natgillin/translations-raw huggingface dataset:
No clinically meaningful trends with respect to tachyphylaxis or rebound effects (worsening of baseline erythema after cessation of treatment) were observed with use of Mirvaso for 29 days.
Po 29-dnevni uporabi zdravila Mirvaso niso opazili klinično pomembnih trendov glede tahifilaksije ali povratnega (rebound) učinka (poslabšanje izhodiščnega eritema po končanem zdravljenju).
Uncommon Dry mouth
Bolezni prebavil občasni suha usta
Recurrences of aggravated erythema and flushing have been reported after re-administration of Mirvaso topical gel.
O ponovitvi eritema in vročinskih oblivov v hujši obliki so poročali pri ponovni uporabi zdravila Mirvaso topikalni gel.
You should use these products only after the applied Mirvaso has dried.
Te izdelke uporabite šele, ko se zdravilo Mirvaso osuši.
Table 1 - Adverse reactions
Preglednica 1: Neželeni učinki
Do not swallow.
Ne zamrzujte.
Aggravated erythema, flushing and skin burning sensation have been reported during the post-marketing period (see section 4.4).
V obdobju trženja zdravila so poročali o poslabšanju eritema, vročinskih oblivov in pekočega občutka na koži (glejte poglavje 4.4).
Uncommon side effects (may affect up to 1 in 100 people): - acne - dry mouth - feeling cold in hands and feet - feeling hot - headache - nasal congestion - swelling of the eyelid - urticaria - dizziness
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - akne - suha usta - hladen občutek rok in nog - občutek vročine - glavobol
Uncommon Acne, allergic contact dermatitis, contact dermatitis, dermatitis, dry skin, pain of skin, skin discomfort, rash papular, skin irritation, skin warm, swelling face*, urticaria*
Bolezni kože in podkožja pogosti eritem, pruritus, rozacea, skeleč občutek na koži občasni akne, alergijski kontaktni dermatitis, kontaktni dermatitis, dermatitis, suha koža, boleča koža, nelagodje na koži, papulozni izpuščaj, draženje kože, topla koža, otekanje obraza*, utrikarija*
The effect of Mirvaso topical gel begins to diminish hours after application.
Učinek zdravila Mirvaso začne pojenjati nekaj ur po nanosu.
Vehicle Gel n=128
Gel z vehiklom n = 128
Tube of 10 g and 30g
10 g; 30 g tuba
If you experience worsening of redness or burning you should stop using Mirvaso and contact your doctor if needed.
V primeru poslabšanja pordelosti ali pekočega občutka na koži, prekinite zdravljenje z zdravilom Mirvaso in se po potrebi posvetujte z zdravnikom.
Symptomatic measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms.
K olajšanju simptomov lahko pripomore simptomatično zdravljenje, kot je hlajenje, nesteroidina protivnetna zdravila in antihistaminiki.
STATEMENT OF ACTIVE SUBSTANCE(S) One gram of gel contains 3.3 mg of brimonidine.
NAVEDBA ENE ALI VEČ UČINKOVIN En gram gela vsebuje 3,3 mg brimonidina.
Polypropylene (PP) / Thermoplastic Polyolefin (TPO) / high density polyethylene (HDPE) and polypropylene (PP) child resistant closure.
Polipropilen (PP)/termoplastični poliolefin (TPO)/polietilen visoke gostote (HDPE) in za otroke varna zaporka iz polipropilena (PP).
NAME OF THE MEDICINAL PRODUCT Mirvaso 3 mg/g gel
IME ZDRAVILA Mirvaso 3 mg/g gel
clonidine; so-called alpha blockers or alpha antagonists, e.g. prazosin, isoprenaline which are most often used for treatment of high blood pressure, slow heart rate or asthma).
klonidin, tako imenovani zaviralci alfa, npr. prazosin, izoprenalin, ki se najpogosteje uporabljajo za zdravljenje visokega krvnega tlaka, počasnega srčnega utripa ali astme); - srčne glikozide (npr. digoksin), ki se uporabljajo za zdravljenje težav s srcem; - zdravila za nižanje krvnega tlaka, kot npr. zaviralci beta ali zaviralci kalcijevih kanalčkov (npr.
