FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people) - loss of consciousness (fainting, which may be preceded by feeling dizzy, lightheaded or confused) - acute renal insufficiency (kidney problems which can be recognised from fluid retention, swelling in legs, ankles or feet, drowsiness, shortness of breath or fatigue) - hypersensitivity and serious allergic reaction (symptoms including localised or diffuse skin itching, dizziness, difficulty breathing, chest pain, gastrointestinal symptoms such as nausea, vomiting, diarrhea or intestinal pain, swelling of the throat, face, lips or tongue)
Croatian: - gubitak svijesti (nesvjestica, kojoj mogu prethoditi omaglica, ošamućenost ili smetenost) - akutno zatajenje bubrega (problemi s bubrezima koji se mogu prepoznati po zadržavanju tekućine, oticanju nogu, gležnjeva ili stopala, omamljenosti, nedostatku zraka ili umoru) - preosjetljivost i ozbiljna alergijska reakcija (simptomi uključuju lokaliziran ili proširen svrbež kože, omaglicu, otežano disanje, bol u prsnom košu, probavne simptome kao što su mučnina,
English: The IRRs observed in clinical studies of velmanase alfa were characterised by a rapid onset of symptoms and were of mild to moderate severity.
Croatian: Reakcije povezane s infuzijom opažene u kliničkim ispitivanjima velmanaze alfa bile su obilježene brzim nastupom simptoma i blagom do umjerenom težinom.
English: 5 vials
Croatian: 5 bočica.
English: <18 years(2) ≥18 years(2) 3MSCT (steps/min) Overall(1)
Croatian: < 18 godina(2) ≥ 18 godina(2) 3MSCT (stepenica/minuti) Ukupno(1)
English: The reconstituted solution of Lamzede should be administered using an infusion set equipped with a pump and an in-line low protein-binding 0.22 µm filter.
Croatian: Rekonstituiranu otopinu lijeka Lamzede potrebno je primijeniti pomoću kompleta za infuziju opremljenog pumpom i ugrađenim filtrom veličine pora od 0,22 µm i niske sposobnosti vezanja proteina.
English: The recommended dose of 1 mg/kg is determined using the following calculation: Patient's weight (kg) × dose (mg/kg) = Patient dose (in mg) Patient dose (in mg) divided by 10 mg/vial (content of one vial) = number of vials to reconstitute.
Croatian: Tjelesna težina bolesnika (kg) × doza (mg/kg) = doza za bolesnika (u mg) Doza za bolesnika (u mg) podijeljena s 10 mg/bočica (sadržaj jedne bočice) = broj bočica za rekonstituciju.
English: Cardiac disorders
Croatian: Srčani poremećaji bradikardija
English: Administration of Lamzede should be carried out by a healthcare professional with the ability to manage ERT and medical emergencies.
Croatian: Primjenu lijeka Lamzede treba provoditi zdravstveni radnik koji može voditi enzimsku nadomjesnu terapiju i zbrinuti hitne slučajeve.
English: How Lamzede is used
Croatian: Kako primjenjivati Lamzede
English: The patient should be kept under observation for IRRs for one hour or longer after the infusion, according to the treating physician's judgement.
Croatian: Bolesnik mora biti pod nadzorom zbog reakcija povezanih s infuzijom jedan sat nakon infuzije ili dulje, sukladno procjeni nadležnog liječnika.
English: Adverse reactions are classified by system organ class and preferred term according to the MedDRA frequency convention.
Croatian: Nuspojave su kategorizirane prema klasifikaciji organskih sustava i preporučenim pojmovima prema MedDRA-inim kategorijama učestalosti.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Croatian: Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po doznoj jedinici, tj. zanemarive količine natrija.
English: Maximum infusion rate (mL/h)
Croatian: Najveća brzina infuzije (ml/sat)
English: There are no data from the use of velmanase alfa in pregnant women.
Croatian: Trudnoća Nema podataka o primjeni velmanaze alfa u trudnica.
English: Very common side effects (may affect more than 1 in 10 people) - diarrhoea - weight increase - fever/increased body temperature
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - proljev
English: Pharmacodynamic
Croatian: Farmakodinamička
English: Combined
Croatian: Kombinirano
English: QoL Domain
Croatian: Tri domene
English: Lamzede 10 mg powder for solution for infusion velmanase alfa
Croatian: Lamzede 10 mg prašak za otopinu za infuziju velmanaza alfa
English: It is used to treat patients with mild to moderate alpha-mannosidosis disease.
