FrancophonIA/ELRC3.0 huggingface dataset:
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Slovenian: 3+ Močno obarvane celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
English: The reconstituted Ogivri solution contains 21 mg/mL of trastuzumab.
Slovenian: Pripravljena raztopina zdravila Ogivri vsebuje 21 mg/ml trastuzumaba.
English: or - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle).
Slovenian: ali - docetaksel intravensko - 75 mg/m² v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 6 ciklov (na 2. dan prvega cikla z docetakselom, nato na 1. dan vsakega nadaljnjega cikla), čemur je sledilo: - karboplatin (pri tarčni AUC 6 mg/ml/min) v obliki intravenske infuzije v 30 do 60 minutah, vsake 3 tedne, skupaj 6 ciklov.
English: Hazard Ratio versus AC→P (95 % CI)
Slovenian: Razmerje ogroženosti v primerjavi z AC→P (95% IZ)
English: Anaphylactic shock
Slovenian: +anafilaktični šok neznano
English: Distant recurrence No. patients with event p = 0.0008
Slovenian: Pojav oddaljenih metastaz št. bolnikov z dogodkom p < 0,0008
English: Patients with EBC should be treated with trastuzumab for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Slovenian: Podaljšanje zdravljenja zgodnjega raka dojk na več kot eno leto ni priporočljivo (glejte poglavje 5.1).
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval * At the time of the definitive analysis of DFS.
Slovenian: A: doksorubicin; C: ciklofosfamid; P: paklitaksel; D: docetaksel; Carb: karboplatin; H: trastuzumab IZ = interval zaupanja * V času končne analize preživetja brez bolezni.
English: Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion
Slovenian: Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje
English: Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935
Slovenian: 2 Študija MO16982: uvajalni odmerek 6 mg/kg na teden 3 tedne; sledil je odmerek 6 mg/kg po 3-tedenskem režimu
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega febrilna nevtropenija
English: Uncommon side effects: may affect up to 1 in 100 people
Slovenian: Občasni neželeni učinki, ki se lahko pojavijo pri največ 1 od 100 bolnikov:
English: 21 (mg/mL, concentration of reconstituted solution) The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Slovenian: Primerno količino raztopine je treba odvzeti iz viale in dodati infuzijski vrečki, ki vsebuje 250 ml raztopine natrijevega klorida (0,9 %) za injiciranje.
English: Study MO22982 investigated switching between the trastuzumab intravenous and trastuzumab subcutaneous formulation with a primary objective to evaluate patient preference for either intravenous or the subcutaneous route of trastuzumab administration.
Slovenian: V študiji MO22982 so proučevali prehajanje med zdravljenjem s trastuzumabom v intravenski in subkutani obliki.
English: Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
English: Ogivri is given as an infusion into a vein (intravenous infusion, drip), this intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Slovenian: Intravenska oblika zdravila Ogivri ni namenjena subkutanemu (podkožnemu) dajanju in se lahko daje le z intravensko infuzijo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 150 mg trastuzumab.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 150 mg trastuzumaba.
English: Very common side effects: may affect more than 1 in 10 people
Slovenian: Zelo pogosti neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov • okužbe
English: Ogivri 420 mg powder for concentrate for solution for infusion 50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab.
Slovenian: Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje Ena 50-ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 420 mg trastuzumaba.
English: N = 172
Slovenian: Trastuzumab1 n = 172
English: Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing System organ class
Slovenian: Preglednica 1 Neželeni učinki, o katerih so poročali pri intravenski obliki trastuzumaba v monoterapiji ali v kombinaciji s kemoterapijo v ključnih kliničnih preskušanjih
English: Distant recurrence No. patients with event p < 0.0001
Slovenian: Pojav oddaljenih metastaz št. bolnikov z dogodkom p < 0,0001
English: Biopsy specimenstaining pattern
Slovenian: Vzorci biopsije - videz preparata po barvanju
English: Hydrochloric acid (for pH adjustment)
Slovenian: L-histidin sorbitol makrogol 3350 klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH)
English: 360 mg/m2.
Slovenian: 8 mg/kg).
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer Score
Slovenian: Preglednica 3 Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku želodca
English: Each vial contains either; o 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injections, or o 420 mg trastuzumab that has to be dissolved in 20 mL of water for injections.
