FrancophonIA/ELRC3.0 huggingface dataset:
English: Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with Imlygic.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom Imlygic uporabljajo učinkovito kontracepcijsko zaščito za preprečitev nosečnosti.
English: Ask your healthcare professional for advice if you:
Slovenian: Posvetujte se z zdravstvenim delavcem:
English: Cellulitis
Slovenian: Celulitis
English: Imlygic 108 plaque forming units (PFU)/mL solution for injection Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 x 108 (100 million) plaque forming units (PFU)/mL.
Slovenian: Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje Ena viala vsebuje 1 ml uporabne količine zdravila Imlygic z nominalno koncentracijo 1 x 108 (100 milijonov) plakotvornih enot (PFU)/ml.
English: Accidental exposure to Imlygic
Slovenian: Nenamerna izpostavljenost zdravilu Imlygic
English: Imlygic 106 plaque forming units (PFU)/mL solution for injection Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 x 106 (1 million) plaque forming units (PFU)/mL
Slovenian: Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje Ena viala vsebuje 1 ml uporabne količine zdravila Imlygic z nominalno koncentracijo 1 x 106 (1 milijon) plakotvornih enot (PFU)/ml.
English: Mice that had complete regression of theirprimary tumours following treatment were resistant to subsequent tumour rechallenge.
Slovenian: Domnevno naj bi skupaj z GM-CSF spodbudil sistemski protitumorski imunski odziv in odziv efektorskih celic T. Miši, ki so po zdravljenju dosegle popolno regresijo primarnih tumorjev, so bile odporne proti poznejši ponovni tumorski provokaciji.
English: Subsequent doses will be up to 4 mL of Imlygic at a concentration of 108 (100 million) PFU/mL.
Slovenian: Nadaljnji odmerki bodo do 4 ml zdravila Imlygic s koncentracijo 108 (100 milijonov) PFU/ml.
English: > 0.5 cm to 1.5 cm up to 0.5 mL
Slovenian: > 0,5 cm do 1,5 cm do 0,5 ml
English: No effects on embryo-foetal development were observed when talimogene laherparepvec was administered during organogenesis to pregnant mice at doses up to 4 x 108 (400 million) PFU/kg (60-fold higher, on a PFU/kg basis, compared to the maximum clinical dose).
Slovenian: Po uporabi talimogena laherparepveka pri brejih miših v obdobju organogeneze v odmerkih do 4 x 108 (400 milijonov) PFU/kg (to je na podlagi PFU/kg 60-krat več od največjega kliničnega odmerka) niso ugotovili učinkov na embriofetalni razvoj.
English: Necrosis or ulceration of tumour tissue may occur following Imlygic treatment.
Slovenian: Po zdravljenju z zdravilom Imlygic se lahko pojavita nekroza ali ulceracija tumorskega tkiva.
English: Life-threatening herpes infection may occur in patients with weakened immune systems.
Slovenian: Bolnikom z oslabelim imunskim sistemom se lahko pojavi smrtno nevarna okužba s herpesom.
English: > 1.5 cm to 2.5 cm up to 1 mL
Slovenian: > 1,5 cm do 2,5 cm do 1 ml
English: How Imlygic is given
Slovenian: Kako se daje zdravilo Imlygic
English: 2 weeks after previous treatment
Slovenian: 2 tedna po predhodnem zdravljenju do 4 ml
English: • Compressed airways (obstructive airways disorder)
Slovenian: • stisnjenje dihalnih poti (obstruktivna bolezen dihalnih poti),
English: Maximum cumulative storage time (storage time in vial plus storage time in syringe) for thawed Imlygic
Slovenian: Preglednica 8: Najdaljši kumulativni čas shranjevanja (čas shranjevanja v viali in čas shranjevanja v injekcijski brizgi) za odtajano zdravilo Imlygic
English: Accidental needle stick and splash-back have been reported in healthcare professionals during preparation and administration of Imlygic.
