natgillin/translations-raw huggingface dataset:
The risk/benefit ratio of Lansoprazol ratiopharm 15 mg, 30 mg is considered to be favourable provided that appropriate information regarding H. pylori eradication therapy are included in the SPC.
Razmerje med tveganji in koristmi za zdravilo Lansoprazol ratipharm 15 mg, 30 mg velja za ugodno pod pogojem, da se ustrezni podatki v zvezi z zdravljenjem za eradikacijo H. pylori vključijo v Povzetek glavnih značilnosti zdravila.
Do not use Lansoprazol-ratiopharm after the expiry date which is stated on the carton and the blister.
Zdravila Lansoprazol-ratiopharm ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici ali pretisnem omotu.
The effect of Lansoprazol-ratiopharm may be influenced by the following medicines or drug groups:
Na učinek zdravila Lansoprazol-ratiopharm lahko vplivajo naslednja zdravila ali skupine zdravil
The recommended dosage can be fulfilled by administering one capsule of 30 mg or two capsules of 15 mg twice daily, because the composition of the content of one capsule with 30 mg lansoprazole is exactly the same as the composition of the content of two capsules with 15 mg lansoprazole, as “Description and Composition of the Drug Product” (3.2.P1) of both strengths show
Priporočen odmerek je izpolnjen z dajanjem ene 30 mg kapsule ali dveh 15 mg kapsul dvakrat dnevno, kajti sestava ene kapsule s 30 mg lansoprazola je popolnoma enaka sestavi dveh kapsul s 15 mg lansoprazola, kakor je razvidno iz »Opisa in sestave zdravila (3.2.P1)« za obe jakosti.
It is recommended that you take Lansoprazol-ratiopharm before meals, as simultaneous food intake reduces the availability of lansoprazole to the body.
Zdravilo Lansoprazol-ratiopharm je priporočeno jemati pred obroki, ker sočasno uživanje hrane zmanjša uporabnost lansoprazola v telesu.
NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm GmbH [see Annex I - to be completed nationally]
IME IMETNIKA DOVOLJENJA ZA PROMET ratiopharm GmbH [Glejte Dodatek I - podatke je treba dopolniti v posameznih državah]
“How to take Lansoprazol-ratiopharm”) - if you use Lansoprazol-ratiopharm in combination therapy with antibiotics to eradicate Helicobacter pylori, you should carefully read the package leaflets of these antibiotics, too - if you take Lansoprazol-ratiopharm for longer than 1 year, therapy should be regularly monitored and the doctor should carefully consider the benefit versus risk ratio - if you experience any problems with your eyesight following long-term use (longer than 1 year), treatment with Lansoprazol-ratiopharm should be promptly discontinued and you should consult an ophthalmologist.
"Kako jemati zdravilo Lansoprazol ratiopharm"),- če zdravilo Lansoprazol-ratiopharm uporabljate skupaj z antibiotiki pri kombiniranem zdravljenju za odstranitev bakterije Helicobacter pylori, morate pozorno prebrati tudi navodila za uporabo teh antibiotikov, - če zdravilo Lansoprazol-ratiopharm jemljete več kot eno leto, mora zdravnik redno nadzirati zdravljenje ter oceniti koristi in tveganje, - če po dolgotrajnem zdravljenju (daljšem od 1 leta) z zdravilom Lansoprazol-ratiopharm opazite težave z vidom, morate zdravljenje nemudoma prekiniti in se posvetovati z okulistom.
What Lansoprazol-ratiopharm is and what it is used for Before you take Lansoprazol-ratiopharm How to take Lansoprazol-ratiopharm Possible side effects
Kaj je zdravilo Lansoprazol-ratiopharm in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Lansoprazol-ratiopharm Kako jemati zdravilo Lansoprazol-ratiopharm Možni neželeni učinki
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOL RATIOPHARM 15 MG, 30 MG, GASTRO-RESISTANT CAPSULES, HARD (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LANSOPRAZOL RATIOPHARM 15 MG, 30 MG, GASTROREZISTENTNE KAPSULE, TRDE (glejte Dodatek I)
The concerns rose referred to discrepancies in comparison to the reference products on posology triple therapy for H. pylori eradication and indication of the 15 mg dosage form.
