natgillin/translations-raw huggingface dataset:
• If you have low blood potassium level and your doctor has prescribed potassium supplements,
• če imate nizko koncentracijo kalija v krvi in vam je zdravnik predpisal dodatke kalija, ali če imate okvaro ledvic ali jemljete druga zdravila, ki lahko zvišajo koncentracijo kalija.
Radioactivity passed through the placenta in pregnant rats after administration of radioactively marked nicorandil.
Embriotoksičnost ter peri- in postnatalna toksičnost Po uporabi radioaktivno označenega nikorandila je radioaktivnost pri brejih podganah prehajala skozi placento.
What you need to know before you take <Invented name>
Kaj morate vedeti, preden boste vzeli zdravilo <Izmišljeno ime> Ne jemljite zdravila <Izmišljeno ime>:
• Dizziness
• Bruhanje
• Rash
• Srbenje
The metabolism of nicorandil appears not to be significantly modified by cimetidine or rifampicine, respectively an inhibitor and an inducer of liver microsomal mixed-function oxidases.
Cimetidin, ki je zaviralec jetrnih mikrosomskih mešanofunkcijskih oksidaz, in rifampicin, ki je induktor teh encimov, presnove nikorandila po vsem sodeč ne spremenita pomembno.
Gastrointestina l haemorrhage (see section
Volumen porazdelitve nikorandila po intravenski (i.v.)
Complications of gastrointestinal ulceration such as perforation, fistula, or abscess formation sometimes leading to gastrointestinal haemorrhage and weight loss have been reported (see section
Opisani so bili zapleti razjed na prebavilih, na primer perforacija, fistula ali nastanek abscesov, včasih s posledično krvavitvijo v prebavilih in hujšanjem (glejte poglavje 4.4).
Heart rate increased
Srčne bolezni povečana srčna frekvenca
Severe hyperkalaemia has been very rarely reported with nicorandil.
V zelo redkih primerih je bila med uporabo nikorandila opisana huda hiperkaliemija.
- In case you are particularly prone to headache, a lower dose of 5 mg twice daily might be prescribed by your doctor, for the first few days (2 to 7 days).
Priporočeni odmerek je: - Običajen začetni odmerek je 10 mg dvakrat na dan. - Če ste posebno nagnjeni h glavobolom, vam bo zdravnik za prvih nekaj dni (od 2 do 7 dni) morda predpisal manjši odmerek 5 mg dvakrat na dan. - Zdravnik vam lahko odmerek poveča do 20 mg dvakrat na dan, odvisno od vaših potreb, odziva na zdravljenje in prenašanje zdravila.
If ulceration(s) develops, nicorandil should be discontinued (see section 4.8).
Če se pojavi ena ali več razjed, je treba zdravljenje z nikorandilom prekiniti (glejte poglavje 4.8).
In life-threatening situations, administration of vasopressors must be considered.
V smrtno nevarnih okoliščinah pride v poštev uporaba vazopresorskih zdravil.
How to store <Invented name>
Shranjevanje zdravila <Izmišljeno ime>
Gastrointestinal ulcerations, skin and mucosal ulcerations have been reported with nicorandil (see section 4.8).
Med uporabo nikorandila so bile opisane razjede na prebavilih ter razjede na koži in sluznicah (glejte poglavje 4.8).
The volume of distribution of nicorandil after intravenous (iv) dosing is 1.04 L/kg of body weight.
uporabi je 1,04 l/kg telesne mase.
Dizziness
Razjede
• Acute pulmonary oedema
• Akutni pljučni edem.
Gastrointestina l ulcerations (stomatitis, aphtosis, mouth ulcer, tongue ulcer, small intestinal ulcer, large intestinal ulcer, anal ulcer) (see below and section 4.4)
Neznana jeziku, razjede na tankem črevesu, razjede na debelem črevesu, analne razjede) (glejte spodaj in poglavje 4.4)
Angioedema
(angioedem)
In addition, serious adverse reactions including ulcerations and their complications (see section 4.4) were reported during the post marketing surveillance of nicorandil.
