natgillin/translations-raw huggingface dataset:
According to the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of VICH GL6 and GL381 when “adverse environmental effects are anticipated from the use of products, further assessment of possible exposure of the environment can be performed, even if straightforward application of the Phase I guidance would indicate exemption from further testing.” This provision implies that some products, which do not meet the trigger value for entering a Phase II environmental risk assessment (ERA), may however require further assessment to address specifically the concerns related to their activity and use. 
V skladu s smernico CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL381 velja, da ko „so pričakovani neugodni učinki na okolje zaradi uporabe zdravil, se lahko izvede dodatna ocena morebitne izpostavljenosti okolja, tudi če bi neposredna uporaba navodil iz I. faze pomenila izvzetje iz nadaljnjih testov".
1 CVMP guideline on environmental impact assessment for veterinary medicinal products in support of VICH GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf 2 VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf 
1 Smernica CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf.
R4 is often used to cover a conservative run-off scenario in FOCUS-SW and consequently has been used for the exposure assessment for the FOCUS-SW STEP 3 calculations. 
konservativen scenarij površinskega odtoka, zato so ga uporabili za oceno izpostavljenosti pri izračunih v 3. koraku poročila FOCUS-SW.
The CVMP acknowledged these results, but concluded that data on the metabolism of altrenogest in gilts, indicating a total amount of excreted altrenogest equivalents corresponding to 5% to 16.5% (release factor 0.05-0.15) of the total dose, should have been considered instead of the release factor of 0.31, given the reliability and quality of the study and its results being in line with existing literature data for progestogens and also with residue concentrations found in liver and kidney of pigs. 
Odbor CVMP je potrdil te rezultate, vendar je zaključil, da bi bilo glede na zanesljivost in kakovost študije, katere rezultati so bili v skladu z obstoječimi podatki iz literature o progestogenih in tudi s koncentracijami ostankov, najdenih v jetrih in ledvicah prašičev, treba upoštevati podatke o presnovi altrenogesta pri svinjah mladicah, ki kažejo celotno količino izločenih ekvivalentov altrenogesta, ki znaša od 5 % do 16,5 % (faktor sproščanja 0,05-0,15) celotnega odmerka, in ne faktor sproščanja 0,31.
However it was agreed that risk mitigation measures need to be included in the product information for veterinary medicinal products containing altrenogest to be administered orally to pigs to lower the risk to the environment and to make the user aware that altrenogest may be hazardous for fish and other aquatic organisms. 
Kljub temu je bilo dogovorjeno, da je treba v informacije o zdravilih za uporabo v veterinarski medicini, ki vsebujejo altrenogest, za peroralno dajanje prašičem, vključiti ukrepe za zmanjšanje tveganja, da se zmanjša tveganje za okolje in ozavesti uporabnike, da je altrenogest lahko nevaren za ribe in druge vodne organizme.
The DT50 values for soils 1, 2, 3 and 4 are 23.7, 5.3, 2.0, and 
Vrednosti DT50 za tla 1, 2, 3 in 4 znašajo 23,7, 5,3, 2,0 oziroma 4,6 dneva, iz česar izhaja, da geometrična srednja vrednost DT50 znaša 5,8 dneva.
For surface water the FOCUS STEP 2 and 3 (Phase IIA), were conducted as the STEP 1 resulted in a PECsurfacewater larger than the lowest predicted no effect concentration (PNEC) (0.4 ng/l). 
A faza), ker je bila vrednost PECpovršinska voda v 1. koraku višja od najnižje predvidene koncentracije brez učinka (PNEC) (0,4 ng/l).
Poland Virbac S.A. 1ère avenue 
Češka republika Virbac S.A. 1ère avenue
{Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms. 
{Izmišljeno ime} ne sme priti v vodne tokove, ker je to lahko nevarno za ribe in druge vodne organizme
• the CVMP considered that the overall benefit-risk balance is positive for veterinary medicinal products containing altrenogest to be administered orally to pigs and horses; the CVMP recommended variations of the marketing authorisations for veterinary medicinal products containing altrenogest to be administered orally to pigs (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III. 
je odbor CVMP priporočil spremembo dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo altrenogest, za peroralno dajanje prašičem (glejte Prilogo I), da se spremenijo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
The PECgroundwater (Phase IIA STEP 1) was calculated using the recommended stepwise approach described in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38 (EMEA/CVMP/418282/2005-Rev.1), STEP 1 to STEP 3. 
