natgillin/translations-raw huggingface dataset:
Invented name Strength Pharmaceutical Form Route of Administration Packaging
Farmacevtska Oblika Pot Uporabe
EU Number
Številka EU Izmišljeno Ime Jakost
Ref.: EMEA/464033/2009 EMEA/H/C/546/II/24
: EMEA/464033/2009 EMEA/H/C/546/II/24
The study lasted for six months.
Študija je trajala šest mesecev.
Most of the patients included in the studies came from outside the European Union (EU).
Večina bolnikov, ki so sodelovali v študijah, ni bilo iz Evropske unije (EU).
It is available as capsules.
Na voljo je v obliki kapsul.
London, 23 July 2009
London, 23. julija 2009 Sklic dok.
Lyrica has been authorised since July 2004.
Zdravilo Lyrica je bilo odobreno julija leta 2004.
The main measure of effectiveness was the change in pain levels over eight to 14 weeks of treatment.
Glavno merilo učinkovitosti je bila sprememba števila napadov po osmih do 14 tednih zdravljenja.
The full European Public Assessment Report (EPAR) for Lyrica is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lyrica je na voljo tukaj.
• epilepsy in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
• epilepsijo pri bolnikih s parcialnimi napadi (epileptičnimi napadi, ki izvirajo iz določenega dela možganov), ki jih ni mogoče nadzorovati s trenutnim zdravljenjem;
The company presented the results of five main studies involving over 3,000 adults with fibromyalgia.
Družba je predložila rezultate petih glavnih študij, v katere je bilo vključenih več kot 3 000 odraslih bolnikov s fibromialgijo.
Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Živčni prenašalci so kemične snovi, ki omogočajo medsebojno komunikacijo med celicami.
This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters.
S tem se zmanjša dejavnost nekaterih živčnih celic v možganih in hrbtenjači, zaradi česar se zmanjša sproščanje drugih živčnih prenašalcev.
• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
• generalizirano anksiozno motnjo (dolgotrajno anksioznostjo ali živčnostjo zaradi vsakdanjih stvari).
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica pregabalin
Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Lyrica pregabalin
The change concerned an extension of indication to add the treatment of fibromyalgia.
Sprememba se je nanašala na razširitev indikacije z vstavitvijo zdravljenja fibromialgije.
There were no consistent or relevant reductions in pain or other symptoms in the short-term studies, and the maintenance of Lyrica's effect was not shown in the longer study.
V kratkoročnih študijah ni bilo doslednega ali primernega zmanjšanja bolečin ali drugih simptomov, v daljši študiji pa ni bila dokazana ohranitev učinka zdravila Lyrica.
In this study, the main measure of effectiveness was how long it took until the patient's pain came back.
V tej študiji je bilo glavno merilo učinkovitosti čas do ponovitve bolečin.
This is expected to reduce the symptoms of fibromyalgia, such as pain.
To naj bi pripomoglo k zmanjšanju simptomov fibromialgije, kot je bolečina.
There are no consequences on the use of Lyrica in the authorised indications, for which the balance of benefits and risks remains unchanged.
Zavrnitev nima nobenih posledic za uporabo zdravila Lyrica za odobrene indikacije, pri katerem ostaja razmerje med koristmi in tveganji nespremenjeno.
The Committee was also concerned that the safety and effectiveness of Lyrica had not been shown in patients from the EU.
Odbor je imel tudi zadržke, da varnost in učinkovitost zdravila Lyrica nista bila dokazana pri bolnikih iz EU.
The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Točno delovanje pregabalina ni popolnoma znano, vendar pa naj bi vplival na vstopanje kalcija v živčne celice.
The active substance in Lyrica, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Zdravilna učinkovina v zdravilu Lyrica, pregabalin, ima podobno zgradbo kot telesu lastni „živčni prenašalec“ gama-aminomaslena kislina (GABA), vendar ima bistveno drugačne biološke učinke.
Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Fibromialgija lahko povzroča druge simptome, kot so občutljivost, okorelost, utrujenost, tesnoba in spremembe spanja, občutenja in razmišljanja.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 23 July 2009.
Po proučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 23. julija 2009 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
Four of the studies compared the short-term effects of Lyrica at doses between 150 and 600 mg per day with those of placebo (a dummy treatment) in a total of 2,757 patients.
