FrancophonIA/ELRC3.0 huggingface dataset:
English: Store the vials in the original container in order to protect from light.
Slovenian: Viale shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Close monitoring for evidence of extravasation during the injection of Zevalin is required in order to avoid radiation-associated tissue damage.
Slovenian: Potrebno je skrbno spremljanje pojava ekstravazacije v času injiciranja zdravila Zevalin, da se prepreči poškodovanje tkiva zaradi sevanja.
English: Y]-radiolabelled Zevalin must only be received, handled and administered by qualified personnel and must be prepared in accordance with both radiation safety and pharmaceutical quality requirements (for more details see also sections 4.4, 6.6 and 12).
Slovenian: Y] označeno zdravilo Zevalin sme sprejeti, uporabljati in aplicirati le strokovno usposobljeno osebje, ki ga mora pripraviti v skladu z zahtevami za varstvo pred sevanjem in farmacevtsko kakovost (za več podrobnosti glejte tudi poglavja 4.4, 6.6 in 12).
English: The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
Slovenian: Korist uporabe zdravila Zevalin po zdravljenju z rituksimabom v kombinaciji s kemoterapijo, ni bila potrjena.
English: The path length of beta emission (90) by yttrium-90 in tissue is 5 mm.
Slovenian: Domet delcev (sevanja) beta (90) itrija-90 v tkivu je 5 mm.
English: The product of radioactive decay is stable zirconium-90.
Slovenian: Produkt radioaktivnega razpada je stabilen cirkonij-90.
English: Y] ibritumomab tiuxetan in a total volume of 10 ml.
Slovenian: Y] ibritumomab tiuksetana v skupnem volumnu 10 ml.
English: If your doctor plans to treat you with some other antibody after treatment with Zevalin, you will need to be tested for special antibodies.
Slovenian: Če vas namerava vaš zdravnik zdraviti z drugimi protitelesi po zdravljenju z zdravilom Zevalin, boste morali opraviti tudi preiskave za določena protitelesa.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or approporiate licences of the competent official organisation.
Slovenian: Za njihov sprejem, shranjevanje, uporabo, prenos in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja/licence pristojne uradne organizacije.
English: Total organic carbon (e.g. organic chelators)
Slovenian: Skupni organski ogljik (npr. organski kelatorji)
English: PFS increased from 13.5 months (control) to 37 months (Zevalin; p<0.0001; HR 0.465).
Slovenian: PFS se je podaljšalo s 13,5 mesecev (kontrolne osebe) na 37 mesecev (Zevalin, p < 0,0001, razmerje ogroženosti 0,465).
English: Complete Response Rate (%)
Slovenian: Popolni odgovor (%)
English: The Zevalin therapeutic regimen was administered in two steps (see 4.2).
Slovenian: Terapija z zdravilom Zevalin je potekala v dveh fazah (glejte poglavje 4.2).
English: • severe mucous membrane reactions, which may occur days or months after Zevalin and/or rituximab administration.
Slovenian: • hude reakcije sluznice, ki se lahko pojavijo dneve ali mesece po dajanju zdravila Zevalin in/ali riuksimaba.
English: Empty
Slovenian: prazna
English: 10 ml of formulation buffer
Slovenian: 10 ml pufra za pripravo formulacije
English: Infusions must be administered under the close supervision of an experienced physician with full resuscitation facilities immediately available (for radiopharmaceutical precautions see also sections ‘4.2 and 12').
Slovenian: Infuzijo se daje pod skrbnim nadzorom izkušenega zdravnika v prostoru, ki je ustrezno opremljen s celotno, takoj dosegljivo opremo za oživljanje (za previdnostne ukrepe v zvezi z radiofarmaki glejte tudi poglavji 4.2 in 12).
English: • Risk Management Plan (RMP) The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v farmakovigilančnem načrtu, dogovorjenem v različici 1.1 načrta za obvladovanje tveganja (RMP), predloženi v modulu 1.8.2 vloge za dovoljenje za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Appropriate aseptic precautions must be taken, complying with the requirements of Good Manufacturing Practice of pharmaceuticals.
