natgillin/translations-raw huggingface dataset:
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Osteonekroza čeljusti Osteonekroza čeljusti (ONČ) zabilježena je manje često u kliničkim ispitivanjima i nakon stavljanja u promet u bolesnika koji su se liječili zoledronatnom kiselinom.
- if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic acid Actavis belongs), or any of the other ingredients of this medicine (listed in section 6).
Zoledronatna kiselina Actavis) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
- The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Ako imate tegobe s bubrezima, liječnik će Vam dati nižu dozu ovisno o težini tegoba koje imate s bubrezima.
Caution is advised when zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Savjetuje se oprez kod primjene zoledronatne kiseline s lijekovima za koje je poznato da uzrokuju hipokalcemiju budući da mogu imati sinergistički učinak s posljedičnom teškom hipokalcemijom
- History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
- Bolest zubiju u anamnezi, lošu oralnu higijenu, periodontalnu bolest, invazivne zahvate na zubima (npr. vađenje zuba) i zubnu protezu koja loše prijanja
Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zoledronic acid Actavis in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Kad se počinje liječenje Zoledronatnom kiselinom Actavis u bolesnika s multiplim mijelomom ili solidnim tumorom s metastatskim lezijama kosti, potrebno je odrediti vrijednosti kreatinina u serumu i klirens kreatinina (CLcr).
The following conventional classification is used: 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), very rare (<1/10,000), not known (cannot be estimated from the available data).
Za to se koristila sljedeća uobičajena klasifikacija: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko
Zoledronic acid Actavis is supplied as a clear and colourless concentrate for solution for infusion (sterile concentrate) in a plastic vial.
Zoledronatna kiselina Actavis isporučuje se kao bistri i bezbojni koncentrat za otopinu za infuziju
To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Da biste izbjegli moguće inkompatibilnosti, otopina za infuziju koja se koristi za razrjeđenje mora biti 0,9%-tna m/V otopina natrijevog klorida ili 5%
Zoledronic acid Actavis must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Zoledronatna kiselina Actavis ne smije se miješati s kalcijem ili drugim otopinama za infuziju koje sadrže dvovalentne katione, kao što je otopina Ringerovog laktata, i treba se primijeniti kao jednokratna intravenska otopina kroz posebnu infuzijsku liniju.
Via Pasteur 10
Actavis Italy S.p.A. Via Pasteur 10
In clinical studies, zoledronic acid, used as indicated in sections 4.1 and 4.2, has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
4.2, primjenjivala istodobno s često davanim antitumorskim lijekovima, diureticima, antibioticima i analgeticima bez klinički vidljivih interakcija.
- Severe bone, joint and/or muscle pain, occasionally incapacitating.
- Jaki, ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
In the clinical studies, patients with serum creatinine > 400 micromol/l or > 4.5 mg/dl were excluded.
Bolesnici s vrijednostima kreatinina u serumu > 400 mikromola/l ili > 4,5 mg/dl bili su isključeni iz kliničkih ispitivanja.
The frequencies for each of these identified risks are shown in Table 1.
Učestalosti svakog pojedinog utvrđenog rizika navedene su u
Figure 1: Mean changes from baseline in BPI scores.
Slika 1: Srednja vrijednost promjene rezultata na ljestvici bola (BPI) od početne vrijednosti.
Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
- Teško oštećenje funkcije bubrega (obično će ga utvrditi liječnik pomoću određenih specifičnih krvnih pretraga).
10 x 5 ml vials
10 x 5 ml bočica
This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Lijek se ne smije miješati s infuzijskim otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je Ringerova otopina s laktatom i mora se primijeniti kao pojedinačna intravenska otopina putem odvojene infuzijske linije.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
RMP-a, dokumenti mogu biti podneseni istodobno.
- Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) - Flu-like symptoms including arthritis and joint swelling.
- Intersticijska bolest pluća (upala tkiva oko vrećica zraka u plućima).
Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Uputa o lijeku: Informacije za korisnika Zoledronatna kiselina Actavis 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Medijan vremena do relapsa (ponovnog povišenja kalcija u serumu korigiranog za albumin ≥ 2,9 mmol/l) iznosio je 30 do 40 dana u bolesnika liječenih zoledronatnom kiselinom za razliku od 17 dana u onih liječenih pamidronatom u dozi od
Do not mix Zoledronic acid Actavis concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Koncentrat Zoledronatne kiseline Actavis se ne smije miješati s otopinama koje sadrže kalcij ili druge dvovalentne katione kao što je Ringerova otopina s laktatom.
