natgillin/translations-raw huggingface dataset:
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 Opatanol. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Opatanol, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
If another eye treatment is also being used, there should be a gap of five minutes between treatments; eye ointments should be administered last. 
Če se istočasno izvaja še kako drugo zdravljenje očesa, je treba zdravila dajati z razmikom petih minut, pri čemer mazila za oči nanašamo nazadnje.
Opatanol was as effective as cromolyn sodium and as levocabastine. 
Zdravilo Opatanol je bilo enako učinkovito kot natrijev kromoglikat in levokabastin.
The CHMP decided that Opatanol's benefits are greater than its risks for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Opatanol večje od z njim povezanih tveganj pri zdravljenju očesnih znakov in simptomov sezonskega alergijskega konjunktivitisa, in priporočil, da se zanj izda dovoljenje za promet.
What benefit has Opatanol shown during the studies? 
Kakšne koristi je zdravilo Opatanol izkazalo med raziskavami?
At lower pollen counts, there were no differences between the two treatments. 
Pri nizkih koncentracijah cvetnega prahu razlik med obema zdraviloma ni bilo.
What is the risk associated with Opatanol? 
Kakšna tveganja so povezana z zdravilom Opatanol?
Other information about Opatanol 
Druge informacije o zdravilu Opatanol:
Therefore care should be taken by people who wear soft contact lenses. 
Zato morajo biti osebe z mehkimi kontaktnimi lečami pri uporabi previdne.
Opatanol contains benzalkonium chloride, which is known to discolour soft contact lenses. 
Zdravilo Opatanol vsebuje benzalkonijev klorid, katerega znana lastnost je, da razbarva mehke kontaktne leče.
Opatanol was compared with cromolyn sodium (another anti-allergy medicine), with levocabastine (another antihistamine) and, in two studies, with placebo (a dummy treatment). 
Zdravilo Opatanol so primerjali z natrijevim kromoglikatom (drugo vrsto zdravila proti alergijam), z levokabastinom (drugo vrsto antihistaminskega zdravila), v dveh študijah pa so ga primerjali s placebom (zdravilom brez zdravilne učinkovine).
When compared with placebo, Opatanol was more effective only when pollen counts were taken into account, showing that the higher the level of pollen in the air, the greater the difference between the effects of Opatanol and those of placebo. 
V primerjavi s placebom je bolj učinkovito le, če se upošteva tudi količina cvetnega prahu, pri čemer se je pokazalo, da je bila razlika med učinki zdravila Opatanol in placeba tem večja, čim večja je bila koncentracija cvetnega prahu v zraku.
For the full list of all side effects reported with Opatanol, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Opatanol, glejte navodilo za uporabo.
Opatanol is used to treat the eye symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever). 
Zdravilo Opatanol se uporablja za zdravljenje očesnih simptomov sezonskega alergijskega konjunktivitisa (vnetja oči, ki ga pri bolnikih s senenim nahodom povzroča cvetni prah).
Why has Opatanol been approved? 
Zakaj je bilo zdravilo Opatanol odobreno?
It is given as one drop into the affected eye(s) twice a day, given eight hours apart. 
Odmerek zdravila Opatanol je ena kapljica v prizadeto oko (očesi) dvakrat na dan v osemurnih presledkih.
Olopatadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. 
Olopatadin deluje kot zaviralec receptorjev, na katere se običajno veže histamin, tj. snov v telesu, ki povzroča alergijske
The active substance in Opatanol, olopatadine, is an antihistamine. 
Zdravilna učinkovina zdravila Opatanol je olopatadin, ki je antihistaminsko zdravilo.
How has Opatanol been studied? 
Kako je bilo zdravilo Opatanol raziskano?
What is Opatanol used for? 
Za kaj se zdravilo Opatanol uporablja?
What is Opatanol? 
Kaj je zdravilo Opatanol?
