natgillin/translations-raw huggingface dataset:
In patients who were RBC transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of RBC transfusion independence was 13.9 months in the azacitidine group and was not reached in the CCR group.
Pri bolnikih, ki so bili v izhodišču odvisni od transfuzij eritrocitov in so ob zdravljenju dosegli neodvisnost od transfuzij, je bilo mediano trajanje neodvisnosti od transfuzij eritrocitov v skupini z azacitidinom 13,9 meseca, v skupini s CCR pa neodvisnosti niso dosegli.
How to use Azacitidine Celgene
Kako uporabljati zdravilo Azacitidine Celgene
Method of administration Do not filter the suspension after reconstitution.
Način uporabe Rekonstituirane suspenzije ne filtrirajte.
Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 38.5% (95% CI = 31.1, 46.2) of these patients became RBC transfusion independent during the treatment period, compared with 27.6% of (95% CI = 20.9, 35.1) patients in the combined CCR groups.
Od bolnikov v skupini z azacitidinom, ki so bili v izhodišču odvisni od transfuzij eritrocitov, jih je 38,5 % (95 % IZ = 31,1; 46,2) v obdobju zdravljenja postalo neodvisnih od transfuzij eritrocitov, v primerjavi s 27,6 % (95 % IZ = 20,9; 35,1) bolnikov v skupinah s kombiniranimi CCR.
Following Azacitidine Celgene treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is ≤ 50 %, or greater than 50 % but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
Po zdravljenju z zdravilom Azacitidine Celgene naslednjega cikla ni treba prestaviti in prilagajati odmerka, če je zmanjšanje števila levkocitov ali ANC ali trombocitov ≤ 50 % od stanja pred zdravljenjem ali večje kot 50 % z izboljšanjem v diferenciaciji katerekoli celične linije.
When Azacitidine Celgene is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Pri rekonstituciji zdravila Azacitidine Celgene z vodo za injekcije, ki je bila v hladilniku (2 °C do 8 °C), je rekonstituirano zdravilo kemijsko in fizikalno stabilno 22 ur pri 2 °C do 8 °C.
White lyophilised powder.
Prašek za suspenzijo za injiciranje Bel liofiliziran prašek.
Read the leaflet for the shelf life of the reconstituted medicine.
Za rok uporabnosti rekonstituiranega zdravila preberite priloženo navodilo.
*Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count]) Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 10
*Obnovitev = število ≥ število v najnižji točki + (0,5 x [izhodiščno število - število v najnižji točki]) Bolniki, pri katerih je pred prvim zdravljenjem zmanjšano izhodiščno število krvnih celic (t.j.
Necrotising fasciitis, including fatal cases, have been reported in patients treated with azacitidine.
Pri bolnikih, zdravljenih z azacitidinom, so poročali o nekrotizantnem fasciitisu, vključno s smrtnimi primeri.
1 vial - 100 mg
prašek za suspenzijo za injiciranje 1 viala - 100 mg
Talk to your doctor or nurse if you have any questions about how Azacitidine Celgene works or why this medicine has been prescribed for you.
Če imate kakšna vprašanja o tem, kako zdravilo Azacitidine Celgene deluje, ali o tem, zakaj so vam predpisali to zdravilo, se posvetujte s svojim zdravnikom ali medicinsko sestro.
Elderly patients
Starejši ljudje
Tell your doctor straight away if you become pregnant during treatment.
Takoj obvestite zdravnika, če med zdravljenjem z zdravilom Azacitidine Celgene zanosite.
ANC ≥ 1.5 x 10
9/l in ANC ≥ 1,5 x 10
If the Azacitidine Celgene suspension is prepared using water for injections that has been stored in the refrigerator (2 °C - 8 °C), the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 22 hours.
Če suspenzijo zdravila Azacitidine Celgene pripravite z vodo za injekcije, ki je bila v hladilniku (2 °C - 8 °C), morate dati suspenzijo takoj po pripravi v hladilnik (2 °C - 8 °C), kjer sme biti shranjena največ 22 ur.
