natgillin/translations-raw huggingface dataset:
Other information about Savene:
Druge informacije o zdravilu Savene:
Savene was not compared with any other medicines in these studies.
V teh študijah zdravila Savene niso primerjali z nobenim drugim zdravilom.
The summary of the opinion of the Committee for Orphan Medicinal Products for Savene is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Savene je na voljo tukaj.
Patients will be monitored for these side effects before, during and after treatment.
Bolnike je treba glede neželenih učinkov nadzorovati pred in med zdravljenjem ter po njem.
The first infusion of Savene is given as soon as possible after the accident, and no later than six hours after it happened.
Prva infuzija se da čimprej po nehotenem dogodku in ne več kot šest ur po njem.
What benefit has Savene shown during the studies?
Kakšne koristi je zdravilo Savene izkazalo med študijami?
For more information about treatment with Savene, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Savene preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
It must not be used in women who could become pregnant or who are breastfeeding, or in patients receiving vaccination against yellow fever.
Ne sme se uporabljati pri ženskah, ki bi utegnile zanositi ali dojijo, ter pri bolnikih, ki prejemajo cepljenje proti rumeni mrzlici.
Patients can also develop low blood levels of white blood cells and platelets.
Pri bolniku se utegne pojaviti tudi nizka raven belih krvnih telesc in krvnih ploščic.
What is the risk associated with Savene?
Kakšna tveganja so povezana z zdravilom Savene?
Savene must be used under the supervision of a doctor who has experience in the use of anticancer medicines.
Zdravilo Savene se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil proti raku.
The Committee decided that Savene's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Savene večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Two further infusions are then given, one on day 2 and another on day 3, at the same time as the first infusion.
Naslednji dve infuziji je treba nato dati drugi in tretji dan ob istem času, kot je bila dana prva infuzija.
Anthracycline extravasation is a condition that can currently be managed using various methods, but for which there is no standard authorised treatment.
Antraciklinska ekstravazacija je stanje, za katerega se trenutno uporabljajo različne metode, vendar pa zanj ni standardnega odobrenega zdravljenja.
The most common side effects with Savene (seen in more than 1 patient in 10) are nausea (feeling sick), and pain and infection at the site of the injection.
Najpogostejši neželeni učinki zdravila Savene (opaženi pri več kot 1 bolniku od 10) so slabost ter bolečina in okužba na mestu injiciranja.
Because the number of patients who have extravasation of anthracyclines is low, the condition is considered ‘rare', and Savene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 September 2001.
Ker je število bolnikov, pri katerih se pojavi antraciklinska ekstravazacija, majhno, in je bolezen redka, je bilo zdravilo Savene dne 19. septembra 2001 določeno kot zdravilo sirota (zdravilo, ki se uporablja pri redkih boleznih).
Only one patient among the 54 in whom the effectiveness of Savene could be measured had tissue damage requiring surgery.
Samo en bolnik od 54, pri katerih je bilo mogoče meriti učinkovitost zdravila Savene, je imel poškodbe tkiv, ki so zahtevale operacijo.
Savene has been tested in two main studies involving a total of 80 patients who had extravasation of anthracyclines such as epirubicin or doxorubicin.
Zdravilo Savene je bilo preskušeno v dveh glavnih študijah, ki sta vključevali skupaj 80 bolnikov, pri katerih je prišlo do antraciklinske ekstravazacije zaradi zdravil kot sta epirubicin ali doksorubicin.
Together, these effects can reduce the amount of tissue damage caused by anthracycline extravasation.
Skupaj lahko ti učinki zmanjšajo količino tkiva, poškodovanega zaradi antraciklinske ekstravazacije.
This document is a summary of the European public assessment report (EPAR) for Savene.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Savene.
The way it works is not entirely clear, but may be linked to the way the medicine attaches to iron in the body to form a ‘chelate' and to its effect on some enzymes, such as topoisomerase II.
Njegov način delovanja ni v celoti znan, vendar utegne biti povezan z načinom, kako se veže na železo v telesu, da tvori kelat, in njegovimi učinki na nekatere encime, kot je topoizomeraza II.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Savene.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Savene, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Extravasation happens when an anticancer medicine that is normally injected into a vein leaks or is accidentally injected in the tissue surrounding the vein, where it can cause serious damage.
Do ekstravazacije pride, če se zdravilo proti raku, ki je bilo normalno injicirano v veno, izlije, ali če je nehote injicirano v tkivo, ki obkroža veno, kjer lahko povzroči resne poškodbe.
Why has Savene been approved?
Zakaj je bilo zdravilo Savene odobreno?
For the full list of all side effects reported with Savene, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Savene, glejte navodilo za uporabo.
The studies looked at how many patients needed surgery to correct the damage due to the extravasation.
V študijah so proučevali, koliko bolnikov je potrebovalo operacijo za odpravo posledic ekstravazacije.
Dexrazoxane has been in use since the 1990s as a medicine to help prevent the cardiomyopathy (harm to the heart muscle) associated with the use of anthracyclines.
Deksrazoksan se uporablja od devetdesetih let prejšnjega stoletja kot zdravilo za preprečevanje kardiomiopatije (poškodb srčne mišice), povezane z uporabo antraciklinov.
Although this may be caused by their anti-cancer treatment, it can also be caused by Savene, because it is a cytotoxic (a medicine that destroys cells that are multiplying) that can affect the bone marrow.
To je lahko posledica zdravljenja proti raku, vendar pa tudi zdravila Savene, saj je tudi to zdravilo citotoksično (uničuje celice, ki se množijo) in lahko prizadene kostni mozeg.
Savene should not be used in people who may be hypersensitive (allergic) to dexrazoxane or any of the other ingredients.
Zdravila Savene ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) deksrazoksan ali katero koli drugo sestavino zdravila.
The infusion should last between one and two hours, and be given at a site other than where the extravasation happened.
Infuzija mora trajati eno do dve uri, mesto injiciranja pa ne sme biti isto kot je mesto, kjer je prišlo do ekstravazacije.
The CHMP concluded that Savene had shown its ability to treat anthracycline extravasation, allowing patients to continue their anticancer treatment.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo Savene izkazalo učinkovitost pri zdravljenju antraciklinske ekstravazacije, kar bolnikom omogoča nadaljevanje zdravljenja proti raku.
What is Savene?
Kaj je zdravilo Savene?
Savene is a powder and diluent that are made up into a solution for infusion (drip into a vein).
Zdravilo Savene sestavljata prašek in vehikel, namenjena za pripravo raztopine za infundiranje (dajanje v veno).
Savene is used to treat extravasation of anthracyclines (a group of anticancer medicines).
Zdravilo Savene se uporablja za zdravljenje antraciklinske ekstravazacije(ki jo povzroča skupina zdravil proti raku).
How is Savene used?
Kako se zdravilo Savene uporablja?
How has Savene been studied?
Kako je bilo zdravilo Savene raziskano?
What is Savene used for?
Za kaj se zdravilo Savene uporablja?
The active substance in Savene, dexrazoxane, is an antidote to anthracyclines.
Zdravilna učinkovina zdravila Savene, deksrazoksan, je antidot (protisredstvo) antraciklinov.
The full EPAR for Savene can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Savene je na voljo tukaj.
How does Savene work?
Kako zdravilo Savene deluje?
Enzepi is available as capsules (5,000; 10,000; 25,000 and 40,000 units).
Na voljo je v obliki kapsul (5 000, 10 000, 25 000 in 40 000 enot).
Treatment is started at a low dose, which the doctor may then increase slowly until an appropriate dose is reached.
Zdravljenje se začne z nizkim odmerkom, ki ga zdravnik nato lahko počasi povečuje do ustreznega odmerka.
The full EPAR for Enzepi 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 Enzepi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Enzepi
Druge informacije o zdravilu Enzepi
In one main study involving 96 patients, treatment with Enzepi led to the absorption of 84% of the fats consumed by patient over 72 hours compared with 85% absorption with the already authorised medicine.
V glavni študiji, v katero je bilo vključenih 96 bolnikov, je zdravljenje z zdravilom Enzepi privedlo do absorpcije 84 % maščob, ki jih je bolnik zaužil v 72 urah, pri že odobrenem zdravilu pa do absorpcije 85 % maščob.
This is a summary of the European public assessment report (EPAR) for Enzepi.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Enzepi.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Enzepi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Enzepi večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Enzepi should be taken during meals or snacks with a drink of water or juice.
Zdravilo Enzepi je treba vzeti z obrokom ali prigrizkom, skupaj s kozarcem vode ali soka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enzepi have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Enzepi, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The appropriate dose depends on the symptoms of the disease, amount of fat in the stool, fat content of the diet and the patient's weight.
Ustrezni odmerek je odvisen od simptomov bolezni, količine maščobe v blatu, deleža maščob v prehrani in bolnikove telesne mase.
What measures are being taken to ensure the safe and effective use of Enzepi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila
The most common side effects with Enzepi (which may affect more than 1 in 100 people) are effects on the gut (abdominal pain, bloating, diarrhoea, vomiting, constipation and nausea) and headache.
Najpogostejši neželeni učinki zdravila Enzepi (ki lahko prizadenejo več kot 1 osebo od 100) so učinki na črevesje (bolečine v trebuhu, napihnjenost, driska, bruhanje, zaprtost in slabost) ter glavobol.
For patients who cannot swallow capsules, the capsules may be opened and the content mixed with a small amount of acidic food such as fruit puree which should be swallowed immediately without chewing.
Pri bolnikih, ki kapsul ne morejo pogoltniti, se kapsule lahko odprejo in njihova vsebina zmeša z majhno količino kisle hrane, kot je sadna kaša.
What benefits of Enzepi have been shown in studies?
Kakšne koristi je zdravilo Enzepi izkazalo v študijah?
Enzepi was shown to be as effective as the already well-known marketed medicine.
Zdravilo Enzepi se je izkazalo za enako učinkovito kot dobro poznano zdravilo, ki je že na trgu.
What is Enzepi and what is it used for?
Kaj je zdravilo Enzepi in za kaj se uporablja?
It is not intended to provide practical advice on how to use Enzepi.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Enzepi will therefore help the body absorb nutrients better, especially fats.
Zdravilo Enzepi bo telesu pomagalo hranila, zlasti maščobe, bolje absorbirati.
For more information about treatment with Enzepi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Enzepi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most important serious side effects observed with all pancreatic enzyme medicines are anaphylactic (allergic) reactions and fibrosing colonopathy (scarring and thickening of the bowel wall).
Najpomembnejši resni neželeni učinki, opaženi pri vseh zdravilih z encimi trebušne slinavke, so anafilaktične (alergijske) reakcije in fibrozirajoča kolonopatija (brazgotinjenje in zadebelitev črevesne stene).
In clinical trials most side effects were mild to moderate in severity.
V kliničnih preskušanjih so bili neželeni učinki večinoma blagi do zmerni.
A lack of these enzymes leads to poor growth, weight loss, abdominal pain and diarrhoea.
Pomanjkanje teh encimov povzroča upočasnjeno rast, izgubo telesne mase, bolečino v trebuhu in drisko.
What are the risks associated with Enzepi?
Kakšna tveganja so povezana z zdravilom Enzepi?
The CHMP considered that the use of pancreas powder to treat pancreatic insufficiency has been well established in medical practice for more than 20 years.
Odbor CHMP je ugotovil, da je uporaba uprašenega pankreasa za zdravljenje pomanjkljivega delovanja trebušne slinavke v medicini dobro uveljavljena že več kot 20 let.
Why is Enzepi approved?
Zakaj je bilo zdravilo Enzepi odobreno?
For practical information about using Enzepi, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Enzepi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
EPAR summary for the public
Povzetek EPAR za javnost uprašeni pankreas
It contains enzymes that help with the digestion of fats, carbohydrates and proteins.
Vsebuje encime, ki pomagajo pri prebavi maščob, ogljikovih hidratov in beljakovin.
Pancreas enzymes are needed to digest fats, carbohydrates and proteins.
Encimi trebušne slinavke so potrebni za prebavo maščob, ogljikovih hidratov in beljakovin.
In terms of safety, Enzepi's side effects are comparable to other marketed products.
Z vidika varnosti so neželeni učinki zdravila Enzepi primerljivi z neželenimi učinki drugih zdravil na trgu.
Enzepi is a medicine used to treat adults and children whose pancreas does not produce enough enzymes (a condition known as pancreatic insufficiency) due to cystic fibrosis or other conditions such as pancreatic cancer.
Zdravilo Enzepi se uporablja za zdravljenje odraslih in otrok, pri katerih trebušna slinavka zaradi cistične fibroze ali drugih bolezni, npr. raka trebušne slinavke, ne proizvaja dovolj encimov (bolezen, znana kot pomanjkljivo delovanje trebušne slinavke).
For the full list of restrictions and all side effects reported with Enzepi, see the package leaflet.
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Enzepi, glejte navodilo za uporabo.
Enzepi has been shown to be as effective as an already authorised medicine containing pancreas powder and used in pancreatic insufficiency.
Zdravilo Enzepi se je izkazalo za enako učinkovito kot že odobreno zdravilo, ki vsebuje uprašeni pankreas in se uporablja pri pomanjkljivem delovanju trebušne slinavke.
Pancreas powder is a well-known substance that has been authorised in the treatment of pancreatic insufficiency for many years.
Uprašeni pankreas je dobro poznana snov, ki je za zdravljenje pomanjkljivega delovanja trebušne slinavke odobrena že vrsto let.
The active substance of Enzepi, pancreas powder, is intended to replace missing enzymes in patients whose pancreas does not produce sufficient amounts of them.
Zdravilna učinkovina v zdravilu Enzepi, uprašeni pankreas, je namenjena nadomeščanju encimov pri bolnikih, pri katerih jih trebušna slinavka ne proizvaja v zadostni količini.
Enzepi can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Enzepi je le na recept.
How does Enzepi work?
Kako zdravilo Enzepi deluje?
The active substance in Enzepi is pancreas powder which is obtained from pig pancreas.
Zdravilna učinkovina v zdravilu Enzepi je uprašeni pankreas, pridobljen iz trebušne slinavke prašičev.
How is Enzepi used?
Kako se zdravilo Enzepi uporablja?
Intravenous use vial (glass)
25mg/ml koncentrat za raztopino za infundiranje intravenska uporaba viala (steklo)
Blepharitis; keratitis.
blefaritis; keratitis.
a) Grade 1:
a) 1. stopnja:
Such patients should be closely monitored.
Take bolnike je treba skrbno spremljati.
They can occur despite the use of premedication.
Pojavijo se lahko kljub uporabi premedikacije.
The recommended infusion period is 120 minutes.
Priporočena dolžina infuzije je 120 minut.
The pharmacokinetic results were comparable to those in adults.
Rezultati farmakokinetike so bili primerljivi s tistimi pri odraslih.
Overall, no clinically relevant difference between genders was observed.
Na splošno niso opažali nobene klinično pomembne razlike med spoloma.
In this study EGFR expression was not an inclusion criterion.
V tej študiji ekspresija EGFR ni bila vključitveni kriterij.
Your doctor will then discuss with you the risks and benefits of using Erbitux in these situations.
Zdravnik se bo potem z vami pogovoril o tveganjih in koristih uporabe zdravila Erbitux v teh situacijah.
RAS is one of the most frequently activated family of oncogenes in human cancers.
RAS je ena od najpogosteje aktiviranih družin onkogenov pri človeških rakih.
Availability of resuscitation equipment must be ensured.
Vedno mora biti na voljo oprema za oživljanje.
Such reactions may be allergic in nature.
Te reakcije so lahko alergijske.
Your doctor will discuss appropriate measures with you.
Vaš zdravnik se bo z vami pogovoril o ustreznih ukrepih.
Tell your doctor if you are pregnant or if you are not using reliable contraception (speak to your doctor if you are not sure).
Povejte zdravniku, če ste noseči ali ne uporabljate zanesljive kontracepcije (če niste prepričani, se pogovorite z zdravnikom).
• excessive growth of hair
• prekomerna rast dlak
On the basis of this data and since no independent review of imaging data was conducted, results in relation to mutation status are considered non-interpretable.
Na podlagi teh podatkov, in ker neodvisnega pregleda podatkov slikanja niso opravili, velja, da rezultatov statusa mutacije ni mogoče razlagati.
Before the first dose, you will receive an antiallergic medicine in order to reduce the risk of an allergic reaction.
Pred prvim odmerkom boste prejeli še zdravilo proti alergijam, da bi zmanjšali tveganje za pojav alergijske reakcije.
1082 MA Amsterdam The Netherlands
1082 MA Amsterdam Nizozemska
Variable/ statistic
Spremenljivka/statistika
From a microbiological point of view, the product shall be used immediately after opening.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po odprtju.
Increase in liver enzyme levels (ASAT, ALAT, AP).
povečanje ravni jetrnih encimov (ASAT, ALAT, AP).
Thus, a benefit-risk ratio for this combination has not yet been established.
Zato še ni bilo postavljeno razmerje med koristjo in tveganjem za to kombinacijo.
Your doctor will discuss with you whether you may need any preventive measures or early treatment.
Vaš zdravnik se bo z vami pogovoril, ali morebiti potrebujete preventivne ukrepe ali zgodnje zdravljenje.
• severe breathing difficulties which develop rapidly
• hude težave z dihanjem, ki se pojavijo hitro
However, since it does not contain any antimicrobial preservative or bacteriostatic agent, it is intended for immediate use.
Ker pa ne vsebuje antimikrobnih konzervansov ali bakteriostatikov, je namenjeno za takojšnjo uporabo.
Skin reactions*.
kožne reakcije*.
For details, see section 5.1.
Za podrobnosti glejte poglavje 5.1
Merck Healthcare KGaA Frankfurter Straße 250 64293 Darmstadt Germany
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Your doctor will discuss with you whether you need to consult a specialist.
Vaš zdravnik se bo z vami pogovoril, ali se morate posvetovati s specialistom.
Data for the XELOX regimen and the third experimental arm are not presented.
Podatki za režim XELOX in tretjo eksperimentalno skupino niso predstavljeni.
continue slow infusion under close supervision b) Grade 2:
nadaljujte s počasnim infundiranjem pod skrbnim nadzorom b) 2. stopnja:
As a result of this binding, the cancer cell can no longer receive the messages it needs for growth, progression and metastasis.
Zaradi te vezave rakava celica ne more več sprejemati sporočil, ki jih potrebuje za rast, napredovanje procesa in metastaziranje.
For the subsequent weekly doses, the recommended infusion period is 60 minutes.
Za kasnejše tedenske odmerke je priporočena dolžina infuzije 60 minut.
A close monitoring of patients, particularly during the first administration, is required.
Bolnike je treba skrbno spremljati, zlasti med prvim dajanjem.
The efficacy data generated in this study are summarised in the table below:
Podatki o učinkovitosti, ki so bili zbrani v tej študiji, so povzeti v spodnji preglednici:
Approximately 15% of the skin reactions are severe, including single cases of skin necrosis.
Približno 15% kožnih reakcij je hudih, vključno s posameznimi primeri nekroze kože.
It is recommended to warn patients of the possibility of such a late onset and instruct them to contact their physician if symptoms or signs of an infusion-related reaction occur.
Priporočljivo je, da bolnike opozorite na možnost takšne pozne reakcije in jim naročite, naj pokličejo svojega zdravnika, če se pojavijo simptomi ali znaki reakcije, povezane z infundiranjem.
If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Če se diagnosticira keratitis, je treba skrbno pretehtati koristi in tveganja nadaljevanja zdravljenja.
EGFR activates proteins called RAS. RAS proteins play an important role in the EGFR pathway -a complex signalling cascade which is involved in the development and progression of cancer.
EGFR aktivira proteine, imenovane RAS. Proteini RAS imajo pomembno vlogo pri poti EGFR - zapleteni kaskadi signaliziranja, ki sodeluje v razvoju in napredovanju raka.
Erbitux is used to treat two different types of cancer:
Zdravilo Erbitux se uporablja za zdravljenje dveh različnih vrst raka:
This premedication is recommended prior to all subsequent infusions.
Ta premedikacija je priporočljiva tudi pred vsemi naslednjimi infuzijami.
The efficacy data on the OxMdG regimen generated in this study are summarised in the table below:
Podatki o učinkovitosti režima OxMdG, ki so bili zbrani v tej študiji, so povzeti v spodnji preglednici:
Your doctor will calculate the correct dose of Erbitux for you because it depends on your body surface area.
Zdravnik bo izračunal pravilen odmerek zdravila Erbitux za vas, saj je ta odvisen od telesne površine.
Monoclonal antibodies are proteins that specifically recognise and bind to other unique proteins called antigens.
Monoklonska protitelesa so beljakovine, ki specifično prepoznavajo in se vežejo na druge točno določene beljakovine, ki jih imenujemo antigeni.
For storage conditions after opening, see section 6.3.
Za pogoje shranjevanja po prvem odprtju zdravila glejte poglavje 6.3.