natgillin/translations-raw huggingface dataset:
Bags made of polyolefin/ polyamide co-extruded plastic and over wrapped with a protective plastic bag composed of polyamide/ polypropylene.
Vreče iz poliolefinske/ poliamidne koekstrudirane plastike in ovite v zaščitno plastično vrečko iz poliamida/ polipropilena.
Savene is available in a box consisting of 10 vials of Savene powder containing 500 mg dexrazoxane and 3 bags of 500 ml Savene diluent.
Zdravilo Savene je na voljo v škatlah z 10 vialami praška Savene, ki vsebujejo po 500 mg deksrazoksana, in 3 vrečami po 500 ml vehikla Savene.
Before infusion, Savene powder must be reconstituted with 25 ml sterile water to give a concentration of 20 mg dexrazoxane per ml sterile water.
Pred infundiranjem je treba prašek Savene pripraviti s 25 ml sterilne vode, da nastane koncentracija 20 mg deksrazoksana na ml sterilne vode.
The reconstituted solution is slightly yellow.
Pripravljena raztopina je rahlo rumene barve.
The reconstituted solution should then be diluted in 500 ml Savene diluent.
Pripravljeno raztopino je treba nato dodatno razredčiti v 500 ml vehikla Savene.
Caution must be exercised when handling and preparing the reconstituted solution and the normal procedures for proper handling of cytotoxic medicinal products should be adopted.
Pri ravnanju s pripravljeno raztopino in njeni pripravi je treba ravnati previdno ter upoštevati običajne postopke za pravilno ravnanje s citotoksičnimi zdravili.
TopoTarget A/ S Fruebjergvej 3 DK – 2100 Copenhagen Denmark
TopoTarget A/ S Fruebjergvej 3 DK – 2100 Copenhagen Danska
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. eu. int /
• OTHER CONDITIONS The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Imetnik dovoljenja za promet z zdravilom (MAH) mora zagotoviti, da je sistem farmakovigilance vzpostavljen in deluje preden zdravilo da v promet ter ves čas, ko je zdravilo v prometu.
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box (Pack of 10 vials and 3 bags of diluent)
14 PODATKI NA ZUNANJI OVOJNINI Škatla (pakiranje z 10 vialami in 3 vrečami vehikla)
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion Dexrazoxane
Savene 20 mg/ ml prašek za koncentrat in vehikel za raztopino za infundiranje Deksrazoksan
Each vial contains 500 mg dexrazoxane (as hydrochloride) Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of water for injections
Vsaka viala vsebuje 500 mg deksrazoksana (v obliki lorida) Po pripravi s 25 ml vode za injekcije en ml zdravila vsebuje 20 mg deksrazoksana
Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
Natrijev klorid Kalijev klorid Magnezijev klorid heksahidrat Natrijev acetat trihidrat Natrijev glukonat Natrijev hidroksid Voda za injekcije
Powder for concentrate and diluent for solution for infusion 10 vials of 500 mg dexrazoxane 3 bags of 500 ml diluent
Prašek za koncentrat in vehikel za raztopino za infundiranje 10 vial s 500 mg deksrazoksana 3 vreče s 500 ml vehikla
Intravenous use after reconstitution and dilution Read the package leaflet before use
Intravenska uporaba po rekonstituciji in redčenju Pred uporabo preberite priloženo navodilo
To be administered under the supervision of a physician experienced in the use of cytotoxic agents
Uporabiti pod nadzorom zdravnika, ki ima izkušnje pri uporabi citotoksičnih zdravil
EXP {MM/ YYYY}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
15 9.
15 EXP {MM/ LLLL}
Store below 25°C Reconstituted and diluted solution may be stored at 2 to 8°C for 4 hours Keep vials and bags in the outer carton in order to protect from light
Shranjujte pri temperaturi do 25 °C Rekonstituirana in razredčena raztopina se lahko hrani 4 ure pri 2 do 8 °C Viale in vreče shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
Contains cytostatics.
