FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that other problems in the joint should be corrected before or during MACI implantation.
Croatian: To znači da se sve druge tegobe sa zglobom moraju izliječiti prije ili tijekom usađivanja implantata MACI.
English: A fibrin sealant is a type of glue that is made from human blood-clotting
Croatian: Fibrinsko tkivno ljepilo je vrsta ljepila koja se izrađuje od ljudskih proteina koji zgrušavaju krv.
English: MACI is indicated for the repair of symptomatic, full-thickness cartilage defects of the knee (grade III and IV of the Modified Outerbridge Scale) of 3-20 cm in skeletally mature adult patients.
Croatian: MACI je indiciran za popravak simptomatskih oštećenja čitave debljine hrskavice koljena (stupnja III i IV prema modificiranoj Outerbridgeovoj ljestvici) površine 3-20 cm2, u koštano zrelih odraslih
English: Dulbecco's Modified Eagles Medium (DMEM) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES)
Croatian: Dulbeccova modificirana Eagleova podloga (DMEM) s natrijevom soli 4-(2-hidroksietil)-1piperazinetansulfonske kiseline (HEPES)
English: In addition, an updated RMP should be submitted within a year.
Croatian: Dopunjeni RMP podnosi se jednom godišnje.
English: • Details of appropriate disposal of MACI implant trimmings or unused MACI implants
Croatian: • Detalje o odgovarajućem zbrinjavanju odrezanih dijelova implantata ili neupotrijebljenih
English: Risks involved with implantation of MACI:
Croatian: Rizici kod usađivanja implantata MACI:
English: MACI should be implanted in a reasonably healthy joint.
Croatian: MACI treba implantirati u zglob koljena koji je u razumnoj mjeri zdrav.
English: MACI has been investigated in a parallel, randomised, open-label trial in 144 patients with Outerbridge Grade III or IV focal cartilage defects of the knee of 3-20 cm
Croatian: MACI je ispitan u paralelnom, randomiziranom, otvorenom ispitivanju sa 144 bolesnika s fokalnim oštećenjem hrskavice koljena stupnja III ili IV prema Outerbridgeovoj ljestvici te površine 3-20 cm2).
English: In rare cases the MAH will not be able to produce a MACI implant from the available cells.
Croatian: U rijetkim slučajevima nositelj odobrenja neće moći proizvesti MACI implantat od raspoloživih stanica.
English: The surgeon will organise the date for implantation in consultation with the Marketing Authorisation Holder (MAH) or its local representative.
Croatian: Kirurg će odrediti datum implantacije u dogovoru s nositeljem odobrenja za stavljanje lijeka u promet ili njegovim lokalnim predstavnikom.
English: The implant is an opaque, off-white membrane supplied in 18 ml of colourless solution in a dish.
Croatian: Implantat je neprozirna, bjelkasta membrana koja se isporučuje u 18 ml bezbojne otopine u zdjelici.
English: Your surgeon will give you more information on any special considerations for your particular case.
Croatian: Kirurg će Vam dati dodatne informacije o bilo kakvim posebnim mjerama opreza koje se odnose na
English: • If you have any further questions, ask your doctor, surgeon or physical therapist.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku, kirurgu ili fizioterapeutu.
English: Implantation of MACI is performed using sterile surgical techniques and requires both the preparation of the defect bed and the application of fibrin sealant to the base and rim of the defect in order to secure the implant.
Croatian: Implantacija MACI implantata izvodi se primjenom sterilnih kirurških tehnika, a zahtijeva i pripremu mjesta oštećenja i nanošenje fibrinskog tkivnog ljepila na dno i uz rub oštećenoga područja kako bi se pričvrstio implantat.
English: Characterised viable autologous chondrocytes expanded ex vivo expressing chondrocyte-specific marker genes, seeded onto a CE marked porcine derived Type I/III collagen membrane.
