natgillin/translations-raw huggingface dataset:
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 Clopidogrel Teva Pharma could not have been approved for the prevention of atherothrombotic events in patients who have had myocardial infarction, ischaemic stroke or who have established peripheral arterial disease.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika vloge izrazil nekatere zadržke in začasno menil, da se zdravilo Clopidogrel Teva Pharma ne more odobriti za preprečevanje aterotrombotičnih dogodkov pri bolnikih z miokardnim infarktom, ishemično kapjo ali potrjeno periferno arterijsko boleznijo.
This stops the platelets becoming ‘sticky'.
To preprečuje, da bi trombociti postali lepljivi.
On 22 April 2009, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Clopidogrel Teva Pharma, for the prevention of atherothrombotic events in patients who have myocardial infarction, ischaemic stroke or established peripheral arterial disease.
je dne 22. aprila 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Clopidogrel Teva Pharma, namenjenim preprečevanju aterotrombotičnih dogodkov pri bolnikih z miokardnim infarktom, ishemično kapjo ali potrjeno periferno arterijsko boleznijo.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
pregleda in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
The CHMP concluded that the studies presented did not provide enough evidence to show that Clopidogrel Teva Pharma was bioequivalent to the reference medicine Plavix.
CHMP je zaključil, da predložene študije niso zadosten dokaz, da je zdravilo Clopidogrel Teva Pharma biološko enakovredno referenčnemu zdravilu Plavix.
The active substance in Clopidogrel Teva Pharma and in Plavix, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel Teva Pharma in Plavix, klopidogrel, je zaviralec agregacije trombocitov.
Clopidogrel Teva Pharma was developed as a ‘generic medicine'.
Zdravilo Clopidogrel Teva Pharma je bilo razvito kot generično zdravilo.
Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Clopidogrel Teva Pharma je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
What is Clopidogrel Teva Pharma?
Kaj je zdravilo Clopidogrel Teva Pharma?
Clopidogrel Teva Pharma is expected to work in the same way as the reference medicine, Plavix.
Zdravilo Clopidogrel Teva Pharma naj bi delovalo enako kot referenčno zdravilo Plavix.
At this point in time, the CHMP was of the opinion that Clopidogrel Teva Pharma could not be considered a generic medicine of Plavix, the reference medicinal product.
Takrat je CHMP menil, da zdravilo Clopidogrel Teva Pharma ne more veljati kot zdravilo, ki je biološko podobno referenčnemu zdravilu Plavix.
How is Clopidogrel Teva Pharma expected to work?
Kako naj bi zdravilo Clopidogrel Teva Pharma delovalo?
What was Clopidogrel Teva Pharma expected to be used for?
Za kaj naj bi se zdravilo Clopidogrel Teva Pharma uporabljalo?
This overview was last updated in 10-2018.
Povzetek je bil nazadnje posodobljen 10-2018.
Additional data from an extension of this study in children aged 13 to 18 years confirmed the initial results.
Dodatni podatki iz razžiritve te študije, ki je vključevala otroke, stare od 13 do 18 let, so potrdili prvotne rezultate.
The effectiveness of Strensiq was also generally supported by several additional small studies.
Učinkovitost zdravila Strensiq je na splošno podprlo več dodatnih majhnih študij.
The study also looked at other measures of effectiveness such as growth in height.
V študiji so proučevali tudi druga merila učinkovitosti, kot je telesna rast.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu308594.
Nadaljnje informacijeglede določitve zdravila sirote lahko najdete tukaj: https://www.ema.europa.eu/medicines/human/orphan-designations/eu308594.
What measures are being taken to ensure the safe and effective use of Strensiq?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Strensiq?
The Agency noted that hypophosphatasia is a serious and life-threatening disease for which no treatment is authorised.
Agencija je upoštevala, da je hipofosfatazija resna in smrtno nevarna bolezen, za katero ni odobreno nobeno zdravljenje.
Further information on Strensiq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Strensiq
Več informacij o zdravilu Strensiq je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Strensiq
Given that hypophosphatasia is an extremely rare disease, data in this population will likely remain limited.
Ker je hipofosfatazija izjemno redka bolezen, bodo podatki pri tej skupini bolnikov verjetno ostali omejeni.
Although the main study was small and did not directly compare Strensiq with another treatment or with untreated patients, the Agency considered that the improvement seen in the bones and the apparent growth was relevant.