Vsebuje citostatike.
Emergency kit for Anthracycline Extravasation
Oprema za nujne primere antraciklinske ekstravazacije
No information in Braille is available.
Podatki v Braillovi pisavi niso na voljo.
Savene powder Dexrazoxane Powder for concentrate Intravenous use after reconstitution and dilution
Prašek Savene deksrazoksan Prašek za koncentrat Intravenska uporaba po rekonstituciji in redčenju
17 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
17 PODATKI NA PRIMARNI OVOJNINI
Infusion bag
Infuzijska vreča
Savene diluent
Vehikel Savene
Diluent for solution for infusion 500 ml
Vehikel za raztopino za infundiranje 500 ml
Keep in the outer carton in order to protect from light
Shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
18 11.
18 Po rekonstituciji in redčenju vsebuje citostatike Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi
No information in Braille is available
Podatki v Braillovi pisavi niso na voljo
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion
Savene 20 mg/ ml prašek za koncentrat in vehikel za raztopino za infundiranje
What Savene is and what it is used for 2.
Kaj je zdravilo Savene in za kaj ga uporabljamo 2.
Before you are given Savene 3.
Kaj morate vedeti pred uporabo zdravila Savene 3.
How to use Savene 4.
Kako uporabljati zdravilo Savene 4.
Possible side effects 5 How to store Savene 6.
Možni neželeni učinki 5 Shranjevanje zdravila Savene 6.
WHAT SAVENE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO SAVENE IN ZA KAJ GA UPORABLJAMO
Savene is a detoxifying agent for anti-cancer treatment.
Zdravilo Savene je sredstvo za zaščito organizma pred toksičnostjo zdravil proti raku.
Most anti-cancer medicines are administered intravenously.
Večina zdravil proti raku se daje intravensko.
Occasionally an accident occurs and the medicine is infused outside the vein and into the surrounding tissue.
V določenih primerih se zdravilo nenamerno infundira izven vene v okolnje tkivo.
Savene is used as an antidote to treat extravasations caused by the group of anti-cancer medicines called anthracyclines.
Zdravilo Savene se uporablja kot protisredstvo za zdravljenje ekstravazacij, ki jih povzročijo zdravila proti raku, katerim pravimo antraciklini.
BEFORE YOU ARE GIVEN SAVENE
KAJ MORATE VEDETI PRED UPORABO ZDRAVILA SAVENE
Savene will not be used:
Zdravilo Savene ne smete uporabljati:
- If you are allergic (hypersensitive) to dexrazoxane or any of the other ingredients of Savene
- če ste alergični na (preobčutljivi za) deksrazoksan ali katerokoli sestavino zdravila Savene
- If you are planning to become pregnant and do not use adequate contraceptive measures
- če načrtujete zanositev ali ne uporabljate ustrezne kontracepcije
- If you are breast-feeding
- če dojite
- If you are given yellow fever vaccine
- če ste prejeli cepivo proti rumeni mrzlici
Special care with Savene should be taken
Bodite posebno pozorni pri uporabi zdravila Savene
- Savene should only be given to you if you have had an extravasation in connection with
- Zdravilo Savene lahko prejmete le, če je pri vas prišlo do ekstravazacije v zvezi s kemoterapijo, ki
anthracycline-containing chemotherapy.
vključuje antraciklin.
- During treatment with Savene you will have blood tests taken regularly to check your blood
- Med zdravljenjem z zdravilom Savene vam bodo redno opravljali preiskave krvi, da bodo preverjali
cells.
celice v krvi.
- If you have liver dysfunction your doctor will monitor your liver function during treatment
- Če imate disfunkcijo jeter, bo zdravnik med zdravljenjem spremljal funkcijo jeter
- If you have kidney dysfunction your doctor will monitor for signs of changes to your blood
- Če imate disfunkcijo ledvic, vas bo zdravnik spremljal za znake sprememb krvnih celic.