Croatian: Karakterizirani vijabilni autologni hondrociti umnoženi ex vivo, koji eksprimiraju genske biljege specifične za hondrocite, nasađeni na membrani od kolagena tipa I/III svinjskoga podrijetla s
English: Keep MACI in the outer carton until ready to use.
Croatian: Čuvati MACI u vanjskom pakiranju do primjene.
English: MACI must be administered by a surgeon specifically trained and qualified in the use of MACI.
Croatian: MACI smije primijeniti isključivo kirurg koji je posebno obučen i kvalificiran za primjenu implantata
English: There were no indications of gross inflammatory
Croatian: Nije bilo pokazatelja jake
English: MACI is not recommended in patients with a total menisectomy unless the meniscal deficiency can be addressed with a staged or concurrent meniscal graft.
Croatian: MACI se ne preporučuje u bolesnika s potpunom meniscektomijom, osim ako se oštećenje meniska ne može liječiti presatkom meniska, istodobno ili u odvojenim postupcima.
English: • Educational material on the surgical procedures
Croatian: • Edukacijski materijal za kirurške zahvate
English: Store shipping box in an area below 37°C.
Croatian: Čuvati kutiju u kojoj je MACI isporučen na temperaturi ispod 37°C.
English: • difficulty breathing, chest pain and palpitations • leg swelling, leg pain and redness
Croatian: • otežano disanje, bol u prsima i osjećaj lupanja srca
English: The defect bed should be debrided only down to the subchondral plate and not through it.
Croatian: Treba učiniti debridman oštećenog tkiva sve do subhondralne ploče, ali ne i kroz nju.
English: In the pivotal study of MACI, patients were excluded if they had a history of osteoarthritis (Kellgren-Lawrence Grade 3 or 4) in the target knee, or concomitant inflammatory disease.
Croatian: U pivotalnom ispitivanju implantata MACI nisu bili uključeni bolesnici koji su u anamnezi imali osteoartritis (stupnja 3 ili 4 prema Kellgren-Lawrenceovoj ljestvici) u ciljnome koljenu ili istodobnu
English: At the surgeon's discretion, a few interrupted absorbable sutures may also be used to provide
Croatian: Prema odluci kirurga, za dodatno učvršćivanje implantata može se primijeniti i nekoliko isprekidanih resorbirajućih šavova.
English: If this happens, your surgeon will advise you on the best course of action.
Croatian: Ako se to dogodi, kirurg će Vas savjetovati kako je najbolje dalje postupiti.
English: The use of MACI in elderly with generalised degeneration of the cartilage or osteoarthritis is not recommended.
Croatian: Ne preporučuje se primjena implantata MACI u starijih osoba s generaliziranom degeneracijom hrskavice ili osteoartritisom.
English: This package is enclosed in an outer carton insulated with ambient gel packs.
Croatian: To se pakiranje nalazi u vanjskoj kutiji obloženo vrećicama s gelom za održavanje temperature.
English: Conventional reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the medicinal product.
Croatian: S obzirom na narav i predviđenu kliničku primjenu lijeka, konvencionalna ispitivanja reproduktivne i razvojne toksičnosti ne smatraju se relevantnima.
English: MACI will be sent to the treatment facility.
Croatian: MACI se šalje u ustanovu u kojoj se provodi liječenje.
English: Given the local nature of the medicinal product, adverse reactions of MACI on pregnancy are not anticipated.
Croatian: S obzirom na lokalnu prirodu lijeka, ne očekuju se da bi MACI mogao izazvati nuspojave u trudnica.
English: Ask your doctor or surgeon for more information as to which pain medicine you can safely use.
Croatian: Pitajte svog liječnika ili kirurga za više informacija o tome koje lijekove protiv bolova smijete sigurno Ne preporučuje se primjena lijekova protiv bolova u zglob.
English: Any unused medicinal product or waste material should be disposed of as surgical waste in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti kao kirurški otpad sukladno lokalnim propisima.
