FrancophonIA/ELRC3.0 huggingface dataset:
English: Antibody titres drop over the course of the 3-year duration of immunity, although dogs are protected when challenged.
Slovenian: Titer protiteles pade v obdobju triletnega trajanja imunosti, kljub temu so psi zaščiteni, če so izpostavljeni okužbi.
English: The duration of immunity against CAV-2 was not established by challenge.
Slovenian: Trajanje imunosti proti CAV-2 virusu z izzivom ni bilo ugotovljeno.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae), živa virusna cepiva.
English: It was shown that 3 years after the vaccination CAV-2 antibodies are still present.
Slovenian: Dokazano je bilo, da so 3 leta po cepljenju, protitelesa proti CAV-2 še vedno prisotna.
English: A transient swelling (up to 5 cm) may commonly be observed at the injection site following subcutaneous administration in dogs.
Slovenian: Prehodna oteklina (do 5 cm) se lahko pogosto pojavi na mestu injiciranja po subkutani aplikaciji pri psih.
English: The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies.
Slovenian: Učinkovitost komponente za steklino po enkratnem odmerku v starosti od 12 tednov naprej je dokazana v laboratorijskih študijah.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: At least one year following the primary vaccination course for canine parainfluenza virus.
Slovenian: Vsaj eno leto po osnovnem cepljenju proti virusu pasje parainfluence.
English: However, in field studies 10% of seronegative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Slovenian: Študije na terenu so pokazale, da pri 10 % serološko negativnih psov ne pride do serološke konverzije (> 0,1 i.e./ml) 3-4 tedne po enkratnem cepljenju proti steklini.
English: If such a reaction occurs, appropriate treatment should be administered without delay.
Slovenian: V primeru pojava je potrebno takojšnje ustrezno zdravljenje.
English: However, in a minority of animals pain was observed at the injection site immediately after administration of a 10-fold overdose of the vaccine.
Slovenian: Pri manjšem številu živali so opazili bolečino na mestu injiciranja takoj po dajanju 10-krat prevelikega odmerka cepiva.
English: A single dose of Versican Plus DHPPi should be given every 3 years.
Slovenian: Enkratni odmerek Versican Plus DHPPi je potrebno dati vsaka 3 leta.
English: VIAL (1 ML SOLVENT)
Slovenian: VIALA (1 ML VEHIKEL)
English: Annual re-vaccination is required for Parainfluenza, therefore a single dose of compatible vaccine Versican Plus Pi can be used annually as required.
Slovenian: Vsako leto je treba ponoviti cepljenje proti virusu parainfluence, za kar se lahko uporabi enkratni odmerek kompatibilnega cepiva Versican Plus Pi.
English: Solvent: clear colourless liquid.
Slovenian: Vehikel: bistra brezbarvna tekočina.
English: Solve nt: Water for injections (Aqua ad iniectabilia)
Slovenian: voda za injekcije (Aqua ad iniectabilia)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po
English: Immunological responses to the CDV, CAV and CPV components of the vaccine may be delayed due to maternally derived antibody interference.
Slovenian: Imunski odgovor na komponente cepiva CDV, CAV in CPV je lahko zapoznel zaradi navzkrižnega delovanja maternalnih protiteles.
English: The mixed vaccines should be injected immediately via the subcutaneous route.
Slovenian: Zmešani cepivi je treba takoj injicirati subkutano.
English: The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination.
Slovenian: Vakcinalni sev CPV-2b ni bil preizkušen na drugih mesojedih (z izjemo psov in domačih mačk), ki so dovzetni za pasje parvoviruse, zato je po cepljenju treba cepljene pse od njih ločiti.
English: Hypersensitivity reactions (e.g. gastrointestinal signs such as diarrhoea and vomiting, anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur rarely.
Slovenian: Preobčutljivostne reakcije (gastrointestinalni znaki, kot so driska in bruhanje, anafilaksa, angioedem, dispneja, cirkulatorni šok, kolaps) se redko pojavljajo.
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versiguard Rabies and Versican Plus L4.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen za Versiguard Rabies in Versican Plus L4.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus Types 1 and 2, and canine parainfluenza virus.
