natgillin/translations-raw huggingface dataset:
approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
V kliničnih preskušanjih je več kot 3.100 bolnikov prejelo najmanj en cikel zdravljenja, po tem so jih spremljali od 6 mesecev do več kot 5 let; približno 2.400 bolnikov je prejelo dva ali več ciklov zdravljenja, od teh pa več kot 1.000 bolnikov 5 ali več ciklov zdravljenja.
Rituximab was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients.
Rituksimab so bolnikom s KLL dajali v obliki intravenske infuzije v odmerku 375 mg/m2 telesne površine v prvem ciklu zdravljenja, odmerek pa se je v naslednjih 5 ciklih zdravljenja povečal na
For retreatment with Ritemvia monotherapy for patients who have responded to previous treatment with Ritemvia monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (see section 5.1).
Priporočeni odmerek zdravila Ritemvia za ponovno samostojno zdravljenje bolnikov s folikularnim limfomom, ki so se odzvali na prejšnje samostojno zdravljenje z zdravilom Ritemvia po tem, ko se na predhodno zdravljenje niso odzvali ali se je pri njih bolezen ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne (glejte poglavje 5.1).
The rate of overall infections and serious infections was not increased after the development of low IgA, IgG or IgM.
Po znižanju IgA, IgG oz. IgM se delež vseh okužb in delež resnih okužb nista povečala.
Median FU, months
Mediana spremljanja (meseci)
Influenza-like illness Oedema peripheral
Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura gripi podobna bolezen periferni edemi
Very Rare Not known
Ni znano
Common side effects (may affect up to 1 in 10 people): infections such as herpes infections and eye infection mood disorders such as irritability and depression skin disorders such as itching, hives, and benign lumps feeling tired or dizzy fever headache pain in the tummy pain in the muscles heart beating faster than normal
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): okužbe, npr. okužbe v prsih, okužbe sečil (bolečine pri odvajanju vode), prehladi in okužbe s herpesom, pojav alergijskih reakcij je najverjetnejši med infuzijo, a pojavijo se lahko 24 ur po infuziji, driska, kašelj ali kratka sapa, krvavitve iz nosu, zvišan krvni tlak,
LIST OF EXCIPIENTS
Izkušnjeprinavadnem pemfigusu
The MAH must ensure that all physicians who are expected to prescribe Ritemvia are provided with the following:
Imetnik dovoljenja za promet mora zagotoviti, da zdravniki, ki lahko predpišejo zdravilo Ritemvia, prejmejo: povzetek glavnih značilnosti zdravila, gradivo za zdravnika
Closely monitor patients with pre-existing cardiac conditions and those who experienced prior cardiopulmonary adverse reactions.
Bolnike, ki imajo težave s srcem, in tiste, pri katerih so v preteklosti opazili kardio-pulmonalne neželene učinke, je treba pozorno spremljati.
Muscle weakness Musculoskeletal pain Pain in extremities
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični krči bolečina v sklepih bolečina v hrbtu mišična šibkost mišično-skeletna bolečina bolečina v okončinah
• skin disorders such as itching, hives, and benign lumps
spremembe razpoloženja, kot sta razdražljivost in depresija, bolezni kože, kot so srbenje, koprivnica in benigne bule,
In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58% vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
(12 %); boljši pri bolnikih, katerih največje lezije so bile v največjem premeru manjše od 5 centimetrov (53 %) kot pri bolnikih, katerih lezije so bile v največjem premeru večje kot 7 centimetrov (38 %).
It should not be administered as an intravenous push or bolus.
Pripravljene infuzijske raztopine ne smemo dajati v obliki hitre intravenske infuzije ali bolusa.
Baseline CD19-positive cell counts and size of measurable tumour lesions contributed to some of the variability in CL2 of rituximab in data from 161 patients given 375 mg/m2 as an intravenous infusion for 4 weekly doses.