Slovenian: Upoštevati je treba ustrezne previdnostne ukrepe za zagotavljanje aseptičnih pogojev, ki so v skladu z Dobro proizvodno prakso za zdravila.
English: Due to the exposure to ionising radiation derived from the radiolabel, a risk of mutagenic and carcinogenic effects has to be taken into account.
Slovenian: Zaradi izpostavljenosti ionizirajočemu sevanju, ki izvira iz radioaktivnega markerja, je treba upoštevati možnost mutagenih in tumorogenih učinkov.
English: Grade 3 and grade 4 infections were reported commonly.
Slovenian: Pogosto so poročali o okužbah 3. in 4. stopnje.
English: In clinical studies, the [
Slovenian: V kliničnih študijah je povzročilo z [
English: After radiolabelling, immediate use is recommended.
Slovenian: Po označevanju z radioizotopom se priporoča takojšnja uporaba.
English: In case of a potential severe infusion reaction treatment must be stopped immediately.
Slovenian: V primeru potencialno hude reakcije je treba zdravljenje z infuzijo takoj prekiniti.
English: These reports originated either from clinical trials or from postmarking experience.
Slovenian: Poročila izvirajo iz kliničnih preskušanj ali iz obdobja trženja.
English: In particular, your doctor will need to interrupt treatment with growth factors such as filgrastim for a period of three weeks before giving you Zevalin to two weeks after Zevalin treatment.
Slovenian: Vaš zdravnik bo moral prekiniti predvsem zdravljenje z rastnimi faktorji kot je filgrastim za obdobje treh tednov, v katerem prejemate zdravilo Zevalin, in dva tedna po zdravljenju z zdravilom Zevalin.
English: Zevalin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Slovenian: Uporaba zdravila Zevalin se ne priporoča pri otrocih in mladostnikih, mlajših od 18 let, ker ni na voljo dovolj podatkov o varnosti in učinkovitosti.
English: The safety and efficacy of immunization with any vaccine, particularly live viral vaccines, following therapy with Zevalin have not been studied.
Slovenian: Študij varnosti in učinkovitosti imunizacije s katerimkoli cepivom, zlasti z živimi virusnimi vakcinami, po zdravljenju z zdravilom Zevalin niso izvedli.
English: Since Zevalin is used after pretreatment with rituximab (for details see section 4.2), see also the prescribing information of rituximab.
Slovenian: Ker se zdravilo Zevalin uporablja po predhodnem zdravljenju z rituksimabom (za podrobnosti glejte poglavje 4.2), glejte tudi informacije o predpisovanju rituksimaba.
English: Patients were considered refractory if their last prior treatment with rituximab did not result in a complete or partial response, or if time to disease progression (TTP) was  6 months.
Slovenian: Bolniki brez odgovora so bili tisti, pri katerih po zadnjem predhodnem zdravljenju z rituksimabom ni prišlo do popolne ali delne remisije, oziroma, če je bil čas do napredovanja bolezni (TPP - time to progress) < 6 mesecev.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Slovenian: Ugotovljeno je bilo, da je raztopina kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi od 2 °C - 8 °C in zaščitena pred svetlobo.
English: Overall Response Rate (%)
Slovenian: Celokupni odgovor (%)
English: In most patients, administration of Zevalin (after pretreatment with rituximab) results in severe and prolonged cytopenia which is generally reversible (see section 4.8).
Slovenian: Pri večini bolnikov povzroči dajanje zdravila Zevalin (po predhodnem zdravljenju z rituksimabom) hudo in dolgo trajajočo citopenijo, ki je večinoma reverzibilna (glejte poglavje 4.8).
English: No data are available on patients with CNS-lymphoma as those patients were not included in clinical studies.
Slovenian: Na voljo ni podatkov o bolnikih z limfomom osrednjega živčevja, ker ti bolniki niso bili vključeni v klinične študije.
