natgillin/translations-raw huggingface dataset:
The Committee, as consequence, concluded that the benefit-risk balance of thiocolchicoside containing medicinal products for systemic use as adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwardsremains favourable, subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed.
Posledično je CHMP zaključil, da je razmerje med tveganji in koristmi zdravil za sistemsko uporabo, ki vsebujejo tiokolhikozid in so indicirana za adjuvantno zdravljenje bolečega krčenja mišic pri akutni patologiji hrbtenice pri odraslih in mladostnikih, starejših od 16 let, še naprej ugodno pod pogojem, da se upoštevajo dogovorjene omejitve, opozorila in druge spremembe informacij o zdravilu, dodatne dejavnosti farmakovigilance ter ukrepi za zmanjšanje tveganja.
However, more concern was raised in relation to the potential risk of foetal anomalies due to elevated sperm aneuploidy rather than to the male infertility per se.
Vendar pa se je več zadržkov zaradi tovrstne anevploidije pojavilo v zvezi z možnim tveganjem za nepravilnosti ploda kot v zvezi z neplodnostjo pri moških kot tako.
Having noted the above, the CHMP concluded that the benefit-risk balance of TCC containing medicinal products indicated as adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and RMMs agreed.
Ob upoštevanju vsega navedenega je CHMP zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo tiokolhikozid in so indicirana za adjuvantno zdravljenje bolečega krčenja mišic pri akutni patologiji hrbtenice pri odraslih in mladostnikih, starejših od 16 let, še naprej ugodno pod pogojem, da se upoštevajo dogovorjene omejitve, opozorila in druge spremembe informacij o zdravilu, dodatne dejavnosti farmakovigilance ter ukrepi za zmanjšanje tveganja.
Pre-clinical studies
Predklinične študije
Based on common use in acute settings, other recommendations for the posology were included as the limitation of the treatment duration to 7 days in case of oral administration and to 5 days in case of IM administration; a reference to the maximum dose allowed was also recommended .Finally a 12 hours interval between 2 consecutive administrations was requested in view of the elimination half-life of the M2 metabolite.
Glede na pogosto uporabo v akutnih primerih so vključili tudi druga priporočila glede odmerjanja, in sicer omejitev trajanja zdravljenja na 7 dni v primeru peroralne uporabe in na 5 dni v primeru intramuskularne uporabe; priporočili so tudi, da se navede največji dovoljeni odmerek.
Clinical trials and post marketing spontaneous reports were submitted by the MAHs.
Imetniki dovoljenja za promet z zdravilom so predložili klinična preskušanja in spontana poročila iz obdobja trženja.
The CHMP was therefore of the view that the available data allow to confirm a clear aneugenic effect of the thiocolchicoside metabolite M2 at concentrations which are 4 fold the human exposure in plasma after oral 8 mg TCC treatment bid (recommended dose) and starting from 25 mg/kg dose.The submitted data did not allow establishing a NOEL for aneuploidy, thus not excluding the potential for a human risk.
CHMP je zato menil, da je na podlagi razpoložljivih podatkov mogoče potrditi, da ima presnovek tiokolhikozida M2 nedvomno anevgeni učinek pri koncentracijah, ki so 4-krat večje od plazemske izpostavljenosti pri človeku po zdravljenju s peroralnim odmerkom 8 mg tiokolhikozida dvakrat na dan (priporočeni odmerek) in se začnejo pri odmerku 25 mg/kg.
Finally educational material for prescribers and for patients highlighting the risks and warnings of genotoxicity reactions will also be submitted to national competent authorities within the RMP.
Poleg tega se bo v okviru RMP pristojnim nacionalnim organom predložilo izobraževalno gradivo za zdravstvene delavce, ki predpisujejo zdravilo, in bolnike, da se jih seznani s tveganji in opozorili v zvezi z genotoksičnimi neželenimi učinki.
Widely used by prescribers in the concerned Member States (see Annex I), the benefits of TCC containing medicinal products are recognised in clinical practice.
Koristi zdravil, ki vsebujejo tiokolhikozid, so priznane v klinični praksi, saj zdravstveni delavci v zadevnih državah članicah (glejte Prilogo I) ta zdravila pogosto predpisujejo.
In addition, three-yearly PSURs should be submitted by all MAHs of these products.
