natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new indication for use in children with Prader-Willi syndrome. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je bil pozvan, naj sprejme odločitev o zahtevani spremembi dovoljenja za promet za ta zdravila, ki se nanaša na vključitev nove indikacije za uporabo pri otrocih s Prader-Willijevim sindromom.
It is also used to correct short height in girls who have the genetic disease called Turner syndrome, in children who have long-standing kidney problems, and in children born small for their gestational age and who have not caught up by the age of four. 
Uporablja se tudi za uravnavanje nizke rasti pri deklicah z genetsko boleznijo, imenovano Turnerjev sindrom, pri otrocih, ki imajo dolgotrajne težave z ledvicami, ter otrocih, ki so se rodili majhni za svojo gestacijsko starost in do četrtega leta niso nadomestili zaostanka.
The new indication was for the use of Norditropin in children with Prader-Willi syndrome, a rare genetic disease that affects children's growth and development. 
Nova indikacija je zajemala uporabo zdravila Norditropin pri otrocih s Prader-Willijevim sindromom, redko genetsko boleznijo, ki vpliva na rast otrok in njihov razvoj.
Norditropin is a medicine that contains somatropin, which is a copy of naturally occurring human growth hormone. 
Norditropin je zdravilo, ki vsebuje somatropin, kopijo naravnega humanega rastnega hormona.
The grounds for the referral were the concerns of some Member States that the data on Norditropin submitted in the application were not sufficient to demonstrate its effectiveness in Prader-Willi syndrome. 
Podlaga za napotitev so bili pomisleki nekaterih držav članic, da podatki o zdravilu Norditropin, predloženi v vlogi, niso zadostni, da bi dokazovali njegovo učinkovitost pri zdravljenju Prader-Willijevega sindroma.
Norditropin is used as replacement therapy in children and adults who have a growth hormone deficiency. 
Zdravilo Norditropin se uporablja kot nadomestna terapija pri zdravljenju otrok in odraslih s pomanjkanjem rastnega hormona.
The somatropin in Norditropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes the organism able to produce it. Norditropin is marketed in the EU Member States under the names Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx and associated names. 
Zdravilo Norditropin se v državah članicah EU trži pod imeni Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx in povezanimi imeni.
The Reference Member State (RMS) for the decentralised procedure for Pantoprazole Olinka application was UK and the Concerned Member States (CMS) were: Germany and Poland. 
Referenčna država članica decentraliziranega postopka za uporabo zdravila Pantoprazole Olinka je bila Združeno kraljestvo, zadevne države članice pa so bile Češka republika, Nemčija, Poljska in Slovaška.
Other concerns LoOI-Q1: The Applicant was requested to clarify the origin and name of the reference product used in the new bioequivalence study. 
Drugi zadržki s seznama izrazitih zadržkov - V1: Predlagatelj je bil pozvan, naj pojasni izvor in ime referenčnega zdravila, uporabljenega v novi bioekvivalenčni študiji.
It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to any of the active substances in the medicine. 
Uporablja se le pri bolnikih, ki so se dobro odzvali na dosedanje zdravljenje okužbe z virusom HIV in ki niso okuženi z virusom HIV, odpornim proti zdravljenju ali verjetno neodzivnim na katero koli od zdravilnih učinkovin v zdravilu.
It does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS. 
Ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa podaljša čas do nastopa poškodb imunskega sistema in razvoja okužb in bolezni, povezanih z aidsom.
The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one. 
Družba, ki trži zdravilo, bo zagotovila, da bodo vsi zdravniki, ki naj bi predpisovali zdravilo, prejeli izobraževalno gradivo, ki bo vsebovalo informacije o povečanem tveganju ledvične bolezni pri zdravilih, ki vsebujejo dizoproksiltenofovirat, kot ga tudi to zdravilo.
The company also carried out a study that showed that the medicine is ‘bioequivalent' to the reference medicine. 
Opravila je tudi študijo, ki je pokazala, da je zdravilo biološko enakovredno referenčnemu zdravilu.
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). 
Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti-1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan. 
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Atripla, zato jih ni treba ponoviti za zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan.
Because Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan keeps the amount of HIV in the blood at a low level. 
Zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan ohranja nizko raven virusa HIV v krvi.
For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan.
This medicine should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine). 
To zdravilo se ne sme jemati sočasno z drugimi zdravili, ki vsebujejo efavirenz, emtricitabin, dizoproksiltenofovirat ali lamivudin (drugo protivirusno zdravilo).
What is Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan and what is it used for? 
Kaj je zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan in za kaj se uporablja?
