natgillin/translations-raw huggingface dataset:
• successful implementation of new legislation, with the pharmacovigilance legislation being most relevant for 2011;
• uspešnemu izvajanju nove zakonodaje, pri čemer je v letu 2011 najpomembnejša zakonodaja na področju farmakovigilance;
The Agency will also be affected in the longer term by the ongoing debate within the institutions of the European Union (EU) about the falsified medicines legislation.
Na agencijo bo dolgoročno vplivala tudi razprava, ki trenutno poteka v institucijah Evropske unije (EU) o zakonodaji na področju ponarejenih zdravil.
The transitional period for submission of gene- and cell-therapy medicinal products subject to the legislation on advanced therapy medicinal products will also expire.
Prav tako se bo izteklo prehodno obdobje za predložitev zdravil za gensko in celično zdravljenje, za katera velja zakonodaja o zdravilih za napredno zdravljenje.
In this context, the Agency will continue in 2011 to focus effort in the field of reducing the risk of antimicrobial resistance arising as a result of the use of antibiotics in man and animals.
V zvezi s tem si bo v letu 2011 še naprej prizadevala za zmanjševanje tveganja za pojav protimikrobne odpornosti kot posledice uporabe antibiotikov pri ljudeh in živalih.
In addition to the Agency's strong bilateral cooperation with a number of international regulatory authorities, the Agency is particularly involved in the areas of clinical trials, manufacturing of active pharmaceutical ingredients and medicinal products, and ongoing regulatory collaboration with its international partners.
Poleg tesnega dvostranskega sodelovanja agencije s številnimi mednarodnimi regulativnimi organi je agencija še posebej dejavna na področju kliničnih preskušanj, proizvodnje farmacevtskih zdravilnih učinkovin in zdravil ter stalnega regulativnega sodelovanja z mednarodnimi partnerji.
Initiatives will continue to be implemented in the context of the European Risk Management Strategy, with emphasis on the operation of the EU regulatory system, improving signal detection and data analysis.
Tudi v prihodnje se bodo izvajale pobude na področju Evropske strategije za obvladovanje tveganja, s posebnim poudarkom na delovanju regulativnega sistema EU, izboljšanju odkrivanja signalov in analizi podatkov.
In light of the approaching end of the transitional period for registration of traditional herbal medicinal products, the Agency will address, depending on available resources, specific challenges in the field, such as the need to improve the output of the Committee on Herbal Medicinal Products in terms of monographs and list entries, and to respond to any actions arising from the end of the transition period by which Member States shall apply the provisions of Directive 2004/24/EC.
Ker se približujemo koncu prehodnega obdobja za registracijo tradicionalnih zdravil rastlinskega izvora, bo agencija glede na razpoložljive vire obravnavala posebne izzive na tem področju, kot je potreba po izboljševanju rezultatov Odbora za zdravila rastlinskega izvora v zvezi z monografijami in vnosi na seznam, ter se odzivala na ukrepe, ki jih bodo države članice po koncu prehodnega obdobja sprejele za izvajanje določil Direktive 2004/24/ES.
In this context, the Agency will continue to support various initiatives undertaken by the Heads of Medicines Agencies aimed at strengthening the existing cooperation and ensuring the continuous availability of top-quality scientific expertise, which is of paramount importance to the success of this and future work programmes.
V zvezi s tem bo podpirala različne pobude vodij agencij za zdravila s ciljem okrepiti obstoječe sodelovanje in zagotavljati nenehno razpoložljivost vrhunskega znanstvenega strokovnega znanja, ki je ključnega pomena za uspešno izvajanje tega delovnega programa in prihodnjih.
In the field of public health, we will continue to strengthen the Agency's input into European activities regarding medicinal products for use in the elderly population.
Na področju javnega zdravja bomo nadaljevali s krepitvijo delovanja agencije pri evropskih dejavnostih v zvezi z zdravili za uporabo pri starejšem prebivalstvu.
The Agency will pursue initiatives in the framework of a proactive conduct of pharmacovigilance by supporting the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) as a functional network of centres for the monitoring of targeted authorised medicines.
Agencija si bo prizadevala za pobude v okviru proaktivnega izvajanja farmakovigilance s podporo Evropski mreži centrov za farmakoepidemiologijo in farmakovigilanco kot funkcionalni mreži centrov za spremljanje ciljnih odobrenih zdravil.
Covering medicines for both man and animals, the Agency is particularly well placed to implement in practice the concept of 'One World, One Health', whereby promoting health in animals promotes health in man.
Ker delovanje agencije zajema zdravila za ljudi in živali, ima posebno dobro priložnost, da v praksi izvaja koncept „En svet, eno zdravje“ in s spodbujanjem zdravja živali krepi zdravje ljudi.
The Agency addresses those expectations in its road map and is planning initiatives in this field, while ensuring that cost/benefit assessment remains separate from the licensing process.
Agencija je ta pričakovanja vključila tudi v časovni načrt in na tem področju načrtuje pobude, pri čemer želi zagotoviti, da ocenjevanje razmerja med stroški in koristmi ostane ločeno od postopka odobritve zdravil.
• communicating and engaging with stakeholders, empowering patients and enabling their participation in healthcare decisions, as well as increasing transparency of the Agency's activities;
• komuniciranju in sodelovanju z zainteresiranimi stranmi, pooblaščanju bolnikov, omogočanju, da bolniki sodelujejo pri odločanju na področju zdravstvene nege, ter povečevanju preglednosti dejavnosti agencije;
Engagement with the scientific community and academia will increase as part of this and other activities.
V okviru te dejavnosti in drugih se bo povečalo tudi sodelovanje z znanstveno skupnostjo in akademiki.
In the field of animal health, attention will remain focused on maintaining and improving the availability of veterinary medicines, particularly for minor species/minor uses (MUMS)/limited markets, and we will continue our contribution to the Community Animal Health Strategy where this relates to the use of medicines.
Na področju zdravja živali bo tudi v prihodnje velik poudarek namenjen ohranjanju in izboljševanju razpoložljivosti veterinarskih zdravil, zlasti za manj pomembne vrste/manjšo uporabo/omejena tržišča ter nadaljevali s prispevanjem k strategiji Skupnosti na področju zdravja živali v zvezi z uporabo zdravil.
• contributing to international activities and responding to globalisation of pharmaceutical research,
• prispevanju k mednarodnim dejavnostim in odzivanju na globalizacijo raziskovanja, razvoja in proizvodnje na področju farmacije;
Agendas and minutes of scientific-committee and working-party meetings will be published, and work will be progressed to provide interested parties with access to certain information contained in clinical-trials and EudraVigilance databases.
Objavljene bodo točke dnevnega reda in zapisniki sej znanstvenih odborov in delovnih skupin, nadaljevalo pa se bo tudi delo na področju zagotavljanja dostopa zainteresiranim stranem do določenih informacij iz podatkovnih zbirk kliničnih preskušanj in podatkovne zbirke EudraVigilance.
Globalisation of pharmaceutical research, development and manufacturing is a predominant theme.
Prevladujoča tema je globalizacija raziskovanja, razvoja in proizvodnje na področju farmacije.
As recognised in the road map, EU initiatives in the field of relative effectiveness of pharmaceuticals will also impact on the Agency.
Kot je bilo navedeno v časovnem načrtu, bodo na agencijo vplivale tudi pobude EU na področju sorazmerne učinkovitosti farmacevtskih izdelkov.
Work programme 2011
Delovni program Evropske agencije za zdravila za leto
Other initiatives outlined in the road map will be planned.
Oblikovani bodo tudi načrti za druge pobude, navedene v časovnem načrtu.
Engagement of the Agency's stakeholders, patient empowerment and participation in healthcare decisions is one of the themes and objectives of the road map.
Sodelovanje agencije z zainteresiranimi stranmi, pooblaščanje bolnikov in sodelovanje pri odločanju na področju zdravstvene oskrbe je le nekaj izmed področij in ciljev časovnega načrta.
We will work to extend international partnerships in the areas of goodmanufacturing-practice (GMP) and good-clinical-practice (GCP) inspections, will extend initiatives with the US Food and Drug Administration (FDA) on GCP and on GMP inspections of finished products, and will extend the active pharmaceutical ingredient inspection programme.
