FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit-risk evaluation is deemed to be positive for granting of the variation to the terms of the marketing authorisations for Cydectin TriclaMox concerning treatment of Linognatus vituli, Bovicola bovis and Solenopotes capillatus infestations caused by moxidectin sensitive strains.
Croatian: Procjena dobrobiti i rizika smatrala se pozitivnom za odobrenje izmjene uvjeta odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda za liječenje Cydectinom TriclaMox infestacije vrstama ušiju Linognatus vituli, Bovicola bovis i Solenopotes capillatus uzrokovane sojevima osjetljivim na moksidektin.
English: Treatment of mixed trematode (fluke) and nematode infections and certain arthropod infestations caused by moxidectin and triclabendazole sensitive strains of:
Croatian: Liječenje miješanih infekcija uzrokovanih trematodima (metilj) i nematodima, te nekih infestacija člankonošcima (artropodima) uzrokovanih sojevima osjetljivim na moksidektin i triklabendazol:
English: the CVMP recommended the granting of the variation to the terms of the marketing authorisations for the veterinary medicinal products referred to in annex I. The recommended changes in the relevant sections of the product information are set out in annex III.
Croatian: Preporučene promjene u relevantnim poglavljima informacija o proizvodu prikazane su u Prilogu III.
English: • the CVMP reviewed all available data submitted by the marketing authorisation holder, to support the indication for treatment of lice infestations caused by Linognatus vituli, Bovicola bovis and Solenopotes capillatus;
Croatian: • CVMP je pregledao sve dostupne podatke koje je predao nositelj odobrenja kako bi podržao indikaciju za liječenje infestacije ušima uzrokovane vrstama
English: Overall summary of the scientific evaluation of Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene za lijek Cydectin TriclaMox (5 mg/ml i 200 mg/ml) poliv otopina za stoku (vidjeti Prilog I)
English: • the CVMP on the basis of the available data considered that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field;
Croatian: • CVMP smatrao je da se na temelju dostupnih podataka može očekivati zadovoljavajuća djelotvornost na terenu protiv vrsta Linognatus vituli, Bovicola bovis i Solenopotes capillatus; CVMP preporučio je odobrenje izmjene uvjeta odobrenja za stavljanje u promet veterinarskomedicinskih proizvoda navedenih u Prilogu I.
English: Grounds for the variation to the terms of the marketing authorisations
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda
English: Pfizer GmbH Linkstraße 10 10785 Berlin Germany
Croatian: Njemačka Pfizer GmbH Linkstraße 10
English: Liver fluke:
Croatian: Uputa o VMP:
English: Belgium Pfizer Animal Health s.a. Rue Laid Burniat 1
Croatian: Pfizer Animal Health s.a. Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgija
English: Avda.
Croatian: EKTOPARAZITI
English: Solvent: 10 ml Matrix: 7.5 x 10 cm
Croatian: Otapalo: 10 ml Matrica: 7,5 x 10 cm
English: Strength Pharmaceutical form
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Solvent: 10 ml Matrix: 2 x (2.5 x 5 cm)
Croatian: Prašak: 4 mg; Otapalo: 10 ml Matrica: 2 x (2,5 x 5 cm)
English: 1 vial + 1 vial + 2 matrices + 2 syringes + 2 needles
Croatian: 1 bočica + 1 bočica + 2 matrice + 2 štrcaljke + 2 igle
English: 1 vial + 1 vial + 1 matrix + 2 syringes + 2 needles
Croatian: 1 bočica + 1 bočica + 1 matrica + 2 štrcaljke + 2 igle
English: Further information on Ogivri can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ogivri.
Croatian: Više informacija o lijeku Ogivri nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Ogivri.
English: Ogivri can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Croatian: Ogivri može uzrokovati kardiotoksičnost (oštećenje srca), uključujući zatajenje srca (kada srce ne radi kako bi trebalo).
English: A response to treatment after 24 weeks was seen in 70% of the patients given Ogivri (160 of 230) and 64% of the patients given Herceptin (146 of 228).
Croatian: Nakon 24 tjedna zabilježen je odgovor na liječenje u 70 % bolesnika koji su primali Ogivri (160 od 230) i u 60 % bolesnika koji su primali Herceptin (146 od 228).
English: This means that Ogivri is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je Ogivri vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: • metastatic breast cancer (cancer that has spread to other parts of the body).
Croatian: • metastatskog raka dojke (raka koji se proširio na ostale dijelove tijela).
English: It is given by infusion (drip) into a vein over 90 minutes every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer.
Croatian: Primjenjuje se intravenskom infuzijom (drip) tijekom 90 minuta jedanput tjedno ili svaka tri tjedna u slučaju raka dojke i svaka tri tjedna u slučaju raka želudca.
English: Ogivri is a cancer medicine used to treat the following conditions:
Croatian: Ogivri je lijek protiv raka koji se primjenjuje za liječenje sljedećih bolesti:
English: Ogivri is a ‘biosimilar medicine'.
Croatian: Ogivri je „biosličan lijek”.
English: What is Ogivri and what is it used for?
Croatian: Što je Ogivri i za što se primjenjuje?
English: The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion for signs such as fever and chills.
Croatian: Infuzija može uzrokovati alergijske reakcije te je stoga potreban nadzor bolesnika tijekom infuzije i nakon nje kako bi se uočili simptomi vrućice i zimice.
English: The most common or serious side effects with Ogivri are heart problems, reactions related to the infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Croatian: Najčešće ili ozbiljne nuspojave lijeka Ogivri jesu srčani problemi, reakcije na infuziju lijeka Ogivri, snižena razina krvnih stanica (posebice bijelih krvnih stanica), infekcije i problemi s plućima.
English: What measures are being taken to ensure the safe and effective use of Ogivri?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ogivri?
English: Side effects reported with Ogivri are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ogivri pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart.
Croatian: Potrebno je pripaziti ako se lijek daje bolesnicima koji već imaju srčanih problema ili visok krvni tlak, a funkciju srca svih bolesnika potrebno je pratiti tijekom liječenja i nakon njega.
English: Ogivri can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Croatian: Ogivri se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u primjeni lijekova protiv raka.
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another type of medicine called an aromatase inhibitor;
Croatian: Također se primjenjuje u kombinaciji s drugim lijekovima protiv raka: s paklitakselom, docetakselom ili s drugom vrstom lijekova zvanima inhibitori aromataze;
English: • early breast cancer (when the cancer has spread within the breast or to the lymph nodes (‘glands') under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Croatian: • ranog raka dojke (ako se rak proširio unutar dojke ili do limfnih čvorova (žlijezda) ispod pazuha, ali ne i na ostale dijelove tijela) nakon kirurškog zahvata, kemoterapije (lijekova za liječenje raka) i radioterapije (liječenja zračenjem), ako su provedeni.
English: For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Ogivri is used before surgery in combination with chemotherapy and then again after surgery on its own;
Croatian: U slučaju karcinoma koji su lokalno uznapredovali (uključujući upalne karcinome) ili koji su širi od 2 cm, lijek Ogivri primjenjuje se u kombinaciji s kemoterapijom prije kirurškog zahvata i ponovno nakon njega kao monoterapija;
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ogivri has a highly similar structure, purity and biological activity to Herceptin and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Ogivri ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Herceptin te se u tijelu raspoređuje na isti način.
English: Ogivri must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Croatian: Ogivri se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na trastuzumab, mišje bjelančevine ili bilo koji drugi sastojak lijeka.
English: Because Ogivri is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Ogivri.
Croatian: Budući da je lijek Ogivri biosličan lijek, ispitivanja učinkovitosti i sigurnosti trastuzumaba provedena za lijek Herceptin nije potrebno ponavljati za lijek Ogivri.
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Croatian: Do povećane ekspresije bjelančevine HER2 dolazi u otprilike četvrtini slučajeva raka dojke i petini slučajeva raka želudca.
English: Why is Ogivri authorised in the EU?
Croatian: Zašto je lijek Ogivri odobren u EU-u?
English: What are the risks associated with Ogivri?
Croatian: Koji su rizici povezani s lijekom Ogivri?
English: The dose depends on the patient's body weight, on the condition being treated and on whether Ogivri is given every week or every 3 weeks.
Croatian: Doza lijeka Ogivri ovisi o tjelesnoj težini bolesnika, o bolesti koja se liječi i o tome uzima li se lijek jedanput tjedno ili svaka tri tjedna.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Croatian: Vezivanjem na bjelančevinu HER2 trastuzumab aktivira djelovanje stanica imunosnog sustava, koje zatim uništavaju tumorske stanice.
English: An overview of Ogivri and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ogivri i zašto je odobren u EU-u
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).
Croatian: • metastatskog raka želudca, u kombinaciji s cisplatinom zajedno s kapecitabinom ili fluorouracilom (drugim lijekovima protiv raka).
English: The reference medicine for Ogivri is Herceptin.
Croatian: Referentni lijek za lijek Ogivri je Herceptin.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ogivri have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ogivri nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: In addition, one study involving 500 patients with metastatic breast cancer that overexpressed HER2 showed that Ogivri was effective in treating the condition.
Croatian: Osim toga, u jednom ispitivanju na 500 bolesnika s metastatskim rakom dojke s povećanom ekspresijom bjelančevine HER2 utvrđeno je da je Ogivri djelotvoran u liječenju toga stanja.
English: Therefore, the Agency's view was that, as for Herceptin, the benefit of Ogivri outweighs the identified risks and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Ogivri, kao i od lijeka Herceptin, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: The safety of Ogivri has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Herceptin.
Croatian: Ocijenjena je sigurnost primjene lijeka Ogivri i na temelju svih provedenih ispitivanja nuspojave lijeka smatraju se usporedivima s onima za referentni lijek Herceptin.
English: Patients received Ogivri or the reference medicine Herceptin, together with other cancer medicines (paclitaxel or docetaxel).
Croatian: Bolesnici su primali lijek Ogivri ili referentni lijek Herceptin s drugim lijekovima za liječenje raka (paklitaksel ili docetaksel).
English: Ogivri can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Croatian: Primjena lijeka Ogivri moguća je samo ako rak pokazuje „povećanu ekspresiju bjelančevine HER2”, što znači da rak proizvodi velike količine bjelančevine HER2 na tumorskim stanicama.
English: Other information about Ogivri
Croatian: Ostale informacije o lijeku Ogivri
English: All these data were considered sufficient to conclude that Ogivri will behave in the same way as intravenous Herceptin in terms of effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Ogivri djelovati na isti način kao lijek Herceptin, primljen intravenozno, u pogledu učinkovitosti i sigurnosti primjene.
English: For more information about using Ogivri, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Ogivri pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Laboratory studies comparing Ogivri with Herceptin have shown that the active substance in Ogivri is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Ogivri i Herceptin pokazala su da je djelatna tvar u lijeku Ogivri vrlo slična djelatnoj tvari u lijeku Herceptin u pogledu strukture, čistoće i biološke aktivnosti.
English: The active substance in Ogivri, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Croatian: Djelatna tvar u lijeku Ogivri, trastuzumab, monoklonsko je protutijelo (vrsta bjelančevine) namijenjeno za prepoznavanje bjelančevine HER2 i vezivanje za nju.
English: As for all medicines, data on the use of Ogivri are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Ogivri kontinuirano se prate.
English: In addition, studies in metastatic breast cancer that overexpressed HER2 have shown that the effectiveness of Ogivri infusion is equivalent to that of Herceptin infusion.
Croatian: Osim toga, ispitivanja metastatskog raka dojke u kojima je zabilježena povećana ekspresija bjelančevine HER2 pokazala su da je učinkovitost infuzije lijeka Ogivri jednaka infuziji lijeka Herceptin.
English: Studies have also shown that giving Ogivri infusion produces similar levels of the active substance in the body to giving an infusion of Herceptin.
Croatian: Ispitivanja su pokazala i da primjena lijeka Ogivri dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Herceptin.
English: In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Ogivri would behave in the same way as Herceptin in its approved indications.
Croatian: Na temelju svih dostavljenih podataka ocijenjeno je da ta razlika nije relevantna te je zaključeno da će se lijek Ogivri za odobrene indikacije ponašati na isti način kao lijek Herceptin.
English: What benefits of Ogivri have been shown in studies?
Croatian: Koje su koristi od lijeka Ogivri utvrđene u ispitivanjima?
English: Ogivri contains the active substance trastuzumab.
Croatian: Lijek Ogivri sadrži djelatnu tvar trastuzumab.
English: How is Ogivri used?
Croatian: Kako se Ogivri primjenjuje?
English: Date of first authorisation: 11 May 2016
Croatian: Datum prvog odobrenja: 11. svibnja 2016.
English: Age < 65 years ≥ 65 years
Croatian: Dob < 65 godina ≥ 65 godina
English: Other symptoms may occur as well.
Croatian: Mogu se javiti i drugi simptomi.
English: Do not try to treat your symptoms with other medicines.
Croatian: Nemojte pokušavati liječiti simptome drugim lijekovima.
English: Risk factors High risk
Croatian: Faktori rizika Visok rizik
English: IRC assessment was performed post-hoc.
Croatian: Ocjena IRC-a provodila se post-hoc.
English: The lyophilised powder should dissolve in less than 10 minutes.
Croatian: Liofilizirani prašak trebao bi se rastopiti za manje od 10 minuta.
English: ATC code: L01XC23.
Croatian: ATK oznaka: L01XC23.
English: The minimum follow-up was 70.6 months.
Croatian: Minimalno vrijeme praćenja bilo je 70,6 mjeseci.
English: Children and adolescents Empliciti is not recommended for use in children and adolescents aged under 18 years.
Croatian: Djeca i adolescenti Primjena lijeka Empliciti ne preporučuje se u djece i adolescenata mlađih od 18 godina.
English: Amount of water for injections, required for reconstitution
Croatian: Količina vode za injekcije koja je potrebna za rekonstituciju
English: See Table 8 and Figure 2.
Croatian: Vidjeti tablicu 8 i sliku 2.
English: However, results should be taken with caution as assessment of consistency of effect within the different subgroups was hampered by the very limited number of patients included in the different subgroups.
Croatian: Međutim, rezultate treba tumačiti uz oprez jer je ocjenu dosljednosti učinka unutar različitih podskupina otežavao vrlo ograničen broj bolesnika uključenih u različite podskupine.
English: You will receive Empliciti under the supervision of an experienced healthcare professional.
Croatian: Empliciti ćete primati pod nadzorom iskusnog zdravstvenog radnika.
English: Paracetamol (650-1000 mg orally).
Croatian: Paracetamol (650 - 1000 mg peroralno).
English: None reported
Croatian: Nije prijavljeno
English: Assessment of tumour response was conducted every 4 weeks.
Croatian: Odgovor tumora ocjenjivao se svaka 4 tjedna.
English: Data on the efficacy and safety of Empliciti in patients ≥ 85 years of age are very limited.
Croatian: Podaci o djelotvornosti i sigurnosti lijeka Empliciti u bolesnika u dobi od ≥ 85 godina vrlo su ograničeni.
English: What Empliciti is and what it is used for 2.
Croatian: Što je Empliciti i za što se koristi 2.
English: All patients had documented progression following their most recent therapy.
Croatian: Svi su bolesnici imali dokumentiranu progresiju bolesti nakon posljednje terapije.
English: Do not freeze the reconstituted or diluted solution.
Croatian: Ne zamrzavati rekonstituiranu ili razrijeđenu otopinu.
English: All reports of infusion reaction were ≤ Grade 3.
Croatian: Sve prijavljene reakcije na infuziju bile su ≤ 3. stupnja.
English: It will be given into a vein (intravenously) as a drip (infusion) over several hours.
Croatian: Primat ćete ga u venu (intravenski) u obliku dripa (infuzije) tijekom nekoliko sati.
English: After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes.
Croatian: Nakon što se sve preostale krutine potpuno otope, ostavite rekonstituiranu otopinu da odstoji 5 do 10 minuta.
English: Eleven (9.4%) patients had high-risk myeloma.
Croatian: Jedanaest (9,4%) bolesnika imalo je visokorizičan mijelom.
English: Standard risk Cytogenetic category Presence of del17p
Croatian: Standardni rizik Citogenetska kategorija Prisutnost del17p
English: Frequencies are defined as: 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 available data).
Croatian: Učestalosti pojavljivanja 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); i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: What you need to know before you use Empliciti
Croatian: Što morate znati prije nego počnete primati Empliciti
English: b modified International Myeloma Working Group (IMWG) criteria.
Croatian: b modificirani kriteriji Međunarodne radne skupine za mijelom (IMWG).
English: PFS results per the investigator and IRC are summarised in Table 10 (minimum follow-up of 9.1 months).
Croatian: Rezultati za PFS prema ocjeni ispitivača i IRC-a sažeto su prikazani u Tablici 10 (minimalno praćenje od 9,1 mjeseca).
English: After dilution, the infusion must be completed within 24 hours of preparation.
Croatian: Nakon razrjeđivanja, infuzija se mora dovršiti unutar 24 sata od pripreme.
English: Patients should be monitored and infections should be managed with standard treatment.
Croatian: Bolesnike je potrebno nadzirati, a infekcije zbrinuti standardnim liječenjem.
English: What Empliciti looks like and contents of the pack
Croatian: Kako Empliciti izgleda i sadržaj pakiranja
English: Lenalidomide and pomalidomide are present in the blood and sperm of patients receiving the medicine.
Croatian: Lenalidomid i pomalidomid prisutni su u krvi i spermi bolesnika koji ih primaju.
English: The OS data from the exploratory analysis were not mature at the data cut-off (29 November 2018) with a minimum follow up of 18.3 months.
Croatian: Podaci za OS iz eksploracijske analize nisu bili zreli na dan prestanka prikupljanja podataka (29. studenoga 2018.), uz minimalno praćenje od 18,3 mjeseca.
English: The effects of Empliciti in pregnant women or its possible harm to an unborn baby are unknown.
Croatian: Učinci lijeka Empliciti u trudnica i njegovi mogući štetni učinci na nerođeno dijete nisu poznati.
English: Kaplan-Meier curve for PFS per the investigator is provided in Figure 3.
Croatian: Kaplan-Meierova krivulja za PFS prema ocjeni ispitivača prikazana je na Slici 3.
English: What Empliciti is and what it is used for
Croatian: Što je Empliciti i za što se koristi
English: Empliciti is used if your cancer has not responded to, or has come back after certain treatments.
Croatian: Empliciti se koristi ako Vam rak nije odgovorio na određene terapije ili ako se vratio nakon tih terapija.
English: Of the patients who experienced an infusion reaction, 70% (23/33) had the reaction during the first dose.
Croatian: Među bolesnicima koji su doživjeli reakciju na infuziju, u njih 70% (23/33) reakcija se javila tijekom prve doze.
English: This results in damage to the bones and kidneys.
Croatian: To dovodi do oštećenja kostiju i bubrega.
English: Dose 2 and all subsequent doses
Croatian: 2. doza i sve sljedeće doze
English: Multiple myeloma is a cancer of a type of white blood cell called plasma cells.
Croatian: Multipli mijelom je rak jedne vrste bijelih krvnih stanica koje se zovu plazmatske stanice.
English: You should not be given Empliciti: if you are allergic to elotuzumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
Croatian: Ne smijete primiti Empliciti: ako ste alergični na elotuzumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6. "Sadržaj pakiranja i druge informacije").
English: If you have any further questions, ask your doctor, or pharmacist or nurse.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Empliciti is available in packs containing 1 vial.
Croatian: Empliciti je dostupan u pakiranjima koja sadrže 1 bočicu.
English: Women of childbearing potential should use effective contraception.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju.