FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the Agency's view was that, as for Cortavance, the benefit of Cortacare outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od VMP-a Cortacare, kao i od VMP-a Cortavance, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Why is Cortacare authorised in the EU?
Croatian: Zašto je VMP Cortacare odobren u EU-u?
English: Because Cortacare is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Cortacare hibridni VMP, smatra se da su njegove koristi i rizici jednaki onima utvrđenima za referentni VMP.
English: Two sprays is sufficient to treat an area of skin 10 cm by 10 cm. Care should be taken to avoid spraying the eyes of the dog.
Croatian: Dva raspršivanja dovoljna su za liječenje područja kože veličine 10 cm puta 10 cm.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Cortacare, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava, kao i u uputi o VMP-u Cortacare, nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For more information about using Cortacare, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Cortacare pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: How has Cortacare been studied?
Croatian: Kako se Cortacare primjenjuje?
English: The reference medicine for Cortacare is Cortavance.
Croatian: Referentni lijek za VMP Cortacare je Cortavance.
English: Cortacare is available as a spray and can only be obtained with a prescription.
Croatian: VMP Cortacare dostupan u obliku spreja i izdaje se samo na veterinarski recept.
English: How is Cortacare used?
Croatian: Kako djeluje Cortacare?
English: EU/1/19/1383/028 Lacosamide UCB 50 / 100/
Croatian: EU/1/19/1383/028 Lakozamid UCB 50 / 100 / mg
English: Treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Croatian: Pakiranje za početak liječenja: 14 tableta + 14 tableta + 14 tableta + 14 tableta
English: 1 bottle + 1 measuring cup + 1 oral syringe + 1 adaptor
Croatian: 1 boca + 1 mjerna čaša + 1 štrcaljka za usta + 1 adapter
English: Film-coated tablet Oral use
Croatian: Filmom obložena tableta
English: 5 vials
Croatian: 200 ml
English: Syrup
Croatian: 28 tablete
English: December 2018
Croatian: prosinac 2018
English: - information about:
Croatian: - informacije o:
English: Do not open before use.
Croatian: Nemojte otvarati prije uporabe.
English: Not known (cannot be estimated from available data)
Croatian: - Nepoznato (ne može se utvrditi iz postojećih podataka)
English: Place it subcutaneously if possible.
Croatian: Postavite ga supkutano, ako je to moguće.
English: EU/1/08/489/001 EU/1/08/489/002
Croatian: EU/1/08/489/002
English: Grounds for one additional renewal
Croatian: Temelji za jednu dodatnu obnovu
English: • Use of this medicine does not guarantee fusion.
Croatian: • Uporaba ovog lijeka ne jamči fuziju.
English: 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: vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100), rijetko (1/10 000 do <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • the recommended manner of placement of the material together with some comments on the importance of local haemostasis
Croatian: • preporučenog načina postavljanja materijala zajedno s komentarima o važnosti lokalne hemostaze
English: Not surprisingly, the antibody peak concentration was higher after the second exposure.
Croatian: Nije iznenađujuće da su vršne koncentracije protutijela bile više nakon drugog izlaganja.
English: Date of first authorisation: 19 February 2009 Date of renewal: 19 February 2014
Croatian: Datum prvog odobrenja: 19. veljače 2009.
English: Opgenra must not be used in patients who:
Croatian: Opgenra se ne smije koristiti kod bolesnika koji:
English: Do not place a drain directly in the implant or fusion site.
Croatian: Nemojte postavljati dren izravno na mjesto implantata ili fuzije.
English: It is possible they may impair the effectiveness of this medicine or cause an immune system response.
Croatian: Moguće je da ona smanje učinkovitost ovog lijeka ili prouzroče odgovor imunološkog sustava.
English: Indeed, there has been a limited exposure due to a recent and limited marketing of the product (launched in the EU only in August 2011 and marketed in only few Member States).
Croatian: Uistinu, izloženost ovog lijeka ograničena je zbog nedavnog i ograničenog puštanja u promet (lijek je pušten na tržište EU-a u kolovozu 2011., a dostupan je na tržištu nekoliko država članica).
English: Do not insert a needle through the stoppers.
Croatian: Nemojte umetati iglu kroz čepove.
English: For intraosseous use.
Croatian: Za intraosealnu primjenu.
English: The collagen matrix is insoluble and consists of particles with a size range of 75-425µm.
Croatian: Kolagenski matriks je netopiv i sastoji se od čestica veličine od 75 do 425 µm.
English: - if you have an active infection in your spine or have been told that you have an active internal
Croatian: - ako imate aktivnu infekciju na kralježnici ili Vam je rečeno da imate aktivnu internu (sistemsku)
English: Other medicines and Opgenra
Croatian: Drugi lijekovi i Opgenra
English: Additional surgeries may be needed.
Croatian: Mogu biti potrebni dodatni kirurški zahvati.
English: Opgenra is intended only for single use in each patient.
Croatian: Opgenra je namijenjena samo za jednokratnu uporabu na jednom bolesniku.
English: This is normally done under a full general anaesthetic so you will not be awake during the surgery.
Croatian: To se uobičajeno provodi pod općom anestezijom pa tijekom kirurškog zahvata nećete biti budni.
English: The CHMP recommend an additional five-year renewal based on the following pharmacovigilance grounds: the clinical experience with the product in the designated indication has been very limited in the EU during the first 5-year period of marketing authorisation.
Croatian: CHMP preporučuje dodatnu petogodišnju obnovu na temelju sljedećih razloga vezanih za farmakovigilanciju: tijekom prvih pet godina nakon puštanja lijeka u promet kliničko iskustvo s lijekom za određene indikacije u EU-u je vrlo ograničeno.
English: The maximum dose of this medicine should not exceed 2 units (6.6 mg eptotermin alfa) since its effectiveness and safety in higher doses has not been studied.
Croatian: Maksimalna doza ovog lijeka ne smije premašiti dvije jedinice (6,6 mg eptotermina alfa) jer njegova djelotvornost i neškodljivost pri višim dozama nisu proučavane.
English: The clinical significance of these antibodies is not known.
Croatian: Klinički značaj tih protutjela nije poznat.
English: - if you have inadequate skin coverage and inadequate blood supply at the site of surgery (your doctor should have told you if this is the case).
Croatian: infekciju. - imate neodgovarajuću pokrivenost kožom i neodgovarajuću opskrbu krvlju na mjestu kirurškog zahvata (liječnik Vam je trebao reći ako je to slučaj).
English: Treatment requires a single surgery.
Croatian: Liječenje zahtijeva jedan kirurški zahvat.
English: • There is a possibility that new antibodies can form in your body when this medicine is used.
Croatian: • Postoji mogućnost stvaranja novih protutijela u tijelu nakon liječenja ovim lijekom.
English: The same procedure should be used to prepare the medicinal product for the contralateral side of the spine.
Croatian: Isti postupak treba koristiti za pripremu lijeka za kontralateralnu stranu kralježnice.
English: Women of childbearing potential
Croatian: Žene s reproduktivnim potencijalom
English: Within the test group, 26% of patients produced antibodies with neutralizing capacity versus 1% in the control group.
Croatian: Unutar testne skupine 26% bolesnika stvorilo je protutijela s neutralizirajućim kapacitetom naspram 1% bolesnika u kontrolnoj skupini.
English: However, results from implantation studies in animals demonstrate that the active substance eptotermin alfa is released from the implant site over several weeks and never reaches a level higher than 3% of the total amount implanted in the peripheral blood.
Croatian: Međutim, rezultati ispitivanja implantacije na životinjama ukazuju da se djelatna tvar eptotermin alfa otpušta s mjesta implantacije tijekom nekoliko tjedana i nikada ne dostiže razinu veću od 3% od ukupne ugrađene količine u perifernoj krvi.
English: In a clinical study of the medicinal product, antibodies to the protein eptotermin alfa were detected in 194 out of 207 (94%) patients treated with it and 18 out of 86 (21%) treated with autograft bone (control group).
Croatian: U kliničkim ispitivanjima lijeka protutijela na protein eptotermin alfa detektirana su kod 194 od 207 bolesnika (94%) liječenih lijekom i kod 18 od 86 (21%) liječenih autolognim koštanim presatkom (kontrolna skupina).
English: The edges of the crimp caps are sharp and may cut or damage gloves.
Croatian: Rubovi kapica su oštri i mogu razrezati ili oštetiti rukavice.
English: Antibodies to OP-1 and bovine bone collagen type 1 were found after both exposures.
Croatian: Protutijela na OP-1 i goveđi koštani kolagen tipa 1 nađeni su nakon oba izlaganja.
English: A small quantity (one unit) of this medicine is reconstituted and placed directly on each side of the spine at the site requiring fusion.
Croatian: Mala količina (jedna jedinica) ovog lijeka se priprema i stavlja izravno na svaku stranu kralježnice na mjesto kojemu je potrebna fuzija.
English: Common: post-operative infection
Croatian: Često: postoperativna infekcija
English: Opgenra is an osteoinductive and osteoconductive medicinal product.
Croatian: Opgenra je osteoinduktivan i osteokonduktivan lijek.
English: Olympus Biotech Corporation 9 Technology Drive West Lebanon NH 03784 USA
Croatian: Olympus Biotech Corporation 9 Technology Drive West Lebanon NH 03784 SAD
English: The results of radiological and histological examinations in this study showed bone healing following the initial and repeat exposure in the same animal.
Croatian: Rezultati radioloških i histoloških pretraga u ovom ispitivanju pokazali su zacjeljivanje kosti u početnoj i ponovljenoj izloženosti za iste životinje.
English: • the preparation of the selected paraspinal site where the intended implantation will occur
Croatian: • pripreme odabranog paraspinalnog mjesta na kojem će se obaviti planirana implantacija
English: In another study a difference in body weight gain was seen in the immunized adult females between lactation days 14 to 21 when compared to the control animals.
Croatian: U drugoj studiji uočena je razlika u porastu tjelesne težine u imuniziranih odraslih ženki između 14. i 21. dana laktacije u usporedbi sa životinjama iz kontrolne skupine.
English: This leaflet was last revised in <Month YYYY>.
Croatian: Ova uputa posljednji je put revidirana u <mjesec GGGG>.
English: The MAH shall agree the details of an education programme for surgeons with the National Competent Authorities and must implement such programme nationally to ensure that:
Croatian: Nositelj odobrenja obavezuje se dogovoriti sve pojedinosti edukacijskog programa za kirurge s nadležnim državnim tijelima i mora implementirati takav program na državnoj razini kako bi se osiguralo da:
English: 4 vials:
Croatian: 4 bočice:
English: Opgenra has no known pharmacological effect on neuro-motor coordination or performance consequently it is unlikely to alter any pre-existing skills used for driving vehicles or operating machines.
Croatian: Opgenra nema poznat farmakološki učinak na neuromotoričku koordinaciju ili performanse pa nije vjerojatno da može promijeniti postojeće vještine koje se koriste za upravljanje vozilima ili strojevima.
English: It is recommended that breast-feeding be discontinued following treatment.
Croatian: Preporučljivo je da se dojenje prekine nakon liječenja.
English: An updated RMP should be submitted
Croatian: Nadalje, nadopunjeni RMP treba dostaviti:
English: The hospital pharmacist or surgeon is responsible for the correct storage of this medicine both before and during its use, as well as for its correct disposal.
Croatian: Bolnički farmaceut ili kirurg odgovoran je za ispravno čuvanje lijeka kako prije tako i za vrijeme njegove primjene, te također i za njegovo propisno zbrinjavanje.
English: This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it.
Croatian: Ta skupina lijekova uzrokuje rast nove kosti na mjestu na kojem kirurg postavi (implantira) lijek.
English: Single dose and repeat dose studies in a range of animal models (rats and primates) were performed.
Croatian: Provedene su studije jednokratnih i ponavljanih doza na više životinjskih modela (štakori i primati).
English: Significantly high titers of IgG class anti-OP-1 antibodies were detected in milk throughout the whole post-natal phase study until the lactation day 28 (see section 4.6).
Croatian: Znatno viši titri protutijela IgG klase anti-OP-1 otkriveni su u mlijeku tijekom cijelog razdoblja postnatalne faze ispitivanja sve do 28. dana laktacije (vidjeti dio 4.6).
English: • resorption of bone (osteolysis).
Croatian: • resorpcija kosti (osteoliza).
English: Use of Opgenra does not guarantee fusion; additional surgeries may be required.
Croatian: Primjena lijeka Opgenra ne jamči fuziju i možda će biti potreban dodatni kirurški zahvat.
English: To avoid breakage, do not tap the bottom of the vial when transferring contents.
Croatian: Da biste izbjegli lomljenje, nemojte lupkati dno bočice prilikom prijenosa sadržaja.
English: In the study populations, some patients with common pre-existing co-morbidities (e.g. cardiovascular, respiratory, genitourinary disorders, neoplasms) experienced exacerbations of their prior disease during the long term (three year) follow up period.
Croatian: U populaciji iz ispitivanja neki bolesnici sa zajedničkim prethodnim komorbiditetima (primjerice, kardiovaskularnim, respiratornim i genitourinarnim poremećajima, neoplazmama) iskusili su pogoršanja prethodne bolesti tijekom dugoročnog (trogodišnjeg) razdoblja praćenja.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Croatian: Farmakoterapijska skupina: lijekovi za liječenje bolesti kostiju, koštani morfogenetski proteini, ATK oznaka: M05BC02
English: • have an active infection at the site of spinal fusion or history of recurring infections;
Croatian: • imaju aktivnu infekciju na mjestu spinalne fuzije ili anamnezu recidivirajućih infekcija;
English: Therefore, upon re-administration of Opgenra, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Croatian: Stoga nakon ponovne primjene lijeka Opgenra može postojati rizik od razvoja autoimuniteta prema endogenim BMP proteinima.
English: Fax +353-61-585151 medicalinfo@olympusbiotech.com
Croatian: Faks +353-61-585151 medicalinfo@olympusbiotech.com
English: • the risks of ectopic bone formation
Croatian: • rizicima od ektopičnog stvaranja kosti
English: However the rate of malformations was similar to those from historical controls.
Croatian: Međutim, stopa deformacija bila je slična onima u kontrolnim skupinama.
English: The pivotal study with 295 patients involved un-instrumented postero-lateral lumbar spine fusion in 208 patients treated with Opgenra.
Croatian: Glavno ispitivanje u kojem je sudjelovalo 295 bolesnika uključivalo je posterolateralnu spinalnu fuziju bez instrumentacije u 208 bolesnika liječenih lijekom Opgenra.
English: Closure is critical for containment and maintenance of the product in the area of intended fusion.
Croatian: Zatvaranje je kritično za zadržavanje i održavanje lijeka na području namijenjenom za fuziju.
English: What Opgenra is and what it is used for
Croatian: Što je Opgenra i za što se koristi
English: Eptotermin alfa in Freund's adjuvant was first administered subcutaneously with booster doses given after 14 and 28 days.
Croatian: Eptotermin alfa u Freundovom adjuvansu prvo je primijenjen supkutano, a dodatne doze primijenjene su nakon 14 i 28 dana.
English: This effect, termed solid state carcinogenicity, has been frequently observed in rats in which solid materials (plastics or metals) were implanted subcutaneously.
Croatian: Uočeno je da se taj učinak, nazvan karcinogenošću krutih tvari, često pojavljuje u štakora kad su kruti materijali (plastika ili metal) implantirani supkutano.
English: • the recommended methods for reconstitution of the product prior to implantation
Croatian: • preporučenih metoda za rekonstituciju lijeka prije implantacije
English: Laboratory studies have demonstrated that there is a theoretical risk of developing autoimmunity towards the natural (endogenous) BMP proteins in your body following repeat exposure to this medicine.
Croatian: Laboratorijska ispitivanja pokazala su da postoji teoretski rizik od razvoja autoimuniteta prema prirodnim (endogenim) BMP proteinima u Vašem tijelu nakon opetovanog izlaganja ovom lijeku.
English: • increased bone formation or bone formation outside of the fusion area (heterotopic bone formation),
Croatian: • povećano stvaranje kosti ili stvaranje kosti izvan područja fuzije (heterotopično stvaranje kosti),
English: - Uncommon (may affect up to 1 in 100 people):
Croatian: - Manje često (može se javiti u do 1 na 100 osoba):
English: Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related bone morphogenetic proteins BMP-5 and BMP-6.
Croatian: Ispitivanja s protutijelima anti-OP-1 pokazala su ponešto ukrižene reaktivnosti s blisko povezanim koštanim morfogenetskim proteinima BMP-5 i BMP-6.
English: What Opgenra looks like and contents of the pack
Croatian: Kako izgleda Opgenra i sadržaj pakiranja
English: There have been reports of swelling and infection following the use of this medicine with synthetic bone substitutes.
Croatian: Zabilježena su izvješća o oticanju i infekciji nakon uporabe ovog lijeka sa sintetičkim nadomjescima za kost.
English: However, there is no evidence to suggest that heterotopic ossification is linked to sarcoma development in humans.
Croatian: No ne postoje dokazi koji ukazuju na to da je heterotopično okoštavanje povezano s pojavom sarkoma u čovjeka.
English: There are no data on the pharmacokinetics of the active substance in man.
Croatian: Nema dostupnih podataka o farmakokinetici djelatne tvari u ljudi.
English: • Opgenra has not been studied for use in cervical spine surgery.
Croatian: • Opgenra nije proučavana za uporabu u kirurškim zahvatima na cervikalnoj kralježnici.
English: • that the product should only be used once - details of the post marketing surveillance studies including information on how to enroll patients
Croatian: • da se lijek smije koristiti samo jednom - pojedinostima o studijama praćenja nakon stavljanja lijeka u promet uključujući informacije o načinu regrutiranja bolesnika u studiju
English: If you are nursing, you should receive this medicine only if your treating physician or surgeon considers the benefits to you outweigh the risks to your child.
Croatian: Ako ste dojilja, trebali biste biti liječeni ovim lijekom samo ako liječnik ili kirurg smatra da je korist liječenja veća od rizika za vaše dijete.
English: • embryo-foetotoxicity and the need for women with childbearing potential to use effective contraception for 2 years following implant
Croatian: • embrio-fetotoksičnosti i potrebi da žene s reproduktivnim potencijalom koriste djelotvornu kontracepciju tijekom 2 godine nakon ugradnje implantata
English: Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6.
Croatian: Protutijela anti-OP-1 imaju sposobnost in vitro neutralizacije biološke aktivnosti barem za BMP-6.
English: Opgenra should be used immediately after reconstitution.
Croatian: Opgenra se treba upotrijebiti odmah nakon pripreme.
English: Using sterile technique, remove the vials from the packaging.
Croatian: Sterilnom tehnikom izvadite bočice iz pakiranja.
English: • allergic reactions (for example rash or hives)
Croatian: • alergijske reakcije (primjerice osip ili koprivnjača)
English: The reconstituted medicinal product should be used immediately.
Croatian: Rekonstituirani lijek mora se odmah primijeniti.
English: However, an immune response to eptotermin alfa should be considered and appropriate validated tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where the medicinal product is ineffective.
Croatian: Međutim, treba uzeti u obzir imunološki odgovor na eptotermin alfa, a odgovarajući testovi na prisutnost protutijela u serumu moraju se provesti u slučajevima kada se sumnja na imunološki posredovanu nuspojavu, uključujući slučajeve u kojima je lijek nedjelotvoran.
English: The maximum human dose should not exceed 2 units since efficacy and safety for spinal fusion requiring higher doses has not been established.
Croatian: Maksimalna doza za ljude ne smije premašiti 2 jedinice s obzirom da djelotvornost i neškodljivost lijeka kod postupaka spinalne fuzije koji zahtijevaju veće doze još nisu utvrđene.
English: • have inadequate skin coverage and vascularity at the site of spinal fusion;
Croatian: • imaju neadekvatnu pokrivenost kožom i prokrvljenost na mjestu spinalne fuzije;
English: Opgenra is implanted during an invasive surgical procedure performed under general anaesthesia.
Croatian: Opgenra se ugrađuje tijekom invazivnog kirurškog postupka koji se provodi pod općom anestezijom.
English: This specialised medicine is used instead of autograft bone (some of a patient's own bone taken from the hip) to fuse the spine.
Croatian: Ovaj specijalizirani lijek koristi se umjesto autolognog koštanog presatka (dio kosti uzet od bolesnikove vlastite kosti iz kuka) kako bi se provela fuzije kralježnice.
English: The frequency and severity of post-operative adverse events was similar in both test and control groups.
Croatian: Učestalost i težina postoperativnih nuspojava bila je slična i u testnim i u kontrolnim skupinama.
English: The clinical study results suggest that there does not appear to be any association between neutralizing antibodies and the development of adverse events related to the immune system.
Croatian: Rezultati kliničkih ispitivanja ukazuju da ne postoji veza između neutralizirajućih protutijela i razvoja nuspojava povezanih s imunološkim sustavom.
English: Repeat use of this bone morphogenetic protein (BMP) is not recommended.”
Croatian: Ne preporučuje se ponovna primjena ovog koštanog morfogenetskog proteina (BMP).”
English: This medicinal product should be used by an appropriately qualified surgeon.
Croatian: Ovaj lijek treba primijeniti odgovarajuće osposobljen kirurg.
English: The clinical implications of these observations for human use of the finished medicinal product remain uncertain (see section 4.6).
Croatian: Kliničke implikacije tih zapažanja za primjenu gotovog lijeka kod ljudi i dalje nisu pouzdane (vidjeti dio 4.6).
English: There were no patients with neutralizing antibodies 2 years following treatment.
Croatian: Nije bilo bolesnika s neutralizirajućim protutijelima 2 godine nakon liječenja.
English: Clinical studies to investigate the efficacy and safety of this medicinal product in cervical spine surgery have not been performed; consequently its use outside the region of the lumbar spine cannot be recommended.
Croatian: Kliničke studije za ispitivanje djelotvornosti i neškodljivosti lijeka kod kirurških zahvata na cervikalnoj kralježnici nisu provedene pa se ne preporučuje primjena izvan lumbalnog područja kralježnice.