FrancophonIA/ELRC3.0 huggingface dataset:
English: Each hard capsule contains 180 mg temozolomide.
Croatian: Jedna tvrda kapsula sadrži 180 mg temozolomida.
English: At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia,
Croatian: Na početku drugog ciklusa doza se povećava na 200 mg/m2 ako je CTC stupanj nehematološke toksičnosti za prvi ciklus bio ≤ 2 (osim za alopeciju, mučninu i povraćanje) te ako je apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l, a broj trombocita ≥ 100 x 109/l.
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E 171), žuti željezov oksid (E 172), indigo karmin (E 132), voda.
English: Temozolomide Sandoz 5 mg hard capsules
Croatian: Temozolomid Sandoz 5 mg tvrde kapsule
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia,
Croatian: ≥ 1,5 x 109/l; broj trombocita ≥ 100 x 109/l; nehematološka toksičnost prema CTC ≤ stupnja 1 (osim alopecije,
English: Each hard capsule contains 100 mg temozolomide.
Croatian: Jedna tvrda kapsula sadrži 100 mg temozolomida.
English: Temozolomide Sandoz 20 mg hard capsules
Croatian: Temozolomid Sandoz 20 mg tvrde kapsule
English: Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
Croatian: Stomatitis, proljev, dispepsija,
English: Temozolomide Sandoz 140 mg hard capsules
Croatian: Temozolomid Sandoz 140 mg tvrde kapsule
English: Anti-emetic therapy
Croatian: Primjena antiemetika
English: Temozolomide Sandoz 140 mg hard capsules blue
Croatian: Temozolomid Sandoz 140 mg tvrde kapsule plava
English: • a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
Croatian: Obratite se svom liječniku odmah ako imate neki od sljedećih simptoma: jaku alergijsku reakciju (reakciju preosjetljivosti) (koprivnjača, piskanje pri disanju ili druge tegobe s disanjem), nekontrolirano krvarenje, napadaje (konvulzije),
English: • bronchitis
Croatian: 23. bronhitis
English: GENERAL CLASSIFICATION FOR SUPPLY
Croatian: 3. POPIS POMOĆNIH TVARI
English: Temozolomide Sandoz 5 mg capsules temozolomide
Croatian: Temozolomid Sandoz 5 mg kapsule temozolomid
English: Temozolomide Sandoz 250 mg hard capsules
Croatian: Temozolomid Sandoz 250 mg tvrde kapsule
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for
Croatian: U prvom ciklusu monoterapije TMZ se daje u dozi od 150 mg/m2
English: Temozolomide Sandoz 250 mg capsules temozolomide
Croatian: Temozolomid Sandoz 250 mg kapsule temozolomid
English: Temozolomide Sandoz 100 mg hard capsules pink
Croatian: Temozolomid Sandoz 100 mg tvrde kapsule ružičasta
English: Temozolomide Sandoz 140 mg capsules temozolomide
Croatian: Temozolomid Sandoz 140 mg kapsule temozolomid
English: Temozolomide Sandoz 20 mg capsules temozolomide
Croatian: Temozolomid Sandoz 20 mg kapsule temozolomid
English: Male fertility
Croatian: Plodnost muškaraca
English: Temozolomide Sandoz 180 mg hard capsules
Croatian: Temozolomid Sandoz 180 mg tvrde kapsule
English: In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
Croatian: žena naspram 4 % muškaraca, a trombocitopenija stupnja 4 u 8 % žena naspram 3 % muškaraca.
English: • allergic reactions.
Croatian: kožni osip alergijske reakcije.
English: Temozolomide Sandoz 250 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Temozolomid Sandoz 250 mg tvrde kapsule Sadržaj kapsule: bezvodna laktoza, koloidni bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
English: Malignancies
Croatian: angioedem
English: The hard capsules have a white coloured body, a yellow coloured cap, and are imprinted with black ink.
Croatian: Tvrde kapsule imaju bijelo tijelo sa žutom kapicom i označene su crnom tintom.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja
English: Fatigue
Croatian: žeđ
English: Temozolomide Sandoz 100 mg hard capsules
Croatian: Temozolomid Sandoz 100 mg tvrde kapsule
English: Temozolomide Sandoz 5 mg hard capsules temozolomide
Croatian: Temozolomid Sandoz 5 mg tvrde kapsule temozolomid
English: Temozolomide Sandoz 20 mg hard capsules temozolomide
Croatian: Temozolomid Sandoz 20 mg tvrde kapsule temozolomid
English: Musculoskeletal and connective tissue disorders Common:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: Hearing impairment, tinnitus
Croatian: narušena koncentracija, neuropatija,
English: Temozolomide Sandoz 140 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Temozolomid Sandoz 140 mg tvrde kapsule Sadržaj kapsule: bezvodna laktoza, koloidni bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
English: Temozolomide Sandoz 180 mg capsules temozolomide
Croatian: Temozolomid Sandoz 180 mg kapsule temozolomid
English: Neoplasm benign, malignant and unspecified
Croatian: dugotrajna pancitopenija, aplastična anemija† Dobroćudne, zloćudne i nespecificirane novotvorine
English: Temozolomide Sandoz 100 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Temozolomid Sandoz 100 mg tvrde kapsule Sadržaj kapsule: bezvodna laktoza, koloidni bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
English: Temozolomide Sandoz 140 mg hard capsules temozolomide
Croatian: Temozolomid Sandoz 140 mg tvrde kapsule temozolomid
English: Summary of events reported with temozolomide in the post-marketing setting
Croatian: Nakon stavljanja lijeka u promet zabilježene su sljedeće dodatne ozbiljne nuspojave: Tablica 6. Sažetak štetnih događaja prijavljenih nakon stavljanja temozolomida u promet*
English: Temozolomide Sandoz 250 mg hard capsules temozolomide
Croatian: Temozolomid Sandoz 250 mg tvrde kapsule temozolomid
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E 171), žuti željezov oksid (E 172), crveni željezov oksid (E 172), voda.
English: Temozolomide Sandoz 180 mg hard capsules temozolomide
Croatian: Temozolomid Sandoz 180 mg tvrde kapsule temozolomid
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E 171), žuti željezov oksid (E 172), voda.
English: The Temozolomide Sandoz dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Croatian: Ovisno o broju Vaših krvnih stanica i o tome kako podnosite lijek u svakom terapijskom ciklusu, može se prilagoditi doza Temozolomida Sandoz, odnosno odgoditi ili prekinuti davanje lijeka.
English: Temozolomide Sandoz 100 mg hard capsules temozolomide
Croatian: Temozolomid Sandoz 100 mg tvrde kapsule temozolomid
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Croatian: Vrućica, astenija, tresavica, slabost, bol, promjena osjeta okusa
English: Verovškova 57
Croatian: 34. svrbež
English: Temozolomide Sandoz 100 mg capsules temozolomide
Croatian: Temozolomid Sandoz 100 mg kapsule temozolomid
English: Capsule shell: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E 171), crveni željezov oksid (E 172), voda.
English: Micturition frequency, urinary incontinence
Croatian: Učestalo mokrenje, inkontinencija mokraće
English: Dysuria
Croatian: Doziranje
English: • difficulty concentrating
Croatian: 10. otežano gutanje
English: The hard capsules have a white coloured body, a green coloured cap, and are imprinted with black ink.
Croatian: Tvrde kapsule imaju bijelo tijelo sa zelenom kapicom i označene su crnom tintom.
English: The hard capsules have a white coloured body, a pink coloured cap, and are imprinted with black ink.
Croatian: Tvrde kapsule imaju bijelo tijelo s ružičastom kapicom i označene su crnom tintom.
English: Haemorrhage, oedema, oedema leg
Croatian: Krvarenje, edem, edem nogu
English: - organizačná zložka
Croatian: KLINIČKI PODACI
English: How to store Temozolomide Sandoz
Croatian: Moguće nuspojave Kako čuvati Temozolomid Sandoz
English: • tiredness.
Croatian: Citotoksično.
English: Otitis media, tinnitus, hyperacusis, earache
Croatian: Upala srednjeg uha, tinitus, hiperakuzija, bol u uhu
English: • weight gain
Croatian: povećanje tjelesne težine
English: Thrombocyte count
Croatian: IE-Bantry Co.
English: TMZ interruptiona
Croatian: Prekid primjene TMZ-aa
English: Temozolomide Sandoz 180 mg hard capsules maroon
Croatian: Temozolomid Sandoz 180 mg tvrde kapsule kestenjasta
English: • dry or painful eyes
Croatian: 18. poremećen ili zamagljen vid
English: The hard capsules have a white coloured body, a white coloured cap, and are imprinted with black ink.
Croatian: Tvrde kapsule imaju bijelo tijelo sa bijelom kapicom i označene su crnom tintom.
English: The hard capsules have a white coloured body, a maroon coloured cap, and are imprinted with black ink.
Croatian: Tvrde kapsule imaju bijelo tijelo sa kestenjastom kapicom i označene su crnom tintom.
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Water
Croatian: Titanijev dioksid (E171) Željezov oksid, žuti (E172) Voda
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Croatian: Stomatitis, proljev, dispepsija, disfagija,
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance disorder (NOS), peripheral neuropathy
Croatian: hipoestezija, nespecificirani neurološki poremećaj, periferna neuropatija
English: • deafness
Croatian: Dizurija
English: The hard capsules have a white coloured body, a transparent blue coloured cap, and are imprinted with black ink.
Croatian: Tvrde kapsule imaju bijelo tijelo s prozirnom plavom kapicom i označene su crnom tintom.
English: • reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia)
Croatian: smanjen broj krvnih stanica (neutropenija ili limfopenija, trombocitopenija) gubitak apetita glavobolja povraćanje mučnina (loš osjećaj u želucu)
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Water
Croatian: Titanijev dioksid (E171) Željezov oksid, žuti (E172) Željezov oksid, crveni (E172) Voda
English: Hearing impairment
Croatian: suhoća oka
English: • impaired sensations
Croatian: 15. loše osjećanje
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: Sadržaj pakiranja i druge informacije
English: condition aggravated, rigors, tongue discolouration, parosmia, thirst
Croatian: pogoršanje stanja, tresavica, promjena boje jezika, parosmija,
English: • stomach or abdominal pain
Croatian: 27. bol u želucu ili trbuhu 28. žgaravica
English: What to do if you are left-handed
Croatian: Što učiniti ako ste ljevoruki
English: • It is best to use Fuzeon at the same time each day.
Croatian: • Fuzeon je najbolje primjenjivati svakoga dana u isto vrijeme.
English: If you are left-handed, do what comes naturally to you.
Croatian: Ako ste ljevoruki, činite ono što je Vama prirodno.
English: • The other ingredients are:
Croatian: • Drugi sastojci su:
English: • This medicine has been prescribed for you only.
Croatian: • Ovaj je lijek propisan samo Vama.
English: ● Wash your hands well.
Croatian: Dobro operite ruke.
English: You will probably have one or more of the following mild to moderate reactions:
Croatian: Vjerojatno ćete dobiti jednu ili više sljedećih blagih do umjerenih reakcija:
English: • Then pull out the water again.
Croatian: • Zatim ponovno izvucite vodu.
English: As per the judgment of the investigator.
Croatian: Prema prosudbi ispitivača.
English: The pictures in this leaflet show people who are right-handed.
Croatian: Slike u ovoj uputi prikazuju osobe koje su dešnjaci.
English: They generally do not get worse after this time.
Croatian: Nakon toga se u načelu ne pogoršavaju.
English: You will probably find it most comfortable to:
Croatian: Vjerojatno će Vam biti najlakše:
English: Fuzeon with food and drink
Croatian: Fuzeon s hranom i pićem
English: This will reduce the risk of bacterial infections.
Croatian: Tako ćete umanjiti rizik od bakterijskih infekcija.
English: The clinical relevance of these findings is unknown.
Croatian: Klinički značaj ovih nalaza nije poznat.
English: Interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija provedena su samo u odraslih.
English: Pregnancy: There are no adequate and well-controlled studies in pregnant women.
Croatian: Trudnoća: Nisu provedena odgovarajuća i dobro kontrolirana ispitivanja u trudnica.
English: • Try and space the doses evenly apart at times which are good for you - for example, first thing in the morning and then in the early evening.
Croatian: • Pokušajte ravnomjerno rasporediti doze u vrijeme koje Vam odgovara - primjerice, odmah ujutro, a zatim rano navečer.
English: Take the medicine pack with you.
Croatian: Ponesite sa sobom pakiranje lijeka.
English: • Keep using your medicine until your doctor tells you to stop.
Croatian: • Nastavite primjenjivati svoj lijek dok Vam liječnik ne kaže da prestanete.
English: This may feel like lumps under the skin.
Croatian: To ćete možda osjetiti kao kvržice ispod kože.
English: Allow it to dry in the air completely.
Croatian: Pustite da se potpuno osuši na zraku.
English: 27 May 2008
Croatian: 27. svibnja 2008.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: To reduce the risk of infection, it is important that you follow the instructions provided in Section 7.
Croatian: Kako biste umanjili rizik od infekcije, važno je pridržavati se uputa navedenih u dijelu 7.
English: • not being able to concentrate
Croatian: • nemogućnost koncentracije
English: 27 May 2003
Croatian: 27. svibnja 2003.
English: However, these changes are not clinically significant and no dose adjustment is required.
Croatian: Te promjene međutim, nisu klinički značajne i nije potrebna prilagodba doze.
English: These signs do not definitely mean you are allergic to this medicine.
Croatian: Navedeni znakovi ne moraju nužno značiti da ste alergični na ovaj lijek.
English: You should not use Fuzeon unless specifically told to by your doctor.
Croatian: Ne smijete uzimati Fuzeon, osim ako Vam to izričito nije rekao Vaš liječnik.
English: The signs and symptoms generally lasted equal to or less than 7 days.
Croatian: Znakovi i simptomi obično su trajali 7 dana ili manje.
English: Make sure you never touch the needle with your fingers or anything else.
Croatian: Pazite da iglu nikada ne dodirnete prstima niti bilo čime
English: Contents of the box:
Croatian: Sadržaj kutije:
English: Signs of previous infections
Croatian: Znakovi prethodnih infekcija
English: Date of latest renewal:
Croatian: Datum posljednje obnove:
English: If you touch them, make sure you clean them again.
Croatian: Ako ih dodirnete, svakako ih ponovno očistite.
English: Your doctor should discuss this with you at that time.
Croatian: Liječnik treba o tome razgovarati s Vama kada za to dođe vrijeme.
English: • hold the syringe in your left hand and
Croatian: ● držati štrcaljku u lijevoj ruci i
English: • changes shown in blood tests (increased blood fat)
Croatian: • promjene koje se vide na krvnim pretragama (povećana razina masnoća u krvi)
English: • The HIV virus in your blood may eventually become resistant to Fuzeon.
Croatian: • HIV virus u Vašoj krvi može naposljetku postati otporan na Fuzeon.
English: Other medicines and Fuzeon
Croatian: Drugi lijekovi i Fuzeon
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primijenite ovaj lijek.
English: Reactions may be worse when injections are repeated in the same place on the body.
Croatian: Reakcije mogu biti teže ako se injekcije ponavljano primjenjuju na istom mjestu na tijelu.
English: It is believed that these symptoms are due to a recovery of the body's immune system.
Croatian: Vjeruje se da su ti simptomi posljedica oporavka imunološkog sustava organizma.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 5°C when protected from light.
Croatian: Dokazana je kemijska i fizikalna stabilnost u primjeni tijekom 48 sati na temperaturi od 5°C kada je zaštićen od svjetlosti.
English: You can use Fuzeon with or without food.
Croatian: Fuzeon možete primjenjivati s hranom ili bez nje.
English: Long-term animal carcinogenicity studies have not been performed.
Croatian: Nisu provedena dugotrajna istraživanja kancerogenosti na životinjama.
English: • Do not take a double dose to make up for a forgotten dose.
Croatian: • Nemojte primijeniti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: • Do not breast-feed if you have HIV because HIV may be passed on to the baby.
Croatian: • Ne smijete dojiti ako imate HIV jer se HIV može prenijeti na dijete.
English: • If you forget to use a dose, use it as soon as you remember it.
Croatian: • Ako zaboravite primijeniti dozu, primijenite je čim se sjetite.
English: Speak with your doctor if you have a history of liver disease.
Croatian: Razgovarajte sa svojim liječnikom ako u povijesti bolesti imate jetrenu bolest.
English: If you need help, ask your partner, a friend, or a family member.
Croatian: Ako trebate pomoć, zamolite partnera, prijatelja ili člana obitelji.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
English: Discontinued due to other reasons†φ§
Croatian: Prekinuli liječenje zbog drugih razloga†φ§
English: They may also be worse when the injection is given deeper than intended (for example, into a muscle).
Croatian: Mogu se pogoršati i ako se injekcija primijeni dublje nego što treba (primjerice u mišić).
English: OB (N=334)
Croatian: OT (N=334)
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Croatian: Kako bi se spriječio prijenos moraju se poduzeti mjere opreza u skladu s nacionalnim smjernicama
English: When to have someone to help you
Croatian: Kada će Vam biti potrebna pomoć druge osobe
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Croatian: Ova Uputa o lijeku je dostupna na svim EU/EEA jezicima na web stranicama Europske agencije za lijekove.
English: After reconstitution: Store in a refrigerator (2°C - 8°C).
Croatian: Nakon rekonstitucije: Čuvati u hladnjaku (2°C - 8°C).
English: This is less likely if you use it regularly and without gaps in treatment.
Croatian: Vjerojatnost za to je manja ako lijek primjenjujete redovito i bez prekida u liječenju.
English: Confidence Interval p-value
Croatian: Interval pouzdanosti p vrijednost
English: HIV attacks cells in your blood called CD4 or T-cells.
Croatian: HIV napada stanice u krvi koje se zovu CD4 ili T-stanice.
English: - Then pull out the liquid again.
Croatian: - Zatim ponovno izvucite tekućinu.
English: - Make sure you have 1.0 ml of liquid in the syringe (or whatever amount your doctor prescribed, if it is different).
Croatian: - Pazite da u štrcaljki imate 1,0 ml tekućine (ili onu količinu koju je propisao liječnik, ako je različita).
English: This may result in a false positive HIV test with the anti-HIV ELISA test.
Croatian: Ovo može rezultirati lažno pozitivnim nalazom HIV testa koji se provodi anti-HIV ELISA metodom.
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you have any of these reactions do not stop using Fuzeon, but talk to your doctor about any concerns you have.
Croatian: Ako se pojavi neka od tih reakcija, nemojte prestati primjenjivati Fuzeon, ali razgovarajte s liječnikom o svemu što Vas brine.
English: - You will hear a click.
Croatian: - Čut ćete škljocaj.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: Tip: Your doctor or nurse may suggest different injection techniques that will work best for you.
Croatian: Savjet: liječnik ili medicinska sestra mogu predložiti i druge tehnike injiciranja koje će Vama najbolje odgovarati.
English: Pharmacotherapeutic group: Other antivirals, ATC code: J05AX07
Croatian: Farmakoterapijska skupina: Ostali antivirotici, ATK oznaka: J05AX07
English: This is attached to the needle and covers it after use to lower the risk of the needle accidently pricking another person.
Croatian: On je nataknut na iglu i prekriva je nakon uporabe kako bi se smanjio rizik da se druga osoba slučajno ubode.
English: 4% N/A
Croatian: 4% N/D
English: Push the needle into the skin at a 45-degree angle.
Croatian: Ubodite iglu u kožu pod kutom od 45 stupnjeva.
English: Stop using Fuzeon and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Croatian: Prestanite primjenjivati Fuzeon i odmah potražite liječničku pomoć ako primijetite neku od sljedećih ozbiljnih nuspojava - možda će Vam biti potrebno hitno liječenje:
English: 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 web-portal
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: If you use more Fuzeon than you should
Croatian: Ako primijenite više lijeka Fuzeon nego što ste trebali
English: In case a Fuzeon dose is missed, patients should be instructed to administer the dose as soon as possible.
Croatian: U slučaju da propuste dozu lijeka Fuzeon, bolesnike je potrebno uputiti da primijene dozu što je prije moguće.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ako rekonstitucija nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: Elderly: There is no experience in patients > 65 years old.
Croatian: Starije osobe: Nema iskustva u bolesnika starijih od 65 godina.