natgillin/translations-raw huggingface dataset:
Bisphosphonates maintain their activity for extended periods and as a result, do not need continuous dosing.
Bisfosfonati ohranijo svojo aktivnost dolga časovna obdobja in posledično ne potrebujejo stalnega odmerjanja.
The CHMP noted the data submitted in the initial application.
CHMP je upošteval podatke, predložene v prvotni vlogi.
Data submitted by the Applicant
Podatki, ki jih je predložil predlagatelj
• the data submitted in the initial authorisation application product file was considered to sufficiently support the marketing authorisation application,
• Podatki, predloženi v prvotni vlogi za odobritev dovoljenja za promet, so se šteli za zadostno podporo v vlogi za odobritev dovoljenja za promet.
In conclusion, the CHMP considered the Applicant to have submitted all relevant and necessary data to support a full dossier application under Article 8(3).
CHMP je torej menil, da je predlagatelj preložil vse ustrezne in potrebne podatke v podporo vloge s popolno dokumentacijo v skladu s členom 8(3).
The CHMP considered this to be a clear public health benefit.
Upošteval je, da je to jasna korist za javno zdravje.
Therefore, the proposed dosage is one risedronate tablet on day 1 followed by one sachet of calcium/colecalciferol daily for day 2 through to day 7, repeating this 7-day sequence each week.
Zato je predlagano odmerjanje ena tableta risedronata 1. dan, čemur sledi ena vrečka kalcija/holekalciferola dnevno od 2. do 7. dne, nato pa se to 7-dnevno zaporedje vsak teden ponavlja.
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant and marketing authorisation holders in the Member States
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Public health benefit and improved compliance
Korist za javno zdravje in izboljšanje bolnikovega upoštevanja navodil
The CHMP was of the opinion that the application is approvable.
CHMP je menil, da je vlogo mogoče odobriti.
According to the CHMP Guideline on combination products, “combination packs would only be acceptable in exception al cases, when there would be clear public health benefits of the treatment regimen and/or compliance, taking into account the required justifications set-out in section 5 of this guideline”.
V skladu s Smernico CHMP za kombinirana zdravila so „kombinirana pakiranja sprejemljiva le v izjemnih primerih, ko obstajajo jasne koristi za javno zdravje zaradi režima zdravljenja in/ali upoštevanja navodil, če upoštevamo zahtevane utemeljitve v 5. poglavju omenjene smernice“.
The procedure started in November 2009 and the indications applied for are the “treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures” and the “treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures”.
Postopek se je začel novembra leta 2009, predlagani indikaciji pa sta bili „zdravljenje osteoporoze pri ženskah po menopavzi, za zmanjšanje nevarnosti zlomov vretenc“ in „zdravljenje razvite osteoporoze pri ženskah po menopavzi, za zmanjšanje nevarnosti zlomov kolka“.
A concerned member state (CMS) raised Potential Serious Risks to Public Health pertaining to the lack of evidence of efficacy; in particular regarding the claims of improved benefit compared to the individual products and improved compliance compared to standard treatment.
Zadevna država članica je sprožila postopek zaradi možnih resnih tveganj za javno zdravje na osnovi pomanjkanja dokazov učinkovitosti; zlasti v zvezi s trditvami o izboljšanih koristih v primerjavi s posameznimi zdravili ter izboljšanem bolnikovem upoštevanju navodil v primerjavi s standardnim zdravljenjem.
The CHMP was of the opinion that the combination pack will simplify the correct dosage regimen compared to the individual products, thereby reducing the risk of interactions.
CHMP je menil, da kombinirano pakiranje poenostavi režim pravilnega odmerjanja v primerjavi s posameznimi zdravili, zato zmanjša nevarnost interakcij.
The CHMP agreed that the pharmacology and toxicology of calcium and colecalciferol are well-established, that combinations of these two products have been used globally in clinical practice for many years, and that the human experience supersedes non-clinical data.
CHMP je menil, da sta farmakologija in toksikologija kalcija in holekalciferola dobro uveljavljeni, da se kombinaciji teh dveh zdravil uporabljata v klinični praksi povsod po svetu že več let ter da izkušnje pri ljudeh presegajo neklinične podatke.