English: Contents of the kit are intended only for use in the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan and are not to be administered directly to the patient without first undergoing the preparative procedure.
Slovenian: Vsebina kompleta je namenjena samo uporabi pri pripravi ibritumomab tiuksetana, označenega z radioaktivnim itrijem-90, in je ne smete dati neposredno bolniku, ne da bi prej izvedli postopek priprave.
English: Analyses of estimated radiation absorbed dose were carried out using quantitative imaging with the gamma-emitter [
Slovenian: Analizo ocenjenega absorbirane doze sevanja radioaktivnosti so opravljali s kvantitativno analizo slike s sevalcem gama - z [
English: In addition, Zevalin is not recommended for the use in patients with non-Hodgkin's lymphoma involving the brain and/or spinal cord as those patients were not included in clinical studies.
Slovenian: Poleg tega se uporaba zdravila Zevalin ne priporoča pri bolnikih z ne-Hodgkinovim limfomom, ki zajema možgane in/ali hrbtenjačo, saj ti bolniki niso bili vključeni v klinične študije.
English: Place ITLC strip in the developing chamber and allow the solvent front to migrate past the 5.4 cm mark.
Slovenian: 3) Vstavite ploščico za ITLC v razvijalno komoro in pustite, da fronta topila potuje prek oznake 5,4 cm.
English: Induction therapies included CVP n=106, CHOP (-like) n=188, fludarabine combinations n=22, chlorambucil n=39 and rituximab-chemotherapy combinations n=59.
Slovenian: Med indukcijskimi zdravljenji so bile CVP (n = 106), CHOP oz. podobne (n = 188), kombinacije s fludarabinom (n = 22), klorambucil (n = 39) in kombinacije kemoterapije in rituksimaba (n = 59).
English: It should be specified that the frequency ‘common' attributed to this adverse drug reaction has been derived from a study on consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Slovenian: Treba je navesti, da je pogostnost "pogosti", ki je pripisana temu neželenemu učinku zdravila, pridobljena iz študije konsolidacijskega zdravljenja po nastopu remisije, pri predhodno nezdravljenih bolnikih s folikularnim limfomom.
English: • The usual dose is 11 or 15 MBq per kg body weight, depending on your blood platelet count.
Slovenian: • Običajni odmerek je 11 ali 15 MBq na kg telesne mase, odvisno od števila trombocitov.
English: The dose of Zevalin depends on your body weight, blood platelet counts and what Zevalin is being used for (indication).
Slovenian: Odmerek zdravila Zevalin je odvisen od vaše telesne mase, števila trombocitov in namena uporabe zdravila Zevalin (indikacija).
English: • extravasation (leakage of the infusion to the surrounding tissue): pain, burning sensation, stinging or another reaction at the infusion site during administration.
Slovenian: • ekstravazacija (iztekanje infuzije v okoliško tkivo): bolečina, pekoč občutek, zbadanje ali druge reakcije na mestu infundiranja med dajanjem infuzije.
English: The recommended radioactivity dose of [
Slovenian: Priporočen odmerek radioaktivnosti z [
English: • Contraception
Slovenian: • Kontracepcija
English: The safety and efficacy of immunization with any vaccine, particularly live viral vaccines, following therapy with Zevalin have not been studied (see also section ‘Special warnings and precautions for use').
Slovenian: Študij varnosti in učinkovitosti imunizacije s katerimkoli cepivom, zlasti z živimi virusnimi cepivi, po zdravljenju z zdravilom Zevalin niso izvedli (glejte tudi poglavje Posebna opozorila in previdnostni ukrepi).
English: Pharmacodynamic analysis demonstrated that this was a temporary effect; recovery of normal B-cells began within 6 months and median counts of B-cells were within normal range within 9 months after treatment.
Slovenian: CD20 pozitivnih celic B. Farmakodinamična analiza je pokazala, da je ta učinek le začasen; v 6 mesecih so se začele normalne celice B ponovno regenerirati, njihovo mediano število pa je 9 mesecev po zdravljenju bilo znotraj meja normalnih vrednosti.
