natgillin/translations-raw huggingface dataset:
During post marketing surveillance studies with other hepatitis B containing vaccines, serum sickness like disease and thrombocytopenia have been reported very rarely. 
Med postmarketinškimi študijami drugih cepiv s vsebnostjo komponente proti hepatitisu B, so zelo redko poročali o serumski bolezni podobnem stanju in trombocitopeniji.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Results from different studies show that, overall, 95.5% and 99.9% of subjects had anti-diphtheria and anti-tetanus titres ≥ 0.1 IU/ml one month after completion of the primary vaccination course. 
Rezultati različnih študij kažejo, da je, gledano v celoti, en mesec po zaključku osnovnega cepljenja imelo 95,5 % oseb titer protiteles proti davici ≥ 0,1 i.e./ml.
The coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”. 
Kašelj pogosto spremlja značilen zvok, ki zveni kot oslovski glas, zato se bolezen tudi imenuje oslovski kašelj.
Quintanrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. 
Osebam s trombocitopenijo ali motnjami strjevanja krvi je potrebno dajati cepivo Quintanrix previdno, ker se pri njih po intramuskularnem injiciranju lahko pojavi krvavitev.
If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give subsequent doses of a vaccine containing the pertussis component should be carefully considered: 
Če je znano, da se je v določenem času po prejemu cepiva Quintanrix pojavil kateri koli izmed naslednjih neželenih učinkov, je potrebno odločitev o dajanju nadaljnjih odmerkov cepiva s vsebnostjo komponente proti oslovskemu kašlju temeljito pretehtati:
The first injection can be given from the age of 6 weeks onwards. 
Prvi odmerek se lahko da od starosti 6 tednov dalje.
1 adsorbed on aluminium hydroxide, hydrated 
1adsorbiran na aluminijev hidroksid
For 10 doses: - pack size of 50 vials of powder plus 50 vials of liquid 
Za 10 odmerkov: - 50 vial s praškom in 50 vial s tekočino
METHOD AND ROUTE(S) OF ADMINISTRATION intramuscular use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Intramuskularna uporaba
Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials. 
V večih kliničnih raziskavah je bilo s cepivom Quintanrix osnovno cepljenih približno 1.340 zdravih otrok, starejših od 6 tednov.
MANUFACTURER'S BATCH NUMBER LOT: 
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA LOT
Antipyretic treatment should be initiated according to local treatment guidelines. 
Zdravljenje z zdravili za zniževanje zvišane telesne temperature je potrebno uvesti v skladu z lokalnimi smernicami tovrstnega zdravljenja.
Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine. 
Pred aplikacijo cepiva je potrebno odstraniti in zavreči iglo, ki je bila uporabljena pri rekonstituciji ter jo nadomestiti z novo.
In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate injection sites, during the same session. 
Pogosta praksa pri cepljenju otrok je, da se jih ob enkratnem obisku cepi z različnimi cepivi za injiciranje, ki se jih injicira na ločenih mestih.
Storing Quintanrix 
SHRANJEVANJE CEPIVA QUINTANRIX
At this time, the percentage of infants with anti-PRP titres ≥ 0.15 µg/ml was > 99% and the percentage with anti-HBs titres ≥ 10 mIU/ml was 97.3%. 
En mesec po zaključku osnovnega cepljenja je imelo > 99 % otrok titer proti-PRP ≥ 0,15 µg/ml in 97,3 % otrok titer protiteles proti-HBs ≥ 10 i.e./l.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. 
Pri aplikaciji odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48 do 72 urnem spremljanju pljučnega delovanja.
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life. 
Cepivo Quintanrix je indicirano za osnovno cepljenje otrok (med prvim letom življenja) proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in invazivnim boleznim, ki jih povzroča Haemophilus influenzae tipa b ter za obnovitveno cepljenje otrok med drugim letom življenja.
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people. 
Pri okuženih ljudeh se virus nahaja v telesnih tekočinah, kot so kri, sperma, nožnični izločki ali slina (izpljunki).
• if your child has experienced any health problems after previous administration of a vaccine. 
• če je imel vaš otrok po zadnjem cepljenju kakršne koli zdravstvene težave;
Limited information exists on the persistence of the immune response after primary vaccination with Quintanrix as well as on the immunogenicity of booster doses. 
