natgillin/translations-raw huggingface dataset:
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2) REFERRAL Adartrel International Non-Proprietary Name (INN): Ropinirole 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2) Adartrel Mednarodno nelastniško ime (INN): Ropinirol
Supplementary information was provided by the Marketing Authorisation Holder on 18 March 2005. 
Dodatne informacije je imetnik dovoljenja za promet z zdravilom predložil dne 18. marca 2005.
A Marketing Authorisation for Adartrel was granted to GlaxoSmithKline by France on 30 June 2004. 
Dovoljenje za promet z zdravilom Adartrel je Francija odobrila družbi GlaxoSmithKline dne 30. junija 2004.
During its 12-15 September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee was of the opinion that a marketing authorisation should be granted subject to certain conditions considered essential for the safe and effective use of the medicinal product. 
Na svojem zasedanju od 12. do 15. septembra 2005 je CHMP glede na celotne predložene podatke in znanstveno razpravo znotraj Odbora menil, da se dovoljenje za promet z zdravilom lahko podeli pod posebnimi pogoji, za katere je mnenja, da so bistvenega pomena za varno in učinkovito rabo zdravila.
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III. 
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
Conditions of the Marketing Authorisation are set out in Annex IV. 
Pogoji dovoljenja za promet z zdravilom so navedeni v Dodatku IV.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RC on 23 February 2005. 
Evropska komisija je dovoljenje za promet z zdravilom Purevax RC, veljavno po vsej Evropski uniji, izdala 23. februarja 2005.
They included young and adult cats of various breeds, but not young kittens. 
Vanje so bile vključene mlade in odrasle mačke različnih pasem, mladiči pa ne.
The cat should be revaccinated for all components one year after the first vaccination course, then every three years. 
Mačko je treba ponovno cepiti za vse sestavine cepiva eno leto po prvem cepljenju in nato na vsaka tri leta.
The vaccine helps to reduce the symptoms of the diseases and also helps to reduce viral excretion in case of calicivirus infection for one year after vaccination. 
Cepivo pomaga zmanjševati simptome bolezni in tudi prispeva k zmanjšanju izločanja virusa pri okužbi s kalicivirusom eno leto po cepljenju.
If the kitten has high levels of antibodies received from the mother in the womb and in the milk, the first vaccination should be delayed until 12 weeks of age. 
Če ima mačka visoke ravni protiteles, ki jih je prejela v maternici od matere in z mlekom, je treba prvo cepljenje odložiti do 12. tedna starosti.
The antibodies will help to protect against the diseases caused by these viruses. 
To prispeva k obrambi pred boleznimi, ki jih ti virusi povzročajo.
The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine. 
Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusom v cepivu.
The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later. 
Prvo cepivo je treba dati mladim mačkam, starim vsaj osem tednov, drugo injekcijo pa tri do štiri tedne pozneje.
Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days. 
Pri mačkah se občasno pojavijo začasna apatija (izguba interesa za okolico) in anoreksija (izguba teka) ter hipertermija (povišana telesna temperatura), ki traja en dan ali dva.
There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks. 
Na mestu injiciranja se lahko pojavi lokalna reakcija z rahlimi bolečinami ob dotiku, srbečico ali edemom (oteklino), ki izgine v enem do dveh tednih.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RC exceed the risks for the approved indications and recommended that Purevax RC be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RC večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘foreign' and makes antibodies against them. 
Ko mačko cepimo, imunski sistem prepozna oslabljene ali uničene viruse kot „tujke“ in proti njim tvori protitelesa.
In laboratory conditions Purevax RC was demonstrated to provide protection against the diseases listed above. 
V laboratorijskih pogojih je bilo dokazano, da zdravilo Purevax RC ščiti pred zgoraj navedenimi boleznimi.
• inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains). 
• inaktivirane (uničene) antigene proti kalicivirozi (seva FCV 431 in G1).
In the field, the studies of Purevax RC looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination. 
V terenskih študijah zdravila Purevax RC so proučevali osnovno shemo cepljenja (dve injekciji v razmiku od treh do štirih tednov) in obnovitveno cepljenje.