Zadržki so bili predloženi zaradi neskladnosti pri primerjavi z referenčnimi zdravili v zvezi z odmerjanjem v tritirni terapiji za eradikacijo H.pylori ter navedbe oblike 15 mg odmerka.
Lansoprazol-ratiopharm is not recommendes for use in children, as its safety and efficacy have not been established in this patient group.
Zdravilo Lansoprazol-ratiopharmRATIOPHARM ne priporočamo za uporabo pri otrocih, ker v tej skupini bolnikov njegova varnost in učinkovitost nista bili potrjeni.
- Before treatment with Lansoprazol-ratiopharm - the diagnosis of ulcers of the duodenum or stomach and inflammation of the gullet due to reflux of stomach acid should be confirmed by gastroscopy or other appropriate diagnostic measures (e.g. X-ray with contrast media) - a stomach ulcer with Lansoprazol-ratiopharm, the possibility of a malignant stomach tumour should be excluded.
- Pred zdravljenjem z zdravilom Lansoprazol-ratiopharm - diagnozo razjed dvanajstnika ali želodca in vnetje požiralnika zaradi refluksa želodčne kisline je treba potrditi z gastroskopijo ali drugo ustrezno diagnostično metodo (npr. rentgenskim slikanjem s kontrastnim sredstvom) - pred zdravljenjem želodčne razjede z zdravilom Lansoprazol-ratiopharm je treba izključiti možnost obstoja malignega tumorja na želodcu.
When making a decision as to whether breastfeeding or therapy with Lansoprazol-ratiopharm should be continued or discontinued, the benefits of breastfeeding for the child and the benefits of therapy with Lansoprazol-ratiopharm for the mother should be considered.
Pri odločitvi, ali je treba dojenje ali zdravljenje z zdravilom Lansoprazol-ratiopharm nadaljevati ali prekiniti, je treba upoštevati koristi dojenja za otroka in koristi zdravljenja z zdravilom Lansoprazolratiopharm za mater.
Patients with severely impaired liver function should not take Lansoprazol-ratiopharm, nor should they be given combination therapy with clarithromycin.
Bolniki s hudo okvaro delovanja jeter ne smejo jemati zdravila Lansoprazol-ratiopharm niti ne smejo biti podvrženi kombiniranemu zdravljenju s klaritromicinom.
At the beginning or end of simultaneous use of Lansoprazol-ratiopharm, plasma tacrolimus concentrations should be monitored.
Na začetku in koncu sočasne uporabe zdravila Lansoprazol-ratiopharm je treba nadzorovati koncentracijo takrolimusa v plazmi.
Fluvoxamine (a medicine for the treatment of depression), ketoconazole and itraconazole (medicines for the treatment of fungal infections), protease inhibitors (active substances used in the treatment of the AIDS virus) and macrolides (certain types of antibiotics) may markedly raise the concentration of lansoprazole in the blood and thus increase the effect of Lansoprazol-ratiopharm.
Fluvoksamine (zdravilo za zdravljenje depresije), ketokonazol in itrakonazol (zdravili za zdravljenje glivičnih okužb), zaviralci proteaze (zdravilne učinkovine za zdravljenje okužbe z virusom AIDS) in makrolidi (vrsta antibiotikov) lahko znatno povečajo koncentracijo lansoprazola v krvi tako povečajo učinek zdravila Lansoprazol-ratiopharm.
Use of Lansoprazol-ratiopharm is not recommended during pregnancy.
Uporaba zdravila Lansoprazol-ratiopharm med nosečnostjo ni priporočena.
There is no need and it is not planned to reduce the dosage to 15 mg 2 times daily.
Zmanjšanje odmerka na 15 mg dvakrat dnevno ni potrebno niti ni načrtovano.
BEFORE YOU TAKE Lansoprazol-ratiopharm Do not take Lansoprazol-ratiopharm - if you are allergic (hypersensitive) to Lansoprazol or any of the other ingredients of Lansoprazol-ratiopharm.
