natgillin/translations-raw huggingface dataset:
Children who received ProQuad at 4 through 6 years of age after primary immunization with Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Otroci, ki so bili cepljeni s cepivom ProQuad v starosti 4 do 6 let, po primarni imunizaciji s cepivom z živim virusom noric (Oka/Merck) in cepivom proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
Children who received ProQuad intramuscularly
Otroci, ki so prejeli 2 odmerka cepiva ProQuad intramuskularno ali subkutano
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in a pack size of 1, 10 and 20.
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in pokrovčkom (stiren-butadienska guma), z eno ali dvema nepritrjenima iglama, v pakiranjih po 1, 10 in 20.
The use of salicylates (for example, acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever) should be avoided for 6 weeks following vaccination with ProQuad.
Šest tednov po cepljenju s cepivom ProQuad se je treba izogibati jemanju salicilatov (npr. acetilsalicilne kisline, ki jo vsebujejo mnoga zdravila proti bolečinam in vročini).
Measles virus Enders' Edmonston strain .....................................≥ 3.00 log10 CCID 50 Mumps virus Jeryl Lynn™ (Level B) strain ................................≥ 4.30 log10 CCID50 Rubella virus Wistar RA 27/3 strain............................................≥ 3.00 log10 CCID50 Varicella virus Oka/Merck strain.................................................≥ 3.99 log10 PFU
Virus ošpic, sev Enders' Edmonston........................................................... ≥ 3,00 log10 CCID Virus mumpsa, sev Jeryl Lynn™ (nivo B).................................................. ≥ 4,30 log10 CCID Virus rdečk, sev Wistar RA 27/3................................................................. ≥ 3,00 log10 CCID Virus noric, sev Oka/Merck......................................................................... ≥ 3,99 log10 PFU
The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
Pri bolnikih s trombocitopenijo ali katero koli motnjo koagulacije je treba cepivo injicirati subkutano.
Gently agitate to dissolve completely.
Z rahlim stresanjem vsebino dobro raztopite.
Two doses of ProQuad administered by the IM route of administration were as immunogenic as two doses administered by the SC route in terms of antibody response rates and antibody titres to measles, mumps, rubella, and varicella.
Dva odmerka cepiva ProQuad, dana intramuskularno, sta bila glede na odziv protiteles in titre protiteles proti ošpicam, mumpsu, rdečkam in noricam enako imunogena kot dva odmerka, dana subkutano.
Bronchiolitis, Candida nappy rash, Candidiasis, Cellulitis, Infectious croup, Viral gastroenteritis, Hand-foot-mouth disease, Influenza, Pseudocroup, Respiratory infection, Skin infection, Tonsillitis, Varicella
Infekcijske in parazitske bolezni okužba zgornjih dihal pogosti vnetje ušesa, gastroenteritis, nazofaringitis, vnetje srednjega ušesa, vnetje žrela, rozeola, virusna okužba, virusni izpuščaj občasni bronhiolitis, kandidiazni plenični izpuščaj, kandidiaza, celulitis, infekcijski krup, virusni gastroenteritis, virusna okužba dlani-stopal-ust (hand-footmouth disease), gripa, psevdokrup, okužba dihal, okužba kože, tonzilitis, norice
Withdraw the entire volume of solvent into a syringe.
Celotno količino vehikla povlecite v brizgo.
Febrile seizures
Vročinski krči
Intramuscular or subcutaneous use.
intramuskularna ali subkutana uporaba Pred uporabo preberite priloženo navodilo!
Complications of varicella from vaccine strain including herpes zoster and disseminated disesase such as aseptic meningitis and encephalitis have been reported in immunocompromised or immunocompetent individuals.
Pri posameznikih z oslabljenim imunskim sistemom ali posameznikih z normalnim imunskim odzivom so poročali o zapletih s cepilnim sevom virusa noric, vključno s herpes zostrom (pasovcem), in o širjenju bolezni kot sta aseptični meningitis in encefalitis.
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in a pack size of 1, 10 and 20.
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in pokrovčkom (stiren-butadienska guma) brez igle v pakiranjih po 1, 10 in 20.
EU/1/05/323/010 - pack of 1 EU/1/05/323/011 - pack of 10 EU/1/05/323/013 - pack of 20
EU/1/05/323/010 - pakiranje po 1 EU/1/05/323/011 - pakiranje po 10 EU/1/05/323/013 - pakiranje po 20
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a vial (glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10.
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v viali (steklo) z zamaškom (klorobutilna guma) v pakiranjih po 1 in 10.
However, the efficacy of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. has been demonstrated in numerous studies.