A faza, 1. korak) je bila izračunana s pomočjo priporočenega postopnega pristopa, opisanega v smernici odbora CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/418282/2005-Rev.1), od 1. koraka do 3. koraka.
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet 
Dopolnitve v ustreznih poglavjih v SPC, Označevanju in Navodilu za uporabo
Based on the available data and conservative calculations, a risk for fish and other aquatic organisms associated with the zootechnical use of veterinary medicinal products containing altrenogest in gilts cannot be excluded for certain geographical areas (i.e. Middle European Mediterranean). 
Na podlagi razpoložljivih podatkov in konservativnih izračunov na nekaterih geografskih območjih (tj. v srednjem evropskem Sredozemlju) ni mogoče izključiti tveganja za ribe in druge vodne organizme, povezanega z zootehnično uporabo zdravil za uporabo v veterinarski medicini, ki vsebujejo altrenogest, pri svinjah mladicah.
Risk mitigation measures are recommended in the product information for veterinary medicinal products containing altrenogest to be administered orally to pigs to lower the risk to the environment and to make the user aware that altrenogest may be hazardous for fish and other aquatic organisms. 
V informacije o zdravilih za uporabo v veterinarski medicini, ki vsebujejo altrenogest, za peroralno dajanje prašičem, je priporočeno vključiti ukrepe za zmanjšanje tveganja, da se zmanjša tveganje za okolje in ozavesti uporabnike, da je altrenogest lahko nevaren za ribe in druge vodne organizme.
Consequently the use of altrenogest in mares is not considered to pose a risk to the environment when used as specified in the SPCs given the minimal environmental exposure associated with this use, and the environmental risk assessment presented below is based on the use of altrenogest in gilts. 
Zato uporaba altrenogesta pri kobilah ne pomeni tveganja za okolje, ko se uporablja v skladu s povzetki glavnih značilnosti zdravila, ker je izpostavljenost okolja pri taki uporabi minimalna.
A Phase I and a Phase II environmental risk assessment were conducted. 
faza ocene tveganja za okolje.
SPC section 4.5 Special precautions for use. 
Povzetek glavnih značilnosti zdravila, poglavje 4.5 - Posebni previdnostni ukrepi
5 OECD 54 guideline on Current Approaches in the Statistical Analysis of Ecotoxicity Data: A Guidance to Application http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono%282006%2918&doclanguage =en http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31991L0676&from=en relevant for winter cereals, as proposed by the FOCUS-SW report and need to be calculated as well. 
5 Smernica OECD št. 54 „Trenutni pristopi k statistični analizi podatkov o ekotoksičnosti: navodila za uporabo“ (2006)http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono%282006%2918&doclanguage =en.
Environmental fate studies 
Študije obnašanja v okolju
MATERIALS, IF ANY {Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms. 
ALI ODPADNIH SNOVI, ČE OBSTAJAJO {Izmišljeno ime} ne sme priti v vodne tokove, ker je to lahko nevarno za ribe in druge vodne organizme.
The MAHs proposes the following risk mitigation measure: “When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment”. 
Imetniki dovoljenja za promet z zdravilom predlagajo naslednji ukrep za zmanjšanje tveganja: „Pri nanašanju gnoja zdravljenih živali je treba natančno upoštevati najmanjšo razdaljo do površinske vode, kot jo določajo nacionalni ali lokalni predpisi, ker lahko gnoj vsebuje altrenogest, ki bi v vodnem okolju lahko povzročil škodljive učinke.“
For the Phase I the PECsoil initial for gilts, sows and mares was established using the daily doses and the default values from the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38 (EMEA/CVMP/418282/2005Rev.1). 
Začetna vrednost PECtla za svinje mladice, svinje in kobile za I. fazo je bila določena s pomočjo dnevnih odmerkov in privzetih vrednosti iz smernice odbora CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/418282/2005-Rev.1).
