FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: Please discuss with you doctor or nurse the best sites for you.
Croatian: Molimo da se o najboljim mjestima za primjenu injekcije posavjetujete s liječnikom ili medicinskom sestrom.
English: Study ENB-006-09/ENB-008-10 was an open-label, randomised study.
Croatian: Ispitivanje ENB-006-09/ENB-008-10 bilo je randomizirano ispitivanje otvorenog tipa.
English: - 7 patients were weaned off invasive ventilation (time on ventilation from 12 to 168 weeks), 4 patients were off any ventilation support, and 3 patients were on noninvasive ventilation support.
Croatian: • 16 bolesnika trebalo je invazivnu ventilacijsku potporu (intubaciju ili traheostomiju) na početku ispitivanja (jedan od njih imao je na početku, prije prijelaza na invazivnu ventilaciju, kratko razdoblje neinvazivne ventilacije) - u 7 bolesnika invazivna ventilacijska potpora bila je ukinuta (vrijeme na ventilacijskoj potpori iznosilo je od 12 do 168 tjedana), 4 bolesnika nije imalo nikakvu ventilacijsku potporu, a 3 bolesnika bila su na neinvazivnoj ventilacijskoj potpori.
English: The maximum volume of medicinal product per injection should not exceed 1 ml.
Croatian: Maksimalni volumen lijeka po injekciji ne smije prelaziti 1 ml.
English: • Areas with a good amount of fat below the skin (thighs, arms (deltoids), abdomen and buttocks) are the most suitable areas to inject.
Croatian: • Za primjenu injekcije najpogodnija su područja s dosta masnog tkiva ispod kože (bedra, ruke (deltoidni mišić), trbuh i stražnjica).
English: Periodic monitoring (including fundoscopy for signs of papilloedema) and prompt intervention for increased intracranial pressure is recommended in hypophosphatasia patients below 5 years of age.
Croatian: U bolesnika s hipofosfatazijom mlađih od 5 godina preporučuje se redovito praćenje (uključujući fundoskopiju radi otkrivanja znakova edema papile) i brza intervencija zbog povišenog intrakranijalnog tlaka.
English: You may need to use several vials to withdraw the complete amount needed to reach the correct dose.
Croatian: Da biste uvukli svu količinu koja je potrebna za pravilnu dozu, možda će Vam biti potrebno nekoliko bočica.
English: In asfotase alfa clinical studies ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis have been reported in patients with hypophosphatasia.
Croatian: U kliničkim ispitivanjima asfotaze alfa, u bolesnika s hipofosfatazijom zabilježene su oftalmička kalcifikacija (konjunktive i korneje) i nefrokalcinoza.
English: What is Strensiq used for
Croatian: Za što se Stresiq koristi
English: See package leaflet for further information.
Croatian: Vidjeti uputu o lijeku za više informacija.
English: The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate and water for injections.
Croatian: Drugi sastojci su: natrijev klorid; monobazični natrijev fosfat, hidrat; dibazični natrijev fosfat, heptahidrat i voda za injekcije.
English: At study completion, patients had received a median of over 79 months (6.6 years) of treatment (1 to >84 months).
Croatian: Na završetku ispitivanja, medijan liječenja (u trajanju od 1 do > 84 mjeseca) bolesnika iznosio je više od 79 mjeseci (6,6 godina).
English: While continuing to hold the skin, push the syringe plunger to inject the medicine slowly, and steadily all the way in. 5.
Croatian: Nastavite držati kožu i polako i ravnomjerno potiskujte klip štrcaljke da biste ubrizgali sav lijek.
English: Dispose the needle with the protective cap in your sharps container.
Croatian: Iglu sa zaštitnom kapicom bacite u spremnik za oštre predmete.
English: Skin discolouration Skin disorder (stretched skin)
Croatian: • rastegnuta koža, promjena boje kože
English: Each vial contains 40 mg of asfotase alfa (40 mg/1 ml).
Croatian: Jedna bočica sadrži 40 mg asfotaze alfa (40 mg/1 ml).
English: What Strensiq looks like and contents of the pack Strensiq is presented as a clear colourless to slightly yellow aqueous solution for injection in vials containing 0.8 ml of solution.
