natgillin/translations-raw huggingface dataset:
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Ne uporabite pri mačkah z obolenji prebavil, kot so zdraženost prebavil in krvavitve, oslabljeno delovanje jeter, srca ali ledvic ter hemoragične motnje.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Občasno so poročali o značilnih neželenih učinkih NSAID, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), apatija in odpoved ledvic.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Vsak ml vsebuje
People with known hypersensitivity to Non-Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila (NSAR) naj se izogibajo stiku z zdravilom za uporabo v veterinarski medicini.
Equidae
INDIKACIJAE
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
hours before commencement of treatment.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Target tissues
España Laboratorios Karizoo
Typical adverse drug reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil (NSAR), kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev),letargija in odpoved ledvic.
Should irritation occur and persist, seek medical advice.
Če draženje ne preneha, se posvetujte z zdravnikom.
Loxicom 1.5 mg/ml oral suspension for dogs.
Loxicom 1,5 mg/ml peroralna suspenzija za pse meloksikam2.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Ne uporabite pri psih z obolenji prebavil, kot so zdraženost prebavil in krvavitev, oslabljeno delovanje jeter, srca ali ledvic ter hemoragične motnje.
Shelf-life after first opening the immediate packaging: 28 days
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported.
Občasno so poročali o značilnih neželenih učinkih NSAR, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), letargija in odpoved ledvic.
Pale yellow solution
Bleda rumena raztopina.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml vsebuje:
Pack size
Pretisni omot
The syringe has an integrated adapter and has a kg/body weight graduation.
Brizga ima na batu odmerni obroč in merilno skalo z oznakami telesne mase v kilogramih.
Blisters
Kopitarji
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Ref.: EMA/758850/2009 EMEA/H/C/391
: EMA/5534/2010 EMEA/H/C/391
This can result in serious loss of vision and even blindness.
To lahko povzroči resno izgubo vida in celo slepoto.
The European Commission granted a marketing authorisation valid throughout the European Union for Lumigan to Allergan Pharmaceuticals Ireland on 8 March 2002.
Evropska komisija je dovoljenje za promet z zdravilom Lumigan, veljavno po vsej Evropski uniji, odobrila podjetju Allergan Pharmaceuticals Ireland dne 8. marca 2002.
Other information about Lumigan:
Druge informacije o zdravilu Lumigan:
In all of the studies, the main measure of effectiveness was the reduction in eye pressure.
V vseh študijah je bilo glavno merilo učinkovitosti znižanje očesnega tlaka.
Some of these patients carried on receiving the medicines for up to two or three years (379 and 183 patients, respectively).
Nekateri od teh bolnikov so zdravila prejemali do dveh (379 bolnikov) ali treh let (183 bolnikov).
Lumigan bimatoprost EPAR summary for the public
Lumigan bimatoprost Povzetek EPAR za javnost
The Committee for Medicinal Products for Human Use (CHMP) decided that Lumigan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Lumigan večje od z njim povezanih tveganj in je priporočil, da se za zdravilo odobri dovoljenje za promet.
This helps to reduce the pressure inside the eye and the risk of damage.
S tem zniža tlak v očesu in zmanjša nevarnost poškodb.
It is available in two strengths, 0.1 and 0.3 mg per millilitre.
Na voljo je v dveh jakostih, 0,1 mg in 0,3 mg na mililiter.
Therefore, care should be taken by people who wear soft contact lenses.
Zato morajo biti ljudje, ki uporabljajo mehke kontaktne leče, pri uporabi previdni.
What is the risk associated with Lumigan?
Kakšna tveganja so povezana z zdravilom Lumigan?
What benefit has Lumigan shown during the studies?
Kakšne koristi je zdravilo Lumigan izkazalo med študijami?
It is used in adults with long-term open angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal).
Uporablja se pri odraslih bolnikih z dolgotrajnim glavkomom odprtega zakotja (boleznijo, pri kateri se tlak v očesu zviša, ker tekočina ne more iztekati iz očesa) in pri odraslih bolnikih z okularno hipertenzijo (kadar je tlak v očesu višji od običajnega).
Lumigan should not be used in people who may be hypersensitive (allergic) to bimatoprost or any of the other ingredients.
Zdravila Lumigan ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) bimatoprost ali katero koli drugo sestavino zdravila.
Lumigan is used to reduce the pressure inside the eye.
Zdravilo Lumigan se uporablja za zniževanje tlaka v očesu.
Eye pressure is measured in ‘millimetres of mercury' (mmHg).