The effectiveness of Purevax RC has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus and calicivirus. 
Učinkovitost zdravila Purevax RC so proučili v več preskušanjih v laboratorijskih pogojih, v katerih so mačke cepili in okužili s herpesvirusom in kalicivirusom.
Other information about Purevax RC: 
Druge informacije o zdravilu Purevax RC:
Purevax RC is a vaccine. 
Zdravilo Purevax RC je cepivo.
Purevax RC contains small amounts of weakened or killed viruses that cause feline rhinotracheitis and calicivirosis. 
Zdravilo Purevax RC vsebuje majhne količine oslabljenih ali uničenih virusov, ki povzročajo rinotraheitis in kalicivirozo mačk.
Purevax RC should not be used in pregnant cats. 
Zdravilo Purevax RC se ne sme uporabljati pri brejih mačkah.
Purevax RC is used to vaccinate cats from the age of 8 weeks against: 
Zdravilo Purevax RC se uporablja za cepljenje mačk, starih osem tednov ali več, proti:
• feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus). 
• kalicivirozi mačk (gripi podobni bolezni z vnetjem ust, ki jo povzroča kalicivirus).
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus and calicivirus infection remained stable at a high level or increased slightly. 
V študiji obnovitvenega cepljenja so ravni protiteles proti herpesvirusu rinotraheitisa in kalicivirusu ostale stabilne na visoki vrednosti ali pa so se rahlo zvišale.
Purevax RC is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection. 
Zdravilo Purevax RC je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) in vehikla za pripravo suspenzije za injiciranje.
For a full list of the side-effects reported with Purevax RC, see the package leaflet. 
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax RC, glejte navodilo za uporabo.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection. 
V terenski študiji osnovnega cepljenja so se zvišale ravni protiteles proti okužbi s herpesvirusom rinotraheitisa in kalicivirusom mačk.
Purevax RC is a veterinary vaccine that contains: 
Zdravilo Purevax RC je cepivo, ki se uporablja v veterinarski medicini in vsebuje:
What is the risk associated with Purevax RC? 
Kakšna tveganja so povezana z zdravilom Purevax RC?
What benefit has Purevax RC shown during the studies? 
Kakšne koristi zdravila Purevax RC so se pokazale v študijah?
Why has Purevax RC been approved? 
Zakaj je bilo zdravilo Purevax RC odobreno?
Feline viral rhinotracheitis (live attenuated) and feline calicivirosis (inactivated) vaccine 
Cepivo proti virusnemu rinotraheitisu mačk (živo oslabljeno) in kalicivirozi mačk (oslabljeno)
What is Purevax RC used for? 
Za kaj se zdravilo Purevax RC uporablja?
How has Purevax RC been studied? 
Kako je bilo zdravilo Purevax RC raziskano?
What is Purevax RC? 
Kaj je zdravilo Purevax RC?
How does Purevax RC work? 
Kako zdravilo Purevax RC deluje?
