natgillin/translations-raw huggingface dataset:
Sabumalin is used to relieve symptoms, and its use should not delay the use of inhaled steroids. 
Zdravilo Sanohex se uporablja za lajšanje simptomov, zaradi uporabe tega zdravila pa se ne sme preložiti uporabe inhalacijskih steroidov.
Sabumalin is a ‘generic medicine'. 
Zdravilo Sanohex je „generično zdravilo“.
This means that salbutamol activates the beta2receptors in the body. 
To pomeni, da salbutamol aktivira receptorje beta-2 v telesu.
Salbutamol is a beta2-adrenergic receptor agonist. 
Salbutamol je agonist adrenergičnih receptorjev beta-2.
Sabumalin is a medicine in a pressurised inhaler that contains salbutamol as active substance. 
Sanohex je zdravilo v inhalatorju pod tlakom, ki vsebuje zdravilno učinkovino salbutamol.
When given by inhalation as in Sabumalin, salbutamol directly activates the beta2-receptors in the respiratory system. 
Pri jemanju zdravila z inhaliranjem, kot velja za zdravilo Sanohex, salbutamol neposredno aktivira receptorje beta-2 v dihalih.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Sabumalin outweigh its risks, and that the marketing authorisation can be granted in Sweden as well as in the following Member States of the European Union: Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom. 
Odbor za zdravila za uporabo v humani medicini (CHMP), ki je del agencije EMEA, je zaključil, da koristi zdravila Sanohex odtehtajo z njim povezana tveganja in da se lahko dovoljenje za promet z zdravilom odobri na Švedskem ter tudi v naslednjih državah članicah Evropske unije: Avstrija, Nemčija, Irska in Španija.
What is Sabumalin? 
Kaj je zdravilo Sanohex?
(Invented) name 
(izmišljeno)
EMA Number 
Številka postopka
Pack size 
EMA
MA (EU) number (Invented) Name 
(Izmišljeno) ime
Content (concent ration) 
Vsebina (koncentracija)
MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK (the ‘reference Member State') in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain (the ‘concerned Member States'). 
Podjetje MIKA Pharma GmbH je zahtevalo, da se dovoljenje za promet z zdravilom Diclofenac Sodium Spray Gel 4%, ki ga je leta 2001 izdalo Združeno kraljestvo (referenčna država članica), pozneje pa tudi Avstrija, Estonija, Madžarska, Irska, Latvija, Litva in Slovenija, prizna tudi v Nemčiji, Italiji in Španiji (zadevne države članice).
The review of Diclofenac Sodium Spray Gel 4% was initiated at the request of the United Kingdom under Article 29(4) of Directive 2001/83/EC. 
Pregled zdravila Diclofenac Sodium Spray Gel 4% se je začel na zahtevo Združenega kraljestva v skladu s členom 29(4) Direktive 2001/83/ES.
However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 4 April 2018. 
Ker pa države članice niso dosegle soglasja, je britanska regulativna agencija za zdravila 4. aprila 2018 zadevo napotila na Evropsko agencijo za zdravila v arbitražo.
The spray gel is applied on the skin of affected areas to relieve pain and swelling due to trauma in small and medium joints and surrounding tissues. 
Gel v obliki pršila se nanese na kožo na prizadete dele, kjer lajša bolečino in otekanje zaradi poškodbe majhnih in srednje velikih sklepov in obdajajočih tkiv.
The grounds for the referral were concerns raised by Germany and Spain that the data provided by the company were not sufficient to show that the product was effective at treating joint pain and swelling. 
Podlaga za napotitev so bili pomisleki, ki sta jih izrazili Nemčija in Španija, da podatki, ki jih je predložilo podjetje, ne zadoščajo za dokaz, da je zdravilo učinkovito pri zdravljenju bolečine v sklepih in otekanja sklepov.
The Agency also considered that, although the effectiveness of diclofenac and other NSAIDs applied to the skin is somewhat modest, these medicines have been authorised and used for decades and their safety is not in question. 
Agencija je tudi upoštevala, da se, čeprav je učinkovitost diklofenaka in drugih nesteroidnih protivnetnih zdravil, ki se nanesejo na kožo, precej skromna, dovoljenja za promet s temi zdravili izdajajo že desetletja, toliko časa pa se ta zdravila tudi uporabljajo, tako da njihova varnost ni vprašljiva.
The Agency concluded that the benefits of the medicine outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation. 
Agencija je zaključila, da koristi zdravila odtehtajo z njim povezana tveganja in da se dovoljenje za promet z njim, izdano v Združenem kraljestvu, lahko prizna tudi v drugih državah članicah EU, v katerih je podjetje zanj zaprosilo.
On 15 November 2018, the European Medicines Agency completed a review of Diclofenac Sodium Spray Gel 4% following a disagreement among EU Member States regarding its authorisation. 
Evropska agencija za zdravila je 15. novembra 2018 zaključila pregled zdravila Diclofenac Sodium Spray Gel 4% po nesoglasju med državami članicami EU v zvezi z izdajo dovoljenja za promet z njim.
What is Diclofenac Sodium Spray Gel 4%? 
Kaj je zdravilo Diclofenac Sodium Spray Gel 4%?
In addition, the use of data from the published literature obtained with other diclofenac medicines to demonstrate the benefits of Diclofenac Sodium Spray Gel 4% needed to be further justified. 
Poleg tega je bilo treba uporabo podatkov iz objavljene literature, ki so jih pridobili z drugimi zdravili z diklofenakom, za prikaz koristi zdravila Diclofenac Sodium Spray Gel 4% dodatno utemeljiti.
Since Diclofenac Sodium Spray Gel 4% is absorbed in a similar way to other diclofenac medicines applied to the skin and the supporting study demonstrated an effect similar to that of other diclofenac medicines in the published literature, the Agency considered that it was acceptable to use published data on the effectiveness and safety of other diclofenac medicines to support the use of Diclofenac Sodium Spray Gel 4%. 
Ker se zdravilo Diclofenac Sodium Spray Gel 4% absorbira podobno kot druga zdravila, ki vsebujejo diklofenak in se nanesejo na kožo, in ker so v podporni študiji dokazali, da ima zdravilo podoben učinek kot druga zdravila z diklofenakom v objavljeni literaturi, je agencija zaključila, da je sprejemljivo uporabiti objavljene podatke o učinkovitosti in varnosti drugih zdravil, ki vsebujejo diklofenak, tudi v podporo uporabi zdravila Diclofenac Sodium Spray Gel 4%.
Diclofenac Sodium Spray Gel 4% contains the active substance diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). 
Zdravilo Diclofenac Sodium Spray Gel 4% vsebuje učinkovino diklofenak, ki spada v skupino nesteroidnih protivnetnih zdravil.
The company also provided the results of a study indicating that Diclofenac Sodium Spray Gel 4% is effective at reducing joint swelling and relieving pain. 
Podjetje je predložilo tudi rezultate študije, ki kažejo, da je zdravilo Diclofenac Sodium Spray Gel 4% učinkovito pri zmanjševanju otekanja sklepov in lajšanju bolečine.
The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diclofenac Sodium Spray Gel 4% on 18/01/2019. 
Evropska komisija je 18. januarja 2019 izdala končni pravno zavezujoči sklep, ki velja po vsej EU, o izdaji dovoljenja za promet z zdravilom Diclofenac Sodium Spray Gel 4%.
Overall, the totality of the data provided by the company was considered sufficient to demonstrate that Diclofenac Sodium Spray Gel 4% is effective at treating joint swelling and pain due to trauma. 
V splošnem je bilo mogoče sklepati, da so vsi podatki, ki jih je predložilo podjetje, zadostni za dokaz, da je zdravilo Diclofenac Sodium Spray Gel 4% učinkovito pri zdravljenju otekanja sklepov in lajšanju bolečin zaradi poškodbe.
The Agency considered that the data provided by the company show that, when applied to the skin, Diclofenac Sodium Spray Gel 4% produces similar levels of diclofenac in the body to another diclofenac 
Agencija je zaključila, da podatki, ki jih je predložilo podjetje, dokazujejo, da je količina diklofenaka v telesu pri nanosu zdravila Diclofenac Sodium Spray Gel 4% na kožo podobna kot pri drugem gelu, ki vsebuje diklofenak, ki je že odobren za enako uporabo.
The Agency therefore concluded that the benefits of the medicine outweigh its risks, and therefore the marketing authorisation should be granted in the concerned Member States. 
Agencija je zaključila, da koristi zdravila Diclofenac Sodium Spray Gel 4% odtehtajo njegova tveganja, in priporočila, da se dovoljenje za promet z zdravilom izda v zadevnih državah članicah.
EMA/631720/2018 Rev. 1 
18. januar 2019
Classification as an exceptional case 
Razvrstitev kot izjemni primer
(Invented) Name Strength 
(Izmišljeno) ime Jakost
Twenty-eight adequate non-clinical literature references were also submitted. 
Predloženih je bilo tudi osemindvajset primernih nekliničnih virov.
Overall summary of the scientific evaluation of Fortipan Combi D and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Fortipan Combi D in z njim povezanih imen (glejte Prilogo I)
Plaça de la Pau s/n 08940 Cornellà de Llobregat (Barcelona) Spain 
Plaça de la Pau s/n 08940 Cornellà de Llobregat (Barcelona) Španija
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.