natgillin/translations-raw huggingface dataset:
Reactions might include wheezing (bronchospasm), badly blocked nose, itchy skin, rash or swelling of the face, lips or tongue, other allergic reactions or nasal polyps after taking these medicines - if you are more than 6 months pregnant - if you are breast-feeding - if you have severe liver disease - if you have inflammation of the intestines (ulcerative colitis or Crohn's disease) - if you have heart failure - if you are about to have heart surgery or surgery on your arteries (including any coronary artery procedure)
Taka reakcija lahko vključuje piskajoče dihanje (bronhospazem), zelo zamašen nos, srbenje kože, izpuščaj ali otekanje obraza, ustnic ali jezika, druge alergijske reakcije ali nosne polipe po jemanju teh zdravil
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Izgled zdravila Dynastat in vsebina pakiranja
Ecchymosis, rash, urticaria
Ekhimoze, izpuščaj, urtikarija
▪ Dry socket (inflammation and pain after a tooth extraction) ▪ Increased sweating ▪ Low levels of potassium in blood test results
• sindrom suhe jamice (vnetje in bolečina po izdrtju zoba)
Some people may be given lower doses: ▪ People with liver problems ▪ People with severe kidney problems ▪ Patients over 65 who weigh less than 50 kg ▪ People taking fluconazole.
• bolniki, starejši od 65 let, ki tehtajo manj kot 50 kg
- if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages - if you have or have had problems with your blood circulation (peripheral arterial disease)
možgansko kap, lažjo obliko možganske kapi (tranzitorna ishemična ataka - TIA), ali zamašitev krvnih žil, ki vodijo do srca ali možganov, ali operativno odstranitev ali obvod zamašenega dela
Surgical wound complications (most involving the sternal wound) were observed at an increased rate with parecoxib/valdecoxib treatment.
Pri zdravljenju s parekoksibom/valdekoksibom so opazili več zapletov v zvezi s kirurškimi ranami (največkrat v zvezi z rano prsnice).
It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors).
Gre za zdravilo iz skupine t. i. zaviralcev COX-2 (to je okrajšava za "zaviralci ciklooksigenaze-2").Bolečino in otekanje v telesu včasih povzročijo posebne snovi, ki se imenujejo prostaglandini.
OUTER CARTON: 40 mg powder and solvent for solution for injection
ZUNANJA ŠKATLA: 40 mg prašek in vehikel za raztopino za injiciranje
Cases of severe hypotension shortly following parecoxib administration have been reported in postmarketing experience with parecoxib.
V obdobju po začetku trženja zdravila so poročali o primerih hude hipotenzije, ki se je pojavila kmalu po aplikaciji parekoksiba.
▪ Acetylsalicylic acid (aspirin) or other anti-inflammatory medicines ▪ Fluconazole - used for fungal infections ▪ ACE inhibitors, Angiotensin-II inhibitors, beta blockers and diuretics - used for high blood pressure and heart conditions ▪ Ciclosporin or Tacrolimus - used after transplants ▪ Warfarin - or other warfarin like medicines used to prevent blood clots including newer medicines like apixaban, dabigatran, and rivaroxaban
• zaviralce ACE, antagoniste angiotenzina II, antagoniste adrenergičnih receptorjev beta in diuretike - uporabljajo se pri visokem krvnem tlaku in boleznih srca
• glucose 50 mg/ml (5%) solution for infusion
• 50 mg/ml (5 %) raztopina glukoze za infundiranje
In a large (N=1050) major orthopedic/general surgery trial, patients received an initial dose of parecoxib 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=525) for the remainder of a 10 day treatment period, or placebo IV followed by placebo PO (n=525).
na 12 ur, nato pa valdekoksib peroralno (20 mg na 12 ur) (n = 525) preostalih 10 dni obdobja zdravljenja ali pa so po prejemanju placeba i.v.
• glucose 50 mg/ml (5%) solution for infusion;
• 50 mg/ml (5%) raztopina glukoze za infundiranje;
Dynastat 40 mg powder for solution for injection
Dynastat 40 mg prašek za raztopino za injiciranje
Administration other than IV or IM
NAVEDBA ENE ALI VEČ UČINKOVIN
▪ Lithium - used to treat depression ▪ Rifampicin - used for bacterial infections ▪ Antiarrhythmics - used to treat an irregular heartbeat ▪ Phenytoin or Carbamazepine - used for epilepsy ▪ Methotrexate - used for rheumatoid arthritis and cancer ▪ Diazepam - used for sedation and anxiety ▪ Omeprazole - used for treating ulcers
• diazepam - uporablja se za pomiritev in pri tesnobi • omeprazol - uporablja se za zdravljenje razjed
Dosing.
Dojenje
Dynastat 40 mg powder for injection Parecoxib
Dynastat 40 mg prašek za raztopino za injiciranje parekoksib
Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
Zdravilo Dynastat je treba pregledati in se tako prepričati, da ne vsebuje delcev in ni obarvan.
No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6).
Bolnikom z blago okvaro jeter (ocena od 5 do 6 po Child-Pughu) odmerka praviloma ni treba prilagajati.
▪ If you are dehydrated - this may happen if you have had diarrhoea or have been vomiting (being sick) or unable to drink fluids ▪ If you have an infection as it may hide a fever (which is a sign of infection) ▪ If you use medicines to reduce blood clotting (e.g. warfarin/warfarin like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban, dabigatran, and rivaroxaban) ▪ If you use medicines called corticosteroids (e.g. prednisone) ▪ If you use a class of medicines used to treat depression called selective serotonin re-uptake inhibitors (e.g. sertraline)
• če jemljete zdravila proti strjevanju krvi (npr. varfarin/varfarinu podobne antikoagulante ali novejše peroralne antikoagulante, npr. apiksaban, dabigatran in rivaroksaban)
• sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion.
• 4,5 mg/ml (0,45 %) raztopina natrijevega klorida in 50 mg/ml (5 %) raztopina glukoze za injiciranje/infundiranje.
• sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion; or
• 4,5 mg/ml (0,45 %) raztopina natrijevega klorida in 50 mg/ml (5 %) raztopina glukoze za injiciranje/infundiranje; ali
• glucose 50 mg/ml (5%) solution for infusion; or
• 5 % (50 mg/ml) raztopino glukoze za infundiranje; ali
Uncommon: may affect up to 1 in 100 people ▪ Heart attack ▪ There is a risk of cerebrovascular disease e.g. stroke, or transient ischaemic attack (transient reduced blood flow to the brain)/mini-stroke or angina, or blockages to blood vessels to the heart or brain ▪ Blood clot in the lungs ▪ Worsening of high blood pressure ▪ Ulcers in the digestive system, chronic stomach acid reflux ▪ The heart may beat more slowly
(prehodno zmanjšan pretok krvi v možgane)/mini možganska kap ali angina pektoris ali ovira do krvnih žil, srca ali možganov
wheezing, difficulty breathing or swallowing (potentially fatal) ▪ Swelling, blistering or peeling of the skin ▪ Acute kidney failure ▪ Hepatitis (inflamed liver) ▪ Inflammation of the gullet (oesophagus) ▪ Inflammation of the pancreas (can lead to stomach pain)
izpuščaj na koži, otekanje obraza, ustnic ali jezika, ki lahko povzroči piskajoče ali težko dihanje ali požiranje - to se pojavi redko
• sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion
• 0,45 % (4,5 mg/ml) raztopino natrijevega klorida in 5 % (50 mg/ml) raztopino glukoze za injiciranje/infundiranje
Renal failure,
Ledvična okvara
Dynastat 40 mg powder and solvent for solution for injection
Dynastat 40 mg prašek in vehikel za raztopino za injiciranje
Dynastat 40 mg powder and solvent for solution for injection parecoxib
Dynastat 40 mg prašek in vehikel za raztopino za injiciranje parekoksib
MA (EU) Number Invented name Strength Pharmaceutical Form Route of Administration
Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe
2 vials +2 pre-filled syringes +2 plunger rods + 2 vial adapters + 2 needles
2 viali + 2 napolnjeni injekcijski brizgi + 2 bata brizge + 2 adapterja viale + 2 igli
3 x (1 vial + 1 prefilled syringe + 1 plunger rod + 1 vial adapter + 1 needle) (multipack)
3 x (1 viala + 1 napolnjena injekcijska brizga + 1 bat brizge + 1 adapter viale + 1 igla) (skupno pakiranje)
1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 needle
1 viala + 1 napolnjena injekcijska brizga + 1 bat brizge + 1 adapter viale + 1 igla
The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
Največji dovoljeni odmerek je ena tableta najvišje jakosti (80/10 mg) enkrat na dan.
Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s.
Obe sta učinkovini za zniževanje krvnega tlaka, ki sta v Evropski uniji (EU) na voljo od devetdesetih let prejšnjega stoletja.
Because telmisartan and amlodipine have been used for many years, the company presented information from scientific literature as well as results from new studies that the company had carried out.
Ker se telmisartan in amlodipin uporabljata že vrsto let, je družba predstavila informacije iz znanstvene literature, pa tudi rezultate novih študij, ki jih je izvedla.
The European Commission granted a marketing authorisation valid throughout the EU for Twynsta on 7 October 2010.
Evropska komisija je dovoljenje za promet z zdravilom Twynsta, veljavno po vsej Evropski uniji, izdala 7. oktobra 2010.
It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine).
Na voljo je v obliki tablet (40 mg telmisartana/10 mg amlodipina; 40 mg telmisartana/5 mg amlodipina; 80 mg telmisartana/10 mg amlodipina; 80 mg telmisartana/5 mg amlodipina).
Other information about Twynsta:
Druge informacije o zdravilu Twynsta:
Twynsta telmisartan / amlodipine
Twynsta telmisartan/amlodipin
It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Povzroči zaporo posebnih kanalčkov na površini celic, imenovanih kalcijevi kanalčki, skozi katere v celico običajno vstopajo kalcijevi ioni.
This is a summary of the European public assessment report (EPAR) for Twynsta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Twynsta.
The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks.
Glavno merilo učinkovitosti v vseh treh študijah je bilo znižanje diastoličnega krvnega tlaka (krvnega tlaka, izmerjenega med dvema udarcema srca) po osmih tednih.
The Committee decided that Twynsta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Twynsta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The full EPAR for Twynsta can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Twynsta je na voljo na spletni strani agencije under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
For more information about treatment with Twynsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Twynsta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Telmisartan je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over).
Zdravilo Twynsta se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih (starejših od 18 let).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Twynsta.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Twynsta shown during the studies?
Kakšne koristi je zdravilo Twynsta izkazalo med študijami?
The most common side effects with Twynsta (seen in up to 1 patient in 10) are dizziness and peripheral oedema (swelling, especially of the ankles and feet).
Najpogostejša neželena učinka zdravila Twynsta (opažena pri več kot 1 bolniku od 10) sta omotica in periferni edem (otekanje, zlasti gležnjev in stopal).
Twynsta must not be used in people who may be hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives' class or to any of the other ingredients.
Zdravila Twynsta ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) telmisartan, amlodipin, druga zdravila iz razreda „derivatov dihidropiridina“ ali katero koli drugo sestavino zdravila.
In addition, studies showed that the medicine was effective in patients whose blood pressure is not adequately controlled by amlodipine alone.
Poleg tega so študije pokazale, da je bilo zdravilo učinkovito pri bolnikih, pri katerih krvni tlak ni bil zadostno uravnan samo z amlodipinom.
The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Twynsta.
CHMP je ugotovil, da se utegnejo bolniki, ki že jemljejo zdravilni učinkovini v ločenih tabletah, lažje držati zdravljenja, če se jim predpiše zdravilo Twynsta.
Studies were also carried to show that Twynsta tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.
Izvedene so bile tudi študije, ki kažejo, da se zdravilo Twynsta v telesu enako absorbira kot ločeni tableti amlodipina in telmisartana.
Twynsta is taken by mouth as one tablet once a day and is used for long-term treatment.
Zdravilo Twynsta se jemlje peroralno, in sicer ena tableta na dan, ter je namenjeno dolgotrajnemu zdravljenju.
Twynsta must not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack).
Prav tako ga ne smejo uporabljati bolniki s hudimi obolenji jeter ali žolčnika, bolniki, ki so doživeli šok (nagel, močan padec krvnega tlaka), bolniki z zaporo pretoka krvi na levi strani srca oziroma bolniki s srčnim popuščanjem po miokardnem infarktu (srčnem napadu).
In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Twynsta or continued to take amlodipine at the same or a higher dose.
V dveh drugih glavnih študijah je 1 978 odraslih, pri katerih visok krvni tlak ni bil ustrezno uravnan zgolj z amlodipinom, prejemalo zdravilo Twynsta ali nadaljevalo jemanje amlodipina v enakem ali višjem odmerku.
For the full list of all side effects reported with Twynsta, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Twynsta, glejte navodilo za uporabo.
In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment).
V eni glavni študiji je 1 461 odraslih s hipertenzijo jemalo kombinacijo telmisartana in amlodipina, samo telmisartan ali samo amlodipin ali placebo (zdravilo brez zdravilne učinkovine).
Twynsta must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Zdravilo Twynsta se prav tako ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo.
V prvi študiji je bilo znižanje diastoličnega krvnega tlaka, opaženo pri bolnikih, ki so jemali kombinacijo telmisartana in amlodipina, večje kot pri bolnikih, ki so jemali samo eno od obeh zdravilnih učinkovin ali placebo.
In the two other studies, Twynsta was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Twynsta and amlodipine, the fall in diastolic blood pressure was greater in patients taking Twynsta by between 1.4 mmHg and 4.9 mmHg.