Slovenian: • 150 mg trastuzumaba, ki ga je treba raztopiti v 7,2 ml vode za injekcije, ali
English: Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance)
Slovenian: volumen (ml) = telesna masa (kg) × odmerek (4 mg/kg za uvajanje ali 2 mg/kg za vzdrževanje) 21 (mg/ml, koncentracija pripravljene raztopine)
English: Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous weekly) and docetaxel (60 mg/m2 intravenous) in Japanese women with HER2
Slovenian: Podatki iz študije JP16003 z eno skupino, v kateri so japonske bolnice s HER2-pozitivnim metastatskim rakom dojk prejemale trastuzumab (uvajalni odmerek 4 mg/kg intravensko in 2 mg/kg intravensko enkrat na teden) in docetaksel (60 mg/m² intravensko) so nakazali, da sočasna aplikacija trastuzumaba ni imela vpliva na farmakokinetiko enkratnega odmerka docetaksela.
English: Palpitation
Slovenian: 1palpitacije
English: - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
Slovenian: - kot monoterapija za zdravljenje tistih bolnikov, ki so za svojo metastatsko bolezen predhodno že prejemali najmanj dve liniji kemoterapije.
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy; additionally, the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Slovenian: - Preskušanji NSABP B-31 in NCCTG N9831, ki imata skupno analizo, sta bili zasnovani za proučevanje klinične koristi kombinacije zdravljenja s trastuzumabom in paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer Score Staining pattern
Slovenian: Preglednica 2 Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku dojk
English: When trastuzumab was administered after completion of adjuvant chemotherapy NYHA Class III - IV heart failure was observed in 0.6 % of patients in the one-year arm after a median follow-up of 12 months.
Slovenian: Srčno popuščanje razreda III−IV po NYHA se je po mediani časa spremljanja 12 mesecev pojavilo pri 0,6 % bolnikov v skupini, ki se je s trastuzumabom po zaključku adjuvantne kemoterapije zdravila eno leto.
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95 % CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95 % CI 0.51-0.79) for FP versus FP + H, respectively.
Slovenian: Mediana celokupnega preživetja v skupini, ki je imela visoko izražen HER2, je bila 11,8 meseca za skupino, ki je prejemala FP, v primerjavi s 16 meseci za skupino, ki je prejemala FP + H - razmerje ogroženosti 0,65 (95-% interval zaupanja; 0,51-0,83).
English: given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Slovenian: Kapecitabin ali 5-fluorouracil so dajali skupaj s: - cisplatinom - 80 mg/m² vsake 3 tedne 6 ciklov, 1. dan vsakega cikla.
English: Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800
Slovenian: Mylan Healthcare GmbH Tel: +49 (0) 511 475 43 400
English: For the sequence intravenous → subcutaneous (subcutaneous vial and subcutaneous formulation in administration system cohorts combined), adverse event rates (all grades) were described preswitching (Cycles 1-4) and post-switching (Cycles 5-8) as 53.8 % vs. 56.4 %, respectively; for the sequence subcutaneous → intravenous (subcutaneous vial and subcutaneous formulation in administration system cohorts combined), adverse event rates (all grades) were described pre- and post-switching as 65.4 % vs. 48.7 %, respectively.
Slovenian: Za prehod intravensko → subkutano (skupaj za obe subkutani obliki: v viali in aplikacijskem sistemu) je bila pogostnost neželenih učinkov (vseh stopenj) pred prehodom (1. do 4. cikel) 53,8 % in po prehodu (5. do 8. cikel) 56,4 %.
English: Ogivri 150 mg contains 115.2 mg sorbitol in each vial.
Slovenian: Ena 150 mg viala zdravila Ogivri vsebuje 115,2 mg sorbitola.
English: Lung infiltration
Slovenian: +pljučni infiltrati neznano
English: Hepatocellular injury
Slovenian: Bolezni jeter, žolčnika in žolčevodov hepatocelularna poškodba hepatitis
English: Ogivri 420 mg contains 322.6 mg sorbitol in each vial.
Slovenian: Ena 420 mg viala zdravila Ogivri vsebuje 322,6 mg sorbitola.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ogivri 150 mg powder for concentrate trastuzumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ogivri 150 mg prašek za koncentrat trastuzumab le za intravensko uporabo
English: • deafness
Slovenian: • driska
English: Primary tumor type N
Slovenian: Režim Vrsta primarnega tumorja n Cmin (μg/ml)
English: Docetaxel was administered as follows: - intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle).
Slovenian: Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m² v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 4
English: The incidence of symptomatic cardiac dysfunction was 1.7 % in the trastuzumab arm.
