FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep out of the sight and reach of children.
Croatian: I DOHVATA DJECE Čuvati izvan pogleda i dohvata djece.
English: Rare (may affect up to 1 in 1000 people) • flushing of the upper body
Croatian: Rijetke (mogu se javiti u manje od 1 na 1000 osoba) • crvenilo gornjeg dijela tijela praćeno osjećajem vrućine
English: Ototoxicity
Croatian: Ototoksičnost
English: • hospital acquired pneumonia,
Croatian: • bolnička pneumonija,
English: Teicoplanin should be administered by the intravenous or intramuscular route.
Croatian: Teikoplanin se primjenjuje intravenskim ili intramuskularnim putem.
English: Preparation of the diluted solution before infusion Targocid can be administered in the following infusion solutions:
Croatian: Targocid se može primijeniti u sljedećim otopinama za infuziju:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL OF POWDER VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU S PRAŠKOM
English: The solvent is a clear and colourless solution.
Croatian: Otapalo je bista i bezbojna otopina.
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: Water for injections [See Annex I - To be completed nationally]
Croatian: Otapalo voda za injekcije [Vidjeti Dodatak I - ispunjava država članica]
English: It is unknown whether teicoplanin is excreted in human milk.
Croatian: Nije poznato izlučuje li se teikoplanin u majčino mlijeko u ljudi.
English: Teicoplanin is not removed by haemodialysis and only slowly by peritoneal dialysis.
Croatian: Teikoplanin se ne uklanja hemodijalizom dok je uklanjanje peritonejskom dijalizom sporo.
English: Rare (≥1/10,000 to
Croatian: manje često (≥1/1000 i <1/100)
English: 5x1 powder vials
Croatian: 5x1 bočica s praškom
English: Clostridium difficile infection-associated diarrhea and colitis The recommended dose is 100-200 mg administered orally twice a day for 7 to 14 days.
Croatian: Proljev i kolitis izazvani infekcijom bakterijom Clostridium difficile Preporučena doza je 100-200 mg primijenjena peroralno dvaput na dan tijekom 7-14 dana.
English: How to store Targocid
Croatian: Kako primjenjivati Targocid
English: Streptococcus dysgalactiae subsp.
Croatian: Streptococcus dysgalactiae podvrsta equisimilis a
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section
Croatian: Za upute o rekonstituciji i razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive bacteria Enterococcus faecium
Croatian: Vrste kod kojih bi stečena rezistencija mogla uzrokovati probleme Aerobne Gram-pozitivne bakterije
English: After a maintenance dose of 12 mg/kg once daily Ctrough values range from 18 to 30 mg/L.
Croatian: Nakon doze održavanja od 12 mg/kg jedanput na dan, vrijednosti Ctrough kreću se u rasponu od 18 do 30 mg/l.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Targocid.
Croatian: Ako se nešto od navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Targocid.
English: 400 mg intravenous or intramuscular (this equates to approximately 6 mg/kg body weight) every 12 hours for 3 administrations
Croatian: 400 mg intravenski ili intramuskularno (jednako dozi od približno 6 mg/kg tjelesne težine) svakih 12 sati tijekom prve 3 doze
English: The solvent is packaged in Type I, colourless glass ampoule.
Croatian: Otapalo je pakirano u bezbojnu staklenu ampulu (staklo tipa I).
English: • you are taking other medicines which may cause hearing problems and/or kidney problems.
Croatian: • ako uzimate druge lijekove koji mogu uzrokovati probleme sa sluhom i/ili bubrezima.
English: What Targocid looks like and contents of the pack Targocid is a powder for solution for injection/infusion or oral solution.
Croatian: Kako Targocid izgleda i sadržaj pakiranja Targocid je prašak za otopinu za injekciju/infuziju ili oralnu otopinu.