English: The efficacy and safety of a variation of the Zevalin therapeutic regimen employing a reduced dose of ibritumomab tiuxetan [
Slovenian: Učinkovitost in varnost različice terapevtske sheme z zdravilom Zevalin, pri kateri so uporabljali nižje odmerke ibritumomab tiuksetana [
English: What Zevalin is and what it is used for What you need to know before you are given Zevalin How to use Zevalin
Slovenian: Kaj je zdravilo Zevalin in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Zevalin Kako uporabljati zdravilo Zevalin Možni neželeni učinki
English: A potentially limited ability to generate a primary or anamnestic humoral response to any vaccine following Zevalin treatment has to be taken into consideration.
Slovenian: Zevalin potencialno omejena sposobnost generiranja primarnega ali anamnestično humoralnega odziva na katerokoli cepivo.
English: A 0.2 or 0.22 micron low protein-binding filter must be on line between the patient and the infusion port.
Slovenian: Na liniji med bolnikom in infuzijskim vhodom mora biti nameščen 0,2- ali 0,22mikronski filter, ki veže beljakovine z nizko molekulsko maso.
English: Like all medicines, Zevalin can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Zevalin neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Seven patients (3.4%, 7/204) were diagnosed with MDS/AML after receiving Zevalin, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years.
Slovenian: Pri sedmih bolnikih (3,4 %, 7/204) so po zdravljenju z zdravilom Zevalin postavili diagnozo MDS/AML, v kontrolnem kraku pa pri enem bolniku (0,5 %, 1/205), ob medianem spremljanju 7,3 leta.
English: Study 2 was a randomized, controlled, multicenter study comparing the Zevalin therapeutic regimen versus treatment with rituximab.
Slovenian: Druga študija je bila randomizirana, kontrolirana, multicentrična študija, v kateri so terapevtsko shemo zdravljenja z zdravilom Zevalin primerjali z zdravljenjem z rituksimabom.
English: After use of Zevalin, patients must generally be tested for HAMA before any further treatment with murine-derived proteins.
Slovenian: Po uporabi zdravila Zevalin je treba bolnike praviloma testirati za prisotnost HAMA pred nadaljevanjem zdravljenja z beljakovinami, pridobljenimi iz glodavcev.
English: In a secondary analysis comparing objective response to the Zevalin therapeutic regimen with that observed with the most recent treatment with rituximab, the median duration of response following the Zevalin therapeutic regimen was 6 vs. 4 months.
Slovenian: V sekundarni analizi, kjer so primerjali objektivne odgovore na terapevtsko shemo z zdravilom Zevalin s tistimi, ki so jih dosegli z najnovejšim zdravljenjem z retuksimabom, je bilo srednje trajanje odgovora po zdravljenju z zdravilom Zevalin 6 mesecev, z retuksimabom pa 4 mesece.
English: Patients who have developed HAMAs may have allergic or hypersensitivity reactions when treated with Zevalin or other murine-derived proteins.
Slovenian: Pri bolnikih, ki so razvili HAMA, se lahko pri zdravljenju z zdravilom Zevalin ali z drugimi beljakovinami, pridobljenimi iz glodavcev pojavijo alergijske ali preobčutljivostne reakcije.
English: • Low counts of blood cells: unusual bruising, more bleeding then usual after injury, fever, or if you feel unusually tired or breathless
Slovenian: • nizko število krvnih celic:nenavadne podplutbe, več krvavitev, kot je navadno po poškodbi, zvišana telesna temperatura ali nenavadna utrujenost ali če ste brez sape
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: Radiofarmake smejo sprejemati, uporabljati in dajati bolnikom samo pooblaščene osebe v za to določenem kliničnem okolju.
English: The risk of haematological toxicity may be increased after prior therapy with fludarabine containing regimens (for details see section 4.5).
