natgillin/translations-raw huggingface dataset:
Overall deltamethrin was not considered to be a PBT compound.
Na splošno se deltametrin ne šteje za spojino, ki je obstojna, se kopiči v organizmu in je strupena.
The benefit-risk balance is considered positive for both Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Razmerje med koristmi in tveganji za zdravili Deltanil 10 mg/ml, raztopino za poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo, se šteje za ugodno.
Grounds for the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Razlogi za izdajo dovoljenj za promet z zdraviloma Deltanil 10 mg/ml, raztopino za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo
Czech Republic Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
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No further assessment of risks to surface water and sediment was necessary and no RMMs were needed.
Na podlagi sprejemljivih objavljenih podatkov za vrste v usedlinah je bila vrednost količnika tveganja manj kot 1, zato niso bile potrebne nadaljnje ocene tveganja za površinske vode in usedline niti ukrepi za zmanjšanje tveganj.
What measures are being taken to ensure the safe and effective use of Halaven?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Halaven?
The European Commission granted a marketing authorisation valid throughout the European Union for Halaven on 17 March 2011.
Evropska komisija je dovoljenje za promet z zdravilom Halaven, veljavno po vsej Evropski uniji, izdala 17. marca 2011.
The full EPAR for Halaven 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 Halaven je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Halaven.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Halaven.
What benefit has Halaven shown during the studies?
Kakšne koristi je zdravilo Halaven izkazalo med študijami?
Women in the Halaven group lived for an average of 13.1 months, compared with 10.6 months in the group that received other treatments.
Ženske v skupini, ki je prejemala zdravilo Halaven, so živele povprečno 13,1 meseca v primerjavi z 10,6 meseca v skupini, ki je prejemala druga zdravila.
Halaven must not be used in women who are breastfeeding.
Zdravilo Halaven se ne sme uporabljati pri ženskah, ki dojijo.
Other information about Halaven
Druge informacije o zdravilu Halaven
The most common side effects with Halaven (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), reduced appetite, peripheral neuropathy (damage to the nerves in the extremities causing numbness, tingling and prickling sensations), headache, dyspnoea (difficulty breathing), cough, nausea (feeling sick), constipation, diarrhoea, vomiting, alopecia (hair loss), muscle and joint pain or pain in the back or limbs, fatigue (tiredness), pyrexia (fever) and weight loss.
Najpogostejši neželeni učinki zdravila Halaven (opaženi pri več kot 1 bolniku od 10) so nevtropenija (nizka raven nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam), levkopenija (nizko število belih krvnih celic), anemija (nizko število rdečih krvnih celic), zmanjšan tek, periferna nevropatija (poškodbe živcev v okončinah, ki povzročajo otopelost, ščemenje ali zbadanje), glavobol, dispneja (oteženo dihanje), kašelj, navzeja (slabost), zaprtost, driska, bruhanje, alopecija (izguba las), bolečine v mišicah in sklepih ali bolečine v hrbtu in okončinah, utrujenost, pireksija (povišana telesna temperatura) in izguba telesne mase.
The calculated dose is given into a vein over two to five minutes on days 1 and 8 of each cycle.
Izračunani odmerek se daje kot 2- do 5-minutna intravenska injekcija 1. in 8. dan vsakega cikla.
Safety in this patient population was considered acceptable and similar to that in patients with breast cancer.
Varnost pri tej populaciji zdravnikov je bila sprejemljiva in podobna tisti, ki so jo opazili pri obolelih za rakom dojke.
A risk management plan has been developed to ensure that Halaven is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Halaven je bil pripravljen načrt obvladovanja tveganj.
It attaches to a protein in cells called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Veže se na beljakovino v celicah, imenovano tubulin, ki ima pomembno vlogo pri tvorjenju notranjega „ogrodja“, ki ga morajo celice zgraditi, da se lahko delijo.
The women were given either Halaven or another approved cancer medicine chosen by their doctor.
Ženske so prejemale bodisi zdravilo Halaven bodisi drugo odobreno zdravilo za zdravljenje raka, ki ga je izbral njihov zdravnik.
What is the risk associated with Halaven?
Kakšna tveganja so povezana z zdravilom Halaven?
It is used in patients who have already been treated with anthracyclines (unless this treatment was not suitable).
Uporablja se pri bolnikih, ki so že bili zdravljeni z antraciklini (razen če ta vrsta zdravljenja ni bila primerna zanje).
Additionally, Halaven prolonged the length of time that liposarcoma patients lived, and this was considered important as these patients have limited treatment options.
Poleg tega je zdravilo Halaven podaljšalo čas preživetja bolnikov z liposarkomom, kar je veljalo kot pomembno, saj imajo ti bolniki omejene možnosti zdravljenja.
It is available as a solution for injection.
Na voljo je v obliki raztopine za injiciranje.
In breast cancer, Halaven was studied in two main studies involving a total of 1,864 patients.
V okviru raka dojk so zdravilo Halaven proučevali v dveh glavnih študijah, ki sta vključevali 1 864 bolnikov.
The main measure of effectiveness was overall survival (how long the patients lived).
Glavno merilo učinkovitosti je bil skupni čas preživetja (kako dolgo so bolnice živele).
The active substance in Halaven, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai.
Zdravilna učinkovina v zdravilu Halaven, eribulin, je podobna snovi, imenovani halihondrin B, ki deluje proti raku in je prisotna v morski spužvi Halichondria okadai.
Halaven was compared with dacarbazine (another cancer medicine), and the main measure of effectiveness was overall survival.
Zdravilo Halaven so primerjali z dakarbacinom (drugim zdravilom za zdravljenje raka), glavno merilo učinkovitosti pa je bilo celokupno preživetje.
The CHMP decided that Halaven's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Halaven večje od z njim povezanih tveganj, zato je priporočil, da se zanj izda dovoljenje za promet.
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 Halaven.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The dose to be given is calculated using the patient's height and weight.
Odmerek, ki ga je treba uporabiti, se izračuna na podlagi telesne višine in mase bolnika.
For more information about treatment with Halaven, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Halaven preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Halaven treatment should be given under the supervision of a doctor experienced in the use of cancer medicines.
Zdravilo Halaven se lahko uporablja samo pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
The third study showed that Halaven was effective at prolonging life in patients with liposarcoma: patients treated with Halaven lived for an average of 15.6 months, compared with 8.4 months for patients treated with dacarbazine.
Tretja študija je pokazala, da je bilo zdravilo Halaven učinkovito pri podaljševanju življenja bolnikov z liposarkomom: bolniki, zdravljeni z zdravilom Halaven, so v povprečju živeli 15,6 meseca v primerjavi z 8,4 meseca pri tistih, ki so bili zdravljeni z dakarbacinom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Halaven, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Why has Halaven been approved?
Zakaj je bilo zdravilo Halaven odobreno?
In the second study, there was no significant difference in the average progression-free survival with Halaven (4.1 months) compared with capecitabine (4.2 months) or in the average overall survival with Halaven (15.9 months) compared with capecitabine (14.5 months).
V drugi študiji ni bilo pomembne razlike v povprečnem času preživetja brez napredovanja bolezni ob primerjavi zdravila Halaven (4,1 meseca) s kapecitabinom (4,2 meseca) ali v povprečnem skupnem času preživetja z zdravilom Halaven (15,9 meseca) in kapecitabinom (14,5 meseca).
Halaven is also used to treat adults with advanced or metastatic liposarcoma (a type of cancer of the soft tissues that develops from fat cells) that cannot be surgically removed.
Zdravilo Halaven se uporablja tudi za zdravljenje odraslih z napredovalim ali metastatskim liposarkomom (vrsto raka mehkih tkiv, ki se razvije iz maščobnih celic), ki ga ni mogoče kirurško odstraniti.
Doses may be delayed or reduced if patients have very low levels of neutrophils (a type of white blood cell) and platelets (components that help the blood to clot) in their blood or if liver or kidney function is impaired.
Odmerki se lahko odložijo ali zmanjšajo, če imajo bolniki zelo nizke ravni nevtrofilcev (vrste belih krvnih celic) in trombocitov (celic, ki pomagajo pri strjevanju krvi) v krvi ali pri bolnikih z okvarjenim delovanjem jeter ali ledvic.
By attaching to tubulin in cancer cells, eribulin disrupts the formation of the skeleton, preventing the division and spread of the cancer cells.
Eribulin s pritrjevanjem na tubulin v rakavih celicah prekine tvorbo ogrodja in tako prepreči delitev in širjenje rakavih celic.
Halaven is a cancer medicine that contains the active substance eribulin.
Halaven je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino eribulin.
The study compared Halaven with capecitabine (another cancer medicine).
V študiji so zdravilo Halaven primerjali s kapecitabinom (drugim zdravilom za zdravljenje raka).
Halaven is given as intravenous (into a vein) injections over 21-day cycles.
Zdravilo Halaven se daje z intravenskimi injekcijami v 21-dnevnih ciklih.
Previous treatment should have included cancer medicines of the types known as anthracyclines and taxanes, unless these treatments were not suitable.
V predhodnem zdravljenju naj bi bila uporabljena zdravila za zdravljenje raka iz skupine antraciklinov in taksanov, razen če tovrstna zdravljenja niso bila primerna.
The main measures of effectiveness were overall survival and progression-free survival (how long the patients lived without their disease getting worse).
Glavno merilo učinkovitosti je bil skupni čas preživetja in čas, med katerim bolezen ni napredovala (čas preživetja bolnikov, med katerim se bolezen ni poslabšala).
For more details on the use of Halaven including recommendations on dose reduction, see the summary of product characteristics (also part of the EPAR).
Več informacij o uporabi zdravila Halaven, vključno s priporočili glede prilagajanja odmerkov, je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
Doctors should consider giving patients an antiemetic (a medicine that prevents nausea and vomiting) as Halaven may cause nausea or vomiting.
Zdravniki naj razmislijo o dajanju antiemetika (zdravila, ki preprečuje slabost in bruhanje) bolnikom, saj lahko zdravilo Halaven povzroči slabost ali bruhanje.
In the first study, when comparing Halaven with all the other treatments grouped together, Halaven was shown to be more effective at prolonging life.
V prvi študiji je primerjava zdravila Halaven z združenimi drugimi režimi zdravljenja pokazala, da je zdravilo Halaven učinkovitejše pri podaljševanju življenja.
Halaven was also studied in 143 patients with liposarcoma who had previously undergone at least two other treatments, which included an anthracycline.
Zdravilo Halaven so proučevali tudi pri 143 bolnikih z liposarkomom, ki so predhodno prejeli najmanj dva druga režima zdravljenja, ki sta vključevala antraciklin.
Halaven is used to treat locally advanced or metastatic breast cancer which has continued to spread after at least one previous treatment for advanced cancer.
Zdravilo Halaven se uporablja za zdravljenje lokalno napredovalega ali metastatskega raka dojke, ki se kljub uporabi vsaj enega predhodnega režima zdravljenja za napredovali rak še dalje širi.
For the full list of all side effects reported with Halaven, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Halaven, glejte navodilo za uporabo.
The CHMP noted that, when Halaven was used as a third-line therapy for breast cancer (after at least two previous treatments with cancer medicines for advanced/metastatic disease), it prolonged the length of time that patients lived and the safety profile is within what is expected for chemotherapy medicines.
Odbor CHMP je ugotovil, da je zdravilo Halaven, kadar je bilo uporabljeno kot zdravilo tretje izbire za zdravljenje raka dojke (po uporabi vsaj dveh režimov zdravljenja napredovalega ali metastatskega raka), podaljšalo čas preživetja in da varnostni profil zdravila ustreza pričakovanjem glede varnosti kemoterapevtikov.
The second study involved 1,102 patients with advanced or metastatic breast cancer, with one or two previous treatments for advanced/metastatic cancer including an anthracycline and a taxane.
V drugi študiji je sodelovalo 1 102 bolnic z napredovalim ali metastatskim rakom dojke, ki so predhodno prejele en ali dva režima zdravljenja, ki sta vključevala antraciklin in taksan.
In the first study, Halaven was compared with other treatments in 762 women with advanced or metastatic breast cancer, who had previously undergone at least two other treatments, which included an anthracycline and a taxane.
V prvi študiji so zdravilo Halaven primerjali z drugimi zdravili pri 762 ženskah z napredovalim ali metastatskim rakom dojke, ki so se predhodno zdravile z vsaj dvema drugima režimoma, ki sta vključevala antraciklin in taksan.
When Halaven was used as breast cancer second-line therapy (after at least one previous cancer treatment for advanced/metastatic disease), Halaven was a valuable treatment option similar to capecitabine and with an acceptable safety profile.
Kadar je bilo uporabljeno kot zdravilo druge izbire za zdravljenje raka dojke (po vsaj enem predhodnem režimu zdravljenja napredovalega ali metastatskega raka), se je izkazalo za dragoceno možnost zdravljenja, podobno kapecitabinu, s sprejemljivim varnostnim profilom.
What is Halaven used for?
Za kaj se zdravilo Halaven uporablja?
How has Halaven been studied?
Kako je bilo zdravilo Halaven raziskano?
How does Halaven work?
Kako zdravilo Halaven deluje?
How is Halaven used?
Kako se zdravilo Halaven uporablja?
What is Halaven?
Kaj je zdravilo Halaven?
Sachet (alu)
Vrečica (alu)
Content
Pakiranje
12 sachets l t o r
12 vrečic o č
Invented name Strength Pharmaceutical Form Route of administration Packaging
Farmacevtska oblika Pot uporabe
EMEA Procedure number
Številka postopka EMEA Izmišljeno ime Jakost
Do not pass it on to others.
Ge det inte till andra.
How much you will be given
Hur mycket du kommer att få
Preparation Date: ______________ Preparation Time: ______________ Prepared By: __________________
Beredningsdatum:______________ Beredningstid:_____________ Beredd av:___________________
These measures will help protect the environment.
Dessa åtgärder är till för att skydda miljön.
This can happen straight away or later on in your treatment.
Detta kan hända omedelbart eller senare under behandlingen.
Date of first authorisation: 13 July 2000 Date of latest renewal: 02 July 2010
Datum för det första godkännandet: 13 juli 2000 Datum för den senaste förnyelsen: 02 juli 2010
• how well your body responds to the medicine.
• Hur väl din kropp svarar på medicinen.
Treatment usually lasts for about 3 to 6 months.
En behandling varar i allmänhet cirka 3 till 6 månader.
- This medicine has been prescribed for you only.
- Detta läkemedel har ordinerats åt dig.
Your doctor will work out exactly how much you need.
Din läkare kommer att räkna ut exakt hur mycket du behöver.
4 Requires parenteral or enteral support
4 Kräver parenteralt eller enteralt stöd.
18 months
18 månader.
The doctor may give you a lower dose if they think you need it.
Läkaren kan ge dig en lägre dos om det bedöms att du behöver det.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING
2031 GA Haarlem Netherlands
2031 GA Haarlem Nederländerna
No data are available.
Inga data finns tillgängliga.
Less than 25,000
Färre än 25 000
The number of times you have the drip depends on:
Antalet gånger som du behöver få droppet beror på:
If extravasation occurs, the infusion should be immediately terminated.
Om extravasation inträffar måste infusionen omedelbart avslutas.
4 Less than 500
4 Färre än 500
The following information is intended for healthcare professionals only: PREPARATION GUIDE
Följande information är endast avsedd för hälso- och sjukvårdspersonal: BEREDNINGSANVISNINGAR
Not all pack-sizes may be marketed.
Eventuellt kommer inte alla förpackningsstorlekar att marknadsföras.
• high blood glucose level (your doctor will see this in a blood test)
• Högt blodglukosvärde (din läkare kommer att se det i ett blodprov)
• this is given once every 3 weeks
• Infusionen ges en gång var tredje vecka.
Ask your pharmacist how to throw away medicines you no longer use.
Fråga apotekspersonalen hur man kastar läkemedel som inte längre används.
For single use only.
Endast för engångsbruk.
Findings regarding response rate and progression-free survival are provided in Table 3.
Resultaten beträffande responsgrad och progressionsfri överlevnad visas i Tabell 3.
Not Known: frequency cannot be estimated from the available data:
Ingen känd frekvens: kan inte beräknas från tillgängliga data
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATUM FÖR FÖRSTA GODKÄNNANDE/FÖRNYAT GODKÄNNANDE
This medicine is normally given by a doctor or nurse.
Detta läkemedel ges vanligtvis av en läkare eller en sjuksköterska.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Detta läkemedel får inte blandas med andra läkemedel förutom de som nämns under avsnitt 6.6.
These are signs of an allergic reaction and your drip (infusion) may have to be stopped:
Detta är tecken på en allergisk reaktion och droppet (infusionen) kan behöva avbrytas:
4.9 Overdose
4.9 Överdosering
You may get painful, red or dry skin.
Du kan få smärta, röd eller torr hud.
Grades ≥ 3
Grader ≥ 3
4.5 Interactions with other medicinal products and other forms of interactions
4.5 Interaktioner med andra läkemedel och övriga interaktioner
These acute phenomena may be avoided by using a 1-hour infusion time.
Dessa akuta fenomen kan undvikas genom att man använder 1 timmes infusionstid.
These side effects may stop if the drip is given more slowly over a longer period of time.
Biverkningarna kan upphöra om droppet ges mera långsamt över en längre tidsperiod.
Three inserts, each with two 43.7mm openings per insert must be used.
Tre inlägg, vart och ett med två öppningar om 43,7 mm per inlägg, måste användas.
It is important you read the entire contents of this guide prior to the preparation of this medicinal product.
Det är viktigt att läsa hela innehållet i denna vägledning före beredning av detta läkemedel.
They will also look out for any side effects such as blood problems or heart problems.
De kommer också att vara uppmärksamma på biverkningar som blodförändringar eller hjärtproblem.
• a change in how you walk, speech problems
• Förändringar i hur du går, talsvårigheter
Liquid waste may be flushed with large amounts of water.
Flytande avfall måste spolas med stora mängder vatten.
6.2 Incompatibilities
6.2 Inkompatibiliteter
Your doctor will do tests during your treatment to check that the medicine is working properly.
Läkare kommer att utföra tester under behandlingen för att kontrollera att medicinen verkar som den ska.
Redness and pain on the hands and feet
Rodnad och smärta på händer och fötter
• the medicine “cyclophosphamide” is given on the same day.
• Medicinen ”cyclofosfamid” ges samma dag
If myelotoxicity delays treatment to greater than 35 days after the first dose of the previous cycle, then consideration should be given to stopping treatment.
Om myelotoxicitet skjuter upp behandlingen mer än 35 dagar efter den första dosen i den tidigare cykeln, bör man överväga att stoppa behandlingen.
• difficulty sleeping
• Svårighet att sova
RECOMMENDATIONS FOR SAFE HANDLING
REKOMMENDATIONER FÖR SÄKER HANTERING
You may need to read it again.
- Spara denna information, du kan behöva läsa den igen.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal
Innehavaren av godkännandet för försäljning ska lämna in periodiska säkerhetsrapporter för detta läkemedel i enlighet med de krav som anges i den förteckning över referensdatum för unionen (EURD-listan) som föreskrivs i artikel 107c.7 i direktiv 2001/83/EG och som offentliggjorts på webbportalen för europeiska läkemedel.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
• Ofrivillig kontakt med hud eller ögon ska omedelbart behandlas med rikliga mängder vatten.
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
FÖRBEREDELSER FÖR INTRAVENÖS ADMINISTRERING
Patients who suffer from this should avoid driving and operating machinery.
Patienter som drabbas av detta bör undvika att framföra fordon och hantera maskinell utrustning.
• you have ever had heart problems such as a heart attack, heart failure or you have had high blood pressure for a long time
• du någon gång haft problem med hjärtat (såsom hjärtinfarkt, hjärtsvikt eller om du har haft högt blodtryck under lång tid).
This type of medicine is called “chemotherapy”.
Denna typ av medicin kallas ”kemoterapi”.
If you feel dizzy or are not sure how you feel, do not drive or use any tools or machines.
Om du känner dig yr eller om du är osäker hur du reagerar ska du inte framföra fordon eller använda verktyg eller maskiner.