English: • 5% dextrose injection
Croatian: • 5%-tnoj otopini dekstroze za injekciju
English: 800 mg intravenous (this equates to approximately 12 mg/kg body weight) every 12 hours for 3 to 5 administrations
Croatian: 800 mg intravenski (jednako dozi od približno 12 mg/kg tjelesne težine) svakih 12 sati tijekom prvih 3-5 doza
English: Targocid contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial and is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
English: • ciclosporin - a medicine that affects the immune system which may cause hearing problems and/or kidney problems
Croatian: • ciklosporin - lijek koji utječe na imunološki sustav i može uzrokovati probleme sa sluhom i/ili bubrezima
English: Life-threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with the use of teicoplanin.
Croatian: Kod primjene teikoplanina prijavljeni su Stevens-Johnsonov sindrom (SJS) i toksična epidermalna nekroliza (TEN), po život opasne kožne reakcije koje mogu imati smrtan ishod.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: • amphotericin B - a medicine that treats fungal infections which may cause hearing problems and/or kidney problems
Croatian: • amfotericin B - lijek za liječenje gljivičnih infekcija koji može uzrokovati probleme sa sluhom i/ili bubrezima
English: Volume of powder vial
Croatian: Volumen bočice s praškom
English: • Week one: 20 mg/L in each dialysis bag
Croatian: • prvi tjedan: 20 mg/l u svakoj vrećici za dijalizu
English: Thrombocytopenia has been reported with teicoplanin.
Croatian: Kod primjene teikoplanina prijavljena je trombocitopenija.
English: The total and renal clearances of teicoplanin depends on the creatinine clearance.
Croatian: Ukupan klirens i bubrežni klirens teikoplanina ovise o klirensu kreatinina.
English: • 10% dextrose injection
Croatian: • 10%-tnoj otopini dekstroze za injekciju
English: (e.g. progressive skin rash often with blisters or mucosal lesions) are present teicoplanin treatment should be discontinued immediately.
Croatian: Ako se pojave simptomi ili znakovi SJS-a ili TEN-a (npr. progresivni kožni osip često praćen mjehurićima na koži ili lezijama sluznice), treba odmah prekinuti liječenje teikoplaninom.
English: One single dose of 16 mg/kg body weight, administered intravenously by infusion on the first day.
Croatian: Jedna doza od 16 mg/kg tjelesne težine primijenjena intravenskom infuzijom prvog dana.
English: Adverse reactions should be monitored when teicoplanin doses of 12 mg/kg body weight twice a day are administered (see section 4.4).
Croatian: Kada se primjenjuju doze teikoplanina od 12 mg/kg tjelesne težine dvaput na dan, bolesnike je potrebno nadzirati zbog moguće pojave nuspojava (vidjeti dio 4.4).
English: Powder for solution for injection/infusion or oral solution: spongy ivory coloured homogeneous mass Solvent: clear, colourless liquid.
Croatian: Prašak za otopinu za injekciju/infuziju ili oralnu otopinu: spužvasta homogena masa boje bjelokosti.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Targocid and associated names [See Annex I - To be completed nationally]
Croatian: NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Targocid i pridružena imena [Vidjeti Dodatak I - ispunjava država članica]
English: One single dose of 10 mg/kg body weight administered intravenously every 12 hours, repeated 3 times.
Croatian: Jedna doza od 10 mg/kg tjelesne težine primijenjena intravenski svakih 12 sati; daju se 3 takve doze.
English: 12 mg/kg body weight intravenous or intramuscular once a day
Croatian: 12 mg/kg tjelesne težine intravenski ili intramuskularno jedanput na dan
English: Renal failure has been reported in patients treated with teicoplanin (see section 4.8).
Croatian: U bolesnika liječenih teikoplaninom prijavljeno je zatajenje bubrega (vidjeti dio 4.8).
English: After a loading dose of 6 mg/kg administered intravenously every 12 hours for 3 to 5 administrations, Cmax values range from 60 to 70 mg/L and Ctrough are usually above 10 mg/L.
