natgillin/translations-raw huggingface dataset:
D.
n
Olmesartan 40 Irbesartan 300 Candesartan 32
Meja za NDMA v ppm v učinkovini valsartan losartan olmesartan 40 irbesartan 300 kandesartan 32
Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Renovaskularna hipertenzija: pri bolnikih z obojestransko stenozo ledvične arterije ali s stenozo arterije ene same delujoče ledvice, je pri uporabi zdravil z vplivom na sistem renin-angiotenzinaldosteron, povečano tveganje za hudo hipotenzijo in ledvično insuficienco.
 This medicine has been prescribed for you only.
Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Aprovel is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
dysgeusia
paragevzija
NAME OF THE MEDICINAL PRODUCT Aprovel 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
IME ZDRAVILA Aprovel 75 mg tablete irbesartan IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM sanofi-aventis groupe DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do: ŠTEVILKA SERIJE
 If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
NAME OF THE MEDICINAL PRODUCT Aprovel 150 mg film-coated tablets.
IME ZDRAVILA Aprovel 150 mg filmsko obložene tablete.
The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.
Običajen odmerek je 150 mg enkrat na dan. Odmerek se lahko kasneje poveča na 300 mg (dve tableti) enkrat na dan, odvisno od odziva krvnega tlaka.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 75 mg irbesartana.
NAME OF THE MEDICINAL PRODUCT Aprovel 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
IME ZDRAVILA Aprovel 300 mg tablete irbesartan IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM sanofi-aventis groupe DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do: ŠTEVILKA SERIJE
Excipient with known effect: 61.50 mg of lactose monohydrate per tablet.
Pomožna snov z znanim učinkom: 61,50 mg laktoze monohidrata na tableto.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 75 mg irbesartana.
Excipient with known effect: 30.75 mg of lactose monohydrate per tablet.
Pomožna snov z znanim učinkom: 30,75 mg laktoze monohidrata na tableto.
Excipient with known effect: 25.50 mg of lactose monohydrate per film-coated tablet.
Pomožne snovi z znanim učinkom: 25,50 mg laktoze monohidrata na filmsko obloženo tableto.
Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 75 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
The dose may later be increased to 300 mg once daily depending on blood pressure response.
Običajen odmerek je 150 mg enkrat na dan. Odmerek se lahko kasneje poveča na 300 mg enkrat na dan, odvisno od odziva krvnega tlaka.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
Excipient with known effect: 102.00 mg of lactose monohydrate per film-coated tablet.
Pomožne snovi z znanim učinkom: 102,00 mg laktoze monohidrata na filmsko obloženo tableto.
Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie
Imetnik dovoljenja za promet: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - Francija
Warnings and precautions Talk to your doctor before taking Aprovel and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Aprovel for diabetic kidney disease.
če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami če imate težave s srcem če zdravilo Aprovel jemljete zaradi diabetične bolezni ledvic.
Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 150 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 300 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 300 mg irbesartana.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 300 mg irbesartana.
Excipient with known effect: 15.37 mg of lactose monohydrate per tablet.
Pomožna snov z znanim učinkom: 15,37 mg laktoze monohidrata na tableto.
Cardiac disorders:
Srčne bolezni Občasni:
Excipient with known effect: 51.00 mg of lactose monohydrate per film-coated tablet.
Pomožne snovi z znanim učinkom: 51,00 mg laktoze monohidrata na filmsko obloženo tableto.
Cartons of 56 x 1 tablet in PVC/PVDC/Aluminium perforated unit dose blisters.
Škatle s 56 x 1 tableto v perforiranih pretisnih omotih iz PVC/PVDC/aluminija za enkratni odmerek.
Fri
Sre
How to store Aprovel
Shranjevanje zdravila Aprovel
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 150 mg irbesartana.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 150 mg irbesartana.
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 filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
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 filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
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 filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
No dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Bolnikom z lažjo do srednje težko jetrno okvaro odmerka ni treba prilagajati.
Cartons of 56 x 1 film-coated tablet in PVC/PVDC/Aluminium perforated unit dose blisters.
Škatle s 56 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih iz PVC/PVDC/aluminija za enkratni odmerek .
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.
Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (štiri tablete) enkrat 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 (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg (dve tableti) enkrat na dan.
Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood pressure lowering effect is maintained for at least 24 hours.
Največje znižanje krvnega tlaka je doseženo v 3-6 urah po jemanju zdravila.
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.
Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg enkrat na dan.
Losartan
tahikardija
Cartons of 56 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 56 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle z 90 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.
Škatle s 30 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
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 tablet EU/1/97/046/004 - 28 tablet EU/1/97/046/005 - 56 tablet EU/1/97/046/014 - 56 x 1 tableta EU/1/97/046/006 - 98 tablet
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Bele do belkaste barve, bikonveksne in ovalne oblike z oznako srca na eni strani in vtisnjeno številko 2771 na drugi strani.