V številnih študijah pa so dokazali učinkovitost cepiva z živim virusom noric (Oka/Merck) in cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
Store and transport refrigerated.
Cepivo shranjujte in prevažajte na hladnem.
1 Jeryl Lynn™ (Level B) strain (live, attenuated)... not less than 4.30 log10 CCID50* Rubella virus
1, sev Jeryl Lynn™ (nivo B) (živ, oslabljen).................najmanj 4,30 log10 CCID50*
1 Jeryl Lynn™ (Level B) strain (live, attenuated)...not less than 4.30 log10 CCID Rubella virus
1, sev Jeryl Lynn™ (nivo B) (živ, oslabljen) ............... najmanj 4,30 log10 CCID
The following adverse reactions were reported as vaccine related by the investigator in individuals after a single dose of ProQuad.
Po enkratnem odmerku cepiva ProQuad so raziskovalci poročali o naslednjih neželenih učinkih, ki so jih opredelili kot povezane s cepljenjem.
ProQuad - Powder in vial and solvent in pre-filled syringe with attached needle - Pack of 1, 10
ProQuad - prašek v viali in vehikel v napolnjeni injekcijski brizgi z iglo - pakiranje po 1, 10
Acne, Clammy skin, Exfoliative dermatitis, Drug eruption, Exanthema, Henoch-Schönlein purpura, Livedo reticularis, Papular rash, Pruritus, Skin discolouration, Skin lesion, Zosteriform rash
virusni izpuščaj, ekcem, eritem občasni akne, lepljiva koža, eksfoliativni dermatitis, izpuščaj zaradi zdravil, ekzantem, Henoch-Schönleinova purpura, livedo reticularis, mozoljasti izpuščaj, srbenje, sprememba barve kože, kožne lezije, pasovcu podoben izpuščaj redki multiformni eritem, herpes simplex, impetigo, panikulitis, purpura, zatrdlina kože, Stevens-Johnsonov sindrom, sončna opeklina neznana pogostnost
• Infants between 9 and 12 months of age: ProQuad may be administered from 9 months of age.
• Dojenčki, stari od 9 do 12 mesecev:
EU/1/05/323/005 - pack of 1 EU/1/05/323/006 - pack of 10 EU/1/05/323/007 - pack of 20
EU/1/05/323/005 - pakiranje po 1 EU/1/05/323/006 - pakiranje po 10 EU/1/05/323/007 - pakiranje po 20
EU/1/05/323/008 - pack of 1 EU/1/05/323/009 - pack of 10 EU/1/05/323/012 - pack of 20
EU/1/05/323/008 - pakiranje po 1 EU/1/05/323/009 - pakiranje po 10 EU/1/05/323/012 - pakiranje po 20
EU/1/05/323/003 - pack of 1 EU/1/05/323/004 - pack of 10
EU/1/05/323/003 - pakiranje po 1 EU/1/05/323/004 - pakiranje po 10
ProQuad - Powder in vial and solvent in pre-filled syringe without needle - Pack of 1, 10, 20
ProQuad - prašek v viali in vehikel v napolnjeni injekcijski brizgi z 2 nepritrjenima iglamapakiranje po 1, 10, 20
1 Enders' Edmonston strain (live, attenuated)........not less than 3.00 log10 CCID50*
1, sev Enders' Edmonston (živ, oslabljen) ..........................najmanj 3,00 log10 CCID50* Virus mumpsa
1 Enders' Edmonston strain (live, attenuated)........ not less than 3.00 log10 CCID50*
1, sev Enders' Edmonston (živ, oslabljen)..........................najmanj 3,00 log10 CCID50* Virus mumpsa
Complications associated with varicella
Zapleti povezani z noricami
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination.
Po cepljenju proti ošpicam, mumpsu in rdečkam so poročali o primerih aseptičnega meningitisa.
Immunocompromised individuals (see section 4.3) Necrotizing retinitis has been reported post-marketing in immunocompromised individuals.
Pri posameznikih z oslabljenim imunskim sistemom so v obdobju trženja zdravila poročali o nekrotizirajočem retinitisu.
2 Wistar RA 27/3 strain (live, attenuated)...............not less than 3.00 log10 CCID Varicella virus
Virus rdečk 2, sev Wistar RA 27/3 (živ, oslabljen) ..............................najmanj 3,00 log10 CCID
EU/1/05/323/001 - pack of 1 EU/1/05/323/002 - pack of 10
EU/1/05/323/001 - pakiranje po 1 EU/1/05/323/002 - pakiranje po 10
Therefore, caution should be exercised when considering whether to administer ProQuad to a breast-feeding woman.
