natgillin/translations-raw huggingface dataset:
• If you do not respond adequately to Abseamed, your doctor will check your dose and will inform you if you need to change doses of Abseamed.
• Ako ne budete odgovarali na liječenje Abseamedom na odgovarajući način, Vaš će liječnik provjeriti Vašu dozu i obavijestiti Vas ako trebate promijeniti doze Abseameda.
Later, your doctor may suggest that you or your caregiver learn how to inject Abseamed under the skin
Kasnije Vaš liječnik može predložiti da Vi ili Vaš njegovatelj naučite kako sami davati Abseamed pod kožu
• Abseamed is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
• Abseamed se daje injekcijom u venu, odmah nakon što ste donirali krv tijekom 3 tjedna prije operacije.
You may still be able to use Abseamed, but discuss it with your doctor first:
Možda ćete i dalje moći primati Abseamed, ali prvo razgovarajte o tome sa svojim liječnikom:
Treatment with Abseamed has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Liječenje Abseamedom mora se započeti pod nadzorom liječnika s iskustvom u liječenju bolesnika s gore navedenim indikacijama.
If you are a cancer patient be aware that products that stimulate red blood cell production (like Abseamed) may act as a growth factor and therefore in theory may affect the progression of your cancer.
Ako ste bolesnik koji ima rak morate znati da lijekovi koji potiču stvaranje crvenih krvnih stanica (kao Abseamed) mogu djelovati kao čimbenici rasta i tako teoretski mogu utjecati na daljnje napredovanje raka.
Abseamed can reduce the need for a blood transfusion.
Abseamed može smanjiti potrebu za transfuzijom krvi.
• Your doctor may initiate treatment with Abseamed if your haemoglobin is 10 g/dL or less.
• Liječnik može započeti liječenje Abseamedom ako Vam je vrijednost hemoglobina 10 g/dl ili manje.
In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Abseamed subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
U situacijama u kojima liječnik ustanovi da bolesnik ili osoba koja se brine o bolesniku može sigurno i učinkovito primijeniti Abseamed supkutano, potrebno je dati upute o ispravnom doziranju i primjeni.
Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, D-58638 Iserlohn, Germany
Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Njemačka
• The usual starting dose of Abseamed for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
• Uobičajena početna doza Abseameda za odrasle i djecu je 50 međunarodnih jedinica (IU) po kilogramu (/kg) tjelesne težine i daje se tri puta tjedno.
If you visit a hospital, clinic or family doctor, tell them you are having Abseamed treatment.
Ako morate ići u bolnicu, na kliniku ili obiteljskom liječniku, recite im da se liječite Abseamedom.
Inject the Abseamed solution as you have been shown by your doctor.
Ubrizgajte otopinu Abseamed kako Vam je pokazao liječnik.
Abseamed can reduce the need for a blood transfusion in these patients.
Abseamed može smanjiti potrebu za transfuzijom krvi u tih bolesnika.
Abseamed is indicated in adults in a predonation programme to increase the yield of autologous blood.
Abseamed je indiciran u odraslih u predonacijskom programu za povećanje količine autologne krvi.
• Abseamed is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
• Abseamed se daje injekcijom pod kožu svaki tjedan tijekom tri tjedna prije kirurškog zahvata i na sam dan kirurškog zahvata.
Abseamed should be administered as a subcutaneous injection.
Abseamed treba primijeniti kao supkutanu injekciju.
• Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Abseamed treatment.
• Liječnik će zatražiti krvne pretrage i možda prilagoditi dozu, ovisno o odgovoru Vaše anemije na liječenje Abseamedom.
• if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Abseamed).
• ako Vam je dijagnosticirana izolirana aplazija crvene krvne loze (koštana srž ne može proizvesti dovoljno crvenih krvnih stanica) nakon prethodnog liječenja bilo kojim lijekom koji potiče stvaranje crvenih krvnih stanica (uključujući Abseamed).
You may still be able to use Abseamed, but discuss it with your doctor first.
Možda ćete i dalje moći primati Abseamed, ali prvo razgovarajte o tome s Vašim liječnikom.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Drugi lijekovi i Abseamed Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
If you forget to use Abseamed
Ako ste zaboravili primijeniti Abseamed
If you are a cancer patient, be aware that use of Abseamed may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
Ako ste bolesnik koji ima rak, morate znati da primjena Abseameda može biti povezana s kraćim preživljenjem i višom stopom smrti u bolesnika s rakom glave i vrata i metastatskim rakom dojke koji primaju kemoterapiju.
Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Abseamed.
Odmah obavijestite liječnika ili medicinsku sestru ako primijetite bilo koju od ovih nuspojava ili ako primijetite bilo kakve druge učinke dok primate Abseamed.
What Abseamed contains
Što Abseamed sadrži
If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), your doctor may order blood tests to check the level of cyclosporin while you are taking Abseamed.