Tako podatki o trajanju imunskega odziva po osnovnem cepljenju s cepivom Quintanrix kot podatki o imunogenosti obnovitvenih odmerkov so pomanjkljivi.
After reconstitution,it is recommended to inject the vaccine promptly. 
Priporočljivo je, da se cepivo po rekonstituciji nemudoma injicira.
After the completion of the primary series, a booster should be administered preferably before the end of the second year of life. 
Po končanem osnovnem cepljenju je potrebno opraviti obnovitveno cepljenje, po možnosti pred dopolnjenim drugim letom starosti.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION HIB for Quintanrix 
IME ZDRAVILA IN POT(I) UPORABE HIB za Quintanrix i.m.
Results from one pilot study showed that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to diphtheria, tetanus, HBs and PRP at levels considered to be protective. 
Rezultati pilotne študije so pokazali, da je protitelesa proti davici, tetanusu, HBs in PRP v vrednostih, ki se smatrajo za zaščitne imelo še > 80 % od 63 otrok, ki so bili osnovno cepljeni po shemi 6., 10., 14 teden.
Your doctor will advise on the possible need for extra doses. 
Zdravnik vam bo povedal, če so potrebni še dodatni (obnovitveni) odmerki.
Sometimes people who have been infected do not look or feel ill. Others have signs of mild flu, but some people can become very ill. 
Nekateri imajo lahko le znake blage gripe, nekateri pa lahko hudo zbolijo.
5 ml of suspension in a vial (type I glass) for 10 doses with a stopper (rubber butyl) in a pack size of 50 vials of powder plus 50 vials of suspension. 
5 ml suspenzije v viali (steklo tipa I) za 10 odmerkov z zamaškom (butilna guma) v velikosti pakiranja 50 vial s praškom in 50 vial s suspenzijo
A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Quintanrix is available in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of liquid - pack size of 100 vials of powder plus 100 vials of liquid. 
Cepivo Quintanrix je na voljo v naslednjih velikostih pakiranja: - 1 viala s praškom in 1 viala s tekočino - 100 vial s praškom in 100 vial s tekočino.
Total: 0.40 milligrams Al3+ 3 produced in Saccharomyces cerevisae cells by recombinant DNA technology 
Skupno: 0,40 miligrama Al 3+ 3pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae
100 x 2 doses (1 ml) 
100 x 2 odmerka (1 ml)
Total: 0.40 mg Al3+ 3 produced in Saccharomyces cerevisae cells by recombinant DNA technology 
Skupno: 0,40 mg Al 3+ 3pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae
Gastrointestinal disorders: very common: loss of appetite rare: vomiting 
Bolezni prebavil: zelo pogosti: izguba apetita redki: bruhanje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPw HBV for Quintanrix 
IME ZDRAVILA IN POT(I) UPORABE DTPw HBV za Quintanrix i.m.
Bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets have been reported very rarely (less than 1 per 10,000 doses of vaccine) with the hepatitis B component of Quintanrix. 
V povezavi s komponento cepiva Quintanrix proti hepatitisu B so zelo redko (manj kot 1 na 10.000 odmerkov cepiva) poročali o krvavitvah ali neobičajno hitrem nastanku modric zaradi zmanjšanja števila krvnih celic imenovanih trombociti.
The disease affects the airways causing severe spells of coughing that may interfere with normal breathing. 
• Oslovski kašelj: Oslovski kašelj je zelo nalezljiva bolezen, ki prizadene dihalne poti in povzroča hude napade kašlja, ki lahko ovirajo normalno dihanje.
Quintanrix is a vaccine used in children to prevent five infectious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b (a type of bacteria). 
Cepivo Quintanrix se pri otrocih uporablja za preprečevanje petih nalezljivih bolezni: davice, tetanusa (mrtvičnega krča), oslovskega kašlja, hepatitisa B in bolezni, ki jih povzroča Haemophilus influenzae tipa b (vrsta bakterije).
The first dose can be administered at 6 weeks of age. 
Otrok lahko prejme prvi odmerek cepiva pri 6 tednih starosti.
The vaccine cannot cause diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B or Haemophilus influenzae type b infections. 
Cepivo ne more povzročiti davice, tetanusa (mrtvičnega krča), oslovskega kašlja, hepatitisa B ali okužb s Haemophilus influenzae tipa b.