Zato je pri odločitvi o cepljenju doječe matere s cepivom ProQuad potrebna previdnost.
Injection site complaints (Burning and/or Stinging of short duration, Eczema, Oedema/Swelling, Hive-like rash, Hematoma, Induration, Lump, Vesicles, Wheal and Flare), Inflammation, Lip abnormality, Papillitis, Roughness/Dryness, Stiffness, Trauma, Varicella-like rash, Venipuncture site haemorrhage, Warm sensation, Warm to touch
‡, eritem ‡ ali bolečina/občutljivost/bolečnost na mestu injiciranja zelo pogosti ekhimoza ali oteklina ‡ na mestu injiciranja, izpuščaj na mestu injiciranja pogosti astenija/utrujenost, krvavitev na mestu injiciranja, zatrdlina ali toplota na mestu injiciranja, oteklina na mestu injiciranja, slabo počutje občasni gripi podobna bolezen, luščenje kože na mestu injiciranja, sprememba barve na mestu injiciranja, srbečica na mestu injiciranja, nespecifični izpuščaj na mestu injiciranja, reakcija na mestu injiciranja, brazgotina na mestu injiciranja, hipertermija, bolečina redki reakcije na mestu injiciranja (kratkotrajen pekoč občutek in/ali zbadanje, ekcem, edem/oteklina, koprivnici podoben izpuščaj, hematom, zatrdlina, bula, mehurčki, mehurčki in rdečina - kot pri alergijskih kožnih testih, vnetje, nenormalnost ustnice, papilitis, hrapava/suha koža, otrdelost, poškodba, noricam podoben izpuščaj, krvavitev na mestu punkcije vene, občutek toplote, toplota na dotik neznana pogostnost
Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients; therefore, some of these patients may acquire measles, mumps, rubella, or varicella in case of contact, despite appropriate vaccine administration.
Pri bolnikih z oslabljenim imunskim sistemom, ki nimajo kontraindikacij za cepljenje s tem cepivom (glejte poglavje 4.3), odziv morda ne bo tako dober kot pri bolnikih z normalnim imunskim odzivom.
ProQuad Powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)
ProQuad prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo)
How to store ProQuad
Shranjevanje cepiva ProQuad
ProQuad Powder and solvent for suspension for injection Measles, mumps, rubella and varicella vaccine (live)
ProQuad prašek in vehikel za suspenzijo za injiciranje cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo)
2 Wistar RA 27/3 strain (live, attenuated)...............not less than 3.00 log10 CCID50* Varicella virus
Virus rdečk 2, sev Wistar RA 27/3 (živ, oslabljen)................................najmanj 3,00 log10 CCID50*
Bronchial spasm, Bronchitis, Epistaxis, Pneumonitis (see section 4.3), Pneumonia, Pulmonary congestion, Rhinitis, Sinusitis, Sore throat
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, kongestija nosu, kongestija dihal, izcedek iz nosu občasni astma, pljučna kongestija, bolezni obnosnih votlin, kihanje, piskanje redki bronhialni spazem, bronhitis, epistaksa, pnevmonitis (glejte poglavje 4.3), pljučnica, pljučna kongestija, rinitis, sinusitis, bolečine v grlu neznana pogostnost
Withdraw the entire content of the solvent vial into a syringe.
Celotno vsebino viale z vehiklom povlecite v brizgo.
ProQuad with Solvent for reconstitution supplied in a Pre-filled syringe: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle shield (natural rubber) in a pack size of 1 and 10.
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo) s pritrjeno iglo z batnim zamaškom (klorobutilna guma) in z zaščito za iglo iz naravne gume v pakiranjih po 1 in 10.
In the event of either being observed, discard the vaccine.
Če opazite prisotnost tujih delcev in/ali nenavaden izgled cepiva, je treba cepivo zavreči.
However, post-exposure prophylaxis for varicella and measles has been demonstrated with Varicella Vaccine live (Oka/Merck) and the measles-containing vaccines manufactured by Merck & Co., Inc., respectively.
Dokazana pa je bila profilaksa s cepivom z živim virusom noric (Oka/Merck) po izpostavitvi noricam ter profilaksa s cepivi, ki vsebujejo cepivo proti ošpicam izdelovalca Merck & Co., Inc., po izpostavitvi ošpicam.