>5 x 10
9/l & >5 x 10
A patient experienced diarrhoea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m almost 4 times the recommended starting dose.
Po enem intravenskem odmerku s približno 290 mg/m2, kar je skoraj 4-kratni priporočeni začetni odmerek, je bolnik dobil diarejo, občutil je navzeo ter je bruhal.
If the Azacitidine Celgene suspension is prepared using water for injections that has not been refrigerated, the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 8 hours.
Če suspenzijo zdravila Azacitidine Celgene pripravite z vodo za injekcije, ki ni bila v hladilniku, morate dati suspenzijo takoj po pripravi v hladilnik (2 °C - 8 °C), kjer sme biti shranjena največ 8 ur.
How Azacitidine Celgene works
Kako zdravilo Azacitidine Celgene deluje
Other medicines and Azacitidine Celgene
Shranjevanje zdravila Azacitidine Celgene
Talk to your doctor, pharmacist or nurse before using Azacitidine Celgene:
Pred začetkom uporabe zdravila Azacitidine Celgene se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Platelets (x 10
Trombociti (x 10 9/l)
What Azacitidine Celgene is
Kaj je zdravilo Azacitidine Celgene
*Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count]) Following dose modifications, the cycle duration should return to 28 days.
*Obnovitev = število ≥ število v najnižji točki + (0,5 x [izhodiščno število - število v najnižji točki])
Azacitidine treatment led to a reduced need for red blood cell (RBC) and platelet transfusions.
Zdravljenje z azacitidinom je povzročilo manjšo potrebo po transfuzijah eritrocitov in trombocitov.
CLINICAL PARTICULARS
Izračun individualnega odmerka
• Hair loss.
• izguba telesne mase
What Azacitidine Celgene contains
Kaj vsebuje zdravilo Azacitidine Celgene
Cytotoxic
• omotica
• Muscle spasms.
• mišični spazmi
These proteins encourage the growth of new cells.
Ti dve beljakovini spodbujata rast novih celic.
The evidence provided was insufficient to show that Balimek fulfils an unmet medical need.
Predloženi dokazi niso bili zadostni, da bi dokazali, da zdravilo Balimek izpolnjuje neizpolnjeno medicinsko potrebo.
Considering this, along with data on the time patients lived overall and their quality of life, the CHMP considered that Balimek's effectiveness was questionable.
Ob upoštevanju tega ter podatkov o skupnem času preživetja bolnikov in njihove kakovosti življenja je odbor CHMP presodil, da je učinkovitost zdravila Balimek vprašljiva.
Withdrawal of the marketing authorisation application for Balimek (binimetinib) EMA/41972/2018
Umik vloge za pridobitev dovoljenja za promet z zdravilom Balimek (binimetinib) EMA/41972/2018
The active substance in Balimek, binimetinib, blocks proteins called MEK1 and MEK2.
Zdravilna učinkovina v zdravilu Balimek, binimetinib, zavira beljakovini, imenovani MEK1 in MEK2.
On 4 January 2018, Pierre Fabre Médicament officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Balimek, for the treatment of melanoma.
Družba Pierre Fabre Médicament je 4. januarja 2018 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Balimek, namenjenim zdravljenju melanoma.
The company presented data from one main study comparing Balimek with dacarbazine (a cancer medicine used for treating melanoma).
Družba je predložila podatke iz ene glavne študije, v kateri so zdravilo Balimek primerjali z dakarbazinom (zdravilom proti raku, ki se uporablja za zdravljenje melanoma).
It was to be available as tablets to be taken by mouth.
Na voljo naj bi bilo v obliki tablet, ki se jemljejo peroralno.
It was to be used in patients who had a specific genetic mutation (change) called NRAS Q61 mutation.
Uporabljalo naj bi se pri bolnikih, ki imajo določeno gensko mutacijo (spremembo), imenovano mutacija NRAS Q61.
Balimek is a medicine that contains the active substance binimetinib.
Balimek je zdravilo, ki vsebuje zdravilno učinkovino binimetinib.
What is Balimek?
Kaj je zdravilo Balimek?
The Committee also considered that although no medicine is approved specifically to treat patients with the NRAS Q61 mutation, there are effective treatments for melanoma in general.
Menil je tudi, da čeprav posebej za zdravljenje bolnikov z mutacijo NRAS Q61 ni odobreno nobeno zdravilo, za zdravljenje melanoma na splošno obstajajo učinkovita zdravila.
The study involved 402 patients with advanced melanoma with the NRAS Q61 mutation that had spread or could not be removed by surgery.
V študijo sta bila vključena 402 bolnika z napredovalim melanomom z mutacijo NRAS Q61, ki se je razširil ali pa ga ni bilo mogoče odstraniti z operacijo.
Balimek was expected to be used for treating melanoma (a type of skin cancer) that had spread or could not be removed by surgery.
Zdravilo Balimek naj bi se uporabljalo za zdravljenje melanoma (vrste kožnega raka), ki se je razširil in ga ni mogoče odstraniti z operacijo.
What was Balimek expected to be used for?
Za kaj naj bi se zdravilo Balimek uporabljalo?
By blocking the MEK proteins, Balimek is expected to slow down the growth of melanoma cells.
Zdravilo Balimek naj bi z zaviranjem beljakovin MEK upočasnilo rast melanomskih celic.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Balimek.
Družba je odbor CHMP obvestila, da umik vloge nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Balimek.
How does Balimek work?
Kako zdravilo Balimek deluje?
Withdrawal of the marketing authorisation application for Balimek (binimetinib)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Balimek (binimetinib)
Based on the data reviewed, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Balimek could not have been approved for the treatment of advanced melanoma in patients with the NRAS Q61 mutation.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Balimek ni mogoče odobriti za zdravljenje napredovalega melanoma pri bolnikih z mutacijo NRAS Q61.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on CHMP's opinion that the data supplied did not provide sufficient evidence to conclude that the medicine's benefits outweigh its risks.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umik temelji na mnenju odbora CHMP, da predstavljeni podatki odboru ne dovoljujejo, da bi pozitivno ocenil razmerje med tveganji in koristmi zdravila Balimek.
The CHMP noted that patients treated with Balimek lived slightly longer without their disease getting worse compared with those receiving dacarbazine.
Ugotovil je, da so bolniki, zdravljeni z zdravilom Balimek, do poslabšanja bolezni živeli le nekoliko dlje kot bolniki, ki so prejemali dakarbazin.
Moreover, the CHMP was concerned that Balimek was linked to worse side effects than dacarbazine.
Poleg tega je odbor CHMP izrazil zadržke, ker je bilo zdravilo Balimek povezano s težjimi neželenimi učinki kot dakarbazin.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Balimek did not outweigh its risks.
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Balimek ne odtehtajo z njim povezanih tveganj.
1 ml (100 mg/ml) 1 pre-filled syringe
Velikost pakiranja napolnjena injekcijska brizga napolnjeni injekcijski brizgi
Strength Pharmaceutical Form
Farmacevtska
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE, PREDLAGATELJEV, IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Novartis Norge AS Postboks 237 Okern 0510 Oslo Norway injection
Novartis Norge AS Postboks 237 Okern 0510 Oslo Norway injiciranje
United Kingdom
Velika Britanjia
As a result, it blocks the growth of tumour cells and eventually kills them.
Posledica tega je, da zaustavi rast tumorskih celic in jih nazadnje tudi uniči.
The doctor will calculate the number of 150- and 500-mg tablets the patient needs to take.
Zdravnik bo izračunal število 150-miligramskih in 500-miligramskih tablet, ki jih mora vzeti bolnik.
The full EPAR for Capecitabine SUN can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Capecitabine SUN je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Capecitabine SUN.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Capecitabine SUN.
Capecitabine SUN tablets should be swallowed with water within the 30 minutes after a meal.
Tablete zdravila Capecitabine SUN je treba pogoltniti z vodo v 30 minutah po obroku.
Capecitabine SUN is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Zdravilo Capecitabine SUN se jemlje dvakrat na dan v odmerkih med 625 in 1 250 mg na kvadratni meter telesne površine (izračunane na podlagi bolnikove višine in telesne mase).
Capecitabine SUN is available as tablets (150 and 500 mg).
Zdavilo Capecitabine SUN je na voljo v obliki tablet (150 in 500 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine SUN on 21 June 2013.
Evropska komisija je dovoljenje za promet z zdravilom Capecitabine SUN, veljavno po vsej Evropski uniji, odobrila dne 21. junija 2013.
It can only be obtained with a prescription and must be prescribed by a doctor who is experienced in the use of anticancer medicines.
Izdaja zdravila je le na recept, predpiše pa ga lahko samo zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
What measures are being taken to ensure the safe and effective use of Capecitabine SUN?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Capecitabine SUN?
A risk management plan has been developed to ensure that Capecitabine SUN is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Capecitabine SUN je bil pripravljen načrt obvladovanja tveganj.
This means that Capecitabine SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Xeloda.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Xeloda.
Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, mainly in tumour cells.
Kapecitabine je „predzdravilo“, ki se v telesu pretvori v 5-fluorouracil (5-FU), in sicer v glavnem v tumorskih celicah.
It is taken as tablets, while 5-FU normally needs to be injected.
Jemlje se v obliki tablet, medtem ko je treba 5-fluoruracil navadno injicirati.
The Committee recommended that Capecitabine SUN be approved for use in the EU.
Priporočil je, da se zdravilo Capecitabine SUN odobri za uporabo v EU.
What are the benefits and risks of Capecitabine SUN?
Kakšne so koristi in tveganja, povezani z zdravilom Capecitabine SUN?
Because Capecitabine SUN is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Capecitabine SUN generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
5-FU is an analogue of pyrimidine.
5-fluorouracil je analog pirimidina.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Capecitabine SUN, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Capecitabine SUN vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Capecitabine SUN has been shown to have comparable quality and to be bioequivalent to Xeloda.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Capecitabine SUN primerljivo raven kakovosti kot zdravilo Xeloda ter da mu je biološko enakovredno.
In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
5-fluorouracil v telesu zavzame mesto pirimidina in ovira encime, ki sodelujejo pri tvorjenju nove DNK.
For more information about treatment with Capecitabine SUN, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Capecitabine SUN preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Capecitabine SUN
Druge informacije o zdravilu Capecitabine SUN
Capecitabine SUN is a ‘generic medicine'.
Zdravilo Capecitabine SUN je „generično zdravilo“.
For practical information about using Capecitabine SUN, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Capecitabine SUN naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Because Capecitabine SUN is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Ker je zdravilo Capecitabine SUN generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Xeloda.
What is Capecitabine SUN and what is it used for?
Kaj je zdravilo Capecitabine SUN in za kaj se uporablja?
Capecitabine SUN is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Zdravilo Capecitabine SUN se uporablja z docetakselom (drugim zdravilom proti raku), potem ko zdravljenje z antraciklini (drugo vrsto zdravila proti raku) ni bilo uspešno.
It is not intended to provide practical advice on how to use Capecitabine SUN.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Capecitabine SUN is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Zdravilo Capecitabine SUN se uporablja z drugimi zdravili proti raku, vključno z zdravilom proti raku, ki vsebuje platino, kot na primer cisplatin;
The active substance in Capecitabine SUN, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Zdravilna učinkovina zdravila Capecitabine SUN, kapecitabin, je citotoksik (zdravilo, ki uničuje celice v fazi delitve, kot na primer rakave celice) iz skupine antimetabolitov.
Capecitabine SUN is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Zdravilo Capecitabine SUN se uporablja z drugimi zdravili proti raku ali kot samostojno zdravilo pri bolnikih po operaciji raka kolona stadija III ali stadija Dukes C;
Why has Capecitabine SUN been approved?