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz / emtricitabine / tenofovir disoproxil 
Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan efavirenz/emtricitabin/dizoproksiltenofovirat
Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 
Druge informacije o zdravilu Efavirenz/emtricitabin/dizoproksiltenofovirat Mylan
Inactivated poliomyelitis virus (IPV): type 1 
Inaktivirane polioviruse (IPV): tipa 1
Recombinant hepatitis B surface antigen, S (HBsAg) 
Površinski antigen virusa hepatitisa B (HbsAg)
EU Number Invented name Strength Pharmaceutical formRoute of administration Packaging 
Zaščiteno ime Jakost Farmacevtska oblika Pot uporabe Ovojnina
1 Monodose preparation of 0.5 ml contains: Purified diptheria toxoid, adsorbed (PDT) 
Posamezni odmerek 0,5 ml vsebuje: Prečiščen davični toksoid, adsorbiran (PDT)
Purified tetanus toxoid, adsorbed (PTT) 
Prečiščen tetanusni toksoid, adsorbiran (PTT)
Purified pertussis toxoid, adsorbed (PTxd) 
Prečiščen toksoid bordetele pertusis, adsorbiran (PTxd)
Purified filamentous haemagglutinin adsorbed (FHA) 
Prečiščen filamentozni hemaglutinin bordetele pertusis,adsorbiran (FHA)
1 syringe with attached needle 
1 injekcijska brizga s priloženo iglo
10 syringes without attached needle with 1 separate needle 
10 injekcijskih brizg brez pritrjeneigle z 1 ločeno iglo
1 syringe without attached needle with 1 separate needle 
1 injekcijska brizga brez pritrjene igle z 1 ločeno iglo
10 syringes without attached needle with 2 separate needles 
10 injekcijskih brizg brez pritrjeneigle z 2 priloženima iglama
1 syringe without attached needle with 2 separate needles 
1 injekcijska brizga brez pritrjene igle z 2 priloženima iglama
Haemophilus influenzae polysaccharide type b conjugated to tetanus protein (PRP-T) 
Polisaharid Haemophilus influenzae tipa B
1 syringe without attached needle 
1 injekcijska brizga brez priložene igle
The European Commission granted a marketing authorisation valid throughout the European Union for Ruconest on 28 October 2010. 
Evropska komisija je dovoljenje za promet z zdravilom Ruconest, veljavno po vsej Evropski uniji, izdala 28. oktobra 2010.
Patients may be able to inject the medicine themselves after they have been properly trained. 
Bolniki si lahko zdravilo injicirajo sami, potem ko so bili za to ustrezno usposobljeni.
What measures are being taken to ensure the safe and effective use of Ruconest? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ruconest?
One injection is usually enough to treat an attack, but a second injection may be given if the patient does not improve enough after the first one. 
Ena injekcija navadno zadošča za zdravljenje napada, vendar se lahko vbrizga drugi odmerek, če se bolnikovo stanje po prvi injekciji ne izboljša dovolj.
Improvement was measured by the patients rating the severity of their symptoms on a scale from 0 to 100. 
Izboljšanje so merili bolniki, ki so ocenjevali resnost simptomov na lestvici od 0 do 100.
It is given by slow injection into a vein lasting around five minutes. 
Zdravilo se daje s počasnim injiciranjem v veno, ki traja približno pet minut.
The main measure of effectiveness was how long it took for the symptoms to start to improve. 
Glavno merilo učinkovitosti je bil čas do začetka izboljšanja simptomov.
A patient should not be given more than two injections within any 24-hour period. 
Bolnik v 24-urnem obdobju ne sme prejeti več kot dve injekciji.
Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. 
Bolniki z angioedemom imajo napade otekanja, ki se lahko pojavijo kjer koli v telesu, na primer na obrazu, okončinah ali okoli črevesja, in povzročajo nelagodje in bolečino.
Patients receiving placebo started to improve after four hours in one study and after over eight hours in the other. 
Pri bolnikih, ki so prejeli placebo, je bilo v eni študiji opaziti izboljšanje po štirih urah, v drugi študiji pa po več kot osmih urah.
In this case the powder that comes with the solvent should be used. 
V tem primeru je treba uporabiti prašek s priloženim vehiklom.
The most common side effect with Ruconest (seen in between 1 and 10 patients in 100) is headache. 
Najpogostejši neželeni učinek zdravila Ruconest (opažen pri 1 do 10 bolnikih od 100) je glavobol.
Other information about Ruconest 
Druge informacije o zdravilu Ruconest
The full EPAR for Ruconest 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 Ruconest je na voljo na spletni strani agencije EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Patients receiving Ruconest at doses of 50 units/kg and 100 units/kg started to improve after one and two hours. 
Pri bolnikih, ki so prejeli zdravilo Ruconest v odmerku 50 enot/kg in 100 enot/kg, je bilo opaziti izboljšanje po eni ali dveh urah.
What benefits of Ruconest have been shown in studies? 
Kakšne koristi je zdravilo Ruconest izkazalo v študijah?
For more information about treatment with Ruconest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ruconest preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ruconest have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ruconest upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What is Ruconest and what is it used for? 