For the population subset of patients with severe erythema at baseline
Za podskupino populacije bolnikov s hudim eritemom ob izhodišču - na 1. dan (t.j.
Common side effects (may affect up to 1 in 10 people): - flushing - excessive whitening (pallor) where the gel is applied - skin redness, burning feeling of the skin or itching
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - vročinski oblivi - prekomerno bledenje (bledica) na mestu nanosa gela - rdečina kože, občutek skelenja na koži ali srbenje
Pump of 30 g
30 g črpalka
Vehicle Gel n=142
Gel z vehiklom n = 142
White to light yellow opaque aqueous gel.
gel Bel do rumenkast neprosojen vodni gel.
Generally, it resolves spontaneously after treatment is stopped.
Pordelost na splošno izzveni sama od sebe po prekinitvi uporabe zdravila Mirvaso.
You should wash your hands immediately after applying this medicine.
Po nanosu zdravila si morate nemudoma umiti roke.
Cutaneous use only.
Samo za dermalno uporabo.
Frequency Adverse reactions
Pogostnost Neželeni učinki
- The other ingredients are carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water.
- Druge sestavine zdravila so karbomer, metilparahidroksibenzoat (E218), fenoksietanol, glicerol, titanov dioksid, propilenglikol (E1520), natrijev hidroksid, prečiščena voda.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora občasni kongestija nosne sluznice
How to open the pump with a child-resistant cap Push down on the cap and turn counterclockwise (turn to the left) until the cap can be removed.
Zaporko potiskajte navzdol in jo obračajte v nasprotni smeri urinega kazalca (obrnite v levo), dokler zaporke ne morete sneti.
Tube of 2g
2 g TUBA
Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure.
Tube z večplastno folijo iz polietilena (PE)/kopolimera/aluminija (Al)/kopolimera/polietilena (PE) z glavo iz polietilena visoke gostote (HDPE) in za otroke varno zaporko iz polipropilena (PP).
Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol, sodium hydroxide, purified water.
Pomožne snovi: karbomer, metilparahidroksibenzoat (E218), fenoksietanol, glicerol, titanov dioksid, propilenglikol, natrijev hidroksid, prečiščena voda.
Worsening of skin redness, flushing or burning feeling of the skin Up to 1 in 6 patients experience the return of their redness worse than it was initially.
Pri do 1 od 6 bolnikov se pordelost ponovi v hujši obliki kot pred zdravljenjem.
3 hours after application 22.8% 6 hours after application 26.6% 9 hours after application 20.3% 12 hours after application 21.5% Day 29 p-value
3 ure po nanosu 6 ur po nanosu 9 ur po nanosu 12 ur po nanosu p-vrednost na 29. dan
What Mirvaso looks like and contents of the pack Mirvaso is a white to light yellow, opaque gel.
Zdravilo Mirvaso je bel do rumenkast, neprosojen gel.
Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water.
Pomožne snovi: karbomer, metilparahidroksibenzoat (E218), fenoksietanol, glicerol, titanov dioksid, propilenglikol (E1520), natrijev hidroksid, prečiščena voda.
Cardiac disorders
Srčne bolezni redki bradikardija*
To apply Mirvaso gel to your face, dispense a pea-sized amount of Mirvaso from the pump onto your fingertip.
Zdravilo Mirvaso gel si nanesite na obraz tako, da si iz črpalke na konico prsta iztisnete za grahovo zrno gela.
Uncommon Feeling hot, peripheral coldness
Splošne težave in spremembe na mestu aplikacije občasni občutek toplote, hladne okončine
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Laboratoires Galderma
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
This is because its effects on your unborn baby are unknown.
Zdravila Mirvaso ne uporabljajte med nosečnostjo, saj njegovi učinki na nerojenega otroka niso znani.
Not applicable.
Ne zaužijte.
Keep Mirvaso gel away from children.
Zdravilo Mirvaso gel shranjujte nedosegljivo otrokom.
Galderma Laboratorium GmbH
Izdelovalec Laboratoires Galderma Z.I.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10 G TUBE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Mirvaso 3 mg/g gel brimonidine
IME ZDRAVILA IN POT(I) UPORABE Mirvaso 3 mg/g gel brimonidin dermalna uporab
NAME OF THE MEDICINAL PRODUCT Mirvaso 3 mg/g gel brimonidine
IME ZDRAVILA Mirvaso 3 mg/g gel brimonidin
How to store Mirvaso
Shranjevanje zdravila Mirvaso
Erythema and flushing
Okvara jeter in ledvic
Propylene glycol (E1520) Sodium hydroxide Purified water
6.1 Seznam pomožnih snovi karbomer metilparahidroksibenzoat (E218) fenoksietanol glicerol titanov dioksid propilenglikol (E1520) natrijev hidroksid prečiščena voda
Erythema, pruritus, rosacea, skin burning sensation
Poslabšanja pordelosti, vročinskih oblivov ali pekočega občutka na koži:
Mirvaso Gel n=79
Študija 1 + študija 2 Zdravilo Mirvaso gel n=79 Gel z vehiklom n=63
Skin and subcutaneous tissue disorders
Eritem in vročinski oblivi
Package leaflet: Information for the patient
Shranjevanje zdravila Mirvaso Vsebina pakiranja in dodatne informacije
New topic coordinators were requested.
Zahtevani so bili novi tematski koordinatorji.
European and international collaboration on these issues is important in order to achieve a positive outcome on this topic.
Evropsko in mednarodno sodelovanje pri teh vprašanjih je pomembno za dosego pozitivnega izida v zvezi s to temo.
In the current financial situation, the contribution is not likely to be increased.
V sedanjih finančnih razmerah se ta prispevek verjetno ne bo zvišal.
Alternates (and other participants)
Namestniki (in drugi udeleženci)
• Revised draft agenda version 3.0.
• Revidirani osnutek dnevnega reda, različica 3.0.
• Communication about the network during international meetings, emphasising the complementarity of the EU system.
• obveščanje o mreži na mednarodnih srečanjih, s poudarkom na komplementarnosti sistema EU.
Substances of human origin (SoHO)
Snovi človeškega izvora (SoHO)
Not represented
Niso bili zastopani
Members expressed regret and dissatisfaction regarding the delay in the nomination process.
Člani so izrazili obžalovanje in nezadovoljstvo glede zamude v postopku imenovanja.
9 February 2012
9. februarja 2012
Project 2014 - move to new premises
Projekt za leto 2014 - selitev v nove prostore
It was recognised that a further debate with the European Commission and within the network should continue.
Ugotovljeno je bilo, da je treba nadaljevati nadaljnjo razpravo z Evropsko komisijo in znotraj mreže.
Members underlined that transparency is of significant importance in this area.
Člani so poudarili, da je preglednost bistvenega pomena na tem področju.
The reduction is largely due to a lower than requested EU contribution.
To znižanje je v glavnem posledica nižjega prispevka EU, kot je bil zahtevan.
Overall, the budget is €15.9 million lower than the preliminary draft budget adopted in March 2011.
Na splošno je proračun za 15,9 milijona EUR manjši od predhodnega predloga proračuna, sprejetega marca 2011.
The implementation of a number of activities will continue in 2013 and subsequent periods, depending on the availability of further funds.
Izvajanje številnih dejavnosti se bo nadaljevalo v letu 2013 in naslednjih obdobjih, odvisno od razpoložljivosti dodatnih sredstev.
The European Commission has decided to take over the responsibilities for SoHO activities.
Evropska komisija se je odločila, da bo prevzela odgovornosti za dejavnosti v zvezi s snovmi SoHO.
The document had been redacted and published on the Agency's website.
Dokument je bil anonimiziran in objavljen na spletni strani agencije.