Slovenian: Med pripravo in dajanjem zdravila Imlygic so pri zdravstvenih delavcih poročali o nenamernih vbodih z iglo in o izbrizganju zdravila iz mesta vboda.
English: • Cough
Slovenian: • kašelj,
English: In clinical studies, immune-mediated events including as glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with Imlygic.
Slovenian: V kliničnih študijah so pri bolnikih, zdravljenih z zdravilom Imlygic, poročali o imunsko pogojenih učinkih, vključno z glomerulonefritisom, vaskulitisom, pnevmonitisom, poslabšanjem psoriaze in vitiligom.
English: Metabolism and nutrition disorders Common
Slovenian: Presnovne in prehranske motnje Pogosti dehidracija
English: Imlygic 106 plaque forming units (PFU)/mL solution for injection Imlygic 108 plaque forming units (PFU)/mL solution for injection
Slovenian: Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje
English: The risks and benefits of Imlygic should be considered before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immunemediated events.
Slovenian: Pred uvedbo zdravljenja bolnikom, ki imajo osnovno avtoimunsko bolezen, in pred nadaljevanjem zdravljenja bolnikov, ki se jim pojavijo imunsko pogojeni učinki, je treba razmisliti o tveganjih in koristih zdravila Imlygic.
English: • Inject largest lesion(s) first.
Slovenian: • Najprej injicirajte v največjo spremembo/največje spremembe.
English: 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been conducted with Imlygic.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Imlygic injection volume
Slovenian: Količina zdravila Imlygic za injiciranje
English: 6.4 Special precautions for storage Store and transport frozen (-90°C to -70°C).
Slovenian: Shranjujte in prevažajte zamrznjeno (-90 °C do -70 °C).
English: Hepatic and renal impairment
Slovenian: Okvara jeter in ledvic
English: What Imlygic contains
Slovenian: Kaj vsebuje zdravilo Imlygic
English: Imlygic is a clear to semi-translucent (106 PFU/mL) or semi-translucent to opaque (108 PFU/mL) liquid.
Slovenian: Zdravilo Imlygic je bistra do polprosojna (106 PFU/ml) ali polprosojna do motna (108 PFU/ml) tekočina.
English: Patients with detectable DNA during treatment
Slovenian: Preglednica 6: Bolniki z zaznavno DNA med zdravljenjem Telesna tekočina/mesto
English: Determining Imlygic dose volume (per lesion)
Slovenian: Določitev količine odmerka zdravila Imlygic (za posamezno spremembo)
English: • Treat all Imlygic spills with a virucidal agent and absorbent materials.
Slovenian: • V primeru razlitja zdravila Imlygic uporabite virucidno sredstvo in vpojne materiale.
English: Post-injection
Slovenian: Po injiciranju
English: • The patient alert card shall contain the following key messages: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using IMLYGIC o Contact details of the IMLYGIC prescriber o Details about IMLYGIC treatment start date, batch number, date administered, product manufacturer and license holder o Information of herpetic lesions
Slovenian: • Opozorilna kartica za bolnika mora vsebovati sledeča ključna sporočila: o Opozorilo za zdravstvene delavce, ki kadar koli zdravijo bolnika, vključno z urgentnimi primeri, da bolnik uporablja zdravilo IMLYGIC.
English: Suspected herpetic lesion samples were collected any time a patient experienced lesions of suspected herpetic origin.
Slovenian: Ob pojavu suma na herpetične spremembe pri bolniku so vedno odvzeli vzorce sprememb, pri katerih je obstajal sum na herpetični izvor.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mL of 1 x 106 (1 million) plaque forming units (PFU) of talimogene laherparepvec.
Slovenian: Ena viala vsebuje 1 ml 1 x 106 (1 milijon) plakotvornih enot (PFU) talimogena laherparepveka.
English: Immune-mediated events
Slovenian: Imunsko pogojeni učinki
English: Recommended dosing schedule for Imlygic
Slovenian: Preglednica 1: Priporočeni razpored odmerjanja zdravila Imlygic
English: Cardiac disorders Common
Slovenian: Srčne bolezni Pogosti tahikardija
English: Subsequent doses should be administered up to 4 mL of Imlygic at a concentration of 108 (100 million) PFU/mL.
Slovenian: Za nadaljnje odmerke je treba uporabiti do 4 ml zdravila Imlygic s koncentracijo 108 (100 milijonov) PFU/ml.
English: Imlygic 106 plaque forming units (PFU)/mL solution for injection Clear to semi-translucent liquid following thaw from its frozen state.
Slovenian: Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje Po odtajanju iz zamrznjenega stanja je to bistra do polprosojna tekočina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mL of 1 x 108 (100 million) plaque forming units (PFU) of talimogene laherparepvec.
Slovenian: Ena viala vsebuje 1 ml 1 x 108 (100 milijon) plakotvornih enot (PFU) talimogena laherparepveka.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1064/002
Slovenian: EU/1/15/1064/001 EU/1/15/1064/002
English: The risks and benefits of treatment should be considered before administering Imlygic to these patients.
Slovenian: Pred uporabo zdravila Imlygic pri takšnih bolnikih je treba razmisliti o tveganjih in koristih zdravljenja.
English: No clinical studies have been conducted to evaluate the effect of hepatic or renal impairment on the pharmacokinetics of talimogene laherparepvec.
Slovenian: Kliničnih študij za ovrednotenje vpliva okvare jeter ali ledvic na farmakokinetiko talimogena laherparepveka niso izvedli, vendar bolnikom z okvaro jeter ali ledvic odmerka ni treba prilagoditi.
English: Patients who were HSV-1 seronegative at baseline were reported to have a greater incidence of pyrexia, chills, and influenza-like illness compared with those who were HSV-1 seropositive at baseline, especially within the period of the first 6 treatments (see section 4.8).
Slovenian: Poročali so, da so imeli izhodiščno HSV-1 seronegativni bolniki večjo incidenco zvišane telesne temperature, mrzlice in gripi podobne bolezni kot bolniki, ki so bili izhodiščno HSV-1 seropozitivni.
English: Posology
Slovenian: Opis
English: Plasmacytoma
Slovenian: Plazmacitom
English: Very commonly, flu-like illnesses, fevers and chills have been seen in patients treated with Imlygic.
Slovenian: Zelo pogosto so pri bolnikih, zdravljenih z zdravilom Imlygic, opažali gripi podobne bolezni, zvišano telesno temperaturo in mrzlico.
English: The risks and benefits of Imlygic should be considered before continuing treatment if persistent infection or delayed healing develops.
Slovenian: Če se pojavi trdovratna okužba ali zakasnjeno celjenje, je pred nadaljevanjem zdravljenja treba razmisliti o tveganjih in koristih zdravila Imlygic.
English: Di-sodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
Slovenian: 6.1 Seznam pomožnih snovi natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat natrijev klorid mioinozitol sorbitol (E420) voda za injekcije
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Imlygic 108 PFU/mL injection talimogene laherparepvec
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Imlygic 108 PFU/ml injekcija talimogen laherparepvek intralezijska uporaba
English: Package leaflet: Information for the patient Imlygic 106 plaque forming units (PFU)/mL solution for injection Imlygic 108 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Slovenian: Navodilo za uporabo Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje talimogen laherparepvek
English: Median 2.8 months (Range: 1.2 to > 14.9 months)
Slovenian: Mediana 2,8 meseca (Razpon: od 1,2 do > 14,9 mesecev) HR: 0,46; (95 % IZ: 0,35, 0,60)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Imlygic 106 PFU/mL injection talimogene laherparepvec
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Imlygic 106 PFU/ml injekcija talimogen laherparepvek intralezijska uporaba
English: • The Patient/carer and close contacts guide shall contain the following key messages: o A description of the important risks associated with the use of IMLYGIC; o Instruction on how to behave after administration and how and how often the dressing has to be changed and who should not change the dressing.
