natgillin/translations-raw huggingface dataset:
The established withdrawal periods are safe and can be retained.
5. so vzpostavljene karence varne in se lahko obdržijo.
The CVMP started the referral procedure during its meeting of 10-12 July 2007.
Odbor za zdravila za uporabo v veterinarski medicini je z napotitvenim postopkom začel na seji, ki je potekala od 10. do 12. julija 2007.
The Marketing Authorisation Holders were requested in a list of questions to provide:
Imetniki dovoljenj za promet z zdravilom so bili s seznamom vprašanj pozvani k predložitvi:
• Justification of the withdrawal period, in case the recommended dose should increase.
• Utemeljitve obdobja karence v primeru priporočenega povečanja odmerka.
On 11 July 2007, France presented to the EMEA a referral under Article 35 of Directive 2001/82/EC, as amended, concerning Tribrissen Oral Paste for Horses (including associated names) and authorised products for which this product served as a reference product, containing trimethoprim and sulfadiazine as active ingredient.
Francija je dne 11. julija 2007 Evropski agenciji za zdravila predložila napotitev v skladu s členom 35 Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo Tribrissen, peroralna pasta za konje, (in z njim povezana imena) ter odobrena zdravila, za katera je to zdravilo predstavljalo referenčno zdravilo in ki vsebujejo zdravilni učinkovini trimetoprim in sulfadiazin.
o Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; o If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data.
o Dela 1, povzetka dokumentacije, vključno s povzetkom glavnih značilnosti zdravila, strokovnimi poročili ter kakovostno in količinsko sestavo zdravila; o če je smiselno, Dela 4, podatki o učinkovitosti, vključno s podatki o farmakokinetiki, farmakodinamiki in odpornosti proti mikrobom.
France considered that the dosing regime of the product is not correct.
Francija je menila, da način odmerjanja zdravila ni primeren.
• Justification of the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria.
• Utemeljitve priporočenih odmerkov za vsako posamezno navedeno indikacijo glede učinkovitosti in potencialne izbire bakterij, odpornih proti mikrobom.
Having assessed the responses, the CVMP concluded that:
Po proučitvi predloženih odgovorov je Odbor za zdravila za uporabo v veterinarski medicini sklenil, da:
Marketing Authorisation Holders submitted written responses, defending the authorised dose of 1x30 mg/kg body weight per day for all indications but suggesting a higher dose may be required in the case of salmonellosis.
Imetniki dovoljenj za promet z zdravilom so predložili pisne odgovore, v katerih so zagovarjali odobrene odmerke 1x30 mg/kg telesne mase na dan za vse indikacije, so pa predlagali večji odmerek v primeru indikacije salmoneloze.
The CVMP recommended varying the Marketing Authorisations of the concerned veterinary medicinal products in accordance with the conclusions where applicable.
Odbor za zdravila za uporabo v veterinarski medicini je priporočil spremembo dovoljenj za promet z zadevnimi zdravili v skladu s sprejetimi sklepi.
Neither the Periodic Safety Update Reports of the products nor the literature presented included reports of lack of efficacy in the field.
Poročil o neustrezni učinkovitosti na terenu ni bilo ne v periodičnih poročilih o varnosti zdravila niti v predloženi literaturi.
It considered that this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Prepričana je, da lahko tako odmerjanje zmanjša učinkovitost in še poveča odpornost ciljnih patogenov, kar bi lahko ogrozilo zdravje ljudi, predvsem kadar gre za bakterije zoonoze.
There is no documented evidence of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
2. do zdaj ni nobenih dokumentiranih dokazov o težavah zaradi slabše učinkovitosti ali kakršnih koli sprememb odpornosti glavnih ciljnih patogenov, ki bi pomenili zadržke zaradi tveganja za zdravje živali ali ljudi;
OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR VETERINARY MEDICINAL PRODUCTS WHICH CONTAIN THE ACTIVE SUBSTANCES TRIMETHOPRIM AND SULFADIAZINE
KI VSEBUJEJO ZDRAVILNI UČINKOVINI TRIMETOPRIM IN SULFADIAZIN
The efficacy of a dose of 1x30 mg/kg body weight per day to be administered over a maximum period of 5 days has been substantiated for all indications, except for salmonellosis.