Old Belfast Road, Millbrook, Larne, County Antrim, BT40 2SH United Kingdom
Old Belfast Road, Millbrook, Larne, County Antrim, BT40 2SH Velika Britanija
Concomitant administration of calcium significantly impairs the absorption of risedronate and must therefore be avoided.
Sočasno jemanje kalcija bistveno zmanjša absorpcijo risedronata, zato se mu je treba izogniti.
On these grounds, the CHMP did not consider the demonstration of improved compliance to be an absolute requirement for the approval of this combination product.
Na osnovi omenjenega CHMP ni štel, da je dokaz izboljšanega upoštevanja navodil absolutna zahteva odobritve tega kombiniranega zdravila.
Module 2 contained the Quality Overall Summary together with the Clinical and Non Clinical overview and summary documents.
V modulu 2 so bili skupni povzetek kakovosti, klinični in neklinični pregled ter dokumenti s povzetki.
Module 4 contained three preclinical risedronate studies.
V modulu 4 so bile tri predklinične študije risedronata.
Treatment with bisphosphonates generally also includes treatment with calcium, to support the remineralisation of the skeleton and with colecalciferol (vitamin D3) which increases calcium absorption.
Zdravljenje z bisfosfonati običajno zajema tudi zdravljenje s kalcijem za podporo remineralizacije skeleta in s holekalciferolom (vitaminom D3), ki poveča absorpcijo kalcija.
The Applicant submitted an application for mutual recognition of the marketing authorisation granted by Sweden in 2006 for Fortipan Combi D, a combination product consisting of risedronate sodium 35 mg film-coated tablets together with 1000 mg calcium carbonate and 880 IU colecalciferol effervescent granules.
Predlagatelj je predložil vlogo za postopek z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je odobrila Švedska leta 2006 za zdravilo Fortipan Combi D, kombinirano zdravilo iz risedronat natrija 35 mg filmsko obložene tablete in 1000 mg kalcijevega karbonata ter 880 i.e. holekalciferola šumeča zrnca.
Treatment with anti-resorptive agents such as bisphosphonates together with oestrogen replacement therapy can prevent or reduce the loss of bone associated with postmenopausal osteoporosis.
Zdravljenje z antiresorpcijskimi sredstvi, kot so bisfosfonati, in nadomestnim estrogenskim zdravljenjem lahko prepreči ali zmanjša izgubo kostnine, povezano z osteoporozo pri ženskah po menopavzi.
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine
The CHMP considered the combination pack of risedronate and calcium plus colecalciferol to be an “exceptional case”, based on the problematic dosing and the risk for interaction prohibiting concomitant intake as per the Guideline for combination products (CHMP/EWP/240/95).
CHMP je upošteval, da je kombinacija risedronata in kalcija s holekalciferolom „izjemen primer“ zaradi težavnega odmerjanja in tveganja interakcije, ki preprečuje sočasen vnos v skladu s Smernico za kombinirana zdravila (CHMP/EWP/240/95).
Risedronate sodium is a bisphosphonate that inhibits bone resorption and has been shown to increase bone mass and biomechanical skeletal strength.
Risedronat natrij je bisfosfonat, ki zavira resorpcijo kostnine in dokazano poveča kostno maso ter biomehansko skeletno jakost.
Annex II
DODATEK II
Module 5 contained pivotal clinical studies and study reports for the 35 mg risedronate tablet and the calcium plus colecalciferol product as well as the pivotal study for approval of the weekly 35 mg risedronate tablet, in which patients were co-administered calcium and vitamin D, along with 46 relevant clinical literature references.
V modulu 5 so bile ključne klinične študije ter študijska poročila za risedronat 35 mg tableta in zdravilo kalcij s holekalciferolom, ključna študija za odobritev tedenske tablete risedronat 35 mg, v kateri so bolniki sočasno prejemali kalcij in vitamin D, in 46 zadevnih virov iz klinične literature.
The procedure was therefore referred to the CMD(h) and subsequently, to the CHMP under Article 29(4), in April 2010.
Postopek je bil zato aprila 2010 napoten na Koordinacijsko skupina za postopke z medsebojnim priznavanjem in decentralizirane postopke za zdravila za uporabo v humani medicini (CMD(h)) in posledično na CHMP v skladu členom 29(4).
