FrancophonIA/ELRC3.0 huggingface dataset:
English: Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: PRILOGA II A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE
English: In patients treated with Zessly, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Slovenian: kokcidioidomikoza ali blastomikoza, poleg tega pa je pri teh bolnikih že zgodaj v poteku preiskav potreben posvet z zdravnikom, ki ima strokovno znanje iz diagnostike in zdravljenja invazivnih glivičnih okužb.
English: a p < 0.001, for each infliximab treatment group vs. control.
Slovenian: 50. teden a p < 0,001 za vsako terapevtsko skupino, ki je prejemala infliksimab, v primerjavi s kontrolno skupino b n = 292
English: If serious reactions occur, symptomatic treatment must be given and further Zessly infusions must not be administered (see section 4.8).
Slovenian: Če se pojavijo resne reakcije, morate uvesti simptomatično zdravljenje in bolniku ne smete več dajati infuzij tega zdravila
English: Myocardial ischaemia/myocardial infarction.
Slovenian: antihistaminik, hidrokortizon in/ali paracetamol.
English: In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Slovenian: • Pri nekaterih bolnikih, ki so prejemali zaviralce TNF, vključno z zdravilom Zessly, se je pojavila redka oblika raka, ki mu pravimo hepatosplenični limfom celic T. Od teh bolnikov je bila večina najstnikov ali mladih moških in večina je imela Crohnovo bolezen ali ulcerozni kolitis.
English: Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4).
Slovenian: Poročila o pojavu lupusa in lupusu podobnih sindromov, pa so še vedno občasna
English: • Feeling tired or weak
Slovenian: • občutek otrplosti ali mravljincev
English: Zessly 100 mg powder for concentrate infliximab
Slovenian: Zessly 100 mg prašek za koncentrat infliksimab samo za i.v.
English: Patients received 5 mg/kg infliximab- or placebo-infusions at weeks 0, 2, and 6 followed by maintenance therapy every 8 weeks through week 22 in the placebo group and through week 46 in the infliximab group.
Slovenian: Bolniki so v tednih 0, 2 in 6 prejeli po 5 mg/kg infliksimaba ali placeba v infuziji, temu pa je sledila vzdrževalna terapija na vsakih 8 tednov,
English: (anaphylactic shock)
Slovenian: (hepatosplenični limfom celic T)
English: Talk to your doctor before or during treatment with Zessly if you have:
Slovenian: Pred ali med zdravljenjem z zdravilom Zessly, se v naslednjih primerih posvetujte z zdravnikom: Predhodno ste se že zdravili s katerim koli zdravilom, ki vsebuje infliksimab
English: At least a six month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab (see section 4.6).
Slovenian: uporabo živih cepiv pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, je priporočljivo počakati vsaj šest mesecev po rojstvu (glejte poglavje 4.6).
English: • In case you have received Zessly while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Slovenian: Zessly, je pomembno, da o tem obvestite zdravnika vašega dojenčka, preden dojenček prejme katero koli cepivo.
English: The following side effects have been observed with medicines containing infliximab:
Slovenian: Pri uporabi infliksimaba so opazili naslednje neželene učinke:
English: Vascular disorders Common:
Slovenian: konjuktivitis občasni:
English: How much Zessly is given
Slovenian: Koliko zdravila Zessly uporabiti
English: Carriers of HBV who require treatment with Zessly should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Slovenian: Pri tistih bolnikih, ki imajo pozitiven izvid na okužbo z virusom HBV, je priporočljiv tudi posvet z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B. Prenašalce virusa HBV, ki potrebujejo zdravljenje z zdravilom Zessly, je treba ves čas zdravljenja in še več mesecev po prekinitvi oz. zaključku zdravljenja skrbno spremljati, da pri njih ugotovite morebitne znake in simptome aktivne okužbe z virusom HBV. Ni zadostnih podatkov o zdravljenju prenašalcev virusa HBV s protivirusno terapijo ob uporabi antagonista TNF za preprečevanje reaktivacije hepatitisa B. Pri bolnikih, pri katerih se ponovno aktivira okužba s HBV, je treba zdravilo Zessly ukiniti in uvesti učinkovito protivirusno terapijo z ustreznimi podpornimi ukrepi.