Opatanol is a clear eye drop solution, which contains the active substance olopatadine. 
Zdravilo Opatanol so kapljice za oko v obliki bistre raztopine, ki vsebuje zdravilno učinkovino olopatadin.
How does Opatanol work? 
Kako zdravilo Opatanol deluje?
In all of the studies, the main measure of effectiveness was based on the degree of itching and redness in the eye. One of the placebo studies also looked at these symptoms in relation to pollen counts. 
V vseh študijah je glavno merilo učinkovitosti temeljilo na intenzivnosti srbenja in pordelosti očesa.
How is Opatanol used? 
Kako se zdravilo Opatanol uporablja?
183 11 Täby Sweden 
183 11 Täby Švedska
2710-444 Sintra Portugal 
2710-444 Sintra Portugalska
0667 Oslo Norway 
0667 Oslo Norveška
Lumiracoxib 100 mg tablets 
Lumiracoxib 100 mg tablete
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
U Nákladového nádraží 10 130 00 Praha 3 
U Nákladového nádraží 10 130 00 Praga 3
Strength Pharmaceutical form Route of administration 
Farmacevtska oblika Pot uporabe
Novartis Hungária Kft. 1114 Budapest Bartók Béla út 43-47 Hungary 
Novartis Hungária Kft. 1114 Budapest Bartók Béla út 43-47 Madžarska
Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 København Ø Denmark 
Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 København Ø Danska
6824 DP Arnhem Nederland 
6824 DP Arnhem
Novartis Pharmaceuticals UK Limited, 
Velika Britanija Novartis Pharmaceuticals UK Limited,
Novartis Pharmaceuticals UK Limited 
Velika Britanija Novartis Pharmaceuticals UK Limited
Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU-167-SR UK 
Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU-167-SR Velika Britanija
Novartis Pharmaceuticals UK Ltd. Frimley Business Park, Frimley, Camberly, GU16 7SR Surrey UK 
Novartis Pharmaceuticals UK Ltd. Frimley Business Park, Frimley, Camberly, GU16 7SR Surrey Velika Britanija
Nederlands 
Nizozemska
Novartis Pharma GmbH Brunner Straße 59 1235 Wien 
Novartis Pharma GmbH Brunner Straße 59 1235 Dunaj
Novartis Finland Oy, Metsänneidonkuja 10, FI-02130, Espoo Finland 
Novartis Finland Oy, Metsänneidonkuja 10, FI-02130, Espoo Finska
Belgium Novartis Pharma NV Medialaan 40 bus 1 
Novartis Pharma NV Medialaan 40 bus 1 B-1800 Vilvoorde Belgija
Member State Marketing Authorisation Holder (Invented) name 
Država članica Imetnik dovoljenja za promet z zdravilom
Novartis Finland Oy, Metsanneidonkuja-10, FIN-02130 Espoo Finland 
Novartis Finland Oy, Metsanneidonkuja-10, FIN-02130 Espoo Litva
U Nákladového nádraží 10 130 00 Prague 3 
Novartis s.r.o., Nagano III. U Nákladového nádraží 10 130 00 Praga 3
90429 Nürnberg Germany 
90429 Nürnberg Nemčija
D-90429 Nuernberg Germany 
D-90429 Nuernberg Nemčija
Novartis Pharma B.V. Raapopseweg 1 
Nizozemska Novartis Pharma B.V.
Frimley Business Park Frimley, Camberley Surrey GU16 7SR UK 
Surrey GU16 7SR
D-90429 Nurnberg Germany 
D-90429 Nürnberg Nemčija
{Name and address} {tel} {fax} {e-mail} 
{Ime in naslov} {tel.} {faks} {e-pošta}
An effect in man cannot be excluded. 
Vpliva pri človeku ni mogoče izključiti.
Number (%) of patients who had died. 
Število (%) umrlih bolnic.
It is a long-term treatment and you may need to take it for several years. 