Invented name Strength Pharmaceutical Form Route of Administration 
Jakost Farmacevtska oblika
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains: A/California/7/2009 (H1N1)pdm09- like strain (A/Brisbane/10/2010, wild type) 
Površinski antigeni virusa gripe (hemaglutinin in nevraminidaza)*, inaktivirani, naslednjih sevov: Sevu A/California/7/2009 (H1N1)pdm09 podoben sev (A/Brisbane/10/2010, divji tip)
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin 
* razmnoženi v celicah pasjih ledvic Madin Darby (MDCK) ** hemaglutinin
A/Switzerland/9715293/2013 (H3N2) - like strain (A/South Australia/55/2014, wild type) 
Sevu A/Switzerland/9715293/2013 (H3N2) podoben sev (A/South Australia/55/2014, divji tip)
B/Phuket/3073/2013 - like strain (B/Utah/9/2014, wild type) 
Sevu B/Phuket/3073/2013 podoben sev (B/Utah/9/2014, divji tip)
2 x 10 pre-filled syringes (Luer Cone) + 20 needles 
2 x 10 napolnjenih injekcijskih brizg (Luer Cone) + 20 igel
1 pre-filled syringe (Luer Lock) + 1 needle 
1 napolnjena injekcijska brizga (Luer Lock) + 1 igla
1 pre-filled syringe (Luer Cone) 
1 napolnjena injekcijska brizga (Luer Cone)
2 x 10 pre-filled syringes (Luer Lock) 
2 x 10 napolnjenih injekcijskih brizg (Luer Lock)
1 pre-filled syringe (Luer Cone) + 1 needle 
1 napolnjena injekcijska brizga (Luer Cone) + 1 igla
1 pre-filled syringe (Luer Lock) 
1 napolnjena injekcijska brizga (Luer Lock)
2 x 10 pre-filled syringes (Luer Cone) 
2 x 10 napolnjenih injekcijskih brizg (Luer Cone)
10 pre-filled syringes (Luer Cone) + 10 needles 
10 napolnjenih injekcijskih brizg (Luer Cone) + 10 igel
10 pre-filled syringes (Luer Cone) 
10 napolnjenih injekcijskih brizg (Luer Cone)
10 pre-filled syringes (Luer Lock) 
10 napolnjenih injekcijskih brizg (Luer Lock)
10 pre-filled syringe (Luer Lock) + 10 needles l t o r 
10 napolnjenih injekcijskih brizg (Luer Lock) + 10 igel o č
Invented name Strength Pharmaceutical Form 
Zaščiteno ime Jakost Farmacevtska oblika
EU numbers 
Številka EU
Route of administration 
Pot uporabe Ovojnina
Following the European Commission Decision the Risk Management Plan should be submitted with any new application for extending the indication regarding the treatment of mania in bipolar disorder, as relevant. 
V skladu z odločbo Evropske komisije je treba načrt za obvladovanje tveganja predložiti z vsako novo vlogo za razširitev indikacije v zvezi z zdravljenjem manije pri bipolarni motnji, kot je primerno.
CONDITIONS OF THE MARKETING AUTHORISATIONS National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM Pristojni nacionalni organi, katerih delo usklajuje referenčna država članica, kadar je primerno, zagotovijo, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednje pogoje:
ANNEX IV CONDITION OF THE MARKETING AUTHORISATIONS 
DODATEK IV POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
This can result in serious vision loss and even blindness. 
To lahko povzroči resno poslabšanje vida in celo slepoto.
Further information on Rhokiinsa can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rhokiinsa 
Nadaljnje informacije o zdravilu Rhokiinsa so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/rhokiinsa.
The European Medicines Agency therefore decided that Rhokiinsa's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Rhokiinsa večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Rhokiinsa? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rhokiinsa?
The safety of Rhokiinsa will be further investigated in a study. 
Varnost zdravila Rhokiinsa bodo dodatno raziskali v študiji.
However, side effects on the eye were more frequent than those of timolol, and this may lead people to stop treatment. 
Kljub temu so bili neželeni učinki na oko pogostejši kot učinki pri timololu, zaradi česar lahko ljudje prenehajo zdravljenje.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rhokiinsa have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Rhokiinsa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
It is available as an eye-drop solution (200 microgram/ml) and the dose is one drop in the affected eye once a day, in the evening. 
Na voljo je v obliki raztopine za kapljice za oči (200 mikrogramov/ml), ki se daje v odmerku ene kapljice v obolelo oko enkrat na dan zvečer.
As for all medicines, data on the use of Rhokiinsa are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rhokiinsa stalno spremljajo.
Other information about Rhokiinsa 
Druge informacije o zdravilu Rhokiinsa
Side effects reported with Rhokiinsa are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Rhokiinsa, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
In patients with moderately high eye pressure (up to 25 mmHg), Rhokiinsa was as effective as timolol (another medicine), lowering the pressure by around 3.9 mmHg to 4.7 mmHg, compared with reductions of 3.8 mmHg to 5.2 mmHg for patients using timolol. 
Pri bolnikih z zmerno povišanim očesnim tlakom (do 25 mmHg) je bilo zdravilo Rhokiinsa enako učinkovito kot timolol (drugo zdravilo), saj je znižalo tlak med 3,9 mmHg in 4,7 mmHg v primerjavi z znižanjem od 3,8 mmHg do 5,2 mmHg pri bolnikih, ki so uporabljali timolol.