1. je bila učinkovitost odmerka 1x30 mg/kg telesne mase na dan, ki se daje največ pet zaporednih dni,
The use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
3. ni bilo mogoče določiti primernega odmerka za zdravljenje salmonelaze; 4. mora uporaba zdravila temeljiti na testiranju občutljivosti in upoštevati uradno in lokalno protimikrobno politiko;
No dose could be established for the treatment of salmonellosis.
ustrezno potrjena za vse indikacije, razen za salmonelozo;
Treatment continued for up to two years.
Zdravljenje se je nadaljevalo do dve leti.
The side effects are similar in adults and in children.
Neželeni učinki so podobni pri odraslih in otrocih.
The site of injection should be changed each week.
Mesto injiciranja je treba vsak teden zamenjati.
The main measure of effectiveness was the number of patients whose disability got worse.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je prizadetost poslabšala.
Further information on Avonex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/avonex.
Nadaljnje informacije za zdravilo Avonex so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/avonex.
• patients who have had a single attack of demyelination, when this is severe enough to need treatment with injectable corticosteroids (anti-inflammatory medicines).
• bolnikov, ki so doživeli en demielinizacijski napad, če je bil ta dovolj resen, da je potrebno zdravljenje z intravenoznimi kortikosteroidi (protivnetnimi zdravili).
Avonex is a medicine used to treat:
Avonex je zdravilo, ki se uporablja za zdravljenje:
These side effects decrease with continued treatment.
Ti neželeni učinki se z nadaljevanjem zdravljenja zmanjšujejo.
• patients with relapsing multiple sclerosis (MS).
• bolnikov s ponavljajočo se multiplo sklerozo (MS).
The European Medicines Agency decided that Avonex's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Avonex večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Avonex received a marketing authorisation valid throughout the EU on 13 March 1997.
Za zdravilo Avonex je bilo 13. marca 1997 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Avonex?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Avonex?
Other information about Avonex
Druge informacije o zdravilu Avonex
In adults (aged 18 years or over), the recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week.
Pri odraslih (starejših od 18 let) je priporočeni odmerek zdravila Avonex 30 mikrogramov, ki se injicira v mišico enkrat na teden.
As for all medicines, data on the use of Avonex are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Avonex stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avonex have 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 Avonex upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Avonex has been compared with placebo (a dummy treatment) in two main studies.
Zdravilo Avonex so primerjali s placebom (zdravilom brez učinkovine) v dveh glavnih študijah.
The second study involved 383 adults who had experienced a single attack of demyelination and compared the ability of Avonex and placebo to reduce the risk of a second attack.
Druga študija je vključevala 383 odraslih, ki so doživeli en demielinizacijski napad, v njej pa so primerjali sposobnost zdravila Avonex in placeba za zmanjševanje tveganja za pojav drugega napada.
The most common side effects with Avonex (which may affect more than 1 in 10 people) are headache, flu-like symptoms, pyrexia (fever), chills and sweating.
Najpogostejši neželeni učinki zdravila Avonex (ki se lahko pojavijo pri več kot 1 od 10 oseb) so glavobol, gripi podobni simptomi, pireksija (povišana telesna temperatura), mrzlica in potenje.
The estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.
Ocenjeno tveganje za pojav drugega demielinizacijskega napada je bilo manjše pri bolnikih, ki so se zdravili z zdravilom Avonex, kot pri bolnikih, zdravljenih s placebom: pri bolnikih, zdravljenih z zdravilom Avonex, je bilo tveganje v dveh letih 21 %, v treh letih pa 35 %, medtem ko je bilo tveganje pri bolnikih, ki so prejemali placebo, v dveh letih 39 %, v treh letih pa 50 %.
Side effects reported with Avonex are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Avonex, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Avonex must not be used in patients who have severe depression or have thoughts of suicide.
Zdravilo Avonex se ne sme uporabljati pri bolnikih, ki imajo hudo depresijo ali samomorilne misli.
In relapsing MS, the patient has attacks (relapses) between periods with no symptoms.
