natgillin/translations-raw huggingface dataset:
Currently available data are not sufficient to establish the efficacy of Menveo in children under 2 years of age.
Trenutno razpoložljivi podatki ne zadostujejo za dokaz učinkovitosti cepiva
The two primary safety studies were randomised, active-controlled trials that enrolled participants aged 11 to 55 years (N=2663) and 19 to 55 years (N=1606), respectively.
V eno so bile vključene osebe, stare 11 do 55 let (n = 2663) in v drugo osebe,
Uncommon: dizziness, injection site itching
Občasni: omotica, srbenje na mestu injiciranja
Immune system disorders
- imate oslabljen imunski sistem.
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.
Po 7 dneh po poživitvenem odmerku je 98 %-100 % oseb, ki so predhodno prejele cepivo Menveo, in 73 %-84 % oseb, ki so predhodno prejele cepivo ACWY-PS, doseglo hSBA ≥ 1 : 8 proti seroskupinam A, C, W-135 in Y. Po enem mesecu po cepljenju je bil odstotek oseb s hSBA ≥ 1 : 8 98 %-100 % oziroma 84 %-96 %.
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1).
Kot pri vsakem drugem cepivu zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah
Concomitant vaccines should always be administered at separate injection sites and preferably contralateral.
Druga, sočasno uporabljena cepiva je treba vedno aplicirati na drugo mesto, po možnosti na nasprotni strani telesa.
Even if you have been vaccinated with Menveo you remain at increased risk of disease caused by the Neisseria meningitidis groups A, C, W-135 and Y bacteria.
Tudi če ste bili cepljeni s cepivom Menveo, imate še vedno večje tveganje za bolezen, ki jo povzročajo bakterije Neisseria meningitidis skupin A, C, W-135 in Y. Kot odziv na vbod z iglo se lahko pojavijo omedlevica, omotica ali druge s stresom povezane reakcije.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo powder for injection
IME ZDRAVILA IN POT(I) UPORABE Menveo raztopina za injiciranje konjugat MenCWY intramuskularna uporaba
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.
Na začetku študije so bili odstotki oseb s hSBA ≥ 1:8 pri obeh starostnih skupinah: 1 %-5 % pri seroskupini A, 13 %-28 % pri seroskupini C, 42 %-64 % pri seroskupini W-135 in 6 %-19 % pri seroskupini Y. En mesec po zadnjem cepljenju so bili odstotki oseb s hSBA ≥ 1:8 po seriji z dvema odmerkoma in z enkratnim odmerkom pri obeh starostnih skupinah: 90 %-95 % v primerjavi s 76 %-80 % pri seroskupini A, 98 %-99 % v primerjavi s 76 %-87 % pri seroskupini C, 99 % v primerjavi s 93 %-96 % pri seroskupini W-135 in 96 % v primerjavi s 65 %-69 % pri seroskupini Y. Geometrične povprečne vrednosti so bile v obeh starostnih skupinah višje v skupini z dvema odmerkoma kot v skupini z enkratnim odmerkom en mesec po cepljenju, vendar pa je bila ta razlika manj izrazita v starejši skupini.
Talk to your doctor or nurse before you or your child are given Menveo if you or your child: - have a weakened immune system.
Preden vas ali vašega otroka cepijo s cepivom Menveo, se posvetujte z zdravnikom ali medicinsko sestro, če vi ali vaš otrok:
These include the following vaccines: tetanus, reduced diphtheria and acellular pertussis (Tdap), human papillomavirus (HPV), yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies, hepatitis A and B and meningococcal group B (Bexsero).
cepivo proti rumeni mrzlici, cepivo proti tifusni vročici (polisaharid Vi), cepivo proti japonskem encefalitisu, cepivo proti steklini, cepivo proti hepatitisu A, cepivo proti hepatitisu B in cepivo proti meningokokom skupine B (Bexsero).
Serogroup hSBA ≥1:8
Seroskupina hSBA ≥1:8
NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Navodilo za uporabo Menveo prašek in raztopina za raztopino za injiciranje konjugirano cepivo proti meningokokom skupin A, C, W-135 in Y
• Meningococcal group Y oligosaccharide
• Oligosaharid meningokoka skupine Y
Menveo does not protect against diphtheria.
Cepivo Menveo ne ščiti pred davico.
W-135 N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
W135 N=96 N=96 N=95 N=95 N=64 N=64 N=60
• Meningococcal group A oligosaccharide
• Oligosaharid meningokoka skupine A
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.
