natgillin/translations-raw huggingface dataset:
Therefore, Livensa should not be used in women on concomitant CEE (see sections 4.2 and 
Zato zdravila Livensa ne smejo uporabljati ženske, ki sočasno prejemajo CEE (glejte poglavji 4.2 in 5.1).
Thin, clear, oval matrix-type transdermal patch consisting of three layers: a translucent backing film, an adhesive matrix drug layer, and a protective release liner that is removed prior to application. 
Tanek, prozoren, ovalen matriksni transdermalni obliž, sestavljen iz treh plasti: prosojne zunanje folije, lepljive matriksne plasti, ki vsebuje zdravilo, in zaščitne plasti, ki se pred aplikacijo odstrani.
Do not use Livensa in case of breast-feeding because it may cause harm to the child. 
Zdravila Livensa ne uporabljajte, če dojite, ker lahko škoduje otroku.
- if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Livensa (see section ‘Further information' at the end of this leaflet). 
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO LIVENSA Ne uporabljajte zdravila Livensa če ste alergični (preobčutljivi) na testosteron ali katerokoli sestavino zdravila Livensa (glejte poglavje „Dodatne informacije“ na koncu tega navodila).
Abnormal blood fibrinogen, increased heart rate, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides 
Preiskave povečanje telesne mase nenormalne vrednosti fibrinogena v krvi, povečanje srčnega utripa, povečana vrednost alanin aminotransferaze, povečana vrednost aspartat aminotransferaze, povečana vrednost bilirubina v krvi, nenormalni rezultati testov delovanja jeter, povečana vrednost trigliceridov v krvi
Serum concentration of SHBG is influenced by the route of administration of concomitant estrogen therapy. 
Na koncentracijo SHBG v serumu vpliva pot uporabe sočasnega zdravljenja z estrogenom.
How and when to change your patch - You will need to change your patch every 3 to 4 days, which means using two patches each week. 
Obliž boste morali zamenjati vsake 3 do 4 dni, kar pomeni, da boste vsak teden uporabili dva obliža.
However, this is not expected from the low dose of testosterone delivered by the Livensa patch. 
Vendar teh učinkov pri nizkih odmerkih testosterona, ki se sproščajo iz obližev Livensa, ni pričakovati.
If you have any of the above, tell your doctor before you start to use Livensa. 
Če imate karkoli od navedenega, povejte svojemu zdravniku, preden začnete uporabljati zdravilo
Testosterone, the primary circulating androgen in women, is a naturally occurring steroid, secreted by the ovaries and adrenal glands. 
Mehanizem delovanja Testosteron, primarni androgen v krvnem obtoku pri ženskah, je naravni steroid, ki ga izločajo jajčniki in nadledvične žleze.
However, patients should be informed that migraine, insomnia, disturbance in attention and diplopia have been reported during treatment with Livensa. 
Vendar je treba bolnicam povedati, da so med zdravljenjem z zdravilom Livensa poročali o migreni, nespečnosti, motnjah pozornosti in diplopiji.
If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Livensa. 
Odstranite vse obliže in se posvetujte z zdravnikom ali s farmacevtom o tem, kako nadaljevati zdravljenje z zdravilom Livensa.
Fertility No data is available of the effect of Livensa on fertility. 
Plodnost Ni podatkov o vplivu zdravila Livensa na sposobnost razmnoževanja.
The sachet material comprises of food grade paper/LDPE/aluminium foil/ethylene methacrylic acid copolymer (outer to inner layer). 
Material zaščitne vrečice je sestavljen iz papirja/LDPE/aluminijaste folije/etilenskega kopolimera z metakrilno kislino, primerno za živila (od zunanje proti notranji plasti).
The patch is designed to remain in place during these times. 
da v takih primerih ostane na mestu.
- On the patch-change day, remove the used patch and immediately stick the new patch on to a different area of skin of your abdomen. 
Na dan, ko menjavate obliž, odstranite uporabljeni obliž in takoj nalepite novega na drugo mesto na koži trebuha.