Pri ponavljajoči se multipli sklerozi ima bolnik napade (relapse) med obdobji brez simptomov.
Avonex slows the progression of disability and reduces the number of relapses;
Zdravilo Avonex upočasnjuje napredovanje prizadetosti in zmanjšuje pogostost relapsov;
In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Pri multipli sklerozi imunski sistem (naravni obrambni mehanizem telesa) ne deluje pravilno in napade dele osrednjega živčnega sistema (možgane, hrbtenjačo in vidni živec [živec, ki pošilja signale iz očesa v možgane]), kar povzroča vnetje, ki poškoduje živce in ovojnico okoli njih.
MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Multipla skleroza je bolezen, pri kateri vnetje poškoduje zaščitno ovojnico okoli živcev (demielinizacija) in živce same.
This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows the lower dose of Avonex to be injected.
To je mogoče le z napolnjeno injekcijsko brizgo, če je opremljena s posebnim pripomočkom, ki se pritrdi nanjo in omogoča injiciranje manjšega odmerka zdravila Avonex.
To help patients adjust to treatment, the doctor may recommend that patients start with a lower dose once a week before increasing to the full dose.
V pomoč bolnikom pri privajanju na zdravljenje lahko zdravnik priporoči, da se zdravljenje pred prehodom na polni odmerek začne s polovičnim odmerkom enkrat na teden.
The active substance in Avonex is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Učinkovina zdravila Avonex je beljakovina interferon beta-1a, ki je ena od skupin interferonov, ki jih lahko telo naravno ustvari za obrambo pred okužbami, ki jih povzročajo virusi, in drugimi napadi.
Each syringe and pen contains 30 micrograms of interferon beta-1a.
Vsaka injekcijska brizga in injekcijski peresnik vsebuje 30 mikrogramov interferona beta-1a.
Why is Avonex authorised in the EU?
Zakaj je bilo zdravilo Avonex odobreno v EU?
An overview of Avonex and why it is authorised in the EU
Pregled zdravila Avonex in zakaj je odobreno v EU
For more information about using Avonex, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Avonex glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Avonex have been shown in studies?
Kakšne koristi zdravila Avonex so se pokazale v študijah?
What is Avonex and what is it used for?
Kaj je zdravilo Avonex in za kaj se uporablja?
What are the risks associated with Avonex?
Kakšna tveganja so povezana z zdravilom Avonex?
The exact way that Avonex works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Natančen način delovanja zdravila Avonex pri multipli sklerozi še ni popolnoma znan, vendar se zdi, da učinkovina, interferon beta-1a, pomirja imunski sistem in preprečuje realpse multiple skleroze.
After two years, 22% of the patients who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability.
Po dveh letih se je prizadetost poslabšala pri 22 % bolnikov, ki so se zdravili z zdravilom Avonex, in 35 % bolnikov, ki so prejemali placebo.
Avonex treatment should be stopped in patients who develop progressive (worsening) MS.
Zdravljenje z zdravilom Avonex je treba prekiniti pri bolnikih, pri katerih se je razvila progresivna (napredujoča) multipla skleroza.
Patients can inject Avonex themselves once they have been trained.
Bolniki si lahko po ustreznem usposabljanju zdravilo Avonex injicirajo sami.
Avonex is available as a solution for injection in a pre-filled syringe or pre-filled pen.
Zdravilo Avonex je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku.
However, it presented information from published studies on the use of Avonex in patients aged between 12 and 18 years, which showed that they had a decrease in the rate of relapse, possibly due to Avonex treatment.
Podjetje ni izvedlo nobenih uradnih študij pri bolnikih, mlajših od 16 let, je pa predstavilo informacije iz objavljenih študij uporabe zdravila Avonex pri bolnikih, starih od 12 do 18 let, ki so pokazale, da se je stopnja relapsov, morda zaradi zdravljenja z zdravilom Avonex, zmanjšala.
Avonex can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.
Predpisovanje in izdaja zdravila Avonex je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
For the full list of side effects and restrictions with Avonex, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Avonex glejte navodilo za uporabo.
Avonex contains the active substance interferon beta-1a.
Zdravilo Avonex vsebuje učinkovino interferon beta-1a.