To je dolgotrajno zdravljenje in morda boste zdravilo morali jemati več let.
Your tablets could harm them. 
Te tablete jim lahko škodujejo.
Keep your tablets in a safe place where children cannot see or reach them. 
Tablete shranjujte na varnem mestu, kjer jih otroci ne morejo videti ali doseči.
51689 Reims Cedex France 
51689 Reims Cedex Francija
Food slightly decreases the rate but not the extent of absorption. 
Hrana nekoliko zmanjša hitrost absorpcije, ne pa njenega obsega.
After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required. 
Po odločbi Komisije bodo pristojni organi držav članic, v povezavi z referenčno državo članico posodobili podatke o zdravilu, kot je potrebno.
This would be seen in a blood test. 
To se pokaže s preiskavo krvi.
Long-term safety data in children and adolescents are not available. 
Dolgoročnih podatkov o varnosti pri otrocih in mladostnikih ni.
Final height data were not available. 
Podatki o končni telesni višini niso bili na voljo.
If you forget to take a dose, just take your next dose as normal. 
Če ste pozabili vzeti odmerek, zgolj vzemite naslednji odmerek kot po navadi.
Detailed information on this medicine is available on the web site of {MA/Agency} 
Podrobne informacije o zdravilu so objavljene na spletni strani {DČ/agencija}
Corticoid supplements are therefore not needed. 
Dodajanje kortikoidov zato ni potrebno.
- if you have problems with your liver or kidneys. 
- če imate težave z jetri ali ledvicami.
Keep your tablets in the container they came in. 
Tablete shranjujte v vsebniku, v katerem ste jih dobili.
All patients received treatment with vitamin D and calcium. 
Vse bolnice so prejemale zdravljenje z vitaminom D in kalcijem.
If bleeding persists, further evaluation should be considered. 
Če krvavitev traja, je potrebno dodatno ovrednotenje.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), če ste pozabili vzeti prejšnji odmerek.
General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated. 
Indicirana je splošna podporna oskrba, vključno s pogostim nadziranjem vitalnih znakov in natančnim opazovanjem bolnika.
- if you are pregnant or breast-feeding (see the section called ‘Pregnancy and breast-feeding'). 
- če ste noseči ali če dojite (glejte poglavje "Nosečnost in dojenje").
This may lower the mineral content of your bones. 
To lahko zmanjša vsebnost mineralov v kosteh.
Your bones may be less strong and may be more likely to fracture. 
Kosti lahko postanejo manj čvrste in poveča se verjetnost zlomov.
• Bleeding from the vagina (usually in the first few weeks of treatment - if the bleeding continues, talk to your doctor). 
• krvavitev iz nožnice (po navadi v prvih nekaj tednih zdravljenja - če se krvavitev nadaljuje, se posvetujte z zdravnikom)
This is known as ‘angioedema'. 
To je znano kot "angioedem".
However, the majority of these events occurred in patients with identifiable risk factors for the development of the condition. 
Vendar se je večina teh primerov pojavila pri bolnikih s prepoznavnimi dejavniki tveganja za pojav te motnje.
Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up). 
Dvanajstmesečno kombinirano zdravljenje je dokončalo 13 od 14 vključenih bolnikov (en bolnik se je izgubil spremljanju).
These effects occurred at clinically relevant doses. 
Ti učinki so se pojavili pri klinično pomembnih odmerkih.
Multiple dose toxicity studies utilized rats and dogs. 
V študijah toksičnosti več odmerkov so uporabili podgane in pse.
Estrone is subsequently converted to estradiol. 
Estron se nato spremeni v estradiol.
There is no specific antidote to overdose and treatment must be symptomatic. 
Specifičnega antidota za preveliko odmerjanje ni in zdravljenje mora biti simptomatsko.
Treatment should be based on a benefit-risk evaluation for the individual patient. 
Zdravljenje mora temeljiti na oceni koristi in tveganja za vsako posamezno bolnico.