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO Lansoprazol-ratiopharm Ne jemljite zdravila Lansoprazol-ratiopharm - če ste alergični na (preobčutljivi za) lansoprazol ali katerokoli sestavino zdravila Lansoprazol-ratiopharm.
Lansoprazol-ratiopharm may not be used in children, as its safety and efficacy have not been established in this patient group.
Otroci ne smejo uporabljati zdravila Lansoprazol-ratiopharm, ker v tej skupini bolnikov njegova varnost in učinkovitost nista bili potrjeni.
Lansoprazol-ratiopharm is given:
Lansoprazol-ratiopharm se uporablja:
Intake of Lansoprazol-ratiopharm may mask the symptoms of a tumour and delay diagnosis of this condition
Jemanje zdravila Lansoprazol-ratiopharm lahko zakrije znake tumorja in prepreči pravočasno diagnosticiranje te bolezni
Ketoconazole and itraconazole (medicines for the treatment of fungal infections) The combination of lansoprazole and ketoconazole or itraconazole should be avoided, as the reduction in stomach acid caused by intake of Lansoprazol-ratiopharm may impair the absorption of the other medicines into the blood, thus leading to an underdose.
Ketokonazol in itrakonazol (zdravili za zdravljenje glivičnih okužb) Kombinaciji lansoprazola in ketokonazola ali itrakonazola se je treba izogibati, ker zmanjšanje količine želodčne kisline pri jemanju zdravila Lansoprazol-ratiopharm lahko poslabša absorpcijo drugih zdravil v kri in tako povzroči zmanjšanje odmerka.
Reduction of the clarithromycin dose in the clarithromycin-metronidazole combination is supported by clinical data as well as the Maastricht Consensus Report, stating that 250 mg dose is sufficient even if the recommended dose is 500 mg.
Zmanjšanje odmerka klaritromicina v kombinaciji klaritromicin-metronidazol podpirajo tako klinični podatki kot poročilo o konsenzu iz Maastrichta, ki navaja, da odmerek 250 mg zadostuje , kljub temu da je priporočen odmerek 500 g. Vendar pa poročilo z 2. konsenz konference v Maastrichtu ne podpira zmanjšanja odmerka klaritromicina na 250 mg v tritirnem zdravljenju, kjer je odmerek amoksiklicina 1000 mg.
Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and Pgp substrate).
Takrolimus Sočasna uporaba z lansoprazolom poveča koncentracijo takrolimusa (substrat encimov CYP3A in P
Eradication of H. pylori and peptic ulcer healing (posology) In order to standardise the treatment regimens for H. pylori eradication guidelines on the management of Helicobacter pylori infection were published by the European Helicobacter pylori Study Group.
Z namenom, da bi standardizirali terapevtske sheme za eradikacijo bakterije H.pylori, je Evropsko združenje za raziskave Helicobacter pylori objavilo smernice o obvladovanju okužbe z Helicobacter pylori.
You should avoid breastfeeding while taking Lansoprazol-ratiopharm, as there has been insufficient experience with its use during lactation.
Med jemanjem zdravila Lansoprazol-ratiopharm se morate izogibati dojenju, ker so izkušnje z njegovo uporabo med dojenjem omejene.
Eradication of H. pylori and peptic ulcer healing (15 mg dosage form) According to the proposed SmPC (> day 60), section 4.2, the recommended dose for H. pylori eradication is 30 mg twice daily.
V skladu s predlaganim SmPC (>60 dni), razdelek 4.2., je predlagan odmerek za eradikacijo H. pylori 30 mg dvakrat dnevno.
WHAT Lansoprazol-ratiopharm IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO Lansoprazol-ratiopharm IN ZA KAJ GA UPORABLJAMO
INFORMATION IN BRAILLE < Lansoprazol-ratiopharm 15 mg > [to be completed nationally]
PODATKI V BRAILLOVI PISAVI Lansoprazol-ratiopharm 15 mg [Podatke je treba dopolniti v posameznih državah]
INFORMATION IN BRAILLE < Lansoprazol-ratiopharm 30 mg > [to be completed nationally]
PODATKI V BRAILLOVI PISAVI Lansoprazol-ratiopharm 30 mg [Podatke je treba dopolniti v posameznih državah]
Treatment with Lansoprazol-ratiopharm therefore leads to a slightly increased risk of infections in the gastrointestinal tract, such as with salmonella and Campylobacter.