Eno leto po cepljenju je bil delež oseb, cepljenih s cepivom Menveo, s hSBA ≥1:8 višji v primerjavi s cepivom ACWY-PS, za seroskupine C, W-135 in Y, s primerljivimi ravnmi za seroskupino A. Podobni so tudi izsledki primerjave GMT hSBA.
Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Oligosaharidi meningokoka skupine W-135, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 3,3-8,3 mikrograma
C N=96 N=96 N=94 N=94 N=64 N=64 N=60 N=60
C N=96 N=96 N=94 N=94 N=64 N=64 N=60
Reconstitution of the vaccine
Shranjevanje cepiva Menveo
Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
Zelo pogosti: glavobol, slabost, bolečina na mestu injiciranja, rdečina na mestu injiciranja (≤ 50 mm), otrdelost na mestu injiciranja (≤ 50 mm), bolečina mišic, splošno slabo počutje
Y N=96 N=96 N=94 N=94 N=64 N=64 N=59 N=59
Y N=96 N=96 N=94 N=94 N=64 N=64 N=59
Skin and subcutaneous tissue disorders:
Zelo pogosti: navzea Bolezni kože in podkožja:
Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Zelo pogosti: razdražljivost, splošno slabo počutje, bolečina na mestu injiciranja, eritem na mestu injiciranja (≤ 50 mm), otrdlina na mestu injiciranja (≤ 50 mm)
Skin and subcutaneous tissue disorders: Common: rash
Bolezni mišično-skeletnega sistema in vezivnega tkiva: Zelo pogosti: mialgija
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml of the reconstituted vaccine) contains: (Originally contained in the powder)
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Menveo En odmerek (0,5 ml rekonstituiranega cepiva) vsebuje:
Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Oligosaharidi meningokoka skupine C, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 7,1-12,5 mikrograma
Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Oligosaharidi meningokoka skupine A, 10 mikrogramov, vezane na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 16,7-33,3 mikrograma
Persistence of immune response and booster response in adolescents
Obstojnost imunskega odziva in odziv po poživitvenem odmerku pri otrocih, starih od 2 do 10 let
Serog roup
Seroskupina
Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills Uncommon: injection site pruritus
Pogosti: eritem na mestu injiciranja (> 50 mm), otrdlina na mestu injiciranja (> 50 mm), zvišana telesna temperatura ≥ 38 °C, mrzlica Občasni: pruritus na mestu injiciranja
Percentages of subjects with hSBA≥1:8
Odstotek oseb s hSBA ≥ 1 : 8
For children 2 to 10 years of age, no data are available for evaluating safety and immunogenicity of other childhood vaccines when administered concomitantly with Menveo.
Podatkov o varnosti in imunogenosti drugih otroških cepiv, ki se dajejo sočasno s cepivom Menveo,
12 mont hs
12 mesec ev
Uncommon: dizziness
Občasni: omotica
Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Oligosaharidi meningokoka skupine Y, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 5,6-10,0 mikrograma
CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
A N=96 N=96 N=95 N=95 N=64 N=64 N=60
P Value Menveo vs ACWYPS
P-vrednost cepiva Men veo v primerjav i z ACWY-PS
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
Ugotovili so prisotnosti protiteles proti seroskupinam C, W-135 in Y, pri čemer je bil delež oseb z vrednostjo hSBA ≥ 1:8 za seroskupino C 32 % v starostni skupini 2-5 let in 56 % v starostni skupini 6-10 let, za seroskupino W-135 74 % v starostni skupini 2-5 let in 80 % v starostni skupini 6-10 let, in za seroskupino Y 48 % v starostni skupini 2-5 let in 53 % v starostni skupini 6-10 let.
CI)
IZ)
The immune response observed in the children 2-10 years of age was very similar to those observed in the V59P8 study shown above: immune response to Menveo at 1 month post vaccination, as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs, was non-inferior to ACWY-PS.
Imunski odziv, ki so ga opazili pri otrocih, starih 2-10 let, je bil podoben kot pri študiji V59P8, kot je prikazano zgoraj: imunski odziv na cepivo
Very common:
Zelo pogosti: Pogosti:
ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
Razmerje oseb s titri hSBA ≥ 1:8 ni bilo inferiorno kot pri ACWY-PS za vse štiri seroskupine, za skupini A in Y pa je bilo statistično boljše (tabela 10).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT
VIALA OZNAKA SESTAVINA S TEKOČIM KONJUGATOM MENCWY
The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216), were similar to that observed in Menveo recipient subjects aged 11-55.
ki so dobili cepivo Menveo (n = 216) so bile podobne tistim, ki so jih opazili pri osebah, cepljenih s cepivom Menveo, starih med 11-55 let.
Menveo Menveo ACWY-P S
ACWYPS Menveo ACWYPS Menveo ACWY-PS
and 6-10 years of age, respectively, had hSBA ≥ 1:8 (GMTs 2.95 and 3.73).
Delež oseb z vrednostjo hSBA ≥ 1:8 za seroskupino A je bil 14 % (GMT 2,95) v starostni skupini 2-5 let in 22 % (GMT 3,73) v starostni skupini 6-10 let.
All subjects in both age groups had hSBA ≥ 1:8 across all serogroups, with antibody titers several fold higher than seen after the primary vaccination (Table 3).
Pri vseh osebah je bila v obeh starostnih skupinah vrednost hSBA ≥ 1:8 za vse seroskupine,
How to use Menveo
Način uporabe
Sodium dihydrogen phosphate monohydrate
Raztopina natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat dihidrat natrijev klorid voda za injekcije
Menveo contains
Cepivo Menveo vsebuje
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).
5 let po cepljenju je odstotek prejemnikov cepiva Menveo s hSBA ≥ 1:8 za seroskupini C in Y ostal značilno večji v primerjavi s prejemniki cepiva ACWY-PS.
Common: rash, injection site redness (> 50 mm), injection site firmness (> 50 mm), joint ache, fever ≥ 38°C, chills
Pogosti: izpuščaj, rdečina na mestu injiciranja (>50 mm), otrdelost na mestu injiciranja (>50 mm), bolečina sklepov, zvišana telesna temperatura ≥ 38 °C, mrzlica
Common (may affect up to 1 in 10 people): change in eating habits, nausea, vomiting, diarrhea, rash, muscle ache, joint ache, chills, fever ≥38oC, injection site redness (>50mm) and injection site firmness (>50mm)
slabost, bruhanje, driska, izpuščaj, bolečina mišic, bolečina sklepov, mrzlica, zvišana telesna temperatura ≥ 38 °C, rdečina na mestu injiciranja (>50 mm) in otrdelost na mestu injiciranja (>50 mm)
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
P Value Menveo vs
Pred poživitveni m odmerkom
hSBA ≥ 1:8 (95% CI)
GMT hSBA (95 % I Z)
Powder
KG
Intramuscular use
Poživitveni odmerek
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENCWY LIQUID CONJUGATE COMPONENT
OVOJNINAH VIALA OZNAKA SESTAVINA LIOFILIZIRANEGA KONJUGATA MENA
Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Pogosti: eritem na mestu injiciranja (> 50 mm), otrdlina na mestu injiciranja (> 50 mm), mrzlica,
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.
Pokazalo se je, da cepivo Menveo ni inferiorno od cepiva ACWY-PS za vse štiri seroskupine (A, C, W-135 in Y) na podlagi serološkega odziva, razmerij v doseganju hSBA ≥1:8 in za GMT.
Metabolism and nutrition disorders:
Ti neželeni učinki so bili: Presnovne in prehranske motnje:
5 year persistence 1 month after booster
1 mesec po poživitvenem odmerku
GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Sero grou p
Seros kupin a
Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Zelo pogosti: bolečina na mestu injiciranja, eritem na mestu injiciranja (≤50 mm), otrdlina na mestu injiciranja (≤ 50 mm), splošno slabo počutje
No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during pregnancy.
Pri samicah kuncev, cepljenih s cepivom Menveo pred paritvijo in med brejostjo, niso opazili vpliva na sposobnost razmnoževanja.
• 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.
Pregled zdravila Protelos/Osseor se je začel maja 2013 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
Background information
Informacije za bolnike
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 so pokazali povečano tveganje za miokardni infarkt pri uporabi zdravila Protelos/Osseor v primerjavi s placebom (1,7 % v primerjavi z 1,1 %) z relativnim tveganjem 1,6 (95-odstotni IZ, 1,07 do 2,38) in povečano tveganje za venske trombotične in embolične dogodke1,9 % v primerjavi z 1,3 %, z relativnim tveganjem 1,5 (95-odstotni IZ, 1,04 do 2,19).
Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
„Odbor CHMP se je strinjal s splošno oceno tveganj, povezanih z zdravilom Protelos/Osseor, ki jo je podal odbor PRAC.
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.
Pri sprejemanju odločitve glede uporabe zdravila Protelos/Osseor je odbor CHMP upošteval analizo koristi in tveganj, ki jo je izvedel odbor PRAC, ter mnenje strokovnjakov za osteoporozo, da obstaja skupina bolnikov, ki bi jim zdravilo lahko koristilo.
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.
Razpoložljivi podatki ne kažejo povečanega srčno-žilnega tveganja pri bolnikih brez ugotovljene obstoječe ali pretekle ishemične bolezni srca, periferne arterijske bolezni in/ali možgansko-žilne bolezni ter pri bolnikih z nenadzorovano hipertenzijo.
Scientific conclusions
Informacije za zdravstvene delavce
Overall conclusion
Več o postopku
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.
• Zdravilo Protelos/Osseor se lahko uporablja samo za zdravljenje hude osteoporoze pri ženskah po menopavzi in moških z velikim tveganjem za zlome, pri katerih zdravljenje z drugimi zdravili, odobrenimi za zdravljenje osteoporoze, ni mogoče, na primer zaradi kontraindikacij ali intolerance.
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.
„Odbor PRAC je med celotnim postopkom tesno sodeloval z odborom CHMP in čeprav se zavedamo, da se priporočila obeh odborov razlikujejo, je naše razumevanje razmerja med tveganji in koristmi zdravila zelo usklajeno, imamo pa tudi enako mnenje o pomembnosti učinkovitega spremljanja srčno-žilnega tveganja,“ je dejala June Raine, predsednica odbora PRAC.
This is expected to better characterise the risk in the restricted population and also to assess the effectiveness of the risk minimisation measures.
Pomembno je, da družba izvede dodatne raziskave, s katerimi bo potrdila učinkovitost novih ukrepov.
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.
Odbor CHMP je menil, da je srčno-žilno tveganje pri bolnikih, ki uporabljajo zdravilo Protelos/Osseor, mogoče obvladati tako, da se uporaba zdravila omeji na bolnike, ki v anamnezi nimajo bolezni srca in ožilja, ter dodatno na tiste, ki ne morejo uporabljati drugih zdravil, ki so odobrena za zdravljenje osteoporoze.
The PRAC, having considered the matter, recommended the suspension of the marketing authorisation for Protelos and Osseor.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ta končna priporočila izdal, potem ko je Odbor za oceno tveganja na področju farmakovigilance (PRAC) najprej priporočil začasni umik dovoljenja za promet z zdravilom zaradi z njim povezanega srčno-žilnega tveganja.
• The Committee considered that, when the fracture data from randomised, placebo-controlled studies in postmenopausal women are reviewed, the magnitude of the benefit in fracture prevention was found to be modest, particularly for the most serious types of fractures.
Pri sprejemanju zaključkov je odbor CHMP upošteval, da so podatki iz študij pokazali ugoden učinek pri preprečevanju zlomov, med drugim tudi pri bolnikih z velikim tveganjem za zlome.
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.
Zdravilo Protelos/Osseor (stroncijev ranelat) je v EU odobreno za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah, pri katerih je že nastopila menopavza in pri katerih obstaja veliko tveganje za zlome (zlomljene kosti), da se zmanjša tveganje za zlome hrbtenice in kolka.
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.
Tveganje za razvoj srčno-žilne bolezni pri bolniku je treba oceniti pred začetkom zdravljenja in nato še v rednih časovnih presledkih, praviloma na vsakih 6 do 12 mesecev.
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).
Poleg tega morajo zdravniki te bolnike še naprej redno spremljati in zdravljenje prekiniti, če se pri njih pojavijo težave s srcem ali ožiljem, na primer nenadzorovan visok krvni tlak ali angina.
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.
Dodatni ukrepi za zmanjšanje tveganja vključujejo razdelitev izobraževalnega gradiva zdravstvenim delavcem, ki predpisujejo to zdravilo, da se zagotovi, da se bo uporabljalo samo pri ustrezni skupini bolnikov.
Points of differences with the PRAC recommendation and scientific rationale of the CHMP position
Podrobnejše informacije o priporočilu odbora PRAC in ozadju tega pregleda so na voljo na spletni strani agencije.
• 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.
• Odločitev zdravnikov, ali bodo predpisali zdravilo Protelos/Osseor, mora še naprej temeljiti na oceni tveganj za posameznega bolnika.
When fracture data from randomised, placebo-controlled studies in postmenopausal women were reviewed, the magnitude of the benefit of fracture prevention was found to be modest, particularly regarding the most serious types of fractures.
Kar zadeva koristi zdravila, so podatki o učinkovitosti pokazali učinek pri preprečevanju zlomov, med drugim tudi pri bolnikih z velikim tveganjem za zlome.
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.
• Zdravljenje z zdravilom Protelos/Osseor je treba prekiniti, če se pri bolniku pojavi ishemična bolezen srca, periferna arterijska bolezen ali možgansko-žilna bolezen, ter v primeru nenadzorovane hipertenzije.