V štirih študijah so primerjali kratkoročne učinke zdravila Lyrica v odmerkih med 150 in 600 mg na dan in placeba (zdravila brez zdravilne učinkovine) pri skupno 2 757 bolnikih.
What are the consequences of the refusal for patients in clinical trials with Lyrica?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Lyrica?
The fifth study compared the long-term effects of Lyrica with those of placebo in 566 patients who had responded to an initial six weeks of treatment with Lyrica.
V peti študiji so primerjali dolgoročne učinke zdravila Lyrica in placeba pri 566 bolnikih, pri katerih so ugotovili odziv na prvotnih šest tednov zdravljenja z istim zdravilom.
Lyrica is a medicine that contains the active substance pregabalin.
Lyrica je zdravilo, ki vsebuje zdravilno učinkovino pregabalin.
The company that applied for authorisation is Pfizer Limited.
Vlogo za pridobitev dovoljenja je vložila družba Pfizer Limited.
What is Lyrica?
Kaj je zdravilo Lyrica?
In fibromyalgia, Lyrica is expected to work in the same way as it does in its existing indications.
Pri fibromialgiji naj bi zdravilo Lyrica delovalo enako kot pri obstoječih indikacijah.
The company informed the CHMP that there are currently no ongoing clinical trials with Lyrica in Europe for fibromyalgia.
Družba je obvestila CHMP, da v Evropi trenutno ne potekajo nobena klinična preskušanja zdravila Lyrica za fibromialgijo.
• neuropathic pain (pain due to nerve damage);
• nevropatsko bolečino (bolečino zaradi poškodbe živcev);
On 23 April 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Lyrica.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 23. aprila 2009 priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Lyrica.
What is happening for Lyrica for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder?
Kakšne so posledice za zdravilo Lyrica, indicirano za zdravljenje nevropatske bolečine, epilepsije in generalizirane anksiozne motnje?
Hence, the CHMP recommended that the change to the marketing authorisation be refused.
CHMP je zato priporočil zavrnitev spremembe dovoljenja za promet.
Lyrica was expected to be used in patients with moderate to severe pain.
Zdravilo Lyrica naj bi se uporabljala pri bolnikih z zmerno do hudo bolečino.
Lyrica was also expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Zdravilo Lyrica naj bi se uporabljalo tudi za zdravljenje odraslih bolnikov s fibromialgijo, boleznijo, ki povzroča dolgotrajne razširjene bolečine in bolečine ob dotiku.
At that point in time, the CHMP was of the opinion that the benefits of Lyrica in the treatment of fibromyalgia did not outweigh its risks.
Takrat je CHMP menil, da koristi zdravila Lyrica pri zdravljenju fibromialgije ne odtehtajo z njim povezanih tveganj.
What was Lyrica expected to be used for?
Za kaj naj bi se zdravilo Lyrica uporabljalo?
The CHMP was concerned that the benefits of Lyrica in fibromyalgia had not been shown in either the short or the long term.
CHMP je menil, da koristi zdravila Lyrica pri zdravljenju fibromialgije niso bila dokazane niti kratkoročno niti dolgoročno.
How is Lyrica expected to work?
Kako naj bi zdravilo Lyrica delovalo?
Make the next injection as soon as you remember.
Naslednji odmerek si injicirajte takoj, ko se spomnite.
Treatment with Binocrit is divided into two stages - correction and maintenance phase.
Zdravljenje z zdravilom Binocrit poteka v dveh fazah - korekcijska in vzdrževalna faza.
Binocrit should not be used and discarded - if the liquid is coloured or you can see particles floating in it, - if the seal is broken, - if you know, or think that it may have been accidentally frozen, or - if there has been a refrigerator failure.
Zdravila Binocrit se ne sme uporabiti in ga je treba zavreči: - če je tekočina obarvana ali v njej vidite plavati delce, - če je tesnilo poškodovano, - če veste ali mislite, da je bila raztopina pomotoma zamrznjena ali - če hladilnik ni pravilno deloval.
Your doctor will monitor your blood pressure regularly while you are using Binocrit.
Zdravnik bo redno nadziral vaš krvni tlak, medtem ko uporabljate zdravilo Binocrit.
