natgillin/translations-raw huggingface dataset:
Subsequent doses will be up to 4 mL of Imlygic at a concentration of 108 (100 million) PFU/mL.
Nadaljnji odmerki bodo do 4 ml zdravila Imlygic s koncentracijo 108 (100 milijonov) PFU/ml.
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).
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.
Necrosis or ulceration of tumour tissue may occur following Imlygic treatment.
Po zdravljenju z zdravilom Imlygic se lahko pojavita nekroza ali ulceracija tumorskega tkiva.
Life-threatening herpes infection may occur in patients with weakened immune systems.
Bolnikom z oslabelim imunskim sistemom se lahko pojavi smrtno nevarna okužba s herpesom.
How Imlygic is given
Kako se daje zdravilo Imlygic
2 weeks after previous treatment
2 tedna po predhodnem zdravljenju do 4 ml
• Compressed airways (obstructive airways disorder)
• stisnjenje dihalnih poti (obstruktivna bolezen dihalnih poti),
Maximum cumulative storage time (storage time in vial plus storage time in syringe) for thawed Imlygic
Preglednica 8: Najdaljši kumulativni čas shranjevanja (čas shranjevanja v viali in čas shranjevanja v injekcijski brizgi) za odtajano zdravilo Imlygic
Accidental needle stick and splash-back have been reported in healthcare professionals during preparation and administration of Imlygic.
Med pripravo in dajanjem zdravila Imlygic so pri zdravstvenih delavcih poročali o nenamernih vbodih z iglo in o izbrizganju zdravila iz mesta vboda.
• Cough
• kašelj,
In clinical studies, immune-mediated events including as glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with Imlygic.
V kliničnih študijah so pri bolnikih, zdravljenih z zdravilom Imlygic, poročali o imunsko pogojenih učinkih, vključno z glomerulonefritisom, vaskulitisom, pnevmonitisom, poslabšanjem psoriaze in vitiligom.
Metabolism and nutrition disorders Common
Presnovne in prehranske motnje Pogosti dehidracija
Imlygic 106 plaque forming units (PFU)/mL solution for injection Imlygic 108 plaque forming units (PFU)/mL solution for injection
Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje
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.
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.
• Inject largest lesion(s) first.
• Najprej injicirajte v največjo spremembo/največje spremembe.
4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been conducted with Imlygic.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Imlygic injection volume
Količina zdravila Imlygic za injiciranje
6.4 Special precautions for storage Store and transport frozen (-90°C to -70°C).
Shranjujte in prevažajte zamrznjeno (-90 °C do -70 °C).
Hepatic and renal impairment
Okvara jeter in ledvic
What Imlygic contains
Kaj vsebuje zdravilo Imlygic
Imlygic is a clear to semi-translucent (106 PFU/mL) or semi-translucent to opaque (108 PFU/mL) liquid.
Zdravilo Imlygic je bistra do polprosojna (106 PFU/ml) ali polprosojna do motna (108 PFU/ml) tekočina.
Patients with detectable DNA during treatment
Preglednica 6: Bolniki z zaznavno DNA med zdravljenjem Telesna tekočina/mesto
Determining Imlygic dose volume (per lesion)
Določitev količine odmerka zdravila Imlygic (za posamezno spremembo)
• Treat all Imlygic spills with a virucidal agent and absorbent materials.
• V primeru razlitja zdravila Imlygic uporabite virucidno sredstvo in vpojne materiale.
Post-injection
Po injiciranju
• 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
• 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.
Suspected herpetic lesion samples were collected any time a patient experienced lesions of suspected herpetic origin.
Ob pojavu suma na herpetične spremembe pri bolniku so vedno odvzeli vzorce sprememb, pri katerih je obstajal sum na herpetični izvor.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mL of 1 x 106 (1 million) plaque forming units (PFU) of talimogene laherparepvec.
Ena viala vsebuje 1 ml 1 x 106 (1 milijon) plakotvornih enot (PFU) talimogena laherparepveka.
Immune-mediated events
Imunsko pogojeni učinki
Recommended dosing schedule for Imlygic
Preglednica 1: Priporočeni razpored odmerjanja zdravila Imlygic
Cardiac disorders Common
Srčne bolezni Pogosti tahikardija
Subsequent doses should be administered up to 4 mL of Imlygic at a concentration of 108 (100 million) PFU/mL.
Za nadaljnje odmerke je treba uporabiti do 4 ml zdravila Imlygic s koncentracijo 108 (100 milijonov) PFU/ml.