English: Zessly is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Slovenian: Zdravilo Zessly je indicirano za zdravljenje hude, aktivne Crohnove bolezni pri otrocih in mladostnikih, starih od 6 do 17 let, ki se niso odzvali na običajno terapijo, vključno s kortikosteroidi,
English: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks.
Slovenian: Ankilozirajoči spondilitis Odmerek je 5 mg/kg v obliki intravenske infuzije, čemur naj sledita dodatni infuziji v odmerku 5 mg/kg 2 in 6 tednov po prvi infuziji, potem pa na vsakih 6 do 8 tednov.
English: Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group.
Slovenian: ki so prejemali infuzije na vsakih 8 tednov, kot pa pri tistih, ki so jih prejemali na vsakih 12 tednov (73,6 % prvih in 38,0 % drugih).
English: All infliximabb
Slovenian: infliksimabb kontrolna skupinaa
English: There have been reports of pancytopenia, leukopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including infliximab.
Slovenian: Pri bolnikih, ki so jemali zaviralce TNF, vključno z infliksimabom, so poročali o pojavu pancitopenije, levkopenije, nevtropenije in trombocitopenije.
English: Malignancies and lymphoproliferative disorders Malignancies, some fatal, have been reported among children, adolescents and young adults (up to
Slovenian: Maligne in limfoproliferativne bolezni Pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF (z začetkom zdravljenja pri starosti ≤ 18 let), vključno z infliksimabom tekom trženja zdravila, so poročali o pojavu malignomov, od katerih so bili nekateri smrtni.
English: Mucosal healing at week 30a a p < 0.001, for each infliximab treatment group vs. placebo.
Slovenian: Celjenje sluznice v 8. tednua Celjenje sluznice v 30. tednua a p < 0,001 za vsako skupino, ki se je zdravila z infliksimabom, v primerjavi s placebom Učinkovitost infliksimaba do 54. tedna so ocenjevali v študiji 6.
English: Zessly contains the active substance infliximab.
Slovenian: Zdravilo Zessly vsebuje učinkovino infliksimab.
English: Patients evaluated (%)
Slovenian: Odziv PASI (% bolnikov)b
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Slovenian: Pri bolnikih, ki v tem času ne pokažejo nobenih znakov koristnega učinka zdravljenja,
English: • Pain.
Slovenian: NYHA).
English: Rheumatoid arthritis Crohn's disease Paediatric Crohn's disease
Slovenian: V preskušanju IIIb faze pri bolnikih s Crohnovo boleznijo,
English: HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Slovenian: c p < 0,001 za vsako od skupin, ki so prejemale infliksimab, v primerjavi s kontrolno skupino d večje vrednosti pomenijo večjo okvaro sklepov e vprašalnik za oceno zdravstvenega stanja (HAQ): višje vrednosti pomenijo manjšo okvaro funkcije
English: TB.
Slovenian: alfa.
English: VIAL LABEL
Slovenian: OVOJNINAH NALEPKA NA VIALI
English: Treatment is continued over a period of up to 72 hours.
Slovenian: Zdravljenje traja največ 72 ur.
English: What is Zalviso and what is it used for?
Slovenian: Kaj je zdravilo Zalviso in za kaj se uporablja?
English: The full EPAR and risk management plan summary for Zalviso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Zalviso sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The tablets must be allowed to dissolve under the tongue and must not be chewed or swallowed.
Slovenian: Tablete je treba pod jezikom raztopiti in se ne smejo žvečiti ali pogoltniti.
English: The main measure of effectiveness was based on a patient score that measured the decrease in intensity of pain over 48 hours of treatment.
Slovenian: Glavno merilo učinkovitosti je temeljilo na oceni bolnika, s katero je bilo merjeno zmanjšanje intenzivnosti bolečine v 48 urah zdravljenja.