Poleg tega so bili med obdobjem spremljanja po začetku trženja nikorandila opisani resni neželeni učinki, med njimi razjede in njihovi zapleti (glejte poglavje 4.4).
Ulcerations
Absorpcija
DATE OF REVISION OF THE TEXT [To be completed nationally]
DATUM ZADNJE REVIZIJE BESEDILA
Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported.
Med sočasno uporabo nikorandila in kortikosteroidov so bile opisane perforacije prebavil.
• Use of phosphodiesterase 5 inhibitors, since this can lead to a serious drop in blood pressure
• Uporaba zaviralcev fosfodiesteraze 5, ker lahko povzroči resen padec krvnega tlaka (glejte poglavje 4.5).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg nicorandil.
Ena tableta vsebuje 10 mg nikorandila.
Gastroinstestina l disorders
- Razjede na prebavilih
Decrease in blood pressure (see section
Žilne bolezni vazodilatacija v koži z zardevanjem znižan krvni tlak (glejte poglavje 4.4)
Talk to your doctor or pharmacist before taking <Invented name>:
Pred začetkom jemanja zdravila <Izmišljeno ime> se posvetujte s svojim zdravnikom ali s farmacevtom:
No clinically relevant modifications of the nicorandil pharmacokinetic profile is evidenced in population at risk such as elderly people, liver disease patients and chronic renal failure patients.
Posebne skupine bolnikov Pri populaciji, pri kateri obstaja tveganje (na primer pri starejših osebah, bolnikih z boleznijo jeter in bolnikih s kronično odpovedjo ledvic), niso ugotovili klinično pomembnih sprememb farmakokinetičnih značilnosti nikorandila.
Summary of product characteristics, labelling and package leaflet
Spremembe ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodilu za uporabo
OTHER SPECIAL WARNING(S), IF NECESSARY Contains a drying agent in each blister strip.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
SPECIAL STORAGE CONDITIONS [To be completed nationally]
POSEBNA NAVODILA ZA SHRANJEVANJE
This leaflet was last revised in. [To be completed nationally]
Navodilo je bilo nazadnje revidirano dne.
Uncommon
• Omotica
Gastroinstestinal disorders
nikorandil Peroralna uporaba
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije občutek šibkosti
EU/2/04/044/014 Aivolsin 625 mg/g Granules for use in drinking water
EU/2/04/044/013 Aivlosin 42,5 mg/g peroralni prašek prašiči
42.5 mg/g 20 kg Meat and offal 2 days
42,5 mg/g 500 g meso in organi: 2 dni
Chickens and turkeys
Ovojnina
If a second treatment is necessary, this should take place at least four weeks later.
Če je potrebno ponovno zdravljenje, ga je treba izvesti vsaj štiri tedne pozneje.
The dose is 0.15 mg per kilogram body weight.
Odmerek je 0,15 mg na kilogram telesne mase.
Around a quarter of the patients in this study also had a reduction in tumour size.
Pri približno četrtini bolnikov v tej študiji je bilo opaženo tudi zmanjšanje velikosti tumorja.
The European Commission granted a marketing authorisation valid throughout the European Union for Foscan on 24 October 2001.
Evropska komisija je dovoljenje za promet z zdravilom Foscan, veljavno po vsej Evropski uniji, odobrila dne 24. oktobra 2001.
Further care must be taken for up to six months.
Glede tega morajo biti previdni najmanj 6 mesecev.
However, in the study looking at improving symptoms of advanced head and neck cancer, 28 (22%) of the 128 patients assessed had a significant improvement in their most troubling symptom.
Vendar pa je v študiji, v kateri so proučevali izboljšanje simptomov napredovalega raka glave in vratu, 28 (22 %) od 128 obravnavanih bolnikov izkazalo pomembno izboljšanje najhujšega simptoma.
