FrancophonIA/ELRC3.0 huggingface dataset:
English: Full Thickness wounds
Croatian: Rane pune debljine kože
English: Benefit/risk assessment should include consideration of the greater frequency of concomitant disease or other medicinal product therapy in the elderly.
Croatian: Kod procjene omjera koristi i rizika u starijih osoba treba uzeti u obzir veću učestalost istovremeno prisutnih bolesti i uzimanje drugih lijekova.
English: NexoBrid should not be applied to more than 15% Total Body Surface Area (TBSA) (see also section 4.4, Coagulopathy).
Croatian: NexoBrid se ne smije nanijeti na više od 15% cjelokupne površine tijela u jednom tretmanu (vidjeti također dio 4.4, Koagulopatija).
English: What NexoBrid is used for
Croatian: Za što se NexoBrid koristi
English: Wound complication*
Croatian: komplikacije rane*
English: When NexoBrid was used in a regimen which included recommended preventive analgesia as routinely practiced for extensive dressing changes in burn patients as well as antibacterial soaking of the treatment area before and after NexoBrid application (see section 4.2), pain was reported in 3.6% of patients, pyrexia/hyperthermia in 19.1% of patients.
Croatian: Kad se NexoBrid primjenjivao prema režimu koji je uključivao primjenu preporučene preventivne analgezije u skladu s rutinskom praksom kod opsežne zamjene povoja u bolesnika s opeklinama, kao i stavljanje antibakterijskih obloga na područje koje se liječi prije i nakon primjene NexoBrida (vidjeti dio 4.2), bol je zabilježena u 3,6% bolesnika, a pireksija/hipertermija u 19,1% bolesnika.
English: Excipients: Acetic acid, ammonium sulphate.
Croatian: Pomoćne tvari: acetatna kiselina, amonijev sulfat.
English: Reduction of platelet aggregation and plasma fibrinogen levels and a moderate increase in partial thromboplastin and prothrombin times have been reported as possible effects following oral administration of bromelain.
Croatian: Smanjena agregacija trombocita i snižena razina fibrinogena u plazmi te umjereno produženje parcijalnog tromboplastinskog i protrombinskog vremena zabilježeni su kao mogući učinci bromelaina nakon peroralne primjene.
English: Children and adolescents NexoBrid is not for use in patients younger than 18 years.
Croatian: Djeca i adolescenti NexoBrid nije namijenjen primjeni u bolesnika mlađih od 18 godina.
English: Careful consideration should also be given to placing permanent skin covers (e.g. autografts) on deep partial thickness wounds soon after NexoBrid debridement.
Croatian: Potrebno je također pažljivo razmotriti prekrivanje rana koje zahvaćaju djelomičnu debljinu kože trajnim presatkom kože (npr. presatkom vlastite kože) ubrzo nakon debridmana NexoBridom.
English: In case of skin exposure, NexoBrid must be rinsed off with water.
Croatian: U slučaju izlaganja kože, NexoBrid se mora isprati s kože vodom.
English: Rare (1/10,000 to <1/1,000)
Croatian: Rijetko (1/10 000 i <1/1000)
English: SOC (Number of wounds)
Croatian: NexoBrid (broj rana)
English: In studies where analgesia was provided in NexoBrid-treated patients on an on-demand basis, local pain was reported in 23.3% of patients treated with NexoBrid and in 11.4% of the control patients.
Croatian: U ispitivanjima u kojima su bolesnici liječeni NexoBridom dobivali analgeziju na zahtjev lokalna bol zabilježena je u 23,3% bolesnika liječenih NexoBridom i u 11,4% kontrolnih bolesnika.
English: • The adhesive barrier must be removed using a sterile blunt-edged instrument (e.g., tongue depressor).
Croatian: • Adhezivna barijera mora se ukloniti pomoću sterilnog tupog instrumenta (npr. špatule za pregled ždrijela).
English: *The endpoint can only be evaluated for deep partial-thickness wounds without full-thickness areas because full-thickness burns always require grafting.
Croatian: *Ishod se može odrediti samo za duboke rane koje zahvaćaju djelomičnu debljinu kože u kojima nema područja zahvaćenosti pune debljine kože zato što rane koje zahvaćaju punu debljinu kože uvijek zahtijevaju pokrivanje presatkom.