Croatian: Nakon udarne doze od 6 mg/kg primijenjene intravenski svakih 12 sati tijekom prvih 3 do 5 doza, vrijednosti Cmax kreću se u rasponu od 60 do 70 mg/l, a vrijednosti Ctrough su obično iznad 10 mg/l.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 100 mg, 200 mg and 400 mg / powder for solution for injection/infusion or oral solution
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA 100 mg, 200 mg i 400 mg / prašak za otopinu za injekciju/infuziju ili oralnu otopinu
English: 6 mg/kg body weight intravenous or intramuscular once a day
Croatian: 6 mg/kg tjelesne težine intravenski ili intramuskularno jedanput na dan
English: • Starting dose (for the first three to five doses): 800 mg (this equates to 12 mg for every kilogram of body weight), given every 12 hours, by injection into a vein or muscle
Croatian: • Početna doza (tijekom prvih tri do pet doza): 800 mg (što je 12 mg po svakom kilogramu tjelesne težine), primijenjeno svakih 12 sati injekcijom u venu ili mišić
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 100 mg, 200 mg and 400 mg / powder and solvent for solution for injection/infusion or oral solution
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA 100 mg, 200 mg i 400 mg / prašak i otapalo za otopinu za injekciju/infuziju ili oralnu otopinu
English: • cisplatin - a medicine that treats malignant tumors which may cause hearing problems and/or kidney problems
Croatian: • cisplatin - lijek koji se koristi za liječenje zloćudnih tumora, a može uzrokovati probleme sa sluhom i/ili bubrezima
English: • complicated urinary tract infections,
Croatian: • komplicirane infekcije mokraćnog sustava,
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection/infusion or oral solution 1 powder vial and 1 solvent ampoule 5 powder vials and 5 solvent ampoules 10 powder vials and 10 solvent ampoules 25 powder vials and 25 solvent ampoules
Croatian: OBLIK I SADRŽAJ Prašak i otapalo za otopinu za injekciju/infuziju ili oralnu otopinu 1 bočica s praškom i 1 ampula s otapalom 5 bočica s praškom i 5 ampula s otapalom 10 bočica s praškom i 10 ampula s otapalom 25 bočica s praškom i 25 ampula s otapalom
English: Serious, life-threatening hypersensitivity reactions, sometimes fatal, have been reported with teicoplanin (e.g. anaphylactic shock).
Croatian: Kod primjene teikoplanina prijavljene su ozbiljne, po život opasne reakcije preosjetljivosti, ponekad sa smrtnim ishodom (npr. anafilaktički šok).
English: Summary of product characteristics, labelling and package leaflet
Croatian: Sažetak opisa svojstava lijeka, označavanje i uputa o lijeku
English: • you have kidney problems
Croatian: • ako imate problema s bubrezima
English: • Starting dose (on the first day): 16 mg for every kilogram of body weight, as an infusion through a drip into a vein.
Croatian: • Početna doza (prvog dana): 16 mg po svakom kilogramu tjelesne težine u obliku infuzije u venu.
English: - Complicated urinary tract infections
Croatian: - Komplicirane infekcije mokraćnog sustava
English: INSTRUCTIONS ON USE [To be completed nationally]
Croatian: UPUTE ZA UPORABU [Ispunjava država članica]
English: 1 powder vial
Croatian: 1 bočica s praškom
English: After an intravenous loading dose of 12 mg/kg administered every 12 hours for 3 administrations, mean values of Cmax and Ctrough are estimated to be around 100 mg/L and 20 mg/L, respectively.
Croatian: Nakon intravenske udarne doze od 12 mg/kg primijenjene svakih 12 sati tijekom 3 doze, srednje vrijednosti Cmax procjenjuju se na približno 100 mg/l, a Ctrough na približno 20 mg/l.
English: After a maintenance dose of 6 mg/kg administered once daily Cmax and Ctrough values are approximately 70 mg/L and 15 mg/L, respectively.
Croatian: Nakon doze održavanja od 6 mg/kg primijenjene jedanput na dan, vrijednost Cmax iznosi približno 70 mg/l, a Ctrough približno 15 mg/l.
