natgillin/translations-raw huggingface dataset:
A booster dose of Menveo was administered 5 years after primary vaccination with Menveo or ACWY-PS. At 7 days after the booster dose, 98%-100% of subjects who previously received Menveo and 73%-84% of subjects who previously received ACWY-PS achieved hSBA ≥1:8 against serogroups A, C, W-135 and Y. At one month post vaccination, the percentages of subjects with hSBA≥1:8 were 98%-100% and 84%-96%, respectively.
Sedam dana nakon docjepljivanja, 98% - 100% ispitanika koji su prethodno cijepljeni cjepivom Menveo i 73% - 84% ispitanika koji su prethodno cijepljeni cjepivom ACWY-PS postigli su hSBA ≥1:8 protiv serogrupa A, C, W-135 i Y.
Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Vrlo često: bol na mjestu injiciranja, eritem na mjestu injiciranja (≤50 mm), otvrdnuće na mjestu injiciranja (≤50 mm), malaksalost
Very rare:
Manje često:
4.7 Effects on ability to drive and use machines
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
Menveo Menveo ACWY-P S
Menveo ACWYPS Menveo ACWY -PS Menveo ACWY-PS
Common: rash, injection site redness (> 50 mm), injection site firmness (> 50 mm), joint ache, fever ≥ 38°C, chills
Često: osip, crvenilo na mjestu injiciranja (> 50 mm), otvrdnuće na mjestu injiciranja (> 50 mm), bol u zglobovima, vrućica ≥ 38°C, zimica
4.4 Special warnings and precautions for use
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
At 1 month post-first vaccination, the percentages of subjects with hSBA ≥ 1:8 were consistently higher in the Menveo group for all four serogroups (63% vs 39%, 46% vs 39%, 78% vs 59%, and 65% vs 57% for Menveo as compared to ACWY-PS for serogroups A, C, W-135, and Y, respectively).
Mjesec dana nakon prvog cijepljenja, postotci ispitanika s hSBA≥1:8 bili su dosljedno viši u skupini koja je primila Menveo za sve četiri serogrupe (63% naspram 39%, 46% naspram 39%, 78%
Menveo ACWYPS Menveo ACWY-P S Menveo ACWYPS Menveo ACWY-PS A N=280 N=281 N=280 N=281 N=253 N=238 N=253 N=238
A N=280 N=281 N=280 N=281 N=253 N=238 N=253 N=238
Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Vrlo često: razdražljivost, malaksalost, bol na mjestu injiciranja, eritem na mjestu injiciranja (≤50 mm), otvrdnuće na mjestu injiciranja (≤50 mm) Često: eritem na mjestu injiciranja (>50 mm), otvrdnuće na mjestu injiciranja (>50 mm), zimica, vrućica ≥38°C
hSBA ≥ 1:8 (95% CI)
hSBA (95% C I)
Reconstitution of the vaccine
PRIMJENU LIJEKA
Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Y konjugirano na 5,6-10,0 mikrograma proteina CRM197 Corynebacterium diphtheriae
At 7 days post vaccination, 64% of subjects achieved hSBA ≥1:8 against serogroup A and 88% through 90% of subjects had bactericidal antibodies against serogroups C, W-135 and Y. At one month post vaccination, 92% through 98% of subjects had hSBA ≥1:8 against serogroups A, C, W-135 and Y. A robust immune response as measured by hSBA GMTs against all serogroups was also observed at 7 days (GMTs 34 through 70) and 28 days (GMTs 79 through 127) after a single dose vaccination.
Sedam dana nakon cijepljenja, 64% ispitanika postiglo je hSBA ≥1:8 protiv serogrupe A i 88% do 90% ispitanika imalo je baktericidna protutijela protiv serogrupa C, W-135 i Y.
In the non-inferiority study, V59P6, immunogenicity was assessed among adolescents aged 11-17 years who had been randomised to receive either Menveo or ACWY-PS. Menveo was shown to be non-inferior to ACWY-PS vaccine for all four serogroups (A, C, W-135 and Y) based on seroresponse, proportions achieving hSBA ≥1:8, and GMTs.
U ispitivanju neinferiornosti, V59P6, procijenjena je imunogenost u adolescenata u dobi od 11 do 17 godina koji su randomizirani prema primanju cjepiva Menveo ili ACWY-PS.
Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
A konjugirano na 16,7-33,3 mikrograma proteina CRM197 Corynebacterium diphtheriae
At one year post vaccination in these same subjects, compared with ACWY-PS, a higher proportion of subjects vaccinated with Menveo had hSBA ≥1:8 for serogroups C, W-135, and Y, with comparable levels for serogroup A. Similar findings were observed in the comparison of hSBA GMTs.
Menveo je imao hSBA ≥1:8 za serogrupe C, W-135 i Y, s usporedivim razinama za serogrupu A.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
Sodium dihydrogen phosphate monohydrate
natrijev hidrogenfosfat dihidrat i voda za injekcije.
Tél/Tel: + 32 10 85 52 00
Tηλ: + 30 210 68 82 100
Background information
Informacije za bolesnike
The relative risk reduction of proximal femur and hip area fractures with strontium ranelate over 3 years (FAS population from TROPOS) was not statistically significant compared with placebo: 15% (RR=0.85, 95% CI [0.61; 1.19], p=0.333) and 21% (RR=0.79, 95% CI [0.59; 1.06], p=0.112), respectively.
Rezultati pokazuju povećan rizik od infarkta miokarda uslijed uzimanja lijekova Protelos/Osseor u usporedbi s placebom (1,7% u odnosu na 1,1 %), s relativnim rizikom od 1,6 (95% CI, 1,07 do 2,38), i povećanim rizikom od venskih trombotskih i embolijskih događaja - 1,9% u odnosu na 1,3 % s relativnim rizikom od 1,5 (95% CI, 1,04 do 2,19).
Scientific conclusions
Informacije za zdravstvene djelatnike
• The Committee considered Protelos and Osseor (strontium ranelate) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission.
Uredbe (EZ) br. 726/2004.
In order to assess the impact of the restrictions introduced in the product information, namely the restriction to patients with severe osteoporosis and patients without the contraindications (current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism; temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest; established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or uncontrolled hypertension), post-hoc subgroup analyses of the existing clinical trial data were performed.
• Lijekovi Protelos/Osseor ne smiju se primjenjivati u bolesnika s utvrđenom, aktualnom ili prošlom ishemijskom bolešću srca, perifernom arterijskom bolesti i/ili cerebrovaskularnom bolesti ili u onih s nekontroliranom hipertenzijom;
In view of the data provided and other treatment alternatives available, some experts, in particular the experts in osteoporosis were of the opinion that a patient population could benefit from the product.
Prilikom donošenja odluke o načinu primjene lijekova Protelos/Osseor, CHMP je razmotrio analizu koristi i rizika koju je proveo PRAC kao i savjet stručnjaka za osteoporozu da postoji grupa bolesnika koji bi mogli imati koristi od lijeka.
Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
„CHMP je se slaže sa cjelokupnom ocjenom rizika za lijekove Protelos/Osseor PRAC-a.
This is expected to better characterise the risk in the restricted population and also to assess the effectiveness of the risk minimisation measures.
Važno je napomenuti, da tvrtka mora provesti daljnje istraživanje kako bi se dokazala djelotvornost novih mjera.
• Given the totality of the risks associated to strontium ranelate, the CHMP considered it appropriate that use of strontium ranelate be restricted to patients for whom treatment with other medicinal products is not possible due to, for example, contraindications or intolerance.
• Lijekove Protelos/Osseor treba koristiti samo za liječenje teškog oblika osteoporoze u žena u postmenopauzi i muškaraca izloženih visokom riziku od prijeloma, u slučaju kojih se liječenje drugim lijekovima pokazalo nemogućim za potrebe liječenja osteoporoze uslijed, primjerice, kontraindikacija ili netolerancije;
The risk minimisation measures included reducing the target population by excluding patients with high risk for ischemic cardiac disorders, and restricting the indication to patients with severe osteoporosis, who are most likely to benefit from treatment.
CHMP je zaključio da se kardiovaskularnim rizikom u bolesnika koji uzimaju lijekove Protelos/Osseor može upravljati na odgovarajući način tako što će se ograničiti uporaba u bolesnika koji nemaju anamnezu problema sa srcem ili optokom, te se ograničiti njihova primjena na one koji ne mogu uzimati druge lijekove odobrene za liječenje osteoporoze.