Čeprav je bila glavna študija majhna in z njo niso neposredno primerjali zdravila Strensiq z drugo obliko zdravljenja ali nezdravljenimi bolniki, je agencija menila, da je bilo izboljšanje, ki so ga opazili pri kosteh in pridobivanju telesne višine, pomembno.
Strensiq has been studied in one main study in 13 children between 6 and 12 years of age.
Zdravilo Strensiq so proučevali v eni glavni študiji, ki je vključevala 13 otrok, starih od 6 do 12 let.
The European Medicines Agency decided that Strensiq's benefits are greater than its risks and it be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Strensiq večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
As the amount given depends on the patient's bodyweight, the doctor will need to adjust the dose as the patient's weight changes, particularly in growing children.
Ker je uporabljena količina odvisna od telesne mase bolnika, bo zdravnik moral odmerek prilagoditi, ko se bo spremenila bolnikova telesna masa, predvsem pri rastočih otrocih.
The enzyme ‘tissue non-specific alkaline phosphatase' (ALP) plays a key role in creating and maintaining healthy bones, and managing calcium and phosphate in the body.
Encim „za tkivo nespecifična alkalna fosfataza“ (ALP) ima ključno vlogo pri ustvarjanju in ohranjanju zdravih kosti, saj uravnava kalcij in fosfate v telesu.
An overview of Strensiq and why it is authorised in the EU
Pregled zdravila Strensiq in zakaj je odobreno v EU
Patients with hypophosphatasia cannot make enough working ALP, which leads to weak bones.
Bolniki s hipofosfatazijo ne morejo proizvesti dovolj delujoče ALP, kar povzroča šibke kosti.
What is Strensiq and what is it used for?
Kaj je zdravilo Strensiq in za kaj se uporablja?
The most common side effects with Strensiq (which may affect more than 1 in 10 people) are headache, erythema (reddening of the skin), pain in arms and legs, fever, irritability, injection site reactions (such as pain, rash and itching) and contusion (bruising).
Najpogostejši neželeni učinki zdravila Strensiq (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, eritem (pordela koža), bolečina v rokah in nogah, povišana telesna temperatura, razdražljivost, reakcije na mestu injiciranja (kot so bolečina, izpuščaj in srbenje) in kontuzija (podplutba).
Strensiq received a marketing authorisation valid throughout the EU on 28 August 2015.
Za zdravilo Strensiq je bilo 28. avgusta 2015 izdano dovoljenje za promet, veljavno po vsej EU.
Strensiq has been authorised under ‘exceptional circumstances'.
Zdravilo Strensiq je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
In the historical controls, most children did not experience similar improvements in their joints or gain in height over a comparable period of time.
Pretekli kontrolni podatki so pokazali, da večina otrok ni imela podobnih izboljšanj v sklepih ali pridobivanju telesne višine v primerljivem časovnem obdobju.
As for all medicines, data on the use of Strensiq is continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Strensiq stalno spremljajo.
The main measure of effectiveness of the medicine was the improvement in x-ray appearance of the wrists and knee joints before and after treatment with Strensiq.
Glavno merilo učinkovitosti zdravila je bilo izboljšanje rentgenskega videza zapestnih in kolenskih sklepov pred zdravljenjem z zdravilom Strensiq in po njem.
Regarding safety, injection site reactions and other side effects were considered manageable with the recommendations in place.
Z varnostnega vidika so bili reakcije na mestu injiciranja in drugi neželeni učinki obvladljivi ob upoštevanju obstoječih priporočil.
It is given by injection under the skin either six times a week (in a dose of 1 mg per kilogram bodyweight) or three times a week (in a dose of 2 mg/kg).
Daje se z injiciranjem pod kožo šestkrat na teden (v odmerku 1 mg na kilogram telesne mase) ali trikrat na teden (v odmerku 2 mg/kg).
Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.
Hipofosfatazija je redka dedna bolezen kosti, ki lahko povzroči zgodnjo izgubo zob, nepravilno oblikovane kosti, pogoste zlome kosti in težave z dihanjem.
Side effects reported with Strensiq are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Strensiq, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Strensiq is a medicine used long-term to treat patients with hypophosphatasia that started in childhood.
Strensiq je zdravilo, ki se uporablja za dolgotrajno zdravljenje bolnikov s hipofosfatazijo, ki se je pojavila v otroštvu.
X-rays of children given Strensiq were also compared with similar x-rays available from 16 children who had not received Strensiq (‘historical controls').
Rentgenske slike otrok, ki so prejemali zdravilo Strensiq, so primerjali s podobnimi rentgenskimi slikami 16 otrok, ki niso prejeli zdravila Strensiq („pretekli kontrolni podatki“).
Asfotase alfa, the active substance in Strensiq, is a version of the human ALP enzyme and serves as a replacement, thereby increasing levels of working ALP.
Asfotaza alfa, učinkovina v zdravilu Strensiq, je različica humanega encima ALP in deluje kot nadomestek, kar poviša ravni delujoče ALP.
What benefits of Strensiq have been shown in studies?
Kakšne koristi je zdravilo Strensiq izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Strensiq have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Strensiq upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Since Strensiq has been authorised under exceptional circumstances, the company that markets Strensiq will set up a registry of patients with hypophosphatasia to collect information on the disease and on the long-term safety and effectiveness of Strensiq.
Ker je zdravilo Strensiq pridobilo dovoljenje za promet v izjemnih okoliščinah, bo podjetje, ki ga trži, vzpostavilo register bolnikov s hipofosfatazijo, s pomočjo katerega bo zbiralo podatke o bolezni in dolgotrajni varnosti ter učinkovitosti zdravila Strensiq.
For more information about using Strensiq, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Strensiq glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The company that markets Strensiq will provide patients and carers with educational materials to ensure that the medicine is used correctly and to minimise the risk of medication errors.
Podjetje, ki trži zdravilo Strensiq, bo za bolnike in negovalce pripravilo izobraževalno gradivo, ki bo zagotavljalo, da se zdravilo uporablja pravilno, in zmanjšalo tveganje za napake pri uporabi zdravila.
Patients were given either 2 mg/kg or 3 mg/kg Strensiq three times a week for 24 weeks.
Bolniki so prejemali zdravilo Strensiq v odmerku 2 mg/kg ali 3 mg/kg trikrat na teden v obdobju 24 tednov.
Hypophosphatasia is rare, and Strensiq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 December 2008.
Bolezen hipofosfatazija je redka, zato je bilo zdravilo Strensiq 3. decembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
This study showed that children given Strensiq had an improvement in their joint structure as demonstrated by x-rays and most of them seemed to gain in height.
Ta študija je pokazala, da se je otrokom, ki so prejemali zdravilo Strensiq, izboljšala struktura sklepov, kar so dokazali z rentgenskimi slikami, večina pa je pridobila tudi na telesni višini.
What are the risks associated with Strensiq?
Kakšna tveganja so povezana z zdravilom Strensiq?
Why is Strensiq authorised in the EU?
Zakaj je bilo zdravilo Strensiq odobreno v EU?
The medicine is available as a solution for injection.
Na voljo je v obliki raztopine za injiciranje.
Some of the studies also looked at the dose of 1 mg/kg Strensiq given six times a week.
V nekaterih od njih so proučevali tudi zdravilo Strensiq v odmerku 1 mg/kg, dano šestkrat na teden.
This material will include a self-injection guide for patients, as well as an injection guide for parents or caregivers of children with the condition.
To gradivo bo vključevalo navodila za samoinjiciranje, namenjena bolnikom, in navodila za injiciranje, namenjena staršem in negovalcem otrok s to boleznijo.
This is because it has not been possible to obtain complete information about Strensiq due to the rarity of the disease.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Other information about Strensiq
Druge informacije o zdravilu Strensiq
What information is still awaited for Strensiq?
Katere informacije o zdravilu Strensiq še pričakujemo?
For the full list of side effects and restrictions with Strensiq, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Strensiq glejte navodilo za uporabo.
Strensiq contains the active substance asfotase alfa.
Zdravilo Strensiq vsebuje učinkovino asfotaza alfa.
Strensiq can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing metabolic or bone disorders.
Predpisovanje in izdaja zdravila Strensiq je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem presnovnih ali kostnih bolezni.
How is Strensiq used?
Kako se zdravilo Strensiq uporablja?
How does Strensiq work?
Kako zdravilo Strensiq deluje?
These medicines include:
Ta zdravila vključujejo:
Safety and efficacy in children have not been established.
Varnost in učinkovitost pri otrocih nista bili dokazani.
if you are pregnant
• če ste noseči.
You should tell your doctor as soon as possible:
Svojemu zdravniku čim prej povejte, če imate:
Patients should be observed and given supportive treatment.
