natgillin/translations-raw huggingface dataset:
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria mepolizumab
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Bosatria mepolizumab
Following the CHMP's opinion, it usually takes around two months for the European Commission to issue a decision on this opinion.
Potem ko CHMP izda svoje mnenje, navadno traja približno dva meseca, preden Evropska komisija dovoljenje odobri.
The effects of Bosatria were first tested in experimental models before being studied in humans.
Učinki zdravila Bosatria so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Bosatria?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Bosatria?
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki prepoznava in se veže na specifično strukturo (ki ji pravimo antigen) v telesu.
During the study the patients received either Bosatria or placebo while the amount of prednisone they received was gradually reduced.
Med študijo so bolniki prejeli bodisi zdravilo Bosatria bodisi placebo, medtem pa so postopoma zmanjšali količino prejetega prednizona.
This is a disease in which eosinophils (a type of white blood cell) start growing out of control, they accumulate in the tissues of many organs, and can cause damage to organs such as the heart, liver and lungs.
Pri tej bolezni ni več nadzora nad nastajanjem eozinofilcev (vrste belih krvnih celic), ki se kopičijo v tkivih številnih organov in lahko poškodujejo organe, kot so srce, jetra in pljuča.
The company informed the CHMP that Bosatria will continue to be made available for patients in the open-label extension study and compassionate use programmes.
Družba je obvestila CHMP, da bo zdravilo Bosatria še naprej na razpolago bolnikom v odprtem podaljšku študije ter v programih sočutne uporabe.
It contains the active substance mepolizumab.
Vsebuje zdravilno učinkovino mepolizumab.
The CHMP was of the opinion that the main study did not provide sufficient evidence to show that Bosatria was effective in reducing the need for corticosteroid treatment.
CHMP je menil, da v glavni študiji ni bilo zadostnih dokazov, s katerimi bi dokazali, da je zdravilo Bosatria učinkovito pri zmanjševanju potrebe po zdravljenju s kortikosteroidi.
The CHMP was also concerned that the method used by the company to quantify the different forms of the active substance in the medicine was not appropriate.
CHMP je imel tudi zadržke glede ustreznosti metode, ki jo je družba uporabljala za določitev količine različnih oblik zdravilne učinkovine v zdravilu.
In one main study involving 85 adults with hypereosinophilic syndrome, Bosatria was compared with placebo (a dummy treatment).
V eni glavni študiji, v katero je bilo vključenih 85 odraslih bolnikov s hipereozinofilnim sindromom, so zdravilo Bosatria primerjali s placebom (zdravilom brez zdravilne učinkovine).
Mepolizumab has been designed to attach to a chemical messenger called interleukin 5 (IL-5), which is involved in the growth of eosinophils.
Mepolizumab je izdelan tako, da se veže na sporočilno kemikalijo, imenovano interlevkin 5 (IL-5), ki sodeluje pri nastajanju eozinofilcev.
All patients lacked the FIP1L1-PDGRF fusion gene and were receiving treatment with prednisone (a corticosteroid) that was helping to stabilise their symptoms.
Vsem bolnikom je manjkal fuzijski gen FIP1L1-PDGRF in so se zdravili s prednizonom (kortikosteroidom), ki je pripomogel k stabilizaciji simptomov.
What is Bosatria?
Kaj je zdravilo Bosatria?
Bosatria was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 July 2004 for the treatment of hypereosinophilic syndrome.
Zdravilo Bosatria je bilo dne 29. julija 2004 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih) za zdravljenje hipereozinofilnega sindroma.
The application was at day 180 when the company withdrew.
Družba je vlogo umaknila na 180. dan postopka.
What was Bosatria expected to be used for?
Za kaj naj bi se zdravilo Bosatria uporabljalo?
Bosatria was expected to be used to treat adults with hypereosinophilic syndrome.
Zdravilo Bosatria naj bi se uporabljajo za zdravljenje odraslih bolnikov s hipereozinofilnim sindromom.
The active substance in Bosatria, mepolizumab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Bosatria je mepolizumab, ki je monoklonsko protitelo.
By attaching to IL-5, mepolizumab was expected to reduce the accumulation of eosinophils in the blood, thereby relieving the symptoms of patients with hypereosinophilic syndrome.
