FrancophonIA/ELRC3.0 huggingface dataset:
English: This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Croatian: To može uzrokovati pogrešno doziranje, koje može dovesti do previsoke ili preniske razine šećera u krvi.
English: Each pre-filled pen contains 300 IU of human insulin in 3 ml suspension for injection.
Croatian: Jedna napunjena brizgalica sadrži 300 IU humanog inzulina u 3 ml suspenzije za injekciju.
English: You can also report side effects via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED PEN.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (NAPUNJENA BRIZGALICA.
English: Each vial contains 1,000 IU of human insulin in 10 ml suspension for injection.
Croatian: Jedna bočica sadrži 1000 IU humanog inzulina u 10 ml suspenzije za injekciju.
English: Never share your pen or your needles with other people.
Croatian: Nikada nemojte dijeliti svoju brizgalicu ili igle s drugim osobama jer može doći do prijenosa infekcije.
English: 1 ml suspension contains 40 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 1.4 mg).
Croatian: 40 internacionalnih jedinica otopine humanog inzulina*/humanog izofan (NPH) inzulina* u omjeru 30/70 (što odgovara 1,4 mg).
English: - If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
Croatian: Proizvođač se može identificirati uz pomoć serijskog broja otisnutog na kutiji i naljepnici: - Ako su druga i treća oznaka S6 ili ZF, proizvođač je Novo Nordisk A/S, Novo Allé, DK-2880
English: leakage of insulin, blocked needles and inaccurate dosing.
Croatian: infekcije, istjecanja inzulina, začepljenja igala i pogrešnog doziranja.
English: Move the pen up and down twenty times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.
Croatian: Prije prvog injiciranja novom brizgalicom FlexPen morate izmiješati inzulin: Pomičite brizgalicu gore - dolje dvadeset puta između dva položaja, kako je prikazano na slici, tako da se staklena kuglica kreće s jednog kraja uloška na drugi.
English: The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
Croatian: To može umanjiti rizik od stvaranja kvržica ili ulegnuća na koži, pogledajte dio 4. Najbolja mjesta za davanje injekcije su: područje trbuha (abdomen), stražnjica, prednja strana bedara ili nadlaktice.
English: Let the insulin reach room temperature before you use it.
Croatian: Svaki puta kada koristite novu brizgalicu Pustite da inzulin dosegne sobnu temperaturu prije nego što ćete ga upotrijebiti.
English: Always make sure that a drop appears at the needle tip before you inject.
Croatian: • Uvijek provjerite protok kroz brizgalicu InnoLet prije injiciranja.
English: Pack sizes of 1, 5 and 10 pre-filled pens.
Croatian: Veličine pakiranja: 1, 5 i 10 napunjenih brizgalica.
English: They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
Croatian: Obično se prvi simptomi hiperglikemije javljaju postupno tijekom nekoliko sati ili dana, a uključuju: žeđ, učestalo mokrenje, mučninu, povraćanje, omamljenost, crvenu suhu kožu, suha usta, gubitak teka kao i acetonski zadah.
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Igle i Actraphane
English: Big outer needle cap
Croatian: Veliki vanjski zatvarač igle
English: Actraphane Penfill is only suitable for subcutaneous injections from a reusable pen.
Croatian: Actraphane Penfill je prikladan samo za potkožne injekcije iz brizgalice za višekratnu uporabu.
English: 1 ml suspension contains 100 IU insulin human (40% as soluble insulin and 60% as isophane insulin) (equivalent to 3.5 mg),
Croatian: 1 ml suspenzije sadrži 100 IU humanog inzulina (40% otopine inzulina i 60% izofan inzulina) (što odgovara 3,5 mg),
English: Making the injection
Croatian: Suspenzija za injekciju
English: Always keep the pen cap on your FlexPen when you are not using it, in order to protect from light.
Croatian: Uvijek držite zatvarač na brizgalici FlexPen kad je ne koristite, radi zaštite od svjetlosti.
English: LIST OF EXCIPIENTS
Croatian: Popis ostalih nuspojava
English: Keep the pen cap on the pen in order to protect from light.
Croatian: Zatvarač držati na brizgalici radi zaštite od svjetlosti.