Very rarely symptoms of joint, stomach, and kidney pain may occur; this is known as ‘Henoch-Schönlein purpura'. 
Zelo redko se lahko pojavijo simptomi v sklepih, želodcu in bolečine ledveno; to imenujemo "Henoch-Schönleinova purpura".
Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored. 
Zdravljenje ali profilakso osteoporoze je treba začeti, kot je ustrezno, in ju natančno nadzirati.
The effect of potent CYP inhibitors is unknown. 
Učinek močnih zaviralcev CYP ni znan.
Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), and very rare (<1/10,000). 
Skupine pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
- if you have ever had a condition that affects the strength of your bones (osteoporosis). 
- če ste kdaj imeli bolezen, ki prizadene čvrstost kosti (osteoporozo).
The rate of prolonged (more than 24 weeks) stable disease, the rate of progression, and survival were also calculated. 
Izračunani so bili tudi delež dolgotrajno stabilne bolezni (več kot 24 tednov), delež napredovanj in preživetje.
Two further similar trials (GABG/ARNO 95 and ITA), in one of which patients had received surgery and chemotherapy, as well as a combined analysis of ABCSG 8 and GABG/ARNO 95, supported these results. 
Dve nadaljnji podobni preskušanji (GABG/ARNO 95 in ITA), v enem od katerih so bolnice zdravili z operacijo in kemoterapijo, ter kombinirana analiza ABCSG 8 in GABG/ARNO 95 potrjujejo te rezultate.
There were too few deaths occurring across treatment groups of both trials to draw conclusions on overall survival differences. 
Smrti je bilo v terapevtskih skupinah obeh preskušanj premalo, da bi bilo mogoče sklepati o razliki v celokupnem v preživetju.
You should talk to your doctor about the risks and treatment options. 
Z zdravnikom se posvetujte o tveganjih in o drugih možnostih zdravljenja.
Measured mean plasma concentrations were 44.4 (±14.7) ng/ml and 165 (±90) ng/ml respectively. 
Izmerjena povprečna koncentracija v plazmi je bila 44,4 (± 14,7) ng/ml in 165 (± 90) ng/ml.
If any of these happen to you, call an ambulance or see a doctor straight away - you may need urgent medical treatment. 
Če se vam pojavi kaj od tega, takoj pokličite reševalce ali pojdite k zdravniku - morda potrebujete nujno zdravniško pomoč.
Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4). 
Ena filmsko obložena tableta vsebuje 93 mg laktoze monohidrata (glejte poglavje 4.4).
The following table presents adverse reactions from clinical trials, post-marketing studies or spontaneous reports. 
Naslednja preglednica prikazuje neželene učinke iz kliničnih preskušanj, postmarketinških študij in spontanih poročil.
In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken. 
Pri obravnavi prevelikega odmerjanja je treba upoštevati možnost, da je bilo uporabljenih več zdravil.
- Swallow the tablet whole with a drink of water. 
- Tableto zaužijte celo z nekaj vode.
p-value Overall survival e 
vrednost p Celokupno preživetje e
Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text. 
Zato ta SmPC, označevanje in navodilo za uporabo mogoče potem ne bodo več predstavljali veljavnega besedila.
Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). 
Spodaj našteti neželeni učinki so razvrščeni po pogostnosti in organskem sistemu (SOC).
- Medicines that contain estrogen, such as hormone replacement therapy (HRT). 
- Zdravila, ki vsebujejo estrogen, npr. hormonsko nadomestno zdravljenje (HNZ).
Only 14 subjects on Arimidex completed 36 months. 
Samo 14 preiskovancev, ki so prejemali zdravilo Arimidex, je dokončalo 36 mesecev.
The incidence of osteoporosis was 10.5% in patients treated with Arimidex and 7.3% in patients treated with tamoxifen. 