Croatian: Strensiq je bistra bezbojna do blago žuta vodena otopina za injekciju, a isporučuje se u bočicama koje sadrže 0,8 ml otopine.
English: There is no experience with overdose of asfotase alfa.
Croatian: 4.9 Predoziranje Nema iskustva s predoziranjem asfotazom alfa.
English: • If you are treated with Strensiq, you may experience a reaction at the injection site (pain, nodule, rash, discoloration) during the injection of the medicine or during the hours following the injection.
Croatian: • Ako se liječite Strensiqom, možda ćete tijekom ubrizgavanja lijeka ili u satima nakon injekcije opaziti reakciju na mjestu davanja injekcije (bol, pojava čvorića, osipa, promjena boje kože).
English: Dose to be injected
Croatian: Doza koju treba ubrizgati
English: Step 2: Withdrawing Strensiq solution from the vial
Croatian: 2. korak: uvlačenje otopine Strensiqa iz bočice
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 mg/ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 40 mg/ml
English: 5/11 subjects displayed apparent catch-up height-gain.
Croatian: Očiti zamah u rastu pokazalo je 5/11 ispitanika.
English: 1 vial of 0.8 mL
Croatian: 1 bočica od 0,8 ml
English: Strensiq 100 mg/ml solution for injection Filled volumes of the vials are: 0.8 ml
Croatian: Strensiq 100 mg/ml otopina za injekciju Volumen punjenja bočica je 0,8 ml.
English: Each vial contains 28 mg of asfotase alfa (28 mg/0.7 ml).
Croatian: Jedna bočica sadrži 28 mg asfotaze alfa (28 mg/0,7 ml).
English: Each vial contains 12 mg of asfotase alfa (12 mg/0.3 ml).
Croatian: Jedna bočica sadrži 12 mg asfotaze alfa (12 mg/0,3 ml).
English: Sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, water for injections.
Croatian: Natrijev klorid, dibazični natrijev fosfat, heptahidrat, monobazični natrijev fosfat, hidrat, voda za injekcije.
English: • Weight gain may occur during your treatment with Strensiq.
Croatian: • Za vrijeme liječenja Strensiqom može doći do povećanja tjelesne težine.
English: Each vial contains 18 mg of asfotase alfa (18 mg/0.45 ml).
Croatian: Jedna bočica sadrži 18 mg asfotaze alfa (18 mg/0,45 ml).
English: Injection site cellulitis
Croatian: Infekcije i infestacije često celulitis na mjestu primjene injekcije
English: • Localized lipodystrophy (fatty lumps or deceased fatty tissue on the surface of the skin) have been reported at injection sites after several months in patients using Strensiq.
Croatian: • U bolesnika koji su se liječili Strensiqom, nakon nekoliko mjeseci primjene zabilježena je na mjestima davanja injekcije lokalizirana lipodistrofija (potkožne nakupine masnog tkiva ili gubitak potkožnog masnog tkiva).
English: Infection of skin at injection site (injection site cellulitis) Reduced levels of calcium in the blood (hypocalcaemia) Kidney stones (nephrolithiasis)
Croatian: • snižene razine kalcija u krvi (hipokalcijemija)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg/ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 100 mg/ml
English: Very common: may affect more than 1 in 10 people Reactions at the injection site during the injection of the medicine or during the hours following the injection (which can lead to redness, discolorations, itching, pain, fatty lumps or decreased fatty tissue on the surface of the skin, skin hypopigmentation, and/or swelling) Fever (pyrexia), irritability
Croatian: • reakcije na mjestu primjene injekcije tijekom ubrizgavanja lijeka ili unutar nekoliko sati nakon injekcije (koje mogu dovesti do crvenila, promjene boje kože, svrbeža, bola, pojave potkožnih nakupina masnog ili gubitka potkožnog masnog tkiva, gubitak boje kože (hipopigmentacija) i/ili oticanja)
English: The volume per injection should not exceed 1 ml.
Croatian: Količina jedne injekcije ne smije prelaziti 1 ml.
English: Ophthalmology examination and renal ultrasounds are recommended at baseline and periodically in hypophosphatasia patients.
Croatian: U bolesnika s hipofosfatazijom preporučuje se na početku, a zatim redovito provoditi oftalmološki pregled i ultrazvučne pretrage bubrega.
English: Anaphylactoid reactions Hypersensitivity
Croatian: Poremećaji imunološkog sustava često anafilaktoidne reakcije preosjetljivost2
English: Any unused solution should be discarded.
Croatian: Svu neupotrijebljenu otopinu treba baciti.
English: How to use Strensiq
Croatian: Kako primjenjivati Strensiq
English: Patients received STRENSIQ at 6 mg/kg per week for the first 4 weeks.
Croatian: Tijekom prva 4 tjedna liječenja bolesnici su primali Strensiq u dozi od 6 mg/kg tjedno.
English: INFORMATION IN BRAILLE STRENSIQ 100 mg/ml 80 mg/0.8 ml
Croatian: STRENSIQ 100 mg/ml
English: Each vial of 0.8 ml solution (100 mg/ml) contains 80 mg of asfotase alfa.
Croatian: Jedna bočica od 0,8 ml otopine (100 mg/ml) sadrži 80 mg asfotaze alfa.
English: Dosage
Croatian: Doza
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 100 mg/ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI 100 mg/ml
English: Each vial contains 80 mg of asfotase alfa (80 mg/0.8 ml)
Croatian: Jedna bočica sadrži 80 mg asfotaze alfa (80 mg/0,8 ml).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 40 mg/ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI 40 mg/ml
English: How to store Strensiq
Croatian: Kako čuvati Strensiq
English: Each vial of 0.7 ml solution (40 mg/ml) contains 28 mg of asfotase alfa.
Croatian: Jedna bočica od 0,7 ml otopine (40 mg/ml) sadrži 28 mg asfotaze alfa.
English: - 2 patients required invasive ventilation support and 1 patient continued with noninvasive ventilation support, all 3 patients died and with RGI-C score <2 The natural history of untreated infant hypophosphatasia patients suggests high mortality if ventilation is required.
Croatian: • 13 bolesnika trebalo je neinvazivnu ventilacijsku potporu na početku - u 10 bolesnika bila je ukinuta svaka ventilacijska potpora (vrijeme provedeno na ventilacijskoj potpori od 3 do 216 tjedana); 9 od 10 bolesnika postiglo je rezultat RGI-C ≥ 2, a samo 1 bolesnik imao je RGI-C < 2 - 2 bolesnika trebala su potporu invazivnom ventilacijom, 1 bolesnik nastavio je s potporom neinvazivnom ventilacijom, a sva su 3 bolesnika umrla pri rezultatu RGI-C < 2. Prirodna povijest neliječenih bolesnika s dječjom hipofosfatazijom upućuje na veliku smrtnost ako je potrebna ventilacija.
English: Each vial of 0.45 ml solution (40 mg/ml) contains 18 mg of asfotase alfa.
Croatian: Jedna bočica od 0,45 ml otopine (40 mg/ml) sadrži 18 mg asfotaze alfa.
English: Each vial contains 0.8 ml solution and 80 mg of asfotase alfa (100 mg/ml).
Croatian: Jedna bočica sadrži 0,8 ml otopine i 80 mg asfotaze alfa (100 mg/ml).
English: Each ml of solution contains 40 mg of asfotase alfa.
Croatian: Jedan ml otopine sadrži 40 mg asfotaze alfa.
English: Each vial contains 0.45 ml solution and 18 mg of asfotase alfa (40 mg/ml).
Croatian: Jedna bočica sadrži 0,45 ml otopine i 18 mg asfotaze alfa (40 mg/ml).
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava vrlo često glavobolja
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 100 mg of asfotase alfa.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml otopine sadrži 100 mg asfotaze alfa.
English: Each ml of solution contains 100 mg of asfotase alfa.
Croatian: Jedan ml otopine sadrži 100 mg asfotaze alfa.
English: NAME OF THE MEDICINAL PRODUCT Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection
Croatian: Strensiq 40 mg/ml otopina za injekciju Strensiq 100 mg/ml otopina za injekciju
English: Each vial of 0.3 ml solution (40 mg/ml) contains 12 mg of asfotase alfa.
Croatian: Jedna bočica od 0,3 ml otopine (40 mg/ml) sadrži 12 mg asfotaze alfa.
English: Each vial contains 0.3 ml solution and 12 mg of asfotase alfa (40 mg/ml).
Croatian: Jedna bočica sadrži 0,3 ml otopine i 12 mg asfotaze alfa (40 mg/ml).
English: Each vial contains 0.7 ml solution and 28 mg of asfotase alfa (40 mg/ml).
Croatian: Jedna bočica sadrži 0,7 ml otopine i 28 mg asfotaze alfa (40 mg/ml).
English: Each vial of 1 ml solution (40 mg/ml) contains 40 mg of asfotase alfa.
Croatian: Jedna bočica od 1 ml otopine (40 mg/ml) sadrži 40 mg asfotaze alfa.
English: NAME OF THE MEDICINAL PRODUCT Strensiq 40 mg/ml solution for injection asfotase alfa
Croatian: Strensiq 40 mg/ml otopina za injekciju asfotaza alfa
English: Each vial contains 1.0 ml solution and 40 mg of asfotase alfa (40 mg/ml).
Croatian: Jedna bočica sadrži 1,0 ml otopine i 40 mg asfotaze alfa (40 mg/ml).
English: No trends in adverse events based on antibody status were observed in clinical trials.
Croatian: U kliničkim ispitivanjima nisu opažene tendencije prema razvoju nuspojava na temelju prisutnosti ili odsutnosti protutijela.
English: Gently pinch the skin of the chosen injection area between your thumb and index finger.
Croatian: Palcem i kažiprstom nježno uhvatite kožu na mjestu izabranom za davanje injekcije.
English: Alternative assays (i.e. not utilizing an ALP-conjugated reporter system) may be considered in patients treated with Strensiq.
Croatian: U bolesnika liječenih Strensiqom može se razmotriti primjena drugih testova (tj. onih u kojima se ne koristi konjugat alkalne fosfataze za dobivanje rezultata).
English: NAME OF THE MEDICINAL PRODUCT Strensiq 100 mg/ml solution for injection asfotase alfa
Croatian: Strensiq 100 mg/ml otopina za injekciju asfotaza alfa
English: Vial type used for injection
Croatian: Vrsta bočice za injekciju
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava često povećana sklonost prema stvaranju modrica
English: Talk to your doctor in case of problems with your vision.
Croatian: U slučaju teškoća s vidom, obratite se liječniku.
English: Sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, water for injections
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari natrijev klorid dibazični natrijev fosfat, heptahidrat monobazični natrijev fosfat, hidrat voda za injekcije
English: 4.9 Overdose
Croatian: 4.8 Nuspojave
English: Frequency category
Croatian: 13. BROJ SERIJE
English: Hypoaesthesia oral Nausea
Croatian: Poremećaji probavnog sustava često oralna hipoestezija mučnina
English: • Periodic safety update reports (PSURs)
Croatian: • Plan upravljanja rizikom (RMP)
English: Musculoskeletal and connective tissue disorders
Croatian: Oštećenje funkcije bubrega i jetre
English: Stretched skin, skin discolouration Feeling sick (nausea), numbness of the mouth (hypoaesthesia oral) Aching muscles (myalgia)
Croatian: • mučnina, utrnulost ustiju (oralna hipoestezija)
English: Nephrocalcinosis occurred in 51.6% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients.
Croatian: U ispitivanju prirodnog tijeka bolesti u neliječenih bolesnika s infantilnim oblikom hipofosfatazije, nefrokalcinoza se pojavila u 51,6% bolesnika između rođenja i dobi od 5 godina.
English: Immunogenicity
Croatian: Imunogenost
English: Patients received a median duration of treatment of 27.6 month (range from 1 day to 90 months).
Croatian: Medijan trajanja liječenja iznosio je 27,6 mjeseci (raspon od 1 dana do 90 mjeseci), a ventilacijska potpora bila je na početku potrebna kod 29 od 80 bolesnika:
English: Invert the vial and syringe.
Croatian: Drugi lijekovi i Strensiq
English: Gastrointestinal disorders
Croatian: Prijavljivanje nuspojava
English: OTHER
Croatian: SAS
English: Renal and hepatic impairment
Croatian: Poremećaji bubrega i mokraćnog sustava često nefrolitijaza
English: Lipodystrophy
Croatian: Lipodistrofija
English: Scar
Croatian: Serija
English: Common
Croatian: Učestalost
English: Date of first authorisation: 10 November 2017
Croatian: Datum prvog odobrenja: 10 studeni 2017
English: • Children and adolescents
Croatian: • Djeca i adolescenti
English: 751 05 Uppsala Sweden
Croatian: 751 05 Uppsala Švedska
English: It can cause death or otherwise harm them.
Croatian: Može uzrokovati smrtni ishod ili im na drugi način naškoditi.
English: This leaflet was last revised in.
Croatian: Ova uputa je zadnji put revidirana u
English: Never open the blister in advance.
Croatian: Blister nikad nemojte otvarati unaprijed.
English: CYP 3A inhibitors
Croatian: CYP 3A inhibitori
English: • insomnia (inability to sleep)
Croatian: • nesanica (nemogućnost spavanja)
English: When a hepatic event is suspected, further biological and etiological evaluation is required.
Croatian: Kad se sumnja na jetreni događaj, potrebne su daljnje biološke i etiološke procjene.
English: Zubsolv with food, drink and alcohol
Croatian: Zubsolv s hranom, pićem i alkoholom
English: Keep this medicine in a safe place to protect it from theft.
Croatian: Čuvajte ovaj lijek na sigurnom mjestu kako biste ga zaštitili od krađe.
English: • sensitivity to heat or cold
Croatian: • osjetljivost na toplinu ili hladnoću
English: Do not push the tablet through the foil.
Croatian: Ne gurajte tabletu kroz foliju.
English: This medicine should not be taken by those under 15 years of age.
Croatian: Ovaj lijek ne smiju uzimati osobe mlađe od 15 godina.
English: Acute alcoholism or delirium tremens.
Croatian: Akutni alkoholizam ili delirium tremens.
English: You may be more closely monitored by your doctor if you are below the age of 18.
Croatian: Vaš liječnik će Vas pomnije pratiti ako imate manje od 18 godina.
English: • accidental injury caused by loss of alertness or co-ordination
Croatian: • slučajne ozljede uzrokovane gubitkom pažnje ili koordinacije
English: These may be signs of a life-threatening allergic reaction
Croatian: Ovo mogu biti znakovi životno ugrožavajuće alergijske reakcije
English: The syndrome is generally delayed for several hours to several days after birth.
Croatian: Sindrom se obično pojavljuje nekoliko sati do nekoliko dana nakon rođenja.
English: Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.
Croatian: Nemojte mijenjati liječenje na bilo koji način ili prekidati liječenje bez suglasnosti liječnika koji Vas liječi.
English: Store the blister safely.
Croatian: Blister spremite na sigurno.
English: Dosage adjustments may therefore be necessary.
Croatian: Zato će možda biti potrebne prilagodbe doze.
English: Use in adolescents (Age 15 - <18 years)
Croatian: Primjena u adolescenata (u dobi od 15 do <18 godina)
English: to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from available data).
Croatian: <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If the blister is damaged, discard the tablet.
Croatian: Ako je blister oštećen, bacite tabletu.
English: They may also cause central nervous system depression, which is very serious.
Croatian: Mogu također uzrokovati depresiju središnjeg živčanog sustava, što je vrlo ozbiljno stanje.
English: The use of this medicinal product by the oral route is therefore inappropriate.
Croatian: Zbog toga je primjena ovog lijeka peroralnim putem neprikladna.
English: Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse.
Croatian: Stoga se doze moraju ograničiti i ta se kombinacija lijekova mora izbjegavati u slučajevima u kojima postoji rizik od zlouporabe.
English: This may appear several days after birth.
Croatian: Do ovoga može doći nekoliko dana nakon poroda.
English: Zubsolv is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
Croatian: Zubsolv se koristi u odraslih osoba i adolescenata starijih od 15 godina, koji također primaju medicinsku, socijalnu i psihološku pomoć.
English: This product can cause dependence.
Croatian: Ovaj lijek može uzrokovati ovisnost.
English: • difficulty in getting or keeping an erection
Croatian: • poteškoće u postizanju ili održavanju erekcije
English: If more than one tablet is required, they may be taken all at the same time or in two divided portions; the second portion is to be taken directly after the first portion has dissolved.
Croatian: Ako je potrebno više od jedne tablete, može se uzeti istovremeno ili u dva podijeljena dijela; drugi dio treba uzeti odmah nakon što se prvi dio otopi.
English: • deterioration of brain function that is a serious complication of liver disease
Croatian: • pogoršanje funkcije mozga koje je ozbiljna komplikacija bolesti jetre
English: Store in the original package below 25°C in order to protect from moisture.
Croatian: Čuvati u originalnom pakiranju na temperaturi ispod 25 °C radi zaštite od vlage.
English: Due to the lack of data in adolescents (age 15 - <18 years), patients in this age group should be more closely monitored during treatment.
Croatian: S obzirom na nedostatak podataka u adolescenata (u dobi od 15 do <18 godina), bolesnici ove dobne skupine trebaju se pažljivije pratiti tijekom liječenja.
English: • Diagnosis of unrelated medical conditions
Croatian: • Dijagnoza nevezanih zdravstvenih stanja
English: Remove just one section from the blister pack, tearing it along the perforated line.
Croatian: Odvojite samo jedan odjeljak od blistera, kidajući ga uzduž perforirane linije.
English: Precautions to be taken before induction
Croatian: Mjere opreza koje treba poduzeti prije uvođenja
English: The patient should be transferred to an environment where full resuscitation facilities are available.
Croatian: Bolesnika treba premjestiti na odjel gdje postoji kompletna oprema za oživljavanje.
English: What Zubsolv is and what it is used for 2.
Croatian: Što je Zubsolv i za što se koristi 2.
English: In some patients, after a satisfactory stabilisation has been achieved, the frequency of dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday.
Croatian: U nekih bolesnika učestalost doziranja, nakon što je postignuta zadovoljavajuća stabilizacija, može se smanjiti na 3 puta tjedno (primjerice, ponedjeljkom, srijedom i petkom.
English: Contents of the pack and other information What Zubsolv contains
Croatian: Sadržaj pakiranja i druge informacije Što Zubsolv sadrži
English: Do not forget to advise your doctor if you take this medicine.
Croatian: Ne zaboravite obavijestiti svog liječnika o tome da uzimate ovaj lijek.
English: PVC/OPA/Al/PVC // Al/PET/Paper child resistant blister cards.
Croatian: PVC/OPA/Al/PVC // Al/PET/papirne blister kartice koje djeca ne mogu otvoriti.
English: Further, no teratogenicity has been observed in either rats or rabbits.
Croatian: Nadalje, nije primijećeno teratogeno djelovanje ni u štakora, niti u kunića.
English: Do not take this medicine in front of children.
Croatian: Lijek nemojte uzimati pred djecom.
English: Only open the blister immediately before taking the dose.
Croatian: Blister otvorite uvijek neposredno prije uzimanja doze.
English: There are other strengths that are available to be used by your doctor who will decide what is the best treatment for you.
Croatian: Ima i drugih jačina koje može propisati Vaš liječnik koji će odlučiti o najboljoj terapiji za Vas.
English: The recommended starting dose for adults and adolescents over the age of 15 years is:
Croatian: Preporučena početna doza u odraslih i adolescenata starijih od 15 godina je:
English: Initial naloxone doses may range up to 2 mg and be repeated every 2-3 minutes.
Croatian: Početne doze naloksona mogu iznositi do 2 mg i mogu se ponavljati svakih 2-3 minute.
English: No synergistic enhancement of toxicity has been observed.
Croatian: Nije primijećeno sinergističko pojačanje toksičnosti.