natgillin/translations-raw huggingface dataset:
Solution for injection (injection).
raztopina za injiciranje (injekcija) Bistra, brezbarvna raztopina.
EU/1/14/944/003 5 cartridges EU/1/14/944/009 10 cartridges
EU/1/14/944/008 5 peresnikov EU/1/14/944/013 5 peresnikov
EU/1/14/944/007 5 pens EU/1/14/944/012 5 pens
EU/1/14/944/007 5 peresnikov EU/1/14/944/012 5 peresnikov
• Hold your pen with the needle pointing up.
• Še naprej držite vaš injekcijski peresnik tako, da je igla obrnjena navzgor.
Dose Indicator
Držalo vložka Oznaka
After injection into the subcutaneous tissue, the acidic solution is neutralised leading to formation of microprecipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action.
Nastanejo mikroprecipitati, iz katerih se trajno sprošča majhna količina insulina glargin.
Troubleshooting
Odmerjanje
Package leaflet: Information for the user ABASAGLAR 100 units/mL solution for injection in a cartridge insulin glargine
Navodilo za uporabo ABASAGLAR 100 enot/ml raztopina za injiciranje v vložku insulin glargin
Not yet known1
Še ni znano1
Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Tel: +44 (0)20 7418 8427 E-pošta: press@ema.europa.eu
16 January 2014 EMA/35464/2014
16. januar 2014 EMA/35464/2014
Contact our press officers Monika Benstetter or Martin Harvey
Stopite v stik z našimi tiskovnimi predstavniki Monika Benstetter ali Martin Harvey
The review of combined hormonal contraceptives was initiated in February 2013 at the request of France, under Article 31 of Directive 2001/83/EC.
Pregled kombiniranih hormonskih kontraceptivov je bil sprožen februarja 2013 na zahtevo Francije v skladu s členom 31 Direktive 2001/83/ES.
• If you have any questions or concerns, speak with your doctor, pharmacist or nurse.
• Če imate kakršna koli vprašanja ali pomisleke, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The classification as ‘second, third or fourth generation' is however not science-based and not standardised, and may differ between institutions and publications.
Vendar pa opredelitev „druga, tretja ali četrta generacija“ ni znanstveno utemeljena in standardizirana, tako da se lahko med ustanovami in publikacijami razlikuje.
The CHMP opinion was forwarded to the European Commission, which issued a final decision on 16 January 2014.
Odbor CHMP je mnenje posredoval Evropski komisiji, ki je dne 16. januarja 2014 izdala končni sklep.
But it is important that you are aware of the risk of blood clots associated with these medicines, even though it is very low.
Pomembno pa je, da se zavedate tveganja za krvne strdke, povezanega s temi zdravili, čeprav je zelo majhno.
If you develop any of these signs and symptoms you should seek medical advice immediately.
Če opazite katerega koli od teh znakov in simptomov, se takoj posvetujte z zdravnikom.
The review has reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.
Pregled je potrdil, kako pomembno je, da se zagotovijo jasne in posodobljene informacije za ženske, ki uporabljajo ta zdravila, in zdravstvene delavce, ki jim svetujejo ter zagotavljajo klinično oskrbo.
• You should also be aware of the factors that increase your risk of a clot and be aware of how these may change over time.
• Prav tako morate poznati dejavnike, ki povečajo tveganje za strdke, in vedeti, da se ti sčasoma lahko spremenijo.
Risk of developing a blood clot (VTE) in a year Women not using a combined hormonal pill/patch/ring and are not pregnant
Tveganje za nastanek krvnega strdka (VTE) v enem letu Ženske, ki ne uporabljajo kombinirane hormonske tabletke/obliža/obročka in niso noseče
• Because a woman's individual risk factors will change over time, there is a need to regularly reassess the suitability of her contraceptive.
• Ker se individualni dejavniki tveganja pri ženski sčasoma spremenijo, je treba redno ocenjevati primernost predpisanega kontraceptiva.
It is important that women are made aware of the risk of VTE and its signs and symptoms, and that doctors take into consideration a woman's individual risk factors when prescribing a contraceptive.
Pomembno je, da so ženske seznanjene s tveganjem za VTE, njenimi znaki in simptomi, ter da zdravniki ob predpisovanju kontraceptivov upoštevajo individualne dejavnike tveganja pri vsaki ženski.
These are sometimes referred to as ‘third generation' or ‘fourth generation' contraceptives and are available as pills, skin patches and vaginal rings.
Tem kontraceptivom včasih pravimo „tretja generacija“ ali „četrta generacija“ kontraceptivov, na voljo pa so v obliki tabletk, kožnih obližev in vaginalnih obročkov.
• When taking CHCs, you should be alert for the signs and symptoms of blood clots, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and weakness or numbness of the face, arm or leg.
• Med jemanjem kombiniranih hormonskih kontraceptivov bodite pozorni na znake in simptome krvnih strdkov, ki lahko vključujejo hude bolečine v nogah ali otekanje nog, nenadno nepojasnjeno zasoplost, hitro dihanje ali kašelj, bolečine v prsnem košu in šibkost ali omrtvičenost obraza, roke ali noge.
Risk factors include being very overweight, increasing age, having a member of your family who has had a blood clot at a relatively young age (e.g. below 50), having migraine or being immobilised for a long time (e.g. because of an illness or injury).
Med dejavnike tveganja spadajo zelo povečana telesna masa, višja starost, dejstvo, da ima član vaše družine krvne strdke pri relativno nizki starosti (npr. pred 50. letom), migrene in daljša imobilizacija (npr. zaradi bolezni ali poškodbe).
1 Further studies are ongoing or planned to collect sufficient data to estimate the risk for these products.
1 Dodatne študije, v katerih bodo zbrali zadostne podatke za oceno tveganja pri teh zdravilih, že potekajo ali pa so predvidene.
This risk is very low and there is no evidence for a difference in the level of risk between products depending on the type of progestogen.
Tveganje je zelo majhno, poleg tega pa ni dokazov o tem, da bi se stopnja tveganja med zdravili razlikovala glede na vrsto progestogena.
With the exception of Zoely (nomegestrol acetate/estradiol), Ioa (nomegestrol acetate/estradiol) and Evra (norelgestromin/ethinylestradiol), which have been authorised centrally through the EMA, all other combined contraceptives in the EU have been authorised via national procedures.
Razen kontraceptivov Zoely (nomegestrolacetat/estradiol), Ioa (nomegestrolacetat/estradiol) in Evra (norelgestromin/etinilestradiol), ki so bili odobreni po centraliziranem postopku, ki ga vodi Evropska agencija za zdravila, so bili vsi drugi kombinirani kontraceptivi v EU odobreni po nacionalnih postopkih.
CHCs are contraindicated if a woman has one serious or multiple risk factors that put her at high risk of blood clots.
Kombinirani hormonski kontraceptivi so kontraindicirani, če ima ženska enega resnega ali več dejavnikov tveganja, zaradi katerih pri njej obstaja veliko tveganje za krvne strdke.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je zaključil, da so koristi kombiniranih hormonskih kontraceptivov pri preprečevanju neželenih nosečnosti še vedno večje od z njimi povezanih tveganj in da je dobro znano tveganje za VTE pri vseh teh kontraceptivih majhno.
A review of the data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Pregled podatkov je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), torej odbor, odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, ki je podal več priporočil.
The review also looked at the risk of arterial thromboembolism (ATE, blood clots in arteries, which can potentially cause a stroke or heart attack).
Med pregledom so proučili tudi tveganje za arterijsko tromboembolijo (ATE, tj. nastajanje krvnih strdkov v arterijah, ki lahko povzročijo možgansko ali srčno kap).
• If you have been taking CHCs without any problem, there is no reason for you to stop taking them on the basis of this review.
• Če med jemanjem kombiniranih hormonskih kontraceptivov niste imeli težav, ni nobenega razloga, da bi jih zaradi tega pregleda nehali jemati.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Priporočila je posredoval Odboru za zdravila za uporabo v humani medicini (CHMP), pristojnemu za vsa vprašanja, povezana z zdravili za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
The CHMP opinion, in agreement with the previous recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), was sent to the European Commission, which adopted on 16 January 2014 a legally binding decision to update the product information of all CHCs throughout the EU.
Mnenje odbora CHMP, ki se je ujemalo s predhodnim priporočilom Odbora za oceno tveganja na področju farmakovigilance (PRAC), je bilo posredovano Evropski komisiji, ki je dne 16. januarja 2014 sprejela pravno zavezujoči sklep, v skladu s katerim je treba posodobiti informacije o zdravilu za vse kombinirane hormonske kontraceptive po vsej EU.
The review included all contraceptives containing low-dose oestrogen and the following progestogens: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin and norgestimate.
V pregled so bili vključeni vsi kontraceptivi, ki vsebujejo nizkoodmerni estrogen in naslednje progestogene: klormadinon, dezogestrel, dienogest, drospirenon, etonogestrel, gestoden, nomegestrol, norelgestromin in norgestimat.
On 21 November 2013, the European Medicines Agency completed its review of combined hormonal contraceptives (CHCs), particularly of the risk of venous thromboembolism (VTE or blood clots in veins) associated with their use.
Evropska agencija za zdravila je dne 21. novembra 2013 zaključila pregled kombiniranih hormonskih kontraceptivov, zlasti tveganja za vensko trombembolijo (VTE, tj. nastajanja krvnih strdkov v venah), povezanega z njihovo uporabo.
• This Europe-wide review looked at the benefits and risks of combined hormonal contraceptives (CHCs), particularly the risk of blood clots associated with these medicines.
• V tem pregledu, ki je potekal na evropski ravni, so bile proučene koristi in tveganja kombiniranih hormonskih kontraceptivov, zlasti tveganje za nastanek krvnih strdkov, povezano s temi zdravili.
• The EU-wide review of combined hormonal contraceptives (CHCs) has confirmed that the known risk of venous thromboembolism (VTE) with all low-dose CHCs (ethinylestradiol < 50 mcg) is small.
• Pregled kombiniranih hormonskih kontraceptivov v EU je potrdil, da je znano tveganje za vensko trombembolijo (VTE) pri vseh nizkoodmernih kombiniranih hormonskih kontraceptivih (etinilestradiol < 50 µg) majhno.
CHCs contain two types of hormones, an oestrogen and a progestogen.
Kombinirani hormonski kontraceptivi vsebujejo dve vrsti hormonov, estrogen in progestogen.
It confirmed that the benefits of CHCs outweigh the risk of blood clots, which has been known for many years and is very low.
Pregled je potrdil, da so koristi kombiniranih hormonskih kontraceptivov večje od tveganja za pojav krvnih strdkov, ki je dobro znano že več let in je zelo majhno.
• When prescribing a CHC, careful consideration should be given to the individual woman's current risk factors, particularly those for VTE, and the difference in risk of VTE between products.
• Ob predpisovanju kombiniranih hormonskih kontraceptivov je treba upoštevati obstoječe individualne dejavnike tveganja pri vsaki ženski, zlasti dejavnike tveganja za VTE, in razlike v tveganju za VTE med zdravili.
Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks
Koristi kombiniranih hormonskih kontraceptivov so še vedno večje od z njimi povezanih tveganj
During the review, the risk of VTE with these medicines was compared with that of CHCs containing levonorgestrel and norethisterone (also known as ‘second generation' contraceptives).
Med pregledom so tveganje za VTE pri teh zdravilih primerjali s tveganjem pri kombiniranih hormonskih kontraceptivih, ki vsebujejo levonorgestrel in noretisteron (t. i. „druga generacija“ kontraceptivov).
Your risk of a blood clot is also higher in the first year of using a CHC.
Prav tako je tveganje za krvne strdke večje prvo leto po začetku uporabe kombiniranih hormonskih kontraceptivov.
Product information updated to help women make informed decisions about their choice of contraception
Informacije o zdravilu so bile posodobljene, da se bodo lahko ženske na podlagi prejetih informacij lažje odločile, katero kontracepcijo izbrati
This compares with 2 cases of blood clots in the veins each year per 10,000 women who are not using CHCs.
Za primerjavo: med tistimi, ki ne uporabljajo kombiniranih hormonskih kontraceptivov, se vsako leto pojavita 2 primera krvnih strdkov v venah na 10 000 žensk.
• You should discuss with your doctor or nurse what is the most appropriate type of contraception for you.
• O tem, katera vrsta kontracepcije je najprimernejša za vas, se posvetujte z zdravnikom ali medicinsko sestro.
Doctors should also consider how the risk of VTE with a particular CHC compares with other CHCs (see table below).
Prav tako morajo proučiti, kakšno je tveganje za VTE pri določenem kombiniranem hormonskem kontraceptivu v primerjavi z drugimi tovrstnimi kontraceptivi (glejte razpredelnico v nadaljevanju).
• Healthcare professionals should always consider the possibility of a CHC-associated thromboembolism when presented with a woman who has symptoms.
• Zdravstveni delavci morajo pri obravnavi ženske, ki ima te simptome, vedno proučiti možnost trombembolije, povezane s kombiniranimi hormonskimi kontraceptivi.
Women using a CHC containing drospirenone, gestodene or desogestrel
Ženske, ki uporabljajo kombinirani hormonski kontraceptiv, ki vsebuje drospirenon, gestoden ali dezogestrel
Women using a CHC containing etonogestrel or norelgestromin
Ženske, ki uporabljajo kombinirani hormonski kontraceptiv, ki vsebuje etonogestrel ali norelgestromin
• There is no evidence for differences between low-dose CHCs in their risk of arterial thromboembolism (ATE).
• Dokazov, da bi med nizkoodmernimi kombiniranimi hormonskimi kontraceptivi obstajale razlike v tveganju za arterijsko trombembolijo (ATE), ni.
• It is also important to raise awareness of the signs and symptoms of VTE and ATE when prescribing a CHC.
• Prav tako je pomembno, da se ob predpisovanju kombiniranega hormonskega kontraceptiva žensko opozori na znake in simptome VTE ter ATE.
• Differences exist between CHCs in their risk of VTE depending on the type of progestogen they contain.
• Tveganje za VTE se med kombiniranimi hormonskimi kontraceptivi razlikuje in je odvisno od vrste progestogena, ki ga vsebujejo.
Currently available data indicate that CHCs containing the progestogens levonorgestrel, norethisterone or norgestimate have the lowest risk of VTE (see table below).
Trenutno razpoložljivi podatki kažejo, da je tveganje za VTE najmanjše pri kombiniranih hormonskih kontraceptivih, ki vsebujejo progestogene levonorgestrel, noretisteron ali norgestimat (glejte razpredelnico v nadaljevanju).
The product information of CHCs has been updated to help women make informed decisions about their choice of contraception together with their healthcare professional.
Informacije o zdravilu za kombinirane hormonske kontraceptive so bile posodobljene, da se bodo lahko ženske na podlagi prejetih informacij skupaj z zdravstvenim delavcem lažje odločile, katero kontracepcijo izbrati.
Women using a CHC containing chlormadinone, dienogest or nomegestrol
Ženske, ki uporabljajo kombinirani hormonski kontraceptiv, ki vsebuje klormadinon, dienogest ali nomegestrol
Women using a CHC containing levonorgestrel, norethisterone or norgestimate
Ženske, ki uporabljajo kombinirani hormonski kontraceptiv, ki vsebuje levonorgestrel, noretisteron ali norgestimat
• The risk of blood clots in the veins varies between CHCs, depending on the type of progestogen (a hormone) they contain, and ranges from 5 to 12 cases of blood clots per 10,000 women who use them for a year (see table below).
Na 10 000 žensk, ki te kontraceptive uporabljajo eno leto, se pojavi od 5 do 12 primerov krvnih strdkov (glejte razpredelnico v nadaljevanju).
Serious and/or fatal outcomes have been reported.
Poročali so tudi o resnih in/ali smrtnih primerih.
• The content of the bottle is stable for 2 months after opening.
• Vsebina steklenice je stabilna 2 meseca po odprtju.
• In adults:
• Pri odraslih:
• Wearing appropriate protective clothing.
• nosite ustrezna zaščitna oblačila.
• Do not store in the refrigerator.
• Ne shranjujte v hladilniku.
These findings have not been demonstrated in other species and their relevance for humans is unknown.
Teh ugotovitev pri drugih živalskih vrstah niso opažali in njihov pomen za ljudi ostaja neznan.
Renal function and blood pressure in these children were normal.
Delovanje ledvic in krvni tlak pri teh otrocih sta bila normalna.
The initial dose should be given on the day before transplantation.
Prvi odmerek je treba dati na dan pred presaditvijo.
You may need medical attention.
Morda boste potrebovali zdravniško pomoč.
The inter- and intrasubject variability ranges between 18 to 74%.
Interindividualna in intraindividualna variabilnost se gibljeta od 18 do 74 %.
Your doctor will also tell you how often to take your medicine.
Zdravnik vam bo tudi povedal, kako pogosto morate jemati zdravilo.
This leaflet was last revised in {MM/YYYY} {month YYYY}.
Navodilo je bilo nazadnje revidirano {MM/LLLL}
Results should therefore serve only as a guide to dosage in relationship to other clinical and laboratory parameters.
Rezultati naj zato služijo le kot smernice pri odmerjanju v povezavi z drugimi kliničnimi in laboratorijskimi parametri.
Elderly population (65 years of age and older)
Populacija starejših (starih 65 let ali več)
• your blood pressure before the start of your treatment and regularly during treatment,
• krvni tlak pred začetkom zdravljenja in redno v času zdravljenja,
Follow your doctor's instructions exactly and never change the dose yourself, even if you feel well.
Natančno upoštevajte zdravnikova navodila in nikdar sami ne spreminjajte odmerkov, ne glede na to, kako dobro se počutite.
Capsule,soft
kapsula, mehka
Sandimmun with food and drink
Sandimmun skupaj s hrano in pijačo
• Your doctor will monitor you more closely for a short time.
• vas bo zdravnik nekaj časa še bolj natančno pregledoval.
{e-mail}
{ime}
These medicines are used to lower the body's immune reactions.
Ta zdravila uporabljamo za zmanjševanje imunskega odziva v telesu.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Interakcije z zdravili
These recommendations apply even if the patient`s values still lie within the laboratory`s normal range.
Ta priporočila veljajo tudi v primeru, da so vrednosti pri bolniku v okviru normalnih vrednosti danega laboratorija.
• Store at room temperature (15°C to 30°C).
• Shranjujete pri sobni temperaturi (15 °C do 30 °C).
Stir and drink the entire mixture right away.
Premešajte in takoj spijte celotno mešanico.
Once the bottle has been opened, the content must be used within 2 months.
Po odprtju steklenice je treba vsebino porabiti v 2 mesecih.
- For initial use, follow steps 1 to 9.
- Pri prvi uporabi izvedite korake od 1 do 9.
Other side effects with frequency not known: Frequency cannot be estimated from the available data.
Drugi neželeni učinki z neznano pogostnostjo: Pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
In all cases of overdosage, general supportive measures should be followed and symptomatic treatment applied.
V vseh primerih prevelikega odmerjanja je treba izvajati splošne podporne ukrepe in simptomatsko zdravljenje.
It must be remembered that the ciclosporin concentration in blood, plasma, or serum is only one of many factors contributing to the clinical status of the patient.
Opozoriti je treba, da je koncentracija ciklosporina v krvi, plazmi ali serumu le eden od številnih dejavnikov, ki vplivajo na bolnikovo klinično stanje.
After the Commission Decision the National Competent Authorities will update the product information as required.
Po tem, ko Odbor izda odločbo, bodo pristojne nacionalne agencije po potrebi dopolnjevale informacije o zdravilu.
In some patients, continuous maintenance therapy may be necessary.
Nekateri bolniki lahko potrebujejo neprekinjeno vzdrževalno zdravljenje.
Containers and stoppers should be free of silicone oil and fatty substances.
Vsebniki in zamaški morajo biti brez silikonskega olja in maščobnih snovi.
The neurological status of these patients should be carefully monitored.
Pri teh bolnikih je treba skrbno spremljati nevrološki status.
• if you are pregnant.
• če ste noseči,
All indications
Vse indikacije
if you have any type of cancer.
• če imate katerokoli vrsto raka.
This medicinal product is authorised in the Member States of the EEA under the following names:
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
• If you forget to take a dose, take it as soon as you remember it.
• Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite nanj.
Transplantation patients receiving this medicinal product should be managed in facilities with adequate laboratory and supportive medical resources.
Bolnike, ki prejemajo to zdravilo zaradi presaditve, je treba zdraviti v ustanovah, ki imajo ustrezno laboratorijsko in podporno medicinsko opremo.
These functional changes are dose-dependent and are initially reversible, usually responding to dose reduction.
Te funkcionalne spremembe so odvisne od odmerka in so sprva reverzibilne ter se navadno odzovejo na znižanje odmerka.
• If the medicine is put in the refrigerator by mistake, let it reach room temperature before using it again.
• Če zdravilo pomotoma postavite v hladilnik, ga pred ponovno uporabo pustite zunaj, da doseže sobno temperaturo.
The absorption of ciclosporin is variable and may be influenced by intake of food.
Absorpcija ciklosporina je variabilna in nanjo lahko vpliva uživanje hrane.
Note:
Opozorilo:
Some malignancies may be fatal.
Nekatere maligne bolezni so lahko smrtne.
Time to improvement varies from 3 to 6 months depending on the type of glomerulopathy.
Do izboljšanja pride po 3 do 6 mesecih, kar je odvisno od vrste glomerulopatije.
Some examples are listed below:
Nekaj primerov takih zdravil je navedenih spodaj:
Types of containers suitable for the infusion solution are mentioned in section 6.2.
Vrste vsebnikov, ki so primerne za infuzijsko raztopino, so navedene v poglavju 6.2.
Effects of ciclosporin on other drugs
Vpliv ciklosporina na druga zdravila
In plasma, approximately 90% is bound to proteins, mostly lipoproteins.
V plazmi se približno 90 % ciklosporina veže na beljakovine, večinoma na lipoproteine.
In the blood, 33 to 47% is present in plasma, 4 to 9% in lymphocytes, 5 to 12% in granulocytes, and 41 to 58% in erythrocytes.
V krvi je 33 do 47 % ciklosporina prisotnega v plazmi, 4 do 9 % v limfocitih, 5 do 12 % v granulocitih in 41 do 58 % v eritrocitih.
- For subsequent use, follow steps 5 to 9.
- Pri nadaljnji uporabi izvajajte korake od 5 do 9.