Croatian: Primjenjuje se za liječenje bolesnika s blagom do umjerenom alfa-manozidozom.
English: Name and address of the manufacturer responsible for batch release
Croatian: Njemačka Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Oligosaccharides 20.0% 100%
Croatian: Nijedna domena 40,0% 0
English: Each mL of reconstituted solution contains 2 mg of velmanase alfa.
Croatian: Jedan ml rekonstituirane otopine sadrži 2 mg velmanaze alfa.
English: Vomiting(1)
Croatian: povraćanje(1)
English: Tel: + 420 261221745
Croatian: Chiesi CZ s.r.o. Tel: + 420 261221745
English: Common side effects (may affect up to 1 in 10 people) - low heart beat (bradycardia) - psychotic behaviour (mental illness with hallucinations, difficulty in thinking clearly and understanding reality, anxiety), initial difficulty in sleeping - confused state, fainting, tremor, dizziness, headache - intestinal (abdominal) pain, irritation of the stomach caused by digestive acids (reflux gastritis),
Croatian: - psihotično ponašanje (duševna bolest s halucinacijama, poteškoćama s jasnim razmišljanjem i razumijevanjem stvarnosti, tjeskobom), početno otežano spavanje - smeteno stanje, nesvjestica, drhtanje, omaglica,glavobolja
English: Domain
Croatian: Domena
English: The treatment should be supervised by a physician experienced in the management of patients with alpha-mannosidosis or in the administration of other enzyme replacement therapies (ERT) for lysosomal storage disorder.
Croatian: 4.2 Doziranje i način primjene Liječenje mora nadzirati liječnik s iskustvom u zbrinjavanju bolesnika s alfa-manozidozom ili primjeni drugih enzimskih nadomjesnih terapija (ENT) za lizosomske bolesti nakupljanja.
English: The results (serum oligosaccharide concentration, 3MSCT, 6MWT and FVC%) are presented in table 2.
Croatian: Rezultati (koncentracija oligosaharida u serumu, 3MSCT, 6MWT i FVC%) su prikazani u tablici 2. Dokazan je farmakodinamički učinak sa statistički značajnim sniženjem oligosaharida u serumu u usporedbi s placebom.
English: Loss of consciousness(2)
Croatian: Poremećaji živčanog sustava stanje smetenosti gubitak svijesti(2)
English: [95% CI] p-value p=0.692
Croatian: [95% CI] p-vrijednost p=0,692
English: Appropriate medical support should be readily available when velmanase alfa is administered.
Croatian: Kad se primjenjuje velmanaza alfa, potrebno je imati na raspolaganju odgovarajuću medicinsku potporu.
English: [95% CI] p-value p<0.001
Croatian: [95% CI] p-vrijednost p< 0,001
English: Due date
Croatian: Dvije domene
English: One vial contains 10 mg of velmanase alfa*.
Croatian: Jedna bočica sadrži 10 mg velmanaze alfa*.
English: [95% CI] p-value p=0.278
Croatian: [95% CI] p-vrijednost p=0,278
English: Other side effects
Croatian: Ostale nuspojave
English: Absolute change from baseline Mean
Croatian: Srednja vrijednost apsolutne promjene u odnosu na početnu vrijednost
English: Contents of the pack and other information
Croatian: Kako čuvati Lamzede Sadržaj pakiranja i druge informacije
English: [95% CI] p-value p=0.406
Croatian: [95% CI] p-vrijednost p=0,406
English: One vial contains 10 mg of velmanase alfa.
Croatian: Jedna bočica sadrži 10 mg velmanaze alfa.
English: All but one patient were naïve to the treatment with velmanase alfa.
Croatian: Samo je jedan od tih bolesnika prije primao velmanazu alfa.
English: c) An immediate visual inspection of the solution for particulate matter and discoloration should be performed after reconstitution.
Croatian: c) Nakon rekonstitucije otopinu odmah treba vizualno pregledati da ne sadrži čestice i da nije promijenila boju.