Slovenian: • Vodnik za bolnika/skrbnika in osebe, ki so v tesnem stiku z bolnikom mora vsebovati sledeča ključna sporočila: o Opis pomembnih tveganj, povezanih z uporabo zdravila IMLYGIC.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: Very common Vomiting, Diarrhoea, Constipation, Nausea Common
Slovenian: Bolezni prebavil Zelo pogosti bruhanje, driska, zaprtost, navzea
English: The risks and benefits of Imlygic treatment should be considered before administering acyclovir or other anti-viral agents indicated for management of herpetic infection.
Slovenian: Pred uporabo aciklovirja ali drugih protivirusnih zdravil, indiciranih za obvladovanje herpetičnih okužb, je treba razmisliti o tveganjih in koristih zdravljenja z zdravilom Imlygic.
English: 106 (1 million) PFU/mL 108 (100 million) PFU/mL
Slovenian: 108 (100 milijonov) PFU/ml
English: Imlygic 108 plaque forming units (PFU)/mL solution for injection Semi-translucent to opaque liquid following thaw from its frozen state.
Slovenian: Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje Po odtajanju iz zamrznjenega stanja je to polprosojna do motna tekočina.
English: Patients may experience increase in size of existing lesion(s) or the appearance of a new lesion prior to achieving a response.
Slovenian: Preden bolniki dosežejo odziv, se jim lahko obstoječe spremembe povečajo, ali se jim pojavijo nove spremembe.
English: Infection and delayed healing at Imlygic injection site
Slovenian: Okužba in zakasnjeno celjenje na mestu injiciranja zdravila Imlygic Zdravilo Imlygic lahko povzroči okužbo na mestu injiciranja.
English: Consider the risks and benefits of Imlygic treatment before administering acyclovir or other anti-viral agents indicated for management of herpetic infection.
Slovenian: Pred uporabo aciklovirja ali drugih protivirusnih zdravil, indiciranih za obvladovanje herpetičnih okužb, razmislite o tveganjih in koristih zdravljenja z zdravilom Imlygic.
English: o Recommendation regarding the accidental transmission of IMLYGIC from patient to close contacts or HCPs: o Instruction on how to behave after administration/accidental transmission and how and how often the dressing has to be changed and who should not change the dressing; o Instructions to minimise the risk of exposure of blood and body fluids to close contacts for the duration of IMLYGIC treatment through 30 days after the last administration of IMLYGIC.
Slovenian: o Navodila za osebe, ki so v tesnem stiku z bolnikom glede zmanjšanja tveganja za izpostavljenost krvi in telesnim tekočinam bolnika, za čas trajanja zdravljenja z zdravilom IMLYGIC in še 30 dni po zadnjem dajanju zdravila IMLYGIC.
English: • Vomiting, diarrhoea, constipation, nausea
Slovenian: • bruhanje, driska, zaprtost, siljenje na bruhanje,
English: General disorders and administration site conditions Very common Influenza like illness*, Pyrexia, Chills, Fatigue, Pain, Injection site reactions§
Slovenian: Pogosti bolečine v hrbtu, bolečine v dimljah Splošne težave in spremembe na mestu aplikacije Zelo pogosti gripi podobna bolezen*, zvišana telesna temperatura, mrzlica, utrujenost, bolečina, reakcije na mestu injiciranja§
English: Incision site infection
Slovenian: Občasni okužba na mestu vboda
English: The initial recommended dose is up to a maximum of 4 mL of Imlygic at a concentration of 106 (1 million) PFU/mL.
Slovenian: Celotna injicirana količina na vsakem terapevtskem obisku sme znašati največ 4 ml. Priporočeni začetni odmerek je do največ 4 ml zdravila Imlygic v koncentraciji 106 (1 milijon) PFU/ml.