Zdravljenje z zdravilom Lansoprazol-ratiopharm zato nekoliko poveča tveganje okužb prebavil, kot so okužbe s salmonelo in bakterijo Campylobacter.
During treatment with Lansoprazol-ratiopharm, side effects such as light-headedness and fatigue may occur (see section 4.
Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom Lansoprazol-ratiopharm se lahko pojavijo stranski učinki, kot sta omotica in utrujenost (glejte poglavje 4 "Možni neželeni učinki").
the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Lansoprazol ratiopharm and associated names (see Annex I).
¾ so bili Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki jih je predlagal vlagatelj, ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora, je CHMP za Lansoprazol ratiopharm in povezana imena (glejte Dodatek I), za katere so Povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo opredeljeni v Dodatku III, priporočil odobritev dovoljenj za promet.
What Lansoprazol-ratiopharm looks like and contents of the pack
Izgled zdravila Lansoprazol-ratiopharm in vsebina pakiranja
hydroxy sulphone, 5-hydroxy sulphide and 5-hydroxy lansoprazole.
V urinu so odkrili tri presnovke: 5-hidroksisulfon, 5-hidroksisulfid in 5-hidroksilansoprazol.
< Lansoprazol ratiopharm and associated names (see Annex I) 15 mg gastro-resistant hard capsules > < Lansoprazol ratiopharm and associated names (see Annex I) 30 mg gastro-resistant hard capsules >
< Lansoprazol -ratiopharm in povezana imena (glejte Dodatek I) 15 mg gastrorezistentne trde kapsule> < Lansoprazol -ratiopharm in povezana imena (glejte Dodatek I) 30 mg gastrorezistentne trde kapsule>
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET Whereas, ¾ The scope of the referral was to agree on a harmonised the dosing schedule for triple therapy for eradication therapy for H. pylori.
¾ je bil namen napotitve uskladiti shemo odmerjanja pri tritirni terapiji za zdravljenje za eradikacijo H. pylori.
Always take Lansoprazol-ratiopharm exactly as your doctor has told you.
Pri jemanju zdravila Lansoprazol-ratiopharm natančno upoštevajte zdravnikova navodila.
HOW TO TAKE Lansoprazol-ratiopharm
KAKO JEMATI ZDRAVILO Lansoprazol-ratiopharm
Take special care with Lansoprazol-ratiopharm
Bodite posebno pozorni pri uporabi jemanju zdravila Lansoprazol-ratiopharm
Marketing Authorisation Holder: ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Imetnik dovoljenja za promet z zdravilom: ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Nemčija
NAME OF THE MEDICINAL PRODUCT < Lansoprazol-ratiopharm and associated names (see Annex I) 15 mg magensaftresistente Hartkapseln > [see Annex I - to be completed nationally]
Lansoprazol-ratiopharm in povezana imena (glejte Dodatek I) 15 mg trde gastrorezistentne kapsule [Glejte Dodatek I - podatke je treba dopolniti v posameznih državah]
How to store Lansoprazol-ratiopharm Further information
Shranjevanje zdravila Lansoprazol-ratiopharm Dodatne informacije
NAME OF THE MEDICINAL PRODUCT < Lansoprazol-ratiopharm and associated names (see Annex I) 30 mg magensaftresistente Hartkapseln >
IME ZDRAVILA Lansoprazol-ratiopharm in povezana imena (glejte Dodatek I) 30 mg trde gastrorezistentne kapsule
What Lansoprazol-ratiopharm contains
Kaj vsebuje zdravilo Lansoprazol-ratiopharm
< Lansoprazol-ratiopharm and associated names (see Annex I) 30 mg magensaftresistente Hartkapseln > Lansoprazol
Lansoprazol-ratiopharm in povezana imena (glejte Dodatek I) 30 mg trde gastrorezistentne kapsule lansoprazol
< Lansoprazol-ratiopharm and associated names (see Annex I) 15 mg magensaftresistente Hartkapseln > Lansoprazol
Lansoprazol-ratiopharm in povezana imena (glejte Dodatek I) 15 mg, trde gastrorezistentne kapsule lansoprazol
changes in liver enzyme values.