English: The surgeon will organise the date for MACI implantation in consultation with the Marketing Authorisation Holder (MAH) or its local representative.
Croatian: Kirurg će odrediti datum implantacije MACI implantata u dogovoru s nositeljem odobrenja za stavljanje lijeka u promet ili njegovim lokalnim predstavnikom.
English: Post-operative haemarthrosis occurs mainly in patients with a predisposition to haemorrhage or poor surgical haemorrhage control.
Croatian: Postoperativna hemartroza se najčešće javlja u bolesnika sklonih krvarenju ili u slučajevima loše kirurške hemostaze.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U
English: In rare cases the cell processing facility will not be able to produce MACI from your cells.
Croatian: U rijetkim slučajevima ustanova za obradu stanica neće moći od Vaših stanica proizvesti implantat MACI.
English: MACI was superior compared to microfracture regarding the improvement of pain and function according to the KOOS scale (Knee Injury and Osteoarthritis Outcome Score).
Croatian: MACI se pokazao boljim u usporedbi s mikrofrakturama s obzirom na ublažavanje boli i poboljšanje funkcije prema ljestvici KOOS (engl.
English: Name and address of the manufacturer of the biological active substance Genzyme Biosurgery ApS
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: The use of MACI in this age group has not been studied.
Croatian: Primjena implantata MACI u ovoj dobnoj skupini nije ispitana.
English: If this occurs, the surgeon will advise the patient on the best course of action.
Croatian: Ako se to dogodi, kirurg će bolesnika savjetovati kako je najbolje postupiti.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove:
English: Complications related to knee surgery in general may also include deep vein thrombosis and pulmonary embolism.
Croatian: Komplikacije općenito povezane s kirurškim zahvatom na koljenu mogu uključivati duboku vensku trombozu te plućnu emboliju.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DISH
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ZDJELICA
English: On average this will be 6 weeks, however, cells can also be frozen and held in storage for up to 2 years until a convenient date for surgery is agreed between you and your surgeon.
Croatian: Međutim, stanice se također mogu zamrznuti i čuvati dok Vi i Vaš kirurg ne dogovorite pogodan datum za kirurški zahvat, a najdulje 2 godine.
English: Each implantation matrix consists of characterised autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of 500,000 to 1,000,000 cells per cm2, to be trimmed by the surgeon to the size and shape of the defect.
Croatian: Jedan matriks za implantaciju sastoji se od karakteriziranih autolognih hondrocita na membrani od kolagena tipa I/III površine 14,5 cm i gustoće 500 000 do 1 000 000 stanica po cm 2, koju kirurg obrezuje prema veličini i obliku oštećenja.
English: The implantation matrix is trimmed by the treating surgeon to the size and shape of the defect, to ensure the damaged area is completely covered, and implanted cell-side down.
Croatian: Kirurg obrezuje matriks za implantaciju sukladno veličini i obliku oštećenja kako bi osigurao potpuno prekrivanje oštećene površine i usađuje matriks tako da strana koja sadrži stanice bude okrenuta prema dolje.
English: Each implant contains matrix applied characterised autologous cultured chondrocytes.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan implantat sadrži kultivirane karakterizirane autologne hondrocite aplicirane na matriks.
English: When treating trochlear and patellar defects, abnormal patellar tracking must be corrected, prior to or concurrent with MACI implantation.
Croatian: Kod liječenja trohlearnih ili patelarnih oštećenja mora se korigirati nepravilno klizanje patele, prije ili istodobno s implantacijom
English: Typical clinical pharmacokinetic (ADME) studies have not been performed on MACI.
Croatian: Nisu provedena tipična klinička farmakokinetička ispitivanja implantata MACI.
English: Other complications have been identified as causally related to MACI.
Croatian: Za ostale je komplikacije utvrđena uzročna povezanost s implantatom MACI.
