natgillin/translations-raw huggingface dataset:
Pholcodine has been used as a cough suppressant since the 1950s.
Folkodin se uporablja kot zdravilo za pomirjanje kašlja od petdesetih let prejšnjega stoletja.
Consequently, the French medicines regulatory agency changed the prescription status for these medicines in France from over-the-counter to prescription-only, and asked the CHMP to carry out a full assessment of the benefit-risk balance of pholcodine and to issue an opinion on whether the marketing authorisations for pholcodine-containing products should be maintained, varied, suspended or withdrawn across the EU.
Posledično je francoska regulativna agencija za zdravila spremenila status predpisovanja za ta zdravila v Franciji iz zdravil, na voljo brez recepta, na zdravila na zdravniški recept, in zaprosila CHMP, da opravi popolno oceno razmerja med tveganji in koristmi za folkodin ter izda mnenje, ali naj se dovoljenje za promet z zdravili, ki vsebujejo folkodin, v EU ohrani, spremeni, začasno odvzame ali umakne.
Regarding pholcodine's benefits, the CHMP noted that there is a large body of data demonstrating the effectiveness of opioids in the management of non-productive cough and that pholcodine has been in use for several decades.
V zvezi s koristmi folkodina je CHMP navedel, da obstajajo številni podatki, ki dokazujejo učinkovitost opioidov pri obvladovanju neproduktivnega kašlja, in da se folkodin uporablja že več desetletij.
NMBAs are used in emergency hospital procedures to prevent spontaneous muscle movements during surgery.
Blokatorji živčnomišičnega prenosa se uporabljajo v urgentnih bolnišničnih postopkih za preprečevanje spontanih mišičnih gibov med operacijo.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of pholcodine-containing medicines continue to outweigh their risks, and therefore recommended that all marketing authorisations for these medicines should be maintained.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravil, ki vsebujejo folkodin, še naprej odtehtajo tveganja, in zato priporočil, da se vsa dovoljenja za promet s temi zdravili ohranijo.
The CHMP considered that, although this is biologically plausible, the available data are weak and not fully consistent.
Čeprav je to biološko verjetno, CHMP meni, da so razpoložljivi podatki neprepričljivi in ne povsem dosledni.
In 2009, a study was published indicating that the reduction in pholcodine consumption in these countries was associated with a decrease in reports of anaphylactic reactions to neuromuscular blocking agents (NMBAs).
Leta 2009 je bila objavljena študija, ki nakazuje, da je bilo zmanjšanje porabe folkodina v teh državah povezano z manjšim številom poročil o anafilaktičnih reakcijah na blokatorje živčnomišičnega prenosa.
Further publications in 2010 and 2011 from the same authors supported the hypothesis that pholcodine use may increase the likelihood of patients having an anaphylactic reaction if they are exposed to an NMBA.
Nadaljnje objave istih avtorjev iz let 2010 in 2011 so podprle hipotezo, da lahko uporaba folkodina poveča verjetnost anafilaktične reakcije pri bolnikih, izpostavljenih blokatorjem živčnomišičnega prenosa.
The CHMP reviewed all the available data on the effects of pholcodine as a cough suppressant.
CHMP je pregledal vse razpoložljive podatke o učinkih folkodina kot sredstva za pomirjanje kašlja.
The Committee noted that the study in Sweden and Norway looked at changes in reporting rates of adverse reactions to NMBAs following the withdrawal of these medicines, without convincingly establishing a causal link with pholcodine use.
Odbor je opozoril, da obravnavajo študije na Švedskem in Norveškem spremembe v stopnji poročanja neželenih učinkov na blokatorje živčnomišičnega prenosa po ukinitvi uporabe teh zdravil, vendar prepričljive vzročne zveze z uporabo folkodina ne vzpostavijo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the existing evidence of the risk is weak, and that the benefits of pholcodine continue to outweigh its risks.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so obstoječi dokazi o tveganju neprepričljivi in da koristi uporabe folkodina še naprej odtehtajo njegova tveganja.
Regarding pholcodine's safety, the majority of adverse effects reported with pholcodine are those commonly seen with opioid medicines.
V zvezi z varnostjo folkodina je večina neželenih učinkov, o katerih poročajo pri uporabi folkodina, enaka kot pri drugih opioidnih zdravilih.
The European Medicines Agency has completed a review of the safety and effectiveness of pholcodine, following concerns that its use may put people at risk of developing anaphylactic (severe allergic) reactions to neuromuscular blocking agents used during surgery.
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti folkodina, saj je bila izražena skrb, da se lahko zaradi njegove uporabe pri bolnikih pojavi tveganje za razvoj anafilaktičnih (hudih alergijskih) reakcij na blokatorje živčnomišičnega prenosa, ki se uporabljajo med operacijami.
from spontaneous reports also suggested a 25% increase in anaphylactic reactions to NMBAs coinciding with a 9% increase in pholcodine use.
Franciji podatki iz spontanih poročil kažejo na 25-odstotno povečanje anafilaktičnih reakcij na blokatorje živčnomišičnega prenosa, kar sovpada z 9-odstotnim povečanjem uporabe folkodina.
Therefore, the CHMP concluded that the existing evidence does not support the conclusion that the use of pholcodine-containing medicines presents a risk of developing anaphylactic reactions to NMBAs.
Zato je CHMP zaključil, da obstoječi dokazi ne podpirajo sklepa, da predstavlja uporaba zdravil, ki vsebujejo folkodin, tveganje za razvoj anafilaktičnih reakcij na blokatorje živčnomišičnega prenosa.
The hypothesis that pholcodine use could trigger anaphylactic reactions to NMBAs is based on the body producing antibodies against pholcodine, which eventually trigger reactions to NMBAs (‘crosssensitisation').
Hipoteza, da lahko uporaba folkodina sproži anafilaktične reakcije na blokatorje živčnomišičnega prenosa, temelji na tem, da v telesu nastajajo protitelesa proti folkodinu, ki sčasoma sprožijo reakcijo na blokatorje živčnomišičnega prenosa („križna senzibilizacija“).
The Committee nevertheless recommended that a new post-marketing study investigating the possibility of an association between pholcodine and anaphylactic reactions to NMBAs should be carried out.
Odbor je kljub temu priporočil izvedbo nove študije v obdobju trženja, ki naj prouči možno povezavo med folkodinom in anafilaktičnimi reakcijami na blokatorje živčnomišičnega prenosa.
• Patients taking pholcodine-containing medicines can continue to do so, and should contact their doctor or pharmacist if they have any questions about their treatment.
Če imajo kakršna koli vprašanja o svojem zdravljenju, naj se posvetujejo z zdravnikom ali farmacevtom.
In France, data
V
Overall Survival was the key secondary study endpoint.
Celokupno preživetje je bil ključni sekundarni cilj študije.
Take the medicine pack with you.
Škatlo zdravila vzemite s seboj.
• you have ever had blood clots in the past.
• ste kadar koli v preteklosti imeli krvne strdke.
Carcinogenicity studies have not been conducted.
Študij kancerogenosti niso izvajali.
31 August 2023
31. avgust 2023
A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Nacionalno nadzorovani sistem razdeljevanja je bil uveden v sodelovanju z vsakim pristojnim nacionalnim organom.
When this happens, it is called ‘response'.
Pojav takega stanja se imenuje "odziv".
However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a period of time.
Vendar lahko zdravljenje zmanjša znake in simptome bolezni ali povzroči, da za nekaj časa izginejo.
CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
SKLEPNE UGOTOVITVE O ODSTOPANJU ZAHTEVKU ZA ENOLETNO TRŽNO ZAŠČITO KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Children and adolescents Imnovid is not recommended for use in children and young people under 18 years.