V dveh drugih študijah je bilo zdravilo Twynsta pri zniževanju diastoličnega krvnega tlaka učinkovitejše od neprekinjenega zdravljenja zgolj z amlodipinom: zmanjšanje diastoličnega krvnega tlaka je bilo večje pri bolnikih, ki so jemali zdravilo Twynsta, in sicer med 1,4 mmHg in 4,9 mmHg, odvisno od uporabljene jakosti tega zdravila.
What is the risk associated with Twynsta?
Kakšna tveganja so povezana z zdravilom Twynsta?
Why has Twynsta been approved?
Zakaj je bilo zdravilo Twynsta odobreno?
For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Twynsta to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.
Pri bolnikih, ki so jemali telmisartan in amlodipin kot ločeni tableti, je odmerek zdravila Twynsta odvisen od odmerkov telmisartana in amlodipina, ki so jih jemali prej.
By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Telmisartan z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, prepreči učinek hormona, kar privede do razširitve žil.
Twynsta can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.
Lahko se uporablja tudi namesto zdravljenja s telmisartanom in amlodipinom pri bolnikih, ki ti učinkovini jemljejo kot ločeni tableti.
Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone.
Zdravilo Twynsta se uporablja pri bolnikih, pri katerih visok krvni tlak ni zadostno uravnan zgolj z amlodipinom.
When appropriate, direct switch to Twynsta may be considered.
Možen je tudi neposreden prehod na zdravilo Twynsta, kadar se to izkaže kot ustrezno.
Twynsta is a medicine that contains two active substances, telmisartan and amlodipine.
Twynsta je zdravilo, ki vsebuje dve zdravilni učinkovini, telmisartan in amlodipin.
For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Twynsta.
Pri bolnikih, pri katerih krvni tlak ni zadostno uravnan z amlodipinom, je treba pred prehodom na zdravilo Twynsta za prilagoditev odmerka uporabiti ločene tablete amlodipina in telmisartana.
Twynsta contains two active substances, telmisartan and amlodipine.
Zdravilo Twynsta vsebuje dve zdravilni učinkovini, telmisartan in amlodipin.
What is Twynsta used for?
Za kaj se zdravilo Twynsta uporablja?
How has Twynsta been studied?
Kako je bilo zdravilo Twynsta raziskano?
What is Twynsta?
Kaj je zdravilo Twynsta?
How is Twynsta used?
Kako se zdravilo Twynsta uporablja?
How does Twynsta work?
Kako zdravilo Twynsta deluje?
ATCvet code: QI06AH09.
Oznaka ATCvet: QI06AH09.
Date of first authorisation: 23/02/2005 Date of last renewal: 25/01/2010
Datum pridobitve dovoljenja za promet: 23/02/2005 Datum podaljšanja dovoljenja za promet: 25/01/2010
69800 Saint-Priest
F-69800 Saint Priest
Manufacturer responsible for the batch release: MERIAL
Izdelovalec, odgovoren za sproščanje serij: MERIAL
1 cell culture infective dose 50%.
1 50% infektivni odmerek za celično kulturo
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev biološkihzdravilnih učinkovin:
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Kjer je pričakovati visoke titre maternalnih protiteles proti komponentam rinotraheitisa, kalici viroze ali panleukopenije (na primer pri mladičih starih od 9 do 12 tednov, rojenih mačkam, ki so bile cepljene pred brejostjo in/ali je znano ali verjetno, da so bile predhodno izpostavljene patogenu (om)), je potrebno osnovno cepljenje odložiti do starosti 12 tednov.
EU/2/04/052/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/052/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/2/04/052/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/052/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
Revaccination: - the first revaccination must be carried out one year after the primary vaccination course, - subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Ponovno cepljenje: - prvo ponovno cepljenje je potrebno opraviti eno leto po osnovnem cepljenju, - naslednja ponovna cepljenja je potrebno opraviti v obdobjih do 3eh let za komponente kužnega rinotraheitisa, kaliciviroze in panleukopenije.
Water for injection ....................................................................................................................... q.s.
Voda za injiciranje....................................................................................................................... q.s.
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Cepivo dokazano zmanjša izločanje kalici viusa mačk ob nastopu imunosti in do eno leto po cepljenju.
Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs.
Aktivna imunizacija 8 tednov starih mačk in starejših: - proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj, - proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj, - proti mačji panleukopeniji, za preprečevanje smrtnosti in ublažitev kliničnih znamenj.
FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U. FPV (PLI IV) .................................................................................................................... ≥ 103.5 CCID50.
FHV (sev F2) ...................................................................................................................... ≥ 104,9 CCID50 FCV (seva 431 in G1) ....................................................................................... ≥ 2,0 enot v testu ELISA FPV (PLI IV) ...................................................................................................................... ≥ 103,5 CCID50
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Imetnik dovoljenja za promet z zdravilom Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein