FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 x single dose of 0.5 ml pre-filled syringe 10 x single dose of 0.5 ml pre-filled syringes
Slovenian: 1 napolnjena injekcijska brizga z enkratnim odmerkom 0,5 ml 10 napolnjenih injekcijskih brizg z enkratnim odmerkom 0,5 ml
English: Adverse reactions in the week following vaccination from 87 children 3-8 years old and 95 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Slovenian: Poročali so o naslednjih neželenih učinkih v tednu po cepljenju za 87 otrok, starih med 3-8 let in za 95 otrok in mladostnikov, starih med 9-17 let, ki so prejemali obliko s 7,5 µg :
English: Among the adolescents the very common events were: sweating, nausea and chills.
Slovenian: Med mladostniki so bili zelo pogosti neželeni učinki: potenje, slabost in mrazenje.
English: Take special care with Focetria:
Slovenian: Bodite posebno pozorni pri uporabi cepiva Focetria
English: Breast-feeding Focetria may be administered to lactating women.
Slovenian: Dojenje S cepivom Focetria se lahko cepi doječe ženske.
English: Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Slovenian: Otekle bezgavke, palpitacije, slabotnost, bolečina okončin in kašelj.
English: “Possible side effects” may affect the ability to drive or use machines.
Slovenian: Nekateri učinki, navedeni v poglavju 4 „Možni neželeni učinki“ lahko vplivajo na sposobnost upravljanja vozil in strojev.
English: Total N=57
Slovenian: Skupno n = 57
English: The side effects listed below have occurred with Focetria in clinical studies in adults, including the elderly:
Slovenian: Neželeni učinki, opisani v nadaljevanju, so se pojavili po cepljenju odraslih oseb in starostnikov s cepivom Focetria v kliničnih študijah:
English: What Focetria contains
Slovenian: Kaj vsebuje cepivo Focetria
English: Seroconversion or Significant Increase (95% CI) * measured by HI assay ** geometric mean ratios of HI
Slovenian: Serokonverzija ali značilno zvečanje (95-% IZ) * merjeno s testom HI ** razmerja geometrične srednje vrednosti (GMR) HI
English: GMR (95% CI) Seroconversion or Significant Increase (95% CI)
Slovenian: Stopnja serološke zaščite (95-% IZ) GMR (95-% IZ) Serokonverzija ali značilno zvečanje (95-% IZ)
English: Cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria.
Slovenian: Pri osebah, cepljenih s cepivom Focetria, so poročali o primerih konvulzij s povišano telesno temperature ali brez nje.
English: Seronegative at baseline N=51
Slovenian: Seronegativni ob začetku spremljanja n = 51
English: Seronegative at baseline N=37
Slovenian: Seronegativni ob začetku spremljanja n = 37
English: PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe.
Slovenian: FARMACEVTSKA OBLIKA suspenzija za injiciranje v napolnjeni injekcijski brizgi mlečno bela tekočina
English: Seronegative at baseline N=48
Slovenian: Seronegativni ob začetku spremljanja n = 48
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Focetria injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Focetria injekcija cepivo proti gripi H1N1v intramuskularna uporaba
English: Respiratory disorders
Slovenian: Bolezni živčevja
English: Clinical trials with Focetria H1N1v
Slovenian: Klinična preskušanja s cepivom Focetria H1N1v
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of Focetria (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
Slovenian: • če ste imeli nenadno, življenjsko ogrožajočo alergijsko reakcijo na katero koli sestavino cepiva Focetria (ki so navedene na koncu navodila za uporabo) ali katere koli ostanke v sledovih, kot sledi: jajčne in kokošje beljakovine, ovalbumin, formaldehid, kanamicin- in neomicinsulfat (antibiotika) in cetiltrimetilamonijev bromid (CTAB).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH OZNAKA ZA BRIZGO
English: There are no data on co-administration of Focetria with other vaccines.
Slovenian: Podatkov o sočasni uporabi cepiva Pandemrix z drugimi cepivi ni.
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 793 to 1065 (N=88) and an increase in GMT from 522 to 870 in children who were seronegative at baseline (N=51).
Slovenian: Podatki o odzivu na drugi odmerek po 3-tedenskem premoru so pokazali zvišanje splošnega GMT s 793 na 1065 (n = 88) in zvišanje GMT od 522 na 870 pri otrocih, ki so bili ob izhodišču seronegativni (n = 51).