Bolezni jeter in žolčnika Občasni: spremembe ravni jetrnih encimov.
ratiopharm GmbH Graf-Arco-Strasse 3 D-89070 Ulm Germany
ratiopharm GmbH GrafArcoStrasse 3 D-89070 Ulm Nemčija
Sweden ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Švedska ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Nemčija
Lantrolix 30 mg enterokapsler, hårde
Lantrolix 30 mg enterokapsler, hĺrde 30 mg
Italy ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Italija ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Nemčija
Luxembourg ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Luksemburg ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Nemčija
Denmark ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Danska ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Nemčija
Please consult your doctor before taking Lansoprazol-ratiopharm if you know that you are intolerant to certain sugars.
Če veste, da nekaterih sladkorjev ne prenašate, se pred jemanjem zdravila Lansoprazol-ratiopharm posvetujte z zdravnikom.
Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with lansoprazole is initiated or ended.
Uporaba lansoprazola lahko poveča povprečno izpostavljenost takrolimusu za do 81 %.Ob začetku in koncu sočasnega zdravljenja z lansoprazolom se priporoča nadzorovanje koncentracije takrolimusa v plazmi.
It is available in all European Member States.
Na voljo je v vseh državah članicah Evropske unije.
Zometa has been authorised since March 2001.
Zdravilo Zometa je odobreno od marca 2001.
The full European Public Assessment Report for Zometa 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 Zometa je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The Committee also had concerns regarding the reliability of the data collected during the study.
Izrazil je tudi zadržke v zvezi z zanesljivostjo podatkov, zbranih med študijo.
The study was ‘open label': both the doctor and the patient knew which treatment they were using.
Študija je bila „odprta“: zdravnik in bolnica sta vedela, katero zdravilo se uporablja.
The study included 1,803 women previously treated with surgery who received Zometa every six months for three years, and were followed up for five years.
V študiji so sodelovale 1 803 ženske, ki so bile predhodno operirane in so tri leta vsakih šest mesecev prejemale zdravilo Zometa, nato pa so jih spremljali še nadaljnjih pet let.
It is approved for use as a drip into a vein every three to four weeks to prevent bone complications such as fractures in adults with advanced cancer that is affecting the bone.
Odobreno je za uporabo kot kapalna infuzija v veno vsake tri do štiri tedne za preprečevanje z okostjem povezanih težav, kot so zlomi pri odraslih z napredovalim rakom, ki zajamejo kosti.
All women also received goserelin, a medicine that suppresses the activity of the ovaries.
Vse ženske so prejele tudi goserelin, zdravilo, ki zavira delovanje jajčnikov.
The study measured ‘disease-free survival' (how long the patients lived without cancer).
V študiji so merili „preživetje brez ponovitve bolezni“ (kako dolgo so bolnice živele brez raka).
It also had concerns regarding the way the study in early breast cancer had been carried out.
Prav tako je izrazil zadržke glede načina izvedbe študije pri zgodnjem raku dojke.
The study compared anastrozole and tamoxifen (medicines used in hormone-receptor positive breast cancer) with or without Zometa.
V študiji so primerjali anastrozol in tamoksifen (zdravili, ki se uporabljata pri zdravljenju raka dojke s pozitivnimi hormonski receptorji) z zdravilom Zometa ali brez njega.
On 14 December 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zometa, in the treatment of early breast cancer in premenopausal women.
Družba Novartis Europharm Limited je dne 14. decembra 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo pri zdravilu Zometa za zdravljenje zgodnjega raka dojke pri ženskah pred menopavzo.
Zometa is a medicine that contains the active substance zoledronic acid.
Zometa je zdravilo, ki vsebuje zdravilno učinkovino zoledronsko kislino.