- Men being treated with dexrazoxane are advised not to father a child during and up to three
- Moškim, ki se zdravijo z deksrazoksanom, odsvetujemo spočetje otroka med zdravljenjem in do tri
months after treatment.
mesece po zdravljenju.
- Women of childbearing potential must use contraceptive measures during treatment.
- Ženske v rodni dobi morajo uporabljati kontracepcijo med zdravljenjem.
- If you receive live attenuated vaccines or phenytoin (anti-epileptic medicines).
- Če ste prejeli živo oslabljeno cepivo ali fenitoin (zdravilo proti epilepsiji).
- Savene should not be administered to children.
- Zdravilo Savene se ne sme uporabiti pri otrocih.
Taking other medicines Savene should not be mixed with any other medicines during the infusion.
Jemanje drugih zdravil Med infuzijo zdravila Savene se zdravila ne sme mešati z nobenim drugim zdravilom.
21 Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
21 Priporočljivo je, da pred jemanjem kateregakoli zdravila o tem obvestite svojega zdravnika, saj lahko pride do medsebojnega delovanja zdravila Savene z drugimi zdravili.
Pregnancy and breast-feeding Savene should not be administered if you are pregnant.
Nosečnost in dojenje Zdravilo Savene se ne sme uporabiti, če ste noseči.
If you are a man, you must take adequate contraceptive precautions during therapy and for at least three months after treatment.
Če ste moški, morate med zdravljenjem in do tri mesece po njem uporabljati ustrezno kontracepcijo.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed but it is unlikely that Savene will affect this function.
Vpliv na sposobnost upravljanja vozil in strojev Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli, vendar ni verjetno, da bi zdravilo Savene vplivalo na to funkcijo.
Important information about some of the ingredients of Savene The Savene diluent contains potassium (98 mg/ 500 ml) which may be harmful to people on a low potassium diet.
Pomembne informacije o nekaterih sestavinah zdravila Savene Vehikel Savene vsebuje kalij (98 mg/ 500 ml), ki je lahko škodljiv za osebe na dieti z nadzorovanim vnosom kalija.
It also contains sodium (1.61 g/ 500 ml) which may be harmful to people on a low sodium diet.
Vsebuje tudi natrij (1, 61 g/ 500 ml), ki je lahko škodljiv za osebe na dieti z nadzorovanim vnosom natrija.
HOW TO USE SAVENE
KAKO UPORABLJATI ZDRAVILO SAVENE
Usual dose The dose will depend on your height and weight.
Običajni odmerek Odmerek je odvisen od telesne višine in mase.
Your doctor will calculate your body surface area in square meter (m2) and will determine the dose you should receive.
Zdravnik bo izračunal površino vašega telesa v kvadratnih metrih (m2) in določil odmerek, ki ga morate prejeti.
The usual adult dose is Day 1 and Day 2:
Priporočeni odmerek za odrasle je prvi dan in drugi dan:
1000 mg/ m2 Day 3:
1000 mg/ m2 tretji dan:
Savene will be given by infusion into one of your veins.
Zdravilo Savene se daje z infuzijo v eno veno.
The infusion will last 1-2 hours.
Infuzija traja 1- 2 uri.
Before infusion, Savene powder is reconstituted with 25 ml sterile water to give a concentration of 20 mg dexrazoxane per ml sterile water.
Pred infundiranjem se prašek Savene pripravi s 25 ml sterilne vode, da nastane koncentracija 20 mg deksrazoksana na ml sterilne vode.
Frequency of administration You will receive your infusion once daily for 3 consecutive days.
Pogostnost uporabe Infuzijo boste dobili enkrat dnevno 3 zaporedne dni.
The first infusion will be given as soon as possible, and within the first six hours, after extravasation with an anthracycline medicine.
