FrancophonIA/ELRC3.0 huggingface dataset:
English: or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Slovenian: ali s katero koli drugo obliko protiretrovirusne terapije, lahko še vedno pride do oportunistične okužbe in drugih zapletov okužbe z virusom HIV.
English: The following may be signs of lactic acidosis: deep rapid breathing drowsiness feeling sick (nausea), being sick (vomiting) stomach pain → If you think you may have lactic acidosis, get medical help immediately.
Slovenian: Naslednji znaki lahko kažejo na laktacidozo: - globoko, hitro dihanje - zaspanost - občutek siljenja na bruhanje, bruhanje - bolečine v trebuhu
English: As of week 144: - The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil /efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine+tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
Slovenian: se je mutacija M184V/I razvila pri 2/19 (10,5 %) izolatov, ki so jih analizirali pri bolnikih v skupini, ki je prejemala emtricitabin/dizoproksiltenofovirat/efavirenz, in pri 10/29 (34,5 %) izolatov, analiziranih pri skupini, ki je prejemala lamivudin/zidovudin/efavirenz (vrednost p < 0,05, Fisherjev test, ki je skupino z emtricitabinom in dizoproksiltenofoviratom primerjal s skupino z lamivudinom/zidovudinom pri vseh bolnikih); noben analiziran virus ni vseboval mutacije K65R ali K70E; genotipska rezistenca za efavirenz, predvsem mutacija K103N, se je razvila v virus pri 13/19 (68 %) bolnikov v skupini, ki je prejemala emtricitabin/dizoproksiltenofovirat/efavirenz, in pri 21/29 (72 %) bolnikov v primerjalni skupini.
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Ob odkritju nenormalnega delovanja ledvic ali sumu nanj se je treba posvetovati z nefrologom in razmisliti o prekinitvi uporabe zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: should not be administered concomitantly with adefovir dipivoxil.
Slovenian: se ne sme sočasno uporabljati z dipivoksiladefoviratom.
English: The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/or tenofovir disoproxil were nausea (12%) and diarrhoea (7%) in an open-label randomised clinical study in adults (GS-01-934, see section 5.1).
Slovenian: Najpogostejša neželena učinka, o katerih so poročali iz odprte, randomizirane klinične študije pri odraslih (GS-01-934, glejte poglavje 5.1), in ki sta bila verjetno oziroma morda povezana z emtricitabinom in/ali dizoproksiltenofoviratom, sta bila navzea (12 %) in driska (7 %).
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV 1 infected paediatric patients aged 2 to < 12 years in clinical study GS-US-104-0352 (see sections 4.8 and 5.1).
Slovenian: Pri pediatričnih bolnikih, starih od 2 do < 12 let, okuženih s HIV-1, so v klinični študiji GS-US-104-0352 poročali o neželenih učinkih na ledvice, skladnih s proksimalno renalno tubulopatijo (glejte poglavji 4.8 in 5.1).
English: should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Slovenian: Bolniki z okužbo s HBV, ki prekinejo zdravljenje z zdravilom Emtricitabin/dizoproksiltenofovirat Krka d.d., potrebujejo natančno spremljanje z ustreznimi kliničnimi in laboratorijskimi preiskavami še vsaj nekaj mesecev po prenehanju zdravljenja.
English: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197)
Slovenian: AUC: ↑ 98 % (↑ 77 do ↑ 123) Cmax: ↑ 79 % (↑ 56 to ↑ 104) Cmin: ↑ 163 % (↑ 137 do ↑ 197)
English: if you are already taking other medicines that contain the components of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: ne jemljite, če že jemljete druga zdravila, ki vsebujejo učinkovine zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24) Cmin: NC
Slovenian: AUC: ↓ 4 % (↓ 32 do ↑ 34) Cmax: ↓ 5 % (↓ 27 do ↑ 24) Cmin: n/i
English: HIV-1 infected patients receiving Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Pri bolnikih s HIV-1, ki se zdravijo z zdravilom Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Antimycobacterials Rifampicin/Tenofovir disoproxil
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami rifampicin/dizoproksiltenofo virat tenofovir:
English: should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: ni dovoljeno uvesti pri pediatričnih bolnikih z ledvično okvaro, pri bolnikih, pri katerih se med zdravljenjem z zdravilom Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: This may cause the child to be tired or breathless → If you notice any of these symptoms tell your doctor.
Slovenian: To lahko povzroči utrujenost ali zasoplost otroka.
English: If bone abnormalities are detected or suspected during use of emtricitabine/tenofovir disoproxil in any paediatric patient, consultation with an endocrinologist and/or nephrologist should be obtained.