• the CVMP considered that veterinary medicinal products containing altrenogest are essential in modern pig production since the oestrus synchronisation of gilts is a tool facilitating strict batch farrowing with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals; 
• odbor CVMP je upošteval, da so zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest, nujna v sodobni prašičereji, saj je sinhronizacija estrusa svinj mladic orodje, ki omogoča točno serijsko prasitev in tako prinaša očitne koristi pri upravljanju in higieni na zadevnih kmetijah in posledično pri zdravju živali;
However, veterinary medicinal products containing altrenogest are essential in modern pig production since the synchronisation of gilts is a tool facilitating strict batch farrowing, with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals. 
Kljub temu so zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest, nujna v sodobni prašičereji, saj je sinhronizacija svinj mladic orodje, ki omogoča točno serijsko prasitev in tako prinaša očitne koristi pri upravljanju in higieni na zadevnih kmetijah in posledično pri zdravju živali.
Veterinary medicinal products containing altrenogest are essential in modern pig production, as the synchronisation of gilts is a tool facilitating strict batch farrowing, with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals. 
Zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest, so nujna v sodobni prašičereji, saj je sinhronizacija svinj mladic orodje, ki omogoča točno serijsko prasitev in tako prinaša očitne koristi pri upravljanju in higieni na zadevnih kmetijah in posledično pri zdravju živali.
Germany considered that, although according to the VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I2, the estimated Predicted Environmental Concentrations in soil (PECsoil) for altrenogest (<100 µg/kg) would not trigger a Phase II ERA, hazard concerns related to endocrine disruption and identified in structurally very similar molecules, require a deeper understanding of the potential environmental impacts of altrenogest when used following the recommended use, and a tailored Phase II ERA is consequently considered necessary. 
faze ocene tveganja za okolje, je po mnenju Nemčije zaradi pomislekov glede nevarnosti, povezanih z endokrinimi motnjami, ki so bile ugotovljene v molekulah z zelo podobno strukturo, treba podrobneje poznati morebitne vplive altrenogesta na okolje ob priporočljivem načinu uporabe in je zato potrebna prilagojena II.
Route of administration 
Način in pot uporabe
Spain aniMedica GmbH Im Sudfeld 
Španija aniMedica GmbH Im Sudfeld
The anaerobic transformation of altrenogest was investigated in pig manure incubated anaerobically according to the CVMP guideline on determining the fate of veterinary medicinal products in manure (EMA/CVMP/ERA/430327/2009)3. 
Anaerobno pretvorbo altrenogesta so preučevali v anaerobno inkubiranem svinjskem gnoju skladno s smernico odbora CVMP o ugotavljanju obnašanja zdravil za uporabo v veterinarski medicini v
When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment. 
Pri nanašanju gnoja zdravljenih živali je treba natančno upoštevati najmanjšo razdaljo do površinske vode, kot jo določajo nacionalni ali lokalni predpisi, ker lahko gnoj vsebuje altrenogest, ki bi v vodnem okolju lahko povzročil škodljive učinke.
No NOEC (No-Observed Effect Concentration) could be derived (NOEC <0.4 ng/l) for altrenogest from the study, especially as analytical limitations proved difficult any further decrease in test concentrations. 
Iz študije ni bilo mogoče izpeljati koncentracije brez opaženega učinka (NOEC < 0,4 ng/l) za altrenogest, zlasti ker
Hungary aniMedica GmgH, Im Südfeld 9 
Madžarska aniMedica GmgH, Im Südfeld 9
United Kingdom aniMedica GmbH Im Sudfeld 
Združeno kraljestvo aniMedica GmbH Im Sudfeld
0.4% w/v Oral suspension Pigs 
0.4% w/v Peroralna raztopina Prašiči
40 pg/l was established. 
Zato so določili vrednost PNEC pod 40 pg/l.
France aniMedica GmbH Im Südfeld 9 
Francija aniMedica GmbH Im Südfeld 9
Romania aniMedica GmbH Im Südfeld 9 
Romunija aniMedica GmbH Im Südfeld 9
However, for buffer zone calculations, which represent the highest tier exposure scenario, the entire representative R-scenario set is recommended. 