K variabilnosti Cl2 rituksimaba pri 161 bolnikih, ki so v štirih tednih enkrat na teden dobili 375 mg/m2 rituksimaba z intravensko infuzijo, je prispevalo začetno število CD19 pozitivnih celic in velikost izmerljivih tumorskih lezij.
log-rank p value hazard ratio (95% CI) risk reduction
vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab for induction of remission of GPA and MPA, and at a higher frequency than the comparator group.
Neželeni učinki, ki so se v 6 mesecih pojavili pri ≥ 5% bolnikov, ki so prejeli rituksimab za indukcijo remisije GPA in MPA in pogosteje kot v primerjalni skupini.
Mean change from baseline: Modified total sharp score Erosion score Joint space narrowing score Proportion of patients with no radiographic change
Ocena zožitve sklepne špranje Delež bolnikov brez radioloških
Severe infections were reported in about 4% of patients treated with rituximab monotherapy.
Pri 4% bolnikov, ki so prejemali rituksimab kot samostojno zdravljenje, so opazili hude okužbe.
Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during rituximab maintenance treatment up to 2 years when compared to observation.
V primerjavi z opazovano skupino so med največ dveletnim vzdrževalnim zdravljenjem z rituksimabom opazili večjo pogostnost okužb na splošno,
The most frequent reported or observed serious adverse drug reactions were:  IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
• z infuzijo povezane reakcije (vključno s sindromom sproščanja citokinov, sindromom razpada tumorja), glejte poglavje 4.4;
• allergic reactions (hypersensitivity)
3reakcije, povezane z infuzijo (hipertenzija,
Patients in both arms received 1000 mg of pulse intravenous (IV) methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Bolniki v obeh terapevtskih skupinah so prejemali 1000 mg metilprednizolona (ali drugega glukokortikoida v enakovrednem odmerku) na dan pulzno intravensko (i.v.)
A total of 23/99 (23%) rituximab-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Do 18. meseca je imelo pozitiven izvid ADA skupno 23 od 99 (23%) bolnikov, ki so bili v preskušanju zdravljeni z rituksimabom.
For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Za 60 ponovnih zdravljenj je bil celokupen odgovor na zdravljenje 38% (95-% interval zaupanja 26-51%; 10% popoln odgovor, 28% delni odgovor).
Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 × 500 mg dose and ranged from 21 to 22 days for the 2 × 1000 mg dose.
Povprečni končni razpolovni čas izločanja po drugi infuziji, po drugem ciklu zdravljenja, je bil 19 dni za 2 x
• pain in the tummy
bolečina v zgornjem delu trebuha
Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets.
nelagodje v grlu, otekanje jezika ali grla, srbeč ali smrkav nos, bruhanje, pordevanje ali hitro in močno utripanje srca, srčna kap ali nizko število trombocitov.
Common Uncommon
Navadni pemfigus
Localised candida infections as well as Herpes zoster were reported at a higher incidence in the rituximab-containing arm of randomised studies.
V randomiziranih študijah so pri bolnikih, ki so prejemali rituksimab, opažali večjo incidenco lokaliziranih okužb s kandido in herpesom zostrom.
3infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
pruritus, urtikarija, draženje žrela, vročinski oblivi, hipotenzija, rinitis, okorelost, tahikardija, utrujenost, orofaringealna bolečina, periferni edem, eritem)
The vial contains 500 mg of rituximab.
Viala vsebuje 500 mg rituksimaba.
infusion site pain
bolečina na mestu infundiranja
Nervous system disorders paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety dysgeusia peripheral neuropathy, facial nerve palsy5
vazodilatacija, omotica, anksioznost sprememba okusa periferna nevropatija, paraliza obraznega živca5
Mean change in SF‐36 PHS
Health Score) po SF-36.
The vial contains 100 mg of rituximab.
Viala vsebuje 100 mg rituksimaba.
Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Uporaba zdravila rituksimab pri bolnikih, ki še niso prejemali metotreksata, ni priporočljiva, ker ni bilo dokazano ugodno razmerje med koristjo in tveganji.