ProQuad - Powder in vial and solvent in pre-filled syringe with 1 unattached needle - Pack of 1,
ProQuad - prašek v viali in vehikel v napolnjeni injekcijski brizgi brez igle - pakiranje po 1, 10,
Conjunctivitis, Eye discharge, Eyelid inflammation, Eye irritation, Eye swelling, Ocular hyperaemia, Tearing, Visual discomfort
Očesne bolezni konjunktivitis, izcedek iz oči, vnetje očesne veke, draženje oči, otekanje oči, hiperemija zrkla, solzenje, neprijeten občutek v očeh redki edem vek, draženje, optični nevritis, retinitis, retrobulbarni nevritis neznana pogostnost
ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)
ProQuad prašek in vehikel za suspenzijo za injiciranje ProQuad prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo)
Abdominal pain upper, Abnormal faeces, Constipation, Flatulence, Nausea, Salivation increase, Stomatitis, Teething
Bolezni prebavil driska, bruhanje pogosti bolečine v zgornjem delu trebuha, nenormalno blato, zaprtje, vetrovi, navzea, povečano slinjenje, stomatitis, dobivanje zob redki bolečine v trebuhu, hemohezija, razjeda v ustih neznana pogostnost
ProQuad should not be given to pregnant women.
Nosečnic se ne sme cepiti s cepivom ProQuad.
Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem P.O.
Merck Sharp & Dohme BV Waarderweg 39
Extravasation
Odmerjanje
Information was available from 23 patients.
Na voljo so bile informacije o 23 bolnikih.
London, 19 March 2008 Doc.
London, 19. marca 2008 Sklic na dok.
International non-proprietary name (INN): miglustat
Mednarodno nelastniško ime (INN): miglustat
Ref. EMEA/121008/2008
EMEA/186568/2008
The medicine was also studied in 12 patients aged less than 12 years.
Zdravilo so preučevali tudi pri 12 bolnikih, starih manj kot 12 let.
The disease can result in dementia and is usually fatal before the patient has reached adulthood.
Bolezen lahko privede do demence in je običajno usodna, še preden bolnik doseže obdobje odraslosti.
This is expected to reduce the symptoms of the disease.
To bi naj izboljšalo simptome bolezni.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Družba je zahtevala ponovno presojo negativnega mnenja, ki pa še ni bila zaključena, ko je družba umaknila vlogo.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for ZAVESCA
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET z zdravilom ZAVESCA
There are no consequences on the use of Zavesca in its authorised indication, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za uporabo zdravila Zavesca za odobreno indikacijo, pri kateri ostaja razmerje med koristmi in tveganji nespremenjeno.
The effects of Zavesca were first tested in experimental models before being studied in humans.
Učinki zdravila Zavesca so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Symptoms include a progressive loss of co-ordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, increased muscle tone, fits, and learning difficulties.
Njeni simptomi vključujejo progresivno izgubljanje koordinacije, težave s hitrimi, sunkovitimi gibi oči, ki lahko privedejo do okrnjenega vida, zaostanek v razvoju, težave pri požiranju, povečan mišični tonus, krči ter težave pri učenju.
In patients with this disease, fatty substances such as ‘glycosphingolipids' build up within cells in the brain, as well as elsewhere in the body.
Pri bolnikih s to boleznijo se maščobne snovi, kot npr. „glikosfingolipidi“, kopičijo v celicah v možganih, kakor tudi drugje po telesu.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Zavesca?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Zavesca?
The medicine showed a very limited benefit in the main study: there was only a marginal difference in the change in the speed of eye movements between the patients taking Zavesca and those receiving standard care, and there were uncertainties over whether looking at eye movements was the best way to measure the medicine's effectiveness.
Zdravilo je v glavni študiji izkazalo zelo omejeno korist: pri spremembi hitrosti gibov z očmi so ugotovili le minimalno razliko med bolniki, ki so prejemali zdravilo Zavesca, in tistimi, ki so prejemali standardno oskrbo, poleg tega ni bilo gotovo, ali je preučevanje gibov oči najboljši način za merjenje učinkovitosti zdravila.
The company also presented additional information from a worldwide survey of patients with Niemann Pick type C disease who had been treated with miglustat outside of the main study.
Družba je predstavila tudi dodatne informacije iz globalne raziskave bolnikov z Niemann-Pick-ovo boleznijo tipa C, ki so bili zdravljeni z miglustatom izven glavne študije.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Zavesca.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Zavesca.
By preventing the enzyme from working, miglustat can reduce the production of glycosphingolipids in cells.
S tem, ko preprečuje delovanje encima, lahko miglustat zmanjša delež glikosfingolipidov v celicah.
In patients with this disease, a fatty substance called glucosylceramide builds up in different parts of the body, such as the spleen, liver, and bones.