50 x 10 doses (5 ml) 
50 x 10 odmerkov (5 ml)
The lyophilised Haemophilus influenzae type b (HIB) component is a white powder. 
Komponenta cepiva proti boleznim, ki jih povzroča Haemophilus influenzae tipa b (HIB) je v liofiliziranem stanju in sicer v obliki belega praška.
Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens. 
Skopi podatki kažejo, da antigeni peroralnega polio cepiva (OPV - oral polio vaccine) ne motijo imunskega odziva na cepivo proti ošpicam, mumpsu in rdečkam (MMR - Measles-Mumps-Rubella).
Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting. 
Če je sestava cepiva Quintanrix v skladu z uradnimi priporočili za obnovitveno cepljenje, se cepivo Quintanrix lahko uporablja za obnovitev odziva na DTP, HBV in HIB antigene.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. 
Tako kot pri vseh cepivih, ki se jih injicira, mora biti vedno na voljo možnost takojšnjega ustreznega zdravljenja, saj v redkih primerih cepljenju lahko sledi anafilaksijska reakcija.
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl) in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of suspension - pack size of 100 vials of powder plus 100 vials of suspension. 
1 ml suspenzije v viali (steklo tipa I) za 2 odmerka z zamaškom (butilna guma) v naslednjih velikostih pakiranja: - 1 viala s praškom in 1 viala s suspenzijo - 100 vial s praškom in 100 vial s suspenzijo
The hepatitis B and Haemophilus influenzae type b components of Quintanrix can only help to protect your child against infections with hepatitis B or Haemophilus influenzae type b viruses. 
Komponenti proti hepatitisu B in okužbi z bakterijo Haemophilus influenzae tipa b lahko pomagata vašega otroka zaščititi le pred okužbo z virusom hepatitisa B ali bakterijo Haemophilus influenzae tipa b. Vašega otroka ne moreta zaščititi pred drugimi okužbami, ki lahko prizadenejo jetra, pred okužbami, ki jih povzročajo druge bakterije in ne Haemophilus influenzae tipa b ali pred meningitisom, ki ga povzročajo drugi povzročitelji.
STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Po rekonstituciji cepiva 1 odmerek (0,5 ml) vsebuje: Davični toksoid1
Quintanrix is a white slightly milky liquid obtained by mixing the vial containing the diphtheria (D), tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid (DTPw-HBV) with the vial containing the Haemophilus influenzae type b (HIB) powder. 
Cepivo Quintanrix je bela, rahlo mlečna tekočina, ki se jo dobi tako, da se vsebina viale s komponentami cepiva proti davici (D), tetanusu (T), oslovskemu kašlju (celotna celica; Pw) in hepatitisu B (HBV) (DTPw-HBV) v obliki tekočine zmeša z vsebino viale s komponento cepiva proti boleznim, ki jih povzroča Haemophilus influenzae tipa b (HIB) v obliki praška.
100 x 1 dose (0.5 ml) 
100 x 1 odmerek (0,5 ml)
As with other vaccines it may be expected that an adequate response may not be achieved in patients receiving immunosuppressive therapy or patients with immunodeficiency. 
Pri bolnikih z imunosupresivnim zdravljenjem ali bolnikih z imunsko pomanjkljivostjo se lahko pričakuje, tako kot tudi pri drugih cepivih, da dosežen imunski odziv ne bo zadosten.
Haemophilus influenzae type b polysaccharide 
Polisaharid bakterije Haemophilus influenzae tipa b
In these trials, the most common reactions occurring after vaccine administration were pain at the site of injection, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) and irritability, which were associated with about 50% of the doses administered. 
Najpogostejše reakcije v teh raziskavah so bile bolečina na mestu injiciranja, zvišana telesna temperatura (aksilarna ≥ 37,5 ºC; rektalna ≥ 38 ºC) in razdražljivost.
Hepatitis B carriers can infect others throughout their lives. 
Imenujejo se klicenosci virusa hepatitisa B in lahko ves čas življenja prenašajo virus hepatitisa B na druge.
The immunoprophylactic measures for hepatitis B should not be modified for children born to hepatitis B virus carrying mothers. 