Binocrit has no or negligible influence on the ability to drive and use machines.
Zdravilo Binocrit nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• For adults and children Binocrit is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
• Odraslim in otrokom se daje zdravilo Binocrit v obliki injekcije bodisi v veno (intravensko) ali s cevko, ki gre v veno.
There are no studies assessing the potential effect of epoetin alfa on male or female fertility.
Ni študij, s katerimi bi ocenili možen vpliv epoetina alfa na plodnost pri moških ali ženskah.
The dose of Binocrit you receive is based on your body weight in kilograms.
Odmerek zdravila Binocrit, ki ga boste prejeli, je odvisen od vaše telesne mase v kilogramih.
Do not administer Binocrit by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Zdravila Binocrit ne dajajte v obliki intravenske infuzije ali v povezavi z drugimi raztopinami zdravil (glejte poglavje 6.6 za dodatne informacije).
• Always use Binocrit exactly as instructed by your doctor or nurse.
• Zdravilo Binocrit vedno uporabljajte natančno po navodilih svojega zdravnika ali medicinske sestre.
For patients on peritoneal dialysis Binocrit may be given twice a week.
Bolniki na peritonealni dializi lahko dobivajo zdravilo Binocrit dvakrat na teden.
• Your doctor may initiate treatment with Binocrit if your haemoglobin is 10 g/dL or less.
• Vaš zdravnik lahko uvede zdravljenje z zdravilom Binocrit, ko je vaš hemoglobin 10 g/dl ali manj.
Following subcutaneous injection, serum levels of epoetin alfa reach a peak between 12 and 18 hours post-dose.
Po subkutanem injiciranju dosežejo ravni epoetina alfa v serumu vrhunec med 12 in 18 urami po odmerku.
• You will usually continue Binocrit treatment for one month after the end of chemotherapy.
• Običajno boste zdravilo Binocrit dobivali še en mesec po končanem zdravljenju s kemoterapijo.
Inject the Binocrit solution as you have been shown by your doctor.
Injicirajte raztopino zdravila Binocrit, kot vam je pokazal zdravnik.
• Only use Binocrit if it has been stored correctly - see section 5, How to store Binocrit.
• Uporabljajte le pravilno shranjeno zdravilo Binocrit - glejte poglavje 5, Shranjevanje zdravila Binocrit.
Your doctor has carried out blood tests and decided you need Binocrit.
Vaš zdravnik je opravil krvne preiskave in odločil, da potrebujete zdravilo Binocrit.
This risk may be higher if you have other risk factors for developing blood clots (for example, if you have had a blood clot in the past or are overweight, have diabetes, have heart disease or you are off your feet for a long time because of surgery or illness).
če imate druge dejavnike tveganja za nastanek krvnih strdkov (na primer, če ste v preteklosti imeli krvni strdek, če ste pretežki, imate sladkorno bolezen, bolezen srca ali dalj časa ne morete vstati zaradi kirurškega posega ali bolezni).
If you are a cancer patient, be aware that use of Binocrit may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
Če ste bolnik z rakom, morate vedeti, da je uporaba zdravila Binocrit lahko povezana s krajšim preživetjem in večjimi stopnjami smrtnosti pri bolnikih z rakom v glavi in vratu ter metastatskim rakom dojke, ki prejemajo zdravljenje s kemoterapijo.
Your doctor will help you to decide if Binocrit is suitable for you.
Vaš zdravnik vam bo pomagal pri odločitvi, ali je zdravilo Binocrit za vas primerno.
Binocrit is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Zdravilo Binocrit je opremljeno z zaščito za iglo ali pa je brez nje, vaš zdravnik ali medicinska sestra pa vam bosta pokazala, kako to uporabljati.
• The usual starting dose of Binocrit for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
• Običajni začetni odmerek zdravila Binocrit za odrasle in otroke je 50 mednarodnih enot (i.e.) na kilogram (/kg) telesne mase, trikrat na teden.
Binocrit is given alone and not mixed with other liquids for injection.
Zdravilo Binocrit se daje samo in se ne meša z drugimi tekočinami za injiciranje.
In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Binocrit subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Če zdravnik oceni, da lahko bolnik ali negovalec zdravilo Binocrit varno in učinkovito subkutano injicira sam, mu je treba dati navodila za pravilno odmerjanje in dajanje.
