natgillin/translations-raw huggingface dataset:
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).
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.
Hazard Ratio versus AC→P (95 % CI)
Razmerje ogroženosti v primerjavi z AC→P (95% IZ)
Anaphylactic shock
+anafilaktični šok neznano
Distant recurrence No. patients with event p = 0.0008
Pojav oddaljenih metastaz št. bolnikov z dogodkom p < 0,0008
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).
Podaljšanje zdravljenja zgodnjega raka dojk na več kot eno leto ni priporočljivo (glejte poglavje 5.1).
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval * At the time of the definitive analysis of DFS.
A: doksorubicin; C: ciklofosfamid; P: paklitaksel; D: docetaksel; Carb: karboplatin; H: trastuzumab IZ = interval zaupanja * V času končne analize preživetja brez bolezni.
Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion
Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje
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
2 Študija MO16982: uvajalni odmerek 6 mg/kg na teden 3 tedne; sledil je odmerek 6 mg/kg po 3-tedenskem režimu
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega febrilna nevtropenija
Uncommon side effects: may affect up to 1 in 100 people
Občasni neželeni učinki, ki se lahko pojavijo pri največ 1 od 100 bolnikov:
21 (mg/mL, concentration of reconstituted solution) The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Primerno količino raztopine je treba odvzeti iz viale in dodati infuzijski vrečki, ki vsebuje 250 ml raztopine natrijevega klorida (0,9 %) za injiciranje.
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.
V študiji MO22982 so proučevali prehajanje med zdravljenjem s trastuzumabom v intravenski in subkutani obliki.
Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
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.
Intravenska oblika zdravila Ogivri ni namenjena subkutanemu (podkožnemu) dajanju in se lahko daje le z intravensko infuzijo.
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 150 mg trastuzumab.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 150 mg trastuzumaba.
Very common side effects: may affect more than 1 in 10 people
Zelo pogosti neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov • okužbe
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.
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.
N = 172
Trastuzumab1 n = 172
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
Preglednica 1 Neželeni učinki, o katerih so poročali pri intravenski obliki trastuzumaba v monoterapiji ali v kombinaciji s kemoterapijo v ključnih kliničnih preskušanjih
Distant recurrence No. patients with event p < 0.0001
Pojav oddaljenih metastaz št. bolnikov z dogodkom p < 0,0001
Biopsy specimenstaining pattern
Vzorci biopsije - videz preparata po barvanju
Hydrochloric acid (for pH adjustment)
L-histidin sorbitol makrogol 3350 klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH)
360 mg/m2.
8 mg/kg).
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
Preglednica 3 Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku želodca
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.
• 150 mg trastuzumaba, ki ga je treba raztopiti v 7,2 ml vode za injekcije, ali
Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance)
volumen (ml) = telesna masa (kg) × odmerek (4 mg/kg za uvajanje ali 2 mg/kg za vzdrževanje) 21 (mg/ml, koncentracija pripravljene raztopine)
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
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.
- in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
- kot monoterapija za zdravljenje tistih bolnikov, ki so za svojo metastatsko bolezen predhodno že prejemali najmanj dve liniji kemoterapije.
- 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.
- 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).
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
Preglednica 2 Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku dojk
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.
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.
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.
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).
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.
Kapecitabin ali 5-fluorouracil so dajali skupaj s: - cisplatinom - 80 mg/m² vsake 3 tedne 6 ciklov, 1. dan vsakega cikla.
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.
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 %.
Ogivri 150 mg contains 115.2 mg sorbitol in each vial.
Ena 150 mg viala zdravila Ogivri vsebuje 115,2 mg sorbitola.
Lung infiltration
+pljučni infiltrati neznano
Hepatocellular injury
Bolezni jeter, žolčnika in žolčevodov hepatocelularna poškodba hepatitis
Ogivri 420 mg contains 322.6 mg sorbitol in each vial.
Ena 420 mg viala zdravila Ogivri vsebuje 322,6 mg sorbitola.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ogivri 150 mg powder for concentrate trastuzumab
IME ZDRAVILA IN POT(I) UPORABE Ogivri 150 mg prašek za koncentrat trastuzumab le za intravensko uporabo
• deafness
• driska
Primary tumor type N
Režim Vrsta primarnega tumorja n Cmin (μg/ml)
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).
Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m² v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 4
The incidence of symptomatic cardiac dysfunction was 1.7 % in the trastuzumab arm.
Pogostnost simptomatske motnje v delovanju srca je bila v skupini, ki je prejemala trastuzumab,
Hazard Ratio vs AC→D (95 % CI) p-value
Razmerje ogroženosti v primerjavi z AC→D (95-% IZ) p-vrednost
or - intravenous paclitaxel - 175 mg/ m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
ali - paklitaksel intravensko - 175 mg/m² v obliki kontinuirane intravenske infuzije, vsake 3 tedne,
Pulmonary fibrosis
+pljučna fibroza neznano
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ogivri 420 mg powder for concentrate trastuzumab
IME ZDRAVILA IN POT(I) UPORABE Ogivri 420 mg prašek za koncentrat trastuzumab le za intravensko uporabo
Disease-free survival No. patients with event p = 0.0003
Preživetje brez bolezni št. bolnikov z dogodkom p < 0,0003
Upper respiratory tract infection
+pljučnica astma motnje delovanja pljuč
The recommended maintenance dose of trastuzumab at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Priporočen vzdrževalni odmerek trastuzumaba je 6 mg/kg telesne mase po 3 tednih od prejema uvajalnega odmerka, in nato v tritedenskih razmakih.