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal (only for the multidose vial presentation), to egg and, chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
Slovenian: • če ste imeli alergijsko reakcijo, ki ni bila nenadna in življenjsko ogrožajoča, na katero koli sestavino cepiva, tiomersal (samo za pakiranje v večodmernih vsebnikih), jajčne in kokošje beljakovine, ovalbumin, formaldehid, kanamicin- in neomicinsulfat (antibiotika) in cetiltrimetilamonijev bromid (CTAB).
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 274 to 1700 (N=57) and an increase in GMT from 162 to 1399 in children who were seronegative at baseline (N=37).
Slovenian: Podatki o odzivu na drugi odmerek po 3-tedenskem premoru so pokazali zvišanje splošnega GMT s 274 na 1700 (n = 57) in zvišanje GMT od 162 na 1399 pri otrocih, ki so bili ob izhodišču seronegativni (n = 37).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novartis Vaccines and Diagnostics S.r.l.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Novartis Vaccines and Diagnostics S.r.l.
English: Intramuscular use.
Slovenian: POSTOPEK UPORABE.
English: Seronegative at baseline N=45
Slovenian: Seronegativni ob začetku spremljanja n = 45
English: Seronegative at baseline N=46
Slovenian: Seronegativni ob začetku spremljanja n = 46
English: Rare (1/10,000 to <1/1,000),
Slovenian: Ugotovljen1 neželeni učinki so navedeni v skladu z naslednjimi pogostnostmi: zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1000 do <1/100), redki (1/1,000 do <1/1,000), zelo redki (<1/10000).
English: How to store Focetria
Slovenian: Shranjevanje cepiva FOCETRIA
English: The other ingredients are: thiomersal (multidose vial only), sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Slovenian: Druge sestavine zdravila so: tiomersal (samo v večodmernem vsebniku), natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina in voda za injekcije.
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 319 to 702 (N=70) and an increase in GMT from 247 to 726 in children who were seronegative at baseline (N=48).
Slovenian: Podatki o odzivu na drugi odmerek po 3-tedenskem premoru so pokazali zvišanje splošnega GMT od 319 na 702 (n = 70) in zvišanje GMT od 247 na 726 pri otrocih, ki so bili ob izhodišču seronegativni (n = 48).
English: Seronegative at baseline N=25
Slovenian: Seronegativni ob začetku spremljanja n = 25
English: Focetria suspension for injection Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Slovenian: Focetria suspenzija za injiciranje cepivo proti gripi H1N1v s površinskimi antigeni, inaktivirano, z adjuvansom
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Slovenian: Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (razen anafilaktičnih reakcij) na zdravilno učinkovino, katero koli pomožno snov in ostanke (jajca in kokošje beljakovine, ovalbumin, kanamicin- in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB)).
English: Prior to administration, the withdrawn vaccine should be allowed to reach room temperature.
Slovenian: Preneseni del cepiva mora pred uporabo doseči sobno temperaturo.
English: Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
Slovenian: Bolezni prebavil Bolezni prebavil kot so navzea, bruhanje, bolečina v trebuhu in diareja.
English: General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue, malaise and shivering
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti: oteklina na mestu injiciranja, bolečina na mestu injiciranja, zatrdlina na mestu injiciranja, rdečica na mestu injiciranja, slabotnost, utrujenost in tresavica Pogosti: ekhimoza na mestu injiciranja in vročina Občasni: influenci podobna bolezen
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
Slovenian: Anafilatične reakcije v anamnezi (tj. življenjsko nevarne) na katero koli sestavino cepiva ali ostanke v sledeh (jajčne in kokošje beljakovine, ovalbumin, kanamicin- in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB)).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin.
Slovenian: A/California/07/2009 (H1N1) 7,5 mikrogramov** na odmerek 0,5 ml * razmnožen v jajcih ** izraženo v mikrogramih hemaglutinina Adjuvans MF59C.1 vsebuje: skvalen
English: Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Slovenian: Zvišana telesna temperatura 39 °C/≥39,9 °C Zvišana telesna temperatura ≥40 °C Vsi drugi neželeni učinki
English: NAME OF THE MEDICINAL PRODUCT Focetria suspension for injection in multidose container Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Slovenian: Focetria suspenzija za injiciranje v večodmernem vsebniku cepivo proti gripi H1N1v s površinskimi antigeni, inaktivirano, z adjuvansom
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 307 to 873 (N=66) and an increase in GMT from 243 to 733 in children who were seronegative at baseline (N=45).
Slovenian: Podatki o odzivu na drugi odmerek po 3-tedenskem premoru so pokazali zvišanje splošnega GMT s 307 na 873 (n = 66) in zvišanje GMT od 243 na 733 pri otrocih, ki so bili ob izhodišču seronegativni (n = 45).