The objecting CMS considered the benefit-risk balance of Fortipan Combi D to be unfavourable and presented specific points for objection to the application.
Nasprotujoča zadevna država članica je upoštevala, da je razmerje koristi in tveganj za zdravilo Fortipan Combi D neugodno ter predstavila specifične zadržke do vloge.
film-coated tablets + effervescent granules
filmsko obložene tablete + šumeča zrnca peroralna uporaba
Summary of product characteristics, labelling and package leaflet
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
In conclusion, the CHMP considered all the objections raised by the objecting concerned member to be adequately addressed and that they should not prevent the authorisation of the product.
CHMP je torej obravnaval vse zadržke nasprotujoče zadevne države članice tako, da so bili primerno upoštevani.
• the CHMP was convinced of the clear public health benefits and improved compliance resulting from the this product, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Fortipan Combi D and associated names (see Annex I).
CHMP je priporočil odobritev dovoljenj za promet z zdravilom, katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki zadnjim različicam, pripravljenim v postopku koordinacijske skupine in navedenim v Prilogi III za zdravilo Fortipan Combi D in povezanih imen (glejte Prilogo I).
Module 3 contained relevant documentation for the risedronate film-coated tablet as well as for the effervescent calcium-colecalciferol effervescent granules, for the drug substance as well as for the drug product.
V modulu 3 so bili ustrezni dokumenti za risedronat filmsko obložene tablete ter šumeča zrnca s kalcijem in holekalciferolom, za učinkovine zdravila in za zdravilo.
This summary was last updated in 12-2015.
Povzetek je bil nazadnje posodobljen 12-2015.
The European Commission granted a marketing authorisation valid throughout the EU for Zutectra on 30 November 2009.
Evropska komisija je dovoljenje za promet z zdravilom Zutectra, veljavno po vsej Evropski uniji, izdala 30. novembra 2009.
Zutectra is given as an injection under the skin once a week or every 2 weeks.
Zdravilo Zutectra se daje z injiciranjem pod kožo enkrat tedensko ali vsaka dva tedna.
What measures are being taken to ensure the safe and effective use of Zutectra?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zutectra?
The full EPAR for Zutectra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zutectra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Antibodies are proteins naturally found in the blood that help the body to fight infections and other diseases.
Protitelesa so beljakovine, ki so naravno prisotne v krvi in pomagajo telesu pri premagovanju okužb in drugih bolezni.
The recommended dose normally ranges from 500 IU to 1,000 IU, and exceptionally up to 1,500 IU.
Priporočeni odmerek običajno znaša od 500 do 1 000 mednarodnih enot, izjemoma do 1 500 mednarodnih enot.
This is a summary of the European public assessment report (EPAR) for Zutectra.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zutectra.
Other information about Zutectra
Druge informacije o zdravilu Zutectra
Zutectra has been studied in one main study involving 30 adults who had undergone liver transplants.
Zdravilo Zutectra je bilo raziskano v eni glavni študiji, v kateri je sodelovalo 30 odraslih, ki so jim presadili jetra.
A risk management plan has been developed to ensure that Zutectra is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Zutectra je bil pripravljen načrt obvladovanja tveganj.
What benefit has Zutectra shown during the studies?
Kakšne koristi je zdravilo Zutectra izkazalo med študijami?
Zutectra is a solution for injection.
Zdravilo Zutectra je raztopina za injiciranje.
Before starting Zutectra, the patient will need to receive medicines that contain the same active substance as in Zutectra, but given into a vein.
Pred uvedbo zdravljenja z zdravilom Zutectra mora bolnik prejemati zdravila, ki vsebujejo enako zdravilno učinkovino kot zdravilo Zutectra, vendar v veno.
For more information about treatment with Zutectra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zutectra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Zutectra (seen in between 1 and 10 patients in 100) are reactions at the injection site, such as pain, urticaria (itchy rash), haematoma (blood under the skin) and erythema (reddening of the skin).
Najpogostejši neželeni učinki zdravila Zutectra (opaženi pri 1 do 10 bolnikih od 100) so reakcije na mestu injiciranja, kot so bolečine, urtikarija (srbeč izpuščaj), hematom (kri pod kožo) in eritem (pordelost kože).