The CHMP considered the PRAC recommendation and the additional information provided by the MAH both in writing and at an oral explanation.
Daljnje informacije o preporukama PRAC-a i osnovne informacije o ovom pregledu dostupne su na internetskim stranicama Agencije.
Overall conclusion
Više o postupku
For this review, new subgroup analyses were conducted in the data from clinical trials to explore whether the modest benefit identified in the PMO population is maintained in the currently approved population of patients.
Ova konačna preporuka EMA-e o primjeni lijekova Protelos/Osseor temelji se na analizi podataka prikupljenih u randomiziranim ispitivanjima na otprilike 7.500 žena u postmenopauzi oboljelih od osteoporoze.
However the CHMP took the view that assessment of cardiovascular risk is a primary task for practising physicians, mainly relying on accessible information (such as family and patient history, smoking status, body mass index, waist circumference, blood pressure) and commonly investigated laboratory values (such as blood glucose and lipids).
Nadalje, liječnici trebaju i dalje redovito evaluirati ove bolesnike, a terapiju treba prekinuti ako se u bolesnika razviju problemi sa srcem ili optokom, poput nekontroliranog visokog krvnog tlaka ili angine.
• The Committee considered that the exclusion of patients with contraindications relating to cardiovascular and thromboembolic risks impacted on the statistical significance of the observed increased risks.
• Liječnici trebaju i dalje temeljiti svoje odluke za propisivanje lijekova Protelos/Osseor na procjeni rizika za individualne bolesnike.
Strontium ranelate is associated with a number of serious adverse events including serious cardiac disorders, thromboembolic events, serious skin reactions, disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
• Ne smijete uzimati lijekove Protelos/Osseor ako bolujete ili ste bolovali od problema sa srcem ili optokom poput moždanog udara, srčanog udara ili opstrukcije krvnog protoka u arterijama.
In line with the concerns expressed by the PRAC, the CHMP concluded that the benefit/risk balance of strontium ranelate needed to be re-evaluated and measures taken in order to minimize those risks so that the benefit in a newly defined target patient population could outweigh the risks.
„No, CHMP je zaključio da će, u slučaju bolesnika koji nemaju alternativno liječenje, redoviti pregledi i praćenje isključiti kardiovaskularne bolesti u dostatnoj mjeri kako bi se smanjio rizik kojeg je PRAC identificirao tako da ovi bolesnici mogu nastaviti uzimati lijek.”
The CHMP agreed with the conclusions of the PRAC that the use of strontium ranelate in a broad osteoporosis population (postmenopausal population) is associated with a number of serious risks; namely serious cardiac disorders (including myocardial infarction), thromboembolic events (including VTE), serious skin reactions (including DRESS syndrome, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis), disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
„PRAC je usko surađivao sa CHMP-om tijekom postupka, te iako priznajemo da se preporuke dva Povjerenstva razlikuju, naše razumijevanje profila omjera koristi i rizika lijeka je usklađeno te dijelimo isto mišljenje o važnosti učinkovitog praćenja kardiovaskularnog rizika”, rekla je June Raine, predsjednica PRAC-a. „PRAC će nastaviti praćenje sigurne primjene lijekova Protelos /Osseor kao i učinkovito smanjivanje rizika dugotrajne primjene.
Data submitted as part of the routine benefit-risk assessment within a periodic safety update report (PSUR), covering the period from 22 September 2011 to 21 September 2012, was assessed by the PRAC and raised concerns regarding cardiovascular safety beyond the already recognised risk for venous thromboembolism.
Trenutne preporuke nadovezuju se na preporuke EMA-e, koje je Agencija donijela u travnju 2013. godine vezano uz nekorištenje lijekova Protelos/Osseor u bolesnika s problemima optoka.
In order to address the concern that cardiovascular risk may increase considerably over time in the predominantly elderly target population, the MAH proposed regular assessment of the patients' cardiovascular risk.
• Prije početka liječenja, Vaš će liječnik procijeniti rizik od srčane bolesti i visokog krvnog tlaka te nastaviti provjeravati ovaj rizik u redovitim intervalima tijekom liječenja.
• The CHMP took into account the PRAC recommendation and all the information provided by the MAH in writing and at an oral explanation.
