FrancophonIA/ELRC3.0 huggingface dataset:
English: Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Pegasys in combination with ribavirin.
Croatian: Mora se poduzeti potpuna zaštita radi izbjegavanja trudnoće u bolesnica odnosno partnerica bolesnika koji primaju Pegasys u kombinaciji s ribavirinom.
English: For paediatric patients, based on toxicities, up to three levels of dose modification can be made before dose interruption or discontinuation is considered (see Table 5).
Croatian: U pedijatrijskih se bolesnika u slučaju toksičnosti može provesti prilagodba doze u najviše tri razine prije nego što se razmotri privremen ili trajan prekid liječenja (vidjeti tablicu 5).
English: In chronic hepatitis B the duration of Pegasys treatment is 48 weeks.
Croatian: Kod kroničnog hepatitisa B, liječenje lijekom Pegasys traje 48 tjedana.
English: ● remove the cap until you are ready to inject.
Croatian: ● ne skidajte zatvarač dok niste spremni injicirati lijek.
English: The absorption of Pegasys is sustained with peak serum concentrations reached 72 to 96 hours after dosing.
Croatian: Apsorpcija lijeka Pegasys je održana, a vršne koncentracije lijeka u serumu dostižu se između 72 do i 96 sati nakon primjene.
English: 1 - <2 log10 decline
Croatian: 1 - < 2 log10
English: All HCV genotypes** HCV genotype 1
Croatian: Svi HCV genotipovi ** HCV genotipa 1
English: A clinical trial investigating the combination of telbivudine 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration for the treatment of HBV, indicates that the combination is associated with an increased risk for developing peripheral neuropathy.
Croatian: Kliničko ispitivanje kombinacije telbivudina 600 mg/dan s pegiliranim interferonom alfa-2a 180 mikrograma jednom tjedno supkutanom primjenom za liječenje HBV-a, pokazuje da je ta kombinacija povezana s povećanim rizikom razvitka periferne neuropatije.
English: The decrease in ANC was reversible upon dose reduction or cessation of therapy (see section 4.2), reached normal values by 8 weeks in the majority of patients and returned to baseline in all patients after about 16 weeks.
Croatian: Smanjenje apsolutnog broja neutrofila reverzibilno je nakon smanjenja doze ili prekida liječenja (vidjeti dio 4.2) te doseže normalne vrijednosti do 8. tjedna u većine bolesnika, a vraća se na početne vrijednosti u svih bolesnika nakon otprilike 16 tjedana.
English: During therapy with Pegasys +/- ribavirin lasting up to 48 weeks in patients aged 3 to 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Croatian: Tijekom liječenja lijekom Pegasys +/- ribavirinom u trajanju do 48 tjedana u bolesnika u dobi od 3 do 17 godina smanjenje tjelesne težine i zastoj u rastu bili su česti (vidjeti dijelove 4.8 i 5.1).
English: It is also used to treat chronic hepatitis B in children and adolescents aged 3 years and older and chronic hepatitis C in children and adolescents aged 5 years and older, who have not been treated before.
Croatian: Također se primjenjuje se za liječenje kroničnog hepatitisa B u djece i adolescenata u dobi od 3 i više godina i kroničnog hepatitisa C u djece i adolescenata u dobi od 5 i više godina koji prethodno nisu bili liječeni.
English: 500 to < 750 cells/mm 3: Immediate 1 level adjustment.
Croatian: 500 do < 750 stanica/mm 3: odmah prilagoditi za 1 razinu.
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be re-assessed (see also Endocrine system in sections 4.4 and 4.8).
Croatian: Treba pažljivo procijeniti bolesnike sa znakovima i simptomima koji odgovaraju onima kod autoimunih poremećaja te ponovno razmotriti odnos koristi i rizika koje donosi nastavak liječenja interferonima (vidjeti Endokrini sustav u dijelovima 4.4 i 4.8).
English: Must not be given to premature babies, neonates or children up to 3 years old.