Binocrit should be administered after the completion of the blood donation procedure.
Zdravilo Binocrit je treba uporabiti po tem, ko je postopek darovanja krvi končan.
During the maintenance phase, Binocrit can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Med vzdrževalno fazo se lahko zdravilo Binocrit daje bodisi 3-krat na teden ali v primeru subkutanega dajanja enkrat na teden ali enkrat na dva tedna.
• if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Binocrit).
• če so vam postavili diagnozo aplazija rdečih krvnih celic (kostni mozeg ne more tvoriti dovolj rdečih krvnih celic) po predhodnem zdravljenju s katerim koli zdravilom, ki spodbuja nastajanje rdečih krvnih celic (vključno z zdravilom Binocrit).
When this access (via a vein or tube) is not readily available, your doctor may decide that Binocrit should be injected under the skin (subcutaneously).
Kadar takšen dostop (v veno ali cevko) ni takoj na razpolago, se vaš zdravnik lahko odloči, da je treba zdravilo Binocrit injicirati pod kožo (subkutano).
• If you do not respond adequately to Binocrit, your doctor will check your dose and will inform you if you need to change doses of Binocrit.
• Če se na zdravljenje z zdravilom Binocrit ne odzivate ustrezno, bo zdravnik preveril vaš odmerek in vas obvestil, če morate spremeniti odmerke zdravila Binocrit.
Other medicines and Binocrit
Druga zdravila in zdravilo Binocrit
• If you are having dialysis treatment when you begin treatment with Binocrit, your dialysis regime may need to be adjusted.
• Če se zdravite z dializo, ko se začenjate zdraviti z zdravilom Binocrit, bo morda treba prilagoditi vaš režim dialize.
Binocrit can reduce the need for a blood transfusion.
Binocrit lahko zmanjša potrebo po transfuziji krvi.
- Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Binocrit or any other erythropoietin (see section 4.4).
- Bolniki, pri katerih se po zdravljenju s katerim koli eritropoetinom razvije aplazija rdečih krvnih celic (PRCA - pure red cell aplasia), ne smejo dobivati zdravila Binocrit ali katerega koli drugega eritropoetina (glejte poglavje 4.4).
• Binocrit is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
• Zdravilo Binocrit se injicira v veno takoj po tem, ko darujete kri, 3 tedne pred kirurškim posegom.
Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Binocrit.
Zdravniku ali medicinski sestri takoj povejte, če ugotovite katerega koli od teh neželenih učinkov ali če med zdravljenjem z zdravilom Binocrit opazite druge neželene učinke.
Later, your doctor may suggest that you or your caregiver learn how to inject Binocrit under the skin
Kasneje lahko zdravnik predlaga, da se vi ali vaš skrbnik naučite, kako si injicirati zdravilo Binocrit pod kožo (subkutano).
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Binocrit, your doctor will check your dose of Binocrit because repeatedly increasing your dose of Binocrit if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Če ste bolnik s kronično ledvično odpovedjo, še zlasti, če se na zdravilo Binocrit ne odzivate ustrezno, bo zdravnik preveril vaš odmerek zdravila Binocrit, saj lahko stalno zviševanje vašega odmerka zdravila Binocrit, če se na zdravljenje ne odzivate, poveča tveganje za težave s srcem ali ožiljem in tudi tveganje za srčni infarkt, možgansko kap in smrt.
• in children on haemodialysis
• pri otrocih na hemodializi
Because Binocrit stimulates the production of red blood cells, doctors can take more blood from these people.
Ker zdravilo Binocrit spodbuja nastajanje rdečih krvnih celic, lahko zdravnik od teh ljudi vzame več krvi.
10, A-6250 Kundl, Austria
10, A-6250 Kundl, Avstrija
You may still be able to use Binocrit, but discuss it with your doctor first:
Morda boste lahko še vedno uporabljali zdravilo Binocrit, vendar se najprej posvetujte s svojim zdravnikom:
Binocrit is indicated in adults in a predonation programme to increase the yield of autologous blood.
Zdravilo Binocrit je indicirano pri odraslih v preddonorskem programu za povečanje količine pridobljene avtologne krvi.
While on Binocrit, some people need medicines to reduce the risk of blood clots.