English: Powder and solvent for solution for injection/infusion or oral solution Powder for solution for injection/infusion or oral solution
Croatian: Prašak i otapalo za otopinu za injekciju/infuziju ili oralnu otopinu Prašak za otopinu za injekciju/infuziju ili oralnu otopinu
English: • Maintenance dose: 6 to 10 mg for every kilogram of body weight, given once a day, by injection into a vein.
Croatian: • Doza održavanja: 6-10 mg po svakom kilogramu tjelesne težine jedanput na dan injekcijom u venu.
English: Diarrhoea, vomiting, nausea
Croatian: Poremećaji probavnog sustava proljev, povraćanje, mučnina
English: • bone and joint infections,
Croatian: • infekcije kostiju i zglobova,
English: • For endocarditis and other severe infections, teicoplanin trough levels of 15-30 mg/L when measured by HPLC, or 30-40 mg/L when measured by FPIA method.
Croatian: 15-30 mg/l mjereno HPLC metodom ili 30-40 mg/l mjereno FPIA metodom.
English: Rash, erythema, pruritus
Croatian: • osip, crvenilo, svrbež
English: • Week three: 20 mg/L in the overnight dialysis bag.
Croatian: • treći tjedan: 20 mg/l u vrećici za noć.
English: • you have a decrease in platelet count (thrombocytopenia)
Croatian: • ako imate smanjen broj krvnih pločica (trombocitopeniju)
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: 1 powder vial with 1 solvent ampoule 5x1 powder vials with 5x1 solvent ampoules 10x1 powder vials with 10x1 solvent ampoules 25x1 powder vials with 25x1 solvent ampoules.
Croatian: 1 bočica s praškom i 1 ampula s otapalom 5x1 bočica s praškom i 5x1 ampula s otapalom 10x1 bočica s praškom i 10x1 ampula s otapalom 25x1 bočica s praškom i 25x1 ampula s otapalom
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: Viridans group streptococci b
Croatian: Streptokoki skupine viridans b
English: For Targocid, powder for solution for injection/infusion or oral solution What Targocid contains
Croatian: Targocid prašak za otopinu za injekciju/infuziju ili oralnu otopinu Što Targocid sadrži
English: Each vial contains 400 mg teicoplanin equivalent to not less than 400,000 IU.
Croatian: Jedna bočica sadrži 400 mg teikoplanina, što odgovara najmanje 400 000 IU.
English: For Targocid, powder and solvent for solution for injection/ infusion or oral solution What Targocid contains
Croatian: Targocid prašak i otapalo za otopinu za injekciju/infuziju ili oralnu otopinu Što Targocid sadrži
English: Red man syndrome (e.g. Flushing of the upper part of the body) (see section 4.4).
Croatian: Poremećaji kože i potkožnog tkiva osip, eritem, pruritus sindrom crvenog čovjeka (npr. crvenilo gornjeg dijela tijela praćeno osjećajem vrućine) (vidjeti dio 4.4).
English: After reconstitution, the solution will contain 100 mg teicoplanin in 1.5 mL.
Croatian: Nakon rekonstitucije, otopine će sadržavati 100 mg teikoplanina u 1,5 ml.
English: • Maintenance dose: 400 mg (this equates to 6 mg for every kilogram of body weight), given once a day, by injection into a vein or muscle
Croatian: • Doza održavanja: 400 mg (što je 6 mg po svakom kilogramu tjelesne težine), primijenjeno jedanput na dan injekcijom u venu ili mišić.
English: - Bone and joint infections
Croatian: - Infekcije kostiju i zglobova
English: • community acquired pneumonia,
Croatian: • izvanbolnički stečena pneumonija,
English: Tests
Croatian: Pretrage
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder [See Annex I - To be completed nationally]
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja [Vidjeti Dodatak I - ispunjava država članica]
English: In people who are given Targocid for a long time, bacteria that are not affected by the antibiotic may grow more than normal - your doctor will check for this.
Croatian: U bolesnika koji primaju Targocid tijekom duljeg razdoblja može doći do pojačanog rasta bakterija na koje antibiotik ne djeluje
English: Each vial contains 200 mg teicoplanin equivalent to not less than 200,000 IU.
Croatian: Jedna bočica sadrži 200 mg teikoplanina, što odgovara najmanje 200 000 IU.
English: For Targocid, powder and solvent for solution for injection/infusion or oral solution - 1 powder vial with 1 solvent ampoule - 5x1 powder vials with 5x1 solvent ampoules - 10x1 powder vials with 10x1 solvent ampoules - 25x1 powder vials with 25x1 solvent ampoules
Croatian: Za Targocid prašak i otapalo za otopinu za injekciju/infuziju ili oralnu otopinu - 1 bočica s praškom s 1 ampulom s otapalom - 5x1 bočica s praškom s 5x1 ampulom s otapalom - 10x1 bočica s praškom s 10x1 ampulom s otapalom - 25x1 bočica s praškom s 25x1 ampulom s otapalom
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Vidjeti Dodatak I - ispunjava država članica]
English: Preparation of reconstituted solution: Slowly inject the entire content of the supplied solvent into the powder vial.
Croatian: Polako ubrizgati cjelokupni sadržaj priloženog otapala u bočicu s praškom.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Ispunjava država članica]
English: Anaphylactic reaction (anaphylaxis) (see section 4.4)
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija (anafilaksija) (vidjeti dio 4.4)
English: Shelf life of diluted medicinal product:
Croatian: Rok valjanosti razrijeđenog lijeka:
English: Streptococci in the viridans group a b Anaerobic Gram-positive bacteria Clostridium difficile a
Croatian: Anaerobne Gram-pozitivne bakterije Clostridium difficile a Peptostreptococcus spp. a
English: One single dose of 8 mg/kg body weight administered intravenously by infusion once a day.
Croatian: Jedna doza od 8 mg/kg tjelesne težine primijenjena intravenskom infuzijom jedanput na dan.
English: Shelf life of reconstituted solution
Croatian: Rok valjanosti rekonstituirane otopine
English: Posology
Croatian: teikoplanin
English: One single dose of 6-10 mg/kg body weight administered intravenously once a day.
Croatian: Jedna doza od 6-10 mg/kg tjelesne težine primijenjena intravenski jedanput na dan.
English: Shelf life of reconstituted solution:
Croatian: Rok valjanosti rekonstituirane otopine:
English: Each vial contains 100 mg teicoplanin equivalent to not less than 100,000 IU.
Croatian: Jedna bočica sadrži 100 mg teikoplanina, što odgovara najmanje 100 000 IU.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja bronhospazam
English: 5 powder vials
Croatian: 5 bočica s praškom
English: • feeling or being sick (vomiting), diarrhoea
Croatian: • mučnina ili povraćanje, proljev
English: • Maintenance dose: 8 mg for every kilogram of body weight, given once a day, as an infusion through a drip into a vein.
Croatian: • Doza održavanja: 8 mg po svakom kilogramu tjelesne težine jedanput na dan u obliku infuzije u venu.
English: Only the infusion method should be used in neonates.
Croatian: U novorođenčadi se lijek smije primijeniti samo infuzijom.
English: For Targocid, powder for solution for injection/infusion or oral solution - 1 powder vial - 5x1 powder vials - 10x1 powder vials - 25x1 powder vials
Croatian: Za Targocid prašak za otopinu za injekciju/infuziju ili oralnu otopinu - 1 bočica s praškom - 5x1 bočica s praškom - 10x1 bočica s praškom - 25x1 bočica s praškom
English: • Maintenance dose: 800 mg (this equates to 12 mg for every kilogram of body weight), given once a day hours, by injection into a vein or muscle
Croatian: • Doza održavanja: 800 mg (što je 12 mg po svakom kilogramu tjelesne težine), primijenjeno jedanput na dan injekcijom u venu ili mišić.
English: After reconstitution, the solutions will contain 400 mg teicoplanin in 3.0 mL.
Croatian: Nakon rekonstitucije, otopine će sadržavati 400 mg teikoplanina u 3,0 ml.
English: High Performance Liquid Chromatography (HPLC), or at least 15 mg/L when measured by
Croatian: 10 mg/l mjereno HPLC metodom ili najmanje 15 mg/l mjereno metodom fluorescentne imunopolarizacije (engl.
English: 0.18% sodium chloride and 4% glucose solution 0.45% sodium chloride and 5% glucose solution Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.
Croatian: Targocid se može primijeniti u sljedećim infuzijskim otopinama: - otopini natrijeva klorida od 9 mg/ml (0,9%) - Ringerovoj otopini - Ringerovoj otopini s laktatom - 5%-tnoj otopini dekstroze za injekciju - 10%-tnoj otopini dekstroze za injekciju - otopini s 0,18% natrijeva klorida i 4% glukoze - otopini s 0,45% natrijeva klorida i 5% glukoze - otopini za peritonejsku dijalizu koja sadrži otopinu glukoze od 1,36% ili 3,86%
English: Shelf life of diluted medicine
Croatian: Rok valjanosti razrijeđenog lijeka
English: Targocid and associated names (see Annex I) 100 mg powder and solvent for solution for injection/infusion or oral solution Targocid and associated names (see Annex I) 200 mg powder and solvent for solution for injection/infusion or oral solution Targocid and associated names (see Annex I) 400 mg powder and solvent for solution for injection/infusion or oral solution
Croatian: Targocid i pridružena imena (vidjeti Dodatak I) 100 mg prašak i otapalo za otopinu za injekciju/infuziju ili oralnu otopinu Targocid i pridružena imena (vidjeti Dodatak I) 200 mg prašak i otapalo za otopinu za injekciju/infuziju ili oralnu otopinu Targocid i pridružena imena (vidjeti Dodatak I) 400 mg prašak i otapalo za otopinu za injekciju/infuziju ili oralnu otopinu
English: Seizures
Croatian: Apsorpcija
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Vidjeti Dodatak I - ispunjava država članica]
English: Powder for solution for injection/infusion or oral solution Sodium chloride
Croatian: Prašak za otopinu za injekciju/infuziju ili oralnu otopinu natrijev klorid natrijev hidroksid (za prilagodbu pH)
English: Nephrotoxicity
Croatian: Nefrotoksičnost
English: After reconstitution, the solution will contain 200 mg teicoplanin in 3 mL.
Croatian: Nakon pripreme za primjenu, otopina će sadržavati 200 mg teikoplanina u 3 ml.
English: Tell your doctor if you are breast-feeding, before being given this medicine.
Croatian: Prije nego primite ovaj lijek, obavijestite liječnika ako dojite.
English: • Starting dose (for the first three doses): 10 mg for every kilogram of body weight, given every
Croatian: • Početna doza (tijekom prve tri doze): 400 mg (što je 6 mg po svakom kilogramu tjelesne težine),
English: Targocid and associated names (see Annex I) 100 mg powder for injection/infusion or oral solution Targocid and associated names (see Annex I) 200 mg powder for injection/infusion or oral solution Targocid and associated names (see Annex I) 400 mg powder for injection/infusion or oral solution [See Annex I - To be completed nationally]
Croatian: Targocid i pridružena imena (vidjeti Dodatak I) 100 mg prašak za injekciju/infuziju ili oralnu otopinu Targocid i pridružena imena (vidjeti Dodatak I) 200 mg prašak za injekciju/infuziju ili oralnu otopinu Targocid i pridružena imena (vidjeti Dodatak I) 400 mg prašak za injekciju/infuziju ili oralnu otopinu [Vidjeti Dodatak I - ispunjava država članica]
English: After reconstitution, the solution will contain 400 mg teicoplanin in 3 mL.
Croatian: Nakon pripreme za primjenu, otopina će sadržavati 400 mg teikoplanina u 3 ml.
English: Preparation of reconstituted solution
Croatian: Priprema rekonstituirane otopine:
English: Immune system disorders
Croatian: Udarni režim doziranja