natgillin/translations-raw huggingface dataset:
The indication for NeoRecormon treatment of nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
NeoRecormon treba donijeti za svakog bolesnika pojedinačno, budući da se kod tih bolesnika ne može sa sigurnošću isključiti moguće ubrzanje progresije bubrežnog zatajenja.
Your healthcare provider will show you how to prepare and inject NeoRecormon properly before you use it for the first time.
Prije prve uporabe NeoRecormon štrcaljke zdravstveni radnik će Vam pokazati kako pravilno pripremiti i injicirati lijek NeoRecormon.
Adverse reactions are listed in Table 1 below.
Nuspojave su navedene u Tablici 1 dalje u tekstu.
If you have missed an injection, or injected too little, talk to your doctor.
Ako ste zaboravili primijeniti NeoRecormon Ako ste propustili injekciju ili ubrizgali premalu dozu, obratite se svom liječniku.
Serious skin reaction including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Prijavljene su ozbiljne kožne reakcije, uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom.
Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.
Jedna štrcaljka se ni u kom slučaju ne smije koristiti za davanje više od jedne doze lijeka.
12 Hold the syringe and needle tightly at the hub and carefully pull the injection needle cap away from the syringe.
Čvrsto držite štrcaljku i iglu na mjestu gdje se spajaju (baza igle) i pažljivo povucite zatvarač igle sa štrcaljke.
This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i.e. essentially “sodium-free”.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po štrcaljki, tj.zanemarive količine natrija.
Lyophilisate
Nuspojava
How to store NeoRecormon
Kako čuvati NeoRecormon
13 Hold the syringe with the needle pointing up.
13. Štrcaljku držite s iglom usmjerenom prema gore.
In the case of subcutaneous administration, the weekly dose can be given as one injection per week or in divided doses three or seven times per week.
Kod supkutane primjene, tjedna se doza može dati kao jedna injekcija tjedno ili u podijeljenim dozama tri ili sedam puta tjedno.
L-Glutamic acid,
L- glutamatna kiselina, L-fenilalanin,
NeoRecormon can be administered through 2 manners, your doctor will decide which way is right for you: · Intravenous administration (into the vein or vein port), only to be performed by healthcare professionals.
NeoRecormon se može primijeniti na 2 načina, a Vaš će liječnik odlučiti koji je način primjene najbolji za Vas:
The initial dose is 250 IU per injection for every 1 kg the infant weighs, three times a week.
Početna doza iznosi 250 IU/kg tjelesne mase djeteta po injekciji, primijenjeno tri puta tjedno.
Do not use the syringe if you have dropped the syringe or if any part of the syringe appears to be damaged.
Nemojte upotrijebiti štrcaljku ako Vam je pala ili ako bilo koji njezin dio izgleda oštećeno.
NeoRecormon 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10,000 IU and 20,000IU 1 prefilled syringe with one needle (27G1/2) or 6 pre-filled syringes with 6 needles (27G1/2).
NeoRecormon 2000 IU, 3000 IU, 4000 IU,5000 IU, 6000 IU, 10 000 IU i 20 000 IU 1 napunjena štrcaljka s jednom iglom (27G1/2) ili
Consult your healthcare provider if you require further information.
Ako Vam trebaju dodatne informacije, obratite se svom zdravstvenom radniku.
Remove the cap from the syringe.
Uklonite zatvarač sa štrcaljke.
1 prefilled syringe with one needle (30G1/2) or 6 pre-filled syringes with 6 needles (30G1/2).
1 napunjena štrcaljka i jedna igla (30G1/2) ili 6 napunjenih štrcaljki i 6 igala (30G1/2).
· Do not touch the plunger while inserting the needle into the skin · Do not insert the needle through clothing.
Nemojte dodirivati klip dok ubadate iglu u kožu.
- In the solvent: benzyl alcohol and benzalkonium chloride as preservatives and water for injections.
U otapalu: konzervansi benzilni alkohol i benzalkonijev klorid i voda za injekcije.
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.8).
Prijavljene su teške kožne nuspojave (SCAR), uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom, koje mogu biti opasne po život ili smrtonosne (vidjeti dio 4.8).