For more information about using Rhokiinsa, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Rhokiinsa glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Rhokiinsa authorised in the EU? 
Zakaj je bilo zdravilo Rhokiinsa odobreno v EU?
This means that it blocks the activity of an enzyme called Rho kinase, which has a role in controlling drainage of fluid from the eye. 
To pomeni, da zavira dejavnost encima, imenovanega Rho-kinaza, ki sodeluje pri nadzorovanju odtoka tekočine iz očesa.
An overview of Rhokiinsa and why it is authorised in the EU 
Pregled zdravila Rhokiinsa in zakaj je odobreno v EU
However, when these results were combined with results from other studies, decreases in eye pressure with Rhokiinsa were larger than those seen in the main study only. 
Ko pa so te rezultate združili z rezultati iz drugih študij, je bilo znižanje očesnega tlaka ob jemanju zdravila Rhokiinsa večje od vrednosti, opaženih v glavni študiji.
In terms of safety, the side effects of Rhokiinsa are considered manageable and were more likely to be confined to the eye. 
Z vidika varnosti se neželeni učinki zdravila Rhokiinsa štejejo za obvladljive in so bolj verjetno omejeni na oko.
What benefits of Rhokiinsa have been shown in studies? 
Kakšne koristi zdravila Rhokiinsa so se pokazale v študijah?
Rhokiinsa, which has a different mode of action from previously authorised treatments, provides another treatment option for patients with open-angle glaucoma and ocular hypertension. 
Zdravilo Rhokiinsa, ki ima drugačen način delovanja od predhodno odobrenih zdravil, zagotavlja drugo možnost zdravljenja bolnikom z glavkomom odprtega zakotja in očesno hipertenzijo.
The effect of Rhokiinsa was less pronounced in patients whose eye pressure was more than 30 mmHg, but these results were considered less important because Rhokiinsa is not expected to be used on its own in this group. 
Učinek zdravila Rhokiinsa je bil manj izrazit pri bolnikih, pri katerih je bil tlak v očesu višji od 30 mmHg, vendar so bili ti rezultati manj pomembni, ker se ne pričakuje, da se bo to zdravilo v tej skupini uporabljalo samostojno.
A main study of 708 patients with open-angle glaucoma or ocular hypertension showed that Rhokiinsa is effective at lowering eye pressure. 
Glavna študija pri skupaj 708 bolnikih z glavkomom odprtega zakotja ali očesno hipertenzijo je pokazala, da je zdravilo Rhokiinsa učinkovito pri znižanju očesnega tlaka.
Other common side effects (which may affect up to 2 in 10 people) are: cornea verticillata (deposits in the cornea, the transparent layer in front of the eye that covers the pupil and iris), eye pain, conjunctival haemorrhage (bleeding in the surface layer of the eye), erythema (reddening) at the site where the medicine was applied and the eyelid, corneal staining, blurred vision and increased lacrimation (watery eyes). 
Drugi pogosti neželeni učinki (ki se pojavijo pri največ 2 bolnikih od 10) so: cornea verticillata (depoziti na roženici, tj. prozorni plasti na prednji strani očesa, ki pokriva zenico in šarenico), bolečina v očesu, krvavitev v veznico (krvavitev na površinski plasti očesa), eritem (pordelost) na mestu vkapanja zdravila in eritem veke, obarvanje roženice, zamegljen vid in povečano solzenje (solzne oči).
What is Rhokiinsa and what is it used for? 
Kaj je zdravilo Rhokiinsa in za kaj se uporablja?
Rhokiinsa is an eye-drop solution that is used to reduce pressure inside the eye in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal). 
Zdravilo Rhokiinsa je raztopina za kapljice za oko, ki se uporablja za zniževanje tlaka v očesu pri odraslih z glavkomom odprtega zakotja (boleznijo, pri kateri se očesni tlak zviša, ker tekočina ne more iztekati iz očesa) ali očesno hipertenzijo (kadar je očesni tlak višji od običajnega).
The most common side effect with Rhokiinsa (which may affect around 5 in 10 people) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness). 