Slovenian: Pogostnost simptomatske motnje v delovanju srca je bila v skupini, ki je prejemala trastuzumab,
English: Hazard Ratio vs AC→D (95 % CI) p-value
Slovenian: Razmerje ogroženosti v primerjavi z AC→D (95-% IZ) p-vrednost
English: or - intravenous paclitaxel - 175 mg/ m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
Slovenian: ali - paklitaksel intravensko - 175 mg/m² v obliki kontinuirane intravenske infuzije, vsake 3 tedne,
English: Pulmonary fibrosis
Slovenian: +pljučna fibroza neznano
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ogivri 420 mg powder for concentrate trastuzumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ogivri 420 mg prašek za koncentrat trastuzumab le za intravensko uporabo
English: Disease-free survival No. patients with event p = 0.0003
Slovenian: Preživetje brez bolezni št. bolnikov z dogodkom p < 0,0003
English: Upper respiratory tract infection
Slovenian: +pljučnica astma motnje delovanja pljuč
English: The recommended maintenance dose of trastuzumab at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Slovenian: Priporočen vzdrževalni odmerek trastuzumaba je 6 mg/kg telesne mase po 3 tednih od prejema uvajalnega odmerka, in nato v tritedenskih razmakih.
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Slovenian: 2+ Šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
English: Hazard Ratio vs AC→P (95% CI) p-value
Slovenian: Razmerje ogroženosti v primerjavi z AC→P (95-% IZ) p-vrednost
English: Trastuzumab and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Slovenian: Pri adjuvantnem zdravljenju raka dojk trastuzumaba in antraciklinov ne smemo dajati sočasno.
English: Disease-free survival No. patients with event p < 0.0001
Slovenian: Preživetje brez bolezni št. bolnikov z dogodkom p < 0,0001
English: Neutropenia
Slovenian: pvrednost
English: Combination Therapy
Slovenian: Kombinirano zdravljenje
English: EBC
Slovenian: MBC EBC
English: How to store Ogivri
Slovenian: Shranjevanje zdravila Ogivri
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 3300
Slovenian: Tel: +31 (0)20 426 3300
English: Ogivri vial
Slovenian: • vnetje dojk
English: - capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Slovenian: Kemoterapijo so dajali, kot je navedeno spodaj: - kapecitabin - 1000 mg/m² peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
English: Do not use Ogivri if you notice any particulate matter or discoloration prior to administration.
Slovenian: Če pred dajanjem opazite kakršne koli delce ali obarvanje, ne uporabljajte zdravila Ogivri.
English: NAME OF THE MEDICINAL PRODUCT Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
English: Cmin (mcg/mL)
Slovenian: dan (μg.dan/ml)
English: BGP Products Switzerland GmbH Eesti filiaal
Slovenian: BGP Products Ges.m.b.H.
English: Paclitaxel, in combination with trastuzumab, was administered as follows: - intravenous paclitaxel - 80 mg/ m2 as a continuous intravenous infusion, given every week for
Slovenian: - paklitaksel intravensko - 80 mg/m² v obliki kontinuirane intravenske infuzije, vsak teden, skupaj 12 tednov;
English: - intravenous cyclophosphamide, at 600 mg/ m2 over 30 minutes, given every 3 weeks for 4
Slovenian: - doksorubicin v obliki intravenskega bolusa - 60 mg/m², vsake 3 tedne, 4 cikle; - ciklofosfamid intravensko - 600 mg/m² v 30 minutah, vsake 3 tedne, 4 cikle.
English: Death (OS event): No. patients with event p < 0.0001
Slovenian: Smrt (dogodek celokupnega preživetja): št. bolnikov z dogodkom p = 0,014**
English: Trastuzumab and anthracyclines should not be given concurrently in combination in the MBC setting.
Slovenian: Pri zdravljenju metastatskega raka dojk kombinacije trastuzumaba in antraciklinov ne smemo dajati sočasno.
English: NAME OF THE MEDICINAL PRODUCT Ogivri 150 mg powder for concentrate for solution for infusion trastuzumab
Slovenian: Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
English: Powder for concentrate for solution for infusion (powder for concentrate).
Slovenian: FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Bel do rahlo rumen liofiliziran prašek.
English: • hair loss
Slovenian: • izguba telesne mase
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: • respiratory distress
Slovenian: • motnje delovanja pljuč
English: N
Slovenian: SN:
English: Asthenia
Slovenian: ZDRAVILOM
English: Common side effects: may affect up to 1 in 10 people
Slovenian: Pogosti neželeni učinki, ki se lahko pojavijo pri največ 1 od 10 bolnikov:
English: • bruising
Slovenian: • srbenje
English: Acute pulmonary oedema
Slovenian: +akutni pljučni edem neznano
English: After a median follow-up of 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95 % CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8 % versus 78.2 %) in favour of the trastuzumab arm.