Poleg tega morajo vsi imetniki dovoljenj za promet s temi zdravili predložiti 3-letna redno posodobljena poročila o varnosti zdravila.
Amendments to the warnings and pregnancy and lactation sections of the product information were also endorsed.
Potrdili so tudi spremembe poglavja povzetka glavnih značilnosti zdravila z opozorili in poglavij o nosečnosti ter dojenju.
No cases of cancer, congenital abnormalities, spontaneous abortion and impaired male fertility were retrieved from a review of clinical trials and literature.
V pregledu kliničnih preskušanj in literature niso zasledili primerov raka, prirojenih nepravilnosti, spontanega splava in zmanjšane plodnosti moških.
• Carcinogenicity and impaired fertility are categorised as important potential risks.Concerning the risk of male infertility: elevated sperm chromosome aneuploidy is known to be associated with male infertility.
Glede tveganja za neplodnost pri moških: znano je, da je anevploidija, ki povzroči povečano število kromosomov v semenčicah, povezana z neplodnostjo moških.
The duration of treatment must not exceed 2 weeks.
Trajanje zdravljenja ne sme presegati 2 tednov.
If a longer duration of use is required, other pharmaceutical forms are available.
Če je potreben daljši čas uporabe, so na voljo druge farmacevtske oblike.
[Solution for injection (i.m.)]
[Raztopina za injiciranje (i.m.)]
[The currently approved indications should be deleted and replaced by the following:]
[Trenutno odobrene indikacije se izbriše in nadomesti s sledečimi:]
Very common: Transaminases increased.
Zelo pogosti: zvišanje transaminaz.
The summary of product characteristics and package leaflet may need to be subsequently updated by the national competent authorities, in liaison with the reference Member State, if appropriate
Povzetek glavnih značilnosti zdravila in navodilo za uporabo bo morda posledično potrebno posodobiti s pristojnimi nacionalnimi organi, v povezavi z referenčno državo članico, kjer je to primerno.
For single dose application in adults with postoperative pain.
Za enkratno odmerjanje pri odraslih s pooperativno bolečino.
A. Summary of Product Characteristics (SmPC) <This medicinal product is subject to additional monitoring.
A. Povzetek glavnih značilnosti zdravila (SmPC) < Za to zdravilo se izvaja dodatno spremljanje varnosti.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
PRILOGA III Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
If liver function tests show pathological results your doctor will ask you to discontinue intake/use of <Product Name> immediately.
Če testi delovanja jeter kažejo patološke rezultate, bo vaš zdravnik nemudoma prekinil jemanje/uporabo < zdravila {X} >.
If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Če opazite kateri koli neželeni učinek, se posvetujte z <zdravnikom> <ali> <,> <farmacevtom> <ali> <medicinsko sestro>.
Very common: Liver enzymes increased Frequency not known: Hepatitis, liver failure
Zelo pogosti: zvišanje jetrnih encimov Neznana pogostnost: vnetje jeter (hepatitis), odpoved jeter
< Product Name > must only be used if treatment with other analgesics (e.g. non-steroidal antiinflammatory drugs, weak opioids) is contraindicated.
< Zdravilo {X} > se sme uporabljati le, če je zdravljenje z drugimi analgetiki (npr. nesteroidnimi protivnetnimi zdravili, šibkimi opioidi) kontraindicirano.
If abnormal liver function tests or clinical symptoms consistent with liver disease occur, treatment with <Product Name> must be discontinued.
Če se pojavijo nenormalni izvidi jetrnih testov ali klinični simptomi značilni za bolezen jeter, je treba zdravljenje z < zdravilom {X} > prekiniti.
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 vzeli < zdravilo {X} > [Spodaj navedeno besedilo je potrebno vključiti v ustrezne odstavke]
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V*.
If you observe any symptoms that may indicate hepatic damage during treatment with <Product Name> (e.g. loss of appetite, nausea, vomiting, abdominal discomfort, fatigue, dark urine, jaundice, pruritus) you have to discontinue intake/use of <Product Name> and to seek medical advice immediately if any such symptoms occur.
Če opazite simptome, ki bi lahko kazali na poškodbo jeter med zdravljenjem z < zdravilom {X} > (npr. izguba apetita, siljenje na bruhanje, bruhanje, bolečine v trebuhu, utrujenost, temen urin, zlatenica, srbenje), morate prekiniti z jemanjem/uporabo < zdravila {X} > in nemudoma poiskati zdravniško pomoč, če se pojavijo takšni simptomi.