The patient or caregiver will also be trained on how to keep a treatment diary and what to do if severe side effects occur.
Bolniki ali njihovi negovalci se usposobijo tudi za vodenje dnevnika zdravljenja in ukrepanje v primeru hudih neželenih učinkov.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zutectra, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In the first study, all 23 of the patients who completed treatment had antibody levels above 100 IU per litre.
V prvi študiji je vseh 23 bolnikov, ki so zaključili zdravljenje, imelo ravni protiteles nad 100 i.e. na liter.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zutectra.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In another study in 49 patients, Zutectra was given at least one week (approximately 8-11 days) after the liver transplant.
V drugi študiji, ki je vključevala 49 bolnikov, se je zdravljenje z zdravilom Zutectra začelo najmanj en teden (približno 8-11 dni) po presaditvi jeter.
What is the risk associated with Zutectra?
Kakšna tveganja so povezana z zdravilom Zutectra?
In the second study, all of the 49 patients had antibody levels above 100 IU per litre and none of them was re-infected during the 24 weeks of treatment.
V drugi študiji je vseh 49 bolnikov imelo ravni protiteles nad 100 i.e. na liter in nihče se v 24 tednih zdravljenja ni ponovno okužil.
Zutectra must not be used in people who are hypersensitive (allergic) to the active substance, to any of the other ingredients or to human immunoglobulins.
Zdravila Zutectra ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilno učinkovino, katero koli drugo sestavino zdravila ali humane imunoglobuline.
Zutectra injections can be given by the patients themselves or their caregiver once they have been trained appropriately.
Injekcije zdravila Zutectra si lahko po ustreznem usposabljanju bolniki ali njihovi negovalci injicirajo sami.
The CHMP decided that Zutectra's benefits are greater than its risks and recommended that Zutectra be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zutectra večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
It is available as a prefilled syringe containing 500 international units (IU) of the active substance, human hepatitis B immunoglobulin.
Na voljo je v napolnjeni injekcijski brizgi, ki vsebuje 500 mednarodnih enot (i.e.) zdravilne učinkovine humani imunoglobulin proti hepatitisu B.
Zutectra treatment was started at least three months after the liver transplant.
Zdravljenje z zdravilom Zutectra se je začelo najmanj tri mesece po presaditvi jeter.
For the full list of all side effects reported with Zutectra, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zutectra, glejte navodilo za uporabo.
This level is considered adequate to protect against re-infection with the hepatitis B virus.
Ta raven velja za zadostno za zaščito pred ponovno okužbo z virusom hepatitisa B.
The main measure of effectiveness was the number of patients who had a blood level of hepatitis B immunoglobulin above 100 IU per litre after 18 to 24 weeks.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so po 18 do 24 tednih imeli v krvi raven imunoglobulina proti hepatitisu B nad 100 i.e. na liter.
Why has Zutectra been approved?
Zakaj je bilo zdravilo Zutectra odobreno?
Zutectra treatment starts at least one week after the liver transplant.
Zdravljenje z zdravilom Zutectra se začne najmanj en teden po presaditvi jeter.
Zutectra prevents the patient from being re-infected with hepatitis B by keeping the blood levels of human hepatitis B immunoglobulins high enough, so that they can attach to the virus and stimulate the immune system to destroy it.
Zdravilo Zutectra preprečuje ponovno okužbo z virusom hepatitisa B tako, da v krvi ohranja dovolj visoke ravni humanih imunoglobulinov proti hepatitisu B, ki se pritrdijo na virus in spodbujajo imunski sistem k uničenju virusa.
Zutectra must not be given into a blood vessel.
Zdravila Zutectra se ne sme dajati v žilo.
Zutectra is used to prevent re-infection with the hepatitis B virus in patients without active infection (i.e. those who test negative for the presence of the hepatitis B protein (HBsAg) and for hepatitis B DNA (HBV-DNA)).
Zdravilo Zutectra se uporablja pri odraslih po presaditvi jeter zaradi odpovedi jeter, ki jo je povzročila okužba z virusom hepatitisa B. Zdravilo Zutectra se uporablja za preprečevanje ponovne okužbe z virusom hepatitisa B pri bolnikih brez aktivne okužbe (tj. tistih, pri katerih je test na prisotnost beljakovine virusa hepatitisa B (HBsAg) in DNA virusa hepatitisa B (HBV-DNA)) negativen).
The active substance in Zutectra, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood.
Zdravilna učinkovina zdravila Zutectra, humani imunoglobulin proti hepatitisu B, so prečiščena protitelesa iz človeške krvi.
Zutectra has been shown to be effective at maintaining antibody levels required to protect against hepatitis B re-infection.
Zdravilo Zutectra se je izkazalo za učinkovito pri ohranjanju ravni protiteles, ki so potrebne za zaščito pred ponovno okužbo z virusom hepatitisa B.
The main measure of effectiveness was the number of patients in whom treatment failed, defined as blood levels of hepatitis B immunoglobulins falling below 100 IU per litre or reinfection by hepatitis B virus during the 24 weeks of treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih zdravljenje ni bilo uspešno, tj. ravni imunoglobulina proti hepatitisu B v krvi so bile pod 100 i.e. na liter oziroma v 24 tednih zdravljenja je prišlo do ponovne okužbe z virusom hepatitisa B.
The dose is established based on the patient's blood levels of antibodies against the hepatitis B virus.
Odmerek temelji na ravni protiteles proti virusu hepatitisa B v krvi bolnika.
What is Zutectra used for?
Za kaj se zdravilo Zutectra uporablja?
How does Zutectra work?
Kako zdravilo Zutectra deluje?
How has Zutectra been studied?
Kako je bilo zdravilo Zutectra raziskano?
Zutectra human hepatitis-B immunoglobulin
Zutectra humani imunoglobulin proti hepatitisu B
What is Zutectra?
Kaj je zdravilo Zutectra?
The use of standard antiviral medicines to prevent hepatitis B re-infection should be considered together with Zutectra.
Razmisliti je treba o sočasni uporabi zdravila Zutectra s standardnimi protivirusnimi zdravili za preprečevanje ponovne okužbe z virusom hepatitisa B.
How is Zutectra used?
Kako se zdravilo Zutectra uporablja?
90 (3 x 30) tablets (multipack)
90 (3 x 30) tablet (3 vsebniki)
1 bottle
1 vsebnik
Oral Suspension Oral use bottle (glass)
100 mg/ml peroralna suspenzija peroralna uporaba vsebnik (steklo)
75 mg
75 mg filmsko obložena tableta
The doctor may decide to stop treatment if the condition does not improve after 16 to 20 weeks.
Zdravnik se lahko odloči za prenehanje zdravljenja, če se stanje po 16 do 20 tednih ne izboljša.
It is used in adults who require systemic treatment (treatment with medicines affecting the whole body).
Uporablja se pri odraslih, ki potrebujejo sistemsko zdravljenje (zdravljenje z zdravili, ki vplivajo na vse telo).
The first dose of 160 mg (two injections) is followed by an injection of 80 mg every two weeks for the first 12 weeks and every 4 weeks thereafter.
Prvemu odmerku v višini 160 mg (dve injekciji) sledi 80-miligramska injekcija vsaka dva tedna prvih 12 tednov in nato na vsake štiri tedne.
Taltz must not be given to patients who have potentially serious infections such as tuberculosis.
Zdravilo Taltz se ne sme dajati bolnikom, ki imajo potencialno resne okužbe, npr. tuberkulozo.
Other information about Taltz
Druge informacije o zdravilu Taltz
What measures are being taken to ensure the safe and effective use of Taltz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Taltz?
This is a summary of the European public assessment report (EPAR) for Taltz.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Taltz.
The full EPAR and risk management plan summary for Taltz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Taltz sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Taltz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Taltz večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The most common side effects with Taltz (which may affect more than 1 in 10 people) are pain and redness at the injection site, and nose, throat or chest infections.
Najpogostejši neželeni učinki zdravila Taltz (ki lahko prizadenejo več kot 1 osebo od 10) so bolečina ali pordelost na mestu injiciranja in okužbe nosu, žrela in prsnega koša.