The albumin-bound fraction and the unbound fraction are collectively termed ‘bioavailable' testosterone. 
Delež, vezan na albumin, in nevezan delež skupaj sestavljata “biološko uporaben” testosteron.
If a patch does begin to come off, you may be able to make it stick again by pressing on it firmly. 
Če se obliž začne dvigovati, ga boste morda z močnim pritiskom nalepili nazaj.
Most reports concerned the chin and upper lip, were mild (≥ 90 %), and less than 1 % of all patients withdrew from the studies due to hirsutism. 
učinki so bili blagi (≥ 90%), zaradi hirsutizma pa je zdravljenje prekinilo manj kot 1% vseh bolnic.
If you use more patches than you should 
Če ste uporabili več obližev, kot bi smeli Če ste nalepili več kot en obliž hkrati
The limited data evaluating the effect of testosterone on the endometrium neither allow conclusions nor reassurances on the incidence of endometrial cancer. 
Na podlagi omejenih podatkov o učinku testosterona na endometrij ni mogoče sklepati ali dajati zagotovil glede pogostosti raka endometrija.
As the efficacy and safety of Livensa have not been evaluated in studies of longer duration than 1 year, it is recommended that an appraisal of the treatment is undertaken every 6 months. 
Ker učinkovitost in varnost zdravila Livensa nista bili ocenjeni v študijah, ki bi trajale dlje kot 1 leto,
Serum concentrations of testosterone and SHBG in patients receiving Livensa in clinical safety and 
Koncentracije testosterona in SHBG v serumu pri bolnicah, ki so prejemale zdravilo Livensa v kliničnih študijah varnosti in učinkovitosti Izhodiščna vrednost
Decide which two days each week you are going to change your patch, and change the patch on the same two days each week. 
Odločite se, ob katerih dveh dnevih v tednu boste zamenjali obliž.
Livensa should not be used in naturally menopausal women Efficacy and safety of Livensa in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated. 
Učinkovitosti in varnosti zdravila Livensa pri ženskah po naravni menopavzi s HSDD, ki sočasno uporabljajo estrogen, s progestagenom ali brez njega, niso ocenili.
The ethylene methacrylic acid copolymer (Surlyn) is the heat seal layer which allows the two laminate sachet stocks to be heat-sealed together to form the sachet. 
Etilenski kopolimer z metakrilno kislino (Surlyn) je toplotno zatesnjena plast, ki omogoča toplotno tesnjenje dveh delov zaščitne vrečice v eno zaščitno vrečico.
- sinusitis (inflammation of nasal sinus) - abnormal clotting factor - hypersensitivity (allergic reactions) - increased appetite - agitation 
- preobčutljivost (alergijske reakcije) - povečanje apetita
Little information is available on the effects of testosterone on the endometrium. 
O učinkih testosterona na endometrij je na voljo malo podatkov.
You may shower, bath, swim and exercise as normal while wearing the patch. 
Med nošenjem obliža se lahko normalno prhate, kopate, plavate in telovadite.
If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Livensa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table. 
Livensa: n = 1.498, bolnice, ki so prejemale placebo: n = 1.297), je pogostnost navedena v tabeli.
Also contains: Sorbitan oleate, 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone copolymer, E110, E180, copper phthalocyanine blue pigment, polyethylene, siliconised polyester film. 
Vsebuje tudi: sorbitanoleat, 2-etilheksilakrilat - 1-vinil-2-pirolidonski kopolimer, E 110, E 180, modri pigment bakrovega ftalocianina, polietilen, silikonizirani poliestrski film.
Signs of virilisation, such as voice deepening, hirsutism or clitoromegaly, may be irreversible and discontinuation of treatment should be considered. 
hirsutizem ali klitoromegalija, so lahko ireverzibilni, zato je treba pretehtati možnost prekinitve zdravljenja.
If an area of the patch lifts, pressure should be applied to that area. 