Preporuke PRAC-a su zatim dostavljene Povjerenstvu za primjenu lijekova u ljudi (CHMP) odgovornom za sva pitanja u vezi s lijekovima za uporabu u ljudi, koje je usvojilo konačno mišljenje Agencije.
Benefits of strontium ranelate in the treatment of osteoporosis
Koristi se također za liječenje teškog oblika osteoporoze u muškaraca koji su izloženi velikom riziku od prijeloma.
Strontium ranelate is associated with a number of serious risks; namely serious cardiac disorders (including myocardial infarction), thromboembolic events (including VTE), serious skin reactions (including DRESS syndrome, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis), disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Lijekovi Protelos/Osseor (stroncij ranelat) odobren je za primjenu u EU za liječenje teškog oblika osteoporoze (bolesti koja čini kosti lomljivima) u žena koje su prošle menopauzu te koje su izložene riziku od prijeloma (slomljenih kostiju) sa ciljem smanjivanja rizika od prijeloma kralježnice i kuka.
Together with the comprehensive risk communication and the educational material consisting of a new DHPC, prescribers' checklists and patient alert cards, it can be reasonably assumed that such prominent restrictions of use will accordingly raise the awareness of both physicians and patients for a cautious exposure to this medicinal product.
Dodatne mjere rizika obuhvaćaju dostavljanje edukacijskih materijala propisivačima kako bi se osiguralo da samo odgovarajući bolesnici primaju ovu terapiju.
• The CHMP agreed that there are a number of risks associated to strontium ranelate, including an increased risk of serious cardiac disorders observed in the postmenopausal population.
Pri donošenju zaključka, CHMP je napomenuo da su podaci ispitivanja pokazali povoljno djelovanje u sprječavanju prijeloma, uključujući i u bolesnika izloženih visokom riziku od prijeloma.
However, the CHMP considered that these show a clear tendency towards neutralisation of the cardiovascular risk when the population is restricted to patients with severe osteoporosis without contraindications.
Nadalje, dostupni podaci nisu dostavili nikakav dokaz o povećanju kardiovaskularnog rizika od lijekova Protelos/Osseor u bolesnika koji nisu imali anamnezu problema sa srcem ili optokom.
However, the experts considered that, if available, strontium ranelate should only be prescribed as second line treatment in patients with severe osteoporosis as defined by the WHO, and who do not tolerate other alternative treatments.
• Protelos/Osseor propisuju se za sprječavanje prijeloma samo u žena u postmenopauzi i muškaraca s teškim oblikom osteoporoze, koji su izloženi visokom riziku od prijeloma i ne mogu se liječiti drugim lijekovima odobrenima za osteoporozu.
The recommended starting dose depends on the patient's height and weight.
Preporučena početna doza ovisi o tjelesnoj težini i visini bolesnika.
If a patient develops severe side effects after a treatment cycle, the treatment must be suspended, delayed or the dose adjusted.
Ako se u bolesnika pojave teške nuspojave nakon ciklusa liječenja, ono se mora prekinuti, odgoditi ili se doza mora prilagoditi.
For more information on generic medicines, see the question-andanswer document here.
Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.
It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
To znači da blokira proteasom, sustav u stanicama koji razgrađuje bjelančevine kada više nisu potrebne.
Patients with moderately or severely impaired liver function should be treated with lower doses.
Bolesnici s umjerenim ili ozbiljnim oštećenjima funkcije jetre trebaju se liječiti manjim dozama.
Further information on Bortezomib Fresenius Kabi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Više informacija o lijeku Bortezomib Fresenius Kabi dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
• adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant.
• u odraslih osoba čija se bolest pogoršava nakon najmanje jednog liječenja i koje su već bile podvrgnute, ili se ne mogu podvrgnuti, transplantaciji krvotvornih matičnih stanica.
This means that Bortezomib Fresenius Kabi contains the same active substance, bortezomib, and works in the same way as a ‘reference medicine' already authorised in the EU called Velcade.
To znači da Bortezomib Fresenius Kabi sadrži istu djelatnu tvar, bortezomib, i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Velcade.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Velcade, and do not need to be repeated for Bortezomib Fresenius Kabi.
Ispitivanja koristi i rizika od djelatne tvari u odobrenoj primjeni već su provedena s referentnim lijekom Velcade i stoga ih nije potrebno ponavljati za lijek Bortezomib Fresenius Kabi.