V primeru, da je mati novorojenčka nosilka virusa hepatitisa B, se ukrepov imunoprofilakse proti hepatitisu B ne sme spreminjati.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOR MULTIDOSE PRESENTATIONS 
PODATKI NA ZUNANJI OVOJNINI ZA VIALE, KI VSEBUJEJO VEČ ODMERKOV
Gastrointestinal disorders: very common: loss of appetite 
Bolezni prebavil: zelo pogosti: izguba apetita
After reconstitution, the vaccine should be injected promptly. 
Cepivo je potrebno injicirati takoj po rekonstituciji.
Both components are presented in a glass vial for 2 doses or for 10 doses and must be mixed together before your child receives the vaccine. 
Obe komponenti sta na voljo v steklenih vialah, ki vsebujejo 2 odmerka ali 10 odmerkov.
General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C) 
Splošne težave in spremembe na mestu aplikacije: zelo pogosti: bolečina, rdečina in oteklina, zvišana telesna temperatura (aksilarna ≥ 37,5 ºC; rektalna ≥ 38 ºC) pogosti: induracija, zvišana telesna temperatura (aksilarna > 39 ºC; rektalna > 39,5 ºC)
Chiron-Behring GmbH & Co. Postfach 1630-35006 Marburg Germany 
Postfach 1630-35006 Marburg
Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension. 
Prašek in suspenzija za pripravo suspenzije za injiciranje Komponente cepiva proti davici (D), tetanusu (T), oslovskemu kašlju (celotna celica; Pw) in hepatitisu B (HBV) (DTPw-HBV) so v tekočem stanju in sicer v obliki motne bele suspenzije.
General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C) uncommon: induration 
Splošne težave in spremembe na mestu aplikacije: zelo pogosti: bolečina, rdečina in oteklina, zvišana telesna temperatura (aksilarna ≥ 37,5 ºC; rektalna ≥ 38 ºC) pogosti: zvišana telesna temperatura (aksilarna > 39 ºC; rektalna > 39,5 ºC) občasni: induracija
Read all of this leaflet carefully before your child starts receiving this medicine. 
Preden vaš otrok prične dobivati to cepivo, natančno preberite navodilo!
Lyophilised HIB component: 
Komponenta HIB v liofiliziranem stanju: laktoza
It can be expected that hepatitis D will also be prevented by immunisation with Quintanrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. 
Ker se hepatitis D (povzroča ga agens delta) v odsotnosti okužbe z virusom hepatitisa B ne pojavlja, se lahko po imunizaciji s cepivom Quintanrix pričakuje tudi preventiva hepatitisa D.
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of suspension - pack size of 100 vials of powder plus 100 vials of suspension Not all pack sizes may be marketed. 
0,5 ml suspenzije v viali (steklo tipa I) za 1 odmerek z zamaškom (butilna guma) v naslednjih velikostih pakiranja: - 1 viala s praškom in 1 viala s suspenzijo - 100 vial s praškom in 100 vial s suspenzijo
Powder in a vial (type I glass) for 1 dose with a stopper (rubber butyl). 
Prašek v viali (steklo tipa I) za 1 odmerek z zamaškom (butilna guma).
• Coughing 
• kašelj
Nervous system disorders: very common: drowsiness 
Bolezni živčevja: zelo pogosti: zaspanost
Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines. 
Po cepljenju s cepivi, ki so vsebovala komponento DTP, komponento proti hepatitisu B in komponento HIB, so zelo redko poročali o alergijskih reakcijah, kar velja tudi za anafilaktoidne reakcije in urtikarijo.
Powder in a vial (type I glass) for 2 doses with a stopper (rubber butyl). 
Prašek v viali (steklo tipa I) za 2 odmerka z zamaškom (butilna guma).
Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed) - The active substances contained in 1 dose (0.5 ml) of Quintanrix are: 
Quintanrix, prašek in suspenzija za pripravo suspenzije za injiciranje Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (celotna celica), hepatitisu B (rekombinantno) in hemofilusu tipa b (konjugirano) - Učinkovine v 1 odmerku (0,5 ml) cepiva Quintanrix so:
Powder in a vial (type I glass) for 10 doses with a stopper (rubber butyl). 
Prašek v viali (steklo tipa I) za 10 odmerkov z zamaškom (butilna guma).
Tell you doctor if your child has any known allergies. 
Če ima otrok kakršno koli alergijo, to povejte svojemu zdravniku.
Medicinal product subject to medical prescription 
DOVOLJENJA ZA PROMET Z ZDRAVILOM
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOR MULTIDOSE PRESENTATIONS 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH (VIALE, KI VSEBUJEJO VEČ ODMERKOV)
Lactose 
• krči
Both components are presented in a glass vial for 1 dose and must be mixed together before your child receives the vaccine. 
Pred cepljenjem vašega otroka je potrebno obe komponenti zmešati skupaj.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/001 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/301/001
Quintanrix powder and suspension for suspension for injection, multidose Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed) 
Quintanrix, prašek in suspenzija za pripravo večih odmerkov suspenzije za injiciranje Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (celotna celica), hepatitisu B (rekombinantno) in hemofilusu tipa b (konjugirano)
MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/005 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/301/005
Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed) 
Quintanrix, prašek in suspenzija za pripravo suspenzije za injiciranje Adsorbirano cepivo proti davici, tetanusu, oslovskemu kašlju (celotna celica), hepatitisu B (rekombinantno) in hemofilusu tipa b (konjugirano)
MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/003 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/04/301/003
For 2 doses : - pack size of 1 vial of powder plus 1 vial of liquid - pack size of 100 vials of powder plus 100 vials of liquid 
- 1 viala s praškom in 1 viala s tekočino - 100 vial s praškom in 100 vial s tekočino
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 odmerka
Diphtheria toxoid, tetanus toxoid, pertussis (whole cell): 
Davični toksoid, tetanusni toksoid, oslovski kašelj (celotna celica): Chiron-Behring GmbH & Co.
Liquid DTPw-HBV component: 
Komponenta DTPw-HBV v tekočem stanju: tiomersal natrijev klorid voda za injiciranje
In drinking water use. 
Za uporabo v vodi za pitje.
The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands as concerned Member States. 
Vloga za pridobitev dovoljenja za promet z zdravilom je bila predložena v Združenem kraljestvu kot referenčni državi članici ter v Avstriji, Belgiji, Češki republiki, na Danskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Luksemburgu, na Poljskem, Portugalskem, Slovaškem, v Španiji in na Nizozemskem kot zadevnih državah članicah.
Add the following text in the relevant sections of the product information: 
Dodajte naslednje besedilo v ustrezne oddelke informacije o izdelku:
Having considered all the data submitted the CVMP concluded that: 
Ob upoštevanju vseh predloženih podatkov je odbor CVMP zaključil naslednje:
Advice for prudent use 
Nasvet za preudarno rabo
During the decentralised procedure Denmark, as a concerned Member State, considered that Solamocta may present a potential serious risk to human and animal health. 
Med decentraliziranim postopkom je Danska, zadevna država članica, menila, da lahko zdravilo Solamocta predstavlja morebitno resno tveganje za zdravje ljudi in živali.
Exemption from the requirement for bioequivalence studies 
Opustitev zahteve za bioekvivalenčne študije
Any unused medicated water should be discarded after 12 hours. 
Neuporabljeno raztopino z zdravilom je po 12 urah treba zavreči.
Prepare the solution with fresh tap water immediately before use. 
Raztopino pripraviti s svežo vodo iz vodovoda tik pred uporabo.
Each of these excipients is well-established and widely used in medicinal products and foodstuffs. 
Vsaka od teh pomožnih snovi je dobro uveljavljena in se pogosto uporablja v zdravilih in živilih.
Extrapolation of the safety and efficacy of the reference product to Solamocta 
Ekstrapolacija varnosti in učinkovitosti referenčnega zdravila na zdravilo Solamocta
They have demonstrated that the highest therapeutic concentration is fully soluble within 10 minutes in hard/high pH water and soft/low pH water and have determined the maximum solubility (within 10 minutes) in water of different qualities and different temperatures, including very cold (4 °C) water. 
Ti so pokazali, da je najvišja terapevtska koncentracija popolnoma topna v 10 minutah v trdi vodi (visoka vrednost pH) in mehki vodi (nizka vrednost pH), in so določili največjo topnost (v 10 minutah) v vodi različnih kakovosti in različnih temperatur, tudi v zelo mrzli (4 °C) vodi.