Mepolizumab naj bi z vezavo na IL-5 zmanjšal kopičenje eozinofilcev v krvi in s tem zmanjšal simptome bolnikov s hipereozinofilnim sindromom.
Bosatria is a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo Bosatria je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
On 28 July 2009, Glaxo Group Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Bosatria, for the treatment of adults with hypereosinophilic syndrome to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
Družba Glaxo Group Limited je dne 28. julija 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Bosatria, namenjenim zdravljenju odraslih bolnikov s hipereozinofilnim sindromom za zmanjšanje ali odpravo potrebe po zdravljenju s kortikosteroidi in zmanjšanje števila eozinofilcev v krvi.
How is Bosatria expected to work?
Kako naj bi zdravilo Bosatria delovalo?
Bosatria was expected to be used in patients who lack a gene called the ‘FIP1L1-PDGRF fusion gene' to reduce or eliminate the need for the patients to be treated with corticosteroids (steroids used to treat the disease) and to reduce the level of eosinophils in the blood.
Zdravilo Bosatria naj bi se uporabljajo pri bolnikih, ki nimajo gena, imenovanega „fuzijski gen FIP1L1PDGRF“, za zmanjšanje ali odpravo potrebe po zdravljenju s kortikosteroidi (steroidi, ki so se uporabljali za zdravljenje te bolezni) in zmanjšanje števila eozinofilcev v krvi.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Bosatria could not have been approved for the treatment of adults with hypereosinophilic syndrome who lack the FIP1L1-PDGRF fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Bosatria ni mogoče odobriti za zdravljenje odraslih bolnikov s hipereozinofilnim sindromom in brez fuzijskega gena FIP1L1-PDGRF za zmanjšanje ali odpravo potrebe po zdravljenju s kortikosteroidi in zmanjšanje števila eozinofilcev v krvi.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Bosatria did not outweigh its risks in the treatment of adults with hypereosinophilic syndrome who lack the FIP1L1-PDGRF fusion gene, to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
CHMP je v času umika menil, da koristi zdravila Bosatria ne odtehtajo z njim povezanih tveganj za zdravljenje odraslih bolnikov s hipereozinofilnim sindromom in brez fuzijskega gena FIP1L1-PDGRF za zmanjšanje ali odpravo potrebe po zdravljenju s kortikosteroidi in zmanjšanje števila eozinofilcev v krvi.
The potential risk for humans is unknown.
Morebitno tveganje za ljudi ni znano.
Efficacy was evaluated in 2,928 patients.
Učinkovitost so preučevali pri 2928 bolnicah.
It may harm them,
To so lahko znaki poškodbe ušesnih kosti,
- Choose one day of the month that will be easy to remember.
- Izberite dan v mesecu, ki si ga boste zlahka zapomnili.
It's important to follow these instructions carefully.
Pomembno je, da natančno upoštevate ta navodila.
- If your kidneys are not functioning normally.
- Če vaše ledvice ne delujejo normalno.
No data are available.
Podatki niso na voljo.
Quality of Life *
kakovost življenja*
Please consult your doctor.
Prosimo, posvetujte se s svojim zdravnikom.
A healthy lifestyle will also help you to get the most benefit from your treatment.
Zdrav način življenja vam bo prav tako pomagal, da bo vaše zdravljenje čim bolj uspešno.
You can drink water but no other drinks.
Lahko pijete vodo, vendar ne drugih pijač.
Choose the date that best fits your routine.
Izberite datum, ki najbolje ustreza vašim navadam.
• feeling tired and exhausted
• občutek utrujenosti in izčrpanosti,
Do not let the tablet dissolve in your mouth.
Ne pustite, da se tableta raztopi v ustih.
Attention should also be paid to the possible existence of simultaneous hypomagnesaemia.
Pozorni moramo biti tudi na možnost sočasno obstoječe hipomagneziemije.
No indication of carcinogenic potential was observed.
Kancerogenega potenciala niso opazili.
This was demonstrated in both the primary analysis at one year and in the confirmatory analysis at two years endpoint (Table 2).
To so dokazali v primarni analizi po enem letu in v potrditveni analizi v končni točki po dveh letih (Preglednica 2).
Do not take a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeno tableto.