English: Your doctor will be cautious and watch for signs of reduced blood coagulation or bleeding when prescribing other medicines that affect blood coagulation, because NexoBrid may reduce blood coagulation.
Croatian: Kod propisivanja drugih lijekova koji utječu na zgrušavanje krvi, Vaš će liječnik biti oprezan i pratiti Vas zbog znakova poremećenog zgrušavanja krvi ili krvarenja zato što NexoBrid može smanjiti zgrušavanje krvi.
English: Non-autografted wounds (ITT)
Croatian: Rane nepokrivene presatkom vlastite kože (ITT)
English: • The dressing must remain in place for 4 hours.
Croatian: • Povoj mora tako ostati na rani 4 sata.
English: In studies implementing routine antibacterial soaking of the treatment area before and after NexoBrid application (see section 4.2) pyrexia or hyperthermia was reported in 19.1% of patients treated with NexoBrid and in 15.8% of the control patients treated according standard of care.
Croatian: U ispitivanjima u kojima su se rutinski primjenjivali antibakterijski oblozi na područje liječenja prije i nakon primjene NexoBrida (vidjeti dio 4.2) pireksija ili hipertermija zabilježena je u 19,1% bolesnika liječenih NexoBridom i 15,8% kontrolnih ispitanika liječenih prema standardnoj skrbi.
English: The age range in the SOC group was 5.1 to 55.7 years.
Croatian: Raspon dobi bolesnika u skupini liječenoj prema standardnoj skrbi iznosio je 5,1 do 55,7 godina.
English: NexoBrid must be stored upright to keep the gel at the bottom of the bottle and in the original package to protect from light.
Croatian: NexoBrid se mora čuvati uspravno kako bi gel ostao na dnu bočice te u originalnom pakiranju radi zaštite od svjetlosti.
English: The co-primary endpoints for the efficacy analysis were: - the percentage of deep partial thickness wounds requiring excision or dermabrasion, and - the percentage of deep partial thickness wounds autografted.
Croatian: Primarne mjere ishoda za analizu djelotvornosti bile su: - postotak dubokih rana koje zahvaćaju djelomičnu debljinu kože i zahtijevaju eksciziju ili dermabraziju i - postotak dubokih rana koje zahvaćaju djelomičnu debljinu kože prekrivenih presatkom vlastite kože.
English: e.g. urinary tract infections, viral infections) were reported more frequently in the NexoBrid group (0.147 events per patient) than in the group treated according to SOC (0.079 events per patient).
Croatian: U fazi II i III kliničkih ispitivanja opće infekcije (nepovezane s ranom, npr. infekcije mokraćnih puteva, virusne infekcije) češće su bile zabilježene u skupini liječenoj NexoBridom (0,147 događaja po bolesniku) nego u skupini liječenoj prema standardnoj skrbi (0,079 događaja po bolesniku).
English: NexoBrid 5 g powder and gel for gel
Croatian: NexoBrid 5 g prašak i gel za gel
English: NexoBrid should not be used in chemical burn wounds, contaminated wounds and wounds where NexoBrid could come in contact with foreign materials (for example, implants, pacemakers, and shunts) or large blood vessels, the eyes or other important body parts.
Croatian: NexoBrid se ne smije koristiti kod kemijskih opeklina, kontaminiranih rana i rana u kojima Nexobrid može doći u dodir sa stranim materijalima (npr. implantatima, elektrostimulatorima srca i premosnicama) ili velikim krvnim žilama, očima ili drugim važnim dijelovima tijela.
English: 65428 Rüsselsheim Germany
Croatian: 65428 Rüsselsheim Njemačka
English: In case of eye exposure, exposed eyes must be irrigated with copious amounts of water for at least 15 minutes.
Croatian: U slučaju izlaganja očiju, izložene oči moraju se isprati obilnom količinom vode najmanje 15 minuta.
English: • Within 15 minutes of mixing, NexoBrid must be applied topically to the burn wound, at a thickness of 1.5 to 3 millimetres.
Croatian: • U roku od 15 minuta nakon miješanja NexoBrid se mora nanijeti topikalno na opeklinu u sloju debljine od 1,5 do 3 milimetra.
English: See also section 4.4.