The Board decided to vote on whether to adopt the policy as proposed.
Upravni odbor se je odločil, da bo glasoval, ali naj sprejme politiko, kot je predlagana.
They were also content with the fact that the meeting budget remains stable even though a new committee will be established in the middle of 2012.
Poleg tega so izrazili zadovoljstvo z dejstvom, da proračun za seje ostaja stabilen, čeprav bo sredi leta 2012 ustanovljen nov odbor.
This item (for information) was deferred to the next meeting.
Ta točka (v vednost) je bila preložena na naslednjo sejo.
The amendments clarify voting arrangements in cases where there is no clear consensus on a topic put forward for adoption.
V spremembah je pojasnjena ureditev glasovanja v primerih, v katerih ni jasnega soglasja o temi, predloženi v sprejetje.
The report confirmed that the response time from rapporteurs on communicated signals shortened compared to the same period in 2010.
V poročilu je bilo potrjeno, da se je odzivni čas poročevalcev v zvezi s sporočenimi znaki skrajšal v primerjavi z enakim obdobjem v letu 2010.
The Agency signed a lease agreement for new premises in October 2011.
Agencija je oktobra 2011 podpisala najemno pogodbo za nove prostore.
Other important areas of activity will include further strengthening the quality of the Agency's scientific work.
Druga pomembna področja dejavnosti bodo vključevala nadaljnjo krepitev kakovosti znanstvenega dela agencije.
Similar issues could also happen in the area of veterinary medicines, and this could have important consequences (human health, animal health or economical concerns).
Podobne težave bi lahko nastale tudi na področju zdravil za uporabo v veterinarski medicini, kar bi lahko imelo resne posledice (za zdravje ljudi, zdravje živali ali negativne ekonomske posledice).
Most of the preparatory stages of the commitment procedures relating to the two projects have been completed.
Dokončana je bila večina pripravljalnih faz postopkov prevzema obveznosti v zvezi s tema dvema projektoma.
There are many underlying drivers creating the problem, and many of those are not linked to globalisation.
To težavo povzročajo številni osnovni dejavniki, pri čemer številni od njih niso povezani z globalizacijo.
• Minutes from the 1st meeting of the working group on substances of human origin.
• Zapisnik 1. seje delovne skupine o snoveh človeškega izvora.
It is equally important to acknowledge that the organisation and management of such issues varies in different Member States due to diverse healthcare settings and alternatives that are available.
Enako pomembno je tudi priznati, da se organizacija in obvladovanje takšnih vprašanj razlikuje po državah članicah zaradi različnih sistemov zdravstvenega varstva in drugih razpoložljivih možnosti.
These TA posts will be financed bythe Agency's own resources (not from the EU contribution).
Ta delovna mesta začasnih uslužbencev bodo financirana iz lastnih sredstev agencije (in ne iz prispevka EU).
Work is ongoing on improving procurement procedures.
Trenutno potekajo dejavnosti za izboljšanje postopkov javnih naročil.
Members raised a number of considerations in this respect.
Člani so v zvezi s tem izrazili več pomislekov.
Report on the Agency's procurement procedure and a proposed improvement action plan
Poročilo o postopku javnih naročil agencije in predlagan akcijski načrt za izboljšave
The document was not adopted in its current form, and a revised policy will be submitted at the March 2012 meeting.
Dokument ni bil sprejet v sedanji obliki, revidirana politika pa bo predložena na seji marca 2012.
As an example, the Agency's staff do not attend events organised by the industry.
Osebje agencije se na primer ne udeležuje dogodkov, ki jih organizira industrija.
However, the Board wishes to return to this question by the end of 2012.
Upravni odbor želi to vprašanje ponovno obravnavati do konca leta 2012.
Medicines Agency and the European Centre for Disease Prevention and Control, during which it was not possible to reach an agreement on how to distribute the responsibilities between the two agencies.
Evropskim centrom za preprečevanje in obvladovanje bolezni (ECDC), v okviru katerih ni bilo mogoče doseči sporazuma, kako porazdeliti odgovornosti med zadevni dve agenciji.