Kljub temu je za izračune varovalnih pasov, ki predstavljajo scenarij najvišje stopnje izpostavljenosti, priporočen celoten niz reprezentativnih scenarijev R. Scenarija R1 (zemljišča v srednji Evropi) in R3 (srednje evropsko Sredozemlje) (ne pa scenarij R2) sta pomembna tudi za ozimna žita, kot je predlagano v poročilu FOCUS-SW, in ju je tudi treba izračunati.
Maximum PECsurfacewater concentrations were calculated using FOCUS STEP 4 modelling for all representative scenarios for different buffer zone (1 m, 3 m, 5 m, 10 m (Directive 91/676/EEC) These buffer zones are minimum distances to surface water which must be maintained when manure (or organic fertilizer) is spread onto cropland for the protection of waters against pollution caused by nitrates from agricultural sources which is implemented in national law in the EU Member States. 
Najvišje koncentracije PECpovršinska voda so bile izračunane s pomočjo 4. koraka modela FOCUS za vse reprezentativne scenarije za različne varovalne pasove (1 m, 3 m, 5 m, 10 m) (Direktiva 91/676/EGS).
Regumate Equine 2.2 mg/ml oral solution for horses 
Regumate Equine 2.2 mg/ml oral solution for Konji
Regumate Equine 2.2 mg/ml Oral Solution for Horses 
Regumate Equine 2.2 mg/ml Oral Solution for Konji
0.4% w/w Oral solution Pigs 
0.4% w/w Peroralna raztopina Prašiči
Other precautions regarding impact on the environment When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment. 
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pri gnojenju z gnojem zdravljenih živali je treba strogo upoštevati državne in lokalne predpise glede minimalne oddaljenosti od površinskih vod, ker gnoj lahko vsebuje altrenogest, ki bi lahko povzročil neželene učinke v vodnem okolju.
100 mg Powder for concentrate for solution for infusion 
100 mg prašek za koncentrat za raztopino za injiciranje intravenska uporaba viala (steklo)
MA (EU) number Name Strength Pharmaceutical Form 
(Izmišljeno) ime Jakost Farmacevtska oblika
(Invented) name 
(Izmišljeno) name
(Invented) name 
(Lastniško ime)
Powder for concentrate for solution for infusion 
29 mg prašek za pripravo koncentrata za pripravo raztopine za infundiranje intravenska uporaba viala (steklena) 1 viala
This summary was last updated on 14.01.2010. 
Povzetek je bil nazadnje posodobljen 14.01.2010.
The vaccine also contains ‘adjuvants' to stimulate a better response. 
Cepivo vsebuje tudi „adjuvanse“ za spodbujanje boljšega odziva.
This protects the pigs against the disease. 
To bo zaščitilo prašiče pred boleznijo.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznimi.
The European Commission granted a marketing authorisation valid throughout the European Union, for Gripovac 3 to Merial on 14.01.2010. 
Evropska komisija je dovoljenje za promet z zdravilom Gripovac 3, veljavno po vsej Evropski uniji, odobrila družbi Merial dne 14.01.2010.
Sometimes, a slight increase in the rectal temperature might occur after vaccination. 
Občasno se lahko po cepljenju rahlo poviša rektalna temperatura.
Gripovac 3 is a suspension for injection. 
Zdravilo Gripovac 3 je suspenzija za injiciranje.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)? 
Koliko časa mora preteči, preden se lahko žival zakolje in meso porabi za prehrano ljudi
When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them. 
Ko prašiča cepimo, imunski sistem prepozna uničene viruse kot „tujke“ in proti njim razvije protitelesa.
What benefit has Gripovac 3 shown during the studies? 
Kakšne koristi je zdravilo Gripovac 3 izkazalo med študijami?
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GRIPOVAC 3 EPAR summary for the public 
GRIPOVAC 3 Povzetek EPAR za javnost
Gripovac 3 is a vaccine. 
Zdravilo Gripovac 3 je cepivo.
A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within 2 days. 