Croatian: Vidjeti također dio 4.4.
English: Gentle pressing of the occlusive dressing at the area of contact with the adhesive barrier will ensure adherence between the occlusive film and the sterile adhesive barrier and achieve complete containment of NexoBrid on the treatment area.
Croatian: Laganim pritiskom na okluzivni povoj na području kontakta s adhezivnom barijerom osigurat će se prianjanje između okluzivnog filma i sterilne adhezivne barijere te postići potpuno zadržavanje
English: • The wound management after NexoBrid treatment with o Application of a dressing soaked with an antibacterial solution for two hours o Performance of grafting procedures as soon as possible after debridement
Croatian: • Obrada rane nakon liječenja NexoBridom o Primjenom zavoja namočenog u otopinu antibakterijskog sredstva tijekom dva sata o Provođenjem presađivanja kože čim je prije moguće nakon debridmana
English: These events included: wound deepening or desiccation (decomposition) in 5 patients (2.4%) with NexoBrid and 0 with SOC as well as (partial) graft failure in 6 patients (2.9%) with NexoBrid and 2 (1.6%) with SOC (see section 4.4).
Croatian: Te su komplikacije uključivale produbljivanje rane ili sušenje (raspadanje) u 5 bolesnika (2,4%) liječenih NexoBridom i 0 bolesnika liječenih prema standardnoj skrbi, kao i (djelomično) neuspjelo presađivanje kože u 6 bolesnika (2,9%) liječenih NexoBridom i 2 (1,6%) bolesnika liječena prema standardnoj skrbi (vidjeti dio 4.4).
English: NexoBrid is for use by specialists in burn clinics only.
Croatian: NexoBrid smije samo koristiti liječnik specijalist za opekline.
English: The NexoBrid gel must fill the entire occlusive dressing, and special care should be taken not to leave air under this occlusive dressing.
Croatian: Gel NexoBrid mora ispuniti cijeli okluzivni povoj, a posebno se treba pobrinuti da ispod okluzivnog povoja ne ostane zrak.
English: • Within 15 minutes of mixing, NexoBrid must be applied topically to the moistened burn wound, at a thickness of 1.5 to 3 millimetres.
Croatian: • U roku od 15 minuta nakon miješanja NexoBrid se mora nanijeti topikalno na opeklinsku ranu u sloju debljine od 1,5 do 3 milimetra.
English: NexoBrid 2 g powder and gel for gel
Croatian: NexoBrid 2 g prašak i gel za gel
English: Store upright to keep the gel at the bottom of the bottle and in the original package to protect from light.
Croatian: Čuvati uspravno kako bi gel ostao na dnu boce i u originalnom pakovanju radi zaštite od svjetlosti.
English: The paraffin layer must not come into contact with the area to be treated in order to avoid covering the eschar, thus isolating the eschar from direct contact with NexoBrid.
Croatian: Parafinski sloj ne smije doći u kontakt s područjem koje treba liječiti kako bi se izbjeglo prekrivanje eshara čime bi se eshar izolirao od izravnog kontakta s NexoBridom.
English: This endpoint can only be evaluated for deep partial-thickness wounds without full-thickness areas because full-thickness burns always require grafting.
Croatian: Ova se mjera ishoda može procijeniti samo kod dubokih opeklinskih rana koje zahvaćaju djelomičnu debljinu kože bez zahvaćanja pune debljine kože zato što opekline koje zahvaćaju punu debljinu kože uvijek zahtijevaju pokrivanje presatkom kože.
English: • Sterile isotonic sodium chloride 9 mg/ml (0.9%) solution must be sprinkled on the burn wound.
Croatian: • Na opeklinu se mora raspršiti sterilna izotonična otopina natrijevog klorida od 9 mg/ml (0,9%).
English: 1 vial of 5 g powder 1 bottle of 50 g of gel
Croatian: Prašak i gel za gel 1 bočica s 5 g praška 1 boca s 50 g gela
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 6.7%, 7.8% and 8.9% of patients, respectively.
Croatian: U skupini liječenoj NexoBridom ovaj je događaj ocijenjen kao blag u 6,7% bolesnika, umjeren u 7,8% bolesnika i težak u 8,9% bolesnika.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: The efficacy of eschar removal was evaluated by determining the percentage of wound area left with eschar that required further removal by excision or dermabrasion, and the percentage of wounds requiring such surgical removal.