The full EPAR for Foscan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Foscan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Foscan
Druge informacije o zdravilu Foscan
This is a summary of the European public assessment report (EPAR) for Foscan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Foscan.
In all studies, the response was assessed between 12 and 16 weeks after the final treatment with Foscan, but Foscan was not compared with any other treatment.
V vseh študijah so odziv ocenjevali 12 do 16 tednov po zadnjem zdravljenju z zdravilom Foscan, vendar pa zdravila Foscan niso primerjali z nobenim drugim zdravilom.
When it is illuminated with laser light of a specific wavelength, temoporfin is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
Ko ga osvetlimo z lasersko svetlobo specifične valovne dolžine, se temoporfin aktivira in reagira s kisikom v celicah, pri čemer se tvori visoko reaktivna in toksična vrsta kisika.
Each area of the tumour should be illuminated only once during each treatment.
Vsako območje tumorja se lahko med vsakim ciklom zdravljenja osvetli samo enkrat.
Four days later, the entire surface of the tumour and the surrounding 0.5 cm margin is illuminated with light from a laser at a specific wavelength, using a fibre-optic cable.
Štiri dni pozneje je treba celotno površino tumorja in območje 0,5 cm okoli tumorja osvetljevati s svetlobo specifične valovne dolžine iz laserskega vira prek kabla iz optičnih vlaken.
This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Ta ubije celice tako, da reagira z njihovimi komponentami, na primer z njihovimi beljakovinami in DNK, in te komponente uniči.
What benefit has Foscan shown during the studies?
Kakšne koristi je zdravilo Foscan izkazalo med študijami?
Therefore, the Committee decided that Foscan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Foscan večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
It is used in patients in whom other treatments have stopped working, and who are not suitable for radiotherapy (treatment with radiation), surgery or systemic chemotherapy (medicines used to treat cancer; ‘systemic' means that they are given as treatments throughout the body).
Uporablja se pri bolnikih, pri katerih so druga zdravila prenehala učinkovati in ki niso primerni za radioterapijo (zdravljenje z obsevanjem), operacijo ali sistemsko kemoterapijo (zdravili za zdravljenje raka; „sistemska“ pomeni, da zdravila delujejo po celem telesu).
For more information about treatment with Foscan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Foscan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Treatment with Foscan is a two-step process: the medicine is given first, and then it is activated using a laser.
Zdravljenje z zdravilom Foscan poteka v dveh korakih: najprej se zdravilo injicira, nato pa se aktivira z laserjem.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Foscan.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Foscan, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The results of the first three studies were insufficient to support the use of Foscan in the eradication of head and neck cancer tumours.
Rezultati prvih treh študij niso zadostovali, da bi podprli uporabo zdravila Foscan pri odpravljanju rakavih tumorjev glave in vratu.
Foscan must also not be used in patients who have an operation planned in the next 30 days, who have an eye disease that is likely to need examination using a ‘slit lamp' (an instrument used by eye specialists to look into the eye) in the next 30 days, or who are already being treated with a photosensitising agent.
Zdravila Foscan prav tako ne smejo uporabljati bolniki, pri katerih je v naslednjih 30 dneh načrtovana operacija, bolniki z očesno boleznijo, pri katerih bo v naslednjih 30 dneh verjetno potreben pregled s špranjsko svetilko (instrumentom, ki ga uporabljajo specialisti za oči za pregled očesa), ali bolniki, ki se že zdravijo z drugim fotosenzitivnim sredstvom.
The medicine is given by an indwelling intravenous cannula (a thin tube permanently inserted into a vein) as a single slow injection over at least six minutes.
Zdravilo se daje skozi stalno vensko kanilo (tanko cevko, ki je stalno vstavljena v veno) z enkratnim počasnim injiciranjem, ki mora trajati vsaj šest minut.
Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer.
Zdravilo Foscan so proučevali v štirih glavnih študijah s skupno 409 bolniki z rakom glave ali vratu.