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Slovenian: Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (razen anafilaktičnih reakcij) na zdravilno učinkovino, katero koli pomožno snov, na tiomersal in ostanke (jajca in kokošje beljakovine, ovalbumin, kanamicin- in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB)) je treba biti previden.
English: Adverse reactions reported are listed according to the following frequency: Very common (1/10),
Slovenian: Ugotovljeni neželeni učinki so navedeni v skladu z naslednjimi pogostnostmi: zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1.000 do <1/100), redki (1/10.000 do <1/1.000), zelo redki (<1/10.000).
English: 21 days after 1st dose(day 22)
Slovenian: Starejši (> 60 let) Protitelesa proti HA 21 dni po prvem odmerku (22. dan)
English: Gastrointestinal disorders Common: nausea
Slovenian: Bolezni prebavil Pogosti: navzea
English: There are no data with Focetria using the subcutaneous route.
Slovenian: Podatkov o subkutani uporabi cepiva Focetria ni.
English: Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue, generally feeling unwell and shivering
Slovenian: Zelo pogosti (pojavijo se pri več kot 1 cepljeni osebi od 10 cepljenih oseb): bolečina, otrdelost kože na mestu injiciranja, pordečeno in oteklo mesto injiciranja, bolečina na mestu injiciranja, bolečine v mišicah, glavobol, zvečano potenje, utrujenost, splošno slabo počutje in tresavica.
English: Please consult the Product Information of:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do:
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor ** for anti-HA antibody to A/H1N1v in adult and elderly subjects by HI assay after administration of 7.5 µg of Focetria were as follows:
Slovenian: Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije**, izmerjeni s testom HI za HA protitelesa proti A/H1N1v po dajanju 7,5 µg cepiva Focetria, so bili pri odraslih naslednji:
English: MARKETING AUTHORISATION HOLDER Novartis Vaccines and Diagnostics S.r.l.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Novartis Vaccines and Diagnostics S.r.l.
English: NAME OF THE MEDICINAL PRODUCT Focetria suspension for injection in pre-filled syringe Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Slovenian: Focetria suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi H1N1v s površinskimi antigeni, inaktivirano, z adjuvansom
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 12-35 months by HI assay after administration of 7.5 µg of Focetria were as follows:
Slovenian: Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije** izmerjeni s testom HI za HA protitelesa H1N1v, po dajanju 7,5 µg cepiva Focetria pri otrocih, starih od 12-35 mesecev, so bili naslednji:
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in infants aged 6-11 months by HI assay after administration of 7.5 µg of Focetria were as follows:
Slovenian: Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije** izmerjeni s testom HI za HA protitelesa H1N1v, po dajanju 7,5 µg cepiva Focetria pri dojenčkih, starih od 6-11 mesecev, so bili naslednji:
English: A dose (0.5 ml) of the vaccine will be given.
Slovenian: Prejmejo odmerek (0,5 ml).
English: A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms haemagglutinin
Slovenian: A/California/07/2009 (H1N1)
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 3-8 years by HI assay after administration of 7.5 µg of Focetria were as follows:
Slovenian: Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije** po dajanju 7,5 µg cepiva Focetria, izmerjeni s SRH za protitelesa proti HA seva H1N1v, so bili pri otrocih, starih od 3 do 8 let, naslednji:
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina, tiomersal, voda za injekcije.
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina, voda za injekcije.
English: Talk to your doctor or nurse before receiving Focetria
Slovenian: Preden prejmete cepivo Focetria, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
English: Respiratory disorders Cough.
Slovenian: Bolezni dihal Kašelj.
English: Children and Adolescents (9-17 years)
Slovenian: Otroci in mladostniki (9-17 let) Protitelesa proti HA 21 dni po prvem odmerku (22. dan)
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children and adolescents aged 9-17 years by HI assay administration of 7.5 µg of Focetria were as follows:
Slovenian: Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije** izmerjeni s testom HI za HA protitelesa H1N1v, po dajanju 7,5 µg cepiva Focetria pri otrocih in mladostnikih, starih od 9-17 let:
English: Ready-to-use syringe, containing a single dose of 0.5 ml for injection:
Slovenian: Za uporabo pripravljena napolnjena injekcijska brizga z enkratnim odmerkom 0,5 ml za injiciranje: Cepivo mora pred uporabo doseči sobno temperaturo.