Otroci in mladostniki Zdravilo Imnovid ni priporočeno za uporabo pri otrocih in mladostnikih, starih manj kot 18 let.
Overall Survival: ITT Population
Celokupno preživetje: populacija ITT
Final clinical study report:
Končno poročilo o klinični študiji:
Day (of 21-day cycle)
Dan (21-dnevnega cikla)
See also section 4 “Possible side effects”).
Glejte tudi poglavje 4 "Možni neželeni učinki").
Your partner should also tell her doctor straight away.
Tudi vaša partnerica mora o tem takoj obvestiti svojega zdravnika.
Patients should be advised to report febrile episodes promptly.
Bolnikom je treba svetovati, da o febrilnih epizodah poročajo takoj.
Allergic reactions and severe skin reactions
Alergijske reakcije in hude kožne reakcije
If this happens to you, do not drive or operate tools or machinery.
Če se vam to zgodi, ne vozite avtomobila in ne upravljajte orodja ali strojev.
Blood donation and blood tests
Darovanje krvi in krvne preiskave
WARNING: Risk of severe birth defects.
OPOZORILO: Tveganje hudih prirojenih okvar.
*In case of neutropenia, the physician should consider the use of growth factors.
*V primeru nevtropenije naj zdravnik razmisli o uporabi rastnih faktorjev.
Pomalidomide should only be resumed after a thorough evaluation of the benefits and the risks.
Pomalidomid smemo spet začeti dajati šele po temeljiti oceni koristi in tveganj.
• Increased blood pressure.
• zvišan krvni tlak,
Based on these results, the observed effects were attributed to the treatment of females.
Na podlagi teh rezultatov so opazovane učinke pripisali zdravljenju samic.
Patients may require use of blood product support and /or growth factors.
Bolniki bodo morda potrebovali podporo v obliki krvnih izdelkov in/ali rastnih faktorjev.
The systemic exposure (AUC) of pomalidomide increases in an approximately linear and dose proportional manner.
Sistemska izpostavljenost (AUC) pomalidomidu se zvišuje približno linearno in sorazmerno z odmerkom.
These patients should be monitored closely and appropriate precautions taken.
Te bolnike je treba skrbno spremljati in ustrezno ukrepati.
Note: CI=Confidence interval; IRAC=Independent Review Adjudication Committee; NE = Not Estimable.
Opomba: IZ = interval zaupanja; IRAC = Neodvisni presojevalni odbor (Independent Review Adjudication Committee); NE = ni mogoče oceniti.
Your doctor should check whether you have ever had hepatitis B infection.
Vaš zdravnik mora preveri, ali ste kadar koli prej imeli okužbo s hepatitisom B.
You may feel tired and weak, and short of breath and you are also more likely to get infections.
Mogoče boste utrujeni in šibki in boste imeli kratko sapo in boste bolj dovzetni tudi za okužbe,
• You must follow the contraception advice described in this leaflet.
Upoštevati morate nasvete o kontracepciji, opisane v tem navodilu.
Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected.
Pomalidomida se ne sme jemati med nosečnostjo, ker se pričakuje teratogeni učinek.
System Organ Class/ Preferred Term
Organski sistem/preferenčni izraz
Treatment continued until patients had disease progression.
Zdravljenje se je nadaljevalo do napredovanja bolezni.
Each cycle lasts 28 days (4 weeks).
Vsak cikel traja 28 dni (4 tedne).
In case of permanent discontinuation of any component of the treatment regimen, continuation of the remaining medicinal products is at the physician's discretion.
V primeru trajne ukinitve katere koli sestavine režima zdravljenja je nadaljnje dajanje preostalih zdravil prepuščeno zdravnikovi presoji.
• A spinning feeling in your head, making it difficult to stand up and move normally.
• občutek vrtenja v glavi, zaradi katerega težko stojite in se normalno premikate,
Based on Cox proportional hazards model.
Na podlagi Coxovega modela proporcionalnih tveganj.
The capsules should not be opened, broken or chewed (see section 6.6).
Kapsul ni dovoljeno odpirati, zdrobiti ali žvečiti (glejte poglavje 6.6).
Imnovid hard capsules should be taken orally at the same time each day.
Zdravilo Imnovid trde kapsule je treba jemati peroralno vsak dan ob istem času.
• if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na pomalidomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In the event of overdose, supportive care is advised.
V primeru prevelikega odmerka se svetuje podporna nega.
The PFS advantage was more pronounced in patients who received only one prior line of therapy.
Korist za PFS je bila izrazitejša pri bolnikih, ki so prejeli samo eno vrsto predhodnega zdravljenja.
Before starting the treatment, you should tell your doctor if you are able to become pregnant, even if you think this is unlikely.
Pred začetkom zdravljenja povejte zdravniku, da lahko zanosite, tudi če mislite, da to ni verjetno.
Pomalidomide has minor or moderate influence on the ability to drive and use machines.
Pomalidomid ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body's natural defences).
To zdravilo je sorodno talidomidu in spada v skupino zdravil, ki vplivajo na delovanje imunskega sistema (naravna obramba telesa).
Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for both treatment groups.
Ne glede na ocenjene podskupine je bila PFS na splošno v skladu z opazovano v populaciji ITT za obe skupini zdravljenja.
A decision to take prophylactic measures should be made after a careful assessment of the individual patient's underlying risk factors.
Odločitev o uporabi profilaktičnih ukrepov je treba sprejeti po skrbni oceni obstoječih dejavnikov tveganja pri posameznem bolniku.
• Guidance on handling pomalidomide for patients, caregivers and family members
• smernice za ravnanje z pomalidomidom za bolnike, skrbnike in družinske člane;
If adverse reactions occur after dose reductions to 1 mg, then the medicinal product should be discontinued.
Če se neželeni učinki pojavijo po znižanju odmerka na 1 mg, je treba zdravilo ukiniti.
In these studies, monkeys exhibited greater sensitivity to pomalidomide effects than rats.
V teh študijah so bile opice bolj občutljive na učinke pomalidomida kot podgane.
• After completing each 3-week cycle, start a new one.
• Po dokončanju vsakega 3-tedenskega cikla začnite z novim.
The difference in OS between the two treatment arms was statistically significant (p < 0.001).
Razlika v celokupnem preživetju med obema skupinama zdravljenja je bila statistično značilna (p < 0,001).
Staphylococcal infection was observed in 4 monkeys; 3 of these animals responded to antibiotic treatment and 1 died without treatment.
Stafilokokno okužbo so opazili pri 4 opicah; 3 med njimi so se odzvale na zdravljenje z antibiotikom, 1 pa je umrla brez zdravljenja.
Neutropenia did not lead to pomalidomide discontinuation in any patient and was infrequently serious.
Nevtropenija ni povzročila ukinitve pomalidomida pri nobenem bolniku in je bila redko resna.
Dizziness and confusion
Omotičnost in zmedenost
Do not use while pregnant or breast-feeding.
Ne uporabljajte med nosečnostjo ali dojenjem.
If you forget to take Imnovid on a day when you should, take your next capsule as normal the next day.
Če ste pozabili vzeti zdravilo Imnovid na tisti dan, ko bi morali, vzemite naslednjo kapsulo naslednji dan kot običajno.
• You can take the capsules either with or without food.
• Kapsule se lahko jemljejo s hrano ali brez nje.
Each cycle lasts 21 days (3 weeks).
Vsak cikel traja 21 dni (3 tedne).
• Take Imnovid at about the same time each day.
• Zdravilo Imnovid jemljite vsak dan približno ob istem času.
As a precaution, and taking into account special populations with potentially prolonged elimination time such as hepatic impairment, all male patients taking pomalidomide must meet the following conditions:
Kot varnostni ukrep in z upoštevanjem posebnih populacij s potencialno podaljšanim časom izločanja, kot je okvara jeter, morajo vsi moški bolniki, ki jemljejo pomalidomid, izpolnjevati naslednje pogoje:
• you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels.
• ste imeli srčni napad, imate popuščanje srca, imate težave z dihanjem ali če kadite, imate visok krvni tlak ali visoke ravni holesterola;
• at least every month after that for as long as you are taking Imnovid.
• po tem pa najmanj enkrat mesečno, dokler jemljete zdravilo Imnovid.
You may also experience an uneven heartbeat.
Morda boste imeli neenakomeren srčni utrip.
Duration of the treatment with Imnovid You should continue the cycles of treatment until your doctor tells you to stop.
Trajanje zdravljenja z zdravilom Imnovid S cikli zdravljenja nadaljujte, dokler vam zdravnik ne pove, da prenehajte.
• She should be capable of complying with effective contraceptive measures
• mora biti zmožna upoštevati zanesljive kontracepcijske ukrepe,
Patients must avoid situations where dizziness or confusion may be a problem and not to take other medicinal products that may cause dizziness or confusion without first seeking medical advice.
Bolniki se morajo izogibati situacijam, kjer omotičnost in zmedenost lahko predstavljata težavo, in ne smejo uporabljati zdravil, ki lahko povzročijo omotičnost in zmedenost, ne da bi prej vprašali zdravnika za nasvet.
If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst you are receiving this medicine.
Če imate težave z jetri ali ledvicami, bo zdravnik skrbno preverjal vaše stanje, medtem ko jemljete to zdravilo.
• The recommended starting dose of bortezomib will be worked out by your doctor and based on your height and weight (1.3 mg/m2 body surface area).
• Priporočeni začetni odmerek bortezomiba bo določil vaš zdravnik na podlagi vaše telesne višine in telesne mase (1,3 mg/m2 telesne površine).
The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Tveganje za vensko trombembolijo se nadaljuje 4−6 tednov po prekinitvi jemanja kombinirane peroralne kontracepcije.
• After completing each 4-week cycle, start a new one.
• Po dokončanju vsakega 4-tedenskega cikla začnite z novim.
• She acknowledges that she understands the hazards and necessary precautions associated with the use of pomalidomide.
• mora potrditi, da razume tveganja in nujne previdnostne ukrepe, povezane z uporabo pomalidomida.
• Feeling down (depressed mood).
• občutek potrtosti (depresivno razpoloženje),
Hepatitis B virus status should be established before initiating treatment with pomalidomide.
Status virusa hepatitisa B je treba ugotoviti pred začetkom zdravljenja s pomalidomidom.
Pregnancy, contraception and breast-feeding - information for women and men The following must be followed as stated in the Imnovid Pregnancy Prevention Programme.
Nosečnost, kontracepcija in dojenje - informacije za ženske in moške Naslednje morate upoštevati, kot je navedeno v programu za preprečevanje nosečnosti za zdravilo Imnovid.
There was no maternal toxicity observed in this study.
V tej študiji niso opazili toksičnosti za mater.
This results in damage to the bones and kidneys.
To poškoduje kosti in ledvice.
• each time your doctor writes a prescription for you, he will ensure you understand the necessary measures that have to be taken to prevent pregnancy.
• bo zdravnik vsakič, ko vam predpiše zdravilo, preveril, da razumete potrebne ukrepe za preprečevanje nosečnosti;
Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Z ustreznimi ukrepi je treba poskusiti zmanjšati vse dejavnike tveganja, na katere je mogoče vplivati (npr. kajenje, hipertenzija in hiperlipidemija).
Infection was the most common non haematological toxicity.
Okužbe Okužbe so bile najpogostejša nehematološka toksičnost.
Before and during the treatment with Imnovid you will have regular blood tests.
Pred zdravljenjem z zdravilom Imnovid in med njim boste imeli redne krvne preiskave.
Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
V idealnem primeru se test nosečnosti, izdaja recepta in izdaja zdravila opravijo na isti dan.
• you have a high total amount of tumour throughout the body, including your bone marrow.
• imate veliko skupno tumorsko maso po vsem telesu, vključno v kostnem mozgu.
Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4).
Odmerjanje se nadaljuje ali spreminja glede na klinične in laboratorijske izvide (glejte poglavje 4.4).
What Imnovid is and what it is used for
Kaj je zdravilo Imnovid in za kaj ga uporabljamo
• Premature ovarian failure confirmed by a specialist gynaecologist
• prezgodnja odpoved jajčnikov, ki jo potrdi specialist ginekolog,
• The need to avoid fetal exposure
• potrebo po izogibanju fetalni izpostavljenosti,
• That the patient should not give pomalidomide to any other person
• opozorilo, da bolnik ne sme dajati pomalidomida nobeni drugi osebi;
• Sore or dry mouth.
• vneta ali suha usta,
What you need to know before you take Imnovid
Kaj morate vedeti, preden boste vzeli zdravilo Imnovid
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
• spolni odnosi samo z moškim partnerjem, ki so mu opravili vazektomijo; vazektomijo je treba potrditi z dvema negativnima preiskavama sperme,
This is because your medicine may cause a fall in the number of blood cells that help fight infection (white cells) and in the number of cells that help to stop bleeding (platelets).
To je zato, ker lahko to zdravilo povzroči zmanjšanje števila krvnih celic, ki pomagajo pri premagovanju okužb (bele krvne celice) in števila krvnih celic, ki pomagajo pri zaustavljanju krvavitev (trombociti).
Each pack contains 14 or 21 capsules.
Vsako pakiranje vsebuje 14 ali 21 kapsul.
• some antibiotics (for example ciprofloxacin, enoxacin)
• nekatere antibiotike (na primer ciprofloksacin, enoksacin),
**ANC - Absolute Neutrophil Count; ***CBC - Complete Blood Count.
**ANC - absolutno število nevtrofilcev (Absolute Neutrophil Counts); ***CKS - celotna krvna slika.
Prescriptions for women of childbearing potential can be for a maximum duration of 4 weeks, and prescriptions for all other patients can be for a maximum duration of 12 weeks.
Recept za ženske v rodni dobi je lahko veljaven največ 4 tedne, recepti za vse druge bolnike pa so lahko veljavni največ 12 tednov.
Summary of overall efficacy data are presented in Table 10 using a cut-off date of 26 Oct 2017.
Povzetek celotnih podatkov učinkovitosti kaže preglednica 10, uporabljen je bil datum zaključka zbiranja podatkov 26. oktober 2017.
Patients with known risk factors for thromboembolism - including prior thrombosis - should be closely monitored.
Bolnike z znanimi dejavniki tveganja za trombembolijo, vključno s predhodno trombozo, je treba skrbno nadzirati.
Prophylaxis with acetylsalicylic acid (and other anticoagulants in high risk patients) was mandatory for all patients in clinical studies.
Profilaksa z acetilsalicilno kislino (in drugimi antikoagulanti pri bolnikih z velikim tveganjem) je bila obvezna za vse bolnike v kliničnih študijah.
• Flu-like symptoms (influenza).
• gripi podobni simptomi (influenca),
This is because this medicine is expected to harm the unborn baby.
To je zato, ker se pričakuje, da bo zdravilo nerojenemu otroku škodovalo.
95% confidence interval about the median overall survival time.
95 % interval zaupanja glede mediane časa celokupnega preživetja.
If you become pregnant despite the prevention measures: • you must stop the treatment immediately and talk to your doctor straight away.
Če kljub preprečevalnim ukrepom zanosite: • se morate takoj prenehati zdraviti in se posvetovati s svojim zdravnikom.
• High blood levels of sugar.
• zvišana raven sladkorja v krvi,