Slovenian: Po mediano 12-mesečnem spremljanju je bilo razmerje ogroženosti za preživetje brez bolezni 0,54 (95-% IZ: 0,44; 0,67).
English: Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
Slovenian: Zdravilo Ogivri je indicirano za zdravljenje odraslih bolnikov s HER2-pozitivno metastatsko obliko raka dojk:
English: Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Slovenian: Post-hoc eksplorativna analiza z dogodki preživetja brez bolezni in simptomatskimi srčnimi dogodki Dolgoročno spremljanje** Razmerje ogroženosti (95-% IZ)
English: Retinal haemorrhage
Slovenian: • dihalna stiska
English: • lung disorders
Slovenian: • bolezni ledvic
English: Contusion
Slovenian: Sledljivost
English: ATC vet code: QI07AD08.
Slovenian: Oznaka ATC vet: QI07AD08.
English: Komenského 212, 683 23 Ivanovice na Hané, CZECH REPUBLIC
Slovenian: 683 23 Ivanovice na Hané, ČEŠKA
English: Do not mix with any veterinary medicinal product except those mentioned in section 4.8.
Slovenian: Ne mešajte z nobenimi drugimi zdravili, razen s tistimi navedenimi v poglavju 4.8.
English: Duration of immunity: At least one year following the primary vaccination course.
Slovenian: Trajanje imunosti: Vsaj eno leto po osnovnem cepljenju.
English: However, due to the low pathogenicity of this strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
Slovenian: Zaradi nizke patogenosti teh sevov ločevanje cepljenih psov od necepljenih ni potrebno.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/168/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/14/168/001
English: Overdose(symptoms, emergency procedures, antidotes):
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):
English: 4.2 Indications for use, specifying the target species Active immunisation of dogs from 6 weeks of age:
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija psov, starejših od 6 tednov:
English: Shake well and administer immediately the entire contents (1 ml) of the reconstituted product.
Slovenian: Pred uporabo dobro pretresite in takoj injicirajte živali celotno rekonstituirano vsebino (1 ml).
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against disease caused by canine parainfluenza virus.
Slovenian: Cepivo je namenjeno aktivni imunizaciji pasjih mladičev in odraslih psov proti boleznim, ki jih povzroča virus pasje parainfluence.
English: 3 weeks after completion of the primary course.
Slovenian: 3 tedne po zaključku osnovnega cepljenja.
English: Bioveta, a.s.,
Slovenian: Bioveta, a.s., Komenského 212,
English: Re-vaccination scheme: A single dose of Versican Plus Pi to be given annually.
Slovenian: Ponovno cepljenje: Enkratni odmerek Versican Plus Pi letno.
English: 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: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini kot je Versiguard Rabies in Versican Plus L4.
English: Once mixed, the contents of the vial should appear a pink/red or yellowish colour with a slight opalescence.
Slovenian: Po zmešanju mora vsebina viale izgledati rožnato/rdeče ali rumenkaste barve z rahlo opaloscenco.
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 Pi 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 Pi, 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: If protection against Leptospira is required, dogs can be vaccinated with two doses of 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 Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Slovenian: Če je treba pse zaščititi pred leptospirozo lahko pse cepimo z dvema odmerkoma Versican Plus Pi, ki ga zmešamo z Versican Plus L4 v razmaku 3-4 tednov od starosti 6 tednov naprej: Vsebino viale zdravila Versican Plus Pi je treba rekonstituirati z vsebino viale zdravila Versican Plus L4 (namesto vehikla).
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: 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: 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: 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 za Versiguard Rabies in Versican Plus L4.
English: Incompatibilities: Do not mix with any other veterinary medicinal product other than those mentioned above.
Slovenian: Ne mešajte z drugimi zdravili kot s tistimi navedenimi zgoraj.
English: The live attenuated virus vaccine strain CPiV may be shed by vaccinated animals following vaccination.
Slovenian: Cepljene živali lahko po cepljenju izločajo žive atenuirane vakcinalne seve CpiV.
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,
English: First dose: Versican Plus Pi from 8-9 weeks of age.
Slovenian: Prvi odmerek: Versican Plus Pi od starosti 8-9 tednov naprej
English: Type 1 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.