The first study involved 301 patients aged 16 years and older with relapsing MS who had experienced at least two relapses in the previous three years or at least one relapse per year if they had had the disease for less than three years.
Ti bolniki so v preteklih treh letih doživeli vsaj dva relapsa ali vsaj en relaps na leto, če so bili bolni manj kot tri leta.
It is used when the patient is considered to be at high risk of developing MS. Before using Avonex, doctors need to exclude other causes for the symptoms.
Pred uporabo zdravila Avonex morajo zdravniki izključiti druge možne vzroke za simptome.
A painkiller that prevents fever can be given before each injection and for 24 hours after injection to reduce the flu-like symptoms that may occur during the first few months of treatment.
Da bi zmanjšali gripi podobne simptome, ki se lahko pojavijo v prvih mesecih zdravljenja, lahko bolnik pred injiciranjem in 24 ur po njem dobi zdravilo proti bolečinam, ki preprečuje povišano telesno temperaturo.
How is Avonex used?
Kako se zdravilo Avonex uporablja?
How does Avonex work?
Kako zdravilo Avonex deluje?
Both the Chennai site and the Coimbatore site follow the same provisions.
Na obeh lokacijah, Chennai in Coimbatore, so upoštevali ista določila.
• The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Micro Therapeutic Research Labs Limited;
• odbor je pregledal vse razpoložljive podatke in informacije, ki so jih zagotovili imetniki dovoljenj za promet z zdravilom/predlagatelji, ter informacije, ki jih je predložila družba Micro Therapeutic Research Labs Limited;
Micro Therapeutic Research Labs Ltd is a contract research organisation (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which have been used to support marketing authorisation applications of medicines in the EU.
Družba Micro Therapeutic Research Labs Ltd je pogodbena raziskovalna organizacija, ki izvaja analitski in klinični del študij biološke enakovrednosti, od katerih so se nekatere uporabile v podporo vlogam za pridobitev dovoljenja za promet z zdravili v EU.
Data from bioequivalence studies submitted to the Competent Authorities to demonstrate bioequivalence of medicinal products with their originator is considered unreliable.
Podatki iz študij biološke enakovrednosti, predložene pristojnim oblastem kot dokaz biološke enakovrednosti zdravil z originatorskim zdravilom, veljajo za nezanesljive.
Therefore, for those products bioequivalence is not established.
To pomeni, da za vsa ta zdravila biološka enakovrednost ni bila dokazana.
Based on the submitted data during the procedure, the medicinal products Tadalafil Mylan 2.5 mg, 5 mg, 10 mg and 20 mg; Paracetamol DAWA 1000 mg film-coated tablets; Memantine Pharmascope 10 mg and 20 mg; Memantine DAWA 10 mg and 20 mg; Morysa 10 mg and 20 mg - SVUS Pharma a.s.; Bendroflumetiazid Alternova 2.5 mg and 5 mg tablets; the CHMP concluded that bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product and recommended the maintenance of these marketing authorisations.
Na podlagi predloženih podatkov med postopkom je odbor CHMP presodil, da je bila za zdravila Tadalafil Mylan 2,5 mg, 5 mg, 10 mg in 20 mg; Paracetamol DAWA 1000 mg filmsko obložene tablete; Memantine Pharmascope 10 mg in 20 mg; Memantine DAWA 10 mg in 20 mg; Morysa 10 mg in 20 mg - SVUS Pharma a.s.
The CHMP was requested in particular to provide its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products should be maintained, varied, suspended, or revoked and whether marketing authorisations applications should be authorised.
Odbor CHMP je bil zlasti zaprošen, naj v skladu s členom 31 Direktive 2001/83/ES poda svoje mnenje o tem, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno prekličejo ali ukinejo in ali naj se vloge za pridobitev dovoljenj za promet odobrijo.
− Marketing authorisation applications for which no alternative data or a justification was submitted.
− vloge za pridobitev dovoljenja za promet z zdravilom, za katere niso bili predloženi drugi možni podatki ali utemeljitev.
The findings of the Austrian and Dutch inspections raise serious concerns relating to the suitability of the quality management system in place at Micro Therapeutics Research LTd, India.