If you have high or rising potassium levels your doctor may reconsider your treatment · your blood platelet count.
Poveća li Vam se razina kalija, liječnik bi mogao ponovno razmotriti Vaše liječenje.
One ml solution for injection contains 16,667 IU epoetin beta.
Jedan mililitar otopine za injekciju sadrži 16 667 IU epoetina beta.
Occlusion of the dialysis system is possible if heparinisation is not optimum.
Neodgovarajuća heparinizacija može dovesti do začepljenja dijaliznog sistema.
In chronic renal failure patients there may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with NeoRecormon, especially after intravenous administration.
Kod bolesnika s kroničnim zatajenjem bubrega tijekom liječenja lijekom NeoRecormon može doći do umjerenog, o dozi ovisnog porasta broja trombocita unutar normalnih granica, poglavito nakon intravenske primjene, koje se povlači u nastavku liječenja.
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.4)
Prijavljene su teške kožne nuspojave (SCAR), uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom, koje mogu biti opasne po život ili smrtonosne (vidjeti dio 4.4.).
NeoRecormon dosing
NeoRecormon.
Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in patients in an autologous blood predonation programme System organ class
Često Tablica 3: Nuspojave pripisane liječenju lijekom NeoRecormon u kontroliranim kliničkim ispitivanjima u bolesnika u programu predonacije autologne krvi
NeoRecormon Multidose is supplied as a lyophilisate for solution for injection in vials.
NeoRecormon Multidose dolazi u obliku liofilizata za otopinu za injekciju u bočicama.
Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in cancer patients System organ class
Tablica 2: Nuspojave pripisane liječenju lijekom NeoRecormon u kontroliranim kliničkim ispitivanjima u bolesnika s rakom
The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve: The required amount of pre-donated blood depends on the anticipated blood loss, use of blood conserving procedures and the physical condition of the patient.
Dozu treba odrediti kirurški tim pojedinačno za svakog bolesnika, ovisno o potrebnoj količini predonirane krvi i endogenoj rezervi eritrocita pojedinog bolesnika:
· 1 dry sterile pad.
● 1 suha sterilna gaza
The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
Tjedna se doza može dati kao jedna injekcija tjedno ili u podijeljenim dozama 3 do7 puta tjedno.
Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in CKD patients System organ class
Tablica 1: Nuspojave pripisane liječenju lijekom NeoRecormon u kontroliranim kliničkim ispitivanjima u bolesnika s kroničnim zatajenjem bubrega Organski sustav
NeoRecormon 5000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 5000 international units (IU) corresponding to 41.5 micrograms epoetin beta* (recombinant human erythropoietin).
NeoRecormon 5000 IU otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 5000 internacionalnih jedinica (IU) što odgovara 41,5 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
The ability to donate blood depends predominantly on the patient's blood volume and baseline PCV.
Sposobnost bolesnika za davanje krvi, u prvom redu, ovisi o njegovom volumenu krvi te početnoj vrijednosti hematokrita.
· Very rarely (may affect up to 1 in 10,000 people), patient experienced flu-like symptoms, especially when they just started treatment.
Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba) se u bolesnika javljaju simptomi nalik gripi, posebno na samom početku liječenja.
One ml solution for injection contains 6667 IU epoetin beta.
Jedan mililitar otopine za injekciju sadrži 6667 IU epoetina beta.
Preparing for injection
Primjena intravenske injekcije
Traceability of NeoRecormon
Sljedivost lijeka NeoRecormon
Throw away the needle cap in a sharps container immediately.
Zatvarač igle odmah odložite u spremnik za oštre predmete.
One ml solution for injection contains 1667 IU epoetin beta.
Jedan mililitar otopine za injekciju sadrži 1667 IU epoetina beta.
- Intravenous administration: The initial dosage is 3 x 40 IU/kg per week.
- Intravenska primjena: Početna doza iznosi 3 x 40 IU/kg tjel. mase tjedno.
haemoglobin concentration ≤ 10g/dl (6.2 mmol/l).
14 g/dl (8,7 mmol/l),
· Treating anaemia with related symptoms in adult cancer patients receiving chemotherapy · Treating people donating their own blood before surgery.