Imlygic 106 plaque forming units (PFU)/mL solution for injection Clear to semi-translucent liquid following thaw from its frozen state.
Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje Po odtajanju iz zamrznjenega stanja je to bistra do polprosojna tekočina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mL of 1 x 108 (100 million) plaque forming units (PFU) of talimogene laherparepvec.
Ena viala vsebuje 1 ml 1 x 108 (100 milijon) plakotvornih enot (PFU) talimogena laherparepveka.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1064/002
EU/1/15/1064/001 EU/1/15/1064/002
The risks and benefits of treatment should be considered before administering Imlygic to these patients.
Pred uporabo zdravila Imlygic pri takšnih bolnikih je treba razmisliti o tveganjih in koristih zdravljenja.
No clinical studies have been conducted to evaluate the effect of hepatic or renal impairment on the pharmacokinetics of talimogene laherparepvec.
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.
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).
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.
Plasmacytoma
Plazmacitom
Very commonly, flu-like illnesses, fevers and chills have been seen in patients treated with Imlygic.
Zelo pogosto so pri bolnikih, zdravljenih z zdravilom Imlygic, opažali gripi podobne bolezni, zvišano telesno temperaturo in mrzlico.
The risks and benefits of Imlygic should be considered before continuing treatment if persistent infection or delayed healing develops.
Če se pojavi trdovratna okužba ali zakasnjeno celjenje, je pred nadaljevanjem zdravljenja treba razmisliti o tveganjih in koristih zdravila Imlygic.
Di-sodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
6.1 Seznam pomožnih snovi natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat natrijev klorid mioinozitol sorbitol (E420) voda za injekcije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Imlygic 108 PFU/mL injection talimogene laherparepvec
IME ZDRAVILA IN POT(I) UPORABE Imlygic 108 PFU/ml injekcija talimogen laherparepvek intralezijska uporaba
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
Navodilo za uporabo Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje talimogen laherparepvek
Median 2.8 months (Range: 1.2 to > 14.9 months)
Mediana 2,8 meseca (Razpon: od 1,2 do > 14,9 mesecev) HR: 0,46; (95 % IZ: 0,35, 0,60)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Imlygic 106 PFU/mL injection talimogene laherparepvec
IME ZDRAVILA IN POT(I) UPORABE Imlygic 106 PFU/ml injekcija talimogen laherparepvek intralezijska uporaba
• 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.
• 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.
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
Very common Vomiting, Diarrhoea, Constipation, Nausea Common
Bolezni prebavil Zelo pogosti bruhanje, driska, zaprtost, navzea
The risks and benefits of Imlygic treatment should be considered before administering acyclovir or other anti-viral agents indicated for management of herpetic infection.
Pred uporabo aciklovirja ali drugih protivirusnih zdravil, indiciranih za obvladovanje herpetičnih okužb, je treba razmisliti o tveganjih in koristih zdravljenja z zdravilom Imlygic.
106 (1 million) PFU/mL 108 (100 million) PFU/mL
108 (100 milijonov) PFU/ml
Imlygic 108 plaque forming units (PFU)/mL solution for injection Semi-translucent to opaque liquid following thaw from its frozen state.
Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje Po odtajanju iz zamrznjenega stanja je to polprosojna do motna tekočina.
Patients may experience increase in size of existing lesion(s) or the appearance of a new lesion prior to achieving a response.
Preden bolniki dosežejo odziv, se jim lahko obstoječe spremembe povečajo, ali se jim pojavijo nove spremembe.
Infection and delayed healing at Imlygic injection site
Okužba in zakasnjeno celjenje na mestu injiciranja zdravila Imlygic Zdravilo Imlygic lahko povzroči okužbo na mestu injiciranja.
Consider the risks and benefits of Imlygic treatment before administering acyclovir or other anti-viral agents indicated for management of herpetic infection.
Pred uporabo aciklovirja ali drugih protivirusnih zdravil, indiciranih za obvladovanje herpetičnih okužb, razmislite o tveganjih in koristih zdravljenja z zdravilom Imlygic.
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.
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.
• Vomiting, diarrhoea, constipation, nausea
• bruhanje, driska, zaprtost, siljenje na bruhanje,
General disorders and administration site conditions Very common Influenza like illness*, Pyrexia, Chills, Fatigue, Pain, Injection site reactions§
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§
Incision site infection
Občasni okužba na mestu vboda
The initial recommended dose is up to a maximum of 4 mL of Imlygic at a concentration of 106 (1 million) PFU/mL.