Zometa was only to be used if the breast cancer was ‘hormone receptor positive' (the cancer is likely to respond to hormonal treatment), and in combination with hormonal treatment.
Zdravilo Zometa naj bi se uporabljalo le, kadar ima rak „hormonsko pozitivne receptorje“ (rak se bo verjetno odzval na hormonsko zdravljenje), in v kombinaciji s hormonskim zdravljenjem.
Zoledronic acid, the active substance in Zometa, blocks an enzyme called ‘farnesyl pyrophosphate synthase'.
Zdravilna učinkovina v zdravilu Zometa, zoledronska kislina, zavira encim „farnezil pirofosfat-sintaza“.
By blocking this enzyme, it was expected to prevent the growth of cancer cells and cause their death.
Z zaviranjem tega encima naj bi preprečevala rast rakavih celic in povzročila njihovo uničenje.
Early breast cancer is breast cancer that has not spread and has been treated by surgery.
Zgodnji rak dojke je rak dojke, ki se še ni razširil in je bil operiran.
The company provided data from one main study to support the use of Zometa in early breast cancer.
Družba je predložila podatke iz ene glavne študije v podporo uporabi zdravila Zometa pri zgodnjem raku dojke.
The Committee noted that the treatments used in the control groups to which Zometa was compared were not all representative of the standards of care in Europe.
Odbor je menil, da vsa zdravljenja v kontrolnih skupinah, s katerimi so primerjali zdravljenje z zdravilom Zometa, niso bila povsem v skladu s standardno oskrbo v Evropi.
The company informed the CHMP that this withdrawal does not an impact on ongoing clinical trials with Zometa.
Družba je CHMP obvestila, da umik nima nobenih posledic za klinična preskušanja z zdravilom Zometa, ki trenutno potekajo.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the medicine could not have been approved based on the data presented by the company.
Tako je CHMP v času umika menil, da na podlagi predloženih podatkov družbe zdravila ni mogoče odobriti.
Based on the review of the data and the company's responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zometa could not have been approved for the adjuvant treatment of early breast cancer.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in je začasno menil, da zdravila Zometa ni mogoče odobriti za dodatno zdravljenje zgodnjega raka dojke.
Zometa was expected to be used as an adjuvant (add-on) in the treatment of early breast cancer in women who have not been through the menopause.
Zdravilo Zometa naj bi se uporabljalo kot adjuvans (dodatno zdravilo) pri zdravljenju zgodnjega raka dojke pri ženskah, ki še niso bile v menopavzi.
Zometa can also be used to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Zdravilo Zometa se lahko uporablja tudi za zdravljenje tumorsko povzročene hiperkalciemije (visokih ravni kalcija v krvi).
There are no consequences on the use of Zometa in its authorised indications.
Pri uporabi zdravila Zometa za odobrene indikacije ni nobenih posledic.
The way Zometa is expected to works in early breast cancer is not fully elucidated.
Natančen način delovanja zdravila Zometa pri zgodnjem raku dojke še ni povsem pojasnjen.
What is happening with Zometa for the prevention of bone events in cancer patients?
Kakšne so posledice za zdravilo Zometa, indicirano za preprečevanje z okostjem povezanih težav pri bolnikih z rakom?
The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
V času umika je CHMP ocenjeval odgovore družbe na podana vprašanja.
The Committee had concerns that the anti-tumour activity of Zometa when used as add-on had not been sufficiently supported by the data from the study.
Odbor je imel zadržke, da podatki iz študije niso ustrezno potrdili protitumorskega delovanja zdravila Zometa, kadar se uporablja kot dodatek.
Studies and Reviews
Študije in pregledi
Particular attention should be given to indication, dosage and duration of treatment.
Posebno pozornost je treba nameniti indikaciji, odmerjanju in trajanju zdravljenja.
Post-marketing surveillance
Postmarketinško spremljanje
Further updates of the Risk Management Plan should be submitted for assessment at national level.
Nadaljnje posodobitve načrta za obvladovanje tveganja je treba predložiti v oceno na nacionalni ravni.