Incidenca osteoporoze je bila 10,5 % pri bolnicah, zdravljenih z zdravilom Arimidex in 7,3 % pri bolnicah, zdravljenih s tamoksifenom.
• Changes in special blood tests that show how your liver is working (gamma-GT and bilirubin). 
• spremembe izvidov posebnih preiskav krvi, ki kažejo delovanje jeter (gama-GT in bilirubin)
Short stature due to Growth Hormone Deficiency 
Nizka rast zaradi pomanjkanja rastnega hormona
This belongs to a group of medicines called ‘aromatase inhibitors'. 
Ta spada v skupino zdravil, imenovanih "zaviralci aromataze".
Clearance of anastrozole was lower in girls (3-10 years) than in the older boys and exposure higher. 
Očistek anastrozola je bil pri deklicah (starih od 3 do 10 let) manjši kot pri starejših dečkih, izpostavljenost pa je bila večja.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se z njim posvetujte, preden vzamete to zdravilo.
Any venous thromboembolic event Deep venous thromboembolic events including PE (pulmonary embolism) 
Katerikoli venski trombembolični dogodek Globoka venska trombembolija, vključno s PE (pljučno embolijo)
In boys with pubertal gynaecomastia (10-17 years), anastrozole was rapidly absorbed, was widely distributed, and was eliminated slowly with a half-life of approximately 2 days. 
Pri dečkih s pubertetno ginekomastijo (starih od 10 do 17 let) se je anastrozol hitro absorbiral, se je široko porazdelil in se je odstranil počasi, z razpolovnim časom približno 2 dni.
Results from the secondary endpoints were supportive of the results of the primary efficacy endpoints. 
Rezultati sekundarnih opazovanih dogodkov so potrjevali rezultate primarnih opazovanih dogodkov.
The recommended dose of Arimidex for adults including the elderly is one 1 mg tablet once a day. 
Priporočeni odmerek zdravila Arimidex za odrasle (vključno s starejšimi) je ena 1-mg tableta enkrat na dan.
Do not use Arimidex after the expiry date which is stated on the carton and <container> [To be completed nationally]. 
Zdravila Arimidex ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in <vsebnik> [Izpolni država članica].
Hair thinning (alopecia) Allergic reactions 
Pogosti redčenje las (alopecija) alergijske reakcije
Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase 
Pogosti zvišanje alkalne fosfataze, alaninaminotransferaze in aspartat-aminotransferaze
Mating indices were adversely affected in both dose groups, whilst a reduction in fertility was evident only at the 400 mg/l dose level. 
Indeksi parjenja so bili slabši v obeh odmernih skupinah, zmanjšanje plodnosti pa je bilo opazno le pri odmerku 400 mg/l.
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet. 
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta
Important information about some of the ingredients of Arimidex Arimidex contains lactose which is a type of sugar. 
Pomembne informacije o nekaterih sestavinah zdravila Arimidex Zdravilo Arimidex vsebujejo laktozo, ki je vrsta sladkorja.
Table 3 ATAC endpoint summary: 5-year treatment completion analysis Efficacy endpoints 
Preglednica 3 Povzetek na koncu ATAC: Analiza po končanem 5-letnem zdravljenju Končne točke učinkovitosti
Ischaemic cardiovascular disease Angina pectoris 
Ishemična kardiovaskularna bolezen Angina pektoris
Growth rate (in cm/year) was significantly reduced (p<0.05) from pretreatment through month 0 to month 12, and from pre-treatment to the second 6 months (month 7 to month 12). 
Hitrost rasti (v cm/leto) se je značilno zmanjšala (p < 0,05) od pred zdravljenja prek meseca nič do 12. meseca ter od pred zdravljenja do drugih 6 mesecev (od 7. do 12. meseca).
A decrease in 50% or more of total breast volume was seen in 56% (20/36) of the boys after 6 months. 
Po 6 mesecih so zmanjšanje celotnega volumna prsi za 50 % ali več opazili pri 56 % (20/36) dečkov.
** Since cutaneous vasculitis and Henoch-Schönlein purpura was not observed in ATAC, the frequency category for these events can be considered as ‘Rare' (≥ 0.01% and < 0.1%) based on the worst value of the point estimate. 
** Ker kožnega vaskulitisa in Henoch-Schönleinove purpure v ATAC niso zabeležili, je mogoče njuno pogostnost na podlagi najneugodnejše vrednosti točkovne ocene oceniti kot "redko" (≥ 0,01 % in
These effects were related to the pharmacological effects of the compound on parturition. 
Ti učinki so bili povezani s farmakološkimi učinki spojine na porajanje.
Approximately 90 to 95% of plasma anastrozole steady-state concentrations are attained after 7 daily doses, and accumulation is 3- to 4-fold. 
Približno 90 do 95 % koncentracije anastrozola v plazmi v stanju dinamičnega ravnovesja je doseženih po 7 dnevnih odmerkih in kopičenje je od 3- do 4-kratno.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Bolniki z redkimi prirojenimi motnjami, kot so galaktozna intoleranca, laponska oblika zmanjšane aktivnosti laktaze ali malabsorbcija glukoze-galaktoze, ne smejo jemati tega zdravila.
Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro. 
Anastrozol in vitro zavira CYP 1A2, 2C8/9 in 3A4.
This includes medicines that you buy without a prescription and herbal medicines. 
To velja tudi za zdravila, ki ste jih dobili brez recepta, in za zeliščne pripravke.
AstraZeneca GmbH Tinsdaler Weg 183 D-22880 Wedel Germany 
AstraZeneca GmbH Tinsdaler Weg 183 D-22880 Wedel Nemčija
The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any patient where there is doubt about menopausal status. 
Menopavzo je treba ugotoviti biokemično (koncentracija luteinizirajočega hormona [LH], folikle stimulirajočega hormona [FSH] in/ali estradiola) pri vsaki bolnici, pri kateri obstaja dvom o menopavzalnem stanju.
These medicines are used to treat breast cancer, certain female health (gynaecological) conditions, and infertility. 
Ta zdravila se uporabljajo za zdravljenje raka dojke, določenih ženskih (ginekoloških) bolezni in neplodnosti.
The efficacy of study treatment was based on the proportion of patients fulfilling defined criteria relating to vaginal bleeding, bone age, and growth velocity. 
Učinkovitost raziskovanega zdravljenja je temeljila na deležu bolnic, ki so izpolnile opredeljena merila, povezana z nožničnimi krvavitvami, kostno starostjo in hitrostjo rasti.
• An extremely severe skin reaction with ulcers or blisters on the skin. 
• izredno huda kožna reakcija z razjedami ali mehurji na koži.
It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on Arimidex treatment reflect a protective effect of tamoxifen, a specific effect of Arimidex, or both. 
Ni ugotovljeno, ali deleži zlomov in osteoporoze, zabeleženi v študiji ATAC pri bolnicah, ki so prejemale zdravilo Arimidex, odraža zaščitni učinek tamoksifena, specifični učinek zdravila Arimidex ali oboje.
The metabolites are excreted primarily via the urine. 
Presnovki se izločijo predvsem v urinu.
A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with Arimidex who also received other commonly prescribed medicinal products. 
Pregled podatkovne baze o varnosti v kliničnih preskušanjih ni odkril klinično pomembnih medsebojnih delovanj pri bolnikih, zdravljenih z zdravilom Arimidex, ki so prejemali tudi druga pogosto predpisovana zdravila.
This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. 
Med takšna spadajo gonadorelin, buserelin, goserelin, levprorelin in triptorelin.
Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission Decision. 
Opomba: Ta povzetek glavnih značilnosti zdravila (SmPC), označevanje in navodilo za uporabo so različice, veljavne ob izdaji odločbe Komisije.