natgillin/translations-raw huggingface dataset:
Push the plunger rod slowly until all air bubbles are gone.
Polako pritišćite potisni klip dok svi mjehurići zraka ne izađu.
Psychiatric disorders Uncommon
Psihijatrijski poremećaji manje često nesanica
In some cases, especially in younger patients, more frequent injections or higher doses may be needed.
U nekim slučajevima, osobito u mlađih bolesnika, injekcije će se možda morati primjenjivati češće ili u većim dozama.
• pain in legs and arms
• bol u nogama i rukama
Keep reconstituted NovoEight solution out of direct light.
Pripremljenu otopinu lijeka NovoEight držite podalje od izravne svjetlosti.
NovoEight is used to treat and prevent bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency) and can be used for all age groups.
NovoEight se koristi za liječenje i sprječavanje epizoda krvarenja u bolesnika s hemofilijom A (prirođeni nedostatak faktora VIII) i može se primjenjivati u svim dobnim skupinama.
During all clinical studies with NovoEight in previously treated patients, a total of 35 adverse reactions were reported in 23 of 242 patients exposed to NovoEight.
Tijekom svih kliničkih ispitivanja lijeka NovoEight u prethodno liječenih bolesnika prijavljeno je ukupno 35 nuspojava u 23 od 242 bolesnika izložena lijeku NovoEight.
Plastic cap
Plastični zatvarač
Mean residence time (h) a BMI groups: Underweight: BMI <18.5 kg/m2, Normal weight: BMI 18.5-24.9 kg/m2, Overweight: BMI 25-29.9 kg/m2, Obese class I: BMI 30-34.9 kg/m2, Obese class II/III: BMI ≥35 kg/m2.
Cmax (IU/dl) Srednja vrijednost vremena zadržavanja(h) a ITM skupina: Ispod normalne tjelesne težine: ITM <18,5 kg/m2, Normalna tjelesna težina: ITM 18,5-24,9 kg/m2, Prekomjerna tjelesna težina: ITM 25-29,9 kg/m2; Pretilost I. stupnja: ITM 30-34,9 kg/m2; Pretilost II./III. stupnja: ITM ≥35 kg/m2.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Liječenje i profilaksa krvarenja u bolesnika s hemofilijom A (prirođeni nedostatak faktora VIII).
Early signs of allergic reactions are rash, hives, weals, generalised itching,
Rani znakovi alergijskih reakcija su osip, koprivnjača, urtike,
Spike (under protective paper)
(ispod zaštitnog papira)
Data on Immune Tolerance Induction (ITI) has been collected in patients with haemophilia A who had developed inhibitors to factor VIII.
Immune Tolerance Induction, ITI) prikupljeni su u bolesnika s hemofilijom A koji su razvili inhibitore faktora VIII.
Frequencies have been evaluated according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često
Bring the vial and the pre-filled syringe to room temperature.
Bočica i napunjena štrcaljka trebaju postići sobnu temperaturu.
The solvent is a sodium chloride 9 mg/ml (0.9%) solution.
Otapalo je 0,9%-tna otopina natrijeva klorida (9 mg/ml).
- 1 glass vial (type I) with powder and chlorobutyl rubber stopper - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 ml solvent with backstop (polypropylene), a rubber plunger
- 1 staklenu bočicu (staklo tipa I) s praškom i čepom od klorbutilne gume - 1 sterilni nastavak za bočicu za rekonstituciju - 1 napunjenu štrcaljku s 4 ml otapala s graničnikom (polipropilen), gumenim klipom (brombutil)
The maximum exposure (Cmax) and the total exposure (AUC) increase with increasing BMI indicating that dose adjustments may be required for underweight (BMI <18.5 kg/m2) and obese patients (BMI ≥30 kg/m2), see section 4.2.
Rast maksimalne izloženosti (Cmax) i ukupne izloženosti (AUC) s porastom ITM ukazuje da mogu biti potrebne prilagodbe doza u bolesnika ispod normalne tjelesne težine (ITM <18,5 kg/m2) i u pretilih bolesnika (ITM ≥30 kg/m2), vidjeti dio 4.2.
The analysis of plasma samples was conducted using both the one-stage clotting assay and the chromogenic assay.
Analiza uzoraka plazme provedena je primjenom i jednostupanjskog testa koagulacije i kromogenog testa.
Sinus tachycardia, acute myocardial infarction
Srčani poremećaji manje često sinusna tahikardija, akutni infarkt miokarda
Do not stop using NovoEight without talking to your doctor.
Nemojte prestati primjenjivati NovoEight bez savjetovanja s liječnikom.
swelling of lips and tongue, difficulty in breathing, wheezing, tightness of the chest, general feeling of being unwell, and dizziness.
svrbež po cijelom tijelu, oticanje usana i jezika, otežano disanje, piskanje pri disanju, stezanje u prsima, opće loše stanje i omaglica.
If a larger dose is needed, repeat steps A to J with additional vials, vial adapters and pre-filled syringes.
Ako je potrebna veća doza, ponovite korake A do J s dodatnim bočicama, nastavcima za bočicu i napunjenim štrcaljkama.
• blood tests showing changes in the way the liver functions • reactions (redness and itching) around the site where you injected the medicine.
• reakcije (crvenilo i svrbež) oko mjesta u koje ste injicirali lijek.
It is recommended to use NovoEight immediately after reconstitution.
Preporučuje se NovoEight primijeniti odmah nakon rekonstitucije.
Table 1 Guide for dosing in bleeding episodes and surgery
Tablica 1 Vodič za doziranje kod epizoda krvarenja i kirurških zahvata Stupanj krvarenja/vrsta kirurškog zahvata
This is because if left, the medicine may no longer be sterile and could cause infections.
Naime, ako se ne primijeni odmah, lijek možda više neće biti sterilan pa bi mogao uzrokovati infekcije.
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with NovoEight.
Do razvoja neutralizirajućih protutijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući lijekom NovoEight.
Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
Obrišite gumeni čep sterilnim alkoholnim tupferom i pričekajte nekoliko sekundi da se osuši na zraku prije uporabe kako biste bili sigurni da je broj mikroorganizama sveden na najmanju moguću mjeru.
Minor surgery including tooth extraction
uključujući vađenje zuba
For storage at room temperature (≤30°C) or up to 40°C and storage conditions after reconstitution of the medicinal product, see section 6.3.
Za čuvanje na sobnoj temperaturi (≤30°C) ili do 40°C i uvjete čuvanja nakon rekonstitucije lijeka,
NovoEight 250 IU powder and solvent for solution for injection NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection
NovoEight 250 IU prašak i otapalo za otopinu za injekciju NovoEight 500 IU prašak i otapalo za otopinu za injekciju NovoEight 1000 IU prašak i otapalo za otopinu za injekciju NovoEight 1500 IU prašak i otapalo za otopinu za injekciju NovoEight 2000 IU prašak i otapalo za otopinu za injekciju NovoEight 3000 IU prašak i otapalo za otopinu za injekciju
The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Kompleks faktora VIII/von Willebrandova faktora sastoji se od dviju molekula (faktora VIII
Grasp the plunger rod by the wide top and immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Uhvatite potisni klip za široki gornji dio i odmah ga spojite sa štrcaljkom tako da ga navijete u smjeru kazaljke na satu u klip koji se nalazi unutar napunjene štrcaljke, sve dok ne osjetite otpor.
After reconstitution the solution appears as a clear or slightly opalescent solution.
Nakon rekonstitucije otopina mora biti bistra ili blago opalescentna.
See ‘Instructions on how to use NovoEight' for more information.
Za više informacija pogledajte dio „Upute za uporabu lijeka NovoEight“.
It must be clear to slightly opalescent
Mora biti bistra do blago opalescentna (blago zamućena).
Each pack of NovoEight 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU and 3000 IU powder and solvent for solution for injection contains:
Jedno pakiranje NovoEight 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU i 3000 IU praška i otapala za otopinu za injekciju sadrži:
The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Broj primijenjenih jedinica faktora VIII izražava se u internacionalnim jedinicama (IU), koje su u skladu s važećim standardom Svjetske zdravstvene organizacije (SZO) za lijekove koji sadrže faktor VIII.
How to store NovoEight
Kako primjenjivati NovoEight
• bleeding in muscle tissue
• krvarenje u mišićno tkivo
Store in refrigerator (2°C - 8°C).
Čuvati u hladnjaku (2°C-8°C).
Do not touch the syringe tip under the syringe cap.
Nemojte dodirnuti vrh štrcaljke ispod zatvarača štrcaljke.
The reconstituted NovoEight must be injected into your vein (intravenous injection).
Pripremljeni NovoEight mora biti injiciran u venu (intravenska injekcija).
• swelling of legs and feet
• oticanje nogu i stopala
Injecting NovoEight via needleless connectors for intravenous (IV) catheters
Injiciranje lijeka NovoEight putem konektora za primjenu bez igle za intravenske (i.v.) katetere:
When infused into a haemophilia patient, factor VIII binds to endogenous von Willebrand Factor in the patient's circulation.
Kada se lijek primjeni u bolesnika s hemofilijom, faktor VIII veže se za endogeni von Willebrandov faktor u bolesnikovu krvotoku.
Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Prestanite pritiskati potisni klip i pustite ga da se samostalno pomiče unatrag dok rekonstituirana otopina ne ispuni štrcaljku.
Do not use this medicine after the expiry date, which is stated after ‘EXP' on the carton and on the vial and the pre-filled syringe labels.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji te na naljepnicama na bočici i napunjenoj štrcaljki iza oznake „Rok valjanosti“.
Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid Solvent: Sodium chloride, water for injections
Prašak: natrijev klorid, L-histidin, saharoza, polisorbat 80, L-metionin, kalcijev klorid dihidrat, natrijev hidroksid, kloridna kiselina
Check the reconstituted solution.
Pregledajte pripremljenu otopinu.
• stiffness of muscles
• ukočenost mišića
Do not freeze reconstituted NovoEight solution or store it in syringes.
Pripremljenu otopinu lijeka NovoEight ne smijete zamrzavati niti čuvati u štrcaljkama.
What you need to know before you use NovoEight Do not use NovoEight:
Što morate znati prije nego počnete primjenjivati NovoEight
While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Dok držite bočicu okrenutu naopako, lagano lupnite štrcaljku kako bi se mjehurići zraka podigli na vrh.
Table 2 Frequency of adverse drug reactions in clinical trials
Tablica 2 Učestalost nuspojava na lijek u kliničkim ispitivanjima Klasifikacija organskih sustava
NovoEight is supplied as a powder.
NovoEight dolazi u obliku praška.
The following side effects may occur with this medicine.
Kod primjene ovog lijeka mogu se javiti sljedeće nuspojave.
Turn the syringe with the vial upside down.
Okrenite štrcaljku s bočicom naopako.
After injection, safely dispose of all unused NovoEight solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
Nakon injiciranja, oprezno bacite u otpad neiskorištenu otopinu lijeka NovoEight, štrcaljku s infuzijskim setom, bočicu s nastavkom za bočicu i drugi otpadni materijal, u skladu s uputama koje ste dobili od ljekarnika.
If you or your child´s bleeding is not being controlled with NovoEight, tell your doctor immediately.
Vašeg djeteta ne može kontrolirati pomoću lijeka NovoEight, odmah se obratite liječniku.
The powder in the vial appears as a white or slightly yellow powder.
U bočici je bijeli ili žućkasti prašak.
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Ti su inhibitori obično IgG imunoglobulini koji djeluju protiv prokoagulantne aktivnosti faktora VIII, a njihova količina određuje se u Bethesda jedinicama (BU) po ml plazme korištenjem modificiranog testa.
Of the 35 adverse reactions, 2 were reported in 1 out of 31 patients below 6 years of age, none in patients from 6 to ≤12 years of age, 1 event in 1 out of 24 patients (12 to <18 years of age) and 32 were reported in 21 out of 155 adults (≥18 years).
Od 35 nuspojava, 2 su prijavljene u 1 od 31 bolesnika mlađeg od 6 godina, nijedna nuspojava nije prijavljena u bolesnika u dobi od 6 do ≤ 12 godina, 1 nuspojava prijavljena je u 1 od 24 bolesnika
• above room temperature (30°C up to 40°C) for a single period no longer than 3 months.
• iznad sobne temperature (30°C do 40°C) tijekom jednokratnog razdoblja od najviše 3 mjeseca.
Instructions on how to use NovoEight
Upute za uporabu lijeka NovoEight
If you touch the sides or the thread, germs from your fingers can be transferred.
Ako dotaknete bočne stranice ili navoj, može doći do prijenosa mikroorganizama s Vaših prstiju.
Each pack of NovoEight contains a vial with white or slightly yellow powder, a 4 ml pre-filled syringe with a clear colourless solution, a plunger rod and a vial adapter.
Jedno pakiranje lijeka NovoEight sadrži bočicu s bijelim ili žućkastim praškom, napunjenu štrcaljku s 4 ml bistre i bezbojne otopine, potisni klip i nastavak za bočicu.
• blushing of the skin
• crvenilo kože
Please record the beginning of storage and the storage temperature on the product carton.
Na kutiji lijeka zabilježite datum početka čuvanja lijeka i temperaturu čuvanja.
NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
NovoEight 500 IU prašak i otapalo za otopinu za injekciju NovoEight 1000 IU prašak i otapalo za otopinu za injekciju NovoEight 1500 IU prašak i otapalo za otopinu za injekciju NovoEight 2000 IU prašak i otapalo za otopinu za injekciju NovoEight 3000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa (humani koagulacijski faktor VIII (rDNK))
Remove the syringe cap from the pre filled syringe by bending it down until the perforation breaks.
Uklonite zatvarač štrcaljke s napunjene štrcaljke savijajući ga prema dolje dok se perforirani dio ne odvoji.
Unopened vial 30 months when stored in a refrigerator (2°C - 8°C).
30 mjeseci kada se čuva u hladnjaku (2°C-8°C).
<6 years) PUP
Mlađa djeca (0 do <6 godina) PUP
NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII.
NovoEight sadrži djelatnu tvar turoktokog alfa, humani koagulacijski faktor VIII.
Overview Vial with NovoEight powder
Pregled Bočica s NovoEight praškom
Taken out of refrigerator: _____________Stored at ≤30°C __ Stored at 30°C up to 40°C __
Datum vađenja iz hladnjaka: ____________Čuvano na ≤30°C __ Čuvano na 30°C do 40°C __ Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
Do not store the solution without your doctor's advice.
Ne čuvajte otopinu bez savjetovanja s liječnikom.
Remove the protective paper from the vial adapter.
Uklonite zaštitni papir s nastavka za bočicu.
NovoEight is now ready to be injected into your vein.
NovoEight je sada spreman za injiciranje u venu.
NovoEight contains turoctocog alfa, a human coagulation factor VIII (rDNA), with a truncated Bdomain.
NovoEight sadrži turoktokog alfa, humani koagulacijski faktor VIII (rDNK), sa skraćenom B-domenom.
If you notice visible particles or discolouration, do not use it. Use a new package instead.
Ako primijetite vidljive čestice ili promjenu boje, nemojte koristiti otopinu.
• pain in muscles
• bol u mišićima
Calcium chloride dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
L-histidin saharoza polisorbat 80 L-metionin kalcijev klorid dihidrat natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
• room temperature (≤ 30°C) for a single period no longer than 9 months or
• na sobnoj temperaturi (≤30°C) tijekom jednokratnog razdoblja od najviše 9 mjeseci ili
Talk to your doctor before using NovoEight.
Upozorenja i mjere opreza Obratite se svom liječniku prije nego primijenite NovoEight.
Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Pritisnite potisni klip do kraja i nježno vrtite bočicu dok se sav prašak ne otopi.
Take the vial, the vial adapter and the pre-filled syringe out of the carton.
Izvadite bočicu, nastavak za bočicu i napunjenu štrcaljku iz kutije.
1 pre-filled syringe with solvent 1 plunger rod (placed under the syringe)
• 1 potisni klip (smješten je ispod štrcaljke)
READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT.
PRIJE PRIMJENE LIJEKA NOVOEIGHT PAŽLJIVO PROČITAJTE OVE UPUTE.
• 4 hours stored up to 40°C, for product which has been kept for a single period no longer than 3 months at above room temperature (30°C up to 40°C).
• 4 sata ako se čuva na temperaturi do 40°C, za lijek koji je tijekom jednokratnog razdoblja od najviše 3 mjeseca čuvan iznad sobne temperature (30°C do 40°C).
Obese class II/III N=7
II./III.stupnja N=7
Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Držite napunjenu štrcaljku lagano nagnutu s bočicom prema dolje.
Pre-filled syringe with solvent
Napunjena štrcaljka s otapalom
Allergic type hypersensitivity reactions are possible with NovoEight.
Kod primjene lijeka NovoEight moguća je pojava reakcija preosjetljivosti alergijskog tipa.
• 4 hours stored at ≤ 30°C, for product which has been kept for a single period no longer than 9 months at room temperature (≤30°C)
• 4 sata ako se čuva na temperaturi od 30°C, za lijek koji je tijekom jednokratnog razdoblja od najviše 9 mjeseci čuvan na sobnoj temperaturi (≤30°C)
4 hours when stored at room temperature or up to 40°C and within 24 hours when stored at 2°C8°C.
Ako ne možete odmah primijeniti pripremljenu otopinu lijeka NovoEight, morate je upotrijebiti unutar 4 sata ako je čuvate na sobnoj temperaturi ili do 40°C, odnosno unutar 24 sata ako je čuvate na temperaturi od 2°C-8°C.
If the plastic cap is loose or missing, do not use the vial.
Ako plastični zatvarač nije dobro pričvršćen ili nedostaje, nemojte koristiti bočicu.
- The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine,
- Drugi sastojci su L-histidin, saharoza, polisorbat 80, natrijev klorid, L-metionin, kalcijev klorid dihidrat, natrijev hidroksid i kloridna kiselina.
Number of patients Dose used for prevention per patient (IU/kg BW) Mean (SD) Min ; Max Dose used for treatment of bleed (IU/kg BW)
Min; Maks Doza primijenjena za liječenje krvarenja (IU/kg TT)
Incremental recovery (IU/dl)/(IU/kg)
Prirast po jedinici doze (IU/dl)/(IU/kg)
White or slightly yellow powder or friable mass. Clear and colourless solution for injection.
Bijeli do žućkasti prašak ili drobljiva masa.
• feeling tired
• osjećaj omaglice
Reconstitute the powder with the solvent
Pripremite prašak s otapalom
NovoEight is recommended to be used immediately after it has been reconstituted.
NovoEight treba primijeniti odmah nakon što ste ga pripremili za primjenu.
Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Lagano povucite potisni klip prema dolje kako biste uvukli rekonstituiranu otopinu u štrcaljku.
Musculoskeletal stiffness, arthropathy, pain in extremity, musculoskeletal pain
artropatija, bol u ekstremitetima, bol u mišićima i kostima često hemartroza, krvarenje u mišićima
Do not shake the vial as this will cause foaming.
Ne tresite bočicu jer će to izazvati pjenjenje.
The expiry date is printed after ‘EXP' on the outer carton, on the vial, on the vial adapter, and on the pre-filled syringe.
Rok valjanosti otisnut je iza „Rok valjanosti“ na kutiji, bočici, nastavku za bočicu i napunjenoj štrcaljki.
Uncommon side effects (may affect up to 1 in 100 people)
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) • osjećaj umora
Turn over the protective cap, and snap the vial adapter onto the vial.
Preokrenite zaštitni omot i pričvrstite nastavak za bočicu na bočicu.
Push the plunger rod to inject all the solvent into the vial.
Pritisnite potisni klip kako biste cjelokupno otapalo ubrizgali u bočicu.
Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 ml solvent in pre-filled syringe, plunger rod and vial adapter
Pakiranje sadrži: 1 bočicu s praškom, 4 ml otapala u napunjenoj štrcaljki, potisni klip i nastavak za bočicu.
Haemorrhage
Šiljak
Keep the plunger rod pushed completely in.
Držite potisni klip pritisnutim do kraja.
NovoEight is a powder and solvent for solution for injection.
NovoEight je prašak i otapalo za otopinu za injekciju.
- The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)).
Što NovoEight sadrži - Djelatna tvar je turoktokog alfa (humani koagulacijski faktor VIII (rDNK)).
NovoEight is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom NovoEight se primjenjuje intravenski nakon rekonstitucije praška s otapalom koje dolazi u štrcaljki.
Life threatening haemorrhages
Krvarenja opasna po život
Do not use the equipment if it is expired.
Nemojte koristiti pribor ako mu je istekao rok valjanosti.
Adolescents <18 years) PTP
(12 do <18 godina) PTP
Administration of the reconstituted solution
Primjena rekonstituirane otopine
NovoEight in previously treated patients with severe haemophilia A (FVIII ≤1%).
Sva farmakokinetička (PK) ispitivanja s lijekom NovoEight provedena su nakon i.v. primjene 50 IU/kg lijeka NovoEight u prethodno liječenih bolesnika s teškom hemofilijom A (FVIII ≤1%).
Underweight N=5
N=5
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica
Contusion
Pretilost
NovoEight 2000 IU powder and solvent for solution for injection.
NovoEight 2000 IU prašak i otapalo za otopinu za injekciju
The reconstituted solution will be clear to slightly opalescent.
Otopina pripremljena za primjenu mora biti bistra do blago opalescentna.
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja često kašalj
Major surgery
Veći kirurški zahvat
BioReliance Ltd
Ltd
NovoEight 250 IU powder and solvent for solution for injection
NovoEight 250 IU prašak i otapalo za otopinu za injekciju
Table 5 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - chromogenic assay - Mean (SD)
Tablica 5 Farmakokinetički parametri jednokratne doze lijeka NovoEight (50 IU/kg) po dobikromogeni test - srednja vrijednost (SD)
1 vial with NovoEight powder 1 vial adapter
• 1 bočicu s NovoEight praškom
NovoEight 1500 IU powder and solvent for solution for injection.
NovoEight 1500 IU prašak i otapalo za otopinu za injekciju
Early haemarthrosis, muscle bleeding or oral bleeding
Rana hemartroza, krvarenje u mišiću ili krvarenje u usnoj šupljini
NovoEight 3000 IU powder and solvent for solution for injection.
NovoEight 3000 IU prašak i otapalo za otopinu za injekciju
NovoEight 1000 IU powder and solvent for solution for injection.
NovoEight 1000 IU prašak i otapalo za otopinu za injekciju
• bruising
• osip
• rash, hives, weals or generalised itching
• osip, koprivnjača, urtike ili svrbež po cijelom tijelu