natgillin/translations-raw huggingface dataset:
The effects on phosphate and calcium were proven to be maintained throughout a study with one year follow-up.
V enoletni raziskavi so dokazali, da se učinki na fosfat in kalcij ohranijo.
Therefore your doctor may monitor the levels of TSH in your blood more closely.
Zato se lahko vaš zdravnik odloči za skrbno nadziranje
Renal impairment The safety and efficacy of this product have not been established in predialysis patients.
Varnosti in učinkovitosti tega zdravila pri bolnikih z ledvično okvaro, ki niso na dializi, niso ugotavljali.
Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Sevelamerijev klorid je treba uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1,25 - dihidroksi vitamin D3 ali kakšen njegov analog, za nadziranje razvoja renalne osteodistrofije.
Fat-soluble vitamins
V maščobi topni vitamini
The safety of sevelamer hydrochloride has not been established in breast-feeding women.
Varnosti sevelamerijevega klorida pri doječih ženskah niso ugotavljali.
Check with your doctor if you are not sure.
Če niste prepričati, se posvetujte z zdravnikom.
Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.
Glede na vnos hrane in naravo končne odpovedi ledvic se lahko pri dializnih bolnikih pojavijo nizke ravni vitaminov A, D, E in K. Ni mogoče izključiti, da lahko sevelamerijev klorid veže v maščobi topne vitamine v zaužiti hrani.
Tasermity may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease.
Zdravilo Tasermity se lahko uporablja sočasno s terapijo preprečevanja razvoja bolezni kosti, v sklopu katere se dodaja kalcij in vitamin D.
Gastrointestinal disorders
Zaviralci protonske črpalke
He/she will base the dose on your serum phosphate level.
Zdravnik bo odmerek določil glede na koncentracijo fosfata v serumu.
How to store Tasermity
Shranjevanje zdravila Tasermity
Uncommon reports of difficulty swallowing the sevelamer hydrochloride tablet have been reported.
Občasno so poročali o težavah s požiranjem tablet s sevelamerijevim kloridom.
Common (may affect up to 1 in 10 people): diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): driska, slaba prebava, bolečine v trebuhu, zaprtost, nabiranje plinov v želodcu in črevesju Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): povečana kislost krvi
- The active substance is sevelamer hydrochloride.
- Zdravilna učinkovina je sevelamerijev klorid.
Therefore caution should be exercised when sevelamer hydrochloride is used in patients with these disorders.
Zato je treba biti pri teh bolnikih z uporabo sevelamerijevega klorida zelo pazljiv.
• if you have bowel obstruction.
• če imate zaporo črevesja,
Acidosis, increased chloride
Presnovne in prehranske motnje acidoza, zvišana vrednost klorida v serumu
Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Pri bolnikih, ki imajo hudo zaprtje ali druge hude gastrointestinalne simptome, je treba ponovno pretehtati smiselnost zdravljenja s sevelamerijevim kloridom.
Posology
Levotiroksin
• if you have problems with motility (movement) in your stomach and bowel
• imate težave z nenormalno ali nepravilno gibljivostjo želodca in črevesja
Sevelamer hydrochloride is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic study in healthy volunteers.
Glede na farmakokinetične raziskave zdravih prostovoljcev z enim samim odmerkom se sevelamerijev klorid ne absorbira iz gastrointestinalnega trakta.
• Bowel obstruction.
Okvara ledvic
Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms.
Pri bolnikih, ki se jim pojavijo hudi simptomi povezani s prebavili, je treba zdravljenje s sevelamerijevim kloridom znova oceniti.
49 x 1 tablets (unit dose)
196 (2 x 98) tablet
l t o r
Pot uporabe
Target Species
Ciljna živalska
Packaging
Farmacevtska
EU Number
EU številka Izmišljeno ime Jakost
Package size
Ovojnina Velikost pakiranja Karenca
London, 19 July 2007 Doc.
London, 19. julij 2007 Sklic na dok.
The Committee also had concerns over the ways in which the study had been carried out, which made it difficult to interpret the results.
Odbor je imel tudi pomisleke v zvezi z načinom izvedbe študije, zaradi česar je bilo rezultate težko interpretirati.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Dopis podjetja, v katerem je agencijo EMEA obvestilo o umiku vloge, je na voljo tukaj.
The main measure of effectiveness was how long the patients survived after the first operation.
Glavno merilo učinkovitosti je bil čas preživetja bolnikov po prvi operaciji.
Ref. EMA/318692/2007
EMA/382244/2007
Cerepro was designated an orphan medicinal product on 6 February 2002.
Zdravilo Cerepro je bilo dne 6. februarja 2002 določeno kot zdravilo sirota.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Podjetje je zahtevalo ponovno preučitev negativnega mnenja, ki pa še ni bila zaključena, ko se je podjetje odločilo za umik svoje vloge.