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
2+ Šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
Hazard Ratio vs AC→P (95% CI) p-value
Razmerje ogroženosti v primerjavi z AC→P (95-% IZ) p-vrednost
Trastuzumab and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Pri adjuvantnem zdravljenju raka dojk trastuzumaba in antraciklinov ne smemo dajati sočasno.
Disease-free survival No. patients with event p < 0.0001
Preživetje brez bolezni št. bolnikov z dogodkom p < 0,0001
Neutropenia
pvrednost
Combination Therapy
Kombinirano zdravljenje
EBC
MBC EBC
How to store Ogivri
Shranjevanje zdravila Ogivri
Ogivri vial
• vnetje dojk
- 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)
Kemoterapijo so dajali, kot je navedeno spodaj: - kapecitabin - 1000 mg/m² peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
Do not use Ogivri if you notice any particulate matter or discoloration prior to administration.
Če pred dajanjem opazite kakršne koli delce ali obarvanje, ne uporabljajte zdravila Ogivri.
NAME OF THE MEDICINAL PRODUCT Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Cmin (mcg/mL)
dan (μg.dan/ml)
BGP Products Switzerland GmbH Eesti filiaal
BGP Products Ges.m.b.H.
Paclitaxel, in combination with trastuzumab, was administered as follows: - intravenous paclitaxel - 80 mg/ m2 as a continuous intravenous infusion, given every week for
- paklitaksel intravensko - 80 mg/m² v obliki kontinuirane intravenske infuzije, vsak teden, skupaj 12 tednov;
- intravenous cyclophosphamide, at 600 mg/ m2 over 30 minutes, given every 3 weeks for 4
- 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.
Death (OS event): No. patients with event p < 0.0001
Smrt (dogodek celokupnega preživetja): št. bolnikov z dogodkom p = 0,014**
Trastuzumab and anthracyclines should not be given concurrently in combination in the MBC setting.
Pri zdravljenju metastatskega raka dojk kombinacije trastuzumaba in antraciklinov ne smemo dajati sočasno.
NAME OF THE MEDICINAL PRODUCT Ogivri 150 mg powder for concentrate for solution for infusion trastuzumab
Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Powder for concentrate for solution for infusion (powder for concentrate).
FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Bel do rahlo rumen liofiliziran prašek.
• hair loss
• izguba telesne mase
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite katerega koli izmed neželenih učinov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
• respiratory distress
• motnje delovanja pljuč
N
SN:
Asthenia
ZDRAVILOM
Common side effects: may affect up to 1 in 10 people
Pogosti neželeni učinki, ki se lahko pojavijo pri največ 1 od 10 bolnikov:
• bruising
• srbenje
Acute pulmonary oedema
+akutni pljučni edem neznano
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.
Po mediano 12-mesečnem spremljanju je bilo razmerje ogroženosti za preživetje brez bolezni 0,54 (95-% IZ: 0,44; 0,67).
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.
Zdravilo Ogivri je indicirano za zdravljenje odraslih bolnikov s HER2-pozitivno metastatsko obliko raka dojk:
Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Post-hoc eksplorativna analiza z dogodki preživetja brez bolezni in simptomatskimi srčnimi dogodki Dolgoročno spremljanje** Razmerje ogroženosti (95-% IZ)
Retinal haemorrhage
• dihalna stiska
• lung disorders
• bolezni ledvic
Contusion
Sledljivost
ATC vet code: QI07AD08.
Oznaka ATC vet: QI07AD08.
Komenského 212, 683 23 Ivanovice na Hané, CZECH REPUBLIC
683 23 Ivanovice na Hané, ČEŠKA
Do not mix with any veterinary medicinal product except those mentioned in section 4.8.
Ne mešajte z nobenimi drugimi zdravili, razen s tistimi navedenimi v poglavju 4.8.
Duration of immunity: At least one year following the primary vaccination course.
Trajanje imunosti: Vsaj eno leto po osnovnem cepljenju.
However, due to the low pathogenicity of this strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
Zaradi nizke patogenosti teh sevov ločevanje cepljenih psov od necepljenih ni potrebno.
MARKETING AUTHORISATION NUMBER(S) EU/2/14/168/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/14/168/001
Overdose(symptoms, emergency procedures, antidotes):
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):
4.2 Indications for use, specifying the target species Active immunisation of dogs from 6 weeks of age:
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija psov, starejših od 6 tednov:
Shake well and administer immediately the entire contents (1 ml) of the reconstituted product.
