natgillin/translations-raw huggingface dataset:
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate.
Jezgra tablete: laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena hipromeloza silicijev dioksid magnezijev stearat
Tablet core:
Mehanizam djelovanja:
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Za učinak liječenja ocjenjivane su podskupine prema spolu, rasi, dobi, trajanju šećerne bolesti, početnom krvnom tlaku, serumskom kreatininu i brzini izlučivanja albumina.U podskupinama žena i pripadnika crne rase, koji su činili 32% odnosno 26% ukupne populacije u ispitivanju, nisu bili vidljivi povoljni učinci na bubrege, premda to intervali pouzdanosti nisu isključivali.
Excipient with known effect: 30.75 mg of lactose monohydrate per tablet.
Pomoćna tvar s poznatim učinkom: 30,75 mg laktoze hidrata po tableti.
Excipient with known effect: 61.50 mg of lactose monohydrate per tablet.
Pomoćna tvar s poznatim učinkom: 61,50 mg laktoze hidrata po tableti.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Općenito: u bolesnika u kojih vaskularni tonus i funkcija bubrega ovise najviše o aktivnosti reninangiotenzin-aldosteronskog sustava (npr. bolesnici s teškim kongestivnim zatajenjem srca ili postojećom bolešću bubrega, uključujući stenozu bubrežne arterije) liječenje inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II, koji utječu na taj sustav, povezano je s pojavom akutne hipotenzije, azotemije, oligurije i rijetko, akutnim zatajenjem bubrega(vidjeti dio 4.5).
Excipient with known effect: 25.50 mg of lactose monohydrate per film-coated tablet.
Pomoćna tvar s poznatim učinkom: 25,50 mg laktoze hidrata po filmom obloženoj tableti.
Excipient with known effect: 15.37 mg of lactose monohydrate per tablet.
Pomoćna tvar s poznatim učinkom: 15,37 mg laktoze hidrata po tableti.
Excipient with known effect: 102.00 mg of lactose monohydrate per film-coated tablet.
Pomoćna tvar s poznatim učinkom: 102,00 mg laktoze hidrata po filmom obloženoj tableti.
Package leaflet: Information for the user Aprovel 75 mg tablets irbesartan
Uputa o lijeku: Informacija za korisnika Aprovel 75 mg tablete irbesartan
Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Aprovel 75 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84, 90 ili 98 filmom obloženih tableta.
Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 75 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Package leaflet: Information for the user Aprovel 75 mg film-coated tablets irbesartan
Uputa o lijeku: Informacija za korisnika Aprovel 75 mg filmom obložene tablete irbesartan
Excipient with known effect: 51.00 mg of lactose monohydrate per film-coated tablet.
Pomoćna tvar s poznatim učinkom: 51,00 mg laktoze hidrata po filmom obloženoj tableti.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
6.1 Popis pomoćnih tvari celuloza, mikrokristalična karmelozanatrij, umrežena laktoza hidrat magnezijev stearat silicijev dioksid, koloidni, hidratizirani kukuruzni škrob, prethodno geliran poloksamer 188
Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 300 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 150 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Package leaflet: Information for the user Aprovel 150 mg tablets irbesartan
Uputa o lijeku: Informacija za korisnika Aprovel 150 mg tablete irbesartan
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 150 mg tablete irbesartan NAZIV NOSITELJA
Package leaflet: Information for the user Aprovel 300 mg tablets irbesartan
Uputa o lijeku: Informacija za korisnika Aprovel 300 mg tablete irbesartan
What Aprovel looks like and contents of the pack Aprovel 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Aprovel 75 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2771 na drugoj strani.
Thu
ČET
What Aprovel looks like and contents of the pack Aprovel 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Aprovel 75 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2871 na drugoj strani.
Package leaflet: Information for the user Aprovel 150 mg film-coated tablets irbesartan
Uputa o lijeku: Informacija za korisnika Aprovel 150 mg filmom obložene tablete irbesartan
Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie
Nositelj odobrenja za stavljanje lijeka u promet: sanofi-aventis groupe
Musculoskeletal and connective tissue disorders
Poremećaji bubrega i mokraćnog sustava
Drug substance*
ortostatska hipotenzija*
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan.
Jedna filmom obložena tableta sadrži 75 mg irbesartana.
NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET sanofi-aventis groupe ROK VALJANOSTI
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg (dvije tablete na dan) jedanput na dan.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg (četiri tablete na dan) jedanput na dan.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan.
Jedna filmom obložena tableta sadrži 150 mg irbesartana.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 75 mg tablete irbesartan NAZIV NOSITELJA
What Aprovel looks like and contents of the pack Aprovel 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Aprovel 300 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2873 na drugoj strani.
Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Kutijas 98 tableta u PVC/PVDC/aluminij blisterima.
fatigue Uncommon: chest pain
umor Manje često: bol u prsištu Pretrage
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA NAZIV LIJEKA Aprovel 75 mg tablete irbesartan NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 75 mg irbesartana POPIS POMOĆNIH TVARI
Package leaflet: Information for the user Aprovel 300 mg film-coated tablets irbesartan
Uputa o lijeku: Informacija za korisnika Aprovel 300 mg filmom obložene tablete irbesartan
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Aprovel 300 mg tablete irbesartan NAZIV NOSITELJA
Aprovel 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Aprovel 150 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg film-coated tablets.
Aprovel 75 mg filmom obložene tablete
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg jedanput na dan.
EU/1/97/046/011 - 14 tablets EU/1/97/046/004 - 28 tablets EU/1/97/046/005 - 56 tablets EU/1/97/046/014 - 56 x 1 tablets EU/1/97/046/006 - 98 tablets
EU/1/97/046/011 - 14 tableta EU/1/97/046/004 - 28 tableta EU/1/97/046/005 - 56 tableta EU/1/97/046/014 - 56 x 1 tableta EU/1/97/046/006 - 98 tableta
Each tablet contains: irbesartan 75 mg
Jedna tableta sadrži 75 mg irbesartana
Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Aprovel 300 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
What Aprovel looks like and contents of the pack Aprovel 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Aprovel 150 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2872 na drugoj strani.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan.
Jedna filmom obložena tableta sadrži 300 mg irbesartana.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Bijela do gotovo bijela, bikonveksna, ovalna tableta, s utisnutom oznakom srca na jednoj i brojem 2771 na drugoj strani.
Hepatobiliary disorders: Uncommon: jaundice Not known:
Poremećaji jetre i žuči Manje često: žutica Nepoznato:
EU/1/97/046/021 - 14 tablets EU/1/97/046/022 - 28 tablets EU/1/97/046/035 - 30 tablets EU/1/97/046/023 - 56 tablets EU/1/97/046/024 - 56 x 1 tablets EU/1/97/046/032 - 84 tablets EU/1/97/046/038 - 90 tablets EU/1/97/046/025 - 98 tablets
EU/1/97/046/021 - 14 tableta EU/1/97/046/022 - 28 tableta EU/1/97/046/035 - 30 tableta EU/1/97/046/023 - 56 tableta EU/1/97/046/024 - 56 x 1 tableta EU/1/97/046/032 - 84 tableta EU/1/97/046/038 - 90 tableta EU/1/97/046/025 - 98 tableta
EU/1/97/046/016 - 14 tablets EU/1/97/046/017 - 28 tablets EU/1/97/046/034 - 30 tablets EU/1/97/046/018 - 56 tablets EU/1/97/046/019 - 56 x 1 tablets EU/1/97/046/031 - 84 tablets EU/1/97/046/037 - 90 tablets EU/1/97/046/020 - 98 tablets
EU/1/97/046/016 - 14 tableta EU/1/97/046/017 - 28 tableta EU/1/97/046/034 - 30 tableta EU/1/97/046/018 - 56 tableta EU/1/97/046/019 - 56 x 1 tableta EU/1/97/046/031 - 84 tableta EU/1/97/046/037 - 90 tableta EU/1/97/046/020 - 98 tableta
Blood and lymphatic system disorders Not known:
Poremećaji krvi i limfnog sustava
Each tablet contains: irbesartan 150 mg
Jedna tableta sadrži 150 mg irbesartana
What Aprovel looks like and contents of the pack Aprovel 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Aprovel 300 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2773 na drugoj strani.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Bijela do gotovo bijela, bikonveksna, ovalna tableta, s utisnutom oznakom srca na jednoj i brojem 2773 na drugoj strani.
EU/1/97/046/012 - 14 tablets EU/1/97/046/007 - 28 tablets EU/1/97/046/008 - 56 tablets EU/1/97/046/015 - 56 x 1 tablets EU/1/97/046/009 - 98 tablets
EU/1/97/046/012 - 14 tableta EU/1/97/046/007 - 28 tableta EU/1/97/046/008 - 56 tableta EU/1/97/046/015 - 56 x 1 tableta EU/1/97/046/009 - 98 tableta
EU/1/97/046/010 - 14 tablets EU/1/97/046/001 - 28 tablets EU/1/97/046/002 - 56 tablets EU/1/97/046/013 - 56 x 1 tablets EU/1/97/046/003 - 98 tablets
EU/1/97/046/010 - 14 tableta EU/1/97/046/001 - 28 tableta EU/1/97/046/002 - 56 tableta EU/1/97/046/013 - 56 x 1 tableta EU/1/97/046/003 - 98 tableta
What Aprovel looks like and contents of the pack Aprovel 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Aprovel 150 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2772 na drugoj strani.