General disorders and administratio n site conditions fever, chills, asthenia, headache tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering, +multi-organ failure4
zardevanje, splošno slabo počutje, prehladni sindrom, +utrujenost, +drgetanje, +
Overall response rate* chi-squared test p value odds ratio (95% CI)
Delež celokupnega odgovora* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ) Delež popolnega odgovora (CR/CRu)* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ)
Date of first infusion:
Povprečna sprememba od izhodišča:
Infections and infestations bacterial infections, viral infections, +bronchitis sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Infekcijske in parazitske bolezni bakterijske okužbe, virusne okužbe, +bronhitis sepsa, +pljučnica,
The recommended dose of Ritemvia monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks.
• Bolniki, ki se na prejšnje zdravljenje niso odzvali ali se je pri njih bolezen ponovila Priporočeni odmerek zdravila Ritemvia za samostojno indukcijsko zdravljenje odraslih bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne.
Non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Ne-Hodgkinov limfom in kronična limfocitna levkemija
A small number of cases of hepatitis B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the postmarketing setting.
Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom, ki so rituksimab prejemali v obdobju trženja, so poročali o majhnem številu primerov reaktivacije hepatitisa B; nekateri od teh primerov so se končali s smrtjo.
Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with rituximab.
Pri bolnikih z revmatoidnim artritisom, ki so jih zdravili z rituksimabom, so opazili hipogamaglobulinemijo (IgG ali IgM pod spodnjo mejo normale).
Ritemvia 500 mg concentrate for solution for infusion Rituximab
Ritemvia 500 mg koncentrat za raztopino za infundiranje rituksimab
Repeated treatment courses with Ritemvia are possible.
zdravljenih z rituksimabom.
Toxicity studies in cynomolgus monkeys have shown no other effect than the expected pharmacological depletion of B cells in peripheral blood and in lymphoid tissue.
Rituksimab se je izkazal kot visokospecifičen za antigen CD20 na celicah B. Študije toksičnosti pri opicah Cynomologus niso pokazale drugih učinkov od pričakovanega farmakološkega upada števila celic
In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or rituximab 375 mg/m2 plus CHOP (R-CHOP).
CHOP (750 mg/m2 ciklofosfamida, 50 mg/m2 doksorubicina, 1,4 mg/m2 do največ 2 mg/m2 vinkristina na prvi dan ter 40 mg/m2 prednizolona na 1. do 5. dan) vsake 3 tedne 8 ciklov ali pa 375 mg/m2 rituksimaba in sheme CHOP (R-CHOP).
Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
doseglo pomembno več bolnikov, ki so se zdravili z rituksimabom in metotreksatom, kakor bolnikov, ki so se zdravili samo z metotreksatom (preglednica 12).
Ritemvia is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Zdravilo Ritemvia je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
• pain in the muscles • heart beating faster than normal
hitrejše bitje srca kot običajno.
Hypogammaglobulinaemia (IgA, IgG or IgM below the lower limit of normal) has been observed in granulomatosis with polyangiitis and microscopic polyangiitis patients treated with rituximab.
Pri bolnikih z granulomatozo s poliangiitisom ali mikroskopskim poliangiitisom, ki so prejemali rituksimab, so opažali hipogamaglobulinemijo (IgA, IgG ali IgM pod spodnjo mejo normale).
No patients were withdrawn due to ADRs.
Zaradi neželenih učinkov zdravila ni iz študije izstopil noben bolnik.
P<0.0001
mediana TTP: 14,7 p < 0,0001
Common Uncommon Rare
navadnega pemfigusa
• respiratory failure
Srčne bolezni
Respiratory, thoracic and mediastinal disorders bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
bolečina v prsnem košu, dispneja, izrazitejši kašelj, rinitis astma, bronhiolitis obliterans,
Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab for induction of remission of GPA and MPA, and at a higher frequency than the comparator group, in the pivotal clinical study.
Neželeni učinki, ki so se v 6 mesecih pojavili pri ≥ 5% bolnikov, ki so prejeli rituksimab za indukcijo remisije GPA in MPA, in pogosteje kot v primerjalni skupini.
Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab.
Pri bolnikih z revmatoidnim artritisom, granulomatozo s poliangiitisom in mikroskopskim poliangiitisom, ki so prejemali rituksimab, so poročali o primerih reaktivacije hepatitisa B, vključno s smrtnim izidom.
Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 × 500 mg dose and 317 to 370 μg/mL for 2 × 1000 mg dose.
do 175 μg/ml za 2 x 500 mg odmerek ter 317 do 370 μg/ml za 2 x 1.000 mg odmerek.
Ritemvia 100 mg concentrate for solution for infusion Rituximab
Ritemvia 100 mg koncentrat za raztopino za infundiranje rituksimab
Acne
ORR
Common side effects (may affect up to 1 in 10 people):
Pogosti neželeni učinki (pojavijo se lahko pri do 1 od 10 bolnikov):
The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab-arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
ki so prejemale rituksimab, podobno ali nižjo incidenco kot v kontrolnih skupinah: hematotoksičnost,
EULAR Response (%)
OS (%)
Rate
CR
Cases of progressive multifocal leukoencephalopathy with fatal outcome have been reported following use of rituximab for the treatment of autoimmune diseases.
Pri uporabi rituksimaba za zdravljenje avtoimunskih bolezni so poročali o smrtnih primerih progresivne multifokalne levkoencefalopatije, in sicer pri revmatoidnem artritisu in avtoimunskih boleznih, za katere zdravilo ni odobreno, sistemskem eritematoznem lupusu (SLE) in vaskulitisu.
Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions.
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (PRES, posterior reversible encephalopathy syndrome)/oziroma sindroma reverzibilne posteriorne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
Herpes zoster Nasopharyngitis
Infekcijske in parazitske bolezni okužba sečil bronhitis herpes zoster nazofaringitis
Gastrointestinal dyspepsia, diarrhoea,
Bolezni prebavil dispepsija, diareja, gastroezofagealni refluks, razjede v ustih,
• What you need to know before having
• Kaj morate vedeti, preden prejmete zdravilo Ritemvia
CHOP 11.6 R-CHOP 22.1 CR 14.3 PR 14.3
CR 13,0 % 24,3 % 0,0007
Treatment of relapse
Zdravljenje recidivov
• bald spots on the scalp, chills, headache
plešasti predeli na lasišču, mrzlica, glavobol,
• tight or painful muscles
trzanje ali tresenje mišic,
Disease‐free survivala Subgroup analysis PFS
Preživetje brez boleznia (DFS) Analiza podskupin Preživetje brez napredovanja bolezni (PFS)
This is because side effects can develop several months after you have had treatment.
Kartico pri sebi hranite še 2 leti po zadnjem odmerku zdravila Ritemvia, ker se lahko neželeni učinki pojavijo več mesecev po zdravljenju.
• producing more tears, tear duct problems, inflamed eye (conjunctivitis)
omotica ali občutek tesnobe, močnejše solzenje, težave s solznimi izvodili, vnetje očesa (konjunktivitis), zvonjenje v ušesih, bolečine v ušesu,
Radiographic response Structural joint damage was assessed radiographically and expressed as change in modified
Radiološka ocena Strukturno okvaro sklepov so ocenili radiološko in jo izrazili kot spremembo ocene po prirejeni Sharpovi lestvici (mTSS, modified Total Sharp Score) in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
3infusion-related reactions (generalised oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
3reakcije, povezane z infuzijo (hipertenzija, navzea, kožni izpuščaj, pireksija,
Please talk to your doctor or nurse if you have any questions about the information in this card.
Če imate kakršna koli vprašanja o tej kartici, se posvetujte z zdravnikom ali medicinsko sestro.
This is a type of protein called a “monoclonal antibody”.
Zdravilo Ritemvia vsebuje učinkovino rituksimab, ki je vrsta beljkovine, imenovana monoklonsko protitelo.
Adverse drug reaction1
Neželeni učinek1
(n=268) or R-FCM (n=44), according to the investigators' choice.
R-FC (n = 408) Vrednost p v testu log-rang
This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
LogRank p
Vrednost p v testu lograng
Muscle spasms Arthralgia
hipoksija intersticijska bolezen pljuč7
Bronchitis Rhinitis
Bolezni prebavil driska
Please see cytokine release syndrome above for severe reactions.
V zvezi s hudimi neželenimi učinki glejte zgornji opis sindroma sproščanja citokinov.
Similarly, in all studies a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
Podobno je v vseh študijah dober do zmeren odziv po klasifikaciji Evropske lige za boj proti revmatizmu (EULAR, European League Against Rheumatism)
The European Commission issued a decision on 17 February 2012.
Evropska komisija je odločbo izdala dne 17. februarja 2012.
17 February 2012
17. februar 2012
Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Rezultat postopka v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena
At the time of the review, pholcodine-containing medicines had been withdrawn from the markets in Sweden (in the 1980s) and Norway (in 2007).
V času pregleda so zdravila, ki vsebujejo folkodin, umaknili s trga na Švedskem (v osemdesetih letih prejšnjega stoletja) in Norveškem (leta 2007).
Pholcodine-containing medicines are currently approved in the EU in Belgium, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, Spain and the United Kingdom, either subject to medical prescription or as over-the-counter medicines.
Zdravila, ki vsebujejo folkodin, so trenutno odobrena v EU v Belgiji, Franciji, na Irskem, v Litvi, Luksemburgu, na Malti, v Sloveniji, Španiji in Združenem kraljestvu, kjer so bodisi na recept ali v prosti prodaji.
A group of experts in immunology and anaesthesia was also convened to provide advice.
Za nasvet je zaprosil tudi skupino strokovnjakov za imunologijo in anestezijo.
Therefore, it recommended that all marketing authorisations for medicines containing pholcodine should be maintained throughout the European Union (EU).
Zato je priporočil, da se v vsej Evropski uniji (EU) ohranijo vsa dovoljenja za promet z zdravili, ki vsebujejo folkodin.
Pholcodine is an opioid medicine that is used for the treatment of non-productive (dry) cough in children and adults.
Folkodin je opioidno zdravilo, ki se uporablja za zdravljenje neproduktivnega (suhega) kašlja pri otrocih in odraslih.
To assess its safety, the Committee reviewed the results from preclinical and clinical studies, postmarketing data, epidemiological studies and data from the published literature.
Za oceno varnosti je Odbor pregledal rezultate predkliničnih in kliničnih študij, podatke iz obdobja trženja, epidemiološke študije in podatke iz objavljene literature.
Why was pholcodine reviewed?
Zakaj je bil folkodin pregledan?
They may be available as syrups, oral solutions, suppositories, tablets and capsules under various trade names and as generics.
Kot sirupi, peroralne raztopine, svečke, tablete in kapsule so na voljo pod različnimi tržnimi imeni in kot generična zdravila.
• Patients and healthcare professionals are reminded that the benefits of pholcodine continue to outweigh its risks for the treatment of non-productive cough.
• Bolnike in zdravstvene delavce je treba opomniti, da koristi uporabe folkodina še naprej odtehtajo tveganja pri zdravljenju neproduktivnega kašlja.
What is pholcodine?
Kaj je folkodin?
It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.
Deluje neposredno v možganih, kjer zavre refleks kašlja z zmanjšanjem živčnih signalov, ki se pošiljajo mišicam, ki sodelujejo pri kašlju.
Cross-sensitisation has also been observed in countries where pholcodine is not on the market, suggesting that other substances may also trigger cross-sensitisation and that the observed changes in reporting rates may be explained by other factors.
Križno senzibilizacijo so opazili tudi v državah, v katerih folkodina ni na trgu, kar kaže na to, da lahko križno senzibilizacijo sprožijo tudi druge snovi in da je mogoče opažene spremembe v stopnjah poročanja razložiti z drugimi dejavniki.
No new risks have been identified with pholcodine.
Novih tveganj zaradi uporabe folkodina niso opredelili.