Med uporabo zdravila Binocrit morajo nekatere osebe jemati zdravila za zmanjšanje tveganja za nastanek krvnih strdkov.
• If you are on a more extended dosing interval (greater than once weekly) of Binocrit, you may not maintain adequate haemoglobin levels and you may require an increase in Binocrit dose or frequency of administration.
• Če uporabljate daljši interval odmerjanja zdravila Binocrit (daljši kot enkrat tedensko), morda ne bo mogoče vzdrževati ustrezne ravni hemoglobina in bo treba odmerek ali pogostnost odmerjanja zdravila Binocrit povečati.
• Binocrit is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
• Zdravilo Binocrit se injicira pod kožo vsak teden tri tedne pred kirurškim posegom in na dan kirurškega posega.
• in adults on haemodialysis or peritoneal dialysis
• pri odraslih bolnikih na hemodializi ali peritonealni dializi
If signs and symptoms suggestive of these reactions appear, Binocrit should be withdrawn immediately and an alternative treatment considered.
Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje z zdravilom Binocrit takoj prekiniti in razmisliti o drugi vrsti zdravljenja.
Caution should be exercised with escalation of Binocrit doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Previdnost je potrebna pri stopnjevanju odmerkov zdravila Binocrit pri bolnikih s kronično ledvično odpovedjo, saj so morda višji kumulativni odmerki epoetina povezani s povečanim tveganjem za umrljivost, resne kardiovaskularne in cerebrovaskularne dogodke.
Binocrit and other products that stimulate red cell production may increase the risk of developing blood clots in all patients.
Zdravilo Binocrit in druga zdravila, ki spodbujajo nastajanje rdečih krvnih celic, lahko povečajo tveganje za nastanek krvnih strdkov pri vseh bolnikih.
Rare side effects These may affect up to 1 in 1,000 people.
Redki neželeni učinki Pojavijo se lahko pri največ 1 od 1.000 bolnikov
If you visit a hospital, clinic or family doctor, tell them you are having Binocrit treatment.
Če obiščete bolnišnico, kliniko ali izbranega zdravnika, povejte, da se zdravite z zdravilom
Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Binocrit 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Blago anemične bolnike (hematokrit 33 do 39 %), ki potrebujejo ≥ 4 enote deponirane krvi, je treba zdraviti z zdravilom Binocrit 600 i.e./kg, intravensko, 2-krat na teden, 3 tedne pred kirurškim posegom.
Treatment with Binocrit has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
4.2 Odmerjanje in način uporabe Zdravljenje z zdravilom Binocrit je treba začeti pod nadzorom zdravnika, ki ima izkušnje z obravnavo bolnikov z zgoraj navedenimi indikacijami.
If you forget to use Binocrit
Če ste pozabili uporabiti zdravilo Binocrit
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Binocrit, treatment with Binocrit must not be restarted in this patient at any time.
Če je pri bolniku zaradi uporabe zdravila Binocrit prišlo do hude kožne reakcije, kot sta SJS ali TEN, zdravljenja z zdravilom Binocrit ni dovoljeno ponovno začeti.
• Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Binocrit treatment.
• Vaš zdravnik bo naročil krvne preiskave in po potrebi prilagodil odmerek, odvisno od odziva vaše anemije na zdravljenje z zdravilom Binocrit.
In patients with a poor haemoglobin response to Binocrit, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Pri bolnikih s slabim odzivom hemoglobina na zdravilo Binocrit je treba iskati druge razlage za slab odziv (glejte poglavji 4.4 in 5.1).
Your Binocrit dose and frequency of administration may be further adjusted to maintain your response to treatment.
Po potrebi vam lahko odmerek zdravila Binocrit in pogostnost uporabe nadalje prilagaja, da se ohrani vaš odziv na zdravljenje.
Patients should be monitored closely to ensure that the lowest approved effective dose of Binocrit is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dL (7.5 mmol/L).
Bolnike je treba skrbno spremljati, da se zagotovi uporaba najmanjšega odobrenega učinkovitega odmerka zdravila Binocrit za doseganje ustreznega nadzora anemije in simptomov anemije ob hkratnem ohranjanju koncentracije hemoglobina pod ali pri 12 g/dl (7,5 mmol/l).