natgillin/translations-raw huggingface dataset:
Nausea, Vomiting, Hiatus hernia, Gastroesophageal reflux disease Uncommon:
Slabost, bruhanje, hiatalna hernija, gastroezofagealna refluksna bolezen Občasno:
Haemorrhoids Renal and urinary disorders Uncommon:
Hemoroidi Bolezni sečil Občasno:
Urinary incontinence, Polyuria, Micturition urgency Skin and subcutaneous tissue disorders Common:
Inkontinenca urina, poliurija, pogosto siljenje na vodo Bolezni kože in podkožja Pogosto:
Sweating increased Musculoskeletal and connective tissue disorders Very common:
Povečano znojenje Bolezni mišično- skeletnega sistema in vezivnega tkiva Zelo pogosto:
Pain in limb Common:
Bolečina v okončinah Pogosto:
Muscle cramps Uncommon:
Mišični krči Občasno:
Myalgia, Arthralgia Not known:
Mialgija, artralgija Ni znano:
Back cramp/ pain* Metabolism and nutrition disorders Common:
Krč/ bolečina v hrbtu * Presnovne in prehranske motnje Pogosto:
Hypercholesterolaemia Uncommon:
Hiperholesterolemija Občasno:
Hypercalcemia greater than 2.76 mmol/ L, Hyperuricemia Rare:
Hiperkalcemija, višja od 2, 76 mmol/ l, hiperurikemija Redko:
Hypercalcemia greater than 3.25 mmol/ L Vascular disorders Common:
Hiperkalcemija, višja od 3, 25 mmol/ l Žilne bolezni Pogosto:
Hypotension General disorders and administration site conditions Common:
Hipotenzija Splošne težave in spremembe na mestu aplikacije Pogosto:
Uncommon:
Utrujenost, bolečina v prsnem košu, astenija, blagi in prehodni učinki na mestu injiciranja, vključno z bolečino, oteklino, rdečino, omejeno podplutbo, srbenjem in manjšo krvavitvijo na mestu injiciranja Občasno:
Injection site erythema, Injection site reaction Rare:
Rdečina na mestu injiciranja, reakcija na mestu injiciranja Redko:
Psychiatric disorders Common:
Možne alergijske reakcije kmalu po injiciranju: akutna dispneja, edem ust/ obraza, generalizirana koprivnica, bolečina v prsnem košu, edem (zlasti periferni) Psihiatrične motnje Pogosto:
Depression * Serious cases of back cramp or pain have been reported within minutes of the injection.
Depresija * Nekaj minut po injiciranju so poročali o resnih primerih krča ali bolečine v hrbtu.
In clinical trials the following reactions were reported at a ≥ 1% difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.
V kliničnih preskušanjih so z ≥ 1% razliko v pogostnosti od placeba poročali o naslednjih reakcijah: vrtoglavica, slabost, bolečina v okončinah, omotica, depresija, dispneja.
FORSTEO increases serum uric acid concentrations.
FORSTEO zvišuje serumske koncentracije sečne kisline.
In clinical trials, 2.8% of FORSTEO patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients.
V kliničnih preskušanjih je imelo 2, 8% bolnikov, ki so prejemali FORSTEO, serumske koncentracije sečne kisline nad zgornjo mejo normalnih vrednosti v primerjavi z 0, 7% bolnikov, ki so prejemali placebo.
In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving FORSTEO.
V velikem kliničnem preskušanju so pri 2, 8% žensk, ki so prejemale FORSTEO, zaznali protitelesa, ki so navzkrižno reagirala s teriparatidom.
There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on BMD response.
Dokazov preobčutljivostnih reakcij, alergijskih reakcij, učinkov na serumske koncentracije kalcija in na odzivnost mineralne gostote kosti (BMD) ni bilo.
5 Signs and symptoms No cases of overdose were reported during clinical trials.
Znaki in simtpomi Med kliničnimi preskušanji niso poročali o primeru prevelikega odmerjanja.
FORSTEO has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/ day for 6 weeks.
FORSTEO so dajali v enkratnih odmerkih do 100 mikrogramov in v večkratnih odmerkih do 60 mikrogramov dnevno 6 tednov.
The effects of overdose that might be expected include delayed hypercalcaemia and risk of orthostatic hypotension.
5 Učinki prevelikega odmerjanja, ki jih lahko pričakujemo, vključujejo podaljšano hiperkalciemijo in tveganje za ortostatsko hipotenzijo.
In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 µg) of the teriparatide pen have been administered as a single dose.
Izkušnje s prevelikim odmerjanjem na podlagi spontanih poročil po uvedbi zdravila na trg V spontanih poročilih po uvedbi zdravila na trg so poročali o primerih napačnega odmerjanja, ko so dali vso vsebino (do 800 µg) peresnika s teriparatidom kot enkratni odmerek.
Transient events reported have included nausea, weakness/ lethargy and hypotension.
Poročali so o naslednjih prehodnih učinkih: slabost, oslabelost/ letargija in hipotenzija.
There is no specific antidote for FORSTEO.
Ravnanje v primeru prevelikega odmerjanja Za FORSTEO ni specifičnega antidota.
Treatment of suspected overdose should include transitory discontinuation of FORSTEO, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration.
Zdravljenje domnevnega prevelikega odmerjanja naj vključuje prehodno ukinitev FORSTEA, spremljanje serumskih koncentracij kalcija in uporabo ustreznih podpornih ukrepov, kot je hidracija.
Pharmaco-therapeutic group: parathyroid hormones and analogues, ATC code:
Obščitnični hormoni in analogi, Oznaka ATC:
Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney.
Mehanizem delovanja Endogeni paratiroidni hormon (PTH) iz 84 aminokislin je primarni regulator presnove kalcija in fosfata v kosteh in ledvicah.
FORSTEO (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone.
FORSTEO (rhPTH( 1- 34)) je aktivni fragment (1- 34) endogenega humanega paratiroidnega hormona.
Pharmacodynamic effects FORSTEO is a bone formation agent to treat osteoporosis.
Farmakodinamični učinki FORSTEO je zdravilo za tvorbo kostnine za zdravljenje osteoporoze.
The skeletal effects of FORSTEO depend upon the pattern of systemic exposure.
Učinki FORSTEA na okostje so odvisni od načina izpostavljanja sistema.
Once-daily administration of FORSTEO increases apposition of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Dajanje FORSTEA enkrat dnevno poveča apozicijo nove kostnine na trabekularne in kortikalne površine kosti s prednostno stimulacijo osteoblastnega delovanja proti osteoklastnimu delovanju.
Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk for fracture (e. g., low bone density [e. g., T score ≤− 2], sustained high dose glucocorticoid therapy [e. g., ≥ 7.5 mg/ day for at least 6 months], high underlying disease activity, low sex steroid levels).
T vrednost ≤ −2], podaljšani visoki odmerki glukokortikoidne terapije [npr. ≥ 7, 5 mg/ dan za najmanj 6 mesecev], visoko osnovno delovanje bolezni, nizki nivoji spolnega steroida).
Postmenopausal osteoporosis:
Pomenopavzalna osteoporoza:
6 The pivotal study included 1637 postmenopausal women (mean age 69.5 years).
Ključna študija je vključevala 1637 žensk po menopavzi (povprečna starost 69, 5 let).
At baseline, ninety percent of the patients had one or more vertebral fractures, and on average, vertebral BMD was 0.82 g/ cm2 (equivalent to a T-score = - 2.6).
V izhodiščnem stanju je imelo devetdeset odstotkov bolnikov enega ali več zlomov vretenc in v povprečju je bila mineralna gostota kosti (BMD) vretenc 0, 82 g/ cm2 (ustrezno T- vrednosti = - 2, 6).
All patients were offered 1000 mg calcium per day and at least 400 IU vitamin D per day.
Vsem bolnikom so ponudili 1000 mg kalcija dnevno in vsaj 400 i. e. vitamina D dnevno.
Results from up to 24 months (median:
Rezultati do 24 mesecev 6 (mediana:
19 months) treatment with FORSTEO demonstrate statistically significant fracture reduction (Table 4).
19 mesecev) trajajočega zdravljenja s FORSTEOM kažejo statistično značilno znižanje števila zlomov (Preglednica 4).
Fracture Incidence in Postmenopausal Women:
Incidenca zlomov pri ženskah po menopavzi:
Relative risk
Relativno tveganje
vs. placebo New vertebral
v primerjavi s placebom 5, 0b
14.3
Nov zlom vretenc (≥ 1) a
5.0 b
14, 3
fracture (≥ 1) a
(0, 22, 0, 55) 1, 1b
Multiple vertebral fractures (≥ 2) a
Več zlomov vretenc (≥ 2) a
1.1 b
0, 23
0.23 (0.09, 0.60)
(0, 09, 0, 60) 2, 6d
Non-vertebral
Nevretenčni zlomi zaradi
5.5%
5, 5
2.6% d
0, 47
0.47
krhkostic
fragility fractures c
1, 5d
3.9%
3, 9
a The incidence of vertebral fractures was assessed in 448 placebo and 444 Forsteo patients who had baseline and follow-up spine radiographs. b p≤ 0.001 compared with placebo c A significant reduction in the incidence of hip fractures has not been demonstrated d p≤ 0.025 compared with placebo.
N = število bolnikov, naključno vključenih v vsako skupino zdravljenja; IZ = interval zaupanja a Incidenca vretenčnih zlomov je bila ocenjena pri 448 bolnikih, ki so prejemali placebo in 444 bolnikih, ki so prejemali Forsteo in so imeli radiografijo osnovnega stanja in ponovne ocene hrbtenice. b p ≤ 0, 001 v primerjavi s placebom c Pomembnega zmanjšanja incidence zlomov kolka niso dokazali. d p ≤ 0, 025 v primerjavi s placebom
After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9% and 4% compared with placebo (p < 0.001).
Po 19 mesecih (mediana) zdravljenja se je mineralna gostota kosti (BMD) povišala v ledvenem delu hrbtenice oziroma celem kolku, za 9% oziroma 4% v primerjavi s placebom (p < 0, 001).
Post-treatment management:
Obravnanva po zdravljenju:
Following treatment with FORSTEO, 1262 postmenopausal women from the pivotal trial enrolled in a post-treatment follow-up study.
Po zdravljenju s FORSTEOM je 1262 žensk po menopavzi iz ključnega preskušanja sodelovalo v kontrolni študiji bolnikov po zdravljenju.
The primary objective of the study was to collect safety data of FORSTEO.
Primarni cilj študije je bil zbrati podatke o varnosti FORSTEA.
During a median of 18 months following discontinuation of FORSTEO, there was a 41% reduction (p=0.004) compared with placebo in the number of patients with a minimum of one new vertebral fracture.
V času po ukinitvi FORSTEA (mediana 18 mesecev) je za 41% (p = 0, 004) manj bolnikov imelo najmanj en novi zlom vretenca v primerjavi z bolniki, ki so prejemali placebo.
In an open-label study, 503 postmenopausal women with severe osteoporosis and a fragility fracture within the previous 3 years (83% had received previous osteoporosis therapy) were treated with FORSTEO for up to 24 months.
V odprti študiji so 503 ženske po menopavzi, ki so imele hudo osteoporozo in zlom zaradi krhkosti v zadnjih 3 letih (83% jih je bilo predhodno zdravljenih za osteoporozo), do 24 mesecev dobivale FORSTEO.
At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5%, 2.6% and 3.9% respectively.
Po 24 mesecih se jim je mineralna gostota kosti (BMD) v ledvenem delu hrbtenice v povprečju povečala za 10, 5%, v celem kolku za 2, 6% in v vratu stegnenice za 3, 9%.
The mean increase in BMD from 18 to 24 months was 1.4%, 1.2%, and 1.6% at the lumbar spine, total hip and femoral neck, respectively.
Povprečno povečanje BMD od 18. do 24. meseca je bilo v ledvenem delu hrbtenice 1, 4%, celem kolku 1, 2% in vratu stegnenice 1, 6%.
7 Male osteoporosis:
Osteoporoza pri moških
437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis.
437 bolnikov (povprečna starost 58, 7 let) je bilo vključenih v klinično preskušanje za moške s hipogonadalno (definirano kot nizek jutranji prosti testosteron ali povišan FSH ali LH) ali idiopatsko osteoporozo.
Baseline spinal and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively.
Povprečni T- vrednosti osnovne mineralne gostote kosti hrbtenice in vratu stegnenice sta bili- 2, 2 in - 2, 1.
At baseline, 35% of patients had a vertebral fracture and 59% had a non-vertebral fracture.
V osnovnem stanju je imelo 35% bolnikov vretenčni zlom in 59% nevretenčni zlom.
Lumbar spine BMD significantly increased by 3 months.
Po 12 mesecih se
After 12 months, BMD had increased in the lumbar spine and total hip by 5% and 1%, respectively, compared with placebo.
7 je mineralna gostota kosti (BMD) v ledvenem delu hrbtenice oziroma celem kolku povišala za 5% oziroma 1% v primerjavi s placebom.
The efficacy of Forsteo in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18- month primary phase of a 36 month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/ day).
Učinkovitost FORSTEA pri moških in ženskah (N=428), ki so prejemali podaljšano sistemsko glukokortikoidno terapijo (kar ustreza 5 mg ali več prednizona v najmanj 3 mesecih) so dokazali v 18 - mesečni začetni fazi 36- mesečne, randomizirane, dvojno slepe, s primerjavo kontrolirane študije (alendronat 10 mg/ dan).
All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.
Vsem bolnikom so ponudili 1000 mg kalcija na dan in 800 i. e. vitamina D dnevno.
At baseline, the postmenopausal women had a mean age of 61 years, mean lumbar spine BMD T score of − 2.7, median prednisone equivalent dose of 7.5 mg/ day, and 34% had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of − 2.5, median prednisone equivalent dose of 10 mg/ day, and 9% had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD T score of − 2.2, median prednisone equivalent dose of 10 mg/ day, and 24% had one or more radiographic vertebral fractures.
V osnovi so imele ženske po menopavzi povprečno starost 61 let, srednjo T- vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice – 2, 7, srednji ustrezni odmerek prednizona 7, 5 mg/ dan in 34% jih je imelo enega li več radiografskih zlomov; ženske pred menopavzo so imele povprečno starost 37 let, srednjo T- vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice – 2, 5, srednji ustrezni odmerek prednizona 10 mg/ dan in 9% jih je imelo enega li več radiografskih zlomov; moški so imeli povprečno starost 57 let, srednjo T- vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice – 2, 2, srednji ustrezni odmerek prednizona 10 mg/ dan in 24% jih je imelo enega li več radiografskih zlomov.
Sixty-nine percent of patients completed the 18-month primary phase.
Devetinšestdeset odstotkov bolnikov je zaključilo 18- mesečno začetno fazo.
At the 18 month endpoint, FORSTEO significantly increased lumbar spine BMD (7.2%) compared with alendronate (3.4%) (p < 0.001).
V končni točki po 18 mesecih je FORSTEO značilno zvišal mineralno gostoto kosti (BMD) v ledvenem delu hrbtenice (7, 2%) v primerjavi z alendronatom (3, 6%) (p < 0, 01).
FORSTEO increased BMD at the total hip (3.6%) compared with alendronate (2.2%) (p < 0.01), as well as at the femoral neck (3.7%) compared with alendronate (2.1%) (p < 0.05).
FORSTEO je zvišal mineralno gostoto kosti (BMD) v celem kolku (7, 2%) v primerjavi z alendronatom (2, 2%) (p < 0, 01), kot tudi v vratu stegnenice (3, 7%) v primerjavi z alendronatom (2, 1%) (p < 0, 05).
In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7%, 0.9%, and 0.4%, respectively.
Pri bolnikih zdravljenih s teriparatidom, se je BMD ledvenega dela hrbtenice od 18. do 24. meseca dodatno povečala za 1, 7%, celega kolka za 0, 9% in vratu stegnenice za 0, 4%.
At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 FORSTEO patients showed that 13 patients in the alendronate group (7.7%) had experienced a new vertebral fracture compared with 3 patients in the FORSTEO group (1.7%) (p=0.01).
Analiza rentgenskih posnetkov 169 bolnikov, ki so dobivali alendronat, in 173 bolnikov, ki so dobivali FORSTEO, je po 36 mesecih pokazala nov zlom vretenc pri 13 bolnikih v skupini z alendronatom (7, 7%) in pri 3 bolnikih v skupini FORSTEA (1, 7%) (p = 0, 01).
In addition, 15 of 214 patients in the alendronate group (7.0%) had experienced a nonvertebral fracture compared with 16 of 214 patients in the FORSTEO group (7.5%) (p=0.84).
Poleg tega se je nevretenčen zlom pojavil pri 15 od 214 bolnikov v skupini z alendronatom (7, 0%) in pri 16 od 214 bolnikov v skupini FORSTEA (7, 5%) (p = 0, 84).
In premenopausal women, the increase in BMD from baseline to 18 month endpoint was significantly greater in the FORSTEO group compared with the alendronate group at the lumbar spine (4.2% versus − 1.9%; p < 0.001) and total hip (3.8% versus 0.9%; p=0.005).
Pri ženskah pred menopavzo je bilo povišanje mineralne gostote kosti (BMD) z osnove na končno točko po 18 mesecih značilno višje v skupini FORSTEA v primerjavi s skupino alendronata za ledveni del hrbtenice (4, 2% proti - 1, 9%; p < 0, 001) in celi kolk (3, 8% proti 0, 9%; p < 0, 005).
However, no significant effect on fracture rates was demonstrated.
Vendar niso pokazali značinega vpliva na razmerja zlomov.
FORSTEO is eliminated through hepatic and extra-hepatic clearance (approximately 62 l/ hr in women and 94 l/ hr in men).
FORSTEO se izloča z jetrnim in zunaj- jetrnim očistkom (približno 62 l/ h pri ženskah in 94 l/ h pri moških).
The volume of distribution is approximately 1.7 l/ kg.
Volumen porazdelitve je približno 1, 7 l/ kg.
The half-life of FORSTEO is approximately 1 hour when administered subcutaneously, which reflects the time required for absorption from the injection site.
Razpolovni čas FORSTEA je približno 1 ura po subkutanem dajanju, kar odraža čas, potreben za absorpcijo z mesta injiciranja.
No metabolism or excretion studies have been performed with FORSTEO but the peripheral metabolism of parathyroid hormone is believed to occur predominantly in liver and kidney.
Za FORSTEO niso opravili nobenih študij presnove ali izločanja, vendar za periferno presnovo paratiroidnega hormona velja, da poteka predvsem v jetrih in ledvicah.
8 Patient characteristics:
Značilnosti bolnikov
Geriatrics No differences in FORSTEO pharmacokinetics were detected with regard to age (range 31 to 85 years).
Starejši V farmakokinetiki FORSTEA niso zaznali razlik glede na starost (razpon od 31 do 85 let).
Teriparatide was not genotoxic in a standard battery of tests.
8 V standardnem naboru testov niso ugotovili genotoksičnosti teriparatida.
There were no important effects observed in pregnant rats or mice administered teriparatide at daily doses of 30 to 1000 µg/ kg.
Niso opazili nobenih pomembnih učinkov pri brejih podganah ali miših, ki so jim dajali teriparatid v dnevnih odmerkih 30 do 1000 µg/ kg.
However, fetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 µg/ kg.
Vendar se je pojavila resorpcija ploda in zmanjšanje zaroda pri brejih kuncih, ki so prejemali dnevne odmerke od 3 do 100 µg/ kg.
No bone tumours were observed in ovariectomised monkeys treated for 18 months or during a 3-year follow-up period after treatment cessation.
Pri opicah, ki so jim izrezali jajčnike in so 18 mesecev prejemale teriparatid, niso opazili nobenih kostnih tumorjev, niti v 3- letnem obdobju spremljanja po končanem zdravljenju.
Animal studies have shown that severely reduced hepatic blood flow decreases exposure of PTH to the principal cleavage system (Kupffer cells) and consequently clearance of PTH(1-84).
Študije na živalih so pokazale, da hudo zmanjšan pretok krvi skozi jetra zniža izpostavitev paratirodnega hormona poglavitnemu sistemu razgradnje (Kupfferjeve celice) in posledično očistek paratiroidnega hormona (1- 84).
Glacial acetic acid Sodium acetate (anhydrous) Mannitol Metacresol Hydrochloric acid Sodium hydroxide Water for injections
Koncentrirana ocetna kislina Natrijev acetat (brezvodni) Manitol Metakrezol Klorovodikova kislina Natrijev hidroksid Voda za injekcije
Hydrochloric acid and/ or sodium hydroxide solution may be added to adjust pH.
Za uravnavanje pH sta morda bili dodani raztopina klorovodikove kisline in/ ali raztopina natrijevega hidroksida.
Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C.
Po odprtju zdravila, lahko izdelek shranjujemo največ 28 dni pri temperaturi med 2 °C in 8 °C.
9 Store in a refrigerator (2°C – 8°C) at all times.
Vedno shranjujte v hladilniku (2 °C – 8 °C).
2.4 ml solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/ bromobutyl rubber laminate)/ aluminium assembled into a disposable pen.
9 2, 4 ml raztopine v vložku (silikonizirano steklo tipa I) z batom (halobutilna guma), zaporno ploščico (poliizopren/ bromobutil gumijasti laminat) / aluminij, sestavljenih v injekcijski peresnik za enkratno uporabo.
FORSTEO is available in pack sizes of 1 or 3 pens.
FORSTEO je na voljo v pakiranjih po 1 ali 3 injekcijske peresnike.
Each pen contains 28 doses of 20 micrograms (per 80 microliters).
Vsak injekcijski peresnik vsebuje 28 odmerkov po 20 mikrogramov (na 80 mikrolitrov).
FORSTEO is supplied in a pre-filled pen.
FORSTEO je na voljo v napolnjenem injekcijskem peresniku.
Each FORSTEO pack is provided with a user manual that fully describes the use of the pen.
V vsakem pakiranju FORSTEA je priložen Priročnik za uporabo, ki v celoti opisuje uporabo injekcijskega peresnika.
FORSTEO should not be used if the solution is cloudy, coloured or contains particles.
FORSTEA ne smete uporabiti, če je raztopina motna, obarvana ali vsebuje trdne delce.
Please also refer to the User Manual for instructions on how to use the pen.
Za navodila, kako uporabljati injekcijski peresnik, prosimo, glejte tudi Priročnik za uporabo.
Eli Lilly Nederland B. V, Grootslag 1-5, NL-3991 RA Houten, The Netherlands
Eli Lilly Nederland B. V, Grootslag 1- 5, NL- 3991 RA Houten, Nizozemska
10 June 2003.
10. junij 2003
Eli Lilly and Company, Lilly Technology Center, Indianapolis, Indiana 46285, United States of America
Eli Lilly and Company, Lilly Technology Center, Indianapolis, Indiana 46285, Združene države Amerike
Lilly France S. A. S., rue du colonel Lilly, 67640 Fegersheim, France
Lilly France S. A. S., rue du colonel Lilly, 67640 Fegersheim, Francija
Lilly S. A., Avda de la Industria 30, 28108 Alcobendas (Madrid), Spain
Lilly SA, Avda de la Industria 30, 28108 Alcobendas (Madrid), Španija
The Marketing Authorisation Holder will submit PSURs annually.
Imetnik dovoljenja za promet bo predajal PSUR enkrat letno.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version n.
Načrt ukrepanja v primeru tveganja Imetnik dovoljenja za promet se zavezuje k izvedbi študij in dodatnih farmakovigilančnih aktivnosti, ki so opisane v Načrtu za farmakovigilanco, po dogovoru v različici št.
2.5 dated 17 January 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
2. 5 z dne 17. januarja 2008, Načrta ukrepanja v primeru tveganja, predstavljenega v Modulu 1. 8. 2 Dovoljenja za promet in katerihkoli naknadnih posodobljenenih Načrtov ukrepanja v primeru tveganja, ki ga je sprejel CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernico CHMP glede Sistemov za ukrepanje v primeru tveganja za zdravila za humano uporabo, mora biti posodobljen Načrt ukrepanja v primeru tveganja predan istočasno kot naslednje Redno poročilo o neželenih učinkih (PSUR).