FrancophonIA/ELRC3.0 huggingface dataset:
English: At 1 year post last vaccination, the percentages of subjects with hSBA ≥1:8 after the 2-dose series and the single dose were both lower than at 1 month post-vaccination (30% after the 2-dose series, 11%20% after the single dose for serogroup A; 61%-81% and 41%-55% for serogroup C; 92%-94% and 90%-91% for serogroup W-135; 67%-75% and 57%-65% for serogroup Y).
Latvian: Vienu gadu pēc pēdējās vakcinācijas tādu pētāmo personu procentuālais daudzums, kurām hSBA bija ≥ 1:8, pēc 2 devu sērijas un 1 devas ievadīšanas bija mazāks nekā 1 mēnesi pēc vakcinācijas (30% pēc 2 devu ievadīšanas un 11-20% pēc 1 devas ievadīšanas pret A serogrupu, 61-81% un 41-55%
English: • Meningococcal group Y oligosaccharide
Latvian: • Y grupas meningokoku oligosaharīdi
English: Immunogenicity in children 2 to 10 years of age
Latvian: Klīniskos pētījumos novērotās nevēlamās blakusparādības Bērni vecumā no 2 līdz 10 gadiem
English: Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Latvian: Bieži: eritēma injekcijas vietā (>50 mm), sacietējums injekcijas vietā (>50 mm), drudzis ≥38°C, drebuļi
English: Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Latvian: 10 mikrogrami Konjugēti ar Corynebacterium diphtheriae CRM197 proteīnu no 16,7 līdz 33,3 mikrogramiem
English: Individuals 11 to 65 years of age
Latvian: Retāk: nieze injekcijas vietā Personas vecumā no 11 līdz 65 gadiem
English: • Meningococcal group A oligosaccharide
Latvian: • A grupas meningokoku oligosaharīdi
English: 3 years
Latvian: 2 gadi
English: and Y, with the percentages of subjects with hSBA ≥ 1:8 being 32% and 56% against serogroup C in subjects 2-5 and 6-10 years of age, respectively, 74% and 80% against serogroup W-135, and 48% and 53% against serogroup Y. GMTs were respectively 6.5 and 12 for serogroup C, 19 and 26 for serogroup W-135, and 8.13 and 10 for serogroup Y. For serogroup A, 14% and 22% of subjects 2-5
Latvian: GMT vērtības pret C serogrupu bija attiecīgi 6,5 un 12, pret W-135 serogrupu - 19 un 26, bet pret Y serogrupu - 8,13 un 10. hSBA pret A serogrupu ≥ 1:8 bija 14% un 22% attiecīgi 2-5 un 6-10 gadus veco pētāmo personu grupās (GMT 2,95 un 3,73).
English: GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Latvian: KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
English: Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Latvian: 5 mikrogramus W-135 grupas meningokoku oligosaharīdu, kas konjugēti ar 3,3-8,3 mikrogramiem Corynebacterium diphtheriae CRM197 proteīna
English: CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Latvian: A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
English: Y. At 1 month post last vaccination, the percentages of subjects with hSBA ≥1:8 in the 2-dose group and in the single dose group across the two age strata were: 90%-95% vs 76%-80% for serogroup A, 98%-99% vs 76%-87% for serogroup C, 99% vs 93%-96% for serogroup W-135, and 96% vs 65%69% for serogroup Y. GMTs were higher in the 2-dose group than the single dose group at 1 month after vaccination in both age strata; however, this difference was less pronounced in the older age stratum.
Latvian: kam ievadīja 1 devu, abos vecuma segmentos bija šāda: 90-95% pret 76-80% A serogrupai, 98-99% pret 76-87% C serogrupai, 99% pret 93-96% W-135 serogrupai, 96% pret 65-69% Y serogrupai.
English: 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.
Latvian: Septiņas dienas pēc revakcinācijas devas ievadīšanas 98-100% pētāmo personu, kuras iepriekš bija saņēmušas Menveo, un 73-84% pētāmo personu, kuras iepriekš bija vakcinētas ar ACWY-PS, novēroja hSBA ≥1:8 pret A, C, W-135 un Y serogrupām.
English: Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Latvian: 5 mikrogramus C grupas meningokoku oligosaharīdu, kas konjugēti ar 7,1-12,5 mikrogramiem Corynebacterium diphtheriae CRM197 proteīna
English: 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.
Latvian: Šīm pašām pētāmajām personām vienu gadu pēc vakcinācijas Menveo grupā tādu pētāmo personu īpatsvars, kurām hSBA pret C, W-135 un Y serogrupu bija ≥1:8, bija lielāks nekā ACWY-PS grupā,
English: Musculoskeletal and connective tissue disorders:
Latvian: Skeleta-muskuļu un saistaudu sistēmas bojājumi Ļoti bieži: mialģija
English: - have haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
Latvian: Iespējams, ka šādām personām Menveo efektivitāte var būt samazināta; - ir hemofīlija vai cita problēma, kas var traucēt pareizu asinsreci, piemēram, personām, kuras saņem asins šķidrinātājus (antikoagulantus), - tiek veikta ārstēšana (piemēram, ar ekulizumabu), kas bloķē imūnsistēmas daļu, ko sauc par komplementa aktivāciju.
English: No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during pregnancy.
Latvian: Trušu mātītēm, kuras saņēma Menveo pirms pārošanās un grūsnības laikā, nenovēroja ietekmi uz fertilitāti.
English: In 5 years post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C and Y. Higher hSBA GMTs were observed for serogroups W-135 and Y (Table 7).
Latvian: Piecu gadu laikā pēc vakcinācijas tādu Menveo saņēmēju procentuālais daudzums, kuriem hSBA pret C un Y serogrupu bija ≥ 1:8, saglabājās ievērojami lielāks nekā ACWY-PS saņēmēju vidū.
English: Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Latvian: 5 mikrogrami Konjugēti ar Corynebacterium diphtheriae CRM197 proteīnu no 5,6 līdz 10,0 mikrogramiem
English: GlaxoSmithKline, S.A. Tel: + 34 900 202 700 es-ci@gsk.com
Latvian: Tel: + 34 900 202 700 es-ci@gsk.com
English: Contents of the pack and other information What Menveo contains
Latvian: Iespējamās blakusparādības Kā uzglabāt Menveo Iepakojuma saturs un cita informācija
English: The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65 years, in study V59P17.
Latvian: Pētījumā V95P17 tika salīdzinoši novērtēta Menveo un ACWY-PS imunogenitāte personām vecumā no 56 līdz 65 gadiem.
English: Common: rash, injection site redness (> 50 mm), injection site firmness (> 50 mm), joint ache, fever ≥ 38°C, chills
Latvian: Bieži: izsitumi, apsārtums injekcijas vietā (>50 mm), sacietējums injekcijas vietā (>50 mm), locītavu sāpes, drudzis ≥38°C, drebuļi.
English: Name and address of the manufacturer responsible for batch release
Latvian: Itālija Ražotāja, kas atbild par sērijas izlaidi, nosaukums un adrese
English: The solution is a colourless clear solution.
Latvian: Šķīdums ir bezkrāsains, dzidrs šķīdums.
English: Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one month post vaccination
Latvian: Vienas Menveo vai ACWY-PS devas imunogenitāte pusaudžiem vienu mēnesi pēc vakcinācijas
English: Timepoint
Latvian: DERĪGUMA TERMIŅŠ
English: 5 year persistence 1 month after booster
Latvian: Reakcijas saglabāšanās pēc 5 gadiem
English: Persistence of immune response and booster response in children 2 to 10 years of age Antibody persistence at 5 years after primary vaccination was assessed in study V59P20E1, this was an extension of study V59P20.
Latvian: Pētījumā V59P20E1, kas bija pētījuma V59P20 pagarinājums, tika vērtēta antivielu saglabāšanās 5 gadus pēc primārās vakcinācijas.
English: Persistence of immune response and booster response in adolescents
Latvian: Imūnās atbildes reakcijas un atbildes reakcijas uz revakcināciju saglabāšanās 2-10 gadus veciem bērniem
English: Uncommon: dizziness
Latvian: Bieži: izsitumi
English: Very common: headache
Latvian: Ļoti bieži: galvassāpes Retāk: reibonis
English: 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.
