FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Imlygic 108 PFU/mL injection talimogene laherparepvec
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Imlygic 108 PFU/ml injekcija talimogene laherparepvec
English: Ear pain
Croatian: Bol u uhu
English: Durable response rate Primary
Croatian: Učestalost održivog odgovora
English: Imlygic 106 plaque forming units (PFU)/mL solution for injection Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 x 106 (1 million) plaque forming units (PFU)/mL
Croatian: Imlygic 106 jedinica formiranih plakova (PFU)/ml, otopina za injekciju Svaka bočica sadrži 1 ml primjenjivog volumena lijeka Imlygic nominalne koncentracije 1 x 106 (1 milijun) jedinica formiranih plakova (PFU, od engl. plaque forming units)/ml Imlygic 108 jedinica formiranih plakova (PFU)/ml, otopina za injekciju Svaka bočica sadrži 1 ml primjenjivog volumena lijeka Imlygic nominalne koncentracije1 x 108 (100 milijuna) jedinica formiranih plakova (PFU)/ml.
English: GRH0149v1
Croatian: GRH0277HR
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Imlygic 106 PFU/mL injection talimogene laherparepvec
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Imlygic 106 PFU/ml injekcija talimogene laherparepvec
English: Obstructive airway disorder has been reported following Imlygic treatment.
Croatian: Nakon liječenja lijekom Imlygic prijavljena je opstruktivna bolest dišnih puteva.
English: Talimogene laherparepvec is degraded by typical endogenous protein
Croatian: Virus talimogene laherparepvec se razgrađuje uobičajenim
English: NAME OF THE MEDICINAL PRODUCT Imlygic 106 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Croatian: Imlygic 106 jedinica formiranih plakova (PFU)/ml otopina za injekciju talimogene laherparepvec
English: Treatment visit
Croatian: Posjeti tijekom liječenja
English: 106 (1 million) PFU/mL 108 (100 million) PFU/mL
Croatian: 106 (1 milijun) PFU/ml
English: NAME OF THE MEDICINAL PRODUCT Imlygic 108 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Croatian: Imlygic 108 jedinica formiranih plakova (PFU)/ml otopina za injekciju talimogene laherparepvec
English: • Thaw Imlygic vial(s) at room temperature.
Croatian: • Odmrznite bočicu/e lijeka Imlygic na sobnoj temperaturi.
English: Very commonly, flu-like illnesses, fevers and chills have been seen in patients treated with Imlygic.
Croatian: U bolesnika liječenih lijekom Imlygic vrlo su često opažene bolest nalik gripi, vrućica i zimica.
English: Cutaneous lesions
Croatian: Kožne lezije
English: Impaired healing at the injection site
Croatian: Otežano zacjeljivanje na mjestu injiciranja
English: Exterior of the occlusive dressing Oral mucosa
Croatian: Mjesto injiciranja Vanjski dio okluzivnog zavoja Oralna sluznica Anogenitalno područje
English: No viral activity was detected in samples of the occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.
Croatian: U uzorcima okluzivnih zavoja, oralne sluznice, anogenitalnog područja i sumnjivih herpetičkih lezija nije detektirana aktivnost virusa.
English: These agents may interfere with the effectiveness of Imlygic if administered systemically or topically directly to the injection site.
Croatian: Ako se primijene sustavno ili topikalno izravno na mjesto injiciranja, ti lijekovi mogu interferirati s djelotvornosti lijeka Imlygic.
English: Life-threatening herpes infection may occur in patients with weakened immune systems.
Croatian: U bolesnika s oslabljenim imunološkim sustavom mogu se javiti po život opasne infekcije herpes virusom.
English: Obstructive airways disorder
Croatian: Opstruktivna bolest dišnih puteva
English: The risks and benefits of Imlygic should be considered before continuing treatment if persistent infection or delayed healing develops.
Croatian: Ako se razvije perzistentna infekcija ili usporeno zacjeljivanje, potrebno je razmotriti rizike i koristi lijeka Imlygic prije nego što nastavite s liječenjem.
English: Pre-injection
Croatian: Prije injiciranja
English: Nodal lesions
Croatian: Prijavljivanje nuspojava
English: Gently swirl.
Croatian: Lezije u limfnim čvorovima
English: 34 Commerce Way
Croatian: - Subsidiary of Amgen, Inc. 34 Commerce Way
English: EU Number
Croatian: EU broj odobrenja
English: MA (EU) Number (Invented) Name
Croatian: Broj (EU) odobrenja
English: Pharmaceutical Form Route of Administration
Croatian: Doza Farmaceutski oblik
English: Strength
Croatian: Put primjene
English: 2 years
Croatian: 2 godine
English: For more information, please consult:
Croatian: Za dodatne informacije, molimo pogledajte:
English: Do not warm Strensiq in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Nemojte Strensiq zagrijavati na neki drugi način (primjerice, nemojte ga zagrijavati u mikrovalnoj pećnici ili u vrućoj vodi).
English: Progress through Tanner stages appeared appropriate.
Croatian: Razvoj se, prema Tannerovim stupnjevima, činio odgovarajućim.
English: Talk to your doctor if you notice any change in the shape of your infant's head.
Croatian: Obratite se liječniku ako opazite bilo kakvu promjenu u obliku glave svoga dojenčeta.
English: • The dose you receive is based on your body weight.
Croatian: • Doza koju primate temelji se na Vašoj tjelesnoj težini.
English: Always follow the instructions provided by your doctor.
Croatian: Uvijek se pridržavajte uputa koje Vam je dao liječnik.
English: Before injecting Strensiq, please read the following instructions carefully
Croatian: Prije ubrizgavanja Strensiqa, molimo da pažljivo pročitate sljedeće upute
English: Pain in hands and feet
Croatian: • bol u šakama i stopalima
English: The current medical standards for emergency treatment should be observed.
Croatian: Treba se pridržavati postojećih medicinskih standarda za hitno liječenje.
English: Body Weight (kg)
Croatian: Tjelesna težina (kg)
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC {number}
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC {broj}
English: These effects were restricted to injection sites and were partially or completely reversible.
Croatian: Ti su učinci bili ograničeni na mjesta injiciranja i bili su djelomično ili potpuno reverzibilni.
English: Pay attention not to hurt yourself with the needle.
Croatian: Budite pažljivi da se ne ozlijedite iglom.
English: There is potential for immunogenicity.
Croatian: Postoji mogućnost imunogenosti.
English: Chemical and physical in-use stability has been demonstrated for up to 3 hours at a temperature between 23°C to 27°C.
Croatian: Kemijska i fizikalna stabilnost u primjeni dokazana je u trajanju do 3 sata na temperaturi između 23°C i 27°C.
English: Do not inject this medicine yourself unless you have received training and you understand the procedure.
Croatian: Nemojte sami ubrizgavati ovaj lijek, osim ako ste za to bili uvježbani i znate postupak.
English: Lonza Biologics 101 International Drive Pease International Tradeport 03801 Portsmouth United States
Croatian: Lonza Biologics 101 International Drive Pease International Tradeport 03801 Portsmouth Sjedinjene Američke Države
English: Educational materials for patients and caregivers shall contain the following key messages:
Croatian: Edukacijski materijali za bolesnike i one koji skrbe o bolesnicima sadržavat će sljedeće ključne poruke:
English: Check with your doctor, pharmacist or nurse if you are not sure.
Croatian: Provjerite s liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: Rotation of injection sites may help to minimize these reactions.
Croatian: Izmjena mjesta primjene injekcije može pomoći minimizirati te reakcije.
English: An aseptic technique should be used.
Croatian: Potrebno je primijeniti aseptičnu tehniku.
English: Annually within annual reassessment
Croatian: Godišnja izvješća unutar godišnjih procjena
English: Green (x2)
Croatian: zelena (x2)
English: SN {number}
Croatian: SN {broj}
English: You are now ready to inject the correct dose.
Croatian: Sada ste spremni primijeniti točnu dozu.
English: Craniosynostosis can lead to increased intracranial pressure.
Croatian: Kraniosinostoza može dovesti do povišenog intrakranijalnog tlaka.
English: Strensiq may cause some tests to show wrongly higher or lower results.
Croatian: Strensiq može prouzročiti da neki testovi pogrešno pokažu više ili niže rezultate.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj se lijek ne smije miješati s drugim lijekovima.
English: • Information on cold chain management for Strensiq during storage and travel
Croatian: • informacije o održavanju hladnog lanca za Strensiq tijekom pohrane i prijevoza
English: The adolescent (and adult) patients in this study did not display apparent height-gain.
Croatian: Adolescentni (i odrasli) bolesnici u ovom ispitivanju nisu pokazali očito povećanje visine.
English: Most injection site reactions were mild and selflimiting, and the majority (> 99%) were reported as non-serious.
Croatian: Većina tih reakcija bile su blage i samoograničavajuće i većinom su (> 99%) bile zabilježene kao nuspojave koje nisu ozbiljne.
English: • Instructions on the correct dose to be administered
Croatian: • upute o pravilnoj dozi koju treba primijeniti
English: It is expected that pharmacokinetic exposures will increase with body weight.
Croatian: Očekuje se da da će se farmakokinetičke izloženosti povećavati s težinom.
English: These reference data were drawn from a representative sample of healthy children and are not specific for children with special health care needs: they have been used in the absence of growth charts for children with hypophosphatasia.
Croatian: Referentni podaci dobiveni su na reprezentativnom uzorku zdrave djece i nisu specifični za djecu s posebnim zdravstvenim potrebama: ti su podaci upotrijebljeni u nedostatku dijagrama rasta za djecu s hipofosfatazijom.
English: Patients can self-inject only if they have properly been trained on administration procedures.
Croatian: Bolesnici mogu sami sebi davati injekcije samo ako su bili pravilno uvježbani u postupcima primjene.
English: After being trained by the doctor or specialized nurse, you can inject Strensiq yourself at home.
Croatian: Nakon što Vas uvježba liječnik ili specijalizirana medicinska sestra, Strensiq možete primjenjivati sami sebi kod kuće.
English: Pack sizes of 1 or 12 vials.
Croatian: Veličine pakiranja su od 1 ili 12 bočica.
English: Nomenclature, symbols and units followed recommendations of the American Society for Bone and Mineral Research.
Croatian: Nomenklatura, simboli i jedinice slijedili su preporuke Američkog udruženja za istraživanje kostiju i minerala (engl.
English: NOTE: do not use any areas in which you feel lumps, firm knots, or pain; talk to your doctor about anything you find.
Croatian: Nemojte davati injekciju u dijelove na kojima osjećate kvrge, čvrste čvorove ili bol; obavijestite svog liječnika o svemu što opazite.
English: After opening the vial, the product should be used immediately (within 3 hours maximum).
Croatian: Nakon otvaranja bočice, lijek se mora primijeniti odmah (najviše unutar 3 sata).
English: Fluctuation in height-gain was apparent and may reflect the more severe disease and higher rate of morbidity in these younger patients.
Croatian: Fluktuacija u povećanju visine bila je očita i može odražavati teži oblik bolesti i veću stopu morbiditeta u tih mlađih bolesnika.
English: Store in the original pack in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from asfotase alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja asfotazom alfa uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: If you need a second injection for your prescribed dose, get another Strensiq vial and repeat steps 1 through 4.
Croatian: Ako Vam je za propisanu dozu potrebna još jedna injekcija, uzmite drugu bočicu Strensiqa i ponovite postupak od 1. do 4. koraka.
English: Of these 11 patients, 9 patients had their doses increased specifically to improve clinical response.
Croatian: Od tih 11 bolesnika, u 9 bolesnika doze su povećane uglavnom radi poboljšanja kliničkog odgovora.
English: The mean age at sign/symptom onset was 1.49 months.
Croatian: Srednja vrijednost dobi pri pojavi znakova/simptoma bila je 1,49 mjeseci.
English: The antibody response (with or without presence of neutralizing antibodies) was time variant in nature.
Croatian: Odgovor protutijela (s prisutnim neutralizirajućim protutijelima ili bez njih) mijenjao se se vremenom.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: Preclinical fertility studies were conducted and showed no evidence of effect on fertility and embryo-fetal development.
Croatian: Provedena su neklinička ispitivanja plodnosti i nisu dala nikakav dokaz o učinku na plodnost i embriofetalni razvoj.
English: NN {number}
Croatian: NN {broj}
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza ili reproduktivne i razvojne toksičnosti.
English: Alkaline Phosphatase (ALP) is used as the detection reagent in many routine laboratory assays.
Croatian: Alkalna fosfataza (ALP) služi kao reagens za detekciju u mnogim rutinskim laboratorijskim testovima.
English: If you experience any severe reaction at the injection site, tell your doctor immediately.
Croatian: Ako Vam se pojavi bilo kakva teška reakcija na mjestu primjene injekcije, odmah obavijestite liječnika.
English: Take the unopened Strensiq vial(s) out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature.
Croatian: Izvadite neotvorenu bočicu (ili bočice) Strensiqa iz hladnjaka 15 do 30 minuta prije primjene kako bi tekućina dosegla sobnu temperaturu.
English: If you use more Strensiq than you should
Croatian: Ako primijenite više lijeka Strensiq nego što ste trebali
English: The MAH shall ensure that in each Member State where Strensiq is marketed all patients/parents or caregivers who are expected to use Strensiq are provided with the following educational package:
Croatian: Nositelj odobrenja osigurat će da u svakoj državi članici u kojoj je Strensiq stavljen na tržište, svi bolesnici/roditelji ili oni koji skrbe o bolesnicima, a za koje se očekuje da će davati Strensiq, dobiju sljedeći edukacijski paket:
English: • When injecting regularly, the injection site should be changed between different areas of the body to help reduce potential pain and irritation
Croatian: • Kada se injekcije primjenjuju redovito, injekcije treba davati na različita mjesta na tijelu kako bi se smanjila mogućnost pojave bola i nadraženosti.
English: Most suitable areas for injection are marked grey in the picture.
Croatian: Mjesta najpogodnija za davanje injekcije označena su na slici sivom bojom.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: If these reactions occur, immediate discontinuation of treatment is recommended and appropriate medical treatment should be initiated.
Croatian: Ako se ove reakcije dogode, preporučuje se odmah prekinuti liječenje i započeti odgovarajuće liječenje.
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Croatian: Budući je ovo odobrenje za stavljanje lijeka u promet u iznimnim okolnostima, sukladno članku 14. stavku 8. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: It is not intended for intravenous or intramuscular injection.
Croatian: Nije namijenjen za primjenu kao intravenska ili intramuskularna injekcija.
English: Thirty-eight patients were treated for at least 2 years (24 months) and 6 patients have been treated for at least 5 years (60 months).
Croatian: Trideset i osam bolesnika bilo je liječeno najmanje 2 godine (24 mjeseca), a 6 bolesnika liječeno je najmanje 5 godina (60 mjeseci).
English: Histological analysis of biopsies used Osteomeasure software (Osteometrics, USA).
Croatian: Histološka analiza biopsije provedena je softverom Osteomeasure (Osteometrics, SAD).
English: Always use a new syringe contained in a protective plastic.
Croatian: 4. Uvijek upotrijebite novu štrcaljku koja se nalazi u zaštitnom plastičnom omotu.
English: Prior to launch of Strensiq in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije puštanja Strensiqa u promet, nositelj odobrenja svake države članice mora se usuglasiti s nacionalnim regulatornim tijelom oko sadržaja i oblika edukacijskog programa, uključujući načine priopćavanja, modalitete distribucije i sve druge aspekte programa.
English: In clinical trials, the development of antibodies has not been shown to affect clinical efficacy or safety (see section 5.2).
Croatian: U kliničkim se ispitivanjima nije pokazalo da razvoj protutijela utječe na kliničku djelotvornost ili sigurnost (vidjeti dio 5.2).
English: Ectopic calcification
Croatian: Ektopična kalcifikacija
English: Common: may affect up to 1 in 10 people Chills
Croatian: Često: mogu se javiti u do 1 na 10 osoba
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB13
Croatian: Farmakoterapijska skupina: drugi lijekovi za probavni sustav i metabolizam, enzimi, ATK oznaka: A16AB13
English: After removing the bubbles, check the dose of medication in the syringe to be sure you have drawn up the correct amount.
Croatian: Kada su mjehurići uklonjeni, provjerite dozu lijeka u štrcaljki kako biste se uvjerili da ste izvukli točnu količinu.
English: * produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Croatian: * Proizvedeno tehnologijom rekombinantne DNK iz kulture stanica jajnika kineskog hrčka (CHO).
English: What Strensiq is and what it is used for What you need to know before you use Strensiq How to use Strensiq
Croatian: Što je Strensiq i za što se koristi Što morate znati prije nego počnete primjenjivati Strensiq Kako primjenjivati Strensiq
English: The effects of asfotase alfa on x-ray appearance
Croatian: Učinci asfotaze alfa na izgled rendgenske snimke
English: Your doctor, pharmacist or nurse will advise you on how you can obtain a sharps container.
Croatian: Liječnik, ljekarnik ili medicinska sestra reći će Vam kako da nabavite takav spremnik.
English: For patients who have little fat under the skin or thin skin, a 45º angle may be preferable.
Croatian: U bolesnika koji imaju malo potkožnog masnog tkiva ili tanku kožu, može biti pogodniji kut od 45º.
English: This will help seal the punctured tissue and prevent any leakage.
Croatian: To će pomoći u zatvaranju uboda i spriječiti curenje.
English: The average ± SD elimination half-life following subcutaneous administration was 2.28 ± 0.58 days.
Croatian: Prosječni ± SD poluvijek eliminacije nakon supkutane primjene iznosio je 2,28 ± 0,58 dana.
English: Patients should be monitored for recurrence of signs and symptoms of a severe hypersensitivity reaction.
Croatian: Bolesnike treba nadzirati zbog moguće ponovne pojave znakova i simptoma teške reakcije preosjetljivosti.
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će svake godine procjenjivati nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: Dietary supervision is recommended.
Croatian: Preporučuje se nadzirati prehranu.
English: Adverse reactions with asfotase alfa are listed by system organ class and preferred term using MedDRA frequency 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) and not known (cannot be estimated from the available data).
Croatian: Nuspojave opažene za asfotazu alfa navedene su prema klasifikaciji organskih sustava i preporučenom izrazu na temelju MedDRA-inog prikaza učestalosti nuspojava 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • Injection guide for parents or caregivers with infant patients
Croatian: • Upute za davanje injekcija za roditelje ili skrbnike male djece.
English: If you need to undergo laboratory tests (giving blood for testing), tell your doctor that you are treated with Strensiq.
Croatian: Ako morate napraviti laboratorijske pretrage (davanje uzoraka krvi), kažite liječniku da se liječite lijekom Strensiq.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Strensiq in one or more subsets of the paediatric population in hypophosphatasia (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Strensiq u jednoj ili više podskupina pedijatrijske populacije s hipofosfatazijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Should you experience anaphylactic reaction, or an event with similar symptoms, your doctor will discuss with you the next steps and the possibility to restart Strensiq under medical supervision.
Croatian: • U slučaju nastupa anafilaktične reakcije ili događaja sa sličnim simptomima, s liječnikom ćete razmotriti sljedeće korake u liječenju te mogućnost da ponovno počnete primjenjivati Strensiq pod medicinskim nadzorom.
English: Always use this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako su Vam rekli liječnik, ljekarnik ili medicinska sestra.
English: The MAH should set up an observational, longitudinal, prospective, long-term registry of patients with HPP to collect information on the epidemiology of the disease, including clinical outcomes and quality of life, and to evaluate safety and effectiveness data in patients treated with Strensiq.
Croatian: Nositelj odobrenja će uspostaviti opservacijski, longitudinalni, prospektivni, dugoročni registar bolesnika s HPP-om kako bi se prikupljali podaci o epidemiologiji bolesti, uključujući kliničke ishode i kvalitetu života, te procjenjivali podaci o sigurnosti i djelotvornosti u bolesnika liječenih Strensiqom.