natgillin/translations-raw huggingface dataset:
Prior HCV therapy
Prethodna terapija HCV-a
Table 4: Adverse drug reactions identified with Harvoni Frequency
Tablica 4: Nuspojave utvrđene uz Harvoni
- Harvoni (without ribavirin) for 24 weeks may be considered in patients who are ineligible for or intolerant to ribavirin.
U pacijenata koji nisu pogodni za liječenje ribavirinom ili ga ne podnose može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 24 tjedna.
No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
U pacijenata s dekompenziranom cirozom i/ili onih poslije transplantacije jetre i koji su primali ledipasvir/sofosbuvir s ribavirinom, nisu otkrivene nove nuspojave.
Recommended dose
UPUTA O LIJEKU
Common side effects (may affect up to 1 in 10 people)
(mogu se javiti u do 1 na 10 osoba) • osip
Harvoni is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
Harvoni je kontraindiciran s rifabutinom, jakim induktorom intestinalnog P-gp (vidjeti dio 4.3).
Elimination Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%).
[14C]-radioaaktivnosti u stolici i mokraći iznosila je 87 %, s time da je najviše radioaktivne doze otkriveno u stolici (86 %).
No dose adjustment of Harvoni or tacrolimus is required.
Nije potrebna prilagodba doze lijeka Harvoni ili takrolimusa.
F0-F1
UGT1A1.
Change in CPT: 59% (79/133) and 34% (45/133) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 39 patients who had CPT C cirrhosis at baseline, 56% (22/39) had CPT B cirrhosis at post-treatment week 12; of the 99 patients who had CPT B cirrhosis at baseline, 29% (27/92) had CPT A cirrhosis at post-treatment week 12.
CPT rezultata od početka do 12. tjedna nakon liječenja; od 39 pacijenata koji su imali CPT C stadij ciroze na početku, 56 % (22/39) imalo je CPT B stadij ciroze u 12. tjednu nakon liječenja; od
Table 12: Response rates in study ION-2 LDV/SOF
Tablica 12: Stope odgovora u ispitivanju ION-2 LDV/SOF
Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
< 50 ml/min (vidjeti dio 5.2).
IL28CC genotype FibroTest-Determined Metavir scoreb
Metavir-rezultat određen FibroTestomb
Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Harvoni s okskarbazepinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)
Rifampicin (600 mg jedanput na dan)/ ledipasvir (jedna doza od 90 mg)d
Harvoni is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Harvoni je kontraindiciran s rifampicinom, jakim induktorom intestinalnog P-gp (vidjeti dio 4.3).
In genotype 3 infected patients experiencing virologic failure, development of NS5A RAVs (including enrichment of RAVs present at baseline) was typically not detected at the time of failure (n = 17).
(uključujući obogaćenje RAV-ova prisutno na početku) obično nije bio otkriven u vrijeme virološkog neuspjeha (n =17).
ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
Odrasli istovremeno zaraženi HCV/HIV-om - ERADICATE ERADICATE je bilo otvoreno ispitivanje kojim se procijenilo 12 tjedana liječenja ledipasvirom/sofosbuvirom u 50 pacijenata s CHC-om uzrokovanim genotipom 1 i istovremenom
The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 5.
Vrijednosti EC50 ledipasvira i sofosbuvira protiv replikona pune duljine ili kimeričkih replikona koji kodiraju sekvence NS5A i NS5B iz kliničkih izolata navedene su u tablici 5. Prisutnost 40 % ljudskog seruma nije imala učinka na anti-HCV djelovanje sofosbuvira, ali je smanjila anti-HCV djelovanje ledipasvira 12 puta protiv replikona genotipa 1a HCV-a.
Darunavir boosted with ritonavir (800 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Darunavir pojačan ritonavirom (800 mg/ 100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)
Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)
Ciklosporin (jedna doza od 600 mg)/ sofosbuvir (jedna doza od 400 mg)h
• The other ingredients are
• Drugi sastojci su Jezgra tablete:
• fainting
• umor
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)
HIV ANTIVIRUSNI LIJEKOVI: INHIBITORI REVERZNE TRANSKRIPTAZE Efavirenz/ emtricitabin/ tenofovirdizoproksilfumarat (600 mg/ 200 mg/ 300 mg/ jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
ANTICOAGULANTS Dabigatran etexilate
OTPADNIH MATERIJALA KOJI POTJEČU
before taking this medicine.
