FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore concluded that while deviations from GCP requirements were identified, the totality of the available evidence confirms that the results of the bioequivalence study are reliable and demonstrates the bioequivalence of the proposed products and the reference product.
Croatian: Stoga je CHMP zaključio da, premda su identificirana odstupanja od zahtjeva dobre kliničke prakse, ukupni dostupni podaci potvrđuju da su rezultati studije bioekvivalencije pouzdani te je dokazana bioekvivalencija predloženih lijekova i referentnog lijeka.
English: • the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibolona Aristo and associated names (see Annex I).
Croatian: CHMP je preporučio izdavanje odobrenja za stavljanje u promet, uz sažetak svojstava proizvoda, označivanje i upute o lijeku koji ostaju kao kod zadnje verzije utvrđene tijekom postupka Skupine za koordinaciju, kao što je navedeno u Prilogu III. ovog mišljenja za lijek Tibolona Aristo i srodne nazive (vidjeti Prilog I.).
English: • Section 3: How to use X
Croatian: • Dio 3: Kako primjenjivati X
English: • third trimester of pregnancy
Croatian: • treće tromjesečje trudnoće
English: Metamizole crosses the placental barrier.
Croatian: Metamizol prolazi placentarnu barijeru.
English: There is no experience available with long-term use.
Croatian: Nema dostupnog iskustva s dugoročnom primjenom.
English: Infants and children
Croatian: Dojenčad i djeca
English: Adults and adolescents 15 years of age or older
Croatian: Odrasli i adolescenti u dobi od 15 godina ili stariji
English: <Invented name> will be given to you as injection into your vein or into muscle.
Croatian: <Zaštićeno ime> će vam davati kao injekciju u venu ili mišić.
English: • Section 4.3 Contraindications
Croatian: • Dio 4.3 Kontraindikacije
English: Existing wording should be amended as necessary.
Croatian: Postojeći tekst potrebno je odgovarajuće izmijeniti.
English: Your doctor will tell you how to take <invented name>.
Croatian: Liječnik će Vam reći kako uzimati <zaštićeno ime>.
English: Section 2: What you need to know before you use X This following wording should be reflected in this section.
Croatian: Dio 2: Što morate znati prije nego počnete uzimati X Tekst u ovom dijelu treba odgovarati niže navedenom tekstu.
English: In animals metamizole induced reproductive toxicity but no teratogenicity (see Section 5.3).
Croatian: U životinja je metamizol inducirao reproduktivnu toksičnost, ali ne teratogenost (vidjeti dio 5.3).
English: 575 mg capsules
Croatian: Kapsule od 575 mg
English: In order to minimize the risk of a hypotensive reaction, the intravenous injection must be administered very slowly.
Croatian: Kako bi se minimizirao rizik od hipotenzivne reakcije, intravensku injekciju mora se davati vrlo polako.
English: Especially the repeated use of metamizole during breastfeeding must therefore be avoided.
Croatian: Stoga se posebice mora izbjegavati ponavljana primjena metamizola u razdoblju dojenja.
English: The following table shows recommended single doses and maximum daily doses depending on weight or age:
Croatian: Sljedeća tablica prikazuje preporučene pojedinačne doze i maksimalne dnevne doze prema tjelesnoj težini ili dobi:
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Croatian: Ove izmjene odgovarajućih dijelova informacija o lijeku rezultat su arbitražnog postupka.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Croatian: Postojeće informacije o lijeku treba izmijeniti (umetanjem, zamjenom ili brisanjem teksta, prema potrebi) tako da odražavaju usuglašeni tekst, kako je navedeno u nastavku.
English: Based on published data from pregnant women exposed to metamizole during the first trimester (n=568) no evidence for teratogenic or embryotoxic effects was identified.
Croatian: Na temelju objavljenih podataka dobivenih u trudnica izloženih metamizolu tijekom prvog tromjesečja (n = 568) nisu ustanovljeni dokazi za teratogene ili embriotoksične učinke.
English: The breakdown products of metamizole pass into breast-milk in considerable amounts and a risk to the breastfed infant cannot be excluded.
Croatian: Produkti razgradnje metamizola prelaze u majčino mlijeko u značajnim količinama pa se rizik za dojenče ne može isključiti.
English: All formulations including fixed combination medicinal products o Do not use X: - if you are in the last three months of pregnancy - if you are breast-feeding
Croatian: Sve formulacije uključujući fiksne kombinacije lijekova o Nemojte primjenjivati X: - ako ste u posljednjem tromjesečju trudnoće - ako dojite
English: For all formulations including fixed combination medicinal products:
Croatian: Za sve formulacije uključujući fiksnu kombinaciju lijekova:
English: If the effect of a single dose is insufficient or later, when the analgesic effect subsides, your doctor may administer another dose up to a daily maximum dose as detailed below.
Croatian: Ako učinak jedne doze nije dovoljan, ili kasnije kada analgetički učinak prestane, liječnik vam može dati drugu dozu do maksimalne dnevne doze kako je detaljno navedeno u nastavku.
English: There are only limited data available on the use of metamizole in pregnant women.
Croatian: Dostupni su samo ograničeni podatci o primjeni metamizola u trudnica.
English: For all formulations including fixed combination medicinal products
Croatian: Za sve formulacije uključujući fiksnu kombinaciju lijekova
English: During the last three months of pregnancy you must not take <invented name> because of an increased risk of complications for the mother and child (haemorrhaging, premature closure of an important vessel, the so-called Ductus Botalli, of the unborn, which naturally closes only after birth).
Croatian: Tijekom posljednjeg tromjesečja trudnoće ne smijete uzimati <zaštićeno ime> zbog povećanog rizika od komplikacija za majku i dijete (krvarenje, prijevremeno zatvaranje važne krvne žile u nerođenog djeteta, tzv. Botallijeva duktusa, koji se inače zatvara tek poslije rođenja).
English: Use during the third trimester is associated with fetotoxicity (renal impairment and ductus arteriosus constriction) and thus the use of metamizole is contraindicated during the third trimester of pregnancy (see section 4.3).
Croatian: Primjena u trećem tromjesečju povezana je s fetotoksičnim učinkom (oštećenje funkcije bubrega i konstrikcija duktusa arteriozusa) pa je stoga primjena metamizola kontraindicirana tijekom trećeg tromjesečja trudnoće (vidjeti dio 4.3).
English: 250 mg tablets
Croatian: Tablete od 250 mg
English: Available data on the use of metamizole during the first three months of pregnancy is limited but do not indicate harmful effects to the embryo.
Croatian: Dostupni podatci o primjeni metamizola tijekom prva tri mjeseca trudnoće ograničeni su, ali ne ukazuju na štetne učinke na zametak.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu, prema potrebi, naknadno ažurirati informacije o lijeku u suradnji s referentnom državom članicom, u skladu s postupcima utvrđenima u poglavlju 4. glave III.
English: To date, there has been insufficient experience with long-term use of metamizole in patients with severe hepatic and renal impairment.
Croatian: Dosad nije zabilježeno dovoljno iskustva s dugoročnom primjenom metamizola u bolesnika s teškim oštećenjem funkcije jetre i bubrega.
English: No dose reduction is needed when used for only a short time.
Croatian: Smanjenje doze nije potrebno kada se lijek primjenjuje samo kraće vrijeme.
English: Patients with impaired kidney or liver function
Croatian: Bolesnici s oštećenom funkcijom bubrega ili jetre
English: In selected cases when no other treatment options exist, single doses of metamizole during the first and second trimester might be acceptable after consultation with your doctor or pharmacist and after the benefits and risks of metamizole use have been carefully weighed up.
Croatian: U određenim slučajevima, ako ne postoje druge mogućnosti liječenja, pojedinačne doze metamizola tijekom prvog i drugog tromjesečja mogu biti prihvatljive nakon savjetovanja s liječnikom ili ljekarnikom te nakon što su pažljivo odvagnuti rizici i koristi od primjene metamizola.
English: In selected cases single doses of metamizole during the first and second trimester might be acceptable when no other treatment options exist.
Croatian: U odabranim slučajevima može biti prihvatljiva primjena pojedinačne doze metamizola tijekom prvog i drugog tromjesečja kada ne postoje druge mogućnosti liječenja.
English: <Invented name> is not recommended for adolescents less than 15 years and children, as formulations containing less active substance are needed.
Croatian: Primjena lijeka <zaštićeno ime> ne preporučuje se u adolescenata mlađih od 15 godina i djece jer su u njih potrebne formulacije koje sadrže manje djelatne tvari.
English: This wording below should be reflected in this section.
Croatian: Tekst u ovom dijelu treba odgovarati niže navedenom tekst.
English: • Section 4.2 Posology and method of administration
Croatian: • Dio 4.2 Doziranje i način primjene
English: 50 mg/ml syrup
Croatian: Sirup od 50 mg/ml
English: Age (body weight)
Croatian: Dob (tjelesna težina)
English: In case of inadvertent use of metamizole during the third trimester amniotic fluid and the ductus arteriosus should be controlled by ultrasound and echocardiographia.
Croatian: U slučaju nehotične primjene metamizola u trećem tromjesečju, potrebno je ultrazvukom i ehokardiografijom kontrolirati amnionsku tekućinu i duktus arteriozus.
English: In children under 1 year of age, metamizole should be injected by the intramuscular route only.
Croatian: Djeci mlađoj od 1 godine metamizol se smije injicirati samo intramuskularno.
English: Children age range (body weight)
Croatian: Raspon dobi u djece (tjelesna težina)
English: In case of a single administration of metamizole, mothers are advised to collect and discard the breastmilk for 48 hours after the dose
Croatian: U slučaju jednokratne primjene metamizola, majkama se savjetuje izdajanje i bacanje izdojenog mlijeka tijekom 48 sati od primjene doze.
English: For adults and adolescents 15 years and over (> 53 kg) other strengths or pharmaceutical forms are available.
Croatian: Za odrasle i adolescente u dobi od 15 godina ili starije (> 53 kg) dostupne su druge jačine ili drugi farmaceutski oblici.
English: Infants 3 - 11 months (ca. 5 - 8 kg)
Croatian: Dojenčad 3 - 11 mjeseci (oko 5 - 8 kg)
English: Do not give this medicine to infants during the first 3 months of life or patients weighing less than 5 kg Do not give this medicine via intravenous route to infants younger than 1 year of age All formulations including fixed combination medicinal products o Pregnancy, breast-feeding and fertility
Croatian: Lijek nemojte davati dojenčadi tijekom prva 3 mjeseca ili bolesnicima težine manje od 5 kg Lijek nemojte davati intravenskim putem dojenčadi mlađoj od 1 godine Sve formulacije uključujući fiksne kombinacije lijekova o Trudnoća, dojenje i plodnost
English: Paediatric population <Invented name> is contraindicated in infants below the age of 3 months or below 5 kg of body weight (see section 4.3).
Croatian: Pedijatrijska populacija Lijek <zaštićeno ime> kontraindiciran je u dojenčadi mlađe od 3 mjeseca ili tjelesne težine manje od 5 kg (vidjeti dio 4.3).
English: A clear effect can be expected 30 minutes after parenteral administration.
Croatian: Jasan učinak može se očekivati 30 minuta nakon parenteralne primjene.
English: The dose should be reduced in elderly people, in debilitated patients and in those with reduced creatinine clearance, as elimination of the metabolic products of metamizole may be prolonged.
Croatian: Dozu treba smanjiti u starijih osoba, bolesnika lošeg općeg zdravlja i onih sa smanjenim klirensom kreatinina jer eliminacija produkata metabolizma metamizola može biti produljena.
English: Elderly and patients in poor general health/with renal impairment
Croatian: Starije osobe i bolesnici lošeg općeg zdravlja / bolesnici s oštećenom funkcijom bubrega
English: 300 mg suppository
Croatian: Čepić od 300 mg
English: The maximum daily dose is 10,0 mL; if needed, the daily dose may be increased up to 12,5 ml (corresponding to 5,000 mg of <invented name>).
Croatian: Maksimalna dnevna doza je 10,0 ml; ako je potrebno, dnevna se doza može povećati do 12,5 ml (što odgovara 5 000 mg lijeka <zaštićeno ime>).
English: Daily maximum dose kg age tablets /sachets mg tablets/sachets mg
Croatian: Tjelesna težina kg dob tablete/vrećice mg tablete/vrećice mg
English: In children under 1 year of age, <invented name> should be injected by the intramuscular route only.
Croatian: Djeci mlađoj od 1 godine, <zaštićeno ime> se smije davati samo intramuskularno.
English: However, in general, the use of metamizole during the first and second trimester is not recommended.
Croatian: Međutim, u načelu se ne preporučuje primjena metamizola tijekom prvog i drugog tromjesečja.
English: As the elimination rate is reduced when renal or hepatic function is impaired, multiple high doses should be avoided.
Croatian: Budući da se kod oštećene funkcije bubrega ili jetre brzina eliminacije smanjuje, potrebno je izbjegavati višestruke visoke doze.
English: The following dosage scheme for single doses intravenous (except infants below 1 year) or intramuscular should be used as a guide:
Croatian: Za primjenu pojedinačnih doza u venu (osim u dojenčadi mlađe od 1 godine) ili mišić, potrebno je pratiti sljedeću preporuku za doziranje:
English: The maximum daily dose for adults and adolescents over 15 years is 4 suppositories/sachets of effervescent powder (corresponding to 4,000 mg).
Croatian: Maksimalna dnevna doza za odrasle i adolescente starije od 15 godina iznosi 4 čepića/vrećice šumećeg praška (što odgovara 4 000 mg).
English: 500 mg/ml oral drops, solution (1 ml = 20 drops)
Croatian: Oralne kapi, otopina od 500 mg/ml (1 ml = 20 kapi)
English: <invented name> should not be used for children younger than 15 years of age.
Croatian: <Zaštićeno ime> ne smije se primjenjivati u djece mlađe od 15 godina.
English: The dose should be reduced in elderly people, in debilitated patients and in those with reduced renal function, as excretion of the breakdown products of metamizole may be delayed.
Croatian: Dozu treba smanjiti u starijih osoba, u bolesnika lošeg općeg zdravlja i onih sa smanjenom funkcijom bubrega jer izlučivanje tvari koje nastaju razgradnjom metamizola može biti odgođeno.
English: Other forms and strengths of this medicine are available for younger children; ask your doctor or pharmacist.
Croatian: Za mlađu djecu dostupni su drugi oblici i jačine ovoga lijeka; o tome upitajte liječnika ili ljekarnika.
English: <invented name> should not be given to children under 3 months of age.
Croatian: <zaštićeno ime> se ne smije davati djeci mlađoj od 3 mjeseca.
English: 500 mg/ml solution for injection/infusion
Croatian: Otopina za injekciju/infuziju od 500 mg/ml
English: Elderly population, debilitated patients, and patients with reduced creatinine clearance
Croatian: Starije osobe, bolesnici lošeg općeg zdravlja i bolesnici sa smanjenim klirensom kreatinina
English: 500 mg tablets/capsules (also applicable for 500mg powder for oral solution/effervescent powder/granules for oral solution)
Croatian: Tablete/kapsule od 500 mg (primjenjivo i za prašak za oralnu otopinu / šumeći prašak / granule za oralnu otopinu od 500 mg)
English: <Invented name> intravenous route is contraindicated in infants under 1 year of age (see section
Croatian: Primjena lijeka <zaštićeno ime> intravenskim putem kontraindicirana je u dojenčadi mlađe od 1 godine (vidjeti dio 4.3).
English: 3,450mg (corresponding to 6 capsules) is the maximum daily dose.
Croatian: Maksimalna dnevna doza iznosi 3 450 mg (što odgovara 6 kapsula).
English: However, in general the use of metamizole during the first and second trimester is not recommended.
Croatian: Međutim, u pravilu se primjena metamizola ne preporučuje u prvom i drugom tromjesečju trudnoće.
English: Daily maximum dose kg age capsules capsules
Croatian: Tjelesna težina kg dob kapsule kapsule
English: Text in strikethrough should be deleted from the summary of product characteristics, if present.
Croatian: Iz sažetka opisa svojstava lijeka potrebno je izbrisati precrtani tekst ako postoji.
English: A clear effect is expected 30 to 60 minutes after using the medicine.
Croatian: Jasan učinak očekuje se od 30 do 60 minuta nakon primjene lijeka.
English: 4,000 mg (corresponding to 8 tablets/sachets) is the maximum daily dose.
Croatian: Maksimalna dnevna doza iznosi 4 000 mg (što odgovara 8 tableta/vrećica).
English: Do not give this medicine to infants during the first 3 months of life or patients weighing less than 5 kg 2000 mg/5ml (i.e. 400 mg/ml) solution for injection/infusion Do not give this medicine to infants during the first 3 months of life or patients weighing less than 5 kg Do not give this medicine via intravenous route to infants younger than 1 year of age 500 mg/ml solution for injection/infusion
Croatian: Lijek nemojte davati dojenčadi tijekom prva 3 mjeseca života ili bolesnicima težine manje od 5 kg Otopina za injekciju/infuziju od 2 000 mg/5ml (tj. 400 mg/ml) Lijek nemojte davati dojenčadi tijekom prva 3 mjeseca života ili bolesnicima težine manje od 5 kg Lijek nemojte davati intravenskim putem dojenčadi mlađoj od 1 godine Otopina za injekciju/infuziju od 500 mg/ml
English: In dependence on the daily maximum dose a single dose can be taken up to 4 times daily at intervals of 6-8 hours.
Croatian: Ovisno o maksimalnoj dnevnoj dozi, pojedinačna doza može se uzimati do 4 puta na dan u razmacima od 6 do 8 sati.
English: Other pharmaceutical forms/strengths are available which can be appropriately be dosed for smaller children (see section 4.3).
Croatian: Dostupni su drugi farmaceutski oblici/jačine koje je moguće odgovarajuće dozirati u mlađe djece (vidjeti dio 4.3.).
English: As the rate of elimination is reduced in patients with impaired kidney or liver function, repeated high doses should be avoided.
Croatian: Budući da je u bolesnika s oštećenom funkcijom bubrega ili jetre smanjena brzina eliminacije (uklanjanja lijeka), potrebno je izbjegavati ponavljanu primjenu visokih doza.
English: Daily maximum dose kg age tablets tablets
Croatian: Tjelesna težina kg dob tablete tablete godina
English: 2000 mg/5ml (i.e. 400 mg/ml) solution for injection/infusion <invented name> is contraindicated for infants below the age of 3 months or below 5 kg of body weight intravenous route: <invented name> is contraindicated for infants under 1 year of age 500 mg/ml solution for injection/infusion <invented name> is contraindicated for infants below the age of 3 months or below 5 kg of body weight intravenous route: <invented name> is contraindicated for infants under 1 year of age
Croatian: <zaštićeno ime> je kontraindiciran u dojenčadi mlađe od 3 mjeseca ili tjelesne težine manje od 5 kg Sirup od 50 mg/ml <zaštićeno ime> je kontraindiciran u dojenčadi mlađe od 3 mjeseca ili tjelesne težine manje od 5 kg Otopina za injekciju/infuziju od 2 000 mg/5ml (tj. 400 mg/ml) <zaštićeno ime> je kontraindiciran u dojenčadi mlađe od 3 mjeseca ili tjelesne težine manje od 5 kg intravenski put primjene: <zaštićeno ime> je kontraindiciran u dojenčadi mlađe od 1 godine Otopina za injekciju/infuziju od 500 mg/ml
English: 4-6 years (19-23 kg)
Croatian: 4 - 6 godina (19 - 23 kg)
English: 10-12 years (31-45 kg)
Croatian: 10 - 12 godina (31 - 45 kg)
English: In dependence on the daily maximum dose a single dose can be given up to 6 times daily at intervals of 4-8 hours.
Croatian: Ovisno o maksimalnoj dnevnoj dozi, pojedinačna se doza može primjenjivati do 6 puta na dan u razmacima od 4 do 8 sati.
English: <Invented name> is not recommended for infants below the age of 3 months.
Croatian: Primjena lijeka <zaštićeno ime> ne preporučuje se u dojenčadi mlađe od 3 mjeseca.
English: 13-14 years (46-53 kg)
Croatian: 13 - 14 godina (46 - 53 kg)
English: Body weight kg age
Croatian: Tjelesna težina kg dob
English: It is essential to choose the lowest dose that controls pain and fever .
Croatian: Nužno je izabrati najnižu dozu kojom se kontroliraju bol i vrućicu.
English: 1 - 3 years (ca. 9 - 15 kg)
Croatian: 1 - 3 godine (oko 9 - 15 kg)
English: 7-9 years (24-30 kg)
Croatian: 7 - 9 godina (24 - 30 kg)
English: In case of fever, a dose of 10 mg metamizole per kilogram body weight is generally sufficient for children.
Croatian: U slučaju vrućice, za djecu je u pravilu dovoljna doza od 10 mg metamizola po kilogramu tjelesne težine.
English: Adolescents of 15 years of age or older (> 53 kg) and adults can administrate 1,000 mg metamizole as a single dose.
Croatian: Adolescenti u dobi od 15 godina ili stariji (> 53 kg) i odrasli mogu primjenjivati 1 000 mg metamizola kao jednu dozu.
English: It is essential to choose the lowest dose that controls pain and fever.
Croatian: Nužno je izabrati najnižu dozu kojom se kontroliraju bol i vrućica.
English: Other pharmaceutical forms/strengths are available which can be appropriately dosed for infants below the age of 3 months.
Croatian: Dostupni su drugi farmaceutski oblici/jačine koje je moguće odgovarajuće dozirati u dojenčadi mlađe od 3 mjeseca.
English: 500 mg tablets/capsules (also applicable for 500 mg powder for oral solution/powder for oral solution in sachet/effervescent powder/granules oral solution) The dose is dependent on the intensity of the pain or fever and the individual's sensitivity of response to <invented name>.
Croatian: Tablete/kapsule od 500 mg (primjenjivo i za 500 mg prašak za oralnu otopinu/prašak za oralnu otopinu u vrećici/šumeći prašak/granule za oralnu otopinu) Doza ovisi o intenzitetu boli ili vrućice i individualnom odgovoru na <zaštićeno ime>.
English: Use in children and adolescents For the treatment of pain children and adolescents up to 14 years old can take from 8 to 16 mg of <invented name> per kilogram body weight as an individual dose (see table above).
Croatian: Za liječenje boli u djece i adolescenata u dobi do 14 godina može se primjenjivati doza od 8 do 16 mg <zaštićeno ime> po kilogramu tjelesne težine kao pojedinačna doza (vidjeti prethodnu tablicu).
English: 1-3 years 4-6 years 7-9 years 31-45 10-12 years 0.5-1.4 46-53 13-14 years 0.8-1.8 ≥ 15 years 1.0-2.0* 500-1,000* 4.0-8.0* 2,000-4,000* * If necessary, the single dose can be increased to 5 ml (corresponding to 2,500 mg metamizole) and the daily dose to 10 ml (corresponding to 5,000 mg metamizole).
Croatian: 5 - 8 3 - 11 mjeseci samo intramuskularno 9 - 15 1 - 3 godine 0,2 - 0,5 100 - 250 0,8 - 2,0 400 - 1 000 16 - 23 4 - 6 godina 0,3 - 0,8 150 - 400 1,2 - 3,2 600 - 1 600 24 - 30 7 - 9 godina 0,4 - 1,0 200 - 500 1,6 - 4,0 800 - 2 000 31 - 45 10 - 12 godina 0,5 - 1,4 250 - 700 2,0 - 5,6 1 000 - 2 800 46 - 53 13 - 14 godina 0,8 - 1,8 400 - 900 3,2 - 7,2 1600 - 3 600 > 53 ≥ 15 godina 1,0 - 2,0* 500 - 1 000* 4,0 - 8,0* 2 000 - 4 000* * Ako je potrebno, jednokratna se doza može povećati na 5 ml (što odgovara 2500 mg metamizola), a dnevna doza na 10 ml (što odgovara 5 000 mg metamizola).
English: Other pharmaceutical forms/strengths are available which can be appropriately be dosed for smaller children.
Croatian: Dostupni su drugi farmaceutski oblici/jačine koje je moguće odgovarajuće dozirati u mlađe djece.
English: Body weight kg age drops
Croatian: Tjelesna težina kg dob kapi