Section 4.5 Interaction with other medicinal products and other forms of interaction [The wording below should be inserted in this section]
Poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
Patients should be advised to remain vigilant for any symptoms compatible with hepatic damage during treatment with <Product Name> (e.g. loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, pruritus) and to discontinue intake of <Product Name> and to seek medical advice immediately if any such symptoms occur.
Bolnikom je treba svetovati, naj bodo med zdravljenjem z < zdravilom {X} > pozorni na morebitne simptome značilne za poškodbo jeter (npr. izguba apetita, navzea, bruhanje, bolečine v trebuhu, utrujenost, temen urin, zlatenica, srbenje) in naj prenehajo z jemanjem < zdravila {X} > ter nemudoma poiščejo zdravniško pomoč, če se pojavijo takšni simptomi.
[All pharmaceutical forms]
[Peroralne farmacevtske oblike in svečke]
[The wording below should be inserted at the end of this section]
[Naslednje besedilo je treba vnesti na konec tega poglavja]
<Product Name> should not be used in patients with pre-existing liver disease or alcohol abuse.
< Zdravila {X} > se ne sme uporabljati pri bolnikih z že obstoječo boleznijo jeter ali bolnikih, ki zlorabljajo alkohol.
<Product name > must only be used if treatment with other analgesics is contraindicated.
< Zdravilo {X} > se sme uporabljati le, če je zdravljenje z drugimi analgetiki kontraindicirano.
[The wording below should be inserted in this section]
[V to poglavje je potrebno vključiti spodaj navedeno besedilo]
Your doctor will test liver function every week during treatment with <Product Name> because increased liver enzyme levels, hepatitis and liver failure have been reported in association with flupirtine therapy.
Vaš zdravnik bo opravil preiskave delovanja jeter vsak teden med zdravljenjem z < zdravilom {X} >, ker so v povezavi s terapijo s flupirtinom poročali o povišani ravni jetrnih encimov, hepatitisu in odpovedi jeter.
Concomitant use of flupirtine with other drugs known to cause drug induced liver injury must be avoided (see Section 4.5).
Sočasni uporabi flupirtina z drugimi zdravili, ki povzročajo z zdravili inducirano poškodbo jeter, se je potrebno izogibati (glejte poglavje 4.5).
Section 4.8 Undesirable effects [The wording below should be inserted in this section]
Poglavje 4.8 Neželeni učinki [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
Concomitant use of flupirtine with other drugs known to cause drug induced liver injury must be avoided (see Section 4.3).
Sočasni uporabi flupirtina z drugimi zdravili, ki povzročajo z zdravili inducirano poškodbo jeter, se je potrebno izogibati (glejte poglavje 4.3).
Not known: Hepatitis, liver failure.
Neznana pogostnost: hepatitis, odpoved jeter.
[Oral pharmaceutical forms and suppositories] Do not <take><use><Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
[Peroralne farmacevtske oblike in svečke] Ne <jemljite> <uporabljajte> zdravila X: če imate že obstoječo bolezen jeter če ste alkoholik če sočasno uporabljate druga zdravila, za katere je znano, da povzročajo z zdravili povzročeno poškodbo jeter
Do not use <Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Ne <jemljite> <uporabljajte> zdravila X: če imate že obstoječo bolezen jeter če ste alkoholik če sočasno uporabljate druga zdravila, za katere je znano, da povzročajo z zdravili povzročeno poškodbo jeter
How to take < product name > [the wording below should be inserted in the relevant sections]
Kako jemati < zdravilo {X} > [Spodaj navedeno besedilo je potrebno vključiti v ustrezne odstavke]
Liver function tests must be performed at weekly intervals during treatment with <Product Name> because increased liver enzyme levels, hepatitis and liver failure have been reported in association with flupirtine therapy.
V tedenskih presledkih med zdravljenjem z < zdravilom {X} > je potrebno opraviti jetrne teste, ker so v povezavi s terapijo s flupirtinom poročali o povišani ravni jetrnih encimov, hepatitisu in odpovedi jeter.
B. Package Leaflet <This medicine is subject to additional monitoring.
< Za to zdravilo se izvaja dodatno spremljanje varnosti.
[100 mg IR pharmaceutical form, suppositories] Flupirtine should be administered at the lowest effective dose for the shortest duration necessary to achieve adequate analgesia.
[100 mg farmacevtska oblika s takojšnjim sproščanjem, svečke] Flupirtin je potrebno uporabljati v najnižjem učinkovitem odmerku najkrajši možni čas, ki je potreben za doseg ustrezne analgezije.
[All pharmaceutical forms] Liver disorders:
[Vse farmacevtske oblike] Bolezni jeter, žolčnika in žolčevodov:
[100 mg IR pharmaceutical form, suppositories] Flupirtine should be used at the lowest effective dose for the shortest duration necessary to achieve adequate pain relief.
[100 mg farmacevtska oblika s takojšnjim sproščanjem, svečke] Flupirtin je potrebno uporabljati v najnižjem učinkovitem odmerku najkrajši možni čas, ki je potreben za lajšanje bolečine.
Section 4.3 Contraindications [The wording below should be inserted in this section]
Poglavje 4.3 Kontraindikacije [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
[Oral pharmaceutical forms and suppositories] Patients with pre-existing liver disease or alcohol abuse must not take <Product Name>.
Bolniki z že obstoječo boleznijo jeter ali bolniki, ki zlorabljajo alkohol, ne smejo jemati < zdravila {X} >.
What < product name > is and what it is used for [This section should replace any existing one and should read as follows:] [Oral pharmaceutical forms and suppositories] Treatment of acute pain in adults.
Kaj je < zdravilo {X} > in za kaj ga uporabljamo [Ta del mora zamenjati obstoječega in se glasi:]
Section 4.4 Special warnings and precautions for use
Poglavje 4.2 Odmerjanje in način uporabe
[Oral pharmaceutical forms and suppositories] Treatment of acute pain in adults.
Zdravljenje akutne bolečine pri odraslih.
Section 4.2 Posology and method of administration [The wording below should be inserted in this section]
Poglavje 4.4 Posebna opozorila in previdnostni ukrepi [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
Flupirtine should be administered for the shortest duration necessary to achieve adequate analgesia.
[400 mg farmacevtska oblika s prirejenim sproščanjem] Flupirtin je potrebno uporabljati najkrajši možni čas, ki je potreben za doseg ustrezne analgezije.
Number of cases Number of individuals*
Število primerov Število oseb*
Use with hormonal contraceptives
Uporaba s hormonskimi kontraceptivi
Date of first authorisation: 20 September 2006
Datum prve odobritve: 20. september 2006 Datum zadnjega podaljšanja: 20. julij 2011
1 dose (0.5 ml) contains approximately:
1 odmerek (0,5 ml) vsebuje približno:
% Efficacy
% učinkovitosti
Results of individual studies support the results from the combined analysis.
Rezultati posameznih študij podpirajo rezultate združene analize.
All three doses should be given within a 1-year period.
Vse tri odmerke je treba dati v obdobju 1 leta.
Silgard should be administered as soon as possible after being removed from the refrigerator.
Cepivo Silgard je treba uporabiti čim prej potem, ko ga vzamete iz hladilnika.
HIV infection was an exclusion criterion (see also section 4.4).
Okužba s HIV je bila izključitveni kriterij (glejte tudi poglavje 4.4).
Other medicines or vaccines and Silgard
Druga zdravila ali cepiva in cepivo Silgard
Efficacy against PIN grades
Učinkovitost proti PIN stopenj
At the end of this period Silgard should be used or discarded.
Ob koncu tega obdobja je treba cepivo Silgard ali uporabiti ali zavreči.
Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C.
Podatki iz stabilnostnih študij kažejo, da so komponente cepiva stabilne 72 ur pri shranjevanju pri temperaturi od 8 °C do 42 °C.
In this study, a durable protection was statistically demonstrated to approximately 10 years.
V tej študiji je bilo trajanje zaščite statistično ocenjeno na približno 10 let.
The results are summarised in Table 3.
Ti rezultati so povzeti v preglednici 3.
Afterwards, the GMTs declined through Month 24 - 48 and then generally stabilized.
Pozneje so se geometrijski srednji titri od 24. do 48. meseca zniževali in se nato na splošno stabilizirali.
The duration of protection is currently unknown.
Trajanje zaščite trenutno ni znano.