What is the risk associated with Foscan?
Kakšna tveganja so povezana z zdravilom Foscan?
By restricting the illumination to the tumour, cell damage is limited to the tumour cells, leaving other areas of the body unaffected.
Z omejitvijo osvetlitve samo na tumor so tudi poškodbe celic omejene samo na tumorske celice, druga območja telesa pa ostanejo neprizadeta.
The fourth study looked at the reduction of symptoms in 220 patients with advanced head or neck cancer who could not receive surgery or radiotherapy.
V četrti študiji so proučevali zmanjšanje simptomov pri 220 bolnikih z napredovalim rakom glave ali vratu, ki niso bili primerni za operacijo ali obsevanje.
Foscan is a solution for injection containing the active substance temoporfin (1 mg/ml).
Zdravilo Foscan je raztopina za injiciranje, ki vsebuje zdravilno učinkovino temoporfin (1 mg/ml).
The most common side effects with Foscan (seen in more than 1 patient in 10) are pain in the illuminated area (such as pain in the face), headache, pain at the injection site, haemorrhage (bleeding), scarring, necrotising stomatitis (death of cells or tissue in the mouth), dysphagia (difficulty swallowing), oedema (swelling) in the illuminated area (such as swelling of the face and tongue) and constipation.
Najpogostejši neželeni učinki zdravila Foscan (opaženi pri več kot 1 bolniku izmed 10) so bolečine na območju osvetlitve (kot so npr. bolečine na obrazu), glavobol, bolečine na mestu inijiciranja, krvavitve, brazgotine, nekrotizirajoči stomatitis (odmiranje celic ali tkiva v ustih), disfagija (težave pri požiranju), edem (oteklina) na območju osvetlitve (kot je npr. otekel obraz ali jezik) in zaprtje.
Foscan is used to relieve the symptoms of advanced head and neck squamous cell carcinoma (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Zdravilo Foscan se uporablja za blaženje simptomov napredovalega ploščatoceličnega raka glave in vratu (vrste raka, ki se začne v celicah sluznice ust, nosu, grla ali ušesa).
The CHMP concluded that Foscan's effects on relieving the symptoms associated with advanced head and neck cancer were of interest.
CHMP je menil, da so učinki zdravila Foscan na lajšanje simptomov, povezanih z napredovalim rakom glave in vratu, pomembni.
Foscan must only be given in a specialist cancer centre where a team can assess the patient's treatment under the supervision of a doctor who has experience in photodynamic therapy (treatment that uses light).
Zdravilo Foscan se sme dajati samo v specialističnih onkoloških klinikah, kjer lahko ekipa zdravstvenih delavcev spremlja bolnikovo zdravljenje pod nadzorom zdravnika, ki ima izkušnje s fotodinamičnim zdravljenjem (zdravljenjem, pri katerem se uporablja svetloba).
When Foscan is injected, temoporfin is distributed within the body, including within the tumour.
Ko zdravilo Foscan injiciramo, se temoporfin porazdeli po celem telesu, tudi v tumorju.
Foscan must not be used in patients with porphyria (an inability to break down porphyrins), other diseases made worse by light, allergy to porphyrins, or tumours that are spreading into a main blood vessel in or next to the area where the laser is to be shone.
Zdravila Foscan ne smejo uporabljati bolniki s porfirijo (nezmožnostjo razgradnje porfirinov), drugimi boleznimi, ki jih svetloba poslabša, alergijo na porfirine ali tumorji, ki se širijo v glavno krvno žilo na mestu, osvetljevanem z laserjem, ali v njegovi bližini.
Patients receiving Foscan should take care to avoid exposure to sun light or bright light for two weeks after injection to avoid skin burns.
Bolniki, ki prejemajo zdravilo Foscan, se morajo dva tedna po injiciranju izogibati izpostavljenosti sončni ali drugi močni svetlobi, sicer lahko pride do kožnih opeklin.