English: What are the risks associated with Zalviso?
Slovenian: Kakšna tveganja so povezana z zdravilom Zalviso?
English: A risk management plan has been developed to ensure that Zalviso is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Zalviso je bil pripravljen načrt obvladovanja tveganj.
English: Regarding safety, the side effects were those expected of opioids, and were considered manageable.
Slovenian: Kar zadeva varnost, so bili neželeni učinki taki, kot se pričakujejo pri opioidih, in so bili ocenjeni za obvladljive.
English: However, considering the fact that post-operative pain improves by itself over time as well as the potential for addiction or the body becoming used to the opioid and requiring larger doses, the medicine and its administration device should only be used in a hospital setting, and restricted to use for a maximum duration of 72 hours.
Slovenian: Vendar pa je ob upoštevanju dejstva, da se pooperativna bolečina sčasoma sama zmanjša, ter da obstaja možnost, da se razvije odvisnost ali da se telo navadi na opioid in zahteva večje odmerke, treba zdravilo in pripomoček za njegovo aplikacijo uporabljati le v bolnišničnem okolju, obdobje uporabe pa omejiti na največ 72 ur.
English: The Committee considered that an additional option for patient-controlled pain relief immediately after surgery, when the pain is worst, was beneficial, especially since it did not need to be given into a vein.
Slovenian: Odbor je menil, da je dodatna možnost za blažitev bolečine, ki jo nadzira bolnik, takoj po operaciji, ko je bolečina najhujša, koristna, še zlasti ker zdravila ni treba dajati v žilo.
English: Why is Zalviso approved?
Slovenian: Zakaj je bilo zdravilo Zalviso odobreno?
English: Zalviso must not be used in patients who already have significant impaired breathing.
Slovenian: Zdravilo Zalviso se ne sme uporabljati pri bolnikih, ki že imajo pomembne težave pri dihanju.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zalviso's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Zalviso večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Zalviso.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zalviso.
English: Zalviso is a ‘hybrid medicine'.
Slovenian: Zdravilo Zalviso je „hibridno zdravilo“.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Zalviso is available in a different form.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isto zdravilno učinkovino, vendar je zdravilo Zalviso na voljo v drugačni obliki.
English: The most serious side effect is respiratory depression (impaired breathing) which could potentially lead to the patient stopping breathing altogether.
Slovenian: Najresnejši neželeni učinek je respiratorna depresija (težave pri dihanju), ki bi lahko povzročila, da bi bolnik prenehal dihati.
English: What measures are being taken to ensure the safe and effective use of Zalviso?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila
English: What benefits of Zalviso have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Zalviso izkazalo v študijah?
English: It is not intended to provide practical advice on how to use Zalviso.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: This allows the medicine to be transported to receptors in the brain and spinal cord where sufentanil acts to relieve pain.
Slovenian: To omogoči prenos zdravila do receptorjev v možganih in hrbtenjači, kjer sufentanil deluje tako, da ublaži bolečino.
English: Because Zalviso is a hybrid generic, the applicant presented data on the reference medicine in addition to results from its own studies.
Slovenian: Ker je zdravilo Zalviso hibridno generično zdravilo, je predlagatelj poleg rezultatov svojih študij predložil tudi podatke o referenčnem zdravilu.
English: Other information about Zalviso
Slovenian: Druge informacije o zdravilu Zalviso
English: The most common side effects with Zalviso (which may affect more than 1 in 10 people) are nausea (feeling sick) and vomiting.
Slovenian: Najpogostejša neželena učinka zdravila Zalviso (ki lahko prizadeneta več kot 1 osebo od 10) sta navzeja (slabost) in bruhanje.
English: Of 177 patients using Zalviso, 139 rated their pain control as excellent or good (79%), compared with 118 of 180 (66%) using morphine.