The outcome of the vote was as follows: 22 members in favour; 7 against; 2 abstained; 4 members sent their apologies for the meeting (votes by delegation and proxies can be found in the Annex).
Rezultat glasovanja je bil: 22 članov za; 7 proti; 2 vzdržana; 4 člani so poslali opravičilo za neudeležbo na seji (podatki o glasovanju po zastopnikih in pooblaščencih so na voljo v Prilogi).
Members also stressed that the austerity environment should be seen as an opportunity for the whole network to rationalise the way it operates.
Člani so tudi poudarili, da je treba obdobje varčevalnih ukrepov šteti za priložnost za vso mrežo, da racionalizira način delovanja.
Additional confidentiality arrangements would help to go further in this domain.
Dodatna ureditev o zaupnosti bi prispevala k doseganju večjega napredka na tem področju.
Discharge for the 2009 budget
Razrešnica za proračun za leto 2009
The Agency carries out the validation of signals and informs rapporteurs.
Agencija opravlja potrjevanje znakov in obvešča poročevalce.
The Board noted that the surplus from 2010 was included in the budget.
Upravni odbor je ugotovil, da je bil presežek iz leta 2010 vključen v proračun.
The Board requires 24 votes in favour to adopt a decision.
Upravni odbor za sprejetje odločitve potrebuje 24 glasov za.
Work on cooperation and capacity-building with the Agency's international partners is ongoing.
Trenutno potekajo dejavnosti v zvezi s sodelovanjem in razvojem zmogljivosti z mednarodnimi partnerji agencije.
Significant improvements have been made in the area of management of potential conflicts of interests of experts and staff members.
Pomembne izboljšave so bile uvedene na področju obvladovanja morebitnih navzkrižij interesov strokovnjakov in članov osebja.
Topic coordinators were satisfied with the way the Agency is preparing for the Olympic period, both from the organisational and budget perspective.
Tematski koordinatorji so bili zadovoljni z načinom, kako se agencija pripravlja na obdobje olimpijskih iger z organizacijskega in proračunskega vidika.
Members were concerned that this is a new initiative for the regulatory system and therefore requires thorough preparation in order to meet the significant expectations of stakeholders.
Izrazili so zaskrbljenost, da je to nova pobuda za regulativni sistem, zato so potrebne temeljite priprave, da se izpolnijo velika pričakovanja zainteresiranih strani.
Members were also informed that a study to assess the governance of the telematics programme is ongoing.
Člani so bili tudi obveščeni, da se izvaja študija za oceno vodenja telematskega programa.
Early in 2012, information on activities to be taken forward in 2012 will be provided through the Agency's website and a new workshop for industry will be organised.
Na začetku leta 2012 bodo na spletni strani agencije objavljene informacije o dejavnostih, ki se bodo nadaljevale v letu 2012, organizirana pa bo tudi nova delavnica za industrijo.
If only one audit engagement can take place in 2012, the Management Board expressed a preference for the audit on planning and budgeting.
Če bo v letu 2012 mogoče opraviti le eno revizijo, upravni odbor daje prednost reviziji načrtovanja in oblikovanja proračuna.
No additional conflicts of interests were declared.
Nihče ni navedel, da obstaja dodatno navzkrižje interesov.
But it was felt that the Agency is not in a position to impose further restrictions on the network, with a condition that any such participation can entail no more than a compensation of reasonable expenses.
Vendar so menili, da agencija mreži ne more naložiti dodatnih omejitev s pogojem, da katera koli takšna udeležba ne sme vključevati ničesar razen nadomestila za razumne izdatke.
The carry-over will concern funding of the relocation project, and the implementation of the next phase of the human resource database.
Prenos se bo nanašal na financiranje projekta premestitve in izvajanje naslednje faze podatkovne zbirke o človeških virih.
The Agency will not be able to pay rapporteurs until pharmacovigilance fees are introduced with the amendment of the Fee Regulation.