Če se del obliža odlepi, je treba na ta del pritisniti.
The active substance is testosterone. 
Zdravilna učinkovina je testosteron.
Other uncommon side effects Most of them are mild in nature and reversible. 
Drugi pogosti neželeni učinki Večina teh učinkov je blagih in prehodnih:
The active substance is released from the patch constantly over 3 to 4 days (corresponding to 300 micrograms per 24 hours) and is absorbed through your skin. 
Zdravilna učinkovina se 3 do 4 dni neprekinjeno sprošča iz obliža (to ustreza 300 mikrogramom na
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva artritis
You should self assess for increased acne (a common side effect), increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of side effects of testosterone, which is the active substance in Livensa. 
Opazujte te znake povečanja pojava aken (pogosti neželeni učinek), povečane rasti dlak na obrazu, izpadanja las, znižanja glasu ali povečanja klitorisa, ker so lahko znaki neželenih učinkov testosterona, ki je zdravilna učinkovina v zdravilu Livensa.
- anxiety - disturbance in attention - dysgeusia (distorted sense of taste) - impaired balance - hyperaesthesia (abnormal increase in sensitivity to stimuli of the senses) - oral paraesthesia (tingling or numb sensation in the mouth) - transient ischemic attack (mini stroke) - diplopia (double vision) - eye redness - palpitations (rapid and irregular heart beat) - nasal congestion - throat tightness - diarrhoea - dry mouth - nausea - eczema - increased sweating - rosacea (redness of the face) - arthritis - breast cyst - clitoral engorgement - genital pruritus (genital itching sensation) - vaginal burning sensation - anasarca (widespread swelling of the skin) - asthenia (lack of energy and strength) - chest tightness - chest discomfort - abnormal blood fibrinogen (abnormal blood clotting) - increased heart rate - increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides (all measures of liver 
- palpitacije (hitro in nepravilno utripanje srca) - kongestija nosne sluznice (zamašen nos) - stiskanje v grlu - driska - suha usta - navzea (slabost) - ekcem - obilnejše potenje - rozacea (pordelost obraza) - artritis - cista na dojki - nabrekanje klitorisa - genitalni pruritus (občutek srbenja spolovil)
There were no significant differences in serum estradiol and estrone levels in patients treated with Livensa for up to 52 weeks compared to baseline. 
ki so prejemale zdravljenje z zdravilom Livensa, po 52 tednih ni bilo pomembnih razlik v koncentracijah estradiola in estrona, v primerjavi z izhodiščno vrednostjo.
The appropriate use and restrictions associated with estrogen therapy should be considered before Livensa therapy is initiated and during routine re-evaluation of treatment. 
Pred zdravljenjem z zdravilom Livensa in med rutinskimi ponovnimi ocenitvami zdravljenja je treba upoštevati ustrezno uporabo in omejitve, povezane z zdravljenjem z estrogenom.
The medical term for this condition is Hypoactive Sexual Desire Disorder, also known as 
Medicinski izraz za to stanje je motnja hipoaktivne spolne želje ali HSDD (hypoactive sexual desire disorder).
On removal of an Livensa patch, testosterone serum concentrations return to near baseline values within 12 hours due to its short terminal exponential half-life (approximately 2 hours). 
Po odstranitvi obliža Livensa se zaradi kratke končne eksponentne razpolovne dobe (približno 2 uri)
STATEMENT OF ACTIVE SUBSTANCE(S) 
N Srednja vrednost (SEM)
Hirsutism Acne, alopecia Eczema, increased sweating, rosacea 
Bolezni kože in podkožja hirsutizem akne, alopecije ekcem, povečano potenje, rozacea
ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
DODATEK II A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, androgens, ATC 
Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, androgeni, oznaka ATC: G03BA03.
Step 1 Tear open the sachet. 
Kako nalepiti obliž 1. korak Odprite zaščitno vrečico.
Oedema (with or without congestive heart failure) may be a serious complication from high doses of testosterone or other anabolic steroids in patients with pre-existing cardiac, renal, or hepatic disease. 
Pri bolnicah z že obstoječo srčno, ledvično ali jetrno boleznijo, je edem (s kongestivno srčno odpovedjo ali brez nje) lahko resen zaplet zaradi velikih odmerkov testosterona ali drugih anabolnih steroidov.
Breast cyst, clitoral engorgement, enlarged clitoris, genital pruritus, vaginal burning sensation 
Motnje reprodukcije in dojk bolečine v dojkah cista na dojki, nabrekanje klitorisa, povečanje klitorisa, genitalni pruritus, občutek pečenja v vagini
The other ingredients are: Sorbitan oleate, 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone co-polymer. 
Pomožne snovi so: sorbitanoleat, 2-etilheksilakrilat - 1-vinil-2-pirolidonski kopolimer.
Use your fingers to make sure the edges of the patch stick to the skin. 
Potipajte robove in se prepričajte, da so prilepljeni na kožo.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 transdermalni obliž
Breast pain 
- bolečina v prsnem košu
Apply the patch immediately after removing it from the sachet. 
Namestite takoj, ko vzamete iz zaščitne vrečice.
Serum concentrations of testosterone attain steady-state by the application of the second patch when applied in a twice-a-week regimen. 
Stanje dinamičnega ravnovesja koncentracije testosterona v serumu se pri apliciranju dvakrat tedensko doseže z aplikacijo drugega obliža.
Migraine 
- migrena
Translucent polyethylene backing film printed with ink containing sunset yellow FCF (E110), latolrubine BK (E180) and copper phthalocyanine blue pigment. 
Prosojna polietilenska zunanja folija, natisnjena s črnilom, ki vsebuje oranžno barvilo FCF (E 110), latolrubin BK (E 180) in modri pigment bakrovega ftalocianina.
1 patch of 28 cm2 contains 8.4 mg of testosterone and provides 300 micrograms per 24 hours. 
1 obliž s površino 28 cm2 vsebuje 8,4 mg testosterona in sprosti 300 mikrogramov testosterona v 24 urah.
Change the patch only on these two days. 
Obliž vsak teden zamenjajte ob istih dveh dnevih.
The transdermal patch should not be flushed down the toilet. 
6.6 Posebni varnostni ukrepi za odstranjevanje Transdermalnega obliža ne odplaknite v stranišče.
Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije Warner Chilcott Deutschland GmbH
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
DHT concentrations increased in parallel with testosterone concentrations during Livensa treatment. 
Med zdravljenjem z zdravilom Livensa se koncentracije DHT povečajo skupaj s koncentracijami testosterona.
Severe skin erythema, local oedema and blistering may occur due to hypersensitivity to the patch at the site of application. 
Zaradi preobčutljivosti na obliž se lahko na mestu aplikacije pojavijo hud kožni eritem, lokalni edem in mehurji.
If an area of the patch lifts, apply pressure to that area. 
Če se del obliža odlepi, ta del pritisnite.
Patients with diabetes mellitus have not been studied. 
Bolnic s sladkorno boleznijo niso preučevali.
Gastrointestinal disorders 
Prosti testosteron
Siliconised polyester film 
Zaščitna plast silikonizirana poliestrska folija
Grounds for one additional renewal 
Podlaga za eno dodatno podaljšanje dovoljenja za promet z zdravilom
Diarrhoea, dry mouth, nausea 
Bolezni prebavil bolečina v trebuhu driska, suha usta, navzea
QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch of 28 cm2 contains 8.4 mg testosterone and provides 300 micrograms of testosterone per 24 hours. 
Vsak obliž s površino 28 cm2 vsebuje 8,4 mg testosterona in sprosti 300 mikrogramov testosterona v 24 urah.