English: Adjusted mean difference
Croatian: Razlika prilagođenih srednjih vrijednosti
English: Nervous system disorders
Croatian: Klasifikacija organskih sustava Nuspojava
English: Renal failure acute(2)
Croatian: Poremećaji bubrega i mokraćnog sustava akutno zatajenje bubrega(2)
English: Package leaflet: Information for the patient Lamzede 10 mg powder for solution for infusion velmanase alfa This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Lamzede 10 mg prašak za otopinu za infuziju velmanaza alfa
English: Malaise(1)
Croatian: umor malaksalost(1)
English: nausea, vomiting - pain at the site the infusion is given, chills, feeling hot, malaise, tiredness (fatigue) - skin rashes (urticaria), increased sweating (hyperhidrosis) - nosebleed - joint pain, back pain, joint stiffness, muscle pain, pain in extremity (hands, feet) - eye irritation, eyelid swelling (eyelid oedema), eye redness - increased appetite
Croatian: - bol na mjestu davanja infuzije, zimica, osjećaj vrućine, malaksalost, umor - kožni osipi (koprivnjača), pojačano znojenje (hiperhidroza) - krvarenje iz nosa
English: Renal or hepatic impairment
Croatian: sinkopa tremor omaglica glavobolja
English: Intravenous use.
Croatian: Intravenski.
English: Statistically significant improvements were detected in serum oligosaccharide levels, 3MSCT, pulmonary function, serum IgG
Croatian: Otkrivena su statistički značajna poboljšanja u razinama oligosaharida u serumu, 3MSCT-u, plućnoj funkciji, IgG-u u serumu te kvaliteti života u 5 dimenzija (EQ-5D-5L) tijekom vremena sve do zadnjeg opažanja (tablica 3).
English: Initial insomnia
Croatian: Psihijatrijski poremećaji psihotično ponašanje početna nesanica
English: Chiesi Hungary Kft. Tel.: + 36-1-429 1060
Croatian: Tel.: + 36-1-429 1060
English: MARKETING AUTHORISATION NUMBER
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: 6MWT (metres)
Croatian: 6MWT (metara) Ukupno FVC (%
English: Anaphylactoid reaction(1)
Croatian: anafilaktoidna reakcija(1)
English: Chiesi Pharmaceuticals B.V. Tel: + 31 88 501 64 00
Croatian: Tel: + 31 88 501 64 00
English: Powder for solution for infusion 1 vial
Croatian: Prašak za otopinu za infuziju
English: Hypersensitivity(1)
Croatian: Poremećaji imunološkog sustava preosjetljivost(1)
English: Myalgia
Croatian: OBLIK
English: Psychotic behaviour
Croatian: FARMAKOLOŠKA SVOJSTVA
English: Urticaria(1)
Croatian: Ukupno(1)
English: Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
English: Amendments to relevant sections of the product information of methadone tablets containing low molecular weight povidone (K25 or K30)
Croatian: Izmjene odgovarajućih dijelova informacija o tabletama metadona koje sadrže povidon niske molekulske mase (K25 ili K30)
English: How to use <Invented Name>?
Croatian: Odjeljak 3. Kako koristiti <zaštićeni naziv>?
English: [The following text should be included in this section] This product is for oral use only, and must not be injected.
Croatian: [Sljedeći tekst treba umetnuti u ovaj odjeljak] Ovaj je lijek namijenjen samo za peroralnu primjenu i ne smije se injicirati.
English: Section 6.1 List of excipients [Information about the type of povidone, e.g. K25 or K30, should be included in this section.]
Croatian: Odjeljak 6.1. Popis pomoćnih tvari [U ovaj odjeljak treba uključiti informacije o vrsti povidona, primjerice K25 ili K30.]
English: Section 4.2 Posology and method of administration [The following text should be included in this section] This product is for oral use only, and must not be injected.
Croatian: Odjeljak 4.2. Doziranje i način primjene [Sljedeći tekst treba umetnuti u ovaj odjeljak] Ovaj je lijek namijenjen samo za peroralnu primjenu i ne smije se injicirati.
English: Section 3.
Croatian: B.
English: B. Package Leaflet
Croatian: Dodatak III
English: A. Summary of Product Characteristics
Croatian: Sažetak opisa svojstava lijeka
English: The potential risk for pregnant women is unknown.
Croatian: Mogući rizik za trudnice nije poznat.
English: Individuals 10 years and older
Croatian: Osobe u dobi od 10 godina i stariji
English: Experience of overdose is limited.
Croatian: Iskustvo s predoziranjem je ograničeno.
English: Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known.
Croatian: S obzirom na to da ova reakcija potječe iz spontanih izvješća, učestalost se ne može odrediti i stoga se smatra nepoznatom.
English: May 2017
Croatian: 24. svibnja 2017.
English: Store in a refrigerator (2 °C-8 °C).
