies from six weeks of age as an injection, under the skin, and repeated three to four weeks later.
Slovenian: Cepivo se daje pasjim mladičem, starim šest tednov ali več, z injiciranjem pod kožo, cepljenje pa je treba ponoviti čez tri do štiri tedne.
English: • canine parainfluenza virus, which causes kennel cough;
Slovenian: • virusom pasje parainfluence, ki povzroča kužni kašelj;
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi/L4 on 31 July 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Versican Plus Pi/L4, veljavno po vsej Evropski uniji, izdala dne 31. julija 2014.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi/L4 exceed the risks for the approved indications and recommended that Versican Plus Pi/L4 be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Versican Plus Pi/L4 večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
English: Versican Plus Pi/L4 is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa).
Slovenian: Versican Plus Pi/L4 je cepivo za uporabo v veterinarski medicini, ki vsebuje živ atenuiran (oslabljen) virus pasje parainfluence tipa 2 ter inaktivirane (uničene) seve bakterij Leptospira (icterohaemorrhagiae, canicola, bratislava ter grippotyphosa).
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi/L4 is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Slovenian: Najpogostejši neželeni učinek cepiva Versican Plus Pi/L4 (opažen pri več kot 1 psu od 100) je kratkotrajna oteklina v velikosti do 5 cm, ki se lahko po cepljenju pojavi na mestu injiciranja.