Pri majhnem številu prašičev se lahko na mestu injiciranja pojavi manjša oteklina, ki pa mine v 2 dneh.
Gripovac 3 contains small amounts of a modified and then killed form of the pig's influenza virus that causes lesions and illness. 
Zdravilo Gripovac 3 vsebuje majhne količine spremenjene in nato uničene oblike virusa prašičje influence, ki povzroča lezije in bolezen.
Gripovac 3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed). 
Zdravilo Gripovac 3 je cepivo, ki vsebuje 3 različne seve virusa prašičje influence A, ki so bili inaktivirani (uničeni).
Other information about Gripovac 3: 
Druge informacije o zdravilu Gripovac 3:
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses. 
Ob ponovni izpostavitvi virusom v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa hitreje.
In case of accidental self-injection only a minor injection site reaction is expected. 
V primeru nenamernega samoinjiciranja lahko pride do blage reakcije na mestu injiciranja.
The effectiveness of Gripovac 3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza. 
Učinkovitost zdravila Gripovac 3 so proučevali pri živalih, starejših od 56 dni, in pri svinjah pred in med brejostjo, te študije pa so pokazale, da jih cepivo ščiti pred prašičjo influenco.
What is the risk associated with Gripovac 3? 
Kakšna tveganja so povezana z zdravilom Gripovac 3?
Use of the Gripovac 3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus. 
Uporaba zdravila Gripovac 3 pri prašičih zmanjša klinične znake in zmanjša prisotnost virusa v pljučih po okužbi, ki jo povzroči virus prašičje influence A.
Why has Gripovac 3 been approved? 
Zakaj je bilo zdravilo Gripovac 3 odobreno?
Gripovac 3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth. 
Zdravilo Gripovac 3 se prav tako uporablja za cepljenje brejih svinj po prvi imunizaciji, z dajanjem enega odmerka 14 dni pred prasitvijo, da mleko svinj vsebuje dovolj protiteles, ki pujske ščijo pred prašičjo influenco vsaj 33 dni po rojstvu.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Gripovac 3 exceed the risks for the vaccination of pigs from the age of 56 days onwards inluding pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that Gripovac 3 be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Gripovac 3 za cepljenje prašičev od 56 dneva starosti naprej, vključno z brejimi svinjami, proti influenci prašičev, ki jo povzročajo podtipi H1N1, H3N2 in H1N2, za zmanjšanje kliničnih znakov in prisotnosti virusa v pljučih po okužbi, večje od tveganj, in priporočil, da se za zdravilo Gripovac 3 odobri dovoljenje za promet.
What is Gripovac 3 used for? 
Za kaj se zdravilo Gripovac 3 uporablja?
What is Gripovac 3? 
Kaj je zdravilo Gripovac 3?
Gripovac 3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs. 
Zdravilo Gripovac 3 se uporablja za cepljenje prašičev od 56 dneva starosti naprej, vključno z brejimi svinjami, proti prašičji influenci za zmanjšanje kliničnih znakov in prisotnosti virusa v pljučih.
How has Gripovac 3 been studied? 
Kako je bilo zdravilo Gripovac 3 raziskano?
84 tablets 10 tablets 30 tablets 100 tablets 
84 tablet 10 tablet 30 tablet 100 tablet
Oral use Oral use Oral use Oral use blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) 
200 µg 200 µg 200 µg 200 µg filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba pretisni omot (OPA/alu/PVC/alu) pretisni omot (OPA/alu/PVC/alu) pretisni omot (OPA/alu/PVC/alu pretisni omot (OPA/alu/PVC/alu
The median time to event was nine days. 
Mediani čas do dogodka je bil devet dni.
Date of first authorisation: 26 April 2019 
Datum prve odobritve: 26. april 2019
Read all of this leaflet carefully, because it contains important information for you. 
Natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
< 8 hours or unknown 
< 8 ur ali neznano
The dissolution time for each vial is approximately three to five minutes. 
Čas raztapljanja za vsako vialo je približno tri do pet minut.
Validation has not been successful, yet. 
Potrditev doslej še ni bila uspešna.