Liječenje bolesnika koji doniraju vlastitu krv prije operacije.
One ml solution for injection contains 50,000 IU epoetin beta.
Jedan mililitar otopine za injekciju sadrži 50 000 IU epoetina beta.
NeoRecormon 30,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 30,000 international units (IU) corresponding to 250 micrograms epoetin beta* (recombinant human erythropoietin).
NeoRecormon 30 000 IU otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 30 000 internacionalnih jedinica (IU) što odgovara 250 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
Hypertension Hypertensive crisis
Poremećaji krvožilnog sustava Hipertenzija
Phenylalanine (up to 0.3 mg/syringe)
fenilalanin (do 0,3 mg/štrcaljki) natrij (manje od 1 mmol/štrcaljki)
Additional side effects in adults receiving chemotherapy for cancer · Increase in blood pressure and headache may occasionally occur.
Povremeno se mogu pojaviti povišeni krvni tlak i glavobolja.
In isolated cases, neutralising anti erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with NeoRecormon therapy has been reported.
U izoliranim je slučajevima uz terapiju lijekom NeoRecormon zabilježena izolirana aplazija crvene krvne loze (PRCA) uzrokovana neutralizirajućim antieritropoetinskim antitijelima.
In preterm infants a potential risk of erythropoietin to cause retinopathy could not be excluded, therefore caution should be exercised and the decision to treat a preterm infant should be balanced against the potential benefit and risk of this treatment and available alternative options.
Odluku o liječenju nedonoščeta treba donijeti uzimajući u obzir moguću korist naspram rizika takvog liječenja te dostupnost zamjenskog liječenja.
One ml solution for injection contains 20,000 IU epoetin beta.
Jedan mililitar otopine za injekciju sadrži 20 000 IU epoetina beta.
NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection Epoetin beta
NeoRecormon Multidose 50 000 IU liofilizat i otapalo za otopinu za injekciju epoetin beta
One ml solution for injection contains 10,000 IU epoetin beta.
Jedan mililitar otopine za injekciju sadrži 10 000 IU epoetina beta.
INFORMATION IN BRAILLE neorecormon 2000 IU
neorecormon 2000 IU
INFORMATION IN BRAILLE neorecormon 20.000 IU
neorecormon 20 000 IU
The reconstituted product is a colourless, clear to slightly opalescent solution.
Pripremljeni lijek je bezbojna, bistra do blago opalescentna otopina.
NeoRecormon Multidose contains up to 5.0 mg phenylalanine/vial as an excipient.
Pomoćne tvari NeoRecormon Multidose sadrži kao pomoćnu tvar do 5,0 g fenilalanina po bočici, što treba uzeti u obzir u bolesnika s teškim oblicima fenilketonurije.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
U bolesnika s kroničnim zatajenjem bubrega kod kojih postoji rizik od tromboze šanta treba razmotriti ranu reviziju šanta i profilaksu tromboze, primjerice primjenom acetilsalicilatne kiseline.
After the injection
Primjena potkožne injekcije
Be sure that you read, understand and follow the Instructions for Use as well as the package leaflet before injecting NeoRecormon.
Prije injiciranja lijeka NeoRecormon važno je da pročitate, razumijete i slijedite ove upute za uporabu kao i uputu o lijeku.
For the purpose of ambulatory use, the patient may remove the unreconstituted product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 5 days.
Ukoliko je potrebno, bolesnik može izvaditi neotopljeni prašak iz hladnjaka i čuvati ga na sobnoj temperaturi (ne višoj od 25°C) ali samo jednom i ne dulje od 5 dana.
NeoRecormon contains phenylalanine and sodium This medicine contains phenylalanine.
NeoRecormon sadrži fenilalanin i natrij
Solvent: 10 ml ampoule (type I glass).
Liofilizat: bočica (staklo tip I) s čepom (guma obložena teflonom) Otapalo: i otapala ampula od10 ml (staklo tip I)
5 Place the syringe on a clean, flat surface.
Položite štrcaljku na čistu i ravnu površinu.
One pre-filled syringe contains either 500, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or 0.6 ml solution.
10 000, 20 000 ili 30 000 IU (internacionalnih jedinica) epoetina beta u 0,3 ml ili 0,6 ml otopine.
· Do not flip the carton upside down to remove the syringe.
Nemojte prevrtati kutiju da biste izvadili štrcaljku.
In clinical trials, an increased risk of death and serious cardiovascular events or cerebrovascular events including stroke was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
U bolesnika s kroničnim zatajenjem bubrega koncentracija hemoglobina tijekom održavanja ne smije premašiti gornju granicu ciljne koncentracije hemoglobina preporučene u dijelu 4.2. U kliničkim ispitivanjima primijećen je povećan rizik od smrti i ozbiljnih kardiovaskularnih događaja ili cerebrovaskularnih događaja uključujući moždani udar, kada su primjenjivani lijekovi za stimulaciju eritropoeze, radi postizanja ciljnog hemoglobina višeg od 12 g/dl (7,5 mmol/l).
· The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C).
● Štrcaljku možete izvaditi iz hladnjaka i ostaviti je na sobnoj temperaturi (ne višoj od 25°C), ali samo jednom i ne dulje od 3 dana.
· Do not recap the injection needle with the cap. · Do not throw away (dispose of) the syringe in your household trash.
Nemojte odložiti štrcaljku u kućni otpad.
Sodium chloride,
kalcijev klorid, glicin,
One vial contains 50,000 international units (IU) corresponding to 415 micrograms epoetin beta* (recombinant human erythropoietin).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 50 000 internacionalnih jedinica (IU) što odgovara 415 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
Administering the intravenous injection Preparing for injection: follow steps 1 to 8
Priprema za injiciranje: slijedite korake 1 - 8.
For the purpose of ambulatory use, the patient may remove the medicinal product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Ukoliko je potrebno, bolesnik može izvaditi lijek iz hladnjaka i čuvati ga na sobnoj temperaturi (ne višoj od 25°C) ali samo jednom i ne dulje od 3 dana.
NeoRecormon 500 IU solution for injection in pre-filled syringe.
NeoRecormon 500 IU otopina za injekciju u napunjenoj štrcaljki
· The vial can be removed from the refrigerator and left at room temperature for a single period of maximum 5 days (but not above 25°C).
● Bočicu možete izvaditi iz hladnjaka i ostaviti je na sobnoj temperaturi (ne višoj od 25°C) , ali samo jednom i ne dulje od 5 dana.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku Za primjenu potkožno i u venu.
ESAs are not indicated for use in this patient population.
Lijekovi za stimulaciju eritropoeze nisu indicirani za primjenu u toj skupini bolesnika.
Administering the subcutaneous injection 11 Move the safety shield away from the needle in direction to the syringe barrel.
11. Maknite zaštitni pokrov s igle pomičući ga prema tijelu štrcaljke.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
ispitivanja i 13933 bolesnika) dok je za bolesnike s rakom na kemoterapiji omjer rizika ukupnog preživljenja iznosio 1.04 (95% CI: 0,97; 1,11; 38 ispitivanja i 10441 bolesnika).
1 ampoule contains solvent (benzyl alcohol and benzalkonium chloride in water for injections).
1 ampula sadrži otapalo (benzilni alkohol i benzalkonijev klorid u vodi za injekcije) Lijek sadrži fenilalanin i natrij, a otapalo benzilni alkohol.
Treatment with NeoRecormon is divided into two stages:
Liječenje lijekom NeoRecormon podijeljeno je na dva stadija: a) Korekcija anemije
L-Isoleucine,
L-izoleucin, L-treonin,
INFORMATION IN BRAILLE neorecormon 10.000 IU
neorecormon 10 000 IU
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 500 IU pre-filled syringe
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 500 IU napunjenu štrcaljku
Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients.
Kod bolesnika s rakom treba redovito kontrolirati broj trombocita i razinu hemoglobina.
Name and address of the manufacturer(s) responsible for batch release
Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet Roche Pharma AG
1 pre-filled syringe (0.3 ml) and 1 needle (30G1/2)
1 napunjena štrcaljka (0,3 ml) i 1 igla (30G1/2)
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 20,000 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 20 000 IU epoetina beta.
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 500 IU napunjenu štrcaljku
What you need to know before you use NeoRecormon
Što morate znati prije nego počnete primjenjivati NeoRecormon Kako primjenjivati NeoRecormon Moguće nuspojave
If signs and symptoms suggestive of these reactions appear, NeoRecormon should be withdrawn immediately and an alternative treatement considered.If the patient has developed a severe cutaneous skin reaction such as SJS orTEN due to the use of NeoRecormon, treatment with ESA must not be restarted in this patient at any time.
U slučaju pojavljivanja znakova i simptoma koji upućuju na te reakcije, potrebno je odmah prekinuti primjenu lijeka NeoRecormon i razmisliti o zamjenskom liječenju.
Table 1:
PRILOG I.
In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4).
Pored toga, u izoliranim slučajevima zapažen je prolazni porast koncentracija kalija i fosfata u serumu (vidjeti dio
6 Attach the needle to the syringe.
Pričvrstite iglu na štrcaljku.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 20,000 IU pre-filled syringe
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 20 000 IU napunjenu štrcaljku
Patients in an autologous blood predonation programme Patients in an autologous blood predonation programme have been reported to show a slightly higher frequency of thromboembolic events.
U bolesnika u programu predonacije autologne krvi prijavljena je nešto veća učestalost tromboembolijskih događaja, međutim nije bilo moguće ustanoviti uzročnu povezanost s terapijom lijekom NeoRecormon.
9 Clean the skin above the injection port with an alcohol swab and let dry.
Kožu iznad katetera očistite tupferom natopljenim alkoholom i pustite da se sama osuši.
This may be given as one injection per week, or in divided doses as 3 to 7 injections per week.
Doza se može dati kao jedna injekcija tjedno ili rasporediti na 3 do 7 injekcija tijekom tjedna.
6 pre-filled syringes (0.3 ml) and 6 needles (30G1/2)
6 napunjenih štrcaljki (0,3 ml) i 6 igala (30G1/2)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 2000 IU pre-filled syringe
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 2000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 6000 IU pre-filled syringe
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 6000 IU napunjenu štrcaljku
Do not increase the dose your doctor has given you.
Ako injektirate preveliku dozu lijeka NeoRecormon Nemojte povećavati dozu koju Vam je propisao liječnik.
MARKETING AUTHORISATION NUMBER EU/1/97/031/019
EU/1/97/031/019
Thromboembolic event
Poremećaji krvi i limfnog sustava Tromboembolijski događaj
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 5000 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 5000 IU epoetina beta.
INFORMATION IN BRAILLE neorecormon 50,000 IU
neorecormon 50 000 IU
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 6000 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 6000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 20,000 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 20 000 IU napunjenu štrcaljku
INFORMATION IN BRAILLE neorecormon 30.000 IU
neorecormon 30 000 IU
INFORMATION IN BRAILLE neorecormon 5000 IU
neorecormon 5000 IU
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 4000 IU pre-filled syringe
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 4000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 50.000 IUVIAL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICE ZA 50 000 IU BOČICU
INFORMATION IN BRAILLE neorecormon 6000 IU
neorecormon 6000 IU
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 6000 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 6000 IU epoetina beta.
Female patients
Žene
- Subcutaneous administration: - The initial dosage is 3 x 20 IU/kg body weight per week.
- Supkutana primjena: Početna doza iznosi 3 x 20 IU/kg tjel. mase tjedno.
He or she may raise or lower your dose, or interrupt your treatment according to the test results.
Obzirom na rezultate krvnih pretraga, liječnik Vam može povećati ili smanjiti dozu ili prekinuti liječenje lijekom NeoRecormon.
NAME OF THE MEDICINAL PRODUCT NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection
NeoRecormon Multidose 50 000 IU liofilizat i otapalo za otopinu za injekciju
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 30,000 IU pre-filled syringe
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 30 000 IU napunjenu štrcaljku
· Keep the vials in the outer carton in order to protect from light.
● Bočice čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
One ml of reconstituted solution contains 5000 IU epoetin beta.
Jedan mililitar pripremljene otopine sadrži 5000 IU epoetina beta.