Slovenian: Cepivo je namenjeno aktivni imunizaciji zdravih pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo virus pasje kuge, pasji parvovirus, pasji adenovirus tipa 1 in 2 in virus pasje parainfluence.
English: However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CDV, CAV and CPV at levels equal or higher to those likely to be encountered under field conditions.
Slovenian: Dokazano je, da je cepivo učinkovito ob prisotnosti maternalnih protiteles za CDV, CAV in CPV ob ravneh, ki so enake ali višje, kot jih običajno srečamo v terenskih pogojih.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: 50 x 1 dose
Slovenian: 25 x 1 odmerek 50 x 1 odmerek
English: Shake well and immediately inject the entire contents (1 ml) of the reconstituted product.
Slovenian: Pred uporabo dobro pretresite in takoj injicirajte živali celotno rekonstituirano vsebino (1 ml).
English: Canine adenovirus Type 2
Slovenian: Pasji adenovirus tipa 2
English: Lyophilisate: Trometamol Edetic acid Sucrose Dextran 70
Slovenian: Liofilizat: trometamol edetna kislina saharoza dekstran 70
English: EXPIRY DATE EXP {month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
English: Once mixed, the contents of the vial should appear a pink/red or yellowish colour with a slight opalescence.
Slovenian: Po mešanju mora vsebina viale izgledati rožnato/rdeče ali rumenkaste barve z rahlo opaloscenco.
English: − 3 weeks after completion of the primary course for CPiV.
Slovenian: − 3 tedne po zaključku osnovnega cepljenja proti CPiV.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku.
English: Incompatibilities: Do not mix with any other veterinary medicinal product other than those mentioned above.
Slovenian: Ne mešajte z nobenimi drugimi zdravili za uporabo v veterinarski medicini razen s tistimi navedenimi zgoraj.
English: Although the efficacy of the rabies fraction has been demonstrated following administration at 12 weeks, at the discretion of the veterinary surgeon, in case of need, dogs younger than 8 weeks can be vaccinated with Versican Plus DHPPi mixed with Versiguard Rabies as the safety of this association has been demonstrated in 6 week old dogs.
Slovenian: Čeprav je bila učinkovitost komponente proti steklini dokazana pri dajanju v starosti 12 tednov, se v primeru, da je to potrebno in ob presoji veterinarja, s cepivom Versican Plus DHPPi, ki se ga zmeša s cepivom Versiguard Rabies lahko cepi pse, mlajše od 8 tednov, ker je bila varnost te kombinacije v starosti 6 tednov pri psih dokazana.
English: Dosage and route of administration:
Slovenian: Odmerjanje in pot uporabe:
English: First dose: Versican Plus DHPPi from 8-9 weeks of age.
Slovenian: Prvi odmerek: Versican Plus DHPPi od starosti 8-9 tednov naprej.
English: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Slovenian: Vsaj tri leta po osnovnem cepljenju proti virusu pasje kuge, pasjemu adenovirusu tipa 1, pasjemu adenovirusu tipa 2 in pasjemu parvovirusu.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04/07/2014.
Slovenian: Datum pridobitve dovoljenja za promet: 04.07.2014.
English: Second dose: Versican Plus DHPPi mixed with Versiguard Rabies 3-4 weeks later, but not before 12 weeks of age.
Slovenian: Drugi odmerek: Versican Plus DHPPi zmešamo z Versiguard Rabies 3-4 tedne kasneje, vendar ne pred starostjo 12 tednov.
English: In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥ 0.5 IU/ml).
Slovenian: V primeru potovanja na območja z večjim tveganjem ali izven EU se lahko veterinarji odločijo za dodatna cepljenja proti steklini po 12. tednu starosti, da zagotovijo titer protiteles v višini ≥ 0,5 i.e./ml, ki na splošno velja za učinkovito zaščito in obenem izpolnjuje zahteve za potovanje živali (titer protiteles ≥ 0.5 i.e./ml).
English: Lyophilisate and solvent for suspension for injection.
Slovenian: Liofilizat in vehikel za suspenzijo za injiciranje.
English: Reconstituted vaccine: whitish to yellowish colour with a slight opalescence.
