natgillin/translations-raw huggingface dataset:
PROTELOS works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture.
Zdravilo PROTELOS deluje tako, da zmanjšuje razgradnjo kosti in spodbuja njeno gradnjo, s čimer zmanjšuje tveganje za zlome.
Quality of life assessment on the QUALIOST specific scale as well as the General Health perception score of the SF-36 general scale indicated benefit of PROTELOS, compared with placebo.
Ocena kakovosti življenja po specifični lestvici QUALIOST (Quality of Life Questionnaire in Osteoporosis) in seštevku za skupno dojemanje zdravja po splošni lestvici SF-36 (Short Form 36) je pokazala koristne učinke zdravila PROTELOS v primerjavi s placebom.
Table 2: Incidence of patients with hip fracture and relative risk reduction in patients with BMD ≤ -2.4 SD (NHANES III) and age ≥ 74 years
Preglednica 2: Pojavnost zlomov kolka in zmanjšanje relativnega tveganja pri bolnicah z mineralno kostno gostoto ≤ -2,4 SD (NHANES III) in starostjo ≥ 74 let
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Jetrna okvara Bolnikom z jetrno okvaro odmerka ni treba prilagajati (glejte poglavje 5.2).
If you develop a rash or serious skin symptoms (see section 4), stop taking PROTELOS, seek urgent advice from a doctor and tell him that you are taking this medicine.
Če na koži opazite izpuščaj ali hude kožne reakcije (glejte poglavje 4), prenehajte z jemanjem zdravila PROTELOS in nemudoma poiščite zdravniško pomoč ter zdravniku povejte, da jemljete to zdravilo.
PROTELOS, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Zdravilo PROTELOS, ki vsebuje učinkovino stroncijev ranelat, spada v skupino zdravil za zdravljenje bolnikov z boleznimi kosti.
Due to the relatively slow absorption of strontium, food and calcium intake should be avoided both before and after administration of PROTELOS.
Zaradi sorazmerno počasne absorpcije stroncija se moramo izogibati uživanju hrane in kalcija tako pred jemanjem zdravila PROTELOS kot med njim.
4.7 Effects on ability to drive and use machines
Vpliv na sposobnost upravljanja vozil in strojev:
EXP If not used immediately after reconstitution, the preparation should be consumed within 24 hours.
Če suspenzije ne uporabite takoj po rekonstituciji, jo je potrebno popiti v roku 24 ur.
Statistically significant increases in BMD were observed as early as 6 months following initiation of PROTELOS treatment versus placebo.
Statistično značilno povečanje mineralne kostne gostote v primerjavi s placebom je bilo opaženo že v 6 mesecih po začetku zdravljenja z zdravilom PROTELOS.
Efficacy of PROTELOS to reduce the risk of new vertebral fracture was confirmed in the TROPOS study, including for osteoporotic patients without fragility fracture at baseline.
Učinkovitost zdravila PROTELOS pri zmanjševanju tveganja novih zlomov vretenc so potrdili v študiji TROPOS, vključno z bolnicami, ki na izhodišču niso imele fragilnostnih zlomov.
During PROTELOS treatment, these cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months.
Med zdravljenjem z zdravilom PROTELOS je potrebno spremljati tveganje za srčno-žilne dogodke v rednih časovnih presledkih, vsakih 6 do 12 mesecev.
The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTELOS should be administered in-between meals.
Absorpcija stroncijevega ranelata se zmanjša ob hrani ter mleku in mlečnih izdelkih, zato je treba zdravilo PROTELOS jemati v času med dvema obrokoma.
Long-term safety has been evaluated in postmenopausal women with osteoporosis treated for up to 60 months with strontium ranelate 2 g/day (n=3,352) or placebo (n=3,317) in phase III studies.
60 mesecev zdravili s stroncijevim ranelatom po 2 g na dan (n = 3352) ali placebom (n = 3317) v študijah III. faze.
• PROTELOS is only indicated for use in patients with severe osteoporosis at high risk of fracture, 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 je indicirano samo za zdravljenje bolnikov s hudo osteoporozo z velikim tveganjem za zlome, pri katerih zdravljenje z drugimi zdravili, ki so odobrena za zdravljenje osteoporoze, zaradi kontraindikacij ali neprenašanja ni mogoče.
PROTELOS contains aspartame (E951):
Zdravilo PROTELOS vsebuje aspartam (E951):
Other symptoms may be nausea/vomiting, sweating, shortness of breath, palpitations, (extreme) tiredness and/or dizziness.
Ostali simptomi so lahko slabost/bruhanje, znojenje, kratka sapa, palpitacije,
What PROTELOS looks like and contents of the pack PROTELOS is available in sachets containing yellow granules for oral suspension.
PROTELOS je na voljo v vrečkah, ki vsebujejo rumena zrnca za peroralno suspenzijo.
It is therefore preferable to take antacids at least two hours after PROTELOS.
Zato je antacide priporočljivo jemati najmanj dve uri po zdravilu PROTELOS.
PROTELOS is contra-indicated in patients with a past history of venous thromboembolic events (see section 4.3) and should be used with caution in patients at risk of VTE.
Zdravilo PROTELOS je kontraindicirano pri bolnikih z vensko trombembolijo v anamnezi (glejte poglavje 4.3), pri bolnikih s tveganjem za vensko trombembolijo pa ga moramo uporabljati previdno.
Physico-chemical data suggest excretion of Strontium ranelate in human milk.
Fizikalnokemijski podatki nakazujejo izločanje stroncijevega ranelata v materino mleko.
The anti-fracture studies program of PROTELOS was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study.
Program študij z zdravilom PROTELOS za preprečevanje zlomov sta sestavljali dve s placebom nadzorovani študiji III. faze: SOTI (Spinal Osteoporosis Therapeutic Intervention) in TROPOS (Treatment of Peripheral Osteoporosis).
In phase III studies, 85% of the patients had a creatinine clearance between 30 and 70 ml/min and 6% below 30 ml/min at inclusion, and the mean creatinine clearance was about 50 ml/min.
bolnikov imelo očistek kreatinina med 30 in 70 ml/min in 6 % pod 30 ml/min, srednja vrednost pa je bila okoli 50 ml/min.
The European Medicines Agency has waived the obligation to submit the results of studies with PROTELOS in all subsets of the paediatric population in osteoporosis (see section 4.2 for information on paediatric use).
PROTELOS za vse podskupine pediatrične populacije pri osteoporozi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Do not take PROTELOS: - if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (listed in section 6).
Kaj morate vedeti, preden boste vzeli zdravilo PROTELOS Ne jemljite zdravila PROTELOS: - če ste alergični na stroncijev ranelat ali katero koli sestavino tega zdravila (navedeno v poglavju
Strontium ranelate has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Stroncijev ranelat nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where PROTELOS is marketed, all physicians who are expected to prescribe PROTELOS are provided with the following educational package:
kjer se zdravilo PROTELOS trži, bo imetnik dovoljenja za promet z zdravilom zagotovil, da bodo vsi zdravniki, za katere se predvideva, da bodo predpisovali zdravilo PROTELOS, dobili naslednji izobraževalni paket:
If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS.
Če jemljete antacide (zdravila proti zgagi), jih vzemite najmanj 2 uri po jemanju zdravila PROTELOS.
Given the slow absorption, PROTELOS should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
PROTELOS jemljemo pred spanjem, najbolje najmanj dve uri po obroku (glejte poglavji 4.5 in 5.2).
Contents of the pack and other information
Shranjevanje zdravila PROTELOS Vsebina pakiranja in dodatne informacije
In phase III studies, as compared to placebo, biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) increased and those of bone resorption (serum C-telopeptide and urinary N-telopeptide cross links) decreased from the third month of treatment up to 3 years.
V študijah III. faze so se v primerjavi s placebom biokemični kazalci tvorjenja kosti (kostno specifična alkalna fosfataza in C-terminalni propeptid prokolagena tipa I) povečali, kazalci resorpcije kosti
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in strontium ranelate treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Miokardni infarkt V združenih randomiziranih, s placebom nadzorovanih študijah pri bolnicah z osteoporozo po menopavzi so opažali pomembno povečanje miokardnega infarkta pri bolnicah, ki so se zdravile s stroncijevim ranelatom v primerjavi s placebom (1,7 % vs. 1,1 %), z relativnim tveganjem 1,6% (95% IZ = [1,07 ; 2,83]).
In this group, over 3 years of treatment, PROTELOS reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Pri takšnih bolnicah je v 3 letih zdravljenja zdravilo PROTELOS zmanjšalo tveganje za zlome kolka za 36 % v primerjavi s placebom (preglednica 2).
Following episodes of overdoses during clinical trials (up to 4 g/day for a maximal duration of 147 days), no clinically relevant events were observed.
Po obdobjih prevelikega odmerjanja v kliničnih študijah (do 4 g na dan največ 147 dni) niso opazili klinično pomembnih dogodkov.Zaužitje mleka ali antacidov lahko pripomore k zmanjševanju absorpcije učinkovine.
No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with PROTELOS in the target population were found during clinical trials.
V kliničnih študijah ni bilo dokazov za klinična medsebojna delovanja ali pomembno povečanje vrednosti stroncija v krvi ob sočasnem dajanju zdravil, ki jih pogosto z zdravilom PROTELOS jemlje ciljna populacija.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Les Laboratoires Servier Industrie 905, route de Saran - 45520 Gidy, Francija Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Therefore, administration of PROTELOS and such products should be separated by at least two hours (see sections 4.2 and 5.2).
Zato je priporočljivo, da bolniki jemljejo zdravilo PROTELOS najmanj dve uri po njihovem zaužitju (glejte poglavji 4.2 in 5.2).
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in PROTELOS treated patients compared to placebo (see section 4.8).
V združenih randomiziranih, s placebom nadzorovanih študijah pri bolnicah z osteoporozo po menopavzi so v primerjavi s placebom opazili pomembno povečanje miokardnega infarkta pri bolnicah, ki so se zdravile z zdravilom PROTELOS (glejte poglavje 4.8).
If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) or DRESS (e.g. rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately.
Če se pojavijo simptomi ali znaki SJS ali TEN (npr. napredujoč kožni izpuščaj, pogosto z mehurji ali poškodbami sluznice) ali sindroma DRESS (npr. izpuščaj, zvišana telesna temperatura, eozinofilija in sistemski zapleti (npr. adenopatija, hepatitis, intersticijska nefropatija, intersticijska pljučna bolezen))
Frequency in Clinical Trials was similar in the drug and placebo group.
Preiskave pogosti povečanje keratin-fosfokinaze (CPK) v krvia § Pogostnost v kliničnih preskušanjih je bila podobna v skupini, ki je prejemala zdravilo in skupini, ki je prejemala s placebo.
− Signs of severe hypersensitivity reactions (DRESS): initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature (uncommon), increased levels of liver enzymes seen in blood tests (uncommon) an increase in a type of white blood cell (eosinophilia) (rare) and enlarged lymph nodes (uncommon).
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): − Znaki hudih preobčutljivostnih reakcij (DRESS): v začetku se pojavijo gripi podobni simptomi in izpuščaji na obrazu, nato razširjen izpuščaj z visoko telesno temperaturo (občasni), zvišane vrednosti jetrnih encimov, opažene v preiskavah krvi (občasni), povečano število določenega tipa belih krvnih celic (eozinofilija) (redki) ter povečane bezgavke (občasni).
Each sachet also contains 20 mg of aspartame (E951).
Pomožne snovi z znanim učinkom: Ena vrečka vsebuje tudi 20 mg aspartama (E951).
How PROTELOS works
Kako zdravilo PROTELOS deluje
Your doctor may advise you to take calcium and vitamin D supplements in addition to PROTELOS.
Zdravnik vam lahko poleg zdravila PROTELOS svetuje pripravke kalcija in vitamina D. Ne jemljite kalcijevih pripravkov pred spanjem hkrati z zdravilom PROTELOS.
Uncommon (may affect up to 1 in 100 people):
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)::
Musculoskeletal pain (muscle spasm, myalgia, bone pain, arthralgia and pain in extremity)
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišično-skeletna bolečina (mišični spazmi, mialgija, bolečine v kosteh, artralgija in bolečine v okončinah) §
Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see sections 4.4 and 5.2).
Za bolnike z blago do zmerno ledvično okvaro (očistek kreatinina 30 do 70 ml/min) odmerka ni treba prilagajati (glejte poglavji 4.4 in 5.2).
Where possible, screening for HLA-A*33:03 and HLA-B*58:01 alleles could be considered before starting treatment with PROTELOS in patients of Han Chinese origin.
Kjer je mogoče, se lahko pred začetkom zdravljenja z zdravilom Protelos pri bolnikih kitajske etnične skupine Han razmisli o izvedbi presejalnih testov za alela HLA-A*33:03 in HLA-B*58:01.
There is no pharmacokinetic data in patients with severe renal impairment (creatinine clearance below 30 ml/min).
Stroncijev ranelat ni priporočljiv za bolnike s hudo ledvično okvaro (očistek kreatinina pod 30 ml/min)
PROTELOS should be discontinued as soon as possible in the event of an illness or a condition leading to immobilisation (see section 4.3) and adequate preventive measures taken.
V primeru bolezni ali stanja, ki privede do nepokretnosti bolnika (glejte poglavje 4.3), je treba zdravljenje z zdravilom PROTELOS nemudoma prekiniti in izvajati ustrezne preventivne ukrepe.
If the patient has developed SJS, TEN or DRESS with the use of PROTELOS, PROTELOS must not be re-started.
Če se je zaradi zdravljenja z zdravilom PROTELOS pri bolniku pojavil SJS, TEN ali DRESS, mu zdravljenja z zdravilom PROTELOS nikoli ne smemo ponovno uvesti.
Annopol 6B - 03-236 Warszawa, Poland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
The efficacy of PROTELOS was demonstrated in men with osteoporosis in a 2-year, doubleblind,placebo-controlled study with a main analysis after one year in 243 patients (Intention to treatpopulation, 161 patients received strontium ranelate) at high risk of fracture (mean age 72,7 years; mean lumbar BMD T-score value of -2.6; 28% of prevalent vertebral fracture).
Učinkovitost zdravila PROTELOS je bila pri moških z osteoporozo dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je trajala 2 leti, z glavno analizo po enem letu pri 243 bolnikov (ITT - populacija bolnikov, ki so jih nameravali zdraviti, 161 bolnikov je prejemalo stroncijev ranelat)
PROTELOS is for oral use.
Zdravilo PROTELOS je namenjeno za peroralno uporabo.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Aspartame (E951)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aspartam (E951) maltodekstrin manitol (E421)
EU/1/04/288/005 84 sachets (3 packs of 28) EU/1/04/288/006 100 sachets
EU/1/04/288/005 84 vrečk (3 pakiranja po 28 vrečk)
Pyrexia (in association with hypersensitivity skin reactions)
eozinofilija (v povezavi s preobčutljivostnimi kožnimi reakcijami)
The outcome of DRESS is favorable in most cases upon discontinuation of PROTELOS and after initiation of corticosteroid therapy when necessary.
V večini primerov je izid sindroma DRESS ugoden po prekinitvi jemanja zdravila
NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension
IME ZDRAVILA PROTELOS 2 g zrnca za peroralno suspenzijo
As a divalent cation, strontium is not metabolised.
Biotransformacija Kot dvovalentni kation se stroncij ne presnavlja.
Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of PROTELOS.
Johnsonovem sindromu (SJS), toksični epidermalni nekrolizi (TEN) in z zdravilom povzročenem kožnem izpuščaju z eozinofilijo in sistemskimi simptomi (DRESS - drug rash with eosinophilia and systemic symptoms)).
Continuation of treatment with PROTELOS in patients developing severe renal impairment should be considered on an individual basis.
Če se razvije huda ledvična okvara, se o nadaljevanju zdravljenja z zdravilom PROTELOS odloča pri vsakem bolniku posebej.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/004 56 sachets
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/288/004 56 vrečk
Driving and using machines: Protelos is unlikely to affect your ability to drive or use machines.
Ni verjetno, da bi zdravilo PROTELOS vplivalo na vašo sposobnost upravljanja vozil in strojev.
In vitro, strontium ranelate: - increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture.
- povečuje tvorjenje kosti v kulturah kostnega tkiva in replikacijo prekurzorjev osteoblastov ter sintezo kolagena v kulturah kostnih celic; - zmanjšuje resorpcijo kosti z zmanjševanjem diferenciacije osteoklastov in resorpcijske dejavnosti.
Eczema
Zdravila
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of PROTELOS.
Pri zdravljenju z zdravilom PROTELOS so poročali o morebitno življenje ogrožajočih kožnih izpuščajih (Stevens-Johnsonovem sindromu, toksični epidermalni nekrolizi in hudih preobčutljivostnih reakcijah (sindrom DRESS)).
Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome and toxic epidermal necrolysis* (see section
Johnsonov sindrom in toksična epidermalna nekroliza* (glejte poglavje 4.4)#
Oral mucosal irritation (stomatitis and/or mouth ulceration)
(izjemna) utrujenost in/ali omotica.
Myocardial infarction
Srčne bolezni pogosti miokardni infarkt
- in adult men, at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Zdravljenje hude osteoporoze: - pri ženskah po menopavzi, - pri odraslih moških, z velikim tveganjem za zlome, pri katerih zdravljenje z drugimi zdravili, ki so odobrena za zdravljenje osteoporoze, zaradi kontraindikacij ali neprenašanja ni mogoče.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of PROTELOS, you must not be re-started on PROTELOS at any time If you are of Asian origin, you may be at higher risk of skin reactions.
Če se je pri vas ob zdravljenju z zdravilom PROTELOS pojavil Stevens-Johnsonov sindrom, toksična epidermalna nekroliza ali sindrom DRESS, zdravljenja z zdravilom PROTELOS nikoli ne smete ponovno začeti.
It is recommended that you take PROTELOS at bedtime, preferably at least 2 hours after dinner.
Priporočeni odmerek je ena vrečka po 2 g na dan. Priporočljivo je, da zdravilo PROTELOS jemljete pred spanjem, najbolje vsaj 2 uri po večerji.
Talk to your doctor or pharmacist before taking PROTELOS: - if you are at risk of heart disease, this includes high blood pressure, high cholesterol, diabetes,
- če imate tveganje za bolezen srca, ki vključuje zvišan krvni tlak, zvišan holesterol, sladkorno bolezen in kajenje, - če imate tveganje za pojav krvnih strdkov,
− Signs of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis): initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): − Znaki morebitno življenje ogrožajočih kožnih izpuščajev (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza): sprva se pojavijo rdečkaste, tarči podobne pike ali krožne lise na trupu,
In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that PROTELOS reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
pokazala, da je zdravilo PROTELOS v 3-letnem zdravljenju zmanjšalo relativno tveganje za pojav novih zlomov vretenc za 32 % (ob stroncijevem ranelatu je bila pojavnost 19,1 % v primerjavi s 26,5 % ob placebu).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION PROTELOS 2 g granules for oral suspension.
IME ZDRAVILA IN POT(I) UPORABE PROTELOS 2 g zrnca za peroralno suspenzijo stroncijev ranelat za peroralno uporabo
If the following happens to you, stop using PROTELOS and talk to your doctor immediately:
Če se pri vas pojavi katerikoli od spodaj navedenih neželenih učinkov, takoj prenehajte z jemanjem zdravila PROTELOS in se takoj posvetujte s svojim zdravnikom: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), PROTELOS reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
toda z vsaj enim dodatnim dejavnikom tveganja zanje (n = 176), je skupna analiza a posteriori pokazala, da je zdravilo PROTELOS zmanjšalo tveganje prvega zloma vretenc za 72 % v 3 letih (pojavnost zlomov vretenc 3,6 % ob stroncijevem ranelatu v primerjavi z 12,0 % ob placebu).
Package leaflet: Information for the patient PROTELOS 2 g granules for oral suspension Strontium ranelate
Navodilo za uporabo PROTELOS 2 g zrnca za peroralno suspenzijo stroncijev ranelat
In addition to their treatment (2 g/day strontium ranelate or placebo), the patients received adapted calcium and vitamin D supplements throughout both studies.
Poleg zdravljenja s stroncijevim ranelatom po 2 g na dan ali placebom so bolnice ves čas obeh študij jemale prilagojene pripravke kalcija in vitamina D. V 3-letnem zdravljenju v študiji SOTI je zdravilo PROTELOS zmanjšal relativno tveganje novih zlomov vretenc za 41 % (preglednica 1).
Hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema)
srbenje, koprivnica, angioedem) §
MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/288/001
NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension Strontium ranelate
PROTELOS 2 g zrnca za peroralno suspenzijo stroncijev ranelat
MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/002
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/288/002