If you are from 9 to and including 13 years of age
Če ste stari od 9 do vključno 13 let
Long-term follow-up studies are currently ongoing to determine the duration of protection (see
Trenutno potekajo študije dolgotrajnega spremljanja, ki bodo pokazale trajanje zaščite (glejte
However, these data are insufficient to recommend use of Silgard during pregnancy.
Vendar pa ti podatki ne zadostujejo za priporočilo uporabe cepiva Silgard med nosečnostjo.
Headache was also seen.
Poročali so tudi o glavobolu.
The median duration of follow-up was 2.9 years.
Mediani čas spremljanja je bil 2,9 leta.
Detailed information on this medicinal product is available on the website of the European Medicines
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
For the 10 individual HPV types, statistical significance was only reached for HPV 31.
Za 10 posameznih tipov HPV je bila statistična značilnost dosežena samo pri HPV 31.
Efficacy was measured starting after the Month 7 visit.
Učinkovitost so začeli meriti po obisku v 7. mesecu.
A subset of individuals enrolled in the Phase III studies was followed up for a long-term period for safety, immunogenicity and effectiveness.
Podskupino oseb, vključenih v študije III. faze, so dolgotrajno spremljali glede varnosti, imunogenosti in učinkovitosti.
Please tell your doctor or pharmacist if you or your child are taking or have taken recently any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
[Very Common (≥1/10); Common (≥1/100 to 1/10); Uncommon (≥1/1,000 to 1/100); Rare (≥1/10,000 to 1/1,000); Very Rare (1/10,000)]
[Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do  1/10); občasni (≥ 1/1.000 do  1/100); redki (≥ 1/10.000
The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o
Silgard is a vaccine.
Silgard je cepivo.
It is important that procedures are in place to avoid injury from faints.
Pomembno je, da so na voljo ukrepi za preprečitev poškodbe zaradi omedlevice.
The exact duration of immunity following a 3-dose series has not been established and is currently being studied.
Natančno trajanje imunosti po cepljenju s 3 odmerki ni ugotovljeno in ga trenutno preučujejo.
The safety profile was similar to non-HIV infected subjects in other studies.
Varnostni profil je bil podoben kot pri s HIV neokuženih osebah v drugih študijah.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
• has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system.
• oslabljen imunski sistem, npr. zaradi genetske okvare, okužbe z virusom HIV ali zdravil, ki vplivajo na imunski sistem.
EXP MM/YYYY
EXP MM/LLLL
The duration of protection against anal cancer is currently unknown.
Trajanje zaščite proti raku anusa trenutno ni znano.
These data are intended to guide healthcare professionals in case of temporary temperature excursion only.
Ti podatki so namenjeni kot vodilo zdravstvenim delavcem le v primeru prehodnih nihanj temperature.
• First injection: at chosen date
• Prva injekcija: ob izbranem času
Evidence of Anamnestic (Immune Memory) Response
Dokaz anamnestičnega odziva (imunskega spomina)
What you need to know before you receive Silgard
Kaj morate vedeti, preden boste prejeli cepivo Silgard
The median duration of follow-up for this study was 4.0 years.
Mediani čas spremljanja te študije je bil 4,0 leta.
Pharmacotherapeutic group: Viral Vaccine, ATC code: J07BM01
Farmakoterapevtska skupina: Virusna cepiva, oznaka ATC: J07BM01
You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Še naprej morate upoštevati zdravnikova navodila o brisih materničnega vratu/Pap testih in preventivnih ter zaščitnih
• you or your child suffer from an illness with high fever.
• če imate vi ali vaš otrok bolezen z močno zvišano telesno temperaturo.
The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity.
Razlike so bile < 10 %, v večini primerov pa so poročali, da je bil neželeni učinek blag do zmeren.
The safety and efficacy of Silgard in children below 9 years of age have not been established.
Varnost in učinkovitost cepiva Silgard pri otrocih, mlajših od 9 let, nista bili dokazani.
• The vaccine should be used as supplied.
• Cepivo morate uporabiti, kot je pripravljeno.
Silgard is intended to prevent these diseases.
Cepivo Silgard je namenjeno preprečitvi teh bolezni.
Table 1 also includes additional adverse events which have been spontaneously reported during the post-marketing use of Silgard worldwide.
Preglednica 1 vključuje tudi dodatne neželene učinke, o katerih so spontano poročali v obdobju trženja cepiva Silgard po vsem svetu.
Side effects that have been reported during marketed use include:
Neželeni učinki, o katerih so poročali v času trženja: