natgillin/translations-raw huggingface dataset:
Hyrimoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Hyrimoz is used.
Predpisovanje in izdaja zdravila Hyrimoz je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se zdravilo Hyrimoz uporablja.
For the full list of side effects and restrictions with Hyrimoz, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Hyrimoz glejte navodilo za uporabo.
For more information about using Hyrimoz, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Hyrimoz glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Therefore, the Agency's view was that, as for Humira, the benefits of Hyrimoz outweigh the identified risks and it can be authorised.
Zato je agencija menila, da koristi zdravila Hyrimoz, enako kot pri zdravilu Humira, odtehtajo znana tveganja in se zdravilo lahko odobri.
Hyrimoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Zdravilo Hyrimoz vsebuje učinkovino adalimumab in je „podobno biološko zdravilo“.
In addition, a study in psoriasis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Poleg tega je študija pri psoriazi pokazala, da so učinki zdravila Hyrimoz pri tej bolezni enakovredni učinkom zdravila Humira.
Eye specialists treating uveitis should also take advice from doctors who have experience of using Hyrimoz.
Zdravniki specialisti za očesne bolezni, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo zdravila Hyrimoz.
In addition Hyrimoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Poleg tega je bilo zdravilo Hyrimoz v študiji, ki je vključevala 465 bolnikov z zmerno do hudo psoriazo v plakih, enako učinkovito kot zdravilo Humira.
How is Hyrimoz used?
Kako se zdravilo Hyrimoz uporablja?
Laboratory studies comparing Hyrimoz with Humira have shown that the active substance in Hyrimoz is highly similar to that in Humira in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Hyrimoz primerjali z zdravilom Humira, so pokazale, da je učinkovina zdravila Hyrimoz po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Humira.
How does Hyrimoz work?
Kako zdravilo Hyrimoz deluje?
Studies have also shown that giving Hyrimoz produces similar levels of the active substance in the body to giving Humira.
Študije so pokazale tudi, da zdravilo Hyrimoz v telesu vzpostavi podobne ravni učinkovine kot zdravilo Humira.
The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Hyrimoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose.
Odmerek in pogostnost injiciranja sta odvisna od zdravljene bolezni, odmerek pri otroku pa se običajno izračuna na podlagi njegove telesne mase.
• hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses
• obolenja hidradenitis suppurativa (inverznih aken), tj. dolgotrajnega obolenja kože, ki povzroča zatrdline, abscese (gnojne tvorbe) in kožne brazgotine;
After training, patients or their carers may inject Hyrimoz if their doctor considers it appropriate.
Ker je zdravilo Hyrimoz na voljo samo v odmerkih po 40 mg, ni primerno za otroke, ki potrebujejo odmerek, manjši od 40 mg. Bolniki ali njihovi skrbniki lahko po opravljenem usposabljanju sami injicirajo zdravilo Hyrimoz, če zdravnik meni, da je to zanje primerno.
These are rare and an appropriate symptomatic treatment should be administered.
Te so redke in jih je treba ustrezno simptomatično zdraviti.
a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
Duration of immunity: 6 months.
Trajanje imunosti: 6 mesecev
A hypersensitivity reaction may occur.
Lahko se pojavi preobčutljivostna reakcija.
Date of last renewal: 23/03/2010
Datum zadnjega podaljšanja dovoljenja za promet: 23/03/2010
MARKETING AUTHORISATION NUMBER(S) EU/2/99/017/001-006
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/99/017/001-006
Shake well prior to use.
Pred uporabo dobro pretresite.
Bovalto Ibraxion can therefore be used as a marker vaccine in association with an appropriate diagnostic test.
Bovalto Ibraxion se lahko torej uporablja kot markersko cepivo v povezavi z ustreznim diagnostičnim testom.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če jepotrebno)
Two injections 21 days apart.
2 odmerka v razmiku 21 dni.
Allow the vaccine to reach a temperature of 15°C-25°C.
Pustite, da se cepivo segreje na 15°C do 25°C.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Administer one dose (2 ml) by subcutaneous injection in the neck (at the front of the shoulder) according to the following regimen:
Injicirajte en odmerek (2 ml) v podkožje v predelu vratu na prednjem delu rame po naslednjem režimu:
The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
The vaccination may cause a slight rise in body temperature (less than 1°C) for a transient period (less than 48 hours after injection) without any consequence to the health or performance of the animal.
Cepljenje lahko povzroči rahel dvig telesne temperature (manj kot 1 oC) v prehodnem obdobju (manj kot 48 ur po injiciranju) brez kakršnihkoli posledic za zdravje ali proizvodno sposobnost živali.
The injection of the vaccine may cause a transient tissue reaction at the site of injection, which may persist for three weeks and rarely up to five weeks.
Vnos cepiva lahko povzroči prehodno reakcijo tkiva na mestu injiciranja, ki lahko traja do treh tednov in le redko do pet tednov.
Laboratoire Porte des Alpes Rue de l'Aviation-69800 Saint Priest France
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCIJA
25 doses (50 ml)
25 odmerkov (50 ml)
Shelf life of the veterinary medicinal product as packaged for sale: 18 months Shelf life after first opening the immediate packaging: 6 hours
Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev Rok uporabnosti po prvem odpiranju stične ovojnine: 6 ur.
The presence of maternally derived antibodies against infectious bovine rhinotracheitis virus may interfere with the vaccination and requires an appropriate vaccination regimen.
Prisotnost maternalnih protiteles proti virusu kužnega govejega rinotraheitisa lahko vpliva na uspešnost cepljenja, zato je potreben poseben program cepljenja.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 5 doses (10 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 5 odmerkov (10 ml)
The gE gene deletion allows differentiation between animals vaccinated with gE-negative vaccines (anti gE antibody negative, IBR vironeutralising antibody positive) and naturally infected animals (positive to both IBR vironeutralising antibody and anti gE antibody).
gE genska delecija omogoča razlikovanje med živalmi, ki so bile cepljene z gE negativnim cepivom (proti gE protitelesa negativne, IBR vironevtralizirajoča protitelesa pozitivne), in naravno okuženimi živalmi (pozitivne na ena in druga; IBR vironevtralizirajoča protitelesa in proti gE protitelesa).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/03/2000
Datum prve pridobitve dovoljenja za promet: 09/03/2000
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Če vam je bilo to zdravilo nenamerno injicirano, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses Cardboard box with 1 or 10 bottles of 10 doses Cardboard box with 1 or 10 bottles of 25 doses
Steklenička iz stekla tipa I z zamaškom iz nitrilnega elastomera in aluminijasto zaporko Kartonska škatla z 1 ali 10 stekleničkami s 5 odmerki Kartonska škatla z 1 ali 10 stekleničkami z 10 odmerki Kartonska škatla z 1 ali 10 stekleničkami s 25 odmerki
For use in animals from the age of 2 weeks in the absence of maternally derived antibodies against IBR virus or from the age of 3 months in the presence of maternally derived antibodies.
Cepimo živali, starejše od 2 tednov, ki nimajo maternalnih protiteles proti virusu IBR ali od 3. meseca starosti dalje, če so maternalna protitelesa prisotna.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN IN POT UPORABE Pred uporabo preberite priložena navodila.
The manufacture, import, possession, sale, supply and/or use of Bovalto Ibraxion may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba zdravila Bovalto Ibraxion je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
No undesirable effects other than those mentioned in section 4.6 have been observed after the administration of an overdose.
Po vnosu čezmernega odmerka niso opazili nobenih drugih neželenih učinkov razen tistih, navedenih v poglavju 4.6.
Bovalto Ibraxion can be used during pregnancy and lactation.
Bovalto Ibraxion se lahko uporablja v obdobju brejosti in laktacije.
EU/2/99/017/001 5 doses (10 ml) EU/2/99/017/004 10 x 5 doses (10 x 10 ml) EU/2/99/017/002 10 doses (20 ml) EU/2/99/017/005 10 x 10 doses (10 x 20 ml) EU/2/99/017/003 25 doses (50 ml) EU/2/99/017/006 10 x 25 doses (10 x 50 ml)
EU/2/99/017/001 5 odmerkov (10 ml) EU/2/99/017/004 10 x 5 odmerkov (10 x 10 ml) EU/2/99/017/002 10 odmerkov (20 ml) EU/2/99/017/005 10 x 10 odmerkov (10 x 20 ml) EU/2/99/017/003 25 odmerkov (50 ml) EU/2/99/017/006 10 x 25 odmerkov (10 x 50 ml)
Special precautions for use in animals: Vaccinate only healthy animals.
POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih: Cepite le zdrave živali.
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin).
Bovalto Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/w emulsion) vaccine which acts by the active immunisation of cattle characterised by the production of Infectious Bovine Rhinotracheitis (IBR) vironeutralising antibodies.
Bovalto Ibraxion je cepivo, ki ima delecijo specifičnega gena (gE) Je inaktivirano pomožno cepivo (o/v emulzija), ki aktivno imunizira govedo tako, da ustvarja vironevtralizirajoča protitelesa proti kužnemu govejemu rinotreheitisu (IBR).
Use sterile syringes and needles
Uporabite sterilne brizge in igle.
Manufacturer responsible for batch release MERIAL
Izdelovalec, odgovoren za sproščanje serij: MERIAL
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURRER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of an overdose.
Po vnosu čezmernega odmerka ni opisanih nobenih drugih neželenih učinkov razen tistih, navedenih v poglavju „Neželeni učinki“.
Onset of immunity: 14 days
Nastop imunosti: 14. dan po cepljenju
Store and transport refrigerated (2°C- 8°C), Do not freeze.
Shranjujte in prevažajte pri temperaturi 2°C - 8°C (v hladilniku), zaščiteno pred svetlobo.
4.2 Indications for use, specifying the target species Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija goveda za ublažitev kliničnih znakov kužnega govejega rinotraheitisa (IBR) in izločanja virusa v naravo.
Any person intending to manufacture, import, possess, sell, supply and/or use Bovalto Ibraxion must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession,sale, supply and/or use.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati zdravilo Bovalto Ibraxion, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom,
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Evropske agencije za zdravila http://www.ema.europa.eu/.
5 doses (10 ml) 10 x 5 doses (10 x 10 ml) 10 doses (20 ml) 10 x 10 doses (10 x 20 ml) 25 doses (50 ml) 10 x 25 doses (10 x 50 ml)
5 odmerkov (10 ml) 10 x 5 odmerkov (10 x 10 ml) 10 odmerkov (20ml) 10 x 10 odmerkov (10 x 20 ml) 25 odmerkov (50 ml) 10 x 25 odmerkov (10 x 50 ml)
Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Aktivna imunizacija goveda za ublažitev kliničnih znakov kužnega govejega rinotraheitisa (IBR) in zmanjšanje izločanja
Store and transport refrigerated (2°C- 8°C).
Shranjujte in prevažajte pri temperaturi 2 °C - 8 °C.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses (1 x 10 ml or 10 x 10 ml) Cardboard box with 1 or 10 bottles of 10 doses (1 x 20 ml or 10 x 20 ml) Cardboard box with 1 or 10 bottles of 25 doses (1 x 50 ml or 10 x 50 ml)
Kartonska škatla z 1 ali 10 stekleničkami s 5 odmerki (1 x 10 ml ali 10 x 10 ml) Kartonska škatla z 1 ali 10 stekleničkami z 10 odmerki (1 x 20 ml ali 10 x 20 ml) Kartonska škatla z 1 ali 10 stekleničkami s 25 odmerki (1 x 50 ml ali 10 x 50 ml)
QUANTITY OF THE ACTIVE SUBSTANCE(S) For 1 dose of 2 ml: gE deleted inactivated IBR virus, at least ................................................ 0.75 VN.U
V 1 odmerku po 2 ml: inaktivirani virus IBR z delecijo gE, najmanj .................................... 0,75 VN.U*
Pharmacotherapeutic group: Immunologicals, bovine rhinotracheitis virus (IBR) ATCvet code: QI02AA03
IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: imunološka zdravila, virus govejega rinotraheitisa (IBR)
QUALITATIVE AND QUANTITATIVE COMPOSITION
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna(e) učinkovina(e):
Shelf life after first opening the container: 6 hours Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
dravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po EXP..
NAME OF THE VETERINARY MEDICINAL PRODUCT Bovalto Ibraxion emulsion for injection Cattle
Bovalto Ibraxion emulzija za injiciranje Govedo
Light paraffin oil Benzyl alcohol
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Parafinsko olje, lahko Benzilalkohol
Polyoxyethylene oleate Polyoxyethylene oleic alcohol Potassium chloride, Sodium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride, Calcium chloride
Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dihidrat
PACKAGE LEAFLET FOR Bovalto Ibraxion emulsion for injection
Bovalto Ibraxion emulzija za injiciranje
Each dose (2 ml) contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* adjuvant: light paraffin oil ........................................................................................... 449.6 to 488.2 mg * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
inaktivirani virus IBR z delecijo gE, najmanj ........................................................................ 0,75 VN.U* adjuvans: lahko parafinsko olje .................................................................................... 449,6 do 488,2 mg
Marketing authorisation holder MERIAL
Imetnik dovoljenja za promet z zdravilom: MERIAL
Triethanolamine
Trietanolamin Polioksietilen oleat
EXPIRY DATE EXP {month/year} Once broached use by: 6 hours
Rok uporabnosti po prvem odpiranju stične ovojnine: 6 ur.
Zero days
Karenca: Nič dni.
SPECIAL WARNING(S), IF NECESSARY Accidental injection is dangerous.
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
29 avenue Tony Garnier 69007 LYON FRANCE
29 avenue Tony Garnier 69007 LYON Francija
29 avenue Tony Garnier 69007 LYON France
29 avenue Tony Garnier 69007 LYON FRANCIJA
a booster injection should be administered at 6 month intervals.
Odprto zdravilo uporabite v 6 urah.
Each dose of 2 ml contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
inaktivirani virus IBR z delecijo gE, najmanj ..................................................................... 0,75 VN.U* .
ROUTE(S) OF ADMINISTRATION
POTI(I) UPORABE ZDRAVILA
ADVICE ON CORRECT ADMINISTRATION See above.
NASVET O PRAVILNI UPORABI ZDRAVILA
4.11 Withdrawal period(s)
4.11 Karenca(e) Nič dni.
4.5 Special precautions for use
NAVODILO ZA UPORABO ZA
SPECIAL WARNING(S)
Adjuvans(i):
Adjuvant light paraffin oil .......................................................................................................... 449.6 to 488.2 mg
lahko parafinsko olje .................................................................................................. 449,6 do 488,2 mg
Vaccinate only healthy animals.
4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
WITHDRAWAL PERIOD Zero days
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Lot
FRANCIJA
The European Commission granted a marketing authorisation valid throughout the EU for Retacrit on 18 December 2007.
Evropska komisija je dovoljenje za promet z zdravilom Retacrit, veljavno po vsej Evropski uniji, odobrila dne 18. decembra 2007.
After that, the two groups switched to receiving the other medicine for a further 12 weeks.
Nato so skupinama zamenjali zdravili za nadaljnjih 12 tednov.
This means that Retacrit is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU), and contains a similar active substance to the reference medicine.
To pomeni, da je podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU) in vsebuje podobno zdravilno učinkovino kot referenčno zdravilo.
The full EPAR for Retacrit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Retacrit je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Retacrit:
Druge informacije o zdravilu Retacrit:
Retacrit is used in the following situations:
Zdravilo Retacrit se uporablja v naslednjih primerih:
It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin zeta.
Proizvajajo jo z metodo, znano kot „tehnologija rekombinantne DNK“, proizvede jo celica, ki je prejela gen (DNK), s katerim lahko tvori epoetin zeta.
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts.
V teh primerih se eritropoetin uporablja za nadomestitev manjkajočega hormona ali za povečanje števila rdečih krvnih celic.
In both studies, the dose of epoetin received was similar with both medicines.
V obeh študijah je bil odmerek prejetega epoetina pri obeh zdravilih podoben.
This document is a summary of the European Public Assessment Report (EPAR) for Retacrit.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Retacrit.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Retacrit.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Retacrit, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
• to treat anaemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions;
• za zdravljenje anemije pri odraslih, pri katerih s kemoterapijo zdravijo določene vrste raka, in za zmanjšanje potrebe po transfuziji krvi;
For more information about treatment with Retacrit, read the Package Leaflet (also part of the EPAR).
Za več informacij o zdravljenju z zdravilom Retacrit preberite navodilo za uporabo (ki je prav tako del EPAR).
What benefit has Retacrit shown during the studies?
Kakšne koristi je zdravilo Retacrit izkazalo med študijami?
For patients with chronic renal failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Pri bolnikih s kronično odpovedjo ledvic ali tistih, ki prejemajo kemoterapijo, morajo ravni hemoglobina ostati v okviru priporočenih vrednosti (od 10 do 12 gramov na deciliter pri odraslih in od 9,5 do 11 gramov na deciliter pri otrocih).
Treatment with Retacrit must be started under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for.
Zdravljenje z zdravilom Retacrit je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov, katerih bolezenska stanja se zdravijo s tem zdravilom.
What is the risk associated with Retacrit?
Kakšna tveganja so povezana z zdravilom Retacrit?
The dose, the frequency of injection and how long Retacrit is used for depend on why it is being used, and are adjusted according to the patient's response.
Odmerek, pogostnost injiciranja in trajanje zdravljenja z zdravilom Retacrit so odvisni od namena uporabe zdravila in jih je treba prilagoditi bolnikovemu odzivu.
The Committee recommended that Retacrit be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Retacrit odobri dovoljenje za promet.