When the proteins in the cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and they eventually die.
Ako se ne razgrade bjelančevine u stanicama raka, poput bjelančevina koje kontroliraju rast stanica, to utječe na stanice i one naposljetku odumiru.
Doses of Bortezomib Fresenius Kabi are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Fresenius Kabi is given alone or in combination with other medicines.
Doze lijeka Bortezomib Fresenius Kabi daju se u razmacima, s razdobljima odmora među dozama, i to u ciklusima liječenja od tri do šest tjedana, ovisno o tome primjenjuje li se lijek Bortezomib Fresenius Kabi kao monoterapija ili u kombinaciji s drugim lijekovima.
The company that markets Bortezomib Fresenius Kabi will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.
Tvrtka koja stavlja lijek Bortezomib Fresenius Kabi u promet osigurat će da zdravstveni radnici prime materijale za obuku u kojima će biti objašnjeno kako izračunati dozu i kako pripremiti te primjenjivati lijek.
When injected under the skin, it is given in the thigh or abdomen (belly).
Ako se daje supkutano, lijek se daje u bedro ili abdomen (trbuh).
There was no need for ‘bioequivalence' studies to investigate whether Bortezomib Fresenius Kabi is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Bortezomib Fresenius Kabi slično referentnom lijeku da bi postigao istu razinu djelatne tvari u krvi.
When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Ako se daje intravenskim putem, otopina se daje injekcijom u trajanju od tri do pet sekundi preko katetera (tanke sterilne cjevčice).
Because Bortezomib Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je Bortezomib Fresenius Kabi generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
The European Medicines Agency concluded that, in accordance with EU requirements, Bortezomib Fresenius Kabi has been shown to be comparable to Velcade.
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je lijek Bortezomib Fresenius Kabi usporediv s lijekom Velcade.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Fresenius Kabi have also been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Bortezomib Fresenius Kabi nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
Bortezomib Fresenius Kabi is a ‘generic medicine'.
Lijek Bortezomib Fresenius Kabi je „generički lijek”.
Bortezomib Fresenius Kabi is a medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Bortezomib Fresenius Kabi je lijek za liječenje multiplog mijeloma, raka krvi, u sljedećim skupinama bolesnika:
Side effects reported with Bortezomib Fresenius Kabi are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Bortezomib Fresenius Kabi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
• previously untreated adults who cannot have high-dose chemotherapy with a blood stem-cell transplant.
• u odraslih osoba koje nisu prethodno liječene i koje ne mogu primati kemoterapiju u visokim dozama s transplantacijom krvotvornih matičnih stanica.
Bortezomib Fresenius Kabi is available in vials (3.5 mg) as a powder to be made up into a solution for injection.
Lijek Bortezomib Fresenius Kabi dostupan je u obliku praška u bočicama (3,5 mg) od kojeg se priprema otopina za injekciju.
Additionally, when Bortezomib Fresenius Kabi is given under the skin, the active substance in both products, which have the same composition, is expected to be absorbed in the same way.
Osim toga, kada se Bortezomib Fresenius Kabi daje supkutano, očekuje se da će se djelatna tvar u oba lijeka (koja imaju jednak sastav) apsorbirati na jednak način.
The active substance in Bortezomib Fresenius Kabi, bortezomib, is a proteasome inhibitor.
Djelatna tvar u lijeku Bortezomib Fresenius Kabi, bortezomib, inhibitor je proteasoma.
For more information about using Bortezomib Fresenius Kabi, see the package leaflet or contact your doctor or pharmacist.
Za više informacija o primjeni lijeka Bortezomib Fresenius Kabi pogledajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
What measures are being taken to ensure the safe and effective use of Bortezomib Fresenius Kabi?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bortezomib Fresenius Kabi?
Bortezomib Fresenius Kabi is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Lijek Bortezomib Fresenius Kabi također se primjenjuje za liječenje limfoma plaštenih stanica, drugog oblika raka krvi, u odraslih osoba koje nisu prethodno liječene i koje se ne mogu podvrgnuti transplantaciji krvotvornih matičnih stanica.
Bortezomib Fresenius Kabi must not be given by other routes.
Lijek Bortezomib Fresenius Kabi ne smije se davati drugim putovima primjene.