Livensa is intended for use by women up to the age of 60 years who: - have a low sexual desire which is causing distress or concern, and - have had both of their ovaries removed, and - have had their womb removed (hysterectomy), and - are receiving estrogen therapy. 
imajo nizko spolno željo, ki povzroča stisko ali skrbi in so jim odstranili oba jajčnika in so jim odstranili maternico (histerektomija) in prejemajo zdravljenje z estrogenom.
What Livensa contains 
DODATNE INFORMACIJE Kaj vsebuje zdravilo Livensa
A responder analysis of the pivotal phase II and III studies showed significant improvements in all three major clinical endpoints versus placebo in patients on concomitant transdermal and oral non-CEE estrogens. 
in III. faze, je pri bolnicah, ki so sočasno prejemale transdermalne in druge peroralne estrogene kot CEE, pokazala pomembno izboljšanje v primerjavi s placebom pri vseh treh kliničnih končnih točkah.
Only one patch is to be worn at a time. 
Hkrati se sme aplicirati le en obliž.
Diplopia, eye redness 
Očesne bolezni diplopija, rdeče oko
Testosterone may induce virilising effects on the female foetus when administered to a pregnant woman. 
Kadar ga uporabljajo nosečnice, testosteron lahko sproži virilizacijske učinke pri ženskem plodu.
Translucent polyethylene backing film sunset yellow FCF (E110) latolrubine BK (E180) copper phthalocyanine blue pigment. 
Zunanja plast prosojna polietilenska zunanja folija Tiskarsko črnilo oranžno barvilo FCF (E 110) latolrubin BK (E 180) modri pigment bakrovega ftalocianina
Testosterone has a masculinising effect on female rat foetuses when dosed subcutaneously at 0.5 or 1 mg/day (as the propionate ester) to pregnant rats during organogenesis. 
Testosteron ima maskulinizirajoči učinek na ženske plodove podgan pri subkutanem odmerjanju 0,5
Transdermal patch. 
Transdermalna uporaba.
EFFECTIVE USE OF THE MEDICINAL PRODUCT 
DOVOLJENJA ZA PROMET Z ZDRAVILOM
HOW TO STORE LIVENSA 
SHRANJEVANJE ZDRAVILA LIVENSA
Anasarca, asthenia, chest tightness, chest discomfort 
anasarka, astenija, stiskanje v prsih, občutek neugodja v prsnem košu
Livensa 300 micrograms/24 hours transdermal patch Testosterone 
Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
Eye disorders 
- pordelost oči
8 transdermal patches 
8 transdermalnih obližev 24 transdermalnih obližev
NAME OF THE MEDICINAL PRODUCT Livensa 300 micrograms/24 hours transdermal patch 
IME ZDRAVILA Livensa 300 mikrogramov/24 ur transdermalni obliž
Hepatic impairment No studies have been conducted in patients with hepatic impairment. 
Študij pri bolnikih z okvarjenim delovanjem jeter niso izvajali.
How to stick on the patch 
Kam nalepiti obliž
Remove the patch. 
Navodilo shranite.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Livensa 300 micrograms/24 hours transdermal patch Testosterone 
IME ZDRAVILA IN POT(I) UPORABE Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
Therefore, based on the safety profile in Livensa, which requires the submission of 6 monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time. 
Zato je Odbor za zdravila za uporabo v humani medicini na podlagi varnostnega profila zdravila Livensa, za katerega je treba periodično poročilo o varnosti zdravila predložiti vsakih 6 mesecev,
Always use Livensa exactly as your doctor has told you. 
Pri uporabi zdravila Livensa natančno upoštevajte zdravnikova navodila.
Breastfeeding Livensa must not be used by breast-feeding women. 
Previdnostni ukrepi Zdravila Livensa se ne sme uporabljati pri ženskah po naravni menopavzi
Acrylic co-polymer adhesive containing 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone co-polymer. 
Samolepilna matriksna plast, ki vsebuje zdravilo sorbitanoleat akrilno kopolimerno lepilo, ki vsebuje 2-etilheksilakrilat - 1-vinil-2-pirolidonski kopolimer
You should check with your doctor or pharmacist if you are not sure of the instructions or if you want any more information. 
Če ste negotovi, da razumete navodila, ali če želite dodatne informacije, se posvetujte z zdravnikom ali s farmacevtom.
THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription. 
Izdaja zdravila je le na recept.
Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt Germany 
Dr.-Otto-Röhm-Strasse 2-4
Reproductive system and breast disorders 
Infekcijske in parazitske bolezni sinuzitis
Baseline 
Livensa.
The mode of administration of Livensa makes overdose unlikely. 
4.9 Preveliko odmerjanje Zaradi načina odmerjanja zdravila Livensa preveliko odmerjanje ni verjetno.
Information to appear on the inside of the flap 
Podatki na notranji strani zavihka Kdaj namestiti obliž:
Special populations 
Posebna opozorila
B. PACKAGE LEAFLET 
DODATEK IV
Press the sticky side of the patch firmly into place for about 10 seconds. 
10 sekund močno pritisnite na kožo.
Where to stick the patch - Stick the patch onto your lower abdomen, below your waist. 
Obliž nalepite na spodnji del trebuha, pod pas.
- Keep out of the reach and sight of children - Do not use Livensa after the expiry date which is stated on the carton and sachet after EXP. 
Zdravila Livensa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in zaščitni vrečici poleg oznake EXP/Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Tabulated list of adverse reactions 
Seznam neželenih učinkov v obliki razpredelnice
The significance of these data for the use of Livensa in patients is not known. 
Livensa pri bolnicah ni znan.
Very common Common 
Pogosti
Subgroup analyses suggested that the route and type of concomitant estrogen (transdermal oestradiol, oral conjugated equine estrogen (CEE), oral non-CEE) can influence patient response. 
Analiza podskupin je nakazala, da lahko na odziv bolnic vpliva način uporabe in vrsta estrogena
NAME OF THE MEDICINAL PRODUCT Livensa 300 micrograms/24 hours transdermal patch Testosterone 
NAVODILO ZA UPORABO Livensa 300 mikrogramov/24 ur transdermalni obliž Testosteron
please tell your doctor or pharmacist. 
Zdravniku takoj povejte:
The CHMP decided that the MAH should continue to submit 6 monthly PSURs. 
Odbor za zdravila za uporabo v humani medicini se je odločil, da naj imetnik dovoljenja za promet z zdravilom predloži periodično poročilo o varnosti zdravila vsakih 6 mesecev.
Livensa is not recommended in naturally 
Uporaba zdravila Livensa se ne priporoča ženskam po naravni menopavzi.
Blood and lymphatic system 
Bolezni krvi in limfatičnega nenormalni faktor strjevanja krvi
Arthritis 
Dojenje
Abnormal clotting factor 
- sinusitis (vnetje nosnih sinusov) - nenormalen faktor strjevanja krvi
Increased appetite 
Presnovne in prehranske motnje povečanje apetita
Each pack contains the vial with concentrate. 
Vsaka škatla vsebuje vialo s koncentratom.
Date of latest renewal: 20th November 2018 
Datum prve odobritve: 16.01.2014 Datum zadnjega podaljšanja: 20. novembra 2018
Packs containing 1, 4 or 10 vials. 
Pakiranje vsebuje 1, 4 ali 10 vial.
EXP Use immediately after dilution. 
EXP Uporabite takoj po redčenju.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: 
Neželeni učinki so razvrščeni glede na pogostnost, najprej najpogostejši, in to po naslednjem dogovoru:
The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established. 
Varnost in učinkovitost zoledronske kisline pri otrocih starih 1 do 17 let nista bili dokazani.
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Accord properly (see section 6). 
Vaš zdravnik, farmacevt ali medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Accord pravilno shranjevati (glejte poglavje 6).
Zoledronic Acid Accord can be given to people aged 65 years and over. 
Zdravilo Zoledronska kislina Accord lahko dajemo ljudem, ki so stari 65 let ali več.