Latvian: Pamatojoties uz seroloģisko atbildes reakciju, pacientu daļu, kas sasniedza hSBA ≥1:8 un GMT, tika pierādīts, ka Menveo efekts pret visām četrām serogrupām (A, C, W-135 un Y) ir vismaz līdzvērtīgs ACWY-PS vakcīnas efektam.
English: Children 2 to 10 years of age
Latvian: Pusaudžiem (vecumā no 11 līdz 18 gadiem)
English: Percentages of subjects with hSBA≥1:8
Latvian: Pētāmo personu ar hSBA≥1:8 procentuālais daudzums hSBA GMT
English: Uncommon: injection site pruritus
Latvian: Retāk: nieze injekcijas vietā
English: 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.
Latvian: 7. dienā pēc vakcinācijas 64% pētāmo personu hSBA bija ≥ 1:8 pret A serogrupu, un 88% līdz 90% pētāmo personu konstatēja batericīdas antivielas pret C, W-135 un Y serogrupu.
English: There was antibody persistence observed against serogroups C, W-135
Latvian: Lielākas hSBA GMT vērtības novēroja pret W-135 un Y serogrupu (7. tabula).
English: hSBA
Latvian: GMT.
English: The onset of immune response after the primary vaccination with Menveo in healthy subjects 18 through 22 years of age was evaluated in study V59P6E1.
Latvian: Pētījumā V59P6E1 tika noteikts imūnās atbildes reakcijas sākums veselām pētāmajām personām vecumā no 18 līdz 22 gadiem pēc primārās vakcinācijas ar Menveo.
English: • 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.
Latvian: Protelos/Osseor lietas pārskatīšanu sāka 2013. gada maijā pēc Eiropas Komisijas lūguma saskaņā ar Regulas (EK) Nr. 726/2004 20. pantu.
English: 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.
Latvian: Rezultāti liecināja par paaugstinātu miokarda infarkta risku, lietojot Protelos/Osseor, salīdzinājumā ar placebo (1,7 %, salīdzinot ar 1,1 %), relatīvais risks 1,6 (95 % TI, no 1,07 līdz 2,38), un paaugstinātu venozu trombotisku un embolisku traucējumu risku - 1,9 %, salīdzinot ar 1,3 %, relatīvais risks 1,5 (95 % TI, no 1,04 līdz 2,19).
English: Background information
Latvian: Informācija pacientiem
English: 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.
Latvian: Pieejamie dati nesniedz pierādījumus par paaugstinātu kardiovaskulāro risku pacientiem, kuriem nav diagnosticēta išēmiska sirds slimība, perifēro artēriju slimība un/vai cerebrovaskulāra slimība pašlaik vai anamnēzē, vai tiem, kuriem nav nekontrolēta hipertensija.
English: Overall conclusion
Latvian: Sīkāka informācija par šo procedūru
English: 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.
Latvian: Lemjot par Protelos/Osseor lietošanu, CHMP ņēma vērā PRAC analīzi par šo zāļu ieguvumiem un risku, kā arī osteoporozes ekspertu ieteikumu, ka ir grupa pacientu, kuri varētu gūt ieguvumu no šīm zālēm.
English: This is expected to better characterise the risk in the restricted population and also to assess the effectiveness of the risk minimisation measures.
Latvian: Svarīgi, ka uzņēmumam ir lūgts veikt papildu pētījumus, lai pierādītu jauno pasākumu efektivitāti.
English: Scientific conclusions
Latvian: Informācija veselības aprūpes speciālistiem
English: Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
Latvian: "CHMP piekrita PRAC vispārējam Protelos/Osseor riska novērtējumam.
English: Strontium ranelate has a different mechanism of action from other available products; this might be a valuable alternative, particularly in long-term treatment of osteoporosis and for patients for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Latvian: • Protelos/Osseor drīkst lietot vienīgi smagas osteoporozes ārstēšanai pēcmenopauzes vecuma sievietēm un vīriešiem ar augstu lūzuma risku, kuriem ārstēšana ar citām osteoporozes ārstēšanai apstiprinātām zālēm nav iespējama, piemēram, kontrindikāciju vai nepanesamības dēļ.
English: 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.
Latvian: CHMP uzskatīja, ka kardiovaskulāro risku pacientiem, kuri lieto Protelos/Osseor, var novērst, ierobežojot šo zāļu lietošanu un izmantojot tās vienīgi pacientiem, kuriem anamnēzē nav sirdsdarbības un asinsrites traucējumu un tiem, kuri nevar lietot citas osteoporozes ārstēšanai apstiprinātas zāles.