How often Zoledronic acid Actavis is given
Koliko se često daje Zoledronatna kiselina Actavis
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
kuku ili preponama, i svakog bolesnika s takvim simptomima treba pregledati na nepotpuni prijelom bedrene kosti.
Paediatric patients
Posebne populacije Pedijatrijski bolesnici
4 x 5 ml vials
4 x 5 ml bočice
In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic acid Actavis is used in combination with thalidomide.
U bolesnika s multiplim mijelomom, rizik od poremećaja funkcije bubrega može biti povećan kad se
Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria Arthritis and joint swelling as a symptom of acute phase reaction
Astenija, periferni edemi, reakcije na mjestu primjene injekcije (uključujući bol, nadraženost, oteklinu, otvrdnuće), bol u prsištu, povećanje tjelesne težine,
Uncommon (may affect up to 1 in 100 people): - Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
- Bol u ustima, zubima i/ili čeljusti, oteklina ili ranice u ustima ili čeljusti koje ne cijele, iscjedak, utrnulost ili osjećaj težine u čeljusti, klimanje zuba.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 micromol/l or > 3.0 mg/dl were excluded.
Bolesnici s vrijednošću kreatinina u serumu > 265 mikromola/l ili > 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa zoledronatnom kiselinom.
4.1 ml for 3.3 mg dose
4,4 ml za dozu od 3,5 mg 4,1 ml za dozu od 3,3 mg 3,8 ml za dozu od 3,0 mg
4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
4,0 mg zoledronatne kiseline 3,5 mg* zoledronatne kiseline 3,3 mg* zoledronatne kiseline 3,0 mg* zoledronatne kiseline
An extension study was conducted in order to examine the long-term general and renal safety of once yearly or twice yearly zoledronic acid over the 12-month extension treatment period in children who had completed one year of treatment with either zoledronic acid or pamidronate in the core study.
12-mjesečnog produžetka terapijskog razdoblja u djece koja su dovršila godinu dana liječenja zoledronatnom kiselinom ili pamidronatom u glavnom ispitivanju.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients that were given zoledronic acid as indicated in sections 4.1 and 4.2.
U razdoblju nakon stavljanja lijeka u promet u bolesnika koji su uzimali zoledronatnu kiselinu sukladno navedenom u dijelovima 4.1 i 4.2 zabilježeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Prije i poslije primjene Zoledronatne kiseline Actavis mora se provjeriti status hidracije bolesnika kako bi se osiguralo da su primjereno hidrirani.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic acid Actavis therapy.
Nakon početka terapije Zoledronatnom kiselinom Actavis potrebno je pažljivo pratiti standardne metaboličke parametre hiperkalcemije, kao što su razine kalcija, fosfata i magnezija u serumu.
- 4.1 ml for 3.3 mg dose
- 4,4 ml za dozu od 3,5 mg - 4,1 ml za dozu od 3,3 mg - 3,8 ml za dozu od 3,0 mg
Zoledronic acid Actavis 4 mg/5 ml sterile concentrate zoledronic acid
Zoledronatna kiselina Actavis 4 mg/5 ml sterilni koncentrat zoledronatna kiselina i.v.
Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Kao posljedica niskih razina kalcija: nepravilni otkucaji srca (srčana artimija, uslijed hipokalcemije).
You must not be given Zoledronic acid Actavis if you are breast-feeding.
Ne smijete primati Zoledronatnu kiselinu Actavis ako dojite.
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
100 ml (vidjeti dio 6.6), potrebno je dati kao jednokratnu intravensku infuziju u trajanju od najmanje 15 minuta.
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion
Zoledronatna kiselina Actavis 4 mg/5 ml koncentrat za otopinu za infuziju
How to store Zoledronic acid Actavis
Kako primjenjivati Zoledronatnu kiselinu Actavis
Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Akutno zatajenje bubrega, hematurija, proteinurija
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Zoledronatna kiselina Actavis 4 mg/5 ml koncentrat za otopinu za infuziju zoledronatna kiselina
1Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid as indicated in sections 4.1 and 4.2 (see section 4.8)
Hipofosfatemija 1 Štetni događaji koji nastaju s učestalošću < 5% bili su medicinski procijenjeni i pokazalo se da su u skladu s dobro utvrđenim sigurnosnim profilom zoledronatne kiseline kako je navedeno u dijelovima
Caution is advised when Zoledronic acid Actavis is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
budući da je uočeno povećanje incidencije osteonekroze čeljusti u bolesnika koji se istodobno liječe tim lijekovima.
Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent.
Jednokratne i višekratne infuzije zoledronatne kiseline u dozi od 2, 4, 8 i 16 mg u trajanju od 5 i 15
How much Zoledronic acid Actavis is given
Koliko se Zoledronatne kiseline Actavis daje
BPI mean change from baseline
Srednja vrijednost promjene u BPI od početne vrijednosti
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid Actavis or after stopping treatment.
Zoledronatnom kiselinom Actavis ili nakon prestanka liječenja dobijete simptome kao što su novonastali ili pogoršani bolovi ili ukočenost.
How Zoledronic acid Actavis is given
Kako se daje Zoledronatna kiselina Actavis
General disorders and administration site conditions Common:
Opći poremećaji i reakcije na mjestu primjene Vrlo često:
- Do not use Zoledronic acid Actavis after the expiry date stated on the vial and carton after EXP. - This medicinal product does not require any specific storage conditions.
- Zoledronatna kiselina Actavis se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza „EXP“.
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Actavis or after stopping treatment.
Ako osjetite ove simptome, za vrijeme ili nakon liječenja Zoledronatnom kiselinom Actavis odmah obavijestite svog liječnika ili zubara.
Placebo Zoledronic acid
Placebo Zoledronatna kiselina hiperkalcemijom izazvanom tumorom.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,06
Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
- Rijetko može nastati neuobičajen prijelom bedrene kosti osobito u bolesnika koji se dugotrajno liječe zbog osteoporoze; osjetite li bol, slabost ili nelagodu u natkoljenici, kuku ili preponama,
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
DODATAK I. SAŽETAK OPISA SVOJSTAVA LIJEKA
Proportion of patients with SREs p-value
Udio bolesnika s koštanim događajem (%)
- Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
0,9%-tne m/V otopine natrijevog klorida ili 100 ml 5%-tne m/V otopine glukoze dokazana je za 24 sata na temperaturi od 2°C do 8°C i na 25°C.
Serum calcium should be measured and hypocalcaemia must be corrected before initiating zoledronic acid therapy.
Prije uvođenja terapije zoledronatne kiseline potrebno je odrediti razinu kalcija u serumu i korigirati hipokalcemiju.
Zoledronic acid Actavis recommended dose*
Preporučena doza Zoledronatne kiseline
Pain in extremities, arthralgia, musculoskeletal pain General disorders and administration site conditions Very common:
Bol u ekstremitetima, artralgija, mišićno-koštana bol
The following information is intended for healthcare professionals only: How to prepare and administer Zoledronic acid Actavis
Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
While being treated with Zoledronic acid Actavis, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Za vrijeme liječenja Zoledronatnom kiselinom Actavis, morate održavati dobru oralnu higijenu
- Low level of magnesium and potassium in the blood.
- Niska razina magnezija i kalija u krvi; liječnik će pratiti ove elektrolite i poduzeti potrebne mjere.
(PAOD Stage II)
(PAOD stadij II).
Results are heterogeneous and inconsistent.
Rezultati su raznoliki i nedosljedni.
Available data is in fact indicative of such causal relationship.
Dostupni podaci zapravo ukazuju na takvu uzročnu povezanost.
The seriousness of such adverse effects and their possible fatal outcome is underlined.
Istaknuti su ozbiljnost takvih štetnih događaja i njihov mogući smrtonosni ishod.
In six of the evaluable studies with population under 100 patients there were similar findings.
U 6 procjenjivih ispitivanja s populacijom ispod 100 bolesnika bila su prisutna slična otkrića.
Under-reporting can also be suspected because the substance has been on the market for a long time and because fibrosis is already mentioned as an undesirable effect in the product information.
Može se također sumnjati i na nedostatno prijavljivanje jer je tvar na tržištu dulje vrijeme i jer se fibroza već spominjala kao neželjeni učinak u informacijama o proizvodu.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
• Povjerenstvo je razmatralo postupak iz članka 31. Direktive 2001/83/EZ za lijekove koji sadrže derivate ergota u navedenim indikacijama.
In Europe, dihydroergocristine is also available in combination with etofyllinum.
U Europi je dihidroergokristin također dostupan u kombinaciji s etofilinom.
In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the identified risk.
Kako bi ukinuli suspenziju, nositelji odobrenja trebaju identificirati specifičnu populaciju bolesnika za koje dobrobiti lijeka nadmašuju identificirani rizik.
There were 3 placebo controlled studies with a study population of 200-240 patients.
Postojala su tri placebom kontrolirana ispitivanja s populacijom ispitanika od 200 do 240 bolesnika.
