FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic Acid Accord.
Croatian: Tijekom liječenja Zoledronatnom kiselinom Accord sve bolesnike se mora poticati da održavaju dobru oralnu higijenu, redovito odlaze na stomatološke kontrole i odmah prijave bilo koji oralni simptom kao što je pomičnost zuba, bol ili oticanje, ili ranice koje ne cijele ili iscjedak.
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Croatian: Bolesnici moraju biti pregledani prije primjene zoledronatne kiseline kako bi se potvrdilo da su ogovarajuće hidrirani.
English: • if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Croatian: • osjećate ili ste osjećali bol, oticanje ili utrnulost čeljusti, težinu u čeljusti ili klimanje zuba.
English: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Croatian: Kad se počinje liječenje zoledronatnom kiselinom u bolesnika s multiplim mijelomom ili solidnim tumorom koji je metastazirao u kosti, potrebno je odrediti vrijednosti kreatinina u serumu i klirens kreatinina.
English: MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka Accord Healthcare S.L.U.
English: • The usual single dose given is 4 mg zoledronic acid.
Croatian: • Obično se daje jednokratna doza od 4 mg zoledronatne kiseline.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Croatian: Bubrežni klirens zoledronatne kiseline korelirao je s klirensom kreatinina, s time da je bubrežni klirens predstavljao 75±33% klirensa kreatinina, koji je prosječno iznosio 84 ± 29 ml/min (raspon, od 22 do 143 ml/min) u 64 uključena onkološka bolesnika.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Accord and will check your response to treatment at regular intervals.
Croatian: Prije nego što počnete primati Zoledronatnu kiselinu Accord, liječnik će Vam napraviti krvne pretrage i u redovitim vremenskim razmacima provjeravati Vaš odgovor na liječenje.
English: Patients treated with Zoledronic Acid Accord should be given the package leaflet and the patient reminder card. Posology
Croatian: Bolesnicima koji se liječe Zoledronatnom kiselinom Accord potrebno je dati Uputu o lijeku i karticu-podsjetnik za bolesnika.
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Croatian: U randomiziranom, dvostruko slijepom ispitivanju faze III uspoređivala se zoledronatna kiselina u dozi od 4 mg s pamidronatom u dozi od 90 mg svaka 3 do 4 tjedna u bolesnika s multiplim mijelomom ili karcinomom dojke i najmanje jednom koštanom lezijom.
English: In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
Croatian: U bolesnika u kojih se pojave znakovi pogoršanja funkcije bubrega tijekom liječenja treba prekinuti primjenu zoledronatne kiseline.
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Croatian: Tablica 2: Rezultati djelotvornosti (bolesnici s karcinomom prostate koji primaju hormonsku terapiju) Bilo koji koštani događaj (+ hiperkalcemija izazvana tumorom)
English: Risk reduction of suffering from multiple events** (%)
Croatian: p-vrijednost Stopa koštanog pobola p-vrijednost Smanjenje rizika od višestrukih događaja** (%)
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Croatian: Fibrilacija atrija pojavila se kao ozbiljna nuspojava u 1,3% (51 od 3862) bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 0,6% (22 od 3852) bolesnica koje su primale placebo.
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Croatian: srčana aritmija (uslijed hipokalcemije)
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Croatian: Rezultati su pokazali podjednaku djelotvornost zoledronatne kiseline u dozi od 4 mg i pamidronata u dozi od 90 mg u sprječavanju koštanih događaja.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Croatian: Tablica 3: Rezultati djelotvornosti (solidni tumori osim karcinoma dojke i prostate) Bilo koji koštani događaj (+ hiperkalcemija izazvana tumorom)
English: Efficacy results are provided in Table 4.
Croatian: Rezultati djelotvornosti prikazani su u tablici 4.
English: • Do not use Zoledronic Acid Accord after the expiry date stated on the pack.
Croatian: Zoledronatna kiselina Accord se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
English: Instructions for preparing reduced doses of Zoledronic Acid Accord Withdraw an appropriate volume of the concentrate needed, as follows: 4.4 ml for 3.5 mg dose
Croatian: Upute za pripremu sniženih doza Zoledronatne kiseline Accord Izvucite odgovarajući volumen potrebnog koncentrata na sljedeći način:
English: • As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Croatian: • kao posljedica niskih vrijednosti kalcija: napadaji, utrnulost i tetanija (kao posljedica hipokalcemije).
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Croatian: Pogoršanje funkcije bubrega, koje napreduje do zatajenja bubrega i dijalize, zabilježeno je u bolesnika nakon početne doze ili jednokratne doze zoledronatne kiseline u dozi od 4 mg.
English: This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Croatian: Ovaj lijek ne smije se miješati s kalcijem ili drugim otopinama za infuziju koje sadrže dvovalentne katione, kao što je otopina Ringerovog laktata, i treba se primijeniti kao jednokratna intravenska otopina kroz zasebnu infuzijsku liniju.
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Croatian: Nepravilan rad srca (srčana aritmija), napadaji, grčevi i trzanje mišića (tetanija) zabilježeni su kao posljedica teške hipokalcemije.
English: • Conjunctivitis.
Croatian: • konjunktivitis.
English: N Proportion of patients with SREs p-value Median time to SRE (days)
Croatian: Udio bolesnika s koštanim događajem (%) p-vrijednost Medijan vremena do koštanog događaja (dani)
English: Efficacy results are provided in Table 3.
Croatian: Rezultati djelotvornosti prikazani su u tablici 3.
English: Zoledronic Acid Accord concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Croatian: Koncentrat Zoledronatna kiselina Accord ne smije se miješati s kalcijem ili drugim otopinama za infuziju koje sadrže dvovalentne katione, kao što je otopina Ringerovog laktata, i treba se primijeniti kao jednokratna intravenska otopina kroz posebnu infuzijsku liniju.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Zoledronic Acid Accord
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Zoledronatnu kiselinu Accord, ako:
English: Efficacy results are provided in Table 2.
Croatian: Rezultati djelotvornosti prikazani su u tablici 2.
English: • Sleepiness.
Croatian: • pospanost.
English: Nasopharyngitis
Croatian: nazofaringitis
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Croatian: Izvučena količina koncentrata mora se dodatno razrijediti u 100 ml sterilne 0,9%-tne m/V otopine za injekciju natrijevog klorida ili 5%-tne m/V otopine glukoze.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Croatian: Sprječavanje koštanih događaja (patološki prijelomi, kompresija kralježaka, zračenje ili kirurški zahvat na kosti ili hiperkalcemija izazvana tumorom) u odraslih bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti.
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Croatian: Da biste izbjegli moguće inkompatibilnosti, otopina za infuziju koja se koristi za razrjeđenje mora biti 0,9%-tna m/V otopina natrijevog klorida ili 5%-tna m/V otopina glukoze.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Croatian: vrućica, sindrom sličan gripi (uključujući umor, tresavicu, malaksalost i crvenilo uz osjećaj vrućine)
English: 4.2 Posology and method of administration Zoledronic Acid Accord must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Croatian: Zoledronatnu kiselinu Accord bolesnicima smiju propisivati i primjenjivati samo zdravstveni djelatnici s iskustvom u intravenskoj primjeni bisfosfonata.
English: EXP Use immediately after dilution.
Croatian: Nakon razrjeđenja odmah upotrijebiti.
English: To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
Croatian: Da bi se izbjegle moguće inkompatibilnosti, koncentrat Zoledronatne kiseline Accord treba razrijediti sa 0,9%-tnom m/V otopinom natrijevog klorida za injekciju ili sa 5%-tnom m/V otopinom glukoze.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Croatian: Tablica 4: Rezultati djelotvornosti (u bolesnika s karcinomom dojke i multiplim mijelomom)
English: How to prepare and administer Zoledronic Acid Accord
Croatian: Kako pripremiti i primijeniti Zoledronatnu kiselinu Accord
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s 5 ml koncentrata sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
English: 6 PHARMACEUTICAL PARTICULARS
Croatian: 6. FARMACEUTSKI PODACI
English: Zoledronic Acid Accord treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Croatian: Liječenje bolesnika s hiperkalcemijom izazvanom tumorom koji imaju i teško oštećenje funkcije bubrega Zoledronatnom kiselinom Accord dolazi u obzir tek nakon procjene rizika i koristi od liječenja.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone:
Croatian: Sprječavanje koštanih događaja u bolesnika s uznapredovalom zloćudnom bolešću koja je zahvatila kosti:
English: What Zoledronic Acid Accord contains
Croatian: Što Zoledronatna kiselina Accord sadrži
English: Very common Vomiting, nausea Common
Croatian: Vrlo često: povraćanje, mučnina Često:
English: • Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Croatian: • bol u ustima, zubima i/ili čeljusti, oteklina ili ranice u ustima ili čeljusti koje ne cijele, iscjedak,
English: There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Accord.
Croatian: U vrlo su rijetkim slučajevima uz primjenu Zoledronatne kiseline Accord nastupile omamljenost i pospanost.
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic Acid Accord or after stopping treatment.
Croatian: Odmah obavijestite svog liječnika ako za vrijeme liječenja Zoledronatnu kiselinu Accord kiselina ili nakon prestanka liječenja dobijete simptome kao što su novonastali ili pogoršani bolovi ili ukočenost.
English: Bone pain, myalgia, arthralgia, generalised pain
Croatian: bolovi u kostima, mialgija, artralgija, generalizirani bolovi
English: Zoledronic Acid Accord contains sodium
Croatian: Zoledronatna kiselina Accord sadrži natrij
English: How to store Zoledronic Acid Accord 6.
Croatian: Kako čuvati Zoledronatnu kiselinu Accord 6.
English: You must not be given Zoledronic Acid Accord if you are breast-feeding.
Croatian: Ne smijete dobivati Zoledronatnu kiselinu Accord ako dojite.
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the postmarketing setting in patients receiving Zoledronic Acid Accord
Croatian: Osteonekroza čeljusti zabilježena je manje često u kliničkim ispitivanjima i nakon stavljanja lijeka u promet, u bolesnika koji su se liječili Zoledronatnom kiselinom Accord.
English: Prior to administration, 5ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution).
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prije primjene, 5 ml koncentrata iz jedne bočice ili izvučen potreban volumen koncentrata mora se dodatno razrijediti sa 100 ml otopine za infuziju koja ne sadrži kalcij (0,9%-tna m/V otopina natrijevog klorida za injekciju ili 5%-tna m/V otopina glukoze).
English: How often Zoledronic Acid Accord is given
Croatian: Koliko se često daje Zoledronatna kiselina Accord
English: Mean changes from baseline in BPI scores.
Croatian: Prosječna promjena u BPI u odnosu na početnu
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Croatian: ATK oznaka: M05BA08
English: Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Croatian: Zoledronatna kiselina Accord 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
English: • Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Croatian: • glavobolja i sindrom sličan gripi koji se sastoji od vrućice, umora, slabosti, omamljenosti,
English: SPECIAL STORAGE CONDITIONS
Croatian: 9. POSEBNE MJERE ČUVANJA
English: Only clear solution free from particles and discolouration should be used.
Croatian: Smije se primijeniti samo bistra otopina koja ne sadrži čestice i nije promijenila boju.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA Zoledronatna kiselina Accord 4 mg/5 ml koncentrat za otopinu za infuziju
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: .Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Baseline creatinine clearance (ml/min) Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg-hr/l) (CLcr = 75 ml/min).
Croatian: 3,0 mg* zoledronatne kiseline *Doze su izračunate uz pretpostavku da je ciljni AUC 0,66 (mg-hr/l) (klirens kreatinina = 75 ml/min).
English: • Confusion.
Croatian: • smetenost.
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated.
Croatian: Prije i poslije primjene Zoledronatne kiseline Accord mora se provjeriti status hidracije bolesnika kako bi se osiguralo da su primjereno hidrirani.
English: Very common Pyrexia, fatigue Common
Croatian: Vrlo često: pireksija, umor Često:
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Croatian: Kao posljedica slučajeva teške hipokalcemije zabilježene su srčane aritimije i neurološki štetni događaji (uključujući konvulzije, hipoesteziju i tetaniju).
English: The following properties have been demonstrated in preclinical studies: In-vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Croatian: U nekliničkim ispitivanjima pokazala je sljedeća svojstva: in vivo: inhibicija osteoklastične resorpcije kosti, koja mijenja mikrookoliš koštane srži i čini je manje pogodnom za rast tumorskih stanica, antiangiogeno djelovanje i analgetsko djelovanje in vitro: inhibicija proliferacije osteoblasta, izravno citostatsko i proapoptotsko djelovanje na tumorske stanice, sinergistički citostatski učinak s drugim antitumorskim lijekovima, antiadhezivno/antiinvazivno djelovanje.
English: Acute renal failure, haematuria, proteinuria
Croatian: akutno zatajenje bubrega, hematurija, proteinurija
English: Zoledronic acid was teratogenic in the rat at subcutaneous doses  0.2 mg/kg.
Croatian: Zoledronatna kiselina primijenjena supkutano u dozama  0,2 mg/kg u štakora pokazala je teratogeno djelovanje.
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Croatian: Bolesnici s vrijednošću kreatinina u serumu > 265 μmol/l ili > 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa zoledronatnom kiselinom.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
Croatian: U razdoblju nakon stavljanja lijeka u promet, u bolesnika koji su uzimali zoledronatnu kiselinu zabilježeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
English: you will be given one infusion of Zoledronic Acid Accord every three to four weeks.
Croatian: • Ako se liječite radi sprječavanja koštanih komplikacija izazvanih metastazama, dobivat ćete jednu infuziju Zoledronatne kiseline Accord svaka tri do četiri tjedna.
English: • Severe bone, joint and/or muscle pain, occasionally incapacitating.
Croatian: • jaki, ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
English: Common:
Croatian: Serija:
English: Muscle spasms, osteonecrosis of the jaw
Croatian: mišićni spazmi, osteonekroza čeljusti
English: In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
Croatian: (zoledronatna kiselina u dozi od 4 mg, 8 mg ili pamidronat u dozi od 90 mg) bilo liječeno zoledronatnom kiselinom u dozi od 8 mg.
English: How much Zoledronic Acid Accord is given
Croatian: Koliko se Zoledronatne kiseline Accord daje
English: Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Croatian: odmah se javite liječniku, jer to mogu biti rani znakovi mogućeg prijeloma bedrene kosti.
English: dysgeusia,
Croatian: bradikardija,
English: Placebo zoledronic acid 4 mg
Croatian: Placebo Zoledronatna kiselina
English: How Zoledronic Acid Accord is given
Croatian: Kako se daje Zoledronatna kiselina Accord
English: How to store Zoledronic Acid Accord
Croatian: Kako primjenjivati Zoledronatnu kiselinu Accord
English: Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Croatian: < 3% primijenjene doze otkrilo se u izmetu, što pokazuje da funkcija jetre nema važnu ulogu u farmakokinetici zoledronatne kiseline.
English: Hypocalcaemia has been reported in patients treated with zoledronic acid.
Croatian: U bolesnika koji su liječeni zoledronatnom kiselinom zabilježena je hipokalcemija.
English: Dizziness,
Croatian: I DOHVATA
English: NA-Not Applicable
Croatian: NP Nije primjenjivo.
English: Tachycardia
Croatian: tahikardija
English: One vial contains 4 mg of zoledronic acid (as monohydrate).
Croatian: Jedan ml koncentrata sadrži 0,8 mg zoledronatne kiseline (u obliku hidrata).
English: Renal impairment TIH:
Croatian: ROK VALJANOSTI Rok valjanosti:
English: How Zoledronic Acid Accord is used 4.
Croatian: Kako primjenjivati Zoledronatnu kiselinu Accord 4. Moguće nuspojave
English: Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Croatian: Zoledronatna kiselina Accord 4 mg/5 ml sterilni koncentrat zoledronatna kiselina i.v. primjena nakon razrjeđenja
English: Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zoledronic Acid Accord therapy.
Croatian: Prije uvođenja terapije Zoledronatnom kiselinom Accord potrebno je odrediti razinu kalcija u serumu i korigirati hipokalcemiju.
English: Read the package leaflet before use.
Croatian: 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, odmah se obratite svom liječniku.
English: Possible side effects Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetke (mogu se pojaviti u do 1 na 1000 osoba):
English: What you need to know before you take [Product name] Pregnancy
Croatian: Što morate znati prije nego počnete uzimati [naziv lijeka] Trudnoća
English: Adopted at the 11-14 June 2019 PRAC
Croatian: Usvojeno na sjednici PRAC-a 11.-14. lipnja 2019.
English: Please see Section 4.4 “Interference with laboratory testing”.
Croatian: Vidjeti dio 4.4. „Interferencija s laboratorijskim ispitivanjima”.
English: Interference with laboratory testing
Croatian: Interferencija s laboratorijskim ispitivanjima
English: Results should be interpreted in conjunction with clinical findings
Croatian: Rezultate je potrebno tumačiti zajedno s kliničkim nalazima
English: You may need treatment with [Product name] during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.
Croatian: Možda ćete trebati liječenje s [naziv lijeka] tijekom trudnoće ako je potencijalna korist veća od potencijalnog rizika za vas i vaše nerođeno dijete.
English: Animal studies are insufficient with respect to reproductive toxicity.
Croatian: Ispitivanja na životinjama su nedostatna u pogledu reproduktivne toksičnosti.