Delovali bomo v smeri razširjanja mednarodnih partnerstev na področju pregledov dobre proizvodne prakse in dobre klinične prakse, nadgradili bomo pobude v sodelovanju z Uradom za živila in zdravila v Združenih državah Amerike (FDA) v zvezi s pregledi dobre proizvodne in klinične prakse končnih zdravil ter razširili program pregledov za farmacevtske zdravilne učinkovine.
The Agency will continue building on its past work and achievements in the area, and will widen the scope of interaction with civil-society representatives through the implementation of a revised framework of interaction with patients and a gradual implementation of the framework of interaction with healthcare professionals.
Agencija bo tudi v prihodnje nadgrajevala svoje preteklo delo in dosežke na tem področju, z izvajanjem revidiranega okvira medsebojnega sodelovanja z bolniki in s postopnim izvajanjem okvira medsebojnega sodelovanja s strokovnjaki na zdravstvenem področju pa bo razširila obseg sodelovanja s predstavniki civilne družbe.
The adoption of the new pharmacovigilance legislation will have a major impact on the Agency.
Na njeno delovanje bo velik vpliv imelo sprejetje nove zakonodaje na področju farmakovigilance.
In 2011, the Agency will focus on preparing for the application of the new measures in 2012 by preparing new procedures and planning important IT developments.
V letu 2011 bo agencija s pripravo novih postopkov in načrtovanjem pomembnega razvoja na področju informacijske tehnologije poseben poudarek namenila pripravi na uvajanje novih ukrepov v letu 2012.
The Agency will contribute as required to these developments.
Agencija bo ta postopek spremljala in prispevala k njegovemu razvoju.
The Agency will further increase transparency in the daily operation of its activities by implementing transparency measures in accordance with the implementation plan of its transparency policy.
Z izvajanjem ukrepov za večjo preglednost v skladu z načrtom izvajanja politike preglednosti bo agencija še naprej povečevala preglednost pri izvajanju vsakodnevnih dejavnosti.
We will contribute to the debate and will monitor possible impact on our activities.
Razprava o prihodnosti direktive o kliničnih preskušanjih se bo nadaljevala, v njej bomo sodelovali in spremljali možen vpliv direktive na naše dejavnosti.
Some development of the legislative proposal on information to patients may take place, and the Agency will follow and contribute to the progress.
Prav tako lahko pride tudi do oblikovanja zakonodajnega predloga o informacijah za bolnike.
Before opening: 30 months.
Pred odprtjem: 30 mesecev
Date of first authorisation: 07 October 2002 Date of latest renewal: 18 September 2007
Datum prve odobritve: 7. oktober 2002 Datum zadnjega podaljšanja: 18. september 2007
ATC code: A10AC01.
ATC oznaka: A10AC01.
Reactions usually resolve in a few days to a few weeks.
Reakcije ponavadi minejo v nekaj dneh do nekaj tednih.
Normally this soon disappears.
Običajno to kmalu mine.
This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
To je lahko nevarno v okoliščinah, v katerih sta ti zmožnosti posebej pomembni (npr. pri vožnji avta ali upravljanju strojev).
If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Če je potrebna prilagoditev, utegne biti potrebna že pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
These reactions are usually of a transitory nature.
Te reakcije so ponavadi prehodne.
The physician determines whether one or several daily injections are necessary.
Zdravnik se odloči, ali je potrebna ena ali več injekcij na dan.
Measure your blood sugar if possible and rest.
Izmerite si krvni sladkor, če je to mogoče, in počivajte.
You should always measure your blood sugar regularly.
Krvni sladkor si morate redno meriti.
Inject the mixture immediately.
Mešanico si takoj injicirajte.
Warning signs of high blood sugar:
Opozorilni znaki visokega krvnega sladkorja
If you do not respond to glucagon treatment, you will have to be treated in a hospital.
Če se ne odzovete na zdravljenje z glukagonom, bo potrebno zdravljenje v bolnišnici.
Elderly (≥ 65 years old)
Posebne skupine bolnikov Starejši (≥ 65 let)
Onset of action is within 1½ hours, reaches a maximum effect within 4-12 hours and the entire duration of action is approximately 24 hours.
Delovati začne v 1½ ure, največji učinek doseže v 4-12 urah, celotni čas delovanja pa je približno
Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Glukozo je treba aplicirati intravensko v primeru, da se bolnik v 10 do 15 minutah ne odzove na glukagon.
Some conditions and activities can affect your need for insulin.
Nekatera stanja in dejavnosti lahko vplivajo na potrebo po insulinu.
Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar.
Ustreznim osebam povejte, da imate sladkorno bolezen in kakšne so lahko posledice, vključno s tveganjem, da se zaradi nizkega krvnega sladkorja onesvestite (izgubite zavest).
Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days.
Prvi simptomi hiperglikemije se ponavadi razvijejo postopoma, v nekaj urah ali dneh.
It is therefore recommended that the diabetic patient always carries sugar-containing products.
Zato je priporočljivo, da bolniki s sladkorno boleznijo vedno nosijo pri sebi živila, ki vsebuje sladkor.
► These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
► To so lahko znaki zelo resnega stanja, ki ga imenujemo diabetična ketoacidoza (kopičenje kisline v krvi, ker telo za pridobivanje energije razgrajuje maščobe namesto sladkorja).
Otherwise the liquid may leak out, which can cause inaccurate dosing.
V nasprotnem primeru lahko tekočina izteka, to pa lahko povzroči netočno odmerjanje.
Protaphane dosing is individual and determined in accordance with the needs of the patient.
Odmerjanje zdravila Protaphane je individualno in določeno skladno z bolnikovimi potrebami.
Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
Natančna urejenost sladkorne bolezni, zlasti preprečevanje hipoglikemij, je pomembna za zdravje vašega otroka.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters.
Potreba po insulinu se v prvem trimesečju ponavadi zmanjša, potem pa se v drugem in tretjem trimesečju zveča.
The pharmacokinetics of insulin medicinal products are therefore affected by significant intra- and inter-individual variation.
Na farmakokinetiko insulinskih zdravil torej vplivajo pomembne intra- in interindividualne razlike.
• Repeatedly inject less insulin than you need.
• si večkrat zapored injicirate manj insulina, kot ga potrebujete,
If you have to mix two types of insulin
Če morate mešati dve vrsti insulina
• Drink alcohol, see Protaphane with alcohol in section 2.
• pijete alkohol, glejte podpoglavje Zdravilo Protaphane skupaj z alkoholom v poglavju 2.
• Anabolic steroids (such as testosterone)
• anabolne steroide (na primer testosteron),
The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
Absorpcija Največja koncentracija insulina v plazmi je dosežena v 2 do 18 urah po subkutani aplikaciji.
These usually disappear after a few weeks of taking your insulin.
Ponavadi minejo po nekaj tednih uporabe insulina.
A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed; none of the metabolites formed following the cleavage are active.
Predlagana so številna mesta razcepa (hidrolize) na molekuli humanega insulina; nobeden od presnovkov, nastalih po razcepu, pa ni aktiven.
Listed below are the most common medicines which may affect your insulin treatment.
Spodaj so našteta najpogostejša zdravila, ki lahko vplivajo na zdravljenje z insulinom.
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it.
Iz nezavesti si boste opomogli prej, če dobite injekcijo hormona glukagona od osebe, ki ga zna ustrezno uporabljati.
Insulin in the blood stream has a half-life of a few minutes.
Insulin ima v krvnem obtoku razpolovni čas nekaj minut.
Inject the air into the vial.
Injicirajte zrak v vialo.
You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).
Insulina si nikoli ne smete injicirati neposredno v veno (intravensko) ali mišico (intramuskularno).
This should be kept in mind if treatment with the combination of pioglitazone and Protaphane is considered.
To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila Protaphane.
If you do not treat it, this could lead to diabetic coma and eventually death.
Če se stanja ne zdravi, lahko povzroči diabetično komo in navsezadnje smrt.
Pull the needle out of the vial.
Potegnite iglo iz viale.
Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge.
Ne uporabite ga, če opazite kakršno koli poškodbo, ali če je gumijasti bat premaknjen nad belo črto na dnu vložka.
This may reduce the risk of developing lumps or skin pitting, see section 4.
To lahko zmanjša tveganje za nastanek zatrdlin ali ugreznjenosti kože (glejte poglavje 4).
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.
Zaviralci adrenergičnih receptorjev beta (uporabljajo se za zdravljenje visokega krvnega tlaka) lahko oslabijo ali popolnoma preprečijo prve opozorilne znake, ki vam pomagajo prepoznati nizek krvni sladkor.
• Eat too little or miss a meal.
• premalo jeste ali izpustite obrok,
In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals.
Pri intenzivnem insulinskem zdravljenju se suspenzija lahko uporablja kot bazalni insulin (injiciranje zvečer in/ali zjutraj) v kombinaciji s hitrodelujočimi insulini, ki se jih uporabi ob obrokih.
Name and address of the manufacturers of the biological active substance Novo Nordisk A/S
Ime in naslov izdelovalcev biološke učinkovine Novo Nordisk A/S
If they do not disappear, or if they spread throughout your body, talk to your doctor immediately.
Če ne minejo ali če se razširijo po telesu, se posvetujte z zdravnikom.
Protaphane will start to lower your blood sugar about 1½ hours after you inject it, and the effect will last for approximately 24 hours.
Zdravilo Protaphane začne krvni sladkor zniževati približno 1½ ure po injiciranju, njegov učinek pa traja približno 24 ur.
The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
Izdelovalca je mogoče ugotoviti po serijski številki, natisnjeni na etiketi škatle in na nalepki:
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dose.
Spremembe v jakosti, znamki (izdelovalec), vrsti, izvoru (živalski insulin, humani insulin ali analog insulina) in/ali načinu izdelave (rekombinantna DNA ali živalski vir insulina) imajo lahko za posledico potrebo po spremembi odmerka.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Prehod bolnika na drugo vrsto ali znamko insulina mora potekati pod strogim zdravniškim nadzorom.
This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
To je posebej pomembno pri bolnikih z zmanjšanim ali odsotnim zaznavanjem opozorilnih znakov hipoglikemije in pri tistih, ki imajo pogoste hipoglikemije.
Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.
Injiciranje v dvignjeno kožno gubo zmanjša tveganje za nenamerno intramuskularno injiciranje.
The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Trajanje delovanja je spremenljivo, odvisno od odmerka, mesta injiciranja, krvnega pretoka, temperature in stopnje telesne dejavnosti.
• Get an infection and/or a fever.
• se vam pojavi okužba in/ali zvišana telesna temperatura,
• Danazol (medicine acting on ovulation).
• danazol (zdravilo, ki deluje na ovulacijo).
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Oktreotid in lanreotid (uporabljata se za zdravljenje akromegalije, redke hormonske motnje, ki se ponavadi pojavi pri odraslih osebah srednjih let in je posledica čezmernega nastajanja rastnega hormona v žlezi hipofizi) lahko zvišata ali znižata krvni sladkor.
• Sulfonamides (used to treat infections).
• sulfonamide (uporabljajo se za zdravljenje okužb).
• Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
• Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti z glukagonom (0,5 do 1 mg), ki ga intramuskularno ali subkutano aplicira ustrezno poučena oseba, ali z glukozo, ki jo intravensko aplicira zdravstveni delavec.
The symptoms of hypoglycaemia usually occur suddenly.
Simptomi hipoglikemije se ponavadi razvijejo nenadoma.
Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics.
Zato časovni potek delovanja insulinskega zdravila določajo samo njegove absorpcijske lastnosti.
Protaphane is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).
Zdravilo Protaphane se uporablja za znižanje visokega krvnega sladkorja pri bolnikih s sladkorno boleznijo (diabetesom).
Animal reproduction studies with human insulin have not revealed any adverse effects on fertility.
Študije vpliva humanega insulina na sposobnost razmnoževanja pri živalih ne kažejo nobenih neželenih učinkov na plodnost.
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
Omejitev za zdravljenje sladkorne bolezni z insulinom med nosečnostjo ni, ker insulin ne prehaja placentne pregrade.
Insulin medicinal products should only be added to compounds with which it is known to be compatible.
Insulinska zdravila je dovoljeno dodajati le snovem, s katerimi so znano kompatibilna.