English: 1 ml suspension contains 100 IU insulin human (50% as soluble insulin and 50% as isophane insulin) (equivalent to 3.5 mg),
Croatian: 1 ml suspenzije sadrži 100 IU humanog inzulina (50% otopine inzulina i 50% izofan inzulina) (što odgovara 3,5 mg),
English: 1 cartridge contains 3 ml equivalent to 300 IU.
Croatian: 1 napunjena brizgalica sadrži 3 ml što odgovara 300 IU.
English: For detailed user instructions, please refer to the package leaflet.
Croatian: Za detaljne upute za uporabu vidjeti uputu o lijeku.
English: Actraphane 30 FlexPen 100 international units/ml suspension for injection in pre-filled pen.
Croatian: Actraphane 30 FlexPen 100 internacionalnih jedinica/ml suspenzija za injekciju u napunjenoj brizgalici.
English: Your FlexPen is a pre-filled dial-a-dose insulin pen.
Croatian: FlexPen je napunjena inzulinska brizgalica s mogućnošću odabira doze inzulina.
English: Each vial contains 400 IU of human insulin in 10 ml suspension for injection.
Croatian: Jedna bočica sadrži 400 IU humanog inzulina u 10 ml suspenzije za injekciju.
English: See your pen manual for further instructions.
Croatian: Za dodatne informacije pročitajte upute za uporabu Vaše brizgalice.
English: How to take Actraphane
Croatian: Kako primijeniti Actraphane
English: 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 3.5 mg).
Croatian: 1 ml suspenzije sadrži 100 internacionalnih jedinica otopine humanog inzulina*/humanog izofan (NPH) inzulina* u omjeru 30/70 (što odgovara 3,5 mg).
English: InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.
Croatian: Kao mjeru opreza, uvijek sa sobom nosite rezervno pomagalo za primjenu inzulina, u slučaju da se Vaš InnoLet izgubi ili ošteti.
English: Actraphane Penfill is only suitable for injecting under the skin using a reusable pen.
Croatian: Actrapid Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
English: ► Actraphane Penfill is only suitable for injecting under the skin using a reusable pen.
Croatian: Actraphane Penfill je prikladan samo za ubrizgavanje pod kožu pomoću brizgalice za višekratnu uporabu.
English: 1 ml suspension contains 100 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 3.5 mg),
Croatian: 1 ml suspenzije sadrži 100 IU humanog inzulina (30% otopine inzulina i 70% izofan inzulina) (što odgovara 3,5 mg),
English: Actraphane 30 100 IU/ml Suspension for injection Insulin human
Croatian: Actraphane 30 100 IU/ml Suspenzija za injekciju humani inzulin
English: Actraphane 30 100 international units/ml suspension for injection in vial.
Croatian: Actraphane 30 100 internacionalnih jedinica/ml suspenzija za injekciju u bočici.
English: Glycerol
Croatian: Hiperglikemija
English: Actraphane 30 40 IU/ml Suspension for injection Insulin human
Croatian: Actraphane 30 40 IU/ml Suspenzija za injekciju humani inzulin
English: FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.
Croatian: Kao mjeru opreza, uvijek sa sobom nosite rezervno pomagalo za primjenu inzulina, u slučaju da se Vaš FlexPen izgubi ili ošteti.
English: Always keep the pen cap on your InnoLet when you are not using it, in order to protect from light.
Croatian: Uvijek držite zatvarač na brizgalici InnoLet kad je ne koristite, radi zaštite od svjetlosti.
English: Suspension for injection 1 vial of 10 ml 5 vials of 10 ml
Croatian: 1 bočica od 10 ml 5 bočica od 10 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (CARTRIDGE.
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (ULOŽAK.
English: Actraphane 50 Penfill 100 international units/ml suspension for injection in cartridge.
Croatian: Actraphane 50 Penfill 100 internacionalnih jedinica/ml suspenzija za injekciju u ulošku.
English: Pack sizes of 1, 5 and 10 cartridges.
Croatian: Veličine pakiranja: 1, 5 i 10 uložaka.
English: Actraphane 30 vial, Penfill and FlexPen:
Croatian: Actraphane 30 bočica, Penfill i FlexPen: Novo Nordisk A/S
English: BATCH NUMBER
Croatian: BROJ SERIJE Serija:
English: Each cartridge contains 300 IU of human insulin in 3 ml suspension for injection.
Croatian: Jedan uložak sadrži 300 IU humanog inzulina u 3 ml suspenzije za injekciju.
English: It may affect more than 1 in 10 people.
Croatian: Može se javiti u više od 1 na
English: How to store Actraphane
Croatian: Kako primjenjivati Actraphane
English: Actraphane 30 InnoLet 100 international units/ml suspension for injection in pre-filled pen.
Croatian: Actraphane 30 InnoLet 100 internacionalnih jedinica/ml suspenzija za injekciju u napunjenoj brizgalici.
English: • Dial 2 units by turning the dose selector clockwise.
Croatian: • Okrenite izbornik doze u smjeru kazaljke na satu kako biste odabrali 2 jedinice.
English: Actraphane 50 contains less than 1 mmol sodium (23 mg) per dose, i.e. Actraphane 50 is essentially ‘sodium-free'.
Croatian: Actraphane 50 sadrži manje od 1 mmol (23 mg) natrija po dozi tj.
English: Do not use this medicine after the expiry date, which is stated on the FlexPen label and carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici FlexPen brizgalice i kutiji iza oznake ‘Rok valjanosti'.
English: Actraphane 30 40 international units/ml suspension for injection in vial.
Croatian: Actraphane 30 40 internacionalnih jedinica/ml suspenzija za injekciju u bočici.
English: Always keep the vial in the outer carton when you are not using it, in order to protect from light.
Croatian: Uvijek čuvajte uložak u vanjskoj kutiji kad ga ne koristite, radi zaštite od svjetlosti.
English: Actraphane 30 FlexPen 100 IU/ml Suspension for injection in pre-filled pen Insulin human
Croatian: Actraphane 30 FlexPen 100 IU/ml Suspenzija za injekciju u napunjenoj brizgalici humani inzulin
English: Preparing your Actraphane 30 FlexPen
Croatian: Priprema Actraphane 30 FlexPen brizgalice
English: EU/1/02/229/003 1 vial of 10 ml EU/1/02/229/004 5 vials of 10 ml
Croatian: EU/1/02/229/004 5 bočica od 10 ml
English: Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain.
Croatian: Ako se razina šećera u krvi vrlo brzo popravlja, može se javiti bol koja je povezana sa živcima.
English: 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 50/50 (equivalent to 3.5 mg).
Croatian: 100 internacionalnih jedinica otopine humanog inzulina*/humanog izofan (NPH) inzulina* u omjeru 50/50 (što odgovara 3,5 mg).
English: 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 40/60 (equivalent to 3.5 mg).
Croatian: 100 internacionalnih jedinica otopine humanog inzulina*/humanog izofan (NPH) inzulina* u omjeru 40/60 (što odgovara 3,5 mg).
English: Repeat until the liquid appears uniformly white and cloudy.
Croatian: Ponavljajte te kretnje sve dok tekućina ne postane jednoliko bijela i zamućena.
English: Actraphane 40 Penfill 100 international units/ml suspension for injection in cartridge.
Croatian: Actraphane 40 Penfill 100 internacionalnih jedinica/ml suspenzija za injekciju u ulošku.
English: Actraphane 30 Penfill 100 international units/ml suspension for injection in cartridge.
Croatian: Actraphane 30 Penfill 100 internacionalnih jedinica/ml suspenzija za injekciju u ulošku.
English: • Discard the needle after each injection.
Croatian: • Nakon svake injekcije iglu bacite u otpad.
English: Small amounts of air may collect in the needle and cartridge during normal use.
Croatian: Priprema za izbacivanje zraka prije svake injekcije U igli i ulošku se tijekom uobičajene primjene mogu nakupiti male količine zraka.
English: Contents of the pack and other information What Actraphane 40 contains
Croatian: Sadržaj pakiranja i druge informacije Što Actraphane 40 sadrži - Djelatna tvar je humani inzulin.
English: Actraphane 30 FlexPen 100 IU/ml Suspension for injection Insulin human
Croatian: Actraphane 30 FlexPen 100 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: Actraphane 30 InnoLet 100 IU/ml Suspension for injection in pre-filled pen Insulin human
Croatian: Actraphane 30 InnoLet 100 IU/ml Suspenzija za injekciju u napunjenoj brizgalici humani inzulin
English: Actraphane 40 contains less than 1 mmol sodium (23 mg) per dose, i.e. Actraphane 40 is essentially ‘sodium-free'.