Očesni tlak se meri v milimetrih živega srebra (mmHg).
Because Lumigan 0.1 mg/ml contains higher levels of benzalkonium chloride than Lumigan 0.3 mg/ml, Lumigan 0.1 mg/ml must not be used in people who have had a reaction to a product containing benzalkonium chloride in the past, and had to stop using the product containing it as a result.
Ker zdravilo Lumigan 0,1 mg/ml vsebuje višje ravni benzalkonijevega klorida kot zdravilo Lumigan 0,3 mg/ml, zdravila Lumigan 0,1 mg/ml ne smejo uporabljati osebe, ki so imele v preteklosti reakcijo na izdelke z benzalkonijevim kloridom in so tak izdelek posledično morale prenehati uporabljati.
The full EPAR for Lumigan is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lumigan je na voljo tukaj.
The active substance in Lumigan, bimatoprost, is a prostaglandin analogue (a man-made copy of a natural substance, prostaglandin).
Zdravilna učinkovina zdravila Lumigan, bimatoprost, je prostaglandinski analog (umetno pripravljena kopija naravne snovi, prostaglandina).
The recommended dose of Lumigan is one drop in the affected eye(s) once a day in the evening.
Priporočeni odmerek je ena kapljica zdravila Lumigan v prizadeto oko/prizadeti očesi enkrat dnevno zvečer.
Lumigan acts in the same way and increases the flow of fluid out of the eye.
Zdravilo Lumigan deluje enako in poveča iztekanje tekočine iz očesa.
For the full list of all side effects reported with Lumigan, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lumigan, glejte navodilo za uporabo.
When the pressure inside the eye is raised, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Zvišan tlak znotraj očesa poškoduje mrežnico (membrano na zadnji strani zrkla, ki je občutljiva za svetlobo) in vidni živec, ki pošilja signale iz očesa v možgane.
Why has Lumigan been approved?
Zakaj je bilo zdravilo Lumigan odobreno?
In a patient with ocular hypertension or glaucoma, the value is generally higher than 21 mmHg.
Pri bolniku z okularno hipertenzijo ali glavkomom je očesni tlak običajno višji od 21 mmHg.
It has also been compared with latanoprost (another prostaglandin analogue used in glaucoma) in a six-month study involving 269 patients.
Zdravilo Lumigan so primerjali tudi z latanoprostom (drugim prostaglandinskim analogom, ki se uporablja za zdravljenje glavkoma) v šestmesečni študiji, ki je vključevala 269 bolnikov.
Lumigan has been studied in adults with glaucoma or ocular hypertension.
Zdravilo Lumigan so proučevali pri odraslih bolnikih z glavkomom ali okularno hipertenzijo.
The most common side effects with Lumigan (seen in more than 1 patient in 10) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness).
Najpogostejši neželeni učinek zdravila Lumigan (opažen pri več kot 1 bolniku od 10) je konjunktivna hiperemija (zvišan dotok krvi v oko, ki povzroči rdečino očesa).
However, the lower strength formulation was better tolerated and was less likely to cause hyperaemia (redness of the eye).
Vendar so bolniki šibkejšo obliko zdravila lažje prenašali, verjetnost pojava hiperemije (rdečine očesa) pri njem pa je bila manjša.
Lumigan contains benzalkonium chloride, which is known to discolour soft contact lenses.
Zdravilo Lumigan vsebuje benzalkonijev klorid, ki dokazano obarva mehke kontaktne leče.
Adding Lumigan 0.3 mg/ml to existing treatment with a beta-blocker was more effective than continuing to use the beta-blocker on its own.
Dodajanje zdravila Lumigan 0,3 mg/ml k obstoječemu zdravljenju z zaviralcem receptorjev beta je bilo učinkovitejše od nadaljnje samostojne rabe zaviralca receptorjev beta.
Lumigan can be used alone or with beta-blocker eye drops (other medicines used for these conditions).
Zdravilo Lumigan se lahko uporablja samostojno ali s kapljicami za oko, imenovanimi zaviralci receptorjev beta (drugimi zdravili za ti dve bolezni).
In the eye, prostaglandin increases the drainage of the watery fluid (aqueous humour) out of the eyeball.
Prostaglandin v očesu poveča odvajanje vodene tekočine (prekatne vodke) iz zrkla.
How has Lumigan been studied?
Kako je bilo zdravilo Lumigan raziskano?
What is Lumigan used for?
Za kaj se zdravilo Lumigan uporablja?
Lumigan 0.3 mg/ml was also more effective than latanoprost, with patients using Lumigan achieving a reduction in eye pressure of 6.0 to 8.2 mmHg after six months of treatment compared with 4.9 to 7.2 mmHg with latanoprost.
Zdravilo Lumigan 0,3 mg/ml je bilo učinkovitejše tudi od latanoprosta, saj se je očesni tlak pri bolnikih, ki so uporabljali zdravilo Lumigan, po 6 mesecih zdravljenja znižal od 6,0 do 8,2 mmHg, pri bolnikih, ki so uporabljali latanoprost, pa od 4,9 do 7,2 mmHg.
Lumigan 0.3 mg/ml used on its own has been compared with timolol (a beta-blocker used to treat glaucoma) in two 12-month studies involving a total of 1,198 patients.
Samostojno uporabo zdravila Lumigan 0,3 mg/ml so primerjali s timololom (zaviralcem receptorjev beta, ki se uporablja za zdravljenje glavkoma) v dveh študijah, v kateri je bilo skupaj vključenih 1 198 bolnikov in sta trajali 12 mesecev.
An additional 12-month study compared Lumigan 0.1 mg/ml with Lumigan 0.3 mg/ml, and with an intermediate strength of 0.125 mg/ml, in 561 patients.
V dodatni 12-mesečni študiji, v kateri je sodelovalo 561 bolnikov, so zdravilo Lumigan 0,1 mg/ml primerjali z zdravilom Lumigan 0,3 mg/ml ter z zdravilom s srednjo jakostjo 0,125 mg/ml.
Lumigan is a clear eye drop solution that contains the active substance bimatoprost.
Zdravilo Lumigan je bistra raztopina v obliki kapljic za oko, ki vsebuje zdravilno učinkovino bimatoprost.
Lumigan 0.3 mg/ml on its own was more effective than timolol at reducing eye pressure.
Zdravilo Lumigan 0,3 mg/ml je bilo kot samostojno zdravilo za zniževanje očesnega tlaka učinkovitejše od timolola.
This effect was maintained after two or three years of treatment, with an average reduction in eye pressure of between 7.1 and 8.6 mmHg with Lumigan used once a day, compared with 4.6 to 6.4 mmHg with timolol.
Pri uporabi zdravila Lumigan enkrat dnevno je bilo povprečno znižanje očesnega tlaka od 7,1 do 8,6 mmHg v primerjavi s 4,6 do 6,4 mmHg pri uporabi timolola.
In addition, the following side effects are also seen in more than 1 patient in 10 using Lumigan 0.3 mg/ml: growth of eyelashes and ocular pruritus (itchy eye).
Poleg tega sta bila pri več kot 1 bolniku od 10, ki so jemali zdravilo Lumigan 0,3 mg/ml, opažena še naslednja neželena učinka: rast trepalnic in srbenje očesa.
How does Lumigan work?
Kako zdravilo Lumigan deluje?
How is Lumigan used?
Kako se zdravilo Lumigan uporablja?
After three months, eye pressure was lowered by 7.4 mmHg in the group adding Lumigan, compared with 3.6 mmHg in the group adding placebo.
Po treh mesecih se je očesni tlak bolnikov, katerim so dodali zdravilo Lumigan, znižal za 7,4 mmHg, očesni tlak bolnikov, katerim so dodali placebo, pa za 3,6 mmHg.
Lumigan 0.1 mg/ml brought about slightly smaller decreases in IOP than Lumigan 0.3 mg/ml.
Zdravilo Lumigan 0,1 mg/ml je sicer znotrajočesni tlak znižalo manj kot zdravilo Lumigan 0,3 mg/ml.
Lumigan's effect when added to beta-blocker treatment has also been compared with that of latanoprost in another study in 437 patients.
V drugi študiji s 437 bolniki so primerjali učinek dodajanja zdravila Lumigan zdravljenju z zaviralcem receptorjev beta tudi z dodajanjem lanoprosta.
Lumigan was as effective as latanoprost when added to beta-blocker treatment, with reductions in eye pressure of 8.0 and 7.4 mmHg, respectively, after three months.
Dodajanje zdravila Lumigan zdravljenju z zaviralcem receptorjev beta (znižanje očesnega tlaka za 8,0 mmHg) je bilo po treh mesecih enako učinkovito kot dodatek latanoprosta (znižanje očesnega tlaka za 7,4 mmHg).
What is Lumigan?
Kaj je zdravilo Lumigan?
The effect of adding Lumigan 0.3 mg/ml to existing treatment with a beta-blocker eye drop has been compared with that of adding placebo (a dummy eye drop) in one study involving 285 patients.
V eni študiji z 285 bolniki so primerjali učinkovitost dodatka zdravila Lumigan 0,3 mg/ml obstoječemu zdravljenju z zaviralcem receptorjev beta v obliki kapljic za oko in dodatka placeba (zdravila brez zdravilne učinkovine).
More information is available below.
Več informacij je na voljo v nadaljevanju.
The review of retinoid medicines was initiated on 8 July 2016 at the request of the United Kingdom, under Article 31 of Directive 2001/83/EC.
Pregled retinoidov se je začel 8. julija 2016 na zahtevo Združenega kraljestva v skladu s členom 31 Direktive 2001/83/ES.
− an assessment of each woman's potential for becoming pregnant;
− ocena možnosti vsake ženske za zanositev;
Updated measures for pregnancy prevention during retinoid use
Posodobljeni ukrepi za preprečevanje nosečnosti med uporabo retinoidov
Particular care should be taken in patients with history of depression.
Posebno pozornost je treba nameniti bolnikom z anamnezo depresije.
Evidence from published literature and individual case reports is conflicting, and many published studies have a number of limitations.
Podatki iz objavljene literature in poročila o posameznih primerih si nasprotujejo, številne od objavljenih študij pa imajo vrsto omejitev.
• Patients who have any questions should speak to their doctor or pharmacist.
• Bolniki, ki imajo vprašanja o svojem zdravljenju, naj se posvetujejo z zdravnikom ali farmacevtom.
Some retinoids are also used to treat certain forms of cancer.
Nekateri retinoidi se uporabljajo tudi za zdravljenje nekaterih oblik raka.
− an ‘acknowledgement form' to confirm that appropriate advice has been given to patients;
− „potrditveni obrazec“ za potrditev, da so bolnice prejele ustrezne nasvete;
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 21/06/2018.
Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 21. 6. 2018 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
− a ‘patient reminder card' stating that the medicine must not be used during pregnancy, and including information about pregnancy testing and the need to use effective contraception.
− „opozorilno kartico za bolnico“, na kateri bo navedeno, da se zdravila ne sme jemati med nosečnostjo, in ki bo vključevala informacije o testiranju nosečnosti in nujnosti uporabe učinkovite kontracepcije.
• Patients taking oral retinoids should be advised that they may experience changes in their mood and/or behaviour and that they and their families should be alert to this, and speak to their doctor if this occurs.
• Bolnicam, ki jemljejo peroralne retinoide, je treba pojasniti, da se lahko spremeni njihovo razpoloženje in/ali vedenje ter da morajo biti one in njihove družine na to pozorni in obvestiti svojega zdravnika, če se to zgodi.
Retinoids taken by mouth are used to treat various forms of severe acne, severe hand eczema that does not respond to treatment with corticosteroids, severe forms of psoriasis and other skin conditions, and certain types of cancer.
Retinoidi za zaužitje se uporabljajo za zdravljenje različnih oblik hudih aken, hudega ekcema rok, ki se ne odziva na zdravljenje s kortikosteroidi, hudih oblik luskavice in drugih bolezni kože ter nekaterih vrst raka.
The following retinoids have been authorised nationally in a number of Member States of the EU and are covered by this review: acitretin, adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin.
Naslednji retinoidi so bili odobreni nacionalno v številnih državah članicah Evropske unije in so zajeti v tem pregledu: acitretin, adapalen, alitretinoin, izotretinoin, tazaroten in tretinoin.
The review confirmed that oral retinoids can harm the unborn child and must not be used during pregnancy.
Ta pregled je potrdil, da lahko peroralni retinoidi škodujejo nerojenim otrokom, zato se ne smejo uporabljati med nosečnostjo.
On 22 March 2018, the European Medicines Agency (EMA) completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed.
Evropska agencija za zdravila (EMA) je zaključila pregled retinoidnih zdravil in potrdila, da je potrebna posodobitev ukrepov za preprečevanje nosečnosti.
The review of retinoids was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which assessed the available data including published literature, post-marketing reports of side effects and additional information collected from stakeholder meetings and written submissions.
Pregled retinoidov je izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC) Evropske agencije za zdravila (EMA), ki je ocenil razpoložljive podatke, vključno z objavljeno literaturo, poročili o neželenih učinkih v obdobju trženja ter na sestankih deležnikov zbranimi in pisno posredovanimi dodatnimi informacijami.
Warnings will be included in the package leaflet of oral retinoids, as well as signs and symptoms that patients and their families should look out for (such as changes in mood or behaviour).
Opozorila bodo vključena v navodilo za uporabo peroralnih retinoidov, v to navodilo pa bodo vključeni tudi znaki in simptomi, na katere morajo biti bolnice in njihove družine pozorni (npr. spremembe vedenja ali razpoloženja).
• Patients treated with oral retinoids should be monitored for signs and symptoms of depression and referred for appropriate treatment, if necessary.
• Pri bolnicah, zdravljenih s peroralnimi retinoidi, je treba biti pozoren na morebitne znake in simptome depresije ter jih po potrebi napotiti na ustrezno zdravljenje.
Retinoids are vitamin A derivatives that are available as capsules to be taken by mouth or as creams and gels to be applied to the skin.
Retinoidi so derivati vitamina A, ki so na voljo kot kapsule za zaužitje ali kot kreme in geli za nanos na kožo.
• The above information will also be included in the package leaflet, and a boxed warning will be added to the outer packaging.
• Navedeni podatki bodo vključeni tudi v navodilo za uporabo, uokvirjeno besedilo pa bo dodano na zunanjo ovojnino.
The CHMP opinion was sent to the European Commission, which issued a final legally binding decision valid across the EU.
Priporočilo odbora CHMP bo predloženo Evropski komisiji, ki bo izdala pravno zavezujoč sklep, veljaven v vsej EU.
Alitretinoin has also been authorised centrally as Panretin for the treatment of skin lesions in AIDS patients with Kaposi's sarcoma (a type of skin cancer).
Alitretinoin je bil po centraliziranem postopku odobren tudi kot zdravilo Panretin za zdravljenje lezij kože pri bolnikih z aidsom in Kaposijevim sarkomom (vrsto raka kože).
They are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including severe acne and psoriasis.
Ti se jemljejo peroralno ali nanašajo kot kreme ali geli za zdravljenje več bolezni, ki prizadenejo predvsem kožo, vključno s hudimi aknami in luskavico.
• However, since severe skin disorders themselves increase the risk of psychiatric disorders, a warning about this possible risk is being included in the product information for oral retinoids.
• Ker pa hude bolezni kože same po sebi povečujejo tveganje za duševne motnje, bo opozorilo o tem možnem tveganju vključeno v informacije o zdravilu za peroralne retinoide.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
Regarding the risk of neuropsychiatric disorders, the limitations of the available data did not allow to clearly establish whether this risk was due to the use of retinoids.
Kar zadeva tveganje za nevropsihiatrične motnje, omejenost razpoložljivih podatkov ne dopušča nedvomne ugotovitve, ali je to tveganje povezano z uporabo retinoidov.
• Oral (taken by mouth) retinoids must not be used during pregnancy.
• Peroralni (ki se jemljejo skozi usta) retinoidi se med nosečnostjo ne smejo jemati.
The EMA's Committee for Medicinal Products for Human use (CHMP) then endorsed the PRAC recommendations and adopted the Agency's final opinion.
Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je zdaj sprejel priporočila odbora PRAC in sprejel končno mnenje agencije.
Bexarotene has been authorised centrally as Targretin for the treatment of cutaneous T-cell lymphoma (CTCL, a rare cancer of the lymph tissue).
Beksaroten je bil po centraliziranem postopku odobren kot zdravilo Targretin za zdravljenje kožnega T-celičnega limfoma (CTCL, redke vrste raka limfatičnega tkiva).
• With oral retinoids, there may be a possible risk of disorders such as depression and anxiety.
• Peroralni retinoidi so lahko povezani s tveganjem za motnje, kot sta depresija in tesnoba.
− the need to use at least one effective method of contraception during and after treatment;
− nujnost uporabe vsaj ene učinkovite kontracepcijske metode med zdravljenjem in po njem;
However, considering that patients with severe skin conditions may be more vulnerable to neuropsychiatric disorders due to the nature of the disease, the prescribing information for oral retinoids will be updated to include a warning about this possible risk.
Vendar pa bodo glede na to, da so lahko bolniki z resnimi boleznimi kože zaradi narave bolezni bolj ranljivi za nevropsihiatrične motnje, informacije o predpisovanju vseh peroralnih retinoidov posodobljene tako, da bodo vključevale opozorilo o tem možnem tveganju.