English: NAME OF THE MEDICINAL PRODUCT Imlygic 106 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Slovenian: Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje talimogen laherparepvek
English: There were no impacts to male or female reproductive tissues following treatment of adult mice at doses up to 4 x 108 PFU/kg (60-fold higher, on a PFU/kg basis, compared to the maximum clinical dose).
Slovenian: Po uporabi odmerkov do 4 x 108 PFU/kg (to je na podlagi PFU/kg 60-krat več od največjega kliničnega odmerka) pri odraslih miših niso ugotovili vpliva na reproduktivna tkiva samcev ali samic.
English: Abdominal pain, Abdominal discomfort Skin and subcutaneous tissue disorders Common
Slovenian: Pogosti bolečine v trebuhu, nelagodje v trebuhu Bolezni kože in podkožja Pogosti vitiligo, izpuščaj, dermatitis
English: NAME OF THE MEDICINAL PRODUCT Imlygic 108 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Slovenian: Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje talimogen laherparepvek
English: The risks and benefits of Imlygic should be considered in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
Slovenian: Pri bolnikih z diseminiranim plazmacitomom in bolnikih, ki se jim plazmacitom pojavi med zdravljenjem, je treba razmisliti o tveganjih in koristih zdravila Imlygic.
English: • Headache
Slovenian: • glavobol,
English: Injection administration for subcutaneous lesions
Slovenian: Injiciranje v podkožne spremembe
English: Impaired healing at the injection site
Slovenian: Slabše celjenje na mestu injiciranja
English: Immune-mediated events†*
Slovenian: Bolezni imunskega sistema Pogosti imunsko pogojeni učinki†*
English: Disposal
Slovenian: Odlaganje
English: Subcutaneous lesions
Slovenian: Podkožne spremembe
English: • Weight loss
Slovenian: • hujšanje,
English: Median 18.9 (95% CI: 16.0, 23.7) months
Slovenian: 16,0, 23,7) mesecev
English: Injection administration for cutaneous lesions
Slovenian: Injiciranje v kožne spremembe
English: Talk to your healthcare professional before being given Imlygic.
Slovenian: Preden začnete dobivati zdravilo Imlygic, se posvetujte z zdravstvenim delavcem.
English: Anaemia
Slovenian: Dojenje
English: Keratitis herpetic Ear and labyrinth disorders Common
Slovenian: Očesne bolezni Občasni herpetični keratitis
English: *Monensin 32.4 g (equivalent to 35.2 g monensin sodium).
Slovenian: *monenzin 32,4 g (kar ustreza 35,2 g monenzin natrija).
English: Invented name
Slovenian: Izmišljen o ime
English: EU Number
Slovenian: Številka postopka EU
English: Withdrawal period intraruminal device
Slovenian: Karenca intrarumi nalni sistem intrarumi nalni sistemi intrarumi nalnih sistemov
English: Packaging Content
Slovenian: Pot uporabe Ovojnina Vsebina Velikost pakiranj a
English: Ref.: EMEA/442332/2009 EMEA/H/C/552
Slovenian: EMEA/442330/2009 EMEA/H/C/552
English: This summary was last updated in 08-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 08-2009.
English: If the treatment is effective, it should then be evaluated at least every three months.
Slovenian: Če je zdravljenje učinkovito, bi ga morali nato ocenjevati vsaj vsake tri mesece.
English: The marketing authorisation holder is Eli Lilly Nederland BV.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba Eli Lilly Nederland BV.
English: Ariclaim duloxetine
Slovenian: Ariclaim duloksetin
English: The response to treatment should be assessed two months after starting treatment.
Slovenian: Odziv na zdravljenje je treba oceniti dva meseca po začetku zdravljenja.
English: It is available as gastroresistant capsules (white and blue: 30 mg; green and blue: 60 mg).