EU/1/97/046/026 - 14 tablets EU/1/97/046/027 - 28 tablets EU/1/97/046/036 - 30 tablets EU/1/97/046/028 - 56 tablets EU/1/97/046/029 - 56 x 1 tablets EU/1/97/046/033 - 84 tablets EU/1/97/046/039 - 90 tablets EU/1/97/046/030 - 98 tablets
EU/1/97/046/026 - 14 tableta EU/1/97/046/027 - 28 tableta EU/1/97/046/036 - 30 tableta EU/1/97/046/028 - 56 tableta EU/1/97/046/029 - 56 x 1 tableta EU/1/97/046/033 - 84 tableta EU/1/97/046/039 - 90 tableta EU/1/97/046/030 - 98 tableta
leukocytoclastic vasculitis Musculoskeletal and connective tissue disorders Common:
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često:
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Bijela do gotovo bijela, bikonveksna, ovalna tableta, s utisnutom oznakom srca na jednoj i brojem 2772 na drugoj strani.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Bijela do gotovo bijela, bikonveksna, ovalna filmom obložena tableta, s utisnutom oznakom srca na jednoj i brojem 2873 na drugoj strani.
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Diuretici i drugi antihipertenzivni lijekovi: drugi antihipertenzivi mogu pojačati hipotenzivni učinak irbesartana.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Bijela do gotovo bijela, bikonveksna, ovalna filmom obložena tableta, s utisnutom oznakom srca na jednoj i brojem 2871 na drugoj strani.
 If you get any side effects, talk to your doctor or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets.
Aprovel 75 mg tablete
NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg tablets.
Aprovel 150 mg tablete
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Bijela do gotovo bijela, bikonveksna, ovalna filmom obložena tableta, s oznakom srca na jednoj i brojem 2872 na drugoj strani.
NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg film-coated tablets.
Aprovel 150 mg filmom obložene tablete
Gastrointestinal disorders Common:
Poremećaji probavnog sustava Često:
orthostatic hypotension* Uncommon: flushing Respiratory, thoracic and mediastinal disorders Uncommon: cough
Manje često: crvenilo praćeno osjećajem vrućine Poremećaji dišnog sustava, prsišta i sredoprsja Manje često: kašalj
Hepatic impairment
Oštećena funkcija bubrega
Nederland sanofi-aventis Netherlands B.V. Tel: +31 (0)182 557 755
Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 48 00
(included in section 1 text)
(Uključeno u tekst u dijelu 1)
This process is called remodelling.
Taj proces naziva se preoblikovanje.
This will help to prevent dehydration.
To će pomoći u sprječavanju dehidracije.
Some side effects could be serious
Neke nuspojave mogu biti ozbiljne
You should therefore be careful when driving, using machines or performing other tasks that need full attention.
Stoga morate biti oprezni dok upravljate vozilima, radite sa strojevima ili obavljate druge zadatke koji zahtijevaju Vašu punu pozornost.
The infusion must be conducted according to standard medical practice.
Infuzija se mora provoditi u skladu sa standardnom liječničkom praksom.
The response rate in these patients was about 52%.
Stopa odgovora u tih bolesnika bila je približno 52%.
Check with your doctor or nurse if you are not sure.
Provjerite s liječnikom ili medicinskom sestrom ako niste sigurni.
Local reactions
Lokalne reakcije
Withdraw an appropriate volume of the concentrate needed, as follows:
Izvucite odgovarajući volumen potrebnog koncentrata na sljedeći način:
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
Median time to normocalcaemia was 4 days.
Medijan vremena do normokalcemije bio je 4 dana.
Date of first authorisation: 19 November 2012 Date of latest renewal: 24 August 2017
Datum prvog odobrenja: 19. studeni 2012 Datum posljednje obnove odobrenja: 24. kolovoza 2017
(to appear in roundel)
(pojavljuje se u krugu)
Unopened bag: 2 years
Neotvorena vrećica: 2 godine
Time on study (weeks)
Vrijeme u ispitivanju (tjedni)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
KVALITATIVNI I KVANTITATIVNI SASTAV
Frequency cannot be estimated from available data.
Učestalost se ne može procijeniti iz dostupnih podataka.
The clinical relevance of these findings is unknown.
Klinički značaj tih nalaza je nepoznat.
Each pack contains one bag.