English: Signifor pasireotide
Slovenian: Signifor pasireotid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Signifor on 24 April 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Signifor, veljavno po vsej Evropski uniji, izdala 24. aprila 2012.
English: What measures are being taken to ensure the safe and effective use of Signifor?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Signifor?
English: The summaries of the opinions of the Committee for Orphan Medicinal Products for Signifor can be found on the Agency's website:
Slovenian: Povzetka mnenj Odbora za zdravila sirote o zdravilu Signifor sta na voljo na spletni strani agencije:
English: Other information about Signifor
Slovenian: Druge informacije o zdravilu Signifor
English: The full EPAR for Signifor 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) za zdravilo Signifor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Signifor.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Signifor.
English: It is not intended to provide practical advice on how to use Signifor.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: If side effects develop the dose may need to be temporarily reduced.
Slovenian: Če se pojavijo neželeni učinki, bo odmerek morda treba začasno zmanjšati.
English: What benefits of Signifor have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Signifor izkazalo v študijah?
English: Continuation of both studies confirmed the long-term benefit of Signifor in patients with acromegaly.
Slovenian: Z nadaljevanjem obeh študij so potrdili dolgoročno korist zdravila Signifor pri bolnikih z akromegalijo.
English: Why is Signifor approved?
Slovenian: Zakaj je bilo zdravilo Signifor odobreno?
English: Pre-defined levels were less than 2.5 micrograms/liter for growth hormone or within normal limits for IGF-1.
Slovenian: Predhodno opredeljene ravni so bile manj kot 2,5 mikrograma/liter za rastni hormon oziroma normalne vrednosti za IGF-1.
English: Signifor must not be used in patients with severe liver problems.
Slovenian: Zdravila Signifor ne smejo uporabljati bolniki z resnimi težavami z jetri.
English: Those patients who do not experience clinical benefit can stop treatment.
Slovenian: Bolniki, pri katerih ni klinične koristi, lahko z zdravljenjem prenehajo.
English: What are the risks associated with Signifor?
Slovenian: Kakšna tveganja so povezana z zdravilom Signifor?
English: The European Medicines Agency concluded that the benefits of Signifor are greater than its risk and recommended that it approved in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Signifor večje od z njim povezanih tveganj, in priporočila, se odobri za uporabo v EU.
English: What is Signifor and what is it used for?
Slovenian: Kaj je zdravilo Signifor in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Signifor have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Signifor upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For this reason, Signifor should be used for acromegaly only when the condition is not controlled by other medicines of its class.
Slovenian: Zato se sme zdravilo Signifor pri bolnikih z akromegalijo uporabljati le, kadar bolezen ni nadzorovana z drugimi zdravili tega razreda.
English: For more information about treatment with Signifor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Signifor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This means that it works in the same way as the natural hormone, somatostatin, to block the release of growth hormone from the pituitary glands located at the base of the brain and indirectly block the release of cortisol from the adrenal gland found above the kidneys.
Slovenian: To pomeni, da deluje enako kot naravni hormon somatostatin in zavira sproščanje rastnega hormona iz hipofize, žleze, ki se nahaja na možganskem dnu, in posredno zavira sproščanje kortizola iz nadledvične žleze, ki se nahaja nad ledvicami.
English: Because the numbers of patients with these diseases are low, the diseases are considered ‘rare', and Signifor was designated an ‘orphan medicine' (a medicine used in rare diseases).
Slovenian: Ker je bolnikov s tema boleznima malo, veljata ti bolezni za redki, zato je bilo zdravilo Signifor določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih).
English: (To reduce cortisol, pasireotide first reduces the production of another hormone ACTH, which controls cortisol production.)
Slovenian: (Pasireotid količino kortizola zmanjša tako, da najprej zmanjša tvorbo drugega hormona, ACTH, ki nadzoruje nastajanje kortizola.)
English: Signifor is used for these conditions when surgery has failed or is not possible and, in the case of acromegaly, when the condition is also not adequately controlled with other medicines similar to Signifor known as ‘somatostatin analogues'.
Slovenian: Zdravilo Signifor se pri teh boleznih uporablja, kadar kirurški poseg ni bil uspešen ali ni mogoč, pri akromegaliji pa se uporablja, kadar bolezni ni mogoče ustrezno nadzorovati z drugimi zdravili, podobnimi zdravilu Signifor, imenovanimi „analogi somatostatina“.
English: The active substance in Signifor, pasireotide is a somatostatin analogue.
Slovenian: Zdravilna učinkovina v zdravilu Signifor, pasireotid, je analog somatostatina.