Najpogostejši neželeni učinek zdravila Rhokiinsa (ki se lahko pojavi pri približno 5 bolnikih od 10) je hiperemija veznice (povečan dotok krvi v oko, kar povzroča pordečitev očesa).
When pressure in the eye is raised, it can cause damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. 
Kadar je tlak v očesu povišan, lahko poškoduje mrežnico (membrano na zadnji strani zrkla, ki je občutljiva za svetlobo) in vidni živec, ki pošilja signale iz očesa v možgane.
What are the risks associated with Rhokiinsa? 
Kakšna tveganja so povezana z zdravilom Rhokiinsa?
The active substance in Rhokiinsa, netarsudil, is a Rho kinase inhibitor. 
Učinkovina v zdravilu Rhokiinsa, netarsudil, je zaviralec Rho-kinaze.
Rhokiinsa contains the active substance netarsudil. 
Zdravilo Rhokiinsa vsebuje učinkovino netarsudil.
For the full list of side effects and restrictions with Rhokiinsa, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Rhokiinsa glejte navodilo za uporabo.
How is Rhokiinsa used? 
Kako se zdravilo Rhokiinsa uporablja?
In patients whose eye pressure was higher than 25 mmHg, Rhokiinsa was less effective than timolol. 
Zdravilo Rhokiinsa je bilo pri bolnikih z očesnim tlakom, višjim od 25 mmHg, manj učinkovito kot timolol.
Rhokiinsa showed good effects across a range of eye pressures. 
Zdravilo je namreč pokazalo dobre učinke pri različnih vrednostnih očesnega tlaka.
How does Rhokiinsa work? 
Kako zdravilo Rhokiinsa deluje?
When it blocks this enzyme, Rhokiinsa increases the flow of fluid out of the eyeball, thereby lowering pressure inside the eye. Rhokiinsa is also thought to lower eye pressure by reducing pressure in the veins around the eyes. 
Zdravilo Rhokiinsa z zaviranjem tega encima poveča izcedek tekočine iz zrkla in s tem zniža tlak v očesu.
Rhokiinsa is only available on prescription and should be started by an eye specialist. 
Predpisovanje in izdaja zdravila Rhokiinsa je le na recept, zdravljenje z njim pa sme uvesti samo oftalmolog.
Packaging Content Package size 
Pot uporabe Pakiranje Vsebina Velikost pakiranja
Invented name 
Številka EMA Izmišljen o ime
1 bottle; 2 sachets 
2 vrečki
1 bottle; 1 sachet 
1 vrečka
ATCvet code: QI06AJ03. 
Oznaka ATCvet: QI06AJ03.
Date of first authorisation: 23/02/2005 Date of last renewal: 14/01/2010 
Datum pridobitve dovoljenja za promet: 23/02/2005 Datum podaljšanja dovoljenja za promet: 14/01/2010
Shelf life after reconstitution according to directions: use immediately. 
Rok uporabnosti po rekonstituciji v skladu z navodili : uporabite takoj.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali med enim zdravljenjem) - pogosti (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 100 živali) - občasni (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 1.000 živali) - redki (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days. 
Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6 »Neželeni učinki«, niso znani, razen povišane temperature , ki izjemoma lahko traja pet dni.
1 cell culture infective dose 50% 
1 50% infektivni odmerek za celično kulturo
* less than 1 animal in 10,000 animals displaying adverse reaction(s) during the course of one treatment, including isolated reports. 
* manj kot 1 živali od 10.000 živali kaže neželene učinke med trajanjem enega zdravljenja, vključujoč posamezne primere
EU/2/04/050/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/050/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml) 
EU/2/04/050/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/050/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components. 
Ponovno cepljenje: - prvo ponovno cepljenje je potrebno opraviti za vse komponente eno leto po osnovnem cepljenju, - nadaljnja ponovna cepljenja je potrebno opraviti: vsako leto za komponento klamidioze in v obdobjih do 3 leta za komponente rinotraheitisa, kaliciviroze in panleukopenije.
2 egg infective dose 50% 
2 50% infektivni odmerek za embrionirana kokošja jajca