Croatian: Ne smije se davati nedonoščadi, novorođenčadi ni djeci mlađoj od 3 godine.
English: Results from pharmacokinetic substudies of pivotal phase III trials demonstrated no pharmacokinetic interaction of lamivudine on Pegasys in HBV patients or between Pegasys and ribavirin in HCV patients.
Croatian: Rezultati farmakokinetičke pivotalne studije faze III pokazali su da ne postoji farmakokinetička interakcija lamivudina s lijekom Pegasys u bolesnika oboljelih od HBV-a ili između lijeka Pegasys i ribavirina u bolesnika oboljelih od HCV-a.
English: With the syringe pointing up, make certain that the tip of the needle is in the Pegasys solution.
Croatian: Dok je štrcaljka okrenuta prema gore, provjerite da je vrh igle u Pegasys otopini.
English: Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with CHC treated with interferon.
Croatian: Prijavljeni su slučajevi Vogt-Koyanagi-Harada (VKH) sindroma u bolesnika s kroničnim hepatitisom C liječenih interferonom.
English: ● if you have advanced liver disease and your liver does not work properly (e.g. your skin has become yellow).
Croatian: • ako bolujete od uznapredovale bolesti jetre pa Vam jetra ne radi pravilno (npr. koža Vam je požutjela).
English: Hormone system disorders: Diabetes (high blood sugar) Metabolic disorders: Dehydration
Croatian: Hormonski poremećaji: šećerna bolest (visoka razina šećera u krvi) Poremećaji metabolizma: dehidracija
English: ● Remove the protective cap from the Pegasys vial (1).
Croatian: Uklonite zaštitnu kapicu s Pegasys bočice (1).
English: Patients with existence of, or history of severe psychiatric conditions: If treatment with Pegasys is judged necessary in patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Croatian: Bolesnici s teškim psihijatrijskim stanjima ili teškim psihijatrijskim stanjima u anamnezi: ako je procijenjeno da je liječenje lijekom Pegasys neophodno bolesniku koji pati ili je patio od teških psihijatrijskih stanja, liječenje treba započeti tek nakon odgovarajuće individualne dijagnoze i terapijskog zbrinjavanja psihijatrijskog stanja.
English: In a clinical trial with 114 paediatric patients (5 to 17 years of age) treated with Pegasys alone or in combination with ribavirin (see section 5.1), dose modifications were required in approximately onethird of patients, most commonly for neutropenia and anaemia.
Croatian: U kliničkom ispitivanju sa 114 pedijatrijskih bolesnika (u dobi od 5 do 17 godina) liječenih lijekom Pegasys samim ili u kombinaciji s ribavirinom (vidjeti dio 5.1), dozu je bilo potrebno prilagoditi u približno jedne trećine bolesnika, najčešće zbog neutropenije i anemije.
English: Patients who withdrew from previous therapy with pegylated interferon alfa-2b/ribavirin because of haematological toxicity were excluded from enrolling in this trial.
Croatian: Bolesnici u kojih je ranije liječenje pegiliranim interferonom alfa-2b/ribavirinom prekinuto zbog hematološke toksičnosti bili su izuzeti i nisu bili uključeni u ovo ispitivanje.
English: Table 20: Sustained virological response in HALT-C by previous treatment regimen in nonresponder population
Croatian: Tablica 20: Trajni virološki odgovor u ispitivanju HALT-C prema prethodnom terapijskom režimu u populaciji koja ranije nije odgovorila na liječenje
English: Use Pegasys exactly as described by your doctor, for as long as prescribed by your doctor.
Croatian: Pegasys primjenjujte točno prema uputama liječnika i tijekom onog razdoblja koje Vam je propisao liječnik.
English: • When receiving Pegasys, your child may have slower growth and development (see section 4).
Croatian: • Tijekom liječenja lijekom Pegasys rast i razvoj Vašega djeteta mogu se usporiti (pogledajte dio 4.).
English: Adult and paediatric patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during Pegasys therapy.
Croatian: Odrasli i pedijatrijski bolesnici s postojećim poremećajima vida (npr. s dijabetičkom ili hipertenzivnom retinopatijom) trebaju tijekom liječenja lijekom Pegasys povremeno napraviti oftalmološki pregled.
English: Assessment
Croatian: Procjena
English: Ribavirin number of tablets
Croatian: Broj tableta ribavirina
English: Exploratory analyses based on limited data show paediatric patients with greater decline in HBV-DNA at week 12 of therapy were more likely to achieve HBeAg seroconversion at 24 weeks of follow-up (Table 24).
Croatian: Eksploracijske analize temeljene na ograničenim podacima pokazuju da je u pedijatrijskih bolesnika s većim sniženjem razine HBV DNK u 12. tjednu liječenja postojala veća vjerojatnost postizanja HbeAg serokonverzije u 24. tjednu praćenja (tablica 24).
English: The major treatment-related change was reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Croatian: Najveća promjena vezana uz liječenje bila je reverzibilna, blaga do umjerena anemija, a njezin je intenzitet bio veći nego kod monoterapijske primjene bilo koje od ovih dviju djelatnih tvari.
English: Reproductive toxicity studies have not been performed with Pegasys.
Croatian: Nisu provedena ispitivanja reprodukcijske toksičnosti lijeka Pegasys.
English: If you forget to take Pegasys
Croatian: Ako ste zaboravili primijeniti Pegasys
English: Patients infected with HCV genotypes other than genotype 1 should receive 800 mg daily of ribavirin.
Croatian: Bolesnici zaraženi drugim genotipovima HCV-a (osim genotipa 1) trebaju primiti dnevnu dozu od 800 mg ribavirina.
English: ● small bandage or sterile gauze
Croatian: • mali zavoj ili sterilna gaza
English: ● if you develop symptoms of Vogt-Koyanagi-Harada syndrome; combination of complaints of neck stiffness, headache, loss of colour in skin or hair, eye disorders (such as blurred vision), and/or hearing abnormality (such as ringing in the ears).
Croatian: • ako se pojave simptomi Vogt-Koyanagi-Harada (VKH) sindroma; kombinacija ukočenosti u vratu, glavobolje, gubitka boje kose ili kože, poremećaja oka (poput zamagljenog vida) i/ili slušnih smetnji (poput zvonjave u ušima).
English: Keep the protective cap on the pre-filled pen until Step 5.
Croatian: Zaštitni zatvarač ne skidajte s brizgalice do 5. koraka.
English: It is recommended that patients who have pre-existing cardiac abnormalities have an electrocardiogram prior to initiation of Pegasys therapy.
Croatian: Preporučuje se da bolesnici s prethodnim srčanim tegobama prije početka liječenja lijekom Pegasys naprave elektrokardiogram.
English: Most of the adverse reactions reported in the study were mild or moderate in severity.
Croatian: Većina prijavljenih nuspojava bile su blage ili umjerene težine.
English: 2) Allow the pre-filled pen to adjust to room temperature
Croatian: 2) Pustite napunjenu brizgalicu da dosegne sobnu temperaturu
English: Pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1).
Croatian: Pegasys je indiciran u kombinaciji s drugim lijekovima, za liječenje kroničnog hepatitisa C u bolesnika s kompenziranom bolesti jetre (vidjeti dijelove 4.2, 4.4 i 5.1).
English: SI unit = µmol/l)
Croatian: međunarodni sustav jedinica SI=µmol/l
English: Consideration should be given to continuing treatment with more frequent monitoring of liver function during ALT flares.
Croatian: Treba razmisliti i o nastavku liječenja uz češće praćenje funkcije jetre tijekom naglog porasta razine ALT-a.
English: At the end of 2 years follow-up after treatment, most patients had returned to baseline normative growth curve percentiles for weight and height (mean weight percentile was 64% at baseline and 60% at 2 years post-treatment; mean height percentile was 54% at baseline and 56% at 2 years post-treatment).
Croatian: Na kraju dvogodišnjeg praćenja nakon liječenja većina se bolesnika vratila na početne percentile normativne krivulje porasta tjelesne težine i visine (srednja vrijednost percentila težine bila je 64% na početku i 60% dvije godine nakon završetka liječenja; srednja vrijednost percentila visine bila je 54% na početku i 56% dvije godine nakon liječenja).
English: The frequency depends on the treatment duration and the dose of ribavirin (see section 4.8).
Croatian: Učestalost anemije ovisi o trajanju liječenja i dozi ribavirina (vidjeti dio 4.8).
English: Pegasys plus ribavirin
Croatian: Pegasys i ribavirin
English: Talk to your doctor, pharmacist or nurse before using Pegasys
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Pegasys
English: Hold the pre-filled pen firmly with one hand and pull off the protective cap with the other hand.
Croatian: Jednom rukom čvrsto držite napunjenu brizgalicu, a drugom skinite zaštitni zatvarač.
English: Pegasys must be used with caution in patients with psoriasis, and in cases of onset or worsening of psoriatic lesions, discontinuation of therapy should be considered.
Croatian: Treba biti oprezan prilikom primjene lijeka Pegasys u bolesnika sa psorijazom, a dođe li do pojave ili pogoršanja psorijatičnih lezija, treba razmotriti prekid liječenja.
English: Adverse events were experienced by 88% of Pegasys-treated patients as compared with 53% of patients in the lamivudine comparator group, while 6% of the Pegasys-treated and 4% of the lamivudine-treated patients experienced serious adverse events during the studies.
Croatian: Nuspojave su se javile u 88% bolesnika liječenih lijekom Pegasys u usporedbi s 53% bolesnika u usporednoj skupini liječenoj lamivudinom, dok su se u 6% bolesnika liječenih lijekom Pegasys i 4% bolesnika liječenih lamivudinom tijekom ispitivanja javile ozbiljne nuspojave.
English: Sustained response
Croatian: Trajni odgovor
English: Adverse events or laboratory abnormalities led to 5% of patients withdrawing from Pegasys treatment, while less than 1% of patients withdrew from lamivudine treatment for these reasons.
Croatian: Nuspojave ili poremećaji laboratorijskih parametara uzrokovali su povlačenje iz liječenja u 5% bolesnika liječenih lijekom Pegasys, dok se iz liječenja lamivudinom iz istih razloga povuklo manje od 1% bolesnika.
English: The dose of ribavirin to be used in combination with Pegasys is given in Table 1.
Croatian: Doza ribavirina koju treba primjenjivati u kombinaciji s lijekom Pegasys prikazana je u tablici 1.
English: The absolute bioavailability of Pegasys is 84% and is similar to that seen with interferon alfa-2a.
Croatian: Apsolutna bioraspoloživost lijeka Pegasys iznosi 84% te je slična onoj interferona alfa-2a.
English: ● Hold the vial and syringe in one hand and turn the vial and the syringe upside down (4).
Croatian: Primite bočicu i štrcaljku jednom rukom, a zatim i bočicu i štrcaljku okrenite naopako (4).
English: Wash your hands carefully before handling any of the items.
Croatian: Prije rukovanja bilo kojim dijelom pribora pažljivo operite ruke.
English: Genotype 2 and 3 (N=96)
Croatian: (N=569) Genotip 2 i 3 (N=96)
English: Table 25: Sustained virological response in the NV17424 study Pegasys 180 mcg x BSA/1.73 m² + Ribavirin 15 mg/kg (N=55)*
Croatian: Tablica 25: Trajni virološki odgovor u ispitivanju NV17424 Pegasys 180 mikrograma x BSA/1,73 m² + ribavirin 15 mg/kg (N=55)*
English:  The red indicator will move down in the viewing window as the injection is ongoing.
Croatian: → Kako ubrizgavanje napreduje, crveni će se pokazatelj spuštati u prozorčić za provjeru.
English: The recommended duration of Pegasys monotherapy is 48 weeks.
Croatian: Preporučeno trajanje monoterapije lijekom Pegasys je 48 tjedana.
English: Preparing the syringe and needle for injection
Croatian: Priprema štrcaljke i igle za ubrizgavanje
English: The risk of growth inhibition should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (for HBVinfection mainly HBV genotype and ALT levels; for HCV-infection mainly HCV genotype and HCV-RNA levels) (see section 5.1).
Croatian: Rizik od zastoja u rastu treba odvagnuti u odnosu na obilježja bolesti u djeteta, primjerice znakove progresije bolesti (prije svega fibroze), popratne bolesti koje mogu negativno utjecati na progresiju bolesti (poput koinfekcije HIV-om) kao i prognostičke faktore odgovora (za infekciju HBV-om prvenstveno genotip HBV-a i razine ALT-a; za infekciju HCV-om prvenstveno genotip HCV-a i razine HCV-RNK) (vidjeti dio 5.1).
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno
English: Pegasys pharmacokinetics have been characterized in paediatric patients with CHB (YV25718), as well as in paediatric patients with CHC (NR16141), using population pharmacokinetics.
Croatian: Farmakokinetika lijeka Pegasys okarakterizirana je u pedijatrijskih bolesnika s kroničnim hepatitisom B (YV25718) i pedijatrijskih bolesnika s kroničnim hepatitisom C (NR16141) korištenjem populacijskog farmakokinetičkog modela.
English: With up to one year of treatment with Pegasys in combination with ribavirin, some children and adolescents with chronic hepatitis C did not grow or gain weight as much as expected.
Croatian: Tijekom liječenja lijekom Pegasys u kombinaciji s ribavirinom u trajanju od najdulje jedne godine, neka djeca i adolescenti s kroničnim hepatitisom C nisu dobili na visini ili težini onoliko koliko se očekivalo.
English: Peginterferon alfa-2a is found predominantly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6 to 14 litres in humans after intravenous administration.
Croatian: Peginterferon alfa-2a nađen je pretežno u krvotoku i izvanstaničnoj tekućini, što je vidljivo i iz volumena raspodjele u stanju dinamičke ravnoteže (Vd) koji nakon intravenske primjene lijeka u ljudi iznosi od 6 do 14 litara.
English: Dose adjustement in paediatric patients - dual therapy with Pegasys and ribavirin
Croatian: Prilagodba doze u pedijatrijskih bolesnika - dvojna terapija lijekom Pegasys i ribavirinom
English: In humans, the systemic clearance of peginterferon alfa-2a is about 100-fold lower than that of the native interferon alfa-2a.
Croatian: U ljudi je sistemski klirens peginterferona alfa-2a otprilike 100 puta manji nego onaj nativnog interferona alfa-2a.
English: Based on drug exposure, pharmacodynamic response and tolerability, a lower dose of Pegasys is not needed in the geriatric patient (see section 4.2).
Croatian: Sudeći prema izloženosti lijeku, farmakodinamičkom odgovoru i podnošljivosti, nije potrebno smanjivati dozu lijeka Pegasys u starijih bolesnika (vidjeti dio 4.2).
English: ● Remove the protective cap that covers the back of the needle (1-2).
Croatian: Uklonite zaštitnu kapicu sa stražnje strane igle (1-2).
English: If you are receiving HAART, the addition of Pegasys + ribavirin may increase your risk of lactic acidosis or liver failure.
Croatian: Ako primate HAART, dodatak kombinacije lijeka Pegasys i ribavirina može povećati opasnost od pojave laktične acidoze ili zatajenja jetre.
English: Do not massage the injection site.
Croatian: Nemojte masirati mjesto primjene.
English: As with other interferons, a higher incidence of neutralising antibodies was seen in CHB.
Croatian: Kao i s drugim interferonima, veća incidencija neutralizirajućih antitijela primijećena je u slučaju kroničnog hepatitisa B.
English: Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Pegasys with or without ribavirin.
Croatian: Pogledajte Sažetke opisa svojstava lijeka pojedinačnih antiretrovirusnih lijekova koji se primjenjuju istodobno s terapijom HCV-a kako biste bili upoznati i mogli nadzirati toksičnost specifičnu za svaki lijek, kao i mogućnost preklapanja toksičnosti s lijekom Pegasys primijenjenim s ribavirinom ili bez njega.
English: The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 14 and 15).
Croatian: Rezultati ispitivanja NV15942 daju osnove za preporuku režima liječenja na temelju genotipa, količine virusa na početku liječenja i virološkog odgovora u 4. tjednu liječenja (vidjeti tablice 1, 14 i 15).
English: A return to original dosing is not recommended.
Croatian: Ne preporučuje se povratak na početnu dozu ribavirina.
English: Laboratory values for HIV-HCV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment.
Croatian: Laboratorijske vrijednosti za bolesnike koinficirane HIV-om i HCV-om Premda su se hematološke toksičnosti u vidu neutropenije, trombocitopenije i anemije češće pojavljivale u bolesnika koinficiranih HIV-om i HCV-om, većinom su se mogle korigirati smanjenjem doze i upotrebom faktora rasta, a u rjeđim slučajevima su zahtijevale prijevremeni prekid liječenja.
English: In clinical trials, Pegasys treatment was associated with decreases in both total white blood cell (WBC) count and ANC, usually starting within the first 2 weeks of treatment (see section 4.8).
Croatian: U kliničkim ispitivanjima liječenje lijekom Pegasys povezivano je s padom ukupnoga broja leukocita (engl. white blood cell, WBC) i ABN-a, obično unutar prva 2 tjedna liječenja (vidjeti dio 4.8).
English: The Child-Pugh classification divides patients into groups A, B, and C, or "Mild", "Moderate" and "Severe" corresponding to scores of 5-6, 7-9 and 10-15, respectively.
Croatian: Prema Child-Pughovoj klasifikaciji, bolesnici se dijele u skupine A, B i C, odnosno bolesnike s "blagim oštećenjem", "umjerenim oštećenjem" i "teškim oštećenjem" jetrene funkcije, što odgovara indeksima 5-6, 7-9 odnosno 10-15.
English: Patients infected with viral genotypes 2 or 3 should receive 24 weeks of treatment, while patients infected with any other genotype should receive 48 weeks of therapy.
Croatian: Bolesnici zaraženi virusom genotipa 2 ili 3 trebaju dobiti 24 tjedna liječenja, dok se bolesnici zaraženi bilo kojim drugim genotipom trebaju liječiti tijekom 48 tjedana.
English: HBV genotype A subgroup size was insufficient to be analyzed.
Croatian: A i D veličina podskupina nije bila dovoljna za analizu.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 June 2002
Croatian: Datum prvog odobrenja: 20. lipnja 2002.
English: During treatment, co-infected patients should be closely monitored for signs and symptoms of hepatic decompensation (including ascites, encephalopathy, variceal bleeding, impaired hepatic synthetic function; e.g., Child-Pugh score of 7 or greater).
Croatian: Tijekom liječenja, bolesnike istodobno zaražene HCV-om i HIV-om treba strogo nadzirati radi znakova i simptoma dekompenzacije jetre (uključujući ascites, encefalopatiju, krvarenje iz varikoziteta, oštećenu funkciju jetre; npr. Child-Pugh indeks 7 ili veći).
English: Pegasys is contraindicated in neonates and young children up to 3 years old due to the excipient benzyl alcohol (see sections 4.3 and 4.4).
Croatian: Pegasys je kontraindiciran u novorođenčadi i male djece do 3 godine starosti jer sadrži benzilni alkohol kao pomoćnu tvar (vidjeti dijelove 4.3. i 4.4).
English: Replace the needle guard and place the syringe in a horizontal position until ready for use.
Croatian: Ponovo stavite zaštitni poklopac na iglu i odložite štrcaljku u vodoravan položaj dok ne bude spremna za uporabu.