OD LIJEKA, AKO JE POTREBNO
Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Atazanavir pojačan ritonavirom (300 mg/ 100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)
Genotype 6a
Genotip 6a b b
Patients with cirrhosis
Pacijenti s cirozom
If you forget to take Harvoni It is important not to miss a dose of this medicine.
Važno je da ne propustite uzeti dozu ovog lijeka.
When co-administered with Harvoni, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 4.4).
Kad se primjenjuju istovremeno s lijekom Harvoni, potrebno je razmotriti sniženu dozu statina i provoditi pažljivo praćenje zbog nuspojava statina
↑ Pravastatin
I DOHVATA
SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a. 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12.
U ispitivanje je bilo uključeno 8 pacijenata s infekcijom genotipom 4 HCV-a; 8/8 ih je postiglo SVR12. b. Nazivnik za relaps je broj pacijenata s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja terapije.
Emtricitabine ↔ Cmax 1.02 (0.96, 1.08) ↔ AUC 1.04 (1.00, 1.08) ↔ Cmin 1.03 (0.97, 1.10)
Norelgestromin ↔ Cmax 1,02 (0,89; 1,16) ↔ AUC 1,03 (0,90; 1,18) ↔ Cmin 1,09 (0,91; 1,31)
Based on the population pharmacokinetic analysis in HCV-infected patients, geometric mean steady-state AUC0-24 for ledipasvir (n = 2,113), sofosbuvir (n = 1,542), and GS-331007 (n = 2,113) were 7,290, 1,320 and 12,000 ng•h/mL, respectively.
Na temelju analize populacijske farmakokinetike u pacijenata zaraženih HCV-om, geometrijska srednja vrijednost AUC0-24 u stanju dinamičke ravnoteže za ledipasvir (n = 2113), sofosbuvir
SVR Outcome for patients without SVR On-treatment virologic failure a
SVR Ishod u pacijenata bez SVR
Due to the limited size of studies, the impact of baseline NS5A RAVs on treatment outcome for patients with genotype 2, 3, 4, 5 or 6 CHC has not been fully evaluated.
Zbog ograničene veličine ispitivanja, utjecaj početnih NS5A RAV-ova na ishod liječenja pacijenata s
Gilead Sciences Ltd. Tel: + 353 214 825999
Gilead Sciences S.r.l. Tel: + 39 02 439201
Marketing Authorisation Holder Gilead Sciences International Ltd. Cambridge
Nositelj odobrenja za stavljanje gotovog lijeka u promet Gilead Sciences International Ltd.
f. Staggered administration (12 hours apart) of atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate or darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate and Harvoni provided similar results.
+ emtricitabin/tenofovirdizoproksilfumarata i lijeka Harvoni u vremenskom razmaku (od 12 sati) dala je slične rezultate.
IMMUNOSUPPRESSANTS Ciclosporing
IMUNOSUPRESIVI
This data indicate that renal clearance is the major elimination pathway for GS-331007 with a large part actively secreted.
GS-331007 s time da se veliki dio izlučuje aktivno.
Use with certain HIV antiretroviral regimens
Pacijenti su primali stabilnu antiretrovirusnu terapiju protiv virusa HIV-1
Gilead Sciences S.r.l.
Gilead Sciences Ltd.
Gilead Sciences International Ltd. Tel: + 44 (0) 20 7136 8820
Gilead Sciences Poland Sp. z o.o. Tel: +48 22 262 8702
(listed in section 6 of this leaflet).
(vidjeti dio 4.3).
ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC
Odrasli s cirozom ili bez nje koji prethodno nisu bili liječeni - ION-1 (ispitivanje 0102) - genotip 1 Ispitivanje ION-1 bilo je randomizirano, otvoreno ispitivanje kojim se procijenilo 12 i 24 tjedna liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega u 865 pacijenata s CHC-om uzrokovanim genotipom 1, uključujući one s cirozom (randomizirani u omjeru 1:1:1:1), koji prethodno nisu bili liječeni.
Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in patients with decompensated disease (irrespective of liver transplantation status), 3/7 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir relapsed, as compared to 4/68 in those without any baseline RAVs or RAVs conferring ≤ 100-fold reduced susceptibility to ledipasvir.
NS5A RAV-ovima koji nose > 100 puta smanjenu osjetljivost na ledipasvir imalo je relaps, u usporedbi s 4/68 pacijenata bez ikakvih početnih RAV-ova ili RAV-ova koji nose ≤ 100 puta smanjenu osjetljivost na ledipasvir.
Randomisation was stratified by the presence or absence of cirrhosis and HCV genotype (1a versus 1b).