Bolnike je treba nadzirati in jim nuditi podporno zdravljenje.
Refer also to section 4.8.
Glejte tudi poglavje 4.8.
Always take your tablets with a drink of water.
Tablete vedno jemljite z vodo.
Refer to sections 4.3 and 4.5 for further information on bleeding risks.
Glejte poglavji 4.3 in 4.5 za več informacij o tveganju za krvavitve.
This corresponds to a relative improvement of 100% over placebo.
To ustreza relativnemu izboljšanju 100 % glede na placebo.
If your blood pressure falls too low, this could cause a fast heartbeat.
Če se krvni tlak preveč zmanjša, lahko to povzroči hiter srčni utrip.
If any of the following side effects happen, you may need urgent medical attention.
Če imate katerega od naslednjih neželenih učinkov, morda potrebujete nujno medicinsko pomoč.
if you have problems with your blood pressure.
• če imate težave s krvnim tlakom.
Refer to sections 4.3 and 4.5.
Glejte poglavji 4.3 in 4.5.
Information on acute overdose in humans is limited.
Informacije o akutnem prevelikem odmerjanju pri ljudeh so omejene.
Remember to take the pack with you so that it is clear what medicine you have taken.
Ne pozabite vzeti s seboj škatle zdravil, da bo jasno, kaj ste vzeli.
Some benefits of taking <Cilostazol-containing medicinal product> may be felt within 4-12 weeks of treatment.
Nekatere koristi jemanja <zdravila, ki vsebuje cilostazol>, se lahko občuti v 4-12 tednih zdravljenja.
The frequencies of reactions observed in the post-marketing period are considered unknown (cannot be estimated from the available data).
Pogostnost učinkov, opaženih v obdobju trženja, se obravnava kot neznana (ni je mogoče oceniti iz razpoložljivih podatkov).
Other frequent causes of discontinuation included palpitation and diarrhoea (both 1.1%).
Drugi pogosti razlogi za prekinitev so vključevali palpitacijo in drisko (oboje po 1,1 %).
(≥1/10,000 to <1/1000)
(≥1/10.000 do < 1/1000)
Allergic reaction
• alergijske reakcije
The apparent elimination half-life of cilostazol is 10.5 hours.
Navidezni končni razpolovni čas cilostazola je 10,5 ure.
You may need to have some blood tests and your doctor will decide on your further treatment.
Morda bo treba opraviti nekaj krvnih preiskav, zdravnik pa se bo odločil za nadaljevanje zdravljenja.
6.6 Special precautions for disposal <and other handling> No special requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje <in ravnanje z zdravilom> Ni posebnih zahtev.
The only adverse event resulting in discontinuation of therapy in  3% of patients treated with cilostazol was headache.
Edini neželeni učinek, ki je imel za posledico prekinitev zdravljenja pri  3 % bolnikov, zdravljenih s cilostazolom, je bil glavobol.
A randomized, double-blind, placebo-controlled Phase IV study was conducted to assess the long-term effects of cilostazol, with focus on mortality and safety.
Izvedli so randomizirano, dvojno slepo, s placebom kontrolirano študije faze IV, v kateri so ocenili dolgoročne učinke cilostazola, s poudarkom na smrtnost in varnost.
Very rare (<1/10,000), not known (cannot be estimated from the available data)
(<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Based on these data, no dose adjustment is necessary.
Na podlagi teh podatkov odmerka ni treba prilagajati.
There are no adequate data in the use of cilostazol in pregnant women.
Ni ustreznih podatkov o uporabi cilostazola pri nosečnicah.
Long-term treatment with cilostazol did not raise safety concerns.
Dolgoročno zdravljenje s cilostazolom ni porodilo vprašanj o njegovi varnosti.
• clopidogrel
• klopidogrel
The primary route of elimination is urinary (74%) with the remainder excreted in the faeces.
Primarna pot izločanja je s sečem (74 %), preostanek pa se izloči v blatu.
These reactions were usually of mild to moderate intensity and were sometimes alleviated by reducing the dose.
Učinki so bili običajno blagi do zmerni, zmanjšanje odmerka pa jih je včasih ublažilo.
The suitability of treatment with cilostazol should be carefully considered alongside other treatment options such as revascularisation.
O primernosti zdravljenja s cilostazolom je treba skrbno premisliti in upoštevati druge možnosti zdravljenja, kot je revaskularizacija.