The release of pharmaceuticals in the environment should be minimized.
Izpust farmacevtskih izdelkov v okolje je treba zmanjšati na najnižjo možno raven.
Instead, consult your calendar and find out when your next scheduled dose is.
Namesto tega poglejte v vaš koledar, kdaj je naslednji načrtovani odmerek.
The results from these trials are summarised below.
Izsledki teh preskušanj so povzeti spodaj.
Note down the date you take your tablet.
Zapišite si datum, ko ste vzeli tableto.
In table 1 a complete list of known adverse reactions is presented.
V preglednici 1 je celoten seznam znanih neželenih učinkov.
Poor healing of these fractures has also been reported.
Poročali so tudi o slabem celjenju teh zlomov.
Especially:
Še posebno:
If you wear dentures you should make sure these fit properly.
Če nosite protezo, morate zagotoviti, da se vam dobro prilega.
There are few data available on patients of African origin.
Na voljo je zelo malo podatkov o bolnikih afriškega izvora.
Patients should not take two tablets within the same week.
Bolnik ne sme vzeti dveh tablet v enem tednu.
If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.
Če jemljete tableto vsak drugi dan ali enkrat na teden, vprašajte vašega zdravnika ali farmacevta za nasvet.
• It also helps to prevent other bone problems that may need surgery or radiotherapy.
• Pomaga preprečiti druge težave s kostmi, zaradi česar bi potrebovali operacijo ali radioterapijo.
You can choose either the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Ibandronic Acid Teva tablet.
Izberite isti datum (na primer prvega v mesecu) ali isti dan (na primer prvo nedeljo vsakega meseca), ko boste vzeli tableto Ibandronska kislina Teva.
Lumbar spine L2-L4
MKG ledvene hrbtenice L2-L4
• Take your tablet with a full glass of water only (about 200 mL).
• Vzemite tableto samo s polnim kozarcem pitne vode (približno 200 ml).
Multiple events were therefore, counted only once in any given 12 week period for the purposes of the analysis.
Večkratne dogodke so za namen analize upoštevali samo enkrat v katerem koli 12-tedenskem obdobju.
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 mora biti navedeno ime in naslov izdelovalca odgovornega za sproščanje zadevne serije.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za nadaljnje informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
• serious, potentially life-threatening allergic reaction
• resna, možno življenjsko ogrožajoča alergijska reakcija,
Summary of the safety profile
Povzetek varnostnega profila zdravila
When taken 30 minutes before a meal, the reduction in bioavailability is approximately 30%.
Pri jemanju 30 minut pred obrokom je zmanjšanje biološke uporabnosti približno 30odstotno.
Water with a high concentration of calcium should not be used.
Vode z visoko koncentracijo kalcija se ne sme uporabljati.
It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Pomembno je, da nastanek osteonekroze čeljustnic poskusimo preprečiti, saj je to boleče stanje, ki ga je težko zdraviti.
• It helps to prevent your bones from breaking (fractures).
• Pomaga preprečiti zlome (frakture) kosti.
Teva Czech Industries s.r.o Ostravska 29/305, 747 70 Opava-Komarov Czech Republic
Teva Czech Industries s.r.o Ostravska 29/305, 747 70 Opava-Komarov
- If you can't stand or sit upright for at least one hour (60 minutes) at a time.
- če ne morete stati ali pokončno sedeti vsaj eno uro (60 minut) naenkrat.
Efficacy results are summarised in Table 2.
Rezultati učinkovitosti so povzeti v preglednici 2.
In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment.
Pri rastočih podganah niso našli dokazov o motnji mineralizacije tudi pri odmerkih, ki so bili 5000-krat večji od odmerkov, potrebnih za zdravljenje osteoporoze.
The extent of absorption is impaired when taken together with food or beverages (other than water).
Obseg absorpcije je pri sočasnem jemanju s hrano ali pijačo (razen pitne vode) zmanjšan.
Month 3
Mesec 3
Do not take your tablet with any drink other than water.
Tablete ne vzemite z nobeno drugo pijačo razen vode.
- After you've waited for an hour, you can have your first food and drink of the day.
- Ko ste počakali eno uro, lahko zaužijete prvo hrano ali pijačo.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Da bi zmanjšali tveganje za razvoj osteonekroze čeljustnic, morate upoštevati nekatere previdnostne ukrepe.
Manufacturer:
Izdelovalci:
You can help stop this happening by doing the following:
To lahko preprečite z upoštevanjem spodnjih navodil:
The serum calcium level may fall to hypocalcaemic values.
Serumske koncentracije kalcija lahko padejo do hipokalciemičnih vrednosti.
• severe adverse skin reactions.
• hude neželene kožne reakcije.
All patients received 500 mg calcium and 400 IU vitamin D daily.
Vse bolnice so prejemale 500 mg kalcija in 400 i.e. vitamina D dnevno.
Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Zdravljenje je bilo najpogosteje povezano z znižanjem serumskega kalcija na pod spodnjo mejo normale (hipokalciemija), sledi dispepsija.
At the menopause, a woman's ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.
V menopavzi jajčniki prenehajo proizvajati ženski hormon estrogen, ki ženskam pomaga ohranjati zdravo okostje.
Pharmacokinetics in special clinical situations
Farmakokinetika v posebnih kliničnih razmerah
Once you've eaten, it's OK to lie down if you wish, and to take any other medication you need.
Ko pojeste, se po želji lahko uležete in vzamete kakšno drugo zdravilo, če ga potrebujete.
Other disturbances of bone and mineral metabolism should also be effectively treated.
Učinkovito je treba zdraviti tudi druge motnje kosti in presnove mineralov.
- If you have, or had in the past low blood calcium.
- če imate ali ste v preteklosti imeli nizko raven kalcija v krvi.
Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
Obrnite se na medicinsko sestro ali zdravnika, če simptomi postanejo moteči ali trajajo več kot nekaj dni.
The most frequently reported adverse reactions are arthralgia and influenza-like symptoms.
Najpogosteje poročani neželeni učinki so bili artralgija in simptomi, podobni gripi.
Both daily and intermittent (with prolonged dose-free intervals) long-term administration in rats, dogs and monkeys was associated with formation of new bone of normal quality and maintained or increased mechanical strength even at doses in the toxic range.
Tako dnevno kot intermitentno (s podaljšanimi premori brez odmerkov) dolgotrajno dajanje zdravila podganam, psom in opicam je bilo povezano s tvorbo nove kosti normalne kakovosti, mehanska moč pa se je ohranila ali celo povečala tudi pri toksičnih odmerkih.
- Swallow your tablet whole, - do not chew it, crush it or let it dissolve in your mouth.
- Pogoltnite celo tableto - ne smete je žvečiti, zdrobiti ali pustiti, da bi se vam raztopila v ustih.
Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Možni dejavniki tveganja za osteonekrozo zunanjega sluhovoda vključujejo uporabo steroidov, kemoterapijo in/ali lokalne dejavnike tveganja, kot so okužbe ali poškodbe.
You may be having a serious, potentially life threatening allergic reaction.
Lahko imate resno, morda življenjsko ogrožajočo alergijsko reakcijo;
Do not take your tablet with water with a high concentration of calcium, fruit juice or any other drinks.
Tablete ne vzemite z vodo z visoko vsebnostjo kalcija, sadnim sokom ali katero koli drugo pijačo.
The vertebral fracture risk reduction was very consistent with that seen in the overall population.
Zmanjšanje relativnega tveganja za zlome vretenc je bilo zelo skladno s tistim, ki so ga opazili v celotni populaciji.
The histological analysis of bone biopsies after two and three years of treatment of postmenopausal women showed bone of normal quality and no indication of a mineralization defect.
Histološka analiza biopsij kosti po dveh in treh letih zdravljenja žensk po menopavzi je pokazala normalno kakovost kosti in odsotnost motenj mineralizacije.
In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Večvariantna analiza je pokazala, da starost med vsemi preskušanimi farmakokinetičnimi parametri ni neodvisen dejavnik.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
The incidence of clinical vertebral fractures was also significantly reduced by 49 % (p=0.011).
Incidenca kliničnih zlomov vretenc je bila pomembno zmanjšana za 49 % (p = 0,011).
As renal function decreases with age, this is the only factor to take into consideration (see renal impairment section).