Randomizacija je bila stratificirana prema prisutnosti ili odsutnosti ciroze i genotipu
Otherb
Nuspojava
Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
↑ Cmin 1,47 (1,38; 1,57) Ledipasvir ↑ Cmax 1,68 (1,54; 1,84)
Interaction not studied Close monitoring of INR is recommended with all vitamin K antagonists.
Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja Harvoni.
Ledipasvir ↔ Cmax 0.92 (0.85, 1.00) ↔ AUC 0.91 (0.84, 1.00) ↔ Cmin 0.89 (0.81, 0.98)
R-metadon ↔ Cmax 0,99 (0,85; 1,16) ↔ AUC 1,01 (0,85; 1,21) ↔ Cmin 0,94 (0,77; 1,14)
Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Atazanavir ↔ Cmax 1,07 (0,99; 1,14)
Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni.
smanjiti koncentraciju ledipasvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
Harvoni is contraindicated with St. John's wort, a potent intestinal P-gp inducer (see section 4.3).
Harvoni je kontraindiciran s gospinom travom, jakim induktorom intestinalnog P-gp (vidjeti dio 4.3).
Cirrhosis
Ciroza
American
DJECE
When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir.
Kad se daje s tenofovirdizoproksilfumaratom koji se primjenjivao zajedno s atazanavirom/ritonavirom,
Ethinyl estradiol ↔ Cmax 1.15 (0.97, 1.36)
↑ Cmin 1,23 (1,00; 1,51) Etinilestradiol ↔ Cmax 1,15 (0,97; 1,36)
a. One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon based regimen.
Prethodno liječenje režimom na temelju nepegiliranog interferona bilo je neuspješno u jednog pacijenta u terapijskoj skupini liječenoj 24 tjedna LDV/SOF-om i jednog pacijenta u skupini liječenoj 24 tjedna LDV/SOF+RBV-om.
Norgestrel ↔ Cmax 1.18 (0.99, 1.41) ↑ AUC 1.19 (0.98, 1.45) ↑ Cmin 1.23 (1.00, 1.51)
↔ Cmin 0,97 (0,86; 1,10) Ledipasvir ↑ Cmax 1,45 (1,34; 1,56)
The safety of these vaccines should continue to be carefully monitored.
Sigurnost ovih cjepiva i dalje se treba pažljivo pratiti.
The vast majority of POTS reports came from a centre in Denmark (Brinth et al, 2015)1.
Velika većina prijava SPOT-a dolazi iz centra u Danskoj (Brinth et al, 2015.)1.
The benefits of HPV vaccines continue to outweigh their risks.
Koristi cjepiva protiv HPV-a i dalje nadmašuju njihove rizike.
On 09 July 2015 the European Commission therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the EMA to assess these concerns.
Stoga je Europska komisija 9. srpnja 2015. pokrenula postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 na temelju podataka o farmakovigilanciji i zatražila od EMA-e da ocijeni ta pitanja.
More than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination.
Više od 80 milijuna djevojčica i žena diljem svijeta primilo je ova cjepiva; u nekim europskim zemljama njima je cijepljeno 90 % pripadnica dobne skupine za koju se preporučuje cijepljenje.
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 20 of Regulation (EC) No 726/2004 for HPV vaccines.
• je Odbor za procjenu rizika u području farmakovigilancije (PRAC) razmotrio postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 za cjepiva protiv HPV-a;
In this respect, the CHMP commented that these comparisons should take into account likely increasing awareness of these syndromes to ensure appropriate interpretation of emerging data.
U tom je smislu CHMP napomenuo da se tim usporedbama treba uzeti u obzir vjerojatno rastuća svijest o tim sindromima kako bi se zajamčilo ispravno tumačenje novih podataka.
The advice of the Scientific advisory group (SAG) on vaccines was sought; the expertise of this group was supplemented with additional European experts on these syndromes and on neurology, cardiology and pharmacoepidemiology.
Zatražen je savjet od znanstvene savjetodavne skupine; stručnost te skupine nadopunjena je dodatnim europskim stručnjacima za te sindrome i neurologiju, kardiologiju i farmakoepidemiologiju.
These syndromes have been subject to previous repeated review by PRAC.
Ovi su sindromi bili predmet prethodnih opetovanih pregleda PRAC-a.
Human papillomavirus (HPV) vaccines have been authorised in the European Union since 2006 for the prevention of cervical and various other cancers caused by HPV infection.
Cjepiva protiv humanih papiloma virusa (HPV) odobrena su u Europskoj uniji od 2006. u svrhu sprječavanja nastanka raka grlića maternice i drugih karcinoma uzrokovanih infekcijom HPV-om.
The CHMP noted the recommendations to the MAHs that had been made by the PRAC in terms of future monitoring.
CHMP je istaknuo preporuke koje je PRAC dao nositeljima odobrenja u pogledu budućeg nadzora.
The onset of symptoms of CRPS is difficult to define because the syndrome is usually only diagnosed from the point when normal recovery from the initiating trauma should have occurred, and is usually only recognised sometime later among those with continuing pain afterwards.
Početak javljanja simptoma KRBS-a teško se može definirati jer se sindrom najčešće dijagnosticira tek u trenutku kada je već trebalo doći do uobičajenog oporavka od prvotne traume te se najčešće prepoznaje nakon nekog vremena, među osobama koje pate od stalne boli.
This is in accordance with the Scientific advisory group conclusions that most of the reviewed reports of POTS could better correspond to the definition of CFS or at least include some features of CFS.
Navedeno je u skladu sa zaključcima znanstvene savjetodavne skupine da većina pregledanih prijava SPOT-a bolje odgovara definiciji SKU-a ili u najmanju ruku obuhvaća neka svojstva SKU-a.
POTS patients typically show persistent tachycardia for more than 10 minutes upon standing, as well as an increase in heart rate to above 120 bpm or by ≥ 30bpm, and in children and juveniles below 19 years of age by ≥ 40bpm, without arterial hypotension.
Bolesnici koji boluju od SPOT-a najčešće proživljavaju neprestanu tahikardiju više od 10 minuta nakon ustajanja, kao i ubrzanje rada srca na više od 120 otkucaja po minuti ili za ≥ 30 otkucaja po minuti, dok kod djece i osoba mlađih od 19 godina to iznosi ≥ 40 bpm, bez arterijske hipotenzije.
Use of these vaccines is expected to prevent many cases of cervical cancer and various other cancers and conditions caused by HPV.
Očekuje se da će se primjenom tih cjepiva spriječiti brojni slučajevi raka grlića maternica te drugih karcinoma i stanja koja uzrokuje HPV.
A diagnosis of POTS cannot solely rely on these criteria; other symptoms (e.g. syncope, fatigue, headaches, lightheadedness, diaphoresis, tremor, palpitations, exercise intolerance, near syncope upon standing upright) vary across patients and are otherwise non-specific.
Dijagnoza SPOT-a ne može se temeljiti isključivo na tim kriterijima; ostali simptomi (npr. gubitak svijesti, umor, glavobolje, ošamućenost, dijaforeza, nevoljno drhtanje, palpitacije, nemogućnost vježbanja, osjećaj gubitka svijesti prilikom ustajanja) razlikuju se među pacijentima i nisu specifični.
CRPS
KRBS
POTS is a systemic syndrome which has been known for a long time under different names and is still poorly understood.
SPOT je sustavni sindrom koji je odavno poznat pod različitim nazivima te i dalje nije u dovoljnoj mjeri razjašnjen.
This centre has recently published more information on these reports, suggesting that some of these individuals were likely to have had chronic fatigue syndrome (CFS).
Taj je centar nedavno objavio dodatne informacije o spomenutim prijavama koje upućuju na to da su neki od tih pojedinaca vjerojatno imali sindrom kroničnog umora (SKU).
The PRAC noted that some symptoms of these syndromes may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME).
PRAC je uočio da se neki simptomi tih sindroma mogu preklapati s kroničnim sindromom umora (SKU, također poznat kao mijalgični encefalomijelitis, ME).
A study by Donegan and colleagues (2013)2, using self-controlled case series design (and therefore avoiding the issue of differential diagnostic practice in vaccinated and unvaccinated), evaluated diagnoses of CFS, as well as referrals from general practice for as yet undiagnosed symptoms of chronic fatigue and exhaustion, as well as diagnoses for fibromyalgia, post viral syndrome and neurasthenia.
U studiji koju su proveli Donegan i suradnici (2013.)2, a u kojoj je korišten model niza samokontrolirajućih slučajeva (čime je izbjegnut problem diferencijalne dijagnoze kod cijepljenih i necijepljenih osoba), ocjenjivale su se dijagnoze SKU-a i upućivanja liječnika opće prakse za dotad nedijagnosticirane simptome kroničnog umora i iscrpljenosti, kao i dijagnoze fibromialgije, postviralnog sindroma i neurastenije.
As many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS, these results were considered relevant for the current evaluation.
Budući da brojne prijave uzete u obzir u pregledu imaju značajke SKU-a, a brojni su pacijenti imali dijagnoze SPOT-a i SKU-a, ti su se rezultati smatrali relevantnima za trenutnu ocjenu.
The review found no evidence that the overall rates of these syndromes in vaccinated girls were different from expected rates in these age groups, even taking into account possible underreporting.
Pregledom nisu utvrđeni dokazi o tome da se ukupne stope pojave tih sindroma u cijepljenih djevojaka razlikuju od očekivanih stopa u tim dobnim skupinama, čak ako se u obzir uzme i neprijavljivanje.
Analyses of observed versus expected number of spontaneous reports were undertaken, covering a wide range of scenarios regarding underreporting (from 1 - 100 % reporting) and including reports that did not fully meet the diagnostic criteria for the syndrome.
Provedene su analize uočenog broja spontanih prijava u odnosu na njihov očekivani broj, pri čemu je obuhvaćen široki raspon scenarija u pogledu neprijavljivanja (od 1 - 100 % prijava) te su uključene prijave koje nisu u potpunosti ispunile dijagnostičke kriterije za sindrom.
Brinth LS, Pors K, Theibel AC, Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papillomavirus; Vaccine, 2015; 33(22):2602-5.
Brinth L.S., Pors K., Theibel A.C., Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papillomavirus (Sindrom ortostatske intolerancije i posturalne tahikardije kao moguća nuspojava cjepiva protiv humanog papiloma virusa);Vaccine, 2015.;
• The PRAC took note of the fact that CRPS and POTS occur in the general unvaccinated population and have been described in the medical literature before HPV vaccines were introduced.
• PRAC je uzeo u obzir činjenicu da se sindromi KRBS i SPOT pojavljuju u općeg necijepljenog stanovništva te da su opisani u medicinskoj literaturi još prije uvođenja cjepiva protiv HPV-a.
In the review of clinical trial data a total of 60,594 subjects were included for Gardasil/Silgard and Gardasil 9 and 42,047 subjects for Cervarix.
U pregledu podataka iz kliničkih ispitivanja ukupno 60 594 ispitanika uključeno je za Gardasil/Silgard i Gardasil 9 te 42 047 za Cervarix.
Overall, in these analyses the rates of these syndromes in vaccinated girls were consistent with expected rates in these age groups.
Ukupno gledajući, u tim su analizama stope pojave tih sindroma u cijepljenih djevojaka bile sukladne očekivanim stopama u tim dobnim skupinama.
Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of the vaccines and two syndromes in particular, which are known as Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS).
Rutinski nadzor prijava sumnji na nuspojave doveo je do pitanja o mogućoj povezanosti između korištenja cjepiva i posebice dvaju sindroma poznatih pod nazivima kompleksni regionalni bolni sindrom (KRBS) i sindrom posturalne ortostatske tahikardije (SPOT).
No cases were identified in the Cervarix and comparator cohorts.
Nije utvrđen nijedan slučaj u skupini koja je primila Cervarix i skupinama koje su primile usporednik.
POTS
SPOT
The PRAC requested data and analyses from the MAHs regarding CRPS and POTS from clinical trials and post-marketing safety data, and took into account literature review, data from Eudravigilance, reports submitted by member states, including Denmark, as well as information from Japan and information submitted voluntarily by the public.
PRAC je od nositelja odobrenja zatražio podatke i analize u vezi s KRBS-om i SPOT-om iz kliničkih ispitivanja i podatke o sigurnosti nakon izdavanja odobrenja za stavljanje lijeka u promet te je uzeo u obzir pregled literature, podatke iz baze podataka Eudravigilance, izvješća država članica, uključujući Dansku, te informacije od Japana i informacije koje je su dobrovoljno dostavili članovi javnosti.
CRPS is defined as continuing pain that is disproportionate to the inciting event and may be associated with dysautonomic signs and symptoms and is usually confined to a single limb.
KRBS se definira kao stalna bol koja nije razmjerna uzročnom događaju, koja se može povezati sa znakovima i simptomima disautonomije te se najčešće pojavljuje samo u jednom udu.
Taking into account the totality of the available information the PRAC concluded that the evidence does not support that HPV vaccines (Cervarix, Gardasil, Gardasil 9, Silgard) cause CRPS or POTS.
Uzimajući u obzir ukupnost dostupnih podataka, PRAC je zaključio da nema dokaza da cjepiva protiv HPV-a (Cervarix, Gardasil, Gardasil 9, Silgard) uzrokuju KRBS ili SPOT.