English: There are no data on the use of MACI during breast-feeding.
Croatian: Nema podataka o primjeni implantata MACI tijekom dojenja.
English: Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the
Croatian: Čak i ako je kirurg već uzeo malen uzorak hrskavičnih stanica (biopsiju) potrebnih za proizvodnju implantata MACI, moguće je da nećete biti podobni za liječenje implantantom MACI.
English: The patient's haemostatic functions should be screened prior to surgery.
Croatian: Prije kirurškoga zahvata treba provjeriti hemostatske funkcije bolesnika.
English: The timing between the removal of the biopsy and MACI implantation can vary depending on logistical factors in addition to the quality and number of cells obtained from the biopsy.
Croatian: Dužina vremena između biopsije i implantiranja MACI implantata može varirati ovisno o logističkim faktorima te kvaliteti i broju stanica dobivenih biopsijom.
English: Given the local nature of the product, adverse reactions of MACI on the nursing infant are not anticipated.
Croatian: S obzirom na lokalnu primjenu proizvoda, ne očekuju se da bi MACI mogao izazvati nuspojave u dojenčadi.
English: What you need to know before you use MACI Do NOT use MACI if you:
Croatian: Što morate znati prije nego primite MACI
English: • Graft delamination (complete or partial, possibly leading to loose bodies in the joint or graft failure)
Croatian: • simptomatska hipertrofija presatka • delaminacija presatka (djelomična ili potpuna; može dovesti do pojave slobodnih tijela u zglobu
English: Clinical pharmacology studies have not been conducted on MACI.
Croatian: Nisu provedena kliničko farmakološka ispitivanja implantata MACI.
English: Talk to your doctor or surgeon if you are breast-feeding.
Croatian: Obratite se svom liječniku ili kirurgu ako dojite.
English: To create a favourable environment for healing, concomitant pathologies must be addressed prior to or concurrent with implantation of MACI.
Croatian: Kako bi se uspostavili povoljni uvjeti za zacjeljivanje, istodobno prisutna patološka stanja moraju se liječiti prije implantacije MACI implantata ili istovremeno s njom.
English: The active substance of MACI consists of viable autologous human cartilage cells on a 14.5 cm² Type I/III collagen membrane, at a density of between 0.5 and 1 million cells per cm
Croatian: Djelatna tvar implantata MACI sastoji se od održivih (vijabilnih) autolognih stanica ljudske hrskavice na membrani od kolagena tipa I/III površine 14,5 cm² i gustoće između 0,5 i 1 milijun stanica po cm
English: MACI is not recommended for pregnant women.
Croatian: Ne preporučuje se primjena implantata MACI u trudnica.
English: The administered dose corresponds to 500,000 to 1,000,000 autologous cells/cm of implantation matrix.
Croatian: Primijenjena doza odgovara količini od 500 000 do 1 000 000 autolognih stanica/cm matriksa za implantaciju.
English: Adverse reactions are listed by System Organ Class and frequency.
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti.
English: Patient: (name - date of birth {DD.Mmm.YYYY}) Biopsy: {biopsy number} Matrix: 1/1
Croatian: Bolesnik: (ime, prezime i datum rođenja {DD.Mmm.GGGG.})
English: Epinephrine or fibrin sealant (see section 4.5), applied sparingly directly to bleeding points, is a suitable haemostatic
Croatian: Prikladni hemostatici su epinefrin ili fibrinsko tkivno ljepilo (vidjeti dio 4.5), primijenjeni u malim količinama izravno na
English: • Clinical follow up details The training materials for healthcare professionals involved in the follow-up of patients treated with MACI shall include the following key messages:
Croatian: Materijali za obuku zdravstvenih djelatnika uključenih u praćenje bolesnika liječenih implantatom MACI moraju uključivati sljedeće ključne poruke:
English: Any spillage or waste material should be disposed as surgical waste material in compliance with local practice.
Croatian: Proliveni ili otpadni materijal valja zbrinuti kao kirurški otpad sukladno lokalnim propisima.
English: The implant is an opaque, off-white membrane, seeded with chondrocytes, supplied in 18 ml of colourless solution in a dish.
Croatian: Implantat je neprozirna bjelkasta membrana na koju su nasađeni hondrociti, a isporučuje se u 18 ml
English: Pharmacotherapeutic group: Other Medicines for Disorders of the Musculo-Skeletal system, ATC code: M09AX02
Croatian: Farmakoterapijska skupina: Ostali pripravci za liječenje bolesti mišićno-koštanog sustava,
English: • Localised surgical site infection
Croatian: • lokalizirane upale na mjestu kirurškoga zahvata • lokalizirane infekcije na mjestu kirurškoga zahvata
English: MACI 500,000 - 1,000,000 cells/cm implantation matrix Matrix applied characterised autologous cultured chondrocytes
Croatian: NAZIV LIJEKA MACI 500 000 - 1 000 000 stanica/cm matriks za implantaciju kultivirani karakterizirani autologni hondrociti aplicirani na matriks
English: Due to the surgical nature of the underlying procedure, implantation with MACI has a major influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Zbog kirurške prirode osnovnoga postupka, implantacija MACI implantata značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: At the cell processing facility, the cartilage cells will be grown aseptically in culture to expand the number of cells and placed onto a sterile CE marked porcine derived type I/III collagen membrane, to make MACI.
Croatian: U ustanovi za obradu stanica hrskavične se stanice uzgajaju u aseptičkim uvjetima u kulturi kako bi im se povećao broj, a zatim se nasađuju na sterilnu membranu od kolagena tipa I/III svinjskoga podrijetla, s oznakom CE, kako bi nastao MACI.
English: At the cell processing facility, the cartilage cells will be grown aseptically in culture to expand the number of cells and placed onto a sterile collagen membrane, to make MACI.
Croatian: U ustanovi za obradu stanica hrskavične se stanice uzgajaju u aseptičkim uvjetima u kulturi kako bi im se povećao broj, a zatim se nasađuju na sterilnu kolagenu membranu, kako bi nastao MACI.
English: On average this will be 6 weeks, however, cells can also be cryopreserved and held in storage for up to 2 years until a convenient date for surgery is agreed between the patient and surgeon.
Croatian: Međutim, stanice se mogu pohraniti krioprezervacijom i čuvati dok bolesnik i kirurg ne dogovore pogodan datum za operaciju, a najdulje 2 godine.
English: At the cell processing facility, your cartilage cells will be grown aseptically (free from germs) in culture, to increase the number of cells, and placed onto a sterile collagen membrane to make MACI.
Croatian: U ustanovi za obradu stanica hrskavične se stanice uzgajaju u aseptičnim uvjetima (bez prisutnosti mikroba) u kulturi kako bi im se povećao broj, a zatim se nasađuju na sterilnu kolagenu membranu te tako nastaje MACI.
English: Do not use MACI after the expiry date which is stated on the outer carton and the dish after EXP. Do not refrigerate or freeze.
Croatian: MACI se ne smije uporabiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i zdjelici
English: Autologous chondrocytes on a 14.5 cm² Type I/III collagen membrane, at a density of between 500,000 and 1,000,000 cells per cm
Croatian: Autologni hondrociti na membrani od kolagena tipa I/III površine 14,5 cm² i gustoće 500 000 do
English: Related to MACI:
Croatian: Komplikacije povezane s implantatom MACI:
English: These include:
Croatian: Među njih se ubrajaju:
English: The minimum amount of time is 6 weeks; however, cells can also be cryopreserved and held in storage for up to 24 months until a surgical date is established.
Croatian: Međutim, stanice se mogu pohraniti krioprezervacijom i čuvati dok se ne odredi datum kirurškoga zahvata, a najdulje 24 mjeseca.
English: During the first procedure, a sample of healthy cartilage tissue (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy.
Croatian: Tijekom prvoga zahvata se artrotomijom ili artroskopijom uzima uzorak zdravog hrskavičnog tkiva (biopsija) iz oštećenoga zgloba.
English: If you get any side effects, talk to your doctor, surgeon or physical therapist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, kirurga ili fizioterapeuta.
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: OZNAČAVANJE I UPUTA O LIJEKU
English: MACI 500,000 to 1,000,000 cells/cm implantation matrix
Croatian: NAZIV LIJEKA MACI 500 000 do 1 000 000 stanica/cm matriks za implantaciju
English: The MACI implant will be secured in place using a fibrin sealant.
Croatian: Implantat MACI učvršćuje se fibrinskim tkivnim ljepilom.
English: Driving and using machines may be limited during the rehabilitation period, and the advice of your doctor, surgeon or physical therapist should be strictly followed during this period.
Croatian: Upravljanje vozilima i rad sa strojevima mogu biti ograničeni za vrijeme razdoblja rehabilitacije.
English: There were no significant differences observed in the structural markers of cartilage repair between both treatments, as assessed by International Cartilage Repair Society (ICRS) II overall assessment histology scores of biopsies, and MRI defect fill scores.
Croatian: International Cartilage Repair Society) II te prema rezultatima ispunjenosti oštećenja dobivenima MR oslikavanjem, nisu primijećene značajne razlike između navedenih metoda liječenja kada su u pitanju strukturni biljezi
English: 6 days.
Croatian: U prosjeku to razdoblje iznosi 6 tjedana.
English: Oliefabriksvej 45
Croatian: Genzyme Biosurgery ApS Oliefabriksvej 45
English: Not Responded
Croatian: I DOHVATA
English: Musculoskeletal and connective tissue disorders
Croatian: Knee Injury and Osteoarthritis Outcome
English: The following information is intended for medical or healthcare professionals only: During the first procedure a sample of healthy cartilage cells (a biopsy) will be taken from the affected joint by an arthrotomy or arthroscopy.
Croatian: U sklopu ovoga liječenja bit će potrebna dva kirurška zahvata: 1. Tijekom prvoga zahvata iz Vašega se zgloba artrotomijom ili artroskopijom uzima uzorak zdravih hrskavičnih stanica (biopsija).
English: Package leaflet: Information for the user MACI 500,000 to 1,000,000 cells/cm2 for implantation
Croatian: Uputa o lijeku: Informacija za korisnika MACI 500 000 do 1 000 000 stanica/cm za implantaciju kultivirani karakterizirani autologni hondrociti aplicirani na matriks
English: At this time MACI will be implanted into the cartilage defect in the affected joint via a second procedure.
Croatian: Tada se tijekom drugog zahvata MACI implantira u oštećenu hrskavicu zahvaćenog zgloba.
English: See responder rates in Table 1 below.
Croatian: Vidjeti stope bolesnika koji su ostvarili odgovor na liječenje u Tablici 1 u nastavku.
English: MACI will be secured in place using a fibrin sealant.
Croatian: MACI se učvršćuje fibrinskim tkivnim ljepilom.
English: EXPIRY DATE
Croatian: Rok valjanosti
English: Risks involved with arthrotomy or arthroscopy or MACI
Croatian: Rizici kod artrotomije, artroskopije ili usađivanja implantata MACI Svi kirurški zahvati podrazumijevaju određen rizik.
English: Tabulated list of adverse reactions
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: MACI 500,000 - 1,000,000 cells/cm implantation matrix
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MACI 500 000 - 1 000 000 stanica/cm matriks za implantaciju
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Croatian: <{MM/GGGG}> <{DD/MM/GGGG}> <{DD mjesec GGGG}>
English: Avoid direct contact with the product.
Croatian: Izbjegavati izravan kontakt s proizvodom.