Ker se delovanje ledvic z leti zmanjšuje, je to edini dejavnik, ki ga je treba upoštevati (glejte razdelek o okvari ledvic).
The analysis of the SMPR was time-adjusted and considered that one or more events occurring in a single 12 week period could be potentially related.
Analiza SMPR je bila časovno omejena, za potencialno povezane dogodke so veljali vsi dogodki, ki so se pojavili enkrat ali večkrat v obdobju 12 tednov.
In some cases, these events did not resolve until the ibandronic acid was discontinued.
V nekaterih primerih ti dogodki niso prenehali dokler niso ibandronske kisline ukinili.
As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Kot pri drugih difosfonatih so bile ledvice primarni tarčni organ sistemske toksičnosti.
• Swallow the tablet whole.
• Tableto pogoltnite celo.
There was no indication of a waning of the effect over time.
Znakov upadanja učinka v tem času ni bilo.
Not known (frequency cannot be estimated from the available data): • asthma attack
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
If you are taking a tablet each day, skip the missed dose completely.
Če jemljete tablete vsak dan, izpustite pozabljeni odmerek v celoti.
- If you forgot to take your tablet on your chosen day and your next scheduled dose is only 1 to 7 days away…
- Če ste pozabili vzeti tableto na vaš izbrani dan in je do vašega naslednjega odmerka le 1 do 7 dni…
Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Difosfonati zavirajo osteoklastno aktivnost, natančni mehanizem delovanja pa še vedno ni jasen.
Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74 % with reduction to a median inhibition of 56 % seen 28 days following the fourth dose.
Po tretjem in četrtem odmerku je bila mediana maksimalne inhibicije 6 dni po odmerku 74 % z zmanjšanjem na mediano inhibicije 56 % 28 dni po četrtem odmerku.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Medsebojno delovanje s hrano
These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Ti prečni ali kratki poševni zlomi se lahko pojavljajo kjer koli na stegnenici, od mesta tik pod malim trohanterjem do tik nad suprakondilarno grčo.
The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Inhibicijo endogene resorpcije kosti so dokazali tudi s kinetičnimi študijami 45Ca in sproščanjem radioaktivnega tetraciklina, predhodno vgrajenega v okostje.
Drink a full glass of milk before you go. Do not make yourself sick.
Pred odhodom popijte poln kozarec mleka.
*See further information below †Identified in post-marketing experience.
*Glejte nadaljnje informacije spodaj † ugotovljeni po prihodu zdravila na trg
• asthma attacks
• napad astme
- Swallow your tablet with a full glass of water (at least 180 ml).
- Pogoltnite tableto in popijte poln kozarec vode (vsaj 180 ml).
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Dokazano je bilo zmanjšanje tveganja za vretenčne zlome, učinkovitosti pri zlomih stegneničnega vratu pa niso ugotovili.
This helps to stop your bones from getting weaker.
To pomaga zaustaviti napredovanje krhkosti vaših kosti.
After taking your tablet, wait at least 30 minutes.
Potem, ko vzamete tableto, počakajte vsaj 30 minut.
If you forget to take Ibandronic Acid Teva - If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day.
Če ste pozabili vzeti zdravilo Ibandronska kislina Teva - Če ste pozabili vzeti tableto na jutro izbranega dne, ne vzemite tablete pozneje v istem dnevu.
Clinically meaningful reductions in serum CTX levels were observed at all time points measured, i.e. months 3, 6, 12 and 24.
Biokemični označevalci kostne premene Klinično pomembno zmanjšanje serumskih vrednosti CTX so opazili ob merjenju v vseh časovnih obdobjih, to je po 3, 6, 12 in 24 mesecih.
As the values calculated are largely a function of the duration of study, the dose used, and assay sensitivity, the true terminal half-life is likely to be substantially longer, in common with other bisphosphonates.
Ker so izračunane vrednosti precej odvisne od trajanja študije, uporabljenega odmerka in občutljivosti metode, je pravi končni razpolovni čas verjetno precej daljši,
Fasting should be continued for at least 30 minutes after taking the tablet.
Bolnik se mora postiti še vsaj 30 minut po tem, ko vzame tableto.
Inability to stand or sit upright for at least 60 minutes
- Nesposobnost stanja ali vzravnanega sedenja vsaj 60 minut.