Croatian: Actraphane 40 sadrži manje od 1 mmol (23 mg) natrija po dozi tj.
English: Usual warning symptoms may disappear in patients with longstanding diabetes.
Croatian: U osoba koje dugo boluju od šećerne bolesti uobičajeni upozoravajući simptomi hipoglikemije mogu nestati.
English: Actraphane 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. Actraphane 30 is essentially ‘sodium-free'.
Croatian: Actraphane 30 sadrži manje od 1 mmol (23 mg) natrija po dozi tj.
English: Actraphane contains less than 1 mmol sodium (23 mg) per dose, i.e. Actraphane is essentially ‘sodium-free'.
Croatian: Actraphane sadrži natrij Actraphane sadrži manje od 1 mmol (23 mg) natrija po dozi, tj.
English: Pointer
Croatian: Uložak
English: Package leaflet: Information for the user Actraphane 30 40 IU/ml (international units/ml) suspension for injection in vial human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actraphane 30 40 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u bočici humani inzulin
English: EU/1/02/229/036 5 packs of 1 x 10 ml vial
Croatian: EU/1/02/229/016 10 uložaka od 3 ml
English: 1 vial contains 10 ml equivalent to 400 international units.
Croatian: 1 uložak sadrži 3 ml što odgovara 300 internacionalnih jedinica.
English: Insulin cartridge Glass ball
Croatian: Glicerol Metakrezol Fenol
English: Do not use this medicine after the expiry date, which is stated on the InnoLet label and carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici InnoLet brizgalice i kutiji iza oznake ‘Rok valjanosti'.
English: Contents of the pack and other information What Actraphane 50 contains
Croatian: Sadržaj pakiranja i druge informacije Što Actraphane 50 sadrži - Djelatna tvar je humani inzulin.
English: Package leaflet: Information for the user Actraphane 30 FlexPen 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actraphane 30 FlexPen 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u napunjenoj brizgalici humani inzulin
English: Package leaflet: Information for the user Actraphane 50 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actraphane 50 Penfill 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u ulošku humani inzulin
English: Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.
Croatian: Actraphane 30 bočica (100 internacionalnih jedinica/ml) 1 bočica sadrži 10 ml što odgovara 1000 internacionalnih jedinica.
English: 1 pre-filled pen contains 3 ml equivalent to 300 international units.
Croatian: Actraphane 30 Penfill 1 uložak sadrži 3 ml što odgovara 300 internacionalnih jedinica.
English: Actraphane 40 Penfill 100 IU/ml Suspension for injection in cartridge Insulin human
Croatian: Actraphane 40 Penfill 100 IU/ml Suspenzija za injekciju u ulošku humani inzulin
English: Actraphane 30 Penfill 100 IU/ml Suspension for injection in cartridge Insulin human
Croatian: Actraphane 30 Penfill 100 IU/ml Suspenzija za injekciju u ulošku humani inzulin
English: Package leaflet: Information for the user Actraphane 30 100 IU/ml (international units/ml) suspension for injection in vial human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actraphane 30 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u bočici humani inzulin
English: Always ensure you use the correct pen before you inject your insulin.
Croatian: Prije injiciranja inzulina uvijek se uvjerite da koristite odgovarajuću brizgalicu.
English: Actraphane 30 40 IU/ml Suspension for injection Insulin human SC
Croatian: Actraphane 30 40 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: Package leaflet: Information for the user Actraphane 40 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actraphane 40 Penfill 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u ulošku humani inzulin
English: Discard the needle and syringe after each injection.
Croatian: Nakon svakog injiciranja iglu i štrcaljku bacite u otpad.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (CARTRIDGE.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (ULOŽAK.
English: Actraphane 30 InnoLet EU/1/02/229/030
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/229/017
English: Package leaflet: Information for the user Actraphane 30 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actraphane 30 Penfill 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u ulošku humani inzulin
English: ► If you notice any of these signs, seek medical advice immediately.
Croatian: ► Ako primijetite neki od tih znakova, odmah zatražite medicinski savjet.
English: Package leaflet: Information for the user Actraphane 30 InnoLet 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Actraphane 30 InnoLet 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u napunjenoj brizgalici humani inzulin
English: EU/1/02/229/033 1 pen of 3 ml EU/1/02/229/034 5 pens of 3 ml EU/1/02/229/035 10 pens of 3 ml
Croatian: EU/1/02/229/034 5 brizgalica od 3 ml
English: EU/1/02/229/011 1 cartridge of 3 ml EU/1/02/229/012 5 cartridges of 3 ml EU/1/02/229/013 10 cartridges of 3 ml
Croatian: EU/1/02/229/013 10 uložaka od 3 ml
English: Do not use this medicine after the expiry date, which is stated on the vial label and carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici uloška i kutiji iza oznake ‘Rok valjanosti'.
English: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danska
English: EU/1/02/229/001 1 vial of 10 ml EU/1/02/229/002 5 vials of 10 ml
Croatian: EU/1/02/229/002 5 bočica od 5 ml
English: EU/1/02/229/037 5 packs of 1 x 10 ml vial
Croatian: EU/1/02/229/018 5 uložaka od 3 ml
English: Dispose of your used FlexPen carefully without the needle attached.
Croatian: Iskorišteni FlexPen pažljivo bacite u otpad, bez pričvršćene igle.
English: Actraphane 30 InnoLet 100 IU/ml Suspension for injection Insulin human
Croatian: Actraphane 30 InnoLet 100 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: Actraphane 30 Penfill 100 IU/ml Suspension for injection Insulin human
Croatian: Actraphane 30 Penfill 100 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: Actraphane 40 Penfill 100 IU/ml Suspension for injection Insulin human
Croatian: Actraphane 40 Penfill 100 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: Residual scale
Croatian: Održavanje brizgalice
English: Actraphane 30 100 IU/ml Suspension for injection Insulin human SC
Croatian: Actraphane 30 100 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: Needles and Actraphane Penfill must not be shared.
Croatian: Penfill ne smiju se dijeliti s drugim osobama.
English: EU/1/02/229/030 1 pen of 3 ml EU/1/02/229/031 5 pens of 3 ml EU/1/02/229/032 10 pens of 3 ml
Croatian: EU/1/02/229/031 5 brizgalica od 3 ml
English: EU/1/02/229/017 1 cartridge of 3 ml EU/1/02/229/018 5 cartridges of 3 ml EU/1/02/229/019 10 cartridges of 3 ml
Croatian: EU/1/02/229/019 10 uložaka od 3 ml
English: MA (EU) Number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza
English: The first infusion lasts 15 minutes.
Croatian: Prva infuzija traje 15 minuta.
English: This means that because the disease is rare, it has not been possible to obtain complete information about ATryn.
Croatian: To znači da zbog rijetkosti bolesti nije bilo moguće dobiti potpune informacije o lijeku ATryn.
English: The full EPAR for ATryn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i plan upravljanja rizikom nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: However, there was not enough information to identify the most appropriate dose to use during childbirth.
Croatian: Međutim, nije bilo dovoljno informacija kako bi se utvrdila najprikladnija doza koja bi se primjenjivala tijekom poroda.
English: ATryn has been authorised under ‘exceptional circumstances'.
Croatian: Lijek ATryn odobren je u „iznimnim okolnostima”.
English: The European Commission granted a marketing authorisation valid throughout the EU for ATryn on 28 July 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek ATryn vrijedi na prostoru Europske unije od 28. srpnja 2006.
English: What measures are being taken to ensure the safe and effective use of Atryn?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka ATryn?
English: ATryn antithrombin alfa
Croatian: ATryn antitrombin alfa
English: In the study, among the 13 patients in whom the effectiveness of the treatment could be assessed, two had an episode of DVT, of which only one needed treatment.
Croatian: U ispitivanju, od 13 bolesnika na kojima se mogla procijeniti učinkovitost liječenja, dvoje ih je imalo epizodu DVT-a od kojih je samo jedan trebao liječenje.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove procjenjuje sve nove dostupne informacije te se ovaj sažetak po potrebi ažurira.
English: ATryn is normally given with heparin (another medicine that helps to prevent blood clots).
Croatian: ATryn se obično daje zajedno s heparinom (drugim lijekom koji pomaže u sprečavanju stvaranja krvnih ugrušaka).
English: For more information about treatment with ATryn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom ATryn pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.