Pri bolnikih s to boleznijo se maščoba, imenovana glukozilceramid, kopiči v različnih delih telesa, kot so vranica, jetra in kosti.
On 19 February 2008, Actelion Registration Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zavesca, in the treatment of neurological manifestations in patients with Niemann Pick type C disease.
Družba Actelion Registration Ltd. je dne 19. januarja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo Zavesca, in sicer zdravljenje nevroloških manifestacij pri bolnikih z Niemann-Pick-ovo boleznijo tipa C.
Zavesca is a hard white capsule, which contains the active substance miglustat.
Zdravilo Zavesca so trde bele kapsule, vsebujoče učinkovino miglustat.
Gaucher disease is a rare, inherited disease that affects the way the body handles fats.
Gaucherjeva bolezen je redka dedna bolezen, ki vpliva na način, kako telo presnavlja maščobe.
Niemann Pick type C disease is a rare inherited disease that affects the way the body handles fats.
Niemann-Pick-ova bolezen tipa C je redka dedna bolezen, ki vpliva na način, kako telo presnavlja maščobe.
Miglustat, the active substance in Zavesca, prevents an enzyme called ‘glucosylceramide synthase' from working.
Miglustat, učinkovina zdravila Zavesca, preprečuje delovanje encima, imenovanega „glukozilceramid sintaza“.
Zavesca was also linked to side effects affecting the stomach and gut, as well as cases of weight loss and thrombocytopenia (low blood platelet counts).
Zdravilo Zavesca je bilo tudi povezano z neželenimi učinki za želodec in črevesje, kakor tudi s primeri izgube telesne mase in trombocitopenije (nizke ravni krvnih ploščic).
In the new indication, Zavesca was expected to be used to treat the ‘neurological' symptoms of Niemann Pick type C disease (affecting the brain and nervous system).
Pri novi indikaciji bi se naj zdravilo Zavesca uporabljalo za zdravljenje nevroloških simptomov Niemann-Pick-ove bolezni tipa C (ki prizadene možgane in živčevje).
Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend the approval of Zavesca for the treatment of neurological manifestations in patients with Niemann Pick type C disease.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je ta izrazil negativno mnenje in ni priporočil odobritve zdravila Zavesca za zdravljenje nevroloških manifestacij pri bolnikih z Niemann-Pick-ovo boleznijo tipa C.
What was Zavesca expected to be used for?
Za kaj naj bi se zdravilo Zavesca uporabljalo?
The CHMP acknowledged that there are no alternative treatments for Niemann Pick type C disease, but it was concerned that a benefit of Zavesca in the treatment of the neurological symptoms of Niemann Pick type C disease had not been sufficiently demonstrated.
CHMP se je strinjal, da za Niemann-Pick-ovo bolezen tipa C ni alternativnega zdravljenja, vendar pa je izrazil pomislek, da korist zdravila Zavesca pri zdravljenju nevroloških simptomov Niemann-Pickove bolezni tipa C ni bila zadostno dokazana.
What is happening for Zavesca for the treatment of type 1 Gaucher disease?
Kakšne so posledice za zdravilo Zavesca, indicirano za zdravljenje Gaucherjeve bolezni tipa 1?
Zavesca was designated as an orphan medicinal product on 16 February 2006 for Niemann Pick type C disease.
Zdravilo Zavesca je bilo dne 16. februarja 2000 določeno kot zdravilo sirota za zdravljenje NiemannPick-ove bolezni tipa C.
It is used for the treatment of mild to moderate type 1 Gaucher disease.
Zdravilo Zavesca je namenjeno za zdravljenje blage do zmerne oblike Gaucherjeve bolezni tipa 1.
The study compared the effects of adding Zavesca taken at a dose of 200 mg three times a day to standard care with the effects of standard care alone.
Učinkovitost zdravila Zavesca so preučevali v eni glavni študiji, ki je vključevala 29 bolnikov v starosti 12 let in več z Niemann-Pick-ovo boleznijo tipa C. V okviru študije so primerjali učinek dodajanja zdravila Zavesca v odmerku 200 mg trikrat dnevno k standardnemu zdravljenju z učinkom standardnega zdravljenja samega.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Zavesca in the treatment of neurological manifestations in Niemann Pick type C disease did not outweigh its risks.
CHMP je tedaj menil, da koristi zdravila Zavesca pri zdravljenju nevroloških simptomov NiemannPick-ove bolezni tipa C ne odtehtajo z njim povezanih tveganj.
How is Zavesca expected to work?
Kako bi naj zdravilo Zavesca delovalo?