Slovenian: Na voljo je v obliki gastrorezistentnih kapsul (belih in modrih: 30 mg; zelenih in modrih: 60 mg).
English: The marketing authorisation was renewed on 11 August 2009.
Slovenian: Dovoljenje za promet je bilo podaljšano dne 11. avgusta 2009.
English: Other information about Ariclaim:
Slovenian: Druge informacije o zdravilu Ariclaim:
English: Ariclaim can be taken with or without food.
Slovenian: Zdravilo Ariclaim se lahko jemlje s hrano ali brez nje.
English: The main measure of effectiveness was the change in the severity of pain each week, as recorded by the patients on an 11-point scale in daily diaries.
Slovenian: Glavno merilo učinkovitosti je bila sprememba jakosti bolečine vsak teden, kot so jo vsakodnevno v svojih dnevnikih zabeležili bolniki s pomočjo 11-točkovne lestvice.
English: The recommended dose of Ariclaim is 60 mg once a day, but some patients may need a higher dose of 120 mg per day.
Slovenian: Priporočeni odmerek zdravila Ariclaim znaša 60 mg enkrat na dan, vendar bodo morda nekateri bolniki potrebovali večji odmerek v višini 120 mg na dan.
English: Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued.
Slovenian: Večina teh učinkov je bila blagih ali zmernih, pojavili pa so se v zgodnjem obdobju zdravljenja in z nadaljevanjem zdravljenja postajali čedalje blažji.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Slovenian: „Gastrorezistentne“ pomeni, da vsebina kapsul potuje skozi želodec, ne da bi se v njem razgradila, dokler ne doseže črevesja.
English: In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Ariclaim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
Slovenian: V obeh študijah je bilo zmanjšanje bolečine opaziti od prvega tedna zdravljenja do 12 tednov, pri čemer so imeli bolniki, ki so jemali zdravilo Ariclaim, za od 1,17 do 1,45 točke nižje rezultate pri ocenjevanju bolečine kot tisti, ki so jemali placebo.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Slovenian: Živčni prenašalci so kemične snovi, ki omogočajo medsebojno sporazumevanje živčnih celic.
English: Treatment must not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Slovenian: Zdravljenje se ne sme uvesti pri bolnikih z nenadzorovanim visokim tlakom zaradi tveganja za hipertenzivno krizo (nenadno nevarno povišanje krvnega tlaka).
English: Ariclaim was originally also authorised at strengths of 20 and 40 mg for the treatment of moderate to severe stress urinary incontinence (SUI) in women, but the company withdrew these strengths when the marketing authorisation was renewed in August 2009.
Slovenian: Zdravilo Ariclaim je bilo prvotno odobreno tudi v jakostih 20 in 40 mg za zdravljenje zmerne do hude stresne urinske inkontinence (SUI) pri ženskah, toda družba je te jakosti ob podaljšanju dovoljenja avgusta 2009 umaknila.
English: Three different doses of Ariclaim were compared with placebo.
Slovenian: Tri različne odmerke zdravila Ariclaim so primerjali s placebom.
English: Ariclaim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Slovenian: Zdravilo Ariclaim so proučevali v dveh 12-tedenskih študijah pri 809 bolnikih s sladkorno boleznijo, ki so imeli vsakodnevne bolečine najmanj šest mesecev.
English: The Committee recommended that Ariclaim be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Ariclaim odobri dovoljenje za promet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ariclaim on 11 August 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ariclaim, veljavno po vsej Evropski uniji, odobrila dne 11. avgusta 2004.
English: The most common side effects with Ariclaim (seen in more than 1 patient 10) are headache, somnolence (sleepiness), dizziness, nausea and dry mouth.
Slovenian: Najpogostejši neželeni učinki zdravila Ariclaim (opaženi pri več kot 1 bolniku od 10) so glavobol, somnolenca (zaspanost), omotica, slabost in suha usta.