Slovenian: Rekonstituirano cepivo: belkaste do rumenkaste barve, rahlo opalescentno.
English: Name and address of the manufacturer of the biological active substances
Slovenian: Ime in naslov proizvajalca(proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
English: Manufacturer responsible for batch release:
Slovenian: BELGIJA Proizvajalec odgovoren za sproščanje serij:
English: Canine distemper virus, strain CDV Bio 11/A
Slovenian: Virus pasje kuge, sev CDV Bio 11/A
English: Aseptically reconstitute the lyophilisate with the solvent.
Slovenian: Aseptično rekonstituirajte liofilizat z vehiklom.
English: STATEMENT OF ACTIVE SUBSTANCES Each dose of 1 ml contains:
Slovenian: Vsak odmerek po 1 ml vsebuje:
English: Rabies:
Slovenian: Steklina:
English: Revaccination scheme:
Slovenian: Ponovno cepljenje:
English: Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of solvent.
Slovenian: Plastična škatla s 25 vialami (s po 1 odmerkom) liofilizata in 25 vialami (po 1 ml) vehikla.
English: The contents of a single vial of Versican Plus DHPPi should be reconstituted with the contents of a single vial of Versiguard Rabies (instead of the solvent).
Slovenian: Vsebino 1 viale zdravila Versican Plus DHPPi je treba rekonstituirati z vsebino 1 viale zdravila Versiguard Rabies (namesto vehikla).
English: − to prevent mortality and clinical signs caused by canine adenovirus type 1,
Slovenian: − za preprečevanje smrtnosti in kliničnih znakov, ki jih povzroča pasji adenovirus tipa 1,
English: Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of solvent.
Slovenian: Plastična škatla s 50 vialami (s po 1 odmerkom) liofilizata in 50 vialami (po 1 ml) vehikla.
English: Canine parvovirus Type 2b, strain CPV-2b Bio 12/B
Slovenian: Pasji parvovirus tipa 2b, sev CPV-2b Bio 12/B
English: Canine parvovirus Type 2b
Slovenian: Pasji parvovirus tipa 2b
English: If protection against Leptospira is required dogs can be vaccinated with two doses of Versican Plus DHPPi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Slovenian: Če je potrebno pse zaščititi pred leptospirozo jih lahko cepimo z dvema odmerkoma Versican Plus DHPPi, ki ga zmešamo z Versican Plus L4 v razmaku 3-4 tednov od starosti 6 tednov naprej: Vsebino 1 viale zdravila Versican Plus DHPPi je treba rekonstituirati z vsebino 1 viale zdravila Versican Plus L4 (namesto vehikla).
English: Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Slovenian: Viala iz stekla tipa I, ki vsebuje 1 odmerek liofilizata, zaprta z zamaškom iz brombutilne gume in aluminijasto zaporko.
English: Type I glass vial containing 1 ml of solvent closed with a chlorobutyl rubber stopper and aluminium cap.
Slovenian: Viala iz stekla tipa I, ki vsebuje 1 ml vehikla, zaprta z zamaškom iz klorobutilne gume in aluminijasto zaporko.
English: Pack sizes:
Slovenian: Velikosti pakiranja:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus.
Slovenian: − za preprečevanje kliničnih znakov (izcedek iz smrčka in oči) in zmanjšanje izločanja virusa, ki jih povzroča virus pasje parainfluence.
English: Lyophilisate (live attenuated):
Slovenian: Učinkovina(e): Liofilizat (živi, atenuirani):
English: Canine adenovirus Type 2, strain CAV-2 Bio 13
Slovenian: Pasji adenovirus tipa 2, sev CAV-2 Bio 13
English: − to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,
Slovenian: − za preprečevanje kliničnih znakov in zmanjšanje izločanja virusa, ki jih povzroča pasji adenovirus tipa 2,
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Special warnings for each target species:
Slovenian: POSEB NO(A) OPOZORILO(A) Posebna opozorila za vsako ciljno živalsko vrsto:
English: − to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus, and
Slovenian: − za preprečevanje kliničnih znakov, levkopenije in izločanja virusa, ki jih povzroča pasji parvovirus, in
English: Primary vaccination scheme: Two doses of Versican Plus DHPPi 3-4 weeks apart from 6 weeks of age.