Slovenian: Tveganje za hematološko toksičnost se lahko zveča po predhodnem zdravljenju s fludarabinom (za podrobnosti glejte poglavje 4.5).
English: • allergic (hypersensitivity) reactions/infusion reactions: symptoms for allergic reactions/ infusion reactions may be skin reactions, breathing difficulties, swelling, itching, flushing, chills, dizziness (as potential sign for low blood pressure).
Slovenian: • alergijske (preobčutljivostne) reakcije/reakcije na infuzijo: simptomi alergijskih reakcij/reakcij na infuzijo so lahko kožne reakcije, težave z dihanjem, oteklost, srbenje, oblivanje, mrzlica, omotičnost (kot možen znak za nizek krvni pritisk).
English: In case of hypersensitivity reactions, Zevalin infusion must be stopped immediately.
Slovenian: V primeru preobčutljivostnih reakcij je treba infundiranje zdravila Zevalin takoj prenehati.
English: The use of Zevalin is associated with an increased risk of secondary malignancies, including acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS), (see also section 4.8).
Slovenian: Uporaba zdravila Zevalin je povezana z zvečanim tveganjem za sekundarne maligne bolezni, vključno z akutno mieloidno levkemijo (AML) in mielodisplastičnim sindromom (MDS) (glejte tudi poglavje
English: The volume of sodium acetate solution added is equivalent to 1.2 times the volume of yttrium-90 chloride to be transferred in step 2.
Slovenian: Volumen dodane raztopine natrijevega acetata je enak 1,2-kratnemu volumnu itrijevega-90 klorida, ki se prenese v 2. fazi.
English: The single and repeated dose toxicity studies of the non-radioactive compound in cynomolgus monkeys did not indicate any other risk than the expected B-cell depletion arising from the use of ibritumomab tiuxetan alone or in combination with rituximab.
Slovenian: Študije toksičnosti ne-radioaktivnih sestavin po enkratnem in večkratnem odmerjanju pri opicah vrste Macacca fascicularis niso pokazale nobenega drugega tveganja razen pričakovanega zmanjšanja števila celic B zaradi uporabe ibritumomab tiuksetana samega ali v kombinaciji z rituksimabom.
English: - Hypersensitivity to ibritumomab tiuxetan, to yttrium chloride, or to any of the excipients listed in section 6.1.
Slovenian: - preobčutljivost na ibritumomab tiuksetan, itrijev klorid ali katero koli pomožno snov, navedeno v poglavju 6.1;
English: How Zevalin is given Zevalin is given by intravenous infusion (drip into a vein) usually lasting about 10 minutes.
Slovenian: Zdravilo Zevalin se daje v obliki intravenske infuzije (iz infuzijske steklenice teče v žilo), kar običajno traja približno 10 minut.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Slovenian: Shranjevanje radiofarmakov mora biti v skladu z nacionalnimi predpisi o radioaktivnih snoveh.
English: You must not be given Zevalin: - if you are allergic (hypersensitive) to any of the following: ibritumomab tiuxetan, yttrium chloride or to any of the other ingredients of Zevalin (listed in section 6 ‘What Zevalin contains') rituximab or other murine-derived proteins - if you are pregnant or breast-feeding (see also section “pregnancy and breast feeding”).
Slovenian: Zdravila Zevalin naj vam ne dajejo: - če ste alergični na karkoli od naslednjega: ibritumomab tiuksetan, itrijev klorid ali katero koli sestavino tega zdravila (navedeno v poglavju 6), rituksimab ali druge beljakovine, pridobljene iz glodavcev, - če ste noseči ali dojite (glejte poglavje Nosečnost in dojenje).
English: Zevalin must be used following pretreatment with rituximab for which breast-feeding is not recommended during treatment and up to 12 months following treatment (please refer to the Summary of Product Characteristics of rituximab for detailed guidance on its use).
Slovenian: Zdravilo Zevalin je treba uporabiti po predhodnem zdravljenju z rituksimabom za katerega se ne priporoča, da ženska med zdravljenjem in še 12 mesecev po zdravljenju doji (za podrobnejše informacije o njegovi uporabi prosimo glejte Povzetek glavnih značilnosti zdravila rituksimab).
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Slovenian: Postopke dajanja zdravila morate izvesti tako, da se kar najbolj zmanjša nevarnost kontaminacije zdravila in obsevanja ljudi, ki rokujejo z zdravilom.
English: Very common side effects (may effect more than 1 in 10 people) - decreased number of blood platelets, white and red blood cells (thrombocytopenia,
Slovenian: Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov): - zmanjšano število trombocitov, belih in rdečih krvnih celic (trombocitopenija,
English: • Pancytopenia
Slovenian: • pancitopenija
English: After completing induction therapy, patients were randomized to receive either Zevalin (250 mg/m rituximab on day -7 and on day 0 followed on day 0 by Zevalin 15 MBq/kg body weight; maximal dose 1200 MBq; [n=208]) or no further treatment (control; n=206).
Slovenian: Po končanem indukcijskem zdravljenju so bolnike randomizirali: dobivali so bodisi zdravilo Zevalin (250 mg/m rituksimaba na dan -7 in na dan 0, čemur je na dan 0 sledilo zdravilo Zevalin 15 MBq/kg telesne mase; največji odmerek 1200 MBq; [n=208]) bodisi nobenega nadaljnjega zdravljenja (kontrolne osebe, n = 206).
English: Appropriate aseptic precautions should be taken.
Slovenian: Upoštevati je treba ustrezne previdnostne ukrepe za zagotavljanje aseptičnih pogojev.
English: Y]-radiolabelled Zevalin could cause toxic effects on female and male gonads.
Slovenian: Y] označenega zdravila Zevalin povzroči toksične učinke na ženske in moške spolne žleze.
English: Using a 10-ml syringe with a large bore needle (18-20 G), draw formulation buffer that will result in a combined total volume of 10 ml.
Slovenian: Z 10-mililitrsko injekcijsko brizgo z iglo velikega notranjega premera (18-20 G) izvlecite toliko pufra za pripravo formulacije, da bo končni skupni volumen znašal 10 ml.
English: Deaths due to second primary malignancy included 8 (3.9%) patients in the Zevalin arm compared to 3 (1.5%) patients in the control arm.
Slovenian: Smrti zaradi druge primarne maligne bolezni so vključevale 8 (3,9 %) bolnikov v kraku z zdravilom Zevalin in 3 (1,5 %) bolnikov v kontrolnem kraku.
English: Haematological toxicity has been very commonly observed in clinical trials, and is dose-limiting (see also section ‘Special warnings and precautions for use').
Slovenian: V kliničnih preskušanjih so zelo pogosto opazili hematološko toksičnost, zaradi katere se omeji odmerek (glejte tudi poglavje Posebna opozorila in previdnostni ukrepi).
English: Fatal outcomes have been reported for each of the following serious adverse drug reactions.
Slovenian: Za vsakega od naslednjih resnih neželenih učinkov so poročali o smrtnih izidih.
English: Major inclusion criteria were: CD20+ grade 1 or 2 follicular lymphoma; stage III or IV at diagnosis; normal peripheral blood cell counts; < 25% bone marrow involvement; age ≥ 18 yrs; and complete response (CR/Cru) or partial response (PR) after first-line chemotherapy determined by physical examination, CT scans and bone marrow biopsy.
Slovenian: Glavna merila za vključitev so bila: CD-20+ folikularni limfom 1. ali 2. stopnje, stadij III ali IV ob postavitvi diagnoze, normalno število krvnih celic v periferni krvi, > 25 % zajetost kostnega mozga, starost ≥ 18 let in popoln odziv (CR/Cru) ali delen odziv (PR) po kemoterapiji prvega izbora, ugotovljen s kliničnim pregledom, računalniško tomografijo in biopsijo kostnega mozga.