Croatian: Čuvati u hladnjaku (2°C-8°C).
English: Not known (cannot be estimated from available data)
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: • have had any problems after any dose of Trumenba such as an allergic reaction or problems with breathing.
Croatian: • ikada imali problema nakon bilo koje doze Trumenbe poput alergijske reakcije ili problema s disanjem.
English: The vaccine works by helping the body to make antibodies (the body's natural defences) which protect you or your child against this disease.
Croatian: Cjepivo djeluje tako da pomaže tijelu proizvesti protutijela (prirodna obrana tijela) koja štite Vas ili Vaše dijete od ove bolesti.
English: • have a severe infection with a high fever.
Croatian: • imate tešku infekciju uz visoku temperaturu.
English: However, some of the side effects mentioned under section 4 ‘Possible side effects' may temporarily affect you.
Croatian: Međutim, neke od nuspojava navedene u dijelu 4 „Moguće nuspojave“ mogu privremeno utjecati na Vas.
English: In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Croatian: U slučaju predoziranja preporučuje se praćenje vitalnih funkcija i moguće simptomatsko liječenje.
English: Do not use the vaccine if it cannot be re-suspended.
Croatian: Nemojte primjenjivati cjepivo ako se ne može resuspendirati.
English: Fever ≥ 38 °C (Pyrexia)
Croatian: Vrućica ≥ 38°C (pireksija)
English: The vaccine contains two important components from the surface of the bacteria.
Croatian: Cjepivo sadrži dva važna sastojka s površine bakterija.
English: Safety and efficacy of Trumenba in children below 10 years of age have not been established.
Croatian: Sigurnost i djelotvornost Trumenbe u djece mlađe od 10 godina nisu ustanovljene.
English: The use of this vaccine should be in accordance with official recommendations.
Croatian: Primjena ovog cjepiva treba se temeljiti na službenim preporukama.
English: - This vaccine has been prescribed for you or your child only.
Croatian: - Ovaj je lijek propisan samo Vama ili Vašem djetetu.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity and reproduction and developmental toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza, reproduktivne i razvojne toksičnosti.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Trumenba is given.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite Trumenbu.
English: Other ingredients:
Croatian: Drugi sastojci:
English: Trumenba should not be given: - if you or your child are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Croatian: Trumenbu ne smijete primiti: - ako ste Vi ili Vaše dijete alergični na djelatne tvari ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6.).
English: Other medicines and Trumenba
Croatian: Drugi lijekovi i Trumenba
English: Not known (cannot be estimated from available data) - Allergic reactions
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka) - alergijske reakcije
English: Results from Groups 2 and 3 are not presented, as only 2 representative strains were evaluated.
Croatian: Rezultati iz 2. i 3. skupine nisu prikazani, jer su procijenjena samo 2 reprezentativna soja.
English: Other paediatric population
Croatian: Ostala pedijatrijska populacija
English: • have a weakened immune system which may prevent you or your child from getting the full benefit from Trumenba.
Croatian: • imate oslabljeni imunološki sustav koji može spriječiti Vas ili Vaše dijete od ostvarivanja pune koristi od Trumenbe.
English: Shake well before use.
Croatian: Prije uporabe dobro protresti.
English: Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Croatian: Međutim, cjepivo se ne smije uskratiti kada postoji jasan rizik od izloženosti meningokoknoj infekciji.
English: If you take medicines that affect your immune system (such as radiation therapy, corticosteroids, or some types of cancer chemotherapies), you may not get the full benefit of Trumenba.
Croatian: Ako uzimate lijekove koji utječu na Vaš imunološki sustav (poput terapije zračenjem, kortikosteroida ili nekih vrsta kemoterapije protiv raka), možda nećete imati punu korist od Trumenbe.
English: Polysorbate 80 (E433) Water for injections For adsorbent, see section 2.
Croatian: Polisorbat 80 (E433) Voda za injekcije Za adsorbens, vidjeti dio 2.
English: In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.
Croatian: U slučaju prisutnosti bilo kakvih stranih čestica i/ili promjene fizičkog izgleda, nemojte primijeniti cjepivo.
English: Trumenba should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Croatian: Trumenba se smije koristiti tijekom dojenja samo kad moguće prednosti nadmašuju moguće rizike.
English: Vaccination should be postponed in individuals suffering from an acute severe febrile illness.
Croatian: Cijepljenje treba odgoditi u osoba s akutnom teškom febrilnom bolešću.
English: White liquid suspension.
Croatian: Bijela tekuća suspenzija.
English: Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Croatian: Odgovarajuće medicinsko liječenje i nadzor trebaju uvijek biti lako dostupni u slučaju anafilaktičkog događaja nakon primjene cjepiva.
English: Time Point
Croatian: Vremenska točka
English: However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
Croatian: Međutim, neki od učinaka navedenih u dijelu 4.8 mogu privremeno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Serum was obtained approximately 1 month after vaccination.
Croatian: Serum je prikupljen približno mjesec dana nakon cijepljenja.
English: In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u zdravstvenom kartonu bolesnika.
English: Limitations of clinical trials
Croatian: Ograničenja kliničkih ispitivanja
English: Pharmacotherapeutic group: vaccines; ATC code: J07AH09
Croatian: Farmakoterapijska skupina: cjepiva; ATK oznaka: J09AH09
English: You or your child will receive 2 injections of the vaccine, the second injection is given 6 months after the first injection.
Croatian: Vi ili Vaše dijete primit ćete 2 injekcije cjepiva, druga injekcija se daje 6 mjeseci nakon prve injekcije.
English: • have a bleeding problem or bruise easily.
Croatian: • imate problema s krvarenjem ili Vam lako nastaju modrice.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility in females (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na plodnost u ženki (vidjeti dio 5.3).
English: Talk to your doctor, pharmacist or nurse before vaccination with Trumenba.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije cijepljenja Trumenbom.
English: Very common (≥ 1/10)
Croatian: Vrlo često (≥1/10)
English: This is a type of bacteria that can cause serious and sometimes life threatening infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning).
Croatian: To je tip bakterije koji može uzrokovati ozbiljne i ponekad po život opasne infekcije kao što su meningitis (upala ovojnice mozga i kralježnične moždine) i sepsa (trovanje krvi).
English: The efficacy of Trumenba has not been evaluated through clinical trials.
Croatian: Djelotvornost Trumenbe nije procjenjivana u kliničkim ispitivanjima.
English: The safety profile presented is based on analysis of over 15,000 subjects (aged 10 years and older) who have been vaccinated with at least 1 dose of Trumenba in 11 completed clinical studies.
Croatian: Prikazani sigurnosni profil temelji se na analizi više od 15 000 ispitanika (u dobi od 10 godina i starijih) koji su cijepljeni barem jednom dozom cjepiva Trumenba u 11 dovršenih kliničkih ispitivanja.
English: The requirements for submission of periodic safety update repots 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: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Tell your doctor, pharmacist or nurse if you have experienced this kind of reaction previously.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako ste prethodno iskusili ovakvu vrstu reakcija.
English: Sodium Chloride Histidine
Croatian: Natrijev klorid Histidin
English: What Trumenba is and what it is used for 2.
Croatian: Što je Trumenba i za što se koristi 2.
English: You or your child may be given a booster.
Croatian: Vi ili Vaše dijete možete biti docijepljeni.
English: Your doctor may still recommend that you receive Trumenba if you are at risk of meningococcal disease.
Croatian: Liječnik Vam može preporučiti primjenu Trumenbe ako u Vas postoji rizik od meningokokne bolesti.
English: Tell your doctor, pharmacist or nurse if you or your child:
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako ste Vi ili Vaše dijete:
English: Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Trumenba.
Croatian: Imunokompromitirane osobe, uključujući osobe koje primaju imunosupresivnu terapiju, mogu imati oslabljeni imunološki odgovor na Trumenbu.
English: Trumenba will be given to you or your child by a doctor, pharmacist or nurse.
Croatian: Trumenbu će Vama ili Vašem djetetu dati liječnik ili medicinska sestra.
English: Of the 1,713 subjects randomised, 427 were in Group 1, 430 were in Group 2, 427 were in Group 3, 286 were in Group 4, and 143 were in Group 5.
Croatian: Od 1713 randomiziranih ispitanika 427 ih je bilo u 1. skupini, 430 u 2. skupini, 427 u 3. skupini, 286 u 4. skupini i 143 u 5. skupini.
English: Procedures should be in place to avoid injury from fainting.
Croatian: Potrebno je poduzeti određene mjere kako bi se izbjeglo ozljeđivanje pri nesvjestici.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Croatian: 13. BROJ SERIJE<, OZNAKE DONACIJE I PROIZVODA>
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „EXP“.