The effects of Cerepro were first tested in experimental models before being studied in humans.
Učinki zdravila Cerepro so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for CEREPRO
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo CEREPRO
It was concerned over the low number of patients included in the main study of Cerepro, which prevented a benefit of the medicine being demonstrated.
Zaskrbljen je bil glede majhnega števila bolnikov, vključenih v glavno študijo zdravila Cerepro, zaradi česar koristi zdravila ni bilo mogoče dokazati.
What are the consequences of the withdrawal for patients in clinical trials with Cerepro?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih zdravila Cerepro?
Cerepro has also been studied in 36 patients with high-grade glioma.
Zdravilo Cerepro so preučevali tudi pri 36 bolnikih z visoko malignimi gliomi.
The study compared the effects of adding Cerepro and ganciclovir sodium to standard treatment with the effects of standard treatment alone.
V okviru študije so primerjali učinek dodajanja zdravila Cerepro in ganciklovir natrija k standardnemu zdravljenju z učinkom standardnega zdravljenja samega.
Cerepro injection was to be followed by a two-week course of treatment with ganciclovir sodium, starting five days after the operation.
Injiciranju zdravila Cerepro bi naj sledilo dvotedensko zdravljenje z ganciklovir natrijem, ki bi se pričelo pet dni po operaciji.
On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma.
Podjetje Ark Therapeutics je dne 13. julija 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za izdajo dovoljenja za promet z zdravilom Cerepro, namenjenim zdravljenju bolnikov z operabilnimi visoko malignimi gliomi.
After removing as much of the brain tumour as possible, the surgeon would have made up to 70 small injections of Cerepro into the area from where the tumour was removed.
Po odstranitvi čim večjega dela možganskega tumorja bi naj kirurg v področje, iz katerega je bil tumor odstranjen, vbrizgal do 70 majhnih injekcij zdravila Cerepro.
This enzyme helps to convert ganciclovir into a form which can kill cells that are dividing, including any cancerous cells that were not removed during the operation.
Ta encim sodeluje pri pretvorbi ganciklovira v obliko, ki lahko ubije celice, ki se razmnožujejo, kot so na primer rakave celice, ki niso bile odstranjene med operacijo.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Cerepro for the treatment of patients with operable high-grade glioma.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj CHMP je v času umika vloge CHMP izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet za zdravilo Cerepro, namenjeno zdravljenju bolnikov z operabilnimi visoko malignimi gliomi.
Glioma is a type of brain tumour that begins in ‘glial' cells (the cells that surround and support nerve cells).
Gliom je vrsta možganskega tumorja, ki se prične v nevroglijski celici (celici, ki obkroža in podpira živčno celico).
In addition, the CHMP considered there to be insufficient information on the safety of Cerepro, and, since the benefits of the medicine had not been demonstrated, that its risks, when used in combination with ganciclovir, could be of concern.
Poleg tega je CHMP menil, da ni dovolj informacij o varnosti zdravila Cerepro ter da utegnejo biti glede na dejstvo, da korist zdravila ni bila dokazana, njegova tveganja ob uporabi v kombinaciji z ganciklovirjem zaskrbljujoča.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Cerepro.
Podjetje je CHMP obvestilo, da ni posledic za bolnike, ki trenutno sodelujejo v kliničnih preizkušanjih zdravila Cerepro.
The gene is carried within a ‘vector', a type of virus that has been altered genetically so that it can carry a gene (DNA) into the cells of the body.
Gen se prenaša s pomočjo „vektorja“, vrste virusa, ki je bila genetsko spremenjena tako, da lahko prenaša gen (DNA) v celice telesa.
Cerepro would only have worked in combination with ganciclovir.
Zdravilo Cerepro bi delovalo izključno v kombinaciji z ganciklovirjem.
What is Cerepro?
Kaj je zdravilo Cerepro?
Cerepro was intended for use during an operation.
Zdravilo Cerepro bi se naj uporabljalo med operacijo.
The virus in Cerepro is an ‘adenovirus' that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Virus, uporabljen pri zdravilu Cerepro, je „adenovirus“, ki je bil gensko spremenjen tako, da se ne more podvojevati in posledično v ljudeh ne more povzročiti okužbe.
The CHMP had concerns that a benefit of Cerepro had not yet been shown.
CHMP je izrazil zadržek, da korist zdravila Cerepro še ni bila dokazana.
Cerepro was to be used in combination with ganciclovir sodium to treat high-grade glioma in patients who are eligible for surgery.
Zdravilo Cerepro bi se naj v kombinaciji z ganciklovir natrijem uporabljalo za zdravljenje visoko malignih gliomov pri bolnikih, primernih za operacijo.
What was Cerepro expected to be used for?
Za kaj naj bi se zdravilo Cerepro uporabljalo?
It is made up into a solution that is injected directly into the brain during surgery.
Zdravilo se pripravi v obliki raztopine, ki se med operacijo injicira neposredno v možgane.
When Cerepro is injected into the brain, the modified virus is taken up by the cells near the injection sites.
Ko se zdravilo Cerepro injicira v možgane, celice v bližini mesta injiciranja privzamejo spremenjeni virus.
How is Cerepro expected to work?
Kako naj bi zdravilo Cerepro delovalo?
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Cerepro had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila Cerepro niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
Cerepro is a medicine containing a gene (a Herpes simplex virus thymidine kinase gene) carried by an adenovirus.
Cerepro je zdravilo, ki vsebuje gen (gen za timidin kinazo virusa Herpes simplex), ki ga nosi adenovirus.
The cells then start to produce the thymidine kinase enzyme.
Celice pričnejo tvoriti encim timidin kinazo.
Cerepro contains the gene for the enzyme ‘thymidine kinase' from the herpes virus.
Zdravilo Cerepro vsebuje gen za encim „timidin kinazo“ iz virusa herpesa.
Active substance: adenovirus-mediated Herpes simplex virus-thymidine kinase gene
Zdravilna učinkovina: gen za timidin kinazo virusa Herpes simplex, posredovan z adenovirusom
Further information on Nivestim can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nivestim.
Nadaljnje informacije o zdravilu Nivestim so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/nivestim.
Nivestim received a marketing authorisation valid throughout the EU on 8 June 2010.
Za zdravilo Nivestim je bilo 8. junija 2010 izdano dovoljenje za promet, veljavno po vsej EU.
This means that Nivestim is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
What measures are being taken to ensure the safe and effective use of Nivestim?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nivestim?
An overview of Nivestim and why it is authorised in the EU
Pregled zdravila Nivestim in zakaj je odobreno v EU
What is Nivestim and what is it used for?
Kaj je zdravilo Nivestim in za kaj se uporablja?
What benefits of Nivestim have been shown in studies?
Kakšne koristi zdravila Nivestim so se pokazale v študijah?
What are the risks associated with Nivestim?
Kakšna tveganja so povezana z zdravilom Nivestim?
The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Učinkovina zdravila Nivestim, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Filgrastim deluje enako kot naravno tvorjeni G-CSF, kar pomeni, da spodbuja kostni mozeg k tvorjenju večjega števila belih krvnih celic.
As for all medicines, data on the use of Nivestim are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nivestim stalno spremljajo.
In addition, a study in 279 female adult patients with breast cancer who were being treated with cancer medicines showed that Nivestim is comparable to the reference medicine, Neupogen.
Poleg tega je študija pri 279 odraslih bolnicah z rakom dojke, ki so se zdravile z zdravili za zdravljenje raka, pokazala, da je zdravilo Nivestim primerljivo z referenčnim zdravilom Neupogen.
Nivestim can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Predpisovanje in izdaja zdravila Nivestim je le na recept, zdravljenje pa se lahko uvede v sodelovanju z centrom za zdravljenje raka.
Other side effects may be seen in more than 1 in 10 patients, depending on the condition that Nivestim is being used for.
Drugi neželeni učinki se lahko pojavijo pri več kot 1 od 10 bolnikov, odvisno od bolezni, ki se zdravi z zdravilom Nivestim.
For more information about using Nivestim, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Nivestim glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The way Nivestim is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Način dajanja in odmerjanje zdravila Nivestim ter trajanje zdravljenja z njim so odvisni od razloga za uporabo zdravila, telesne mase bolnika in odziva na zdravljenje.
The medicine is available in pre-filled syringes and is given by injection under the skin or infusion (drip) into a vein.
Zdravilo je na voljo v obliki napolnjenih injekcijskih brizg in se daje z injiciranjem v podkožje ali infundiranjem (kapalno infuzijo) v veno.
Nivestim can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Zdravilo Nivestim lahko uporabljajo tudi darovalci krvnih matičnih celic, namenjenih za presaditev, da se olajša sproščanje teh celic iz kostnega mozga.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nivestim 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 Nivestim upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Nivestim are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Nivestim, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The most common side effects with Nivestim (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Nivestim (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so povišana telesna temperatura, mišično-skeletne bolečine (bolečine v mišicah in kosteh), anemija (nizko število rdečih krvnih celic), bruhanje in navzeja (slabost).
Why is Nivestim approved?
Zakaj je bilo zdravilo Nivestim odobreno?
• to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
• za povišanje ravni nevtrofilcev in zmanjšanje tveganja okužb pri bolnikih z nevtropenijo, ki imajo anamnezo hudih, ponavljajočih se okužb;
The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.
Pri bolnikih, ki so prejemali zdravilo Nivestim, je huda nevtropenija trajala podobno dolgo kot pri bolnikih, ki so prejemali zdravilo Neupogen.
The safety of Nivestim has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neupogen.
Varnost zdravila Nivestim je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neupogen.
All these data were considered sufficient to conclude that Nivestim will behave in the same way as Neupogen in terms of effectiveness and safety in its authorised uses.
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Nivestim pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neupogen.
Other information about Nivestim
Druge informacije o zdravilu Nivestim
• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes).
• za skrajšanje trajanja nevtropenije (nizke ravni nevtrofilcev, vrste belih krvnih celic) in preprečevanje pojava febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri bolnikih z rakom (razen pri bolnikih s kronično mieloično levkemijo ali mielodisplastičnimi sindromi).
Therefore, the Agency's view was that, as for Neupogen, the benefits of Nivestim are greater than its risks and it can be authorised or use in the EU.
Menila je, da so koristi zdravila Nivestim, enako kot pri zdravilu Neupogen, večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Nivestim has a highly similar structure, purity and biological activity to Neupogen and is distributed in the body in the same way.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Nivestim po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Neupogen in da se po telesu enako prenaša.
Nivestim contains the active substance filgrastim.
Zdravilo Nivestim vsebuje učinkovino filgrastim.
• to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
• za skrajšanje trajanja nevtropenije pri bolnikih, ki prejemajo zdravljenje za uničenje celic kostnega mozga pred njegovo presaditvijo (kot npr. pri nekaterih bolnikih z levkemijo) in pri katerih obstaja tveganje za dolgotrajno, hudo obliko nevtropenije;
Because Nivestim is a biosimilar medicine the studies on effectiveness and safety of filgrastim carried out with Neupogen do not all need to be repeated for Nivestim.
Zdravilo Nivestim je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti filgrastima, ki so že bile izvedene z zdravilom Neupogen, z zdravilom Nivestim ni treba ponavljati.
The reference medicine for Nivestim is Neupogen.
Referenčno zdravilo za zdravilo Nivestim je zdravilo Neupogen.
Nivestim is a medicine that stimulates the production of white blood cells and is used:
Nivestim je zdravilo, ki se uporablja za spodbujanje tvorbe belih krvnih celic v naslednjih primerih:
How is Nivestim used?
Kako se zdravilo Nivestim uporablja?
Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Nevtropenija je pogost neželeni učinek zdravljenja raka, zaradi česar so ti bolniki bolj dovzetni za okužbe;
Nivestim is a ‘biosimilar' medicine.
Zdravilo Nivestim je „biološko podobno“ zdravilo.
For the full list of side effects and restrictions with Nivestim, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Nivestim glejte navodilo za uporabo.
How does Nivestim work?
Kako zdravilo Nivestim deluje?
Laboratory studies comparing Nivestim with Neupogen have shown that the active substance in Nivestim is highly similar to that in Neupogen in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Nivestim primerjali z zdravilom Neupogen, so pokazale, da je učinkovina zdravila Nivestim po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neupogen.
Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen.
Študije so pokazale tudi, da zdravilo Nivestim v telesu vzpostavi podobne ravni učinkovine kot zdravilo Neupogen.
The pregnancy section has been revised in line with the relevant guideline[9].
Poglavje o nosečnosti je bilo popravljeno v skladu z ustrezno smernico[9].
The safety and efficacy of Vepesid and associated names in children below 18 years of age have not been established.
Varnost in učinkovitost zdravila Vepesid in povezanih imen pri otrocih, mlajših od 18 let, še nista bili dokazani.
Based on data on bioavailability[1][2], the recommended oral dose is 100 to 200 mg/m2/day on day 1-5 in a cycle of 21 or 28 days; or 200 mg/m2/day on three days (most often days 1-3 or day 1, 3, and 5) in a cycle of 21 or 28 days.
Na podlagi podatkov o biološki uporabnosti[1][2] je priporočeni peroralni odmerek od 100 do 200 mg/m2/dan od 1. do 5. dneva 21- ali 28-dnevnega cikla ali 200 mg/m2/dan v obdobju treh dni (najpogosteje od 1. do 3. dneva ali na 1., 3. in 5. dan) 21- ali 28-dnevnega cikla.
The text on breastfeeding has been amended accordingly.
Besedilo o dojenju je bilo popravljeno v skladu s tem.
The first European approval was in NL on 29 May 1981.
Zdravilo je dovoljenje za promet v Evropi prvič pridobilo 29. maja 1981 na Nizozemskem.