Ako uzimate lijek koji se zove ciklosporin (uzima se npr., nakon presađivanja bubrega), liječnik će raditi krvne pretrage kako bi provjerio razinu ciklosporina dok primate Abseamed.
If you are given a product in this group other than Abseamed during your treatment, speak to your doctor or pharmacist before using it.
Ako za vrijeme liječenja dobijete neki drugi lijek iz ove skupine koji nije Abseamed, razgovarajte o tome sa svojim liječnikom ili ljekarnikom prije nego što ga uzmete.
- Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Abseamed or any other erythropoietin (see section 4.4).
- Bolesnici koji razviju izoliranu aplaziju crvene loze (engl. pure red cell aplasia, PRCA) nakon liječenja bilo kojim eritropoetinom ne smiju primiti Abseamed ili bilo koji drugi eritropoetin (vidjeti dio 4.4).
Abseamed and other products that stimulate red cell production may increase the risk of developing blood clots in all patients.
Abseamed i drugi lijekovi koji potiču stvaranje crvenih krvnih stanica mogu povećati rizik od nastajanja krvnih ugrušaka u svih bolesnika.
Do not administer Abseamed by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Nemojte primjenjivati Abseamed intravenskom infuzijom ili zajedno s otopinom drugog lijeka (vidjeti dio 6.6 za dodatne informacije).
• You may be given iron supplements before and during Abseamed treatment to make it more effective.
• Možda ćete prije i tijekom terapije Abseamedom dobivati dodatke sa željezom kako bi liječenje bilo djelotvornije.
If you can't take medicines that prevent blood clotting, you must not have Abseamed.
Ako ne smijete uzimati lijekove za sprječavanje zgrušavanja krvi, ne smijete primati Abseamed.
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
• Always use Abseamed exactly as instructed by your doctor or nurse.
• Uvijek primijenite Abseamed točno onako kako su Vam rekli liječnik ili medicinska sestra.
Abseamed is used in moderately anaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation.
Abseamed se primjenjuje u odraslih s umjerenom anemijom koji daju krv prije odlaska na operaciju, kako bi im se ta krv mogla vratiti tijekom ili nakon operacije.
• You may take Abseamed out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
• Možete izvaditi Abseamed iz hladnjaka i čuvati ga na sobnoj temperaturi (do 25 °C) najviše
Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Abseamed 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Blago anemične bolesnike (hematokrit od 33 do 39%) koji moraju pohraniti ≥ 4 jedinice krvi treba liječiti s 600 IU/kg Abseameda intravenski 2 puta tjedno tijekom 3 tjedna prije operacije.
Do not shake Abseamed syringes.
Nemojte tresti štrcaljke Abseamed.
- All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Abseamed.
- Sve kontraindikacije vezane uz programe autologne predonacije krvi moraju se poštovati u bolesnika koji primaju Abseamed.
The recommended starting dose is Abseamed 450 IU/kg (maximum total dose is 40,000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Preporučena početna doza je Abseamed 450 IU/kg (maksimalna ukupna doza je 40 000 IU) primijenjena supkutano jednom svakog tjedna, s ne manje od 5 dana između doza.
The use of Abseamed in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Primjena Abseameda u bolesnika u kojih se planira veliki elektivni ortopedski kirurški zahvat i koji ne sudjeluju u programu autologne predonacije krvi je kontraindicirana ako imaju tešku bolest koronarnih arterija, perifernih arterija, karotida ili cerebralnu vaskularnu bolest, uključujući bolesnike s nedavnim infarktom miokarda ili cerebrovaskularnim incidentom.
Where intravenous access is not readily available (patients not yet undergoing dialysis and peritoneal dialysis patients) Abseamed may be administered as a subcutaneous injection.
Kada intravenski pristup nije lako dostupan (bolesnici koji još nisu na dijalizi i bolesnici na peritonealnoj dijalizi), Abseamed se može primijeniti supkutanom injekcijom.
Abseamed is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Abseamed pripada skupini lijekova koji potiču stvaranje crvenih krvnih stanica kao što to čini ljudski protein eritropoetin.
Pharmacotherapeutic group: other antianaemic preparations, erythropoietin, ATC code: B03XA01.
Farmakoterapijska skupina: ostali antianemici, eritropoetin, ATK oznaka: B03XA01 Abseamed je biosličan lijek.
While on Abseamed, some people need medicines to reduce the risk of blood clots.
Nekim su osobama za vrijeme primanja Abseameda potrebni lijekovi koji smanjuju rizik od krvnih ugrušaka.
Stop using Abseamed if you develop these symptoms and contact your doctor or seek medical attention immediately.
Prestanite primjenjivati lijek Abseamed u slučaju nastanka tih simptoma i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
Because Abseamed stimulates the production of red blood cells, doctors can take more blood from these people.
Budući da Abseamed potiče stvaranje crvenih krvnih stanica, liječnici mogu uzeti veću količinu krvi od tih bolesnika.
When treatment starts, Abseamed is usually injected by a medical professional or a nurse.
Na početku liječenja Abseamed će Vam obično injicirati liječnik ili medicinska sestra.
The recommended dose is Abseamed 600 IU/kg, administered subcutaneously weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery (day 0).
Preporučena doza Abseameda je 600 IU/kg, koja se primjenjuje supkutano svakog tjedna tijekom tri tjedna (dani -21, -14 i -7) prije kirurškog zahvata i na sam dan kirurškog zahvata (dan 0).
Abseamed is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.
Abseamed je indiciran u odraslih koji nemaju nedostatak željeza prije velikog elektivnog ortopedskog kirurškog zahvata, za koje se smatra da imaju visoki rizik od komplikacija transfuzije, radi smanjenja izlaganja transfuzijama alogene krvi.
Alternatively, Abseamed can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
Alternativno se Abseamed može primijeniti u početnoj dozi od 450 IU/kg supkutano jedanput tjedno.
• If you are on a more extended dosing interval (greater than once weekly) of Abseamed, you may not maintain adequate haemoglobin levels and you may require an increase in Abseamed dose or frequency of administration.
• Ako ste na duljem intervalu doziranja (duljem od jedanput tjedno) Abseameda možda nećete moći održati odgovarajuće razine hemoglobina i možda će Vam biti potrebno povisiti dozu ili učestalost primjene Abseameda.
Abseamed is a sterile but unpreserved product and is for single use only.
Abseamed je sterilan lijek, ali ne sadrži konzervanse i namijenjen je samo za jednokratnu primjenu.
Patients should be monitored closely to ensure that the lowest approved effective dose of Abseamed is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dL (7.5 mmol/L).
Bolesnike treba pažljivo pratiti kako bi se osigurala primjena najniže odobrene učinkovite doze Abseameda koja pruža odgovarajuću kontrolu anemije i simptoma anemije, uz istovremeno održavanje koncentracije hemoglobina ispod ili na 12 g/dl (7,5 mmol/l).
Abseamed is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
Abseamed je indiciran u odraslih koji primaju kemoterapiju zbog solidnih tumora, malignog limfoma ili multiplog mijeloma, te kod kojih postoji rizik od transfuzije prema procjeni njihovog općeg stanja (npr. kardiovaskularni status, anemija koja je prisutna na početku kemoterapije), za liječenje anemije i smanjenje potrebe za transfuzijom.
• Before use, leave the Abseamed syringe to stand until it reaches room temperature.
• Prije primjene, ostavite štrcaljku Abseameda izvan hladnjaka dok ne postigne sobnu temperaturu.
• If you are having dialysis treatment when you begin treatment with Abseamed, your dialysis regime may need to be adjusted.
• Ako u vrijeme početka liječenja Abseamedom idete na dijalizu, možda će biti potrebno prilagoditi raspored dijalize.
Abseamed is presented as a clear, colourless solution for injection in a pre-filled syringe.
Abseamed je dostupan u obliku bistre, bezbojne otopine za injekciju u napunjenoj štrcaljki.
If you develop a serious rash or another of these skin symptoms, stop taking Abseamed and contact your doctor or seek medical attention immediately.
U slučaju nastanka ozbiljnog osipa ili drugih kožnih simptoma, prestanite uzimati lijek Abseamed i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
Abseamed is prescribed to stimulate your bone marrow to produce more red blood cells.
Abseamed se propisuje za poticanje koštane srži na stvaranje više crvenih krvnih stanica.
In patients with a poor haemoglobin response to Abseamed, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
U bolesnika sa slabim odgovorom hemoglobina na Abseamed, potrebno je razmotriti druga moguća objašnjenja za slab odgovor (vidjeti dio 4.4 i 5.1).
Before use, leave the Abseamed syringe to stand until it reaches room temperature.
Prije primjene, ostavite štrcaljku Abseameda izvan hladnjaka dok ne postigne sobnu temperaturu.
Abseamed contains sodium
Abseamed sadrži natrij
Abseamed is used in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions.
Abseamed se primjenjuje u odraslih osoba s umjerenom anemijom kojima predstoji veliki ortopedski kirurški zahvat (na primjer, operacija zamjene kuka ili koljena), radi smanjivanja moguće potrebe za transfuzijama krvi.
Abseamed is not approved in the management of anaemia associated with hepatitis C.
Abseamed nije odobren za liječenje anemije povezane s hepatitisom C.
Your doctor will decide how Abseamed will be injected.
Liječnik će odlučiti kako će se davati injekcija Abseamed.
Side effects from an overdose of Abseamed are unlikely.
Nuspojave zbog predoziranja Abseamedom su malo vjerojatne.
Abseamed is used to treat anaemia in adults with a bone marrow disorder that causes a severe disruption in the creation of blood cells (myelodysplastic syndromes).
Abseamed se primjenjuje za liječenje anemije u odraslih osoba s poremećajem koštane srži koji uzrokuje teške poremećaje u stvaranju krvnih stanica (mijelodisplastični sindromi).
Abseamed is used to treat anaemia in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma (bone marrow cancer) who may have a need for a blood transfusion.
Abseamed se primjenjuje za liječenje anemije u odraslih koji primaju kemoterapiju zbog solidnog tumora, zloćudnog limfoma ili multiplog mijeloma (rak koštane srži) i kod kojih bi mogla postojati potreba za transfuzijom krvi.
Your Abseamed dose and frequency of administration may be further adjusted to maintain your response to treatment.
Dodatno Vam može prilagoditi dozu i učestalost primjene Abseameda kako bi se održao odgovor na liječenje.
In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, Abseamed 300 IU/kg should be administered subcutaneously daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.
U slučajevima u kojima je iz medicinskih razloga potrebno skratiti razdoblje do kirurškog zahvata na manje od tri tjedna, treba supkutano primijeniti 300 IU/kg Abseameda dnevno tijekom 10 uzastopnih dana prije kirurškog zahvata, na sam dan kirurškog zahvata i tijekom četiri dana nakon kirurškog zahvata.
Only take one dose of Abseamed from each syringe discarding unwanted solution before injection.
Uzmite samo jednu dozu lijeka Abseamed iz svake štrcaljke i nepotrebnu otopinu bacite prije primjene injekcije.
How to store Abseamed
Kako primjenjivati Abseamed
Abseamed is used to treat symptomatic anaemia caused by kidney disease:
Abseamed se primjenjuje za liječenje simptomatske anemije prouzročene bolešću bubrega:
Some people, depending on why they need Abseamed treatment, may later learn how to inject themselves under the skin: see Instructions on how to inject Abseamed yourself at the end of the leaflet.
Abseamedom, mogu kasnije naučiti kako da same sebi daju injekciju pod kožu: vidjeti Upute za samostalnu primjenu injekcije Abseamed na kraju ove upute.
“Instructions on how to inject Abseamed yourself” can be found at the end of the package leaflet.
„Upute za samostalnu primjenu injekcije Abseamed” mogu se pronaći na kraju upute o lijeku.
If the haemoglobin level reaches 15 g/dL (9.38 mmol/L), or higher, during the preoperative period, administration of Abseamed should be stopped and further dosages should not be administered.
Ako tijekom predoperacijskog razdoblja razina hemoglobina postigne vrijednost od 15 g/dl (9,38 mmol/l) ili više, primjenu Abseameda treba prekinuti i više ne treba primijeniti dodatne doze.
Patients should be monitored closely to ensure that the lowest approved dose of Abseamed is used to provide adequate control of anaemia and of the symptoms of anaemia.
Bolesnike treba pažljivo pratiti kako bi se osigurala primjena najniže odobrene doze Abseameda koja pruža odgovarajuću kontrolu anemije i simptoma anemije.
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Abseamed, your doctor will check your dose of Abseamed because repeatedly increasing your dose of Abseamed if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Abseamedom na primjeren način, Vaš će liječnik provjeriti Vašu dozu Abseameda jer opetovano povećavanje doze Abseameda ako ne odgovarate na liječenje, može povećati rizik od tegoba sa srcem ili krvnim žilama te može povećati rizik od srčanog udara, moždanog udara i smrti.
Take special care with Abseamed:
Potreban je poseban oprez pri primjeni lijeka Abseamed:
Where intravenous access is not readily available Abseamed may be administered subcutaneously.
Kada intavenski pristup nije lako dostupan, Abseamed se može primijeniti supkutano.
The effect of epoetin alfa in facilitating autologous blood donation in patients with low haematocrits (≤ 39% and no underlying anaemia due to iron deficiency) scheduled for major orthopaedic surgery was evaluated in a double-blind, placebo-controlled study conducted in 204 patients, and a single-blind placebo controlled study in 55 patients.
(≤ 39 % i bez podležeće anemije zbog nedostatka željeza) predviđenih za veliki ortopedski kirurški zahvat ocijenjen je u dvostruko slijepom, placebom kontroliranom ispitivanju provedenom na 204 bolesnika i jednostruko slijepom, placebom kontroliranom ispitivanju na 55 bolesnika.
Caution should be exercised with escalation of Abseamed doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Potreban je oprez pri povećavanju doza Abseameda u bolesnika s kroničnim zatajenjem bubrega, budući da visoke kumulativne doze epoetina mogu biti povezane s povećanim rizikom od smrtnosti,