If you are taking such medicines with <Cilostazol-containing medicinal product> your doctor may perform some routine blood tests.
Če jemljete ta zdravila z <zdravilom, ki vsebuje cilostazol>, bo vaš zdravnik morda opravil nekaj rutinskih krvnih preiskav.
The remainder is excreted as metabolites, none of which exceed 5% of the total excreted.
Preostanek se izloči kot presnovki, pri čemer noben ne preseže 5 % skupne izločene količine.
A clinically relevant effect on cilostazol is still possible at higher quantities of grapefruit juice.
Klinično pomemben učinek na cilostazol je še vedno mogoč pri velikih količinah soka grenivke.
CONTENTS OF THE PACK AND OTHER INFORMATION
Vsebina pakiranja in dodatne informacije
You should also tell your doctor immediately if you have a fever or sore throat.
Svojemu zdravniku takoj povejte, če imate zvišano telesno temperaturo ali vneto grlo.
There is no evidence that cilostazol induces hepatic microsomal enzymes.
Ni dokazov, da bi cilostazol induciral jetrne mikrosomalne encime.
Consideration should be given to monitoring the bleeding time at intervals.
Razmisliti je treba o periodičnem spremljanju časa krvavitve.
Oral Anticoagulants like warfarin
Peroralni antikoagulanti, kot je varfarin
Studies in animals have shown reproductive toxicity (see Section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
This dose does not need to be changed for elderly people.
Tega odmerka ni treba prilagajati za starejše bolnike.
If a patient is to undergo elective surgery and antiplatelet effect is not necessary, cilostazol should be stopped 5 days prior to surgery.
Če se pri bolniku načrtuje kirurški poseg in protitrombocitni učinek ni potreben, je treba uporabo cilostazola prenehati 5 dni pred posegom.
20 tablets 28 tablets 30 tablets 50 tablets 56 tablets 100 tablets 112 tablets 168 tablets
20 tablet 28 tablet 30 tablet 50 tablet 56 tablet 100 tablet 112 tablet 168 tablet
Such lesions were not seen in rats or monkeys and are considered species specific.
Teh lezij pri podganah ali opicah niso opazili, zato prevladuje mnenje, da so specifične za vrsto.
The expiry date refers to the last date of the month.
Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
<Cilostazol-containing medicinal product> can increase the distance you can walk without pain since it improves the blood circulation in your legs.
<Zdravilo, ki vsebuje cilostazol>, lahko poveča razdaljo, ki ste jo sposobni prehoditi brez bolečine, saj izboljša cirkulacijo krvi v vaših nogah.
It may still be all right for you to take the above mentioned medicines and <Cilostazol-containing medicinal product> together and your doctor will be able to decide what is suitable for you.
Morda lahko še vedno sočasno jemljete navedena zdravila in <zdravilo, ki vsebuje cilostazol>; vaš zdravnik se bo lahko odločil, kaj je za vas najboljše.
<Cilostazolcontaining medicinal product> must not be used during pregnancy (see section 4.3).
<Zdravila, ki vsebuje cilostazol>, ne smete uporabljati med nosečnostjo (glejte poglavje 4.3).
All healthy subjects in the study had a prolongation of bleeding time on clopidogrel alone and concomitant administration with cilostazol did not result in a significant additional effect on bleeding time.
Vse zdrave osebe v študiji so imele podaljšan čas krvavitve pri uporabi samega klopidogrela; sočasna uporaba s cilostazolom ni imela pomembnih dodatnih učinkov na čas krvavitve.
The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm; in patients at risk this consequently may induce angina pectoris.
Zvišanje srčnega utripa, povezano s cilostazolom, je približno 5 do 7 utripov/minuto; pri bolnikih s tveganjem lahko to posledično povzroči angino pektoris.
Following multiple doses of cilostazol 100 mg twice daily in patients with peripheral vascular disease, steady state is achieved within 4 days.
Po večratnem odmerjanju cilostazola 100 mg dvakrat na dan pri bolnikih s perifernim žilnim obolenjem je bilo stanje dinamičnega ravnovesja doseženo v 4 dneh.
No measurable amount of unchanged cilostazol is excreted in the urine, and less than 2% of the dose is excreted as the dehydro-cilostazol metabolite.
V urinu se ne izločajo merljive nespremenjene količine cilostazola, manj kot 2 % odmerka pa se izloči kot presnovek dehidro-cilostazol.