Slovenian: Osnovno cepljenje: Dva odmerka cepiva Versican Plus DHPPi v razmaku 3-4 tednov od starosti 6 tednov naprej.
English: Some animals may also not show titres > 0.5 IU/ml after the primary vaccination.
Slovenian: Posamezne živali lahko ne dosežejo titra protiteles proti virusu stekline v višini ˃ 0,5 i.e./ml, po prvem cepljenju.
English: Canine parainfluenza Type 2 virus
Slovenian: Virus pasje parainfluence tipa 2
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
Slovenian: Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
English: EXP {month/year} Once reconstituted, use immediately.
Slovenian: Rekonstituirano zdravilo uporabite takoj.
English: − to prevent mortality and clinical signs caused by canine distemper virus,
Slovenian: − za preprečevanje smrtnosti in kliničnih znakov, ki jih povzroča virus pasje kuge,
English: SPECIAL WARNING(S)
Slovenian: INDIKACIJA(E)
English: No other adverse effects other than those mentioned under “Adverse reactions” have been observed after administration of a 10-fold overdose of the vaccine.
Slovenian: Po dajanju 10-krat prevelikega odmerka cepiva ni bilo opaziti drugih neželenih učinkov, razen tistih, navedenih v poglavju »Neželeni učinki«.
English: The live attenuated virus vaccine strains CAV-2, CPiV and CPV-2b may be shed by vaccinated dogs following vaccination, shedding of CPV has been shown for up to 10 days.
Slovenian: Cepljeni psi lahko po cepljenju izločajo žive atenuirane vakcinalne seve CAV-2, CPiV in CPV-2b.
English: PACKAGE LEAFLET: Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs
Slovenian: Versican Plus DHPPi liofilizat in vehikel za suspenzijo za injiciranje za pse
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Aqua ad iniectabilia
Slovenian: Aqua ad iniectabilia
English: Once mixed, the contents of the vial should appear a whitish to yellowish colour with a slight opalescence.
Slovenian: Po mešanju mora vsebina viale izgledati belkasto do rumenkasto z rahlo opaloscenco.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Onset of immunity:
Slovenian: Nastop imunosti:
English: MARKETING AUTHORISATION HOLDER
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs
Slovenian: NAVODILO ZA UPORABO Versican Plus DHPPi liofilizat in vehikel za suspenzijo za injiciranje za pse
English: Minimum Maximum
Slovenian: Najmanj
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca(proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij Bioveta, a.s.,
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate for dogs
Slovenian: Versican Plus DHPPi liofilizat za pse
English: EXPIRY DATE
Slovenian: EXP.
English: Canine distemper virus
Slovenian: Virus pasje kuge
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains:
Slovenian: Vsak odmerek po1 ml vsebuje:
English: Lyophilisate: spongy matter of white colour.
Slovenian: Liofilizat: bela gobasta snov.
English: Active substances:
Slovenian: Osnovno cepljenje:
English: STATEMENT OF THE MRLs Not applicable.
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi solvent for dogs
Slovenian: Versican Plus DHPPi vehikel za pse
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: 103.6 TCID50
Slovenian: 4.11 Karenca
English: Immediate Packaging Pack size
Slovenian: Stična ovojnina Velikost pakiranja
English: The MAM should be prepared fresh daily.
Slovenian: MAM se mora pripravljati dnevno sveža.
English: Appropriate treatment and equipment should be readily available.
Slovenian: Ustrezno zdravljenje in oprema morajo biti takoj na voljo.
English: Continue until a solid residue remains.
Slovenian: Nadaljujte dokler ne ostane ostanek.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
English: A separate cannula should be used.
Slovenian: Uporabljati moramo ločeno kanilo.
English: Higher doses might be justified in some clinical
Slovenian: Višje doze so lahko upravičene v nekaterih kliničnih
English: Incubate for 10 minutes in this condition.
Slovenian: V tem stanju inkubirajte 10 minut.
English: - If you have any further questions, ask your doctor.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: The product label includes the appropriate storage conditions and the expiry date for the product.