Zakaj je bilo zdravilo Capecitabine SUN odobreno?
Capecitabine SUN is an anticancer medicine that contains the active substance capecitabine.
Capecitabine SUN je zdravilo, ki vsebuje zdravilno učinkovino kapecitabin.
Capecitabine SUN is used with or without other anticancer medicines;
Zdravilo Capecitabine SUN se uporablja skupaj z drugimi zdravili proti raku ali kot samostojno zdravilo;
How does Capecitabine SUN work?
Kako zdravilo Capecitabine SUN deluje?
How has Capecitabine SUN been studied?
Kako je bilo zdravilo Capecitabine SUN raziskano?
How is Capecitabine SUN used?
Kako se zdravilo Capecitabine SUN uporablja?
This section should also include literature case reports and review.
To poglavje mora vsebovati tudi poročila o primerih iz literature in njihov pregled.
Furthermore the discussion on the adverse events in this group should be compared with the pattern of adverse events in other age groups.
Poleg tega je treba razpravo o neželenih dogodkih pri tej skupini primerjati z vzorcem neželenih dogodkov v drugih starostnih skupinah;
• discuss the usage in elderly, taking into account the naturally lower level of testosterone in this age group of patients.
• opisati uporabo pri starejših bolnikih, pri čemer je treba upoštevati naravno nižje ravni testosterona pri tej starostni skupini bolnikov.
• submit the PSUR within 90 days following the DLP of 31 December
• predložiti poročilo PSUR v 90 dneh po zaključku vnosa podatkov, ki bo 31. decembra 2015.
The spontaneous reports shall not be presented as a listing of the individual cases, but rather as a general discussion of the aggregated cases, and include all relevant information, e.g. time to onset (when available), haematocrit/haemoglobin level (when available), indication, age, confounding factors and other.
Spontana poročila ne bodo predstavljena kot seznam posameznih primerov, ampak kot splošna razprava združenih primerov, ki mora vključevati vse zadevne informacije, npr. čas pojava (če je na voljo), hematokrit/raven hemoglobina (če je na voljo), indikacijo, starost, sočasne dejavnike in drugo;
Annex IV Conditions to the marketing authorisations
Priloga IV Pogoji dovoljenj za promet z zdravilom
The Marketing Authorisation Holders of testosterone-containing medicinal products should, with the next PSUR:
Imetniki dovoljenj za promet z zdravili, ki vsebujejo testosteron, morajo do naslednjega poročila PSUR:
National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic, če je ustrezno, bodo zagotovili, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
• report on venous thrombolic events (VTE) including deep venous thrombosis (VTE) and pulmonary embolism (PE) in a separate section in the next PSUR.
• poročati o venskih trombotičnih dogodkih (VTE), vključno z globoko vensko trombozo (GVE) in pljučno embolijo (PE) v ločenem poglavju naslednjega poročila PSUR.
• monitor cardiovascular risk (including literature review, clinical trials data and all other relevant data) and discuss the finding in the next PSUR.
• spremljati kardiovaskularno tveganje (vključno s pregledom literature, podatki iz kliničnih preskušanj in vsemi drugimi zadevnimi podatki) in ugotovitve opisati v naslednjem poročilu PSUR;
• discuss a possible mechanism of VTE and the potential association between CV/VTE events and testosterone levels (whether low or high levels compared to eugonadal level may contribute to the risk), and discuss if the information should be included in the product information.
• opisati morebitne mehanizme venskih trombotičnih dogodkov in morebitno povezavo med KV/VTE-dogodki ter ravnmi testosterona (ali lahko nizke ali visoke ravni prispevajo k tveganju v primerjavi z ravnmi pri normalno delujočih gonadah) in razpravljati, ali je treba te podatke vključiti v informacije o zdravilu;
This is a disease where the normal process of bone growth is altered.
To je bolezen, pri kateri se spremeni običajen proces rasti kosti.