Slovenian: Izmed 177 bolnikov, ki so uporabljali zdravilo Zalviso, jih je 139 način obvladovanja bolečine ocenilo kot odličen ali dober (79 %), medtem ko jih je od 180, ki so uporabljali morfin, tako oceno podalo 118 (66 %).
English: Zalviso is available as sublingual tablets containing 15 micrograms of sufentanil.
Slovenian: Zdravilo Zalviso je na voljo v obliki podjezičnih tablet, ki vsebujejo 15 mikrogramov sufentanila.
English: When the patient places a Zalviso tablet under the tongue, a dose of sufentanil is rapidly absorbed into the blood stream through the blood vessels in the lining of the mouth.
Slovenian: Ko si bolnik položi tableto Zalviso pod jezik, se odmerek sufentanila skozi krvne žile v ustni sluznici hitro absorbira v krvni obtok.
English: One main study involved 178 patients who had abdominal surgery (surgery on the belly) and another involved 426 patients who had surgery on the knee or hip.
Slovenian: V eno glavno študijo je bilo vključenih 178 bolnikov, ki so imeli abdominalno operacijo (operacijo na trebuhu), v drugo pa 426 bolnikov z operacijo kolena ali kolka.
English: The reference medicine for Zalviso is called Sufenta Forte, and is available as a solution for injection, whereas Zalviso is available as sublingual tablets (tablets to be dissolved under the tongue).
Slovenian: Referenčno zdravilo za zdravilo Zalviso se imenuje Sufenta Forte in je na voljo kot raztopina za injiciranje, medtem ko je zdravilo Zalviso na voljo v obliki podjezičnih tablet (tablet, ki se raztopijo pod jezikom).
English: For more information about treatment with Zalviso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zalviso preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For abdominal surgery, the average decrease in pain intensity was 50 points greater with Zalviso than with placebo (106 versus 56).
Slovenian: Pri abdominalnih operacijah je bilo povprečno zmanjšanje intenzivnosti bolečine pri uporabi zdravila Zalviso za 50 točk večje kot pri uporabi placeba (106 proti 56).
English: The device also uses an identifier so that only the patient who has been given a special thumb tag can release tablets.
Slovenian: Na pripomočku je tudi identifikator, tako da lahko tablete uporabi le bolnik, ki je prejel posebno palčno oznako.
English: The active substance in Zalviso, sufentanil, is an opioid.
Slovenian: Zdravilna učinkovina v zdravilu Zalviso, sufentanil, je opioid.
English: A third main study compared Zalviso with a patient-controlled pain relief system using morphine, another opioid, and involved 359 patients who had undergone major abdominal, knee or hip surgery.
Slovenian: V tretji glavni študiji so zdravilo Zalviso primerjali s sistemom za blaženje bolečine, ki ga nadzira bolnik in uporablja drug opioid morfin; vanjo je bilo vključenih 359 bolnikov, ki so imeli veliko abominalno operacijo oziroma operacijo kolena ali kolka.
English: It contains the active substance sufentanil.
Slovenian: Vsebuje zdravilno učinkovino sufentanil.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zalviso, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Zalviso in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The device locks for 20 minutes after the patient has taken a tablet and does not allow the patient to take more than 3 doses in one hour.
Slovenian: Ko vzame tableto, se pripomoček za 20 minut zaklene in mu tako prepreči, da bi vzel več kot tri odmerke v eni uri.
English: How is Zalviso used?
Slovenian: Kako se zdravilo Zalviso uporablja?
English: For practical information about using Zalviso, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Zalviso naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Zalviso is an opioid (a strong painkiller) that is used to treat pain occurring in adults after an operation.
Slovenian: Zdravilo Zalviso je opioid (močno zdravilo za lajšanje bolečin), ki se uporablja za zdravljenje pooperativne bolečine pri odraslih.
English: In both cases Zalviso was compared with placebo (a dummy treatment).
Slovenian: Zdravilo Zalviso so v obeh primerih primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: For knee and hip surgery the decrease in pain intensity was around 88 points greater with Zalviso (76 versus -11) than with placebo.