Agencija ne bo mogla plačati poročevalcev, dokler ne bodo s spremembo uredbe o pristojbinah uvedene pristojbine za farmakovigilanco.
Meeting with Commissioner John Dalli and Director-General Paola Testori
Srečanje s komisarjem Johnom Dallijem in generalno direktorico Paolo Testori
The European Commission provided an update on a number of items, including the following:
Evropska komisija je predstavila najnovejše informacije o več temah, vključno z naslednjim:
Results of the study are expected in March 2012.
Rezultati študije bodo predvidoma na voljo marca 2012.
The Agency forecasts that the numbers of applications within most of its activity areas will remain largely similar to those of the previous year.
Agencija predvideva, da bo število vlog na večini področij dejavnosti v glavnem ostalo podobno številu iz lanskega leta.
Members also asked to revise the wording of Article 2 (5) of the rules of procedure to clarify that civil society representatives can be elected as chair.
Člani so poleg tega pozvali k spremembi besedila člena 2(5) poslovnika za pojasnitev, da je predstavnik civilne družbe lahko izvoljen za predsednika odbora.
b.) Implementation of the Pharmacovigilance legislation
b) Izvajanje zakonodaje o farmakovigilanci
Declaration of conflicts of interest related to current agenda
Izjava o navzkrižju interesov v zvezi s sedanjim dnevnim redom
As more systems go into production, the fixed ICT costs will continue to increase.
Ker bo začelo delovati še več sistemov, se bodo fiksni stroški za IKT še naprej višali.
Financial compensation for Member States' participation in the linguistic checking of product related information: Fixed flat hourly cost for 2012
Finančno nadomestilo za sodelovanje držav članic pri jezikovnem preverjanju informacij o zdravilih: fiksna pavšalna urna postavka za leto 2012
The Management Board also adopted a revision of the grading of the 23 posts in accordance with Article 32 of the Agency's Financial Regulation.
Upravni odbor je sprejel tudi spremembo razvrstitve 23 delovnih mest v skladu s členom 32 finančne uredbe agencije.
A number of projects are under way that will see streamlining of certain procedures and the introduction of more quantifiable elements in the assessment process.
Izvaja se več projektov, ki bodo racionalizirali nekatere postopke in uvedli bolj količinsko opredeljive elemente v postopku ocenjevanja.
However, it was explained that the definitions in this policy mirror those adopted for the policy on conflicts of interests of experts, and it would be appropriate to keep both policies in line.
Vendar je bilo pojasnjeno, da opredelitve iz te politike izražajo opredelitve, sprejete za politiko o navzkrižjih interesov strokovnjakov, in da bi bilo ustrezno ohraniti skladnost obeh politik.
However, the overall staffing of the Agency will remain at the previous year's level since the Agency will reduce the number of contract agents and seconded national experts by 23 full-time equivalents.
Vendar bo skupno število zaposlenih agencije ostalo na lanskoletni ravni, saj bo agencija zmanjšala število pogodbenih uslužbencev in napotenih nacionalnih strokovnjakov za 23 ekvivalentov polnega delovnega časa.
The ICT budget continues to show an increase in expenditure, which results in the decrease in the project development budget.
V zvezi s proračunom za IKT se še naprej višajo izdatki, kar povzroča zmanjševanje proračuna za razvoj projektov.
The Board welcomed the framework that aims to strengthen the already existing cooperation with HCPs and to fill remaining gaps.
Pozdravil je okvir, katerega cilj je okrepiti že obstoječe sodelovanje z zdravstvenimi delavci in zapolniti preostale vrzeli.
This aspect will be addressed in the ongoing discussion about the review of the Clinical Trials Directive.
Ta vidik bo obravnavan v tekoči razpravi o pregledu direktive o kliničnih preskušanjih.
The Board asked to include aspects of today's discussion in the report in order to clarify relevant issues.
Upravni odbor je zahteval, da se v poročilo vključijo vidiki današnje razprave za pojasnitev ustreznih vprašanj.