Svako pakiranje sadrži jednu vrećicu.
Patients who have received doses higher than those recommended should be carefully monitored.
Bolesnike koji su primili više doze od preporučenih treba pažljivo pratiti.
No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Nije potrebna prilagodba doze s obzirom da je biološka dostupnost, distribucija i eliminacija slična u starijih bolesnika i mlađih ispitanika.
After opening: 24 hours at 2
Nakon otvaranja: 24 sata na 2
After opening: 24 hours at 2°C - 8°C
Nakon otvaranja: 24 sata na 2°C-8°C.
The following information is intended for medical or health care professionals only.
Sljedeće informacije namijenjene su samo liječnicima i zdravstvenim radnicima.
Adults and elderly
Odrasli i starije osobe
It is normal that old bone is removed and is replaced with new bone material.
Normalno je da se stara kost razgrađuje i da se nadomješta novim koštanim materijalom.
No symptomatic cases of hypocalcaemia were observed.
Nisu opaženi simptomatski slučajevi hipokalcemije.
It is important to try and prevent ONJ developing as it a painful condition that can be difficult to treat.
Važno je pokušati spriječiti razvoj ONČ, jer je to bolno stanje koje može biti problem liječiti.
Special populations (see section 4.2)
Posebne populacije (vidjeti dio 4.2)
Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Liječnik će Vas obavijestiti o simptomima koji su povezani s hipokalcemijom.
It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
Važno je da se pažljivo pridržavate tog savjeta kako razina kalcija u krvi ne bi postala preniska u razdoblju nakon infuzije.
Limited data on re-treatment of Paget's disease are available (see section 5.1).
Dostupni su ograničeni podaci o ponovnom liječenju Pagetove bolesti (vidjeti dio 5.1).
NR Not Reached
ND nije dosegnuto
If the disease is not treated, bones may become deformed and painful, and may break.
Ako se bolest ne liječi, kosti mogu postati deformirane i bolne te se mogu slomiti.
Physicians should consider clinical monitoring for these patients.
Liječnik treba razmotriti kliničko praćenje tih bolesnika.
* Common in Paget's disease only.
* Često samo u Pagetovoj bolesti.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Kako bi se smanjio rizik od razvoja osteonekroze čeljusti, postoje neke mjere opreza koje treba poduzeti.
Mutagenicity and carcinogenic potential
Mutagenost i kancerogeni potencijal
This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
Ovo je posebno važno za bolesnike koji uzimaju diuretike („tablete za mokrenje“) i za starije bolesnike.
The time to onset of symptoms varied from one day to several months after starting treatment.
Vrijeme do nastupa simptoma kretalo se u rasponu od jednog dana do nekoliko mjeseci nakon početka liječenja.
** Based on post-marketing reports.
**Temeljeno na izvješćima poslije stavljanja lijeka u promet.
In some instances the hypocalcaemia may be life-threatening.
U nekim slučajevima hipokalcemija može biti po život opasna.
The infusion will take at least 15 minutes.
Infuzija će trajati najmanje 15 minuta.
No interaction studies with other medicinal products have been performed.
Nisu provedena ispitivanja interakcija s drugim lijekovima.
Zoledronic Acid Hospira may work for longer than one year, and your doctor will let you know if you need to be treated again.
Zoledronatna kiselina Hospira može djelovati dulje od godine dana, a liječnik će Vam reći ako se trebate ponovno liječiti.
Day 7
7. dan
You must not be given Zoledronic Acid Hospira if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Zoledronatnu kiselinu Hospira ne smijete primijeniti ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.
Teratology studies were performed in two species, both via subcutaneous administration.
Teratološka ispitivanja provedena su na dvije vrste, i to u obje supkutanom primjenom.
• Monitoring of serum creatinine should be considered in at-risk patients.
• treba razmotriti praćenje serumskog kreatinina u rizičnih bolesnika
Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego uzmete ovaj lijek.
These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Ti su rezultati bili u skladu s dokazom biokemijskih markera za normalizacije koštane pregradnje.
Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Potrebno je obratiti pozornost i na mogućnost razvoja hipomagnezijemije tijekom liječenja.
Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
Nuspojave povezane s prvom infuzijom su vrlo česte (javljaju se u više od 30% bolesnika), ali su znatno rjeđe nakon narednih infuzija.
− Urticaria.
- koprivnjača.
− Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
- Liječnik će Vam savjetovati da prije svakog liječenja popijete dovoljnu količinu vode kako bi se spriječila dehidracija.
This is especially important for the elderly and for patients receiving diuretic therapy.
To je osobito važno u starijih osoba i bolesnika koji primaju diuretsku terapiju.