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.
NAME OF THE MEDICINAL PRODUCT Imlygic 106 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Imlygic 106 plakotvornih enot (PFU)/ml raztopina za injiciranje talimogen laherparepvek
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).
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.
Abdominal pain, Abdominal discomfort Skin and subcutaneous tissue disorders Common
Pogosti bolečine v trebuhu, nelagodje v trebuhu Bolezni kože in podkožja Pogosti vitiligo, izpuščaj, dermatitis
NAME OF THE MEDICINAL PRODUCT Imlygic 108 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Imlygic 108 plakotvornih enot (PFU)/ml raztopina za injiciranje talimogen laherparepvek
The risks and benefits of Imlygic should be considered in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
Pri bolnikih z diseminiranim plazmacitomom in bolnikih, ki se jim plazmacitom pojavi med zdravljenjem, je treba razmisliti o tveganjih in koristih zdravila Imlygic.
• Headache
• glavobol,
Injection administration for subcutaneous lesions
Injiciranje v podkožne spremembe
Impaired healing at the injection site
Slabše celjenje na mestu injiciranja
Immune-mediated events†*
Bolezni imunskega sistema Pogosti imunsko pogojeni učinki†*
Subcutaneous lesions
Podkožne spremembe
• Weight loss
• hujšanje,
Median 18.9 (95% CI: 16.0, 23.7) months
16,0, 23,7) mesecev
Injection administration for cutaneous lesions
Injiciranje v kožne spremembe
Talk to your healthcare professional before being given Imlygic.
Preden začnete dobivati zdravilo Imlygic, se posvetujte z zdravstvenim delavcem.
Anaemia
Dojenje
Keratitis herpetic Ear and labyrinth disorders Common
Očesne bolezni Občasni herpetični keratitis
*Monensin 32.4 g (equivalent to 35.2 g monensin sodium).
*monenzin 32,4 g (kar ustreza 35,2 g monenzin natrija).
EU Number
Številka postopka EU
Withdrawal period intraruminal device
Karenca intrarumi nalni sistem intrarumi nalni sistemi intrarumi nalnih sistemov
Packaging Content
Pot uporabe Ovojnina Vsebina Velikost pakiranj a
Ref.: EMEA/442332/2009 EMEA/H/C/552
EMEA/442330/2009 EMEA/H/C/552
This summary was last updated in 08-2009.
Povzetek je bil nazadnje posodobljen 08-2009.
If the treatment is effective, it should then be evaluated at least every three months.
Če je zdravljenje učinkovito, bi ga morali nato ocenjevati vsaj vsake tri mesece.
The marketing authorisation holder is Eli Lilly Nederland BV.
Imetnik dovoljenja za promet z zdravilom je družba Eli Lilly Nederland BV.
Ariclaim duloxetine
Ariclaim duloksetin
The response to treatment should be assessed two months after starting treatment.
Odziv na zdravljenje je treba oceniti dva meseca po začetku zdravljenja.
It is available as gastroresistant capsules (white and blue: 30 mg; green and blue: 60 mg).
Na voljo je v obliki gastrorezistentnih kapsul (belih in modrih: 30 mg; zelenih in modrih: 60 mg).
The marketing authorisation was renewed on 11 August 2009.
Dovoljenje za promet je bilo podaljšano dne 11. avgusta 2009.
Other information about Ariclaim:
Druge informacije o zdravilu Ariclaim:
Ariclaim can be taken with or without food.
Zdravilo Ariclaim se lahko jemlje s hrano ali brez nje.
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.
Glavno merilo učinkovitosti je bila sprememba jakosti bolečine vsak teden, kot so jo vsakodnevno v svojih dnevnikih zabeležili bolniki s pomočjo 11-točkovne lestvice.
The recommended dose of Ariclaim is 60 mg once a day, but some patients may need a higher dose of 120 mg per day.
Priporočeni odmerek zdravila Ariclaim znaša 60 mg enkrat na dan, vendar bodo morda nekateri bolniki potrebovali večji odmerek v višini 120 mg na dan.
Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued.
Večina teh učinkov je bila blagih ali zmernih, pojavili pa so se v zgodnjem obdobju zdravljenja in z nadaljevanjem zdravljenja postajali čedalje blažji.
‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
„Gastrorezistentne“ pomeni, da vsebina kapsul potuje skozi želodec, ne da bi se v njem razgradila, dokler ne doseže črevesja.
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.
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.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Živčni prenašalci so kemične snovi, ki omogočajo medsebojno sporazumevanje živčnih celic.
Treatment must not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Zdravljenje se ne sme uvesti pri bolnikih z nenadzorovanim visokim tlakom zaradi tveganja za hipertenzivno krizo (nenadno nevarno povišanje krvnega tlaka).
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.
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.
Three different doses of Ariclaim were compared with placebo.
Tri različne odmerke zdravila Ariclaim so primerjali s placebom.
Ariclaim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Zdravilo Ariclaim so proučevali v dveh 12-tedenskih študijah pri 809 bolnikih s sladkorno boleznijo, ki so imeli vsakodnevne bolečine najmanj šest mesecev.
The Committee recommended that Ariclaim be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ariclaim odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Ariclaim on 11 August 2004.
Evropska komisija je dovoljenje za promet z zdravilom Ariclaim, veljavno po vsej Evropski uniji, odobrila dne 11. avgusta 2004.
The most common side effects with Ariclaim (seen in more than 1 patient 10) are headache, somnolence (sleepiness), dizziness, nausea and dry mouth.
Najpogostejši neželeni učinki zdravila Ariclaim (opaženi pri več kot 1 bolniku od 10) so glavobol, somnolenca (zaspanost), omotica, slabost in suha usta.
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Duloksetin z zaviranjem njihovega prevzemanja poveča količino teh živčnih prenašalcev v prostorih med temi živčnimi celicami in s tem stopnjo sporazumevanja med celicami.
What benefit has Ariclaim shown during the studies?
Kakšne koristi je zdravilo Ariclaim izkazalo med študijami?
The dose should be reduced gradually when stopping treatment.
Ob prenehanju zdravljenja je treba odmerek zmanjševati postopoma.
Ariclaim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Zdravilo Ariclaim je bilo v odmerku 60 mg enkrat ali dvakrat dnevno pri zmanjševanju bolečine učinkovitejše od placeba.
Ariclaim is a medicine that contains the active substance duloxetine.
Ariclaim je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
Since these neurotransmitters are involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may improve the symptoms of neuropathic pain.
Ker ti živčni prenašalci sodelujejo pri zmanjševanju občutka bolečine, se z zaviranjem njihovega ponovnega prevzema v živčne celice izboljšajo tudi simptomi nevropatske bolečine.
It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Deluje tako, da preprečuje ponovno prevzemanje živčnih prenašalcev 5hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v živčne celice možganov in hrbtenjače.
The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim's benefits are greater than its risks for the treatment of diabetic peripheral neuropathic pain in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ariclaim pri zdravljenju bolečin pri diabetični periferni nevropatiji pri odraslih večje od z njim povezanih tveganj.
SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising.
Stresna urinska inkontinenca je nenamerno uhajanje urina med telesnim naporom, kašljanjem, smejanjem, kihanjem, dviganjem ali telesno vadbo.
What is the risk associated with Ariclaim?
Kakšna tveganja so povezana z zdravilom Ariclaim?
This prevents the active substance being destroyed by the acid in the stomach.
Tako se prepreči, da bi želodčna kislina uničila zdravilno učinkovino.
It must not be used together with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Zdravilo Ariclaim se ne sme uporabljati skupaj z zaviralci monoaminooksidaze (skupino zdravil proti depresiji), fluvoksaminom (drugim zdravilom proti depresiji), ciprofloksacinom ali enoksacinom (vrstama antibiotikov).
Ariclaim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Zdravila Ariclaim ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) duloksetin ali katero koli drugo sestavino zdravila.
Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Zdravilo Ariclaim se uporablja za zdravljenje bolečin zaradi diabetične periferne nevropatije (poškodb živcev v okončinah, ki se pojavljajo pri bolnikih s sladkorno boleznijo).
Ariclaim must not be used in patients with certain types of liver disease or with severe kidney disease.
Zdravila Ariclaim ne smejo uporabljati bolniki z določenimi vrstami obolenj jeter ali s hudim obolenjem ledvic.
Why has Ariclaim been approved?
Zakaj je bilo zdravilo Ariclaim odobreno?
The full EPAR for Ariclaim is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ariclaim je na voljo tukaj.
For the full list of all side effects reported with Ariclaim, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Ariclaim, glejte navodilo za uporabo.