It produces a decrease in blood pressure and an increase in peripheral blood flow.
Uzrokuje pad tlaka krvi i povećanje perifernog protoka.
• The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergocristine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk.
• Povjerenstvo smatra da su dokazi značajne kliničke djelotvornosti dihidroergokristina u trenutno procijenjenim indikacijama vrlo ograničeni i da je stoga moguća dobrobit za bolesnike u ovim indikacijama nadmašena prethodno navedenim rizikom.
Its effect results mainly from its α1-blocking properties.
Njegovi učinci uglavnom su rezultat blokade α1 receptora.
There are 2 further studies by Hugonot et al with population of 114-127 patients, both showing superiority over placebo.
Postojala su dva daljnja ispitivanja od strane Hugonota et al s populacijom od 114 do 127 bolesnika i oba su bila superiorna u odnosu na placebo.
• The Committee considered the overall submitted data provided by the MAHs and the outcome of the scientific advisory group.
• Povjerenstvo je razmatralo ukupne predane podatke koje su dostavili nositelji odobrenja i ishod vijećanja znanstvene, savjetodavne skupine.
Moreover the severity of such adverse effects, their possible fatal outcome and the raised risk for patient to develop a fibrotic disorder with long term use according to the authorised indications should be underlined.
Štoviše, potrebno je istaknuti ozbiljnost takvih štetnih događaja, njihov mogući smrtonosni ishod i povećani rizik za bolesnike od razvoja fibrotičkog poremećaja uz dugoročnu primjenu u skladu s odobrenim indikacijama.
The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocristine.
CHMP je uzeo u obzir ukupne dostupne podatke o sigurnosti i djelotvornosti dihidroergokristina.
A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Pregled svih drugih dostupnih podataka (primjerice podataka iz literature, nekliničkih podataka i drugih kliničkih podataka uključujući epidemiološka ispitivanja) koji su bili relevantni za procjenu rizika od fibroze prikazan je kad je to bilo moguće.
Among these 3 studies, the publications by Lazzaroni et al and Aranda et al indicated superiority over placebo, while the study by Vellas et al demonstrated similar efficacy to placebo.
Od ova tri ispitivanja, publikacije koje su objavili Lazzaroni et al i Aranda ukazale su na superiornost nad placebom dok je ispitivanje od strane Vellasa et al pokazalo sličnu djelotvornost placebu.
Of the 6 randomised, double blind, placebo-controlled studies, 5 studies were not considered relevant by the CHMP because the definition of the diagnosis was not standardised, no primary efficacy criterion was selected among the multi-dimensional assessment, the number of patients per group was small (from 47 to 65), and the treatment duration was short (2 and 3 months).
Od 6 randomiziranih, dvostruko slijepih, placebom kontroliranih ispitivanja, 5 njih CHMP nije smatrao važnim jer definicija dijagnoze nije bila standardizirana te nije odabran primarni kriterij djelotvornosti, a broj bolesnika po skupini bio je mali (od 47 do 65) te je trajanje liječenja bilo kratko (2 i 3 mjeseca).
Of these, 18 concerned placebocontrolled trials, 2 concerned actively-controlled trials and 7 concerned open label studies.
Od toga je 18 placebom kontroliranih kliničkih ispitivanja, 2 ispitivanja kontrolirana djelatnom tvari i 7 otvorenih ispitivanja.
The group highlighted that the claimed indication is not used anymore in the clinical practice and that from a clinical viewpoint there is no evidence at present that there is a therapeutic need for this active substance in the treatment of cognitive and neurosensorial impairment in the elderly.
Skupina je istaknula da se tražene indikacija više ne upotrebljava u kliničkoj praksi i da s kliničkog stajališta nema aktualnog dokaza da postoji terapijska potreba za ovu djelatnu tvar u liječenju kognitivnog i neurosenzorskog oštećenja u starijih.
The CHMP considered the MAHs' proposals for risk minimisation measures.
CHMP je razmatrao prijedloge nositelja odobrenja za mjere minimizacije rizika.
On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.
Francuska je pokrenula postupak procjene u skladu s člankom 31. Direktive 2001/83/EZ za sljedeće lijekove koji sadrže derivate ergota: dihidrergokriptinin/kofein, dihidroergokristinin, dihidroergotamin, dihidroergotoksin i nikergolin.
The CHMP was of the opinion that no efficacy conclusion could be drawn based on these studies.
CHMP je smatrao da se na temelju ovih ispitivanja ne mogu donijeti zaključci o djelotvornosti.