Slovenian: pri katerem koli pediatričnem bolniku se je treba posvetovati z endokrinologom in/ali nefrologom.
English: Ethinyl oestradiol:
Slovenian: etinilestradiol:
English: Therefore, a careful benefitrisk assessment is needed when Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Zato je treba skrbno oceniti razmerje med koristmi in tveganjem pri uporabi zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: is not recommended in individuals under the age of 18 years with renal impairment (see sections 4.2 and 4.4).
Slovenian: Uporabe zdravila Emtricitabin/dizoproksiltenofovirat Krka se ne priporoča pri posameznikih, starih manj kot 18 let, z ledvično okvaro (glejte poglavji 4.2 in 4.4).
English: Your doctor will prescribe Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: - Zdravnik vam bo predpisal zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Therefore, the same problems may be seen if Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Zato je možno, da se bodo enake težave pojavile pri jemanju zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Krka d.d..
Slovenian: Pomembno je, da ne izpustite nobenega odmerka zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d..
English: therapy - The importance of regular monitoring of renal function during Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: pri pediatričnih bolnikih treba oceniti začetne vrednosti delovanja ledvic; - pomembnost rednega spremljanja delovanja ledvic v času zdravljenja z zdravilom Emtricitabine/Tenofovir disoproxil Krka d.d.
English: contains lactose", "Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: vsebuje laktozo", "Zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Whenever possible, Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: - Kadar je mogoče, je treba zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: See section 2 "Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Glejte poglavje 2 "Zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: - HIV pediatric renal educational brochure
Slovenian: - izobraževalno gradivo glede ledvic pri HIV za pediatrične bolnike.
English: In patients who received treatment with tenofovir disoproxil, or stavudine or zidovudine, mean lumbar spine BMD Z score was -1.034 and0.498, and mean total body BMD Z-score was -0.471 and -0.386, respectively, at baseline.
Slovenian: ledvene hrbtenice -1,034 oz. -0,498 in povprečna Z-vrednost MGK za celo telo -0,471 oz. -0,386.
English: Do not take Emtricitabine/Tenofovir disoproxil Krka d.d.if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: tenofovir, dizoproksiltenofoviratali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Cmax: ↓ 23% (↓ 30 to ↑ 16) Efavirenz:
Slovenian: Cmax: ↑ 102 % (↓ 96 do ↑ 108) Cmin: n/i efavirenz/dizoproksiltenofo virat efavirenz:
English: Interrupting treatment with Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Prekinitev zdravljenja z zdravilom Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Other medicines and Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Druga zdravila in zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: → Do not stop taking Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Ne prenehajte jemati zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Skin and subcutaneous tissue disorders: Very common:
Slovenian: Bolezni kože in podkožja:
English: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity → If you notice these or any symptoms of inflammation or infection, get medical help immediately.
Slovenian: Bodite pozorni na kakršne koli simptome vnetja ali druge simptome, kot so: - mišična oslabelost - oslabelost, ki se najprej pojavi v dlaneh in stopalih in se nato širi proti trupu - palpitacije, tremor ali hiperaktivnost
English: - Keep this leaflet.
Slovenian: ne dojite.
English: As Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Če se zdravilo Emtricitabine/Tenofovir disoproxil Krka d.d.
English: If you have taken Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Če ste zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Prior to initiating Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: ; - da se zdravila Emtricitabine/Tenofovir disoproxil Krka d.d.
English: If vomiting occurs more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Če v roku 1 ure od jemanja zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Interrupting use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: O prekinitvi uporabe zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Didanosine: The co-administration of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Didanozin: Sočasna uporaba zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Recommendation concerning coadministration with Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Priporočilo glede sočasne uporabe z zdravilom Emtricitabin/dizoproksiltenofovir at Krka d.d.
English: looks like and contents of the pack Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: in vsebina pakiranja Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Cmax: ↑ 102% (↓ 96 to ↑ 108)
Slovenian: Cmax: ↓ 7 % (↓ 22 do ↑ 11)
English: Look out for any symptoms of infection or other symptoms such as:
Slovenian: → Če opazite te ali kakršne koli druge simptome vnetja ali okužbe, nemudoma poiščite zdravniško pomoč.
English: Lamivudine/Tenofovir disoproxil Lamivudine: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12) Cmin: NC
Slovenian: AUC: ↓ 3 % (↓ 8 % do ↑ 15) Cmax: ↓ 24 % (↓ 44 do ↓ 12) Cmin: n/i tenofovir: AUC: ↓ 4 % (↓ 15 do ↑ 8)
English: lactic acidosis
Slovenian: vsebuje laktozo
English: Do not take Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Ne jemljite zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: How to store Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Kako jemati zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: - Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: - Zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: asthenia
Slovenian: Dojenje
English: Adefovir dipivoxil and Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Lamivudina in zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Ribavirin/Tenofovir disoproxil
Slovenian: ribavirin/dizoproksiltenofov irat ribavirin:
English: Increased plasma concentrations of tenofovir resulting from co administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasne uporabe dizoproksiltenofovirata, sofosbuvirja/velpatasvirja in lopinavirja/ritonavirja lahko povečajo neželene reakcije, povezane z dizoproksiltenofoviratom, vključno z ledvičnimi boleznimi.
English: Lamivudine and
Slovenian: laktacidoza
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Priporočeni odmerek zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: + Darunavir/Ritonavir (800 mg q.d./100 mg q.d.)
Slovenian: 3 + darunavir (800 mg enkrat dnevno) + ritonavir (100 mg enkrat dnevno) + emtricitabin/dizoproksilteno fovirat (200 mg/245 mg enkrat dnevno)
English: Scientific conclusions and grounds for the suspension of the marketing authorisation presented by the European Medicines Agency
Slovenian: Znanstveni zaključki in podlaga za začasen umik dovoljenja za promet z zdravilom, ki jih je predstavila Evropska agencija za zdravila
English: On 8 September 2014, Aastrom Biosciences notified the European Medicines Agency of the withdrawal by the Danish authorities of the manufacturing licence for the manufacturing site for the active substance, finished product and batch release of MACI (matrix-applied characterised autologous cultured chondrocytes): Genzyme Biosurgery ApS, Oliefabriksvej 45, DK - 2770 Kastrup, Denmark.
Slovenian: Družba Aastrom Biosciences je 8. septembra 2014 obvestila Evropsko agencijo za zdravila, da so danske oblasti umaknile dovoljenje za proizvodnjo zdravila za mesto, kjer se proizvajata zdravilna učinkovina in končni izdelek ter sproščajo serije zdravila MACI (na matriks naneseni karakterizirani avtologni gojeni hondrociti): Genzyme Biosurgery ApS, Oliefabriksvej 45, DK - 2770 Kastrup, Danska.
English: In view of the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 10 September 2014, requesting the Agency to give its opinion on whether the marketing authorisation for MACI should be suspended or revoked in accordance with Article 118 of
Slovenian: Na podlagi navedenega je Evropska komisija 10. septembra 2014 sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in zahtevala, da agencija poda mnenje o tem, ali naj se dovoljenje za promet z zdravilom MACI začasno umakne ali odvzame v skladu s členom 118 Direktive 2001/83/ES.
English: The CHMP considered that this information does not impact the safety and efficacy profile of MACI but that in the absence of an authorised manufacturing site, the requirements laid down in Article 41 of Directive 2001/83/EC are no longer met.
Slovenian: Odbor CHMP je menil, da ta podatek ne vpliva na profil varnosti in učinkovitosti zdravila MACI, vendar ker odobrenega mesta proizvodnje ni, niso več izpolnjene zahteve, opredeljene v členu 41 Direktive 2001/83/ES.
English: Grounds for the suspension of the marketing authorisation
Slovenian: Podlaga za začasen umik dovoljenja za promet z zdravilom
English: • The Committee considered the notification under Article 20 of Regulation (EC) No 726/2004 for
Slovenian: • odbor je upošteval obvestilo v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravilo MACI in osnutek mnenja odbora CHMP, ki ga pripravil odbor CAT;
English: • The Committee concluded that in view of the absence of an authorised manufacturing site for the active substance, finished product and batch release, the requirements laid down in Article 41 of
Slovenian: • odbor CHMP je zaključil, da zaradi neobstoja odobrenega mesta za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij niso več izpolnjene zahteve, opredeljene v členu 41 Direktive 2001/83/ES.
English: For the suspension of the marketing authorisation to be lifted, the MAH shall register a site for manufacture of the active substance, finished product and batch release.
Slovenian: Za preklic začasnega umika dovoljenja za promet z zdravilom mora imetnik dovoljenja za promet z zdravilom registrirati mesto za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij.
English: For the suspension to be lifted, the MAH shall register a manufacturing site for the active substance, finished product and batch release (see Annex II).
Slovenian: Za preklic začasnega umika mora imetnik dovoljenja za promet z zdravilom registrirati mesto za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij (glejte Prilogo II).
English: EU/2/14/171/002
Slovenian: EU/2/14/171/001 EU/2/14/171/002
English: ATC vet code: QI07AB01.
Slovenian: Oznaka ATC vet: QI07AB01.
English: Pharmacotherapeutic group: Immunologicals for canidae, inactivated bacterial vaccines.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae) - inaktivirana bakterijska cepiva.
English: * Antibody micro agglutination-lytic reaction.
Slovenian: * reakcija mikroaglutinacije-lize protiteles.
English: Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus L4.
Slovenian: Trajanje imunosti: Vsaj eno leto po osnovnem cepljenju proti vsem komponentam cepiva Versican Plus L4.
English: No data are available on the safety of an overdose.
Slovenian: Ni podatkov o varnosti ob prevelikem odmerjanju.
English: 50 x 1 dose
Slovenian: 50 x 1 odmerek
English: Type I glass vial containing 1 ml closed with a chlorobutyl rubber stopper and aluminium cap.
Slovenian: Viala iz stekla tipa I, ki vsebuje 1 ml cepiva, zaprta z zamaškom iz klorobutilne gume in aluminijasto zaporko.
English: Vaccination against distemper, adeno, parvo and parainfluenza virus (DHPPi):
Slovenian: Cepljenje proti virusu pasje kuge, adenovirusu, parvovirusu in virusu parainfluence (DHPPi):
English: 10 DATE OF REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: PACKAGE SIZE 25 x 1 dose
Slovenian: VELIKOST PAKIRANJA 25 x 1 odmerek
English: Plastic box containing 50 vials (1 ml).
Slovenian: Plastična škatla s 50 vialami (po 1 ml).
English: Plastic box containing 25 vials (1 ml).
Slovenian: Plastična škatla s 25 vialami (po 1 ml).
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products except those mentioned in section 4.8.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini, razen s tistimi navedenimi v poglavju 4.8.
English: Appearance: whitish liquid with fine sediment.
Slovenian: Videz: belkasta tekočina s finim sedimentom.
English: Once mixed, the contents of the vial should appear a whitish to yellowish colour with a slight opalescence.
Slovenian: Po zmešanju mora vsebina viale izgledati belkasto do rumenkasto z rahlo opalescenco.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Slovenian: Cepivo je namenjeno aktivni imunizaciji zdravih pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo Leptospira interrogans serološka skupina Australis serovar Bratislava, Leptospira interrogans serološka skupina Canicola serovar Canicola, Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa in Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae.
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injections
Slovenian: Suspenzija: natrijev klorid kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat voda za injekcije
English: Name and address of the manufacturer of the biological active substances
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
English: Primary vaccination scheme: Two doses of Versican Plus L4 3-4 weeks apart from 6 weeks of age.
Slovenian: Dva odmerka cepiva Versican Plus L4 v razmaku 3-4 tednov od starosti 6 tednov naprej.
English: ADVICE ON CORRECT ADMINISTRATION Shake well and administer immediately the entire contents (1 ml) of the product.
Slovenian: Pred uporabo dobro pretresite in takoj aplicirajte celotno vsebino (1 ml).
English: PACKAGE LEAFLET: Versican Plus L4 suspension for injection for dogs
Slovenian: Versican Plus L4 suspenzija za injiciranje za pse
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Slovenian: EXP {mesec/leto} Načeto zdravilo uporabite takoj.
English: Suspension (inactivated):
Slovenian: Učinkovina(e): Sus pe nzija (inaktivirana):
English: ALR* titre ≥ 1:40
Slovenian: titer ALR* ≥ 1:40
English: Active substances:
Slovenian: Pomožna(pomožne) snovi:
English: VIAL (1 ML SUSPENSION)
Slovenian: VIALA (1 ML SUSPENZIJE) IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: Onset of immunity: 4 weeks after completion of the primary course.
Slovenian: 4 tedne po zaključku osnovnega cepljenja.
English: Re-vaccination scheme: A single dose of Versican Plus L4 to be given annually.
Slovenian: Enkratni odmerek cepiva Versican Plus L4 letno.
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 Versican Plus DHPPi and Versican Plus Pi. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: 4.8 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 s cepivoma Versican Plus DHHPi in Versican Plus Pi.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus L4 suspension for injection for dogs
Slovenian: NAVODILO ZA UPORABO Versican Plus L4 suspenzija za injiciranje za pse
English: Once broached, use immediately.
Slovenian: Načeto zdravilo uporabite takoj.
English: ALR* titre ≥ 1:51
Slovenian: titer ALR* ≥ 1:51
English: If protection against DHPPi or Pi is required, dogs can be vaccinated with two doses of Versican Plus DHPPi or Versican Plus Pi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi or Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Slovenian: Vsebino viale cepiva Versican Plus DHPPi ali Versican Plus Pi je treba rekonstituirati z vsebino viale cepiva Versican Plus L4 (namesto vehikla).
English: L. kirschneri serovar Grippotyphosa
Slovenian: L. kirschneri, serološka skupina Grippotyphosa, serovar Grippotyphosa.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products other than those mentioned in section 8.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.