Slovenian: Signatura na izdelku vključuje ustrezne pogoje shranjevanja in datum izteka roka uporabnosti izdelka.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: Use aseptic technique throughout.
Slovenian: Vseskozi uporabljajte aseptično tehniko.
English: Swirl gently for 10 seconds in order to ensure complete dissolution of the powder.
Slovenian: Nežno vrtinčite 10 sekund da zagotovite popolno raztapljanje praška.
English: Equipment and Materials
Slovenian: Oprema in materiali
English: below)
Slovenian: spodaj)
English: See section 4.4
Slovenian: Glejte poglavje 4.4.
English: Pregnancy and lactation.
Slovenian: Nosečnost in dojenje.
English: Treatment of an overdose should be directed towards the support of vital functions.
Slovenian: Zdravljenje prevelikega odmerka mora biti usmerjeno na podpiranje življenskih funkcij.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Slovenian: Vsako žensko, ki ji je izostala menstruacija, moramo šteti za nosečo, dokler se ne dokaže drugače.
English: A value of at least 90% should be obtained in a satisfactory preparation.
Slovenian: Za zadovoljivo pripravo mora doseči vrednost A najmanj 90%.
English: 91192 GIF sur YVETTE cedex FRANCE
Slovenian: 91192 GIF sur YVETTE cedex FRANCIJA
English: The peptide itself has a lower affinity for these receptors.
Slovenian: Peptid sam po sebi ima nižjo afiniteto za te receptorje.
English: Instructions for reconstitution, handling and disposal are given in section 12.
Slovenian: Navodila za rekonstitucijo, ravnanje in odlaganje so navedena v poglavju 12.
English: Trained hospital staff will ensure the correct storage of NeoSpect.
Slovenian: Šolano bolnišnično osebje, bo zagotovilo pravilno shranjevanje NeoSpecta.
English: (The saturated sodium chloride solution can be reused.
Slovenian: (Nasičeno raztopino natrijevega klorida se lahko ponovno uporabi.
English: Toxic effects observed in the animal studies were not considered to be relevant in clinical use in humans.
Slovenian: Smatra se, da škodljivi učinki opaženi v študijah na živalih, niso relevantni za klinično uporabo pri človeku.
English: It tells you about your medicine.
Slovenian: Vsebuje podatke o vašem zdravilu.
English: If any of the above mentioned conditions are applicable to you, you should inform your doctor.
Slovenian: Če katerokoli od navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika.
English: Percent 99mTc-depreotide: 100 - (A + B).
Slovenian: Odstotni delež 99mTc-depreotida: 100 - (A+B).
English: In the same prevalence range the positive predictive value was in the range 52-72%.
Slovenian: Pri istem razponu prevalence je bila pozitivna napovedna vrednost 52-72%.
English: The ammonium acetate solution can be used for up to one month.
Slovenian: Raztopino amonijevega acetata lahko uporabljate do mesec dni.
English: The vial should not be cooled under running water, as this may impede labelling.
Slovenian: Viale ne smete ohladiti pod tekočo vodo, ker to lahko poškoduje označevanje.
English: Repeat administration must be avoided.
Slovenian: Večkratni uporabi se moramo izogibati.
English: Unlabelled NeoSpect should not be administered directly to the patient.
Slovenian: Neoznačenega NeoSpecta se ne sme dajati direktno bolniku.
English: Allow the vial to cool to body temperature (about 15 minutes) at room temperature before proceeding.
Slovenian: Pustite, da se viala ohladi na telesno temperaturo (približno 15 minut) pri sobni temperaturi preden nadaljujete.
English: All were uncommon (0.1%-1%) in occurrence.
Slovenian: Vsi neželeni učinki so se pojavljali redko (0,1% -1%).
English: The use of NeoSpect does involve exposure to small amounts of radioactivity, however your doctor will always consider the possible risks and benefits when considering the use of this product.
Slovenian: Uporaba NeoSpecta vključuje izpostavljenost majhni količini radioaktivnosti, vendar bo vaš zdravnik vedno pretehtal možno tveganje in koristi, ko bo presojal o uporabi tega izdelka.