Pred uporabo dobro pretresite in takoj injicirajte živali celotno rekonstituirano vsebino (1 ml).
The vaccine is intended for the active immunisation of healthy puppies and dogs against disease caused by canine parainfluenza virus.
Cepivo je namenjeno aktivni imunizaciji pasjih mladičev in odraslih psov proti boleznim, ki jih povzroča virus pasje parainfluence.
3 weeks after completion of the primary course.
3 tedne po zaključku osnovnega cepljenja.
Re-vaccination scheme: A single dose of Versican Plus Pi to be given annually.
Ponovno cepljenje: Enkratni odmerek Versican Plus Pi letno.
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.
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.
Once mixed, the contents of the vial should appear a pink/red or yellowish colour with a slight opalescence.
Po zmešanju mora vsebina viale izgledati rožnato/rdeče ali rumenkaste barve z rahlo opaloscenco.
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.
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.
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).
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).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04/07/2014.
Datum pridobitve dovoljenja za promet: 04/07/2014.
Solvent: clear colourless liquid.
vehikel: bistra brezbarvna tekočina.
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.
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.
Incompatibilities: Do not mix with any other veterinary medicinal product other than those mentioned above.
Ne mešajte z drugimi zdravili kot s tistimi navedenimi zgoraj.
The live attenuated virus vaccine strain CPiV may be shed by vaccinated animals following vaccination.
Cepljene živali lahko po cepljenju izločajo žive atenuirane vakcinalne seve CpiV.
Hypersensitivity reactions (e.g. gastrointestinal signs such as diarrhoea and vomiting, anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur rarely.
Preobčutljivostne reakcije (gastrointestinalni znaki, kot so driska in bruhanje, anafilaksa, angioedem,
First dose: Versican Plus Pi from 8-9 weeks of age.
Prvi odmerek: Versican Plus Pi od starosti 8-9 tednov naprej
Type 1 glass vial containing 1 ml of solvent closed with a chlorobutyl rubber stopper and aluminium cap.
Viala iz stekla tipa I, ki vsebuje 1 ml vehikla, zaprta z zamaškom iz klorobutilne gume in aluminijasto zaporko.
EXP {month/year} Once reconstituted, use immediately.
Rekonstituirano zdravilo uporabite uporabite takoj.
First dose: Versican Plus Pi from 8-9 weeks of age Second dose: Versican Plus Pi mixed with Versiguard Rabies 3-4 weeks later, but not before 12 weeks of age.
Prvi odmerek: Versican Plus Pi od starosti 8-9 tednov naprej Drugi odmerek: Versican Plus Pi zmešamo z Versiguard Rabies 3-4 tedne kasneje, toda ne pred starostjo 12 tednov.
Second dose: Versican Plus Pi mixed with Versiguard Rabies 3-4 weeks later, but not before 12 weeks of age.
Drugi odmerek: Versican Plus Pi zmešamo z Versiguard Rabies 3-4 tedne kasneje, toda ne pred starostjo 12 tednov.
Primary vaccination scheme: Two doses of Versican Plus Pi 3-4 weeks apart from 6 weeks of age.
Osnovno cepljenje: Dva odmerka Versican Plus Pi v razmaku 3-4 tednov od starosti 6 tednov naprej.
Once mixed, the contents of the vial should appear a whitish to yellowish colour with a slight opalescence.
Po zmešanju mora vsebina viale izgledati belkasto do rumenkasto z rahlo opaloscenco.
Name and address of the manufacturer of the biological active substances
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin) Bioveta, a.s.,
PACKAGE LEAFLET: Versican Plus Pi lyophilisate and solvent for suspension for injection for dogs
Versican Plus Pi liofilizat in vehikel za suspenzijo za injiciranje za pse
Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of solvent.
Plastična škatla s 25 vialami (s po enim odmerkom) liofilizata in 25 vialami (po 1 ml) vehikla.
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi lyophilisate and solvent for suspension for injection for dogs
NAVODILO ZA UPORABO Versican Plus Pi liofilizat in vehikel za suspenzijo za injiciranje za pse
No other adverse reactions other than those mentioned under “Adverse reactions” were observed after administration of a 10-fold overdose of the vaccine.
Po dajanju 10-krat prevelikega odmerka cepiva ni bilo opaziti drugih neželenih učinkov, razen tistih, navedenih v poglavju »Neželeni učinki«.
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij Bioveta, a.s.,
The contents of a single vial of Versican Plus Pi should be reconstituted with the contents of a single vial of Versiguard Rabies (instead of the solvent).
Vsebino viale zdravila Versican Plus Pi je treba rekonstituirati z vsebino viale zdravila Versiguard
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi solvent for dogs
Versican Plus Pi vehikel za pse
This procedure will involve removing the following recommendations and indications for which no data were provided:
Ta postopek vključuje umik naslednjih priporočil in indikacij, za katere podatki niso bili predloženi:
o use in pigeons.
o uporaba pri golobih.