English: Points of differences with the PRAC recommendation and scientific rationale of the CHMP position
Latvian: Sīkāka informācija par PRAC ieteikumu un šīs pārskatīšanas pamatojums ir atrodams Aģentūras tīmekļa vietnē.
English: 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.
Latvian: Kardiovaskulāras slimības risks pacientam jānovērtē pirms ārstēšanas uzsākšanas un regulāri turpmāk, parasti ik pēc 6-12 mēnešiem.
English: The CHMP, having considered the PRAC recommendation dated January 2014 and the totality of the information provided by the MAH, is of the opinion that the benefit-risk balance of strontium ranelate remains positive in the restricted population, taking into account the agreed risk minimisation measures, including changes to the product information and additional pharmacovigilance activities.
Latvian: "Visu procedūras laiku PRAC cieši sadarbojās ar CHMP, un lai gan mēs atzīstam, ka abu komiteju ieteikumi ir atšķirīgi, mūsu izpratne par zāļu ieguvumu un riska attiecību ir ļoti līdzīga un mēs esam vienisprātis par kardiovaskulārā riska efektīvas uzraudzības nozīmi," teica PRAC vadītāja June Raine.
English: 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.
Latvian: Protelos/Osseor (stroncija ranelāts) Eiropas Savienībā ir reģistrēts smagas osteoporozes (slimības, kas padara kaulus trauslus) ārstēšanai pēcmenopauzes vecuma sievietēm, kurām ir augsts kaulu lūzuma risks, lai pazeminātu mugurkaula un gūžas lūzumu risku.
English: • The Committee concluded, in view of the available data, that given the number of identified serious risks, for which there are considerable doubts that they can be adequately mitigated during long-term treatment, in the context of the modest benefit shown in terms of fracture prevention, the benefit-risk balance of Protelos and Osseor is not favourable.
Latvian: Komiteja secināja, ka, ņemot vērā ieguvumus, kas novēroti, veicot lūzumu profilaksi augsta riska pacientiem, Protelos/Osseor aizvien ir jābūt pieejamiem pacientiem, kuriem anamnēzē nav kardiovaskulāras slimības un kuri nevar lietot citas zāles.
English: • The CHMP took into account the PRAC recommendation and all the information provided by the MAH in writing and at an oral explanation.
Latvian: Pēc tam PRAC ieteikumus nosūtīja Cilvēkiem paredzēto zāļu komitejai (CHMP), kas ir atbildīga par visiem ar cilvēkiem paredzētām zālēm saistītiem jautājumiem un kas sagatavoja Aģentūras galīgo atzinumu.
English: The postmenopausal osteoporotic (PMO) population for strontium ranelate comprises data from 7 randomised studies: 2 phase II studies CL2-004 (Meunier, 2002; NP07869) and CL2-005 (Reginster 2002; NP08511) and 5 phase III studies CL3-009 (Meunier, 2004; NP08338/NP22819), CL3-010 (Reginster 2005; NP08340/NP22824), CL3-013 (Hwang 2008; NP22514), CL3-015 (Liu 2009; NP25026), CL3-017 (NP24357).
Latvian: Tālr. +44 (0)20 7418 8427 E-pasts: press@ema.europa.eu
English: • 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.
Latvian: "Tomēr CHMP uzskatīja, ka pacientiem, kuriem nav pieejama alternatīva terapija, regulārs skrīnings un uzraudzība, lai izslēgtu kardiovaskulāru slimību, pietiekami mazinās PRAC konstatēto risku, lai šie pacientiem šīs zāles aizvien būtu pieejamas."
English: 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.
Latvian: Papildu riska mazināšanas pasākumi ietver izglītojošu materiālu izsniegšanu zāļu parakstītājiem, lai nodrošinātu, ka ar šī zālēm tiek ārstēti vienīgi atbilstoši pacienti.
English: 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.
Latvian: • Jūs nedrīkstat lietot Protelos/Osseor, ja Jums ir vai kādreiz ir bijuši sirdsdarbības vai asinsrites traucējumi, piemēram, insults, sirdslēkme vai asins plūsmas nosprostojums artērijās.