Prvo infuzijo boste dobili čimprej in v roku prvih šest ur po ekstravazaciji z antraciklinskim zdravilom.
Like all medicines, Savene can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Savene neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Side effects described as very common were experienced by more than 1 in 10 patients.
Neželene učinke, ki so opisani kot zelo pogosti, so opazili pri več kot 1 bolniku od 10.
Side effects described as common were experienced by up to 1 in 10 patients.
Neželene učinke, ki so opisani kot pogosti, niso opazili pri več kot 1 bolniku od 10.
The very common (more than 1 in 10 patients) side effects are:
Zelo pogosti (pri več kot 1 od 10 bolnikov) neželeni učinki so:
Nausea.
Slabost.
Pain in the blood vessel where the treatment is given.
Bolečine v žili, v katero je bilo infundirano zdravilo.
Very common side effects are furthermore a temporary lowering of the white blood cells, neutrophils and the platelets, side effects which also are caused by the chemotherapy you receive for your disease.
Zelo pogosti neželeni učinki so dodatno začasno znižanje ravni levkocitov, nevtrofilcev in trombocitov.
Control blood tests will be performed regularly.
Te neželene učinke povzroča tudi kemoterapija, ki jo prejemate zaradi svoje bolezni.
The common (up to 1 in 10 patients) side-effects are:
22 Pogosti (pri ne več kot 1 od 10 bolnikov) neželeni učinki so:
A general feeling of being unwell including feeling tired, sleepy or dizzy.
Splošno slabo počutje, med drugim utrujenost, zaspanost, omotica.
Furthermore there can be inflammation of the blood vessel where the treatment is given (phlebitis), diarrhoea, dry mouth, hair
Dodatno lahko pride do vnetja žile, v katero je bilo infundirano zdravilo (flebitis), driske, suhih ust, izpadanja las.
At the site of injection you may get a reaction, where the skin may be red, swollen or hurt when touched.
V tem primeru bo koža lahko rdeča, otekla ali boleča na dotik.
HOW TO STORE SAVENE
SHRANJEVANJE ZDRAVILA SAVENE
Do not use Savene after the expiry date stated on the label.
Zdravila Savene ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Savene should be stored below 25oC.
Zdravilo Savene shranjujte pri temperaturi do 25 °C.
Keep Savene in the outer carton in order to protect from light.
Zdravilo Savene shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8oC after reconstitution and subsequent dilution in the diluent.
Kemijska in fizikalna obstojnost pri uporabi je bila dokazana za 4 ure ob shranjevanju pri 2 do 8 °C po pripravi in nadaljnjem redčenju v vehiklu.
From a microbiological point of view the product should be used immediately.
Iz mikrobiološkega vidika je treba zdravilo porabiti nemudoma.
If not used immediately, in-use storage times and conditions prior to use are at the responsibility of the user and would normally not be longer than 4 hours at 2 to 8°C.
Če se zdravilo ne porabi takoj, so pogoji in trajanje shranjevanja pred uporabo odgovornost uporabnika, pri čemer shranjevanje običajno ne sme biti daljše od 4 ur pri 2 do 8 °C.
Do not use Savene if you notice that the vial is damaged or show signs of tampering.
Ne uporabljajte zdravila Savene, če opazite poškodbe viale ali znake odpiranja viale.
What Savene contains The active substance is dexrazoxane.
Kaj vsebuje zdravilo Savene Zdravilna učinkovina je deksrazoksan.
Each vial contains 500 mg dexrazoxane as 589 mg dexrazoxane hydrochloride.
Vsaka viala vsebuje 500 mg deksrazoksana v obliki 589 mg deksrazoksanovega hidroklorida.
The other ingredients are hydrochloric acid.
Pomožna snov je klorovodikova kislina.
The diluent contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide and water for injections.
Vehikel vsebuje natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev acetat trihidrat, natrijev glukonat, natrijev hidroksid in vodo za injekcije.