Foscan must not be used in people who are hypersensitive (allergic) to temoporfin or any of the other ingredients.
Zdravila Foscan ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) temoporfin ali katero koli drugo sestavino zdravila.
Foscan temoporfin
Povzetek EPAR za javnost temoporfin
During treatment, other areas of the body should be shielded from the light so that the activation of the medicine is limited to the tumour.
Druga območja telesa morajo biti med terapijo zaščitena pred svetlobo, tako da se zdravilo aktivira samo na območju tumorja.
For the full list of all side effects reported with Foscan, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Foscan, glejte navodilo za uporabo.
The active substance in Foscan, temoporfin, is a photosensitising agent (a substance that changes when exposed to light).
Zdravilna učinkovina zdravila Foscan je temoporfin, ki je na svetlobo občutljiva snov (snov, ki se spremeni, kadar je izpostavljena svetlobi).
Why has Foscan been approved?
Zakaj je bilo zdravilo Foscan odobreno?
The first three studies looked at whether the tumour was eradicated after up to three treatments with Foscan in a total of 189 patients.
V prvih treh študijah so pri skupno 189 bolnikih proučevali, ali je bil tumor po največ treh ciklih zdravljenja z zdravilom Foscan uničen.
What is Foscan used for?
Za kaj se zdravilo Foscan uporablja?
How has Foscan been studied?
Kako je bilo zdravilo Foscan raziskano?
How is Foscan used?
Kako se zdravilo Foscan uporablja?
How does Foscan work?
Kako zdravilo Foscan deluje?
What is Foscan?
Kaj je zdravilo Foscan?
This is particularly important with regards back pain model due to the expected high rate of spontaneous remission.
To je še zlasti pomembno pri vzorcu bolečin v hrbtu zaradi pričakovane visoke stopnje spontane remisije.
Other dosages and pharmaceutical forms are available in Germany only.
Ostali odmerki in farmacevtske oblike so na voljo samo v Nemčiji.
Flupirtine-containing medicinal products are currently approved in 11 Member States (MSs) of the Union on prescription only: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovak Republic.
Zdravila, ki vsebujejo flupirtin, so trenutno odobrena v 11 državah članicah Evropske unije, kjer se izdajajo le na recept: v Bolgariji, Estoniji, Nemčiji, na Madžarskem, v Italiji, Latviji, Litvi, na Poljskem, Portugalskem, v Romuniji in Slovaški republiki.
The CMDh therefore reworded this section, as follows:
Zato je CMDh spremenila besedilo tega poglavja, kot sledi:
Patient exposure to flupirtine was greater in Germany and has increased steadily from 7,9 million DDD in 2001 to 28,1 million DDD in 2011.
Izpostavljenost bolnikov flupirtinu je bila večja v Nemčiji in je enakomerno naraščala od 7,9 milijona DDD leta 2001 do 28,1 milijona DDD leta 2011.
In fact, available efficacy designed studies are for periods no longer than 8 weeks.
Dejansko nobena od razpoložljivih študij, zasnovanih za spremljanje učinkovitosti, ni trajala več kot 8 tednov.
What you need to know before you use < product name > [The wording below should be inserted in the relevant sections]
Kaj morate vedeti, preden boste uporabili zdravilo < ime zdravila > [Besedilo, navedeno spodaj, je treba vstaviti v ustrezna poglavja]
Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Potem ko je pregledala priporočilo, ki ga je izdal PRAC, se je skupina CMDh strinjala s splošnimi znanstvenimi zaključki in podlago za priporočilo.
Whereas,
Ob upoštevanju:
It also acts as functional N-methyl-Daspartate (NMDA) receptor antagonist.
Poleg tega deluje tudi kot funkcionalni antagonist receptorja N-metil-D-aspartata (NMDA).
The 400 mg modified release tablets, although only authorised in Germany, is the most prescribed formulation in the Union since 2007.
400-miligramske tablete s prirejenim sproščanjem so, čeprav so odobrene samo v Nemčiji, najpogosteje predpisana farmacevtska oblika v Evropski uniji od leta 2007.
4 Puls F, Agne C, Klein F et al.
4 Puls F, Agne C, Klein F in sod.
• The PRAC also concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
• PRAC je zaključil tudi, da so potrebni dodatni ukrepi za zmanjšanje tveganja, na primer informacije za bolnike in zdravstvene delavce.
The PRAC also recommended that Periodic Safety Update Reports should be submitted yearly.
Prav tako je priporočil, da se vsako leto predloži redno posodobljeno poročilo o varnosti zdravila.
The 100 mg immediate release capsules are available in all MSs.
100-miligramske kapsule s takojšnjim sproščanjem so na voljo v vseh državah članicah.
The German National Competent Authority (BfArM) identified a growing number of hepatotoxicity reactions (probably idiosyncratic) reported in association with flupirtine.
Nemški pristojni nacionalni organ (BfArM) je opazil naraščanje števila hepatotoksičnih reakcij (najverjetneje idiosinkratičnih), o katerih poročajo v povezavi s flupirtinom.
Based on the current available data as described above, the PRAC concluded that flupirtine is associated with an increased risk of hepatotoxicity.
Na podlagi trenutno razpoložljivih podatkov, opisanih zgoraj, je PRAC zaključil, da je flupirtin povezan s povečanim tveganjem za hepatotoksičnost.
Overall, 11.8 million patients have been treated with flupirtine containing medicinal products since
Od leta 1999 je bilo z zdravili, ki vsebujejo flupirtin, zdravljenih skupno 11,8 milijona bolnikov.
The PRAC considers that there is sufficient evidence on efficacy in the acute (nociceptive) pain indication (mild, moderate and severe).
Meni, da obstaja dovolj dokazov o učinkovitosti pri indikaciji akutne (nociceptivne) bolečine (blage, zmerne in hude).
The reporting rate for hepatic cases with flupirtine (regardless of causality) is of 15,2 cases/100 000 patients years (based on a patient exposure of 893, 000 patients year).
Stopnja poročanja o boleznih jeter, povezanih z uporabo flupirtina (ne glede na vzrok), je 15,2 primera/100 000 bolnikov na leto (na podlagi izpostavljenosti bolnikov 893.000 bolnikov na leto).
The two long term clinical studies presented (which became available since the granting of the initial Marketing Authorisation) were uncontrolled and regarded the use of flupirtine over a period of 2 - 6 months study5 and a one-year6,7.
Dve predloženi dolgoročni klinični študiji (ki sta bili objavljeni po odobritvi prvega dovoljenja za promet z zdravilom) sta bili nenadzorovani in sta bili namenjeni spremljanju uporabe flupirtina v obdobju od 2-6 mesecev5 in enega leta6,7.
The WHO defined daily dose (DDD) for flupirtine oral is 400 mg.
Definirani dnevni odmerek (defined daily dose - DDD) po SZO za flupirtin za peroralno uporabo je 400 mg.
• The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for flupirtine containing medicinal products.
• PRAC je obravnaval postopek v skladu s členom 107i Direktive 2001/83/ES za zdravila, ki vsebujejo flupirtin;
It is authorised in the European Union since 1984 as an alternative analgesic to opioids and NonSteroidal Anti-Inflammatory Drugs (NSAIDs) for the treatment of acute and chronic pain (such as painful muscle tenseness, tension headaches, cancer pain, dysmenorrhoea and pain following trauma or orthopaedic surgery or injuries).
V Evropski uniji je od leta 1984 odobren kot analgetik, ki predstavlja alternativo opioidom in nesteroidnim protivnetnim zdravilom (NSPVZ) za zdravljenje akutnih in kroničnih bolečin (na primer boleče mišične napetosti, tenzijskih glavobolov, bolečin pri raku, dismenoreje in bolečin po poškodbi ali ortopedskem kirurškem posegu).