Croatian: Djelotvornost uklanjanja eshara procijenila se određivanjem postotka površine rane sa zaostalim esharom koji je trebalo naknadno ukloniti ekscizijom ili dermabrazijom i postotka rana iz kojih se morao kirurški ukloniti.
English: • Before a permanent skin cover or temporary skin substitute is applied to a freshly enzymatically debrided area, a soaking wet-to-dry dressing must be applied.
Croatian: • Prije nego što se svježe enzimatski očišćeno područje prekrije trajnim presatkom kože ili privremenom zamjenskom kožom mora se staviti natopljen vlažno-suhi povoj.
English: This should be considered when mixing NexoBrid powder with the gel.
Croatian: To treba uzeti u obzir prilikom miješanja praška NexoBrid s gelom.
English: Use in patients with cardiopulmonary and pulmonary disease NexoBrid should be used with caution in patients with cardiopulmonary and pulmonary disease, including pulmonary burn trauma and suspected pulmonary burn trauma.
Croatian: Primjena u bolesnika s bolešću srca i pluća ili plućnom bolešću NexoBrid treba primjenjivati s oprezom u bolesnika s bolešću srca i pluća ili plućnom bolešću uključujući opeklinu pluća i sumnju na opeklinu pluća.
English: • The area from which you wish to remove the eschar must be surrounded with a sterile paraffin ointment adhesive barrier by applying it a few centimetres outside of the treatment area (using a dispenser).
Croatian: • Sterilna parafinska mast mora se nanijeti kao adhezivna barijera oko područja s kojeg želite ukloniti eshar tako što se nanese na udaljenosti od nekoliko centimetara od područja liječenja (pomoću dispensera).
English: • Other medicines (such as silver sulfadiazine or povidone-iodine) will be removed from the wound area before NexoBrid is applied.
Croatian: • Drugi lijekovi (kao što je srebrni sulfadiazin ili povidon jod) će se ukloniti s područja rane prije primjene NexoBrida.
English: • The wound must be wiped thoroughly first with a large sterile dry gauze or napkin, followed by a sterile gauze or napkin that has been soaked with sterile isotonic sodium chloride 9 mg/ml (0.9%) solution.
Croatian: • Rana se prvo mora temeljito obrisati velikom sterilnom suhom gazom ili ubrusom, a nakon toga sterilnom gazom ili ubrusom natopljenom sterilnom izotoničnom otopinom natrijevog klorida od 9 mg/ml (0,9%).
English: Excipients for the powder: Acetic acid, ammonium sulphate.
Croatian: Pomoćne tvari u prašku: acetatna kiselina, amonijev sulfat.
English: • Before application of the grafts or primary dressing, the debrided bed must be cleaned and refreshed by, e.g., brushing or scraping to allow dressing adherence.
Croatian: • Prije primjene presatka ili primarnog povoja dno obrađene rane mora se očistiti i osvježiti, npr. četkanjem ili struganjem, kako bi se omogućilo prianjanje povoja.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: • NexoBrid powder is then transferred into the corresponding gel bottle.
Croatian: • Prenesite prašak NexoBrid u odgovarajuću bocu s gelom.
English: Prevention of wound complications
Croatian: Prevencija komplikacija kod opeklinskih rana
English: The wound must be kept moist during the application procedure.
Croatian: Opeklina se mora održavati vlažnom za vrijeme postupka nanošenja preparata
English: 1 vial of 2 g powder 1 bottle of 20 g of gel
Croatian: Prašak i gel za gel 1 bočica s 2 g praška 1 boca s 20 g gela
English: • The dissolved eschar must be removed from the wound by wiping it away with a sterile bluntedged instrument.
Croatian: • Rastopljeni eshar mora se ukloniti s rane tako da se sastruže pomoću tupog sterilnog instrumenta.
English: Therefore, wounds with areas of full-thickness and deep burn should be autografted as soon as possible after NexoBrid debridement (see section 5.1 for study results).
Croatian: NexoBridom čim prije pokriti presatkom vlastite kože (vidjeti dio 5.1 za rezultate ispitivanja).
English: In addition, a delayed-type allergic skin reaction (cheilitis) after longer-term dermal exposure (mouthwash) as well as suspected sensitisation following oral exposure and following repeated occupational airway exposure have been reported.
Croatian: Uz to je zabilježen i kasni tip alergijske reakcije (heilitis) nakon dugotrajne izloženosti kože (sredstvo za ispiranje usta), kao i sumnja na senzibilizaciju nakon oralne izloženosti i ponavljane izloženosti dišnih puteva na radnom mjestu.
English: In the patients with indications of higher absorption, dose-normalised (per gram of NexoBrid) AUClast ranged from 4500-9820 ngh/ml per gram of NexoBrid.
Croatian: U bolesnika sa znakovima povećane apsorpcije, raspon AUCzadnji normaliziran prema dozi (po gramu NexoBrida) iznosio je od 4500 do 9820 ngh/ml po gramu NexoBrida.
English: NexoBrid is not recommended for use on: - penetrating burn wounds where foreign materials (e.g. implants, pacemakers, and shunts) and/ or vital structures (e.g. larger vessels, eyes) are or could become exposed during debridement.
Croatian: NexoBrid se ne preporučuje za primjenu na: - Penetrirajućim opeklinama gdje su strani materijali (primjerice implantati, elektrostimulatori i premosnice) i/ili vitalne strukture (primjerice veće krvne žile, oči) izloženi ili bi mogli postati izloženi tijekom debridmana.
English: NexoBrid should be applied to a clean, keratin-free (blisters removed), and moist wound area.
Croatian: NexoBrid treba nanijeti na čisto i vlažno područje rane bez keratina (ukloniti mjehure).
English: • Before NexoBrid application, a dressing soaked with an antibacterial solution will be applied for 2 hours.
Croatian: • Prije primjene NexoBrida stavit će se povoj natopljen antibakterijskom otopinom i ostaviti ga 2 sata.
English: In studies where the NexoBrid regimen included recommended preventive analgesia as routinely practiced for extensive dressing changes in burn patients (see section 4.2) local pain was reported in 3.6% of patients treated with NexoBrid and in 4.0% of the control patients treated according to standard of care.
Croatian: U ispitivanjima u kojima je protokol liječenja NexoBridom uključivao preventivnu analgeziju koja se ruitnski primjenjivala kod opsežne promjene povoja u bolesnika s opeklinama (vidjeti dio 4.2) lokalna bol bila je zabilježena u 3,6% bolesnika liječenih NexoBridom i 4,0% kontrolnih ispitanika liječenih prema standardnoj skrbi.
English: • The dressed wound must be covered with a loose, thick fluffy dressing, held in place with a bandage.
Croatian: • Povijena rana mora se lagano pokriti debelim, mekanim povojem koji se može pričvrstiti zavojem.
English: NexoBrid is provided as a powder and gel for gel (powder in a vial (5 g) and gel in a bottle (50 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel.
Croatian: NexoBrid se isporučuje u obliku praška i gela za gel (prašak u bočici (5 g) i gel u boci (50 g)), veličina pakiranja:1 (pakiranje sadrži jednu bočicu praška i jednu bocu gela).
English: Mixed wounds (with partial and full-thickness area) requiring excision/dermabrasion (surgery) NexoBrid (Number of wounds)
Croatian: Mješovite rane (s područjima djelomične i pune debljine kože) koje zahtijevaju eksciziju/dermoabraziju (kiruršku obradu) NexoBrid (broj rana)
English: In the other patients, dose-normalised Cmax ranged from 141-523 ng/ml per gram of NexoBrid.
Croatian: U ostalih bolesnika, Cmax normaliziran prema dozi kretao se u rasponu od 141 do 523 ng/ml po gramu NexoBrida.
English: • Powder and gel must be mixed thoroughly until a uniform, slightly tan to slightly brown mixture is obtained.
Croatian: • Prašak i gel moraju se temeljito miješati sve dok se ne dobije jednolika mješavina svijetlo bež do svijetlo smeđe boje.
English: In the 4 patients with indications of higher absorption, dose-normalised Cmax ranged from 788-900 ng/ml per gram of NexoBrid.
Croatian: U 4 bolesnika sa znakovima povećane apsorpcije raspon Cmax normaliziran prema dozi iznosio je od 788 do 900 ng/ml po gramu NexoBrida.
English: In the other patients, dose-normalised AUClast ranged from 887-3930 ngh/ml per gram of NexoBrid.
Croatian: U ostalih bolesnika AUCzadnji normaliziran prema dozi bio je u rasponu od 887 do 3930 ngh/ml po gramu NexoBrida.
English: Each NexoBrid vial, gel, or reconstituted gel should be used for a single patient only.
Croatian: Jedna bočica, gel ili pripremljeni gel NexoBrid smiju se primijeniti samo u jednog bolesnika.
English: • Appropriate preventive analgesia medicinal products must be administered.
Croatian: • Primijenite odgovarajuće preventivne lijekove protiv bolova.
English: NexoBrid powder Ammonium sulphate Acetic acid
Croatian: 6.1 Popis pomoćnih tvari Prašak NexoBrid amonijev sulfat acetatna kiselina
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Croatian: • Kada su primljene nove informacije koje mogu utjecati na važeći Sigurnosni profil lijeka,
English: If you notice any of these symptoms or signs, inform your doctor or caregiver immediately.
Croatian: Ako primijetite neki od ovih simptoma ili znakova, odmah obavijestite svog liječnika ili njegovatelja.
English: If you notice any of these signs or symptoms, inform your doctor or caregiver immediately.
Croatian: Ako primijetite neki od ovih znakova ili simptoma,odmah obavijestite svog liječnika ili njegovatelja.
English: Accidental eye exposure must be avoided.
Croatian: Mora se izbjegavati slučajno izlaganje očiju.
English: Wound complications
Croatian: Komplikacije rane
English: • The NexoBrid powder and gel are sterile.
Croatian: • Prašak NexoBrid i gel su sterilni.
English: The use of NexoBrid in subsequent burn injury is not recommended.
Croatian: Ne može se preporučiti primjena NexoBrida kod ponovnih opeklinskih ozljeda.
English: - you have a heart disease; - you have a lung disease; - your lung has been, or may have been damaged by inhalation of smoke;
Croatian: - ako imate srčanu bolest, - ako imate bolest pluća, - ako su Vam pluća oštećena ili su mogla biti oštećenja udisanjem dima, - ako ste alergični na lateks, ubod pčela ili pelud maslinova drveta.
English: Wound care after debridement
Croatian: Liječenje nakon debridmana opekline
English: Autografted wounds (ITT)
Croatian: Rane pokrivene presatkom vlastite kože (ITT)
English: Concentrate of proteolytic enzymes enriched in bromelain: 0.09 g/g (or 2 g/22 g gel) after mixing.
Croatian: Koncentrat proteolitičkih enzima obogaćenih bromelainom: 0,09 g/g (ili gel od 2 g/22 g) nakon miješanja.
English: A total wound area of not more than 15% TBSA can be treated with NexoBrid (see also section 4.4, Coagulopathy).
Croatian: NexoBridom se može liječiti rana čija cjelokupna površina nije veća od 15% cjelokupne površine tijela (vidjeti također dio 4.4, Koagulopatija).
English: Concentrate of proteolytic enzymes enriched in bromelain: 0.09 g/g (or 5 g/55 g gel) after mixing.
Croatian: Koncentrat proteolitičkih enzima obogaćenih bromelainom: 0,09 g/g (ili gel od 5 g/55 g) nakon miješanja.
English: 5 g powder in a vial (glass type II) sealed with a rubber (bromobutyl), stopper and covered with a cap (aluminium), and 50 g gel in a bottle (borosilicate, glass type I), sealed with a rubber stopper and covered with a screw cap (tamper-proof polypropylene).
Croatian: 5 g praška u bočici (staklo tipa II) zatvorenoj gumom (brombutil), čepom i pokrivenoj zatvaračem (aluminij) te 50 g gela u boci (borosilikat, staklo tipa I) zatvorenoj gumenim čepom i pokrivenoj navojnim zatvaračem (polipropilenski s evidencijom otvaranja).
English: • The powder vial must be opened by carefully tearing off the aluminium cap and removing the rubber stopper.
Croatian: • Otvorite bočicu s praškom tako što ćete pažljivo ukloniti aluminijski zatvarač i gumeni čep.
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Hälsa Pharma GmbH