English: • The CHMP requested that the MAH shall conduct a post-authorisation safety study to assess whether, within the limited patient population which is expected to be exposed to strontium ranelate, there is compliance with the restrictions introduced, and to collect further information on the risks of the medicinal product and on the effectiveness of the risk minimisation measures.
Latvian: • Pirms ārstēšanas uzsākšanas ārsts Jums novērtēs sirds slimības un paaugstināta asinsspiediena risku un turpinās pārbaudīt Jūsu risku regulāri ārstēšanas laikā.
English: However, the retrospective subgroup analyses performed by the MAH support the conclusion that the risks for vascular complications seemed to be reduced to a neutral level by the exclusion of patients with identified increased cardiovascular risk while anti-fracture efficacy seems to be preserved, even in the subset of patients with severe osteoporosis.
Latvian: Izdarot secinājumus, CHMP ņēma vērā, ka pētījuma dati liecināja par labvēlīgu ietekmi, novēršot lūzumus, tostarp pacientiem ar augstu lūzuma risku.
English: Hip fracture and the following surgery, in particular, are associated with risks such as permanent disability and increased mortality.
Latvian: Turklāt ārstam šie pacienti aizvien regulāri jāuzrauga, un ārstēšana jāpārtrauc, ja pacientiem rodas sirdsdarbības vai asinsrites traucējumi, piemēram, nekontrolēta asinsspiediena paaugstināšanās vai stenokardija.
English: Study CLE-12911-021, for example, was an observational international prospective cohort survey (non-interventional) performed in seven EU countries with the main objective to follow-up during 3 years a cohort of post-menopausal women treated with strontium ranelate with a special focus on all potential safety concerns.
Latvian: Šis EMA galīgais ieteikums par Protelos/Osseor lietošanu bija balstīts uz nejaušinātu pētījumu apvienoto datu analīzi aptuveni 7500 pēcmenopauzes vecuma sievietēm ar osteoporozi.
English: • The Committee also considered that there are serious concerns on whether the contraindications and warnings implemented to mitigate cardiac and thromboembolic risks could be achievable in clinical practice, considering that Protelos and Osseor are intended for long-term treatment of a population of elderly patients whose cardiovascular status may deteriorate over time.
Latvian: • Protelos/Osseor tiks parakstīts vienīgi lūzumu profilaksei pēcmenopauzes vecuma sievietēm un vīriešiem ar smagu osteoporozi, kuriem ir augsts lūzuma risks un kurus nevar ārstēt ar citām osteoporozes ārstēšanai apstiprinātām zālēm.
English: Information on the reference medicine can also be found on the Agency's website.
Latvian: Informācija par atsauces zālēm ir atrodama aģentūras tīmekļa vietnē.
English: It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
Latvian: Tas bloķē proteasomas, kas ir sistēmas šūnas, kuras noārda proteīnus, kad tie vairs nav vajadzīgi.
English: If a patient develops severe side effects after a treatment cycle, the treatment must be suspended, delayed or the dose adjusted.
Latvian: Ja pēc ārstēšanas cikla pacientam rodas smagas blakusparādības, ārstēšana ir jāpārtrauc, jāaptur vai jāpielāgo deva.
English: For more information on generic medicines, see the question-andanswer document here.
Latvian: Sīkāku informāciju par ģenēriskām zālēm skatīt jautājumu un atbilžu dokumentā šeit.
English: 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.
Latvian: Ja proteīni vēža šunās, piemēram, proteīni, kas kontrolē šūnu augšanu, netiek noārdīti, šūnas tiek traumētas un galu galā iet bojā.
English: The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer medicines.
Latvian: Zāles var iegādāties tikai pret recepti, un ārstēšana ir jāuzsāk un zāļu ievadīšana jāveic tāda ārsta uzraudzībā, kuram ir pieredze pretvēža zāļu lietošanā.
English: Further information on Bortezomib Fresenius Kabi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Latvian: Cita informācija par Bortezomib Fresenius Kabi ir atrodama aģentūras tīmekļa vietnē: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
English: The recommended starting dose depends on the patient's height and weight.
Latvian: Ieteicamā deva ir atkarīga no pacienta auguma un masas.