What Savene looks like and contents of the pack Savene consists of Savene powder and Savene diluent.
Izgled zdravila Savene in vsebina pakiranja Zdravilo Savene je sestavljeno iz praška Savene in vehikla Savene.
Savene powder is presented as a single glass vial containing a white to off-white powder called dexrazoxane (the active substance).
Prašek Savene je v eni stekleni viali z belim do umazano belim praškom, ki ga imenujemo deksrazoksan (zdravilna učinkovina).
Savene is also supplied with an infusion bag containing the Savene diluent.
Zdravilo Savene vsebuje tudi infuzijsko vrečo, ki vsebuje vehikel Savene.
The concentration of the active ingredient following reconstitution with sterile water is 20 mg dexrazoxane per ml.
Koncentracija zdravilne učinkovine po pripravi s sterilno vodo je 20 mg deksrazoksana na ml.
Savene is supplied in a box containing 10 vials of Savene powder and 3 infusion bags of Savene diluent.
Zdravilo Savene je na voljo v škatlah z 10 vialami praška Savene in 3 infuzijskimi vrečami vehikla Savene.
Marketing Authorisation Holder and Manufacturer:
23 Imetnik dovoljenja za promet z zdravilom in izdelovalec:
TopoTarget A/ S Fruebjergvej 3 DK-2100 Copenhagen Denmark Tel: +45 39 17 83 92 Fax: +45 39 17 94 92
TopoTarget A/ S Fruebjergvej 3 DK- 2100 Copenhagen Danska Tel: +45 39 17 83 92 Faks: +45 39 17 94 92
23 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
25 The following information is intended for medical or healthcare professionals only.
25 Naslednje informacije so namenjene samo zdravstvenemu osebju.
Savene is supplied as:
Zdravilo Savene je v obliki:
Savene powder 2.
Prašek Savene 2.
Savene powder must be reconstituted in 25 ml sterile water and diluted in 500 ml diluent prior to administration.
Pred dajanjem je treba prašek Savene pripraviti s 25 ml sterilne vode in razredčiti v 500 ml vehikla.
Savene is an anti-cancer agent and the normal procedures for proper handling and disposal of anticancer medicines should be adopted, namely:
Upoštevati je treba postopke za pravilno ravnanje z zdravili proti raku in njihovo odstranjevanje, zlasti:
- Personnel should be trained to reconstitute the medicine
- Osebje mora biti usposobljeno za pripravo zdravila
- Pregnant staff should be excluded from working with this medicine
- Noseče zdravstvene delavke ne smejo delati s tem zdravilom
- Personnel handling this medicine during reconstitution should wear protective clothing including
- Osebe, ki pripravljajo zdravilo, morajo nositi zaščitna oblačila, vključno z zaščitno masko,
mask, goggles and gloves
zaščitnimi očali in zaščitnimi rokavicami
- Accidental contact with the skin or eyes should be treated immediately and thoroughly with
- V primeru nenamernega stika zdravila s kožo ali očmi, je treba prizadeto področje nemudoma
copious amounts of water
temeljito sprati z obilo vode
3.1 Reconstitution of Savene powder 3.1.1 Using a syringe fitted with a needle, aseptically withdraw 25 ml of sterile water.
3. 1 Priprava praška Savene 3. 1. 1 Z injekcijsko brizgo, ki ima nameščeno iglo, aseptično povlecite 25 ml sterilne vode.
3.1.2 Inject the entire contents of the syringe into the vial containing the Savene powder.
3. 1. 2 Vbrizgajte celotno vsebino brizge v vialo s praškom Savene.
3.1.3 Remove the syringe and needle and mix manually by repeated inversions until the powder is fully dissolved.
3. 1. 3 Odstranite injekcijsko brizgo in iglo ter vialo ročno premešajte z večkratnim obračanjem, dokler se prašek popolnoma ne raztopi.
3.1.4 Allow the vial with the reconstituted solution to stand for 5 minutes at room temperature and check if the solution is homogenous and clear.
Preverite, ali je raztopina homogena in bistra.
The reconstituted solution contains 20 mg dexrazoxane per ml and should be used immediately after preparation.
Pripravljena raztopina vsebuje 20 mg deksrazoksana na ml.
It contains no antibacterial preservative.
Uporabiti jo morate nemudoma po pripravi.
3.2 Dilution of the infusion concentrate 3.2.1 More than one vial containing reconstituted solution may be necessary to obtain the required dose for the patient.
3. 2 Redčenje koncentrata za infuzijo 3. 2. 1 Da dosežete potreben odmerek za bolnika, boste morda potrebovali več kot eno vialo pripravljene raztopine.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding reconstituted volume containing 20 mg dexrazoxane per ml from the appropriate number of vials containing reconstituted solution.
Glede na potreben odmerek za bolnika, izražen v mg, aseptično povlecite ustrezen volumen pripravljene raztopine z 20 mg deksrazoksana na ml iz ustreznega števila vial, ki vsebujejo pripravljeno raztopino.
3.2.2 Inject the required reconstituted volume into the infusion bag with 500 ml diluent.
3. 2. 2 Vbrizgajte potreben volumen pripravljene raztopine v infuzijsko vrečo s 500 ml vehikla.
3.2.3 Mix the infusion bag manually using a rocking motion 3.2.4 Savene should be aseptically administered as a 1-2 hours infusion under room temperature and normal light conditions.
3. 2. 3 Vsebino infuzijske vreče zmešajte ročno z nihajočimi gibi 3. 2. 4 Zdravilo Savene je treba aseptično dati kot infuzijo, ki traja 1- 2 uri pri sobni temperaturi in normalnimi pogoji osvetlitve.
3.2.5 As with all parenteral products, Savene reconstituted solution and infusion solution should be inspected visually for particulate matter and discoloration prior to administration.
3. 2. 5 Kot vsa parenteralna zdravila je treba pripravljeno raztopino zdravila Savene in raztopino zdravila Savene za infundiranje pred uporabo s prostim očesom preveriti na prisotnost delcev ali razbarvanje.
DISPOSAL
ODSTRANJEVANJE
26 All items for preparation, administration or cleaning, including gloves, as well as liquid waste should be disposed of in accordance with local requirements.
Ves material, ki ga uporabite za pripravo, dajanje ali čiščenje (vključno z zaščitnimi rokavicami), ter tekoče odpadke zavrzite v skladu z lokalnimi predpisi.
London, 1 June 2006 Doc. Ref.
London, 1. junija 2006 Ref. dok.
After combination with the radioactive substance and administration, it binds to the antigen present on the surface of a certain type of blood cells, called granulocytes, bringing the radioactivity to them.
Po kombiniranju z radioaktivno snovjo in aplikaciji se veže na antigen, ki se nahaja na površini določenega tipa krvnih celic, imenovanih granulociti, s čimer » prinese « do njih radioaktivno snov.
The application was at Day 120 when the Company withdrew it.
Ko je podjetje vlogo umaknilo, je bila le- ta v postopku 120. dan.
Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the
Ko podjetje pripravi
Once the Company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining question(s) (at day 180).
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za odgovore na dodatna vprašanja (180. dan).
It is available as yellow, oval tablets (600 mg) and as an oral solution (20 mg/ ml).
Na voljo je v obliki rumenih, ovalnih tablet (600 mg) in kot peroralna raztopina (20 mg/ ml).
Sebivo is used to treat adults with chronic (long-term) hepatitis B, a disease of the liver caused by infection with the hepatitis B virus.
Zdravilo Sebivo uporabljamo za zdravljenje odraslih bolnikov s kroničnim (dolgotrajnim) hepatitisom B, boleznijo jeter zaradi okužbe z virusom hepatitisa B.