Slovenian: Pri operacijah kolena in kolka je bilo zmanjšanje intenzivnosti bolečine pri uporabi zdravila Zalviso za približno 88 točk večje kot pri uporabi placeba (76 proti -11).
English: The tablets are only for use in hospital and can only be obtained with a prescription from a doctor experienced in treating patients with opioids.
Slovenian: Tablete so namenjene za uporabo le v bolnišnicah, njihova izdaja je le na recept, predpisati pa jih mora zdravnik z izkušnjami z zdravljenjem z opioidi.
English: For the full list of side effects and restrictions with Zalviso, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zalviso glejte navodilo za uporabo.
English: EPAR summary for the public
Slovenian: Povzetek EPAR za javnost sufentanil
English: The patient places the Zalviso tablets under their tongue when needed using a special device.
Slovenian: Bolnik si tablete Zalvis, ko je to potrebno, s posebnim pripomočkom položi pod jezik.
English: How does Zalviso work?
Slovenian: Kako zdravilo Zalviso deluje?
English: These side effects were normally mild or moderate.
Slovenian: Ti neželeni učinki so bili običajno blagi ali zmerni.
English: The women were followed up for around three and a half years after the third dose of the vaccine.
Slovenian: Ženske so spremljali približno tri leta in pol po prejemu tretjega odmerka cepiva.
English: These virus-like particles are not capable of causing infection or disease.
Slovenian: Ti virusu podobni delci ne morejo povzročiti okužb ali bolezni.
English: The vaccine also contains an ‘adjuvant', a compound containing aluminium to stimulate a better response.
Slovenian: Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij) za spodbujanje boljšega odziva.
English: This is a summary of the European public assessment report (EPAR) for Gardasil 9.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Gardasil 9.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil 9 on 10 June 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Gardasil 9, veljavno po vsej Evropski uniji, izdala 10. junija 2015.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Gardasil 9's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Gardasil 9 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The full EPAR and risk management plan summary for Gardasil 9 can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Gardasil 9 sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For the full list of all restrictions, see the package leaflet.
Slovenian: Za celoten seznam omejitev glejte navodilo za uporabo.
English: The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.
Slovenian: Cepivo se daje v obliki injekcije v mišico, po možnosti v rame ali stegno.
English: There are more than 100 types of papillomavirus, some of which are associated with anogenital cancers in both men and women.
Slovenian: Obstaja več kot 100 tipov papilomavirusov, od katerih nekatere povezujejo z rakavimi obolenji na spolovilih in zadnjiku pri moških in ženskah.
English: What measures are being taken to ensure the safe and effective use of Gardasil 9?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gardasil 9?
English: A further 5 HPV types (31, 33, 45, 52, and 58) also carry a high risk for developing cancer (they cause around 20% of cervical cancers).
Slovenian: Pet dodatnih tipov (31, 33, 45, 52 in 58) prav tako prinaša večje tveganje za razvoj raka (ti tipi povzročajo približno 20 % rakavih obolenj materničnega vratu).
English: Gardasil 9 is given according to official recommendations.
Slovenian: Cepivo Gardasil 9 se daje v skladu z uradnimi priporočili.
English: In Europe, approximately 90% of anal cancers, 15% of vulvar cancers, 70% of vaginal cancers, and 30 to 40% of penile cancers are estimated to be caused by HPV infection.
Slovenian: V Evropi je po ocenah 90 % rakavih obolenj zadnjika, 15 % rakavih obolenj vulve, 70 % rakavih obolenj nožnice in od 30 do 40 % rakavih obolenj penisa posledica okužbe s humanim papilomavirusom.
English: This study also showed that antibody levels against types 6, 11, 16 and 18 were adequate to protect against these four types of HPV infection.
Slovenian: Študija je prav tako pokazala, da so ravni protiteles proti tipom 6, 11, 16 in 18 zadoščale za zaščito pred okužbo s temi štirimi tipi humanega papilomavirusa.