Kaj je zdravilo Ruconest in za kaj se uporablja?
Why is Ruconest approved? 
Zakaj je bilo zdravilo Ruconest odobreno?
Ruconest must not be used in patients with known or suspected allergy to rabbits. 
Zdravilo Ruconest se ne sme uporabljati pri bolnikih z znano ali domnevno alergijo na zajce.
This is a summary of the European public assessment report (EPAR) for Ruconest. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ruconest.
What is the risk associated with Ruconest? 
Kakšna tveganja so povezana z zdravilom Ruconest?
Ruconest is available as a powder (with or without solvent) that is made up into a solution for injection. 
Zdravilo Ruconest je na voljo kot prašek (z vehiklom ali brez njega) za pripravo raztopine za injiciranje.
When it is given during an angioedema attack, conestat alfa stops this excessive activity, helping to relieve the patient's symptoms. 
Če se konestat alfa daje med napadom angioedema, ta ustavi prekomerno delovanje in pomaga lajšati bolnikove simptome.
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 Ruconest. 
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.
The company will also provide prescribers with an alert card for their patients. 
Prav tako bo zdravnikom, ki bodo predpisovali zdravilo, priskrbela tudi opozorilno izkaznico za bolnike.
Ruconest is a medicine used to treat attacks of hereditary angioedema in adults and adolescents. 
Zdravilo Ruconest se uporablja za zdravljenje napadov hereditarnega (dednega) angioedema pri odraslih in mladostnikih.
The C1 esterase inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation. 
Beljakovina, imenovana zaviralec esteraze C1, je potrebna za nadzor sistemov „komplementa“ in „kontakta“, tj. skupkov beljakovin v krvi, ki se borijo proti okužbam in povzročajo vnetja.
Ruconest can only be obtained with a prescription and treatment should be started under the supervision of a doctor with experience in diagnosing and treating hereditary angioedema. 
Predpisovanje in izdaja zdravila Ruconest je le na recept, zdravljenje pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem dednega angioedema.
The company that markets Ruconest will ensure that healthcare professionals who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy. 
Družba, ki izdeluje zdravilo Ruconest, bo zdravstvenim delavcem, ki naj bi predpisovali to zdravilo, zagotovila izobraževalno gradivo z informacijami o njegovi pravilni uporabi in opozorili glede tveganja za pojav alergije.
The CHMP decided that Ruconest's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ruconest večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Ruconest was more effective than placebo at improving the symptoms of patients having an attack of angioedema. 
Zdravilo Ruconest je bilo pri izboljševanju simptomov pri bolnikih, ki so imeli napad angioedema, učinkovitejše od placeba.
Ruconest was studied in two main studies involving a total of 70 adults and adolescents with hereditary angioedema caused by low levels of C1 esterase inhibitor protein. 
Zdravilo Ruconest so raziskovali v dveh glavnih študijah s skupno 70 odraslimi in mladostniki z dednim angioedemom, ki ga povzročajo nizke ravni beljakovine, imenovane zaviralec esteraze C1.
When an attack occurred, the patients were given Ruconest or placebo (a dummy treatment). 
Bolniki so med napadom prejeli zdravilo Ruconest ali placebo (zdravilo brez zdravilne učinkovine).
Ruconest contains the active substance conestat alfa. 
Zdravilo Ruconest vsebuje zdravilno učinkovino konestat alfa.
How does Ruconest work? 
Kako zdravilo Ruconest deluje?
Ruconest is used in patients with hereditary angioedema that is linked to naturally low levels of a protein called ‘C1 esterase inhibitor'. 
Zdravilo Ruconest se uporablja pri bolnikih z dednim angioedemom, ki je povezan z naravno nizkimi ravnmi beljakovine, imenovane zaviralec esteraze C1.
For the full list of all side effects reported with Ruconest, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ruconest, glejte navodilo za uporabo.
The active substance in Ruconest, conestat alfa, is a copy of the C1 esterase inhibitor protein and wor ks in the same way as the natural human protein. 
Zdravilna učinkovina v zdravilu Ruconest, konestat alfa, je kopija beljakovine, imenovane zaviralec esteraze C1, ki učinkuje enako kot naravna človeška beljakovina.
How is Ruconest used? 
Kako se zdravilo Ruconest uporablja?
This mechanism takes place at high concentrations. 
Ta mehanizem se pojavi pri visokih koncentracijah.
Over 50 different enzymes have been identified. 
Identificiranih je bilo več kot 50 različnih encimov.
The interpretation of the EU legislation and consideration of compliance with the legal provisions of Article 6(3) of the Directive are not within the remit of the Committee and therefore these issues are not addressed in the assessment of the referral procedure. 
Interpretacija zakonodaje EU in ugotavljanje skladnosti z zakonskimi določbami člena 6(3) Direktive ne spadata v pristojnost Odbora, zato ta vprašanja v oceni postopka napotitve niso bila obravnavana.
There are insufficient data available to support the currently approved indications. 
Razpoložljivi podatki niso zadostni, da bi podprli trenutno odobrene indikacije.
Croatia PROPHARMA VET d.o.o. 
Hrvaška PROPHARMA VET d.o.o.
Croatia Krka - Farma d.o.o. 
Hrvaška Krka - Farma d.o.o.
Thus, the use of these products may present a serious risk to animal health in terms of lack of efficacy, as well as target animal safety. 
Uporaba teh zdravil lahko torej predstavlja resno tveganje za zdravje živali v smislu pomanjkanja učinkovitosti ter tudi za varnost ciljne živalske vrste.
Additionally, development of antimicrobial resistance towards gentamicin would present a serious risk both to human and animal health. 
Poleg tega bi razvoj odpornosti mikrobov proti gentamicinu predstavljal resno tveganje tako za zdravje ljudi kot živali.
The marketing authorisations of the products concerned by this referral procedure are assumed to have been granted by the national competent authorities on the basis of Article 6(3) of Directive 2001/82/EC. 
Za dovoljenja za promet z zdravili, ki jih zadeva ta napotitveni postopek, se predvideva, da so jih odobrili pristojni nacionalni organi na podlagi člena 6(3) Direktive 2001/82/ES.
Referral procedures on the basis of Article 35 of Directive 2001/82/EC require a clearly formulated question referred to the Committee. 
V napotitvenih postopkih na podlagi člena 35 Direktive 2001/82/ES je treba Odboru predložiti jasno opredeljeno vprašanje.
Whenever possible, use of the product should be based on susceptibility testing of the bacteria isolated from the animal. 
Kadar je mogoče, mora uporaba zdravila temeljiti na testiranju občutljivosti bakterij, izoliranih iz živali.
With relation to the already approved target species horses, the wording below should be used: 
V povezavi z že odobreno ciljno živalsko vrsto, konji, je treba uporabiti besedilo v nadaljevanju:
The Committee concluded that most of the current broad indications would not be supported by data. 
Odbor je zaključil, da podatki ne podpirajo večine trenutnih širokih indikacij.
The CVMP notes that pursuant to Article 36 of the Directive, its obligation is to consider the matter concerned and issue a reasoned opinion within the appropriate time limit. 
Odbor CVMP je upošteval, da mora v skladu s členom 36 Direktive obravnavati zadevo in izdati obrazloženo mnenje v ustreznem časovnem roku.
Spain MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410 
Španija MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410
The scope of referral procedures is limited to evaluation of quality, safety and efficacy of veterinary medicinal products. 
Obseg napotitvenih postopkov je omejen na ovrednotenje kakovosti, varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini.
24010 León Spain 
24010 León Španija
The reference product is Gentaject 10% solution for injection for horses which has been authorised in Ireland since 1988 (VPA 10976/2/1; Franklin Pharmaceuticals Ltd). 
Referenčno zdravilo je zdravilo Gentaject 10-odstotna raztopina za injiciranje za konje, ki je od leta 1988 odobreno na Irskem (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
Constitución, 1 Planta baja 3 08960 Sant Just Desvern Barcelona 
Constitución, 1 Planta baja 3 08960 Sant Just Desvern Barcelona Španija
Thus only the scientific questions posed to the CVMP in the referral notification have been considered and are reported below. 
Zato so bila obravnavana samo znanstvena vprašanja, ki so bila odboru CVMP zastavljena v obvestilu o napotitvi in so navedena v nadaljevanju.
Over-use of gentamicin products might result in an increased risk of the theoretical concept of adaptive resistance. 
Čezmerna uporaba zdravil, ki vsebujejo gentamicin, bi lahko povzročila povečano tveganje za teoretični koncept adaptivne odpornosti.
Since the reference product is only authorised in Ireland, the concept of the European reference product has been applied in this MRP. 
Ker je referenčno zdravilo odobreno samo na Irskem, je bil v tem postopku z medsebojnim priznavanjem uporabljen koncept evropskega referenčnega zdravila.
43206 Tarragona Spain 
43206 Tarragona Španija
All other dosing regimens appear to be approved based on expert reports, scientific publications and PK/PD characteristics. 
Kot kaže, so vsi ostali režimi odmerjanja odobreni na podlagi izvedenskih poročil, znanstvenih publikacij in farmakokinetičnih/farmakodinamičnih lastnosti.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under- or over-dosing. 
Da bi zagotovili ustrezno odmerjanje, je treba čim natančneje določiti telesno maso, saj se s tem prepreči premajhno ali preveliko odmerjanje.
ATCvet code: QJ01GB03 
Oznaka ATC vet: QJ01GB03