Ugotovitve inšpekcijskih pregledov avstrijskega in nizozemskega organa so vzbudile resne pomisleke o primernosti sistema upravljanja kakovosti v družbi Micro Therapeutics Research LTd v Indiji.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Micro Therapeutic Research Labs Limited during the period between June 2012 and June 2016;
• odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za dovoljenja za promet z zdravilom in vloge za pridobitev dovoljenja za promet z zdravilom za zdravila, za katera so bili klinični in/ali bioanalitski deli študij biološke enakovrednosti opravljeni v družbi Micro Therapeutic Research Labs Limited v obdobju med junijem 2012 in junijem 2016;
This period of deferral shall not exceed twenty-four months from the Commission Decision.
Ta odlog je mogoč za obdobje največ štiriindvajsetih mesecev od izdaje sklepa Komisije.
Furthermore, the Committee recommends that the concerned marketing authorisations should be suspended unless the medicinal product is considered critical by the relevant national competent authorities.
Poleg tega odbor priporoča, da se zadevna dovoljenja za promet z zdravilom začasno umaknejo, razen če je zdravilo po mnenju ustreznega nacionalnega pristojnega organa kritičnega pomena.
In view of the critical inspection findings and the necessity to protect public health in the EU, several Member States considered that it is in the interest of the Union to refer the matter to the CHMP and request that it assesses the impact of the findings mentioned above on the benefit-risk balance of the medicinal products which have been authorised by the Member States on the basis of relevant trials performed at these sites between June 2012 and June 2016 and also that of pending marketing authorisation applications (MAA) that include such studies.
Glede na ugotovljene kritične ugotovitve in nujnost zaščite javnega zdravja v EU je več držav članic menilo, da je v interesu Unije napotitev zadeve na odbor CHMP, zato so odbor zaprosili, da oceni vpliv zgoraj omenjenih ugotovitev na razmerje med tveganji in koristmi zdravil, ki so jih države članice odobrile na podlagi zadevnih preskušanj, izvedenih na teh lokacijah med junijem 2012 in junijem 2016, ter še nezaključenih vlog za pridobitev dovoljenja za promet, ki vključujejo te študije.
In addition, a study performed at the Micro Therapeutic Research Labs Pvt. Ltd site in Coimbatore was inspected.
Poleg tega so preučili tudi študijo, izvedeno na lokaciji družbe Micro Therapeutic Research Labs Pvt. Ltd v Coimbatoreju.
For marketing authorisations of a medicinal product considered critical, the suspension may be deferred in the relevant EU Member States for a period which shall not exceed twenty-four (24) months from the Commission Decision.
Za dovoljenja za promet z zdravilom, ki šteje za zdravilo kritičnega pomena, se lahko začasni umik v zadevni državi članici EU odloži za obdobje največ štiriindvajsetih (24) mesecev od izdaje sklepa Komisije.
Grounds for CHMP opinion Whereas,
Podlaga za mnenje odbora CHMP
Critical findings were identified following inspections to check compliance with Good clinical practice (GCP) by the Austrian Federal Office for Safety in Healthcare (BASG) and the Health Care Inspectorate of the Netherlands (IGZ) in February 2016 at Micro Therapeutic Research Labs Pvt. Ltd, Chennai, India.
Z inšpekcijskim pregledom preverjanja skladnosti z dobro klinično prakso, ki sta ga opravila avstrijski zvezni urad za varnost v zdravstvu (BASG) in nizozemski zdravstveni inšpektorat (IGZ) februarja 2016 v družbi Micro Therapeutic Research Labs Pvt. Ltd, Chennai, v Indiji, so prišli do kritičnih ugotovitev.
The CHMP therefore recommended the suspension of the marketing authorisations for all remaining medicinal products concerned by this referral procedure, as bioequivalence vis-à-vis the EU reference medicinal products has not been demonstrated.
Odbor CHMP je zato priporočil začasen umik dovoljenj za promet z vsemi preostalimi zdravili, ki jih zadeva ta napotitveni postopek, saj biološka enakovrednost z referenčnimi zdravili, odobrenimi v EU, ni bila dokazana.