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 tablet EU/1/97/046/017 - 28 tablet EU/1/97/046/034 - 30 tablet EU/1/97/046/018 - 56 tablet EU/1/97/046/019 - 56 x 1 tableta EU/1/97/046/031 - 84 tablet EU/1/97/046/037 - 90 tablet EU/1/97/046/020 - 98 tablet
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 tablet EU/1/97/046/022 - 28 tablet EU/1/97/046/035 - 30 tablet EU/1/97/046/023 - 56 tablet EU/1/97/046/024 - 56 x 1 tableta EU/1/97/046/032 - 84 tablet EU/1/97/046/038 - 90 tablet EU/1/97/046/025 - 98 tablet
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 tablet EU/1/97/046/007 - 28 tablet EU/1/97/046/008 - 56 tablet EU/1/97/046/015 - 56 x 1 tableta EU/1/97/046/009 - 98 tablet
Package leaflet: Information for the user Aprovel 75 mg film-coated tablets irbesartan
Navodilo za uporabo Aprovel 75 mg filmsko obložene tablete irbesartan
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Bele do belkaste barve, bikonveksne in ovalne oblike z oznako srca na eni strani in vtisnjeno številko 2871 na drugi strani.
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 tablet EU/1/97/046/001 - 28 tablet EU/1/97/046/002 - 56 tablet EU/1/97/046/013 - 56 x 1 tableta EU/1/97/046/003 - 98 tablet
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 tablet EU/1/97/046/027 - 28 tablet EU/1/97/046/036 - 30 tablet EU/1/97/046/028 - 56 tablet EU/1/97/046/029 - 56 x 1 tableta EU/1/97/046/033 - 84 tablet EU/1/97/046/039 - 90 tablet EU/1/97/046/030 - 98 tablet
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
IME ZDRAVILA Aprovel 150 mg tablete irbesartan IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM sanofi-aventis groupe DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do: ŠTEVILKA SERIJE
Package leaflet: Information for the user Aprovel 75 mg tablets irbesartan
Navodilo za uporabo Aprovel 75 mg tablete irbesartan
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Bele do belkaste barve, bikonveksne in ovalne oblike z oznako srca na eni strani in vtisnjeno številko 2772 na drugi 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.
Bele do belkaste barve, bikonveksne in ovalne oblike z oznako srca na eni strani in vtisnjeno številko 2873 na drugi strani.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Bele do belkaste barve, bikonveksne in ovalne oblike z oznako srca na eni strani in vtisnjeno številko 2872 na drugi 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.
Bele do belkaste barve, bikonveksne in ovalne oblike z oznako srca na eni strani in vtisnjeno številko 2773 na drugi strani.
Package leaflet: Information for the user Aprovel 150 mg film-coated tablets irbesartan
Navodilo za uporabo Aprovel 150 mg filmsko obložene tablete irbesartan
Package leaflet: Information for the user Aprovel 150 mg tablets irbesartan
Navodilo za uporabo Aprovel 150 mg tablete irbesartan
Package leaflet: Information for the user Aprovel 300 mg film-coated tablets irbesartan
Navodilo za uporabo Aprovel 300 mg filmsko obložene tablete irbesartan
Do not take Aprovel  if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) if you are more than 3 months pregnant.
Ne jemljite zdravila Aprovel če ste alergični na irbesartan ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
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 filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
Package leaflet: Information for the user Aprovel 300 mg tablets irbesartan
Navodilo za uporabo Aprovel 300 mg tablete irbesartan
Tablet core:
Pediatrična populacija:
Hepatobiliary disorders Uncommon: jaundice Not known:
Bolezni sečil Neznana:
Aprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Če nameravate dojiti, še posebej novorojenca ali nedonošenčka, vam zdravnik lahko predpiše zdravljenje z drugim zdravilom.
Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Krvne preiskave lahko pokažejo zvišanje vrednosti encima, ki kaže na delovanje mišic in srca (encim kreatin-kinaza).
Time on study (weeks)
Čas v študiji (tedni)
- if you are pregnant.
− če ste noseči,
You should therefore be careful when driving, using machines or performing other tasks that need full attention.
Zato morate biti previdni pri upravljanju motornih vozil, uporabi strojev in opravljanju drugih nalog, ki zahtevajo vašo celotno pozornost.
The following information is intended for medical or health care professionals only.
Naslednje informacije so namenjene samo zdravstvenemu osebju.
Unopened bag: 2 years
Neodprta vreča: 2 leti
Adults and elderly
Odrasli in starejši
Date of first authorisation: 19 November 2012 Date of latest renewal: 24 August 2017
Datum prve odobritve: 19. november 2012 Datum zadnjega podaljšanja: 24. avgust 2017
NR Not Reached
NR ni bil dosežen
This will help to prevent dehydration.
S tem boste preprečili dehidriranost.
However, such reports have been infrequent.
O takih primerih so poročali le redko.
Withdraw an appropriate volume of the concentrate needed, as follows:
Odvzemite ustrezni volumen koncentrata, ki ga potrebujete, kot sledi:
Some side effects could be serious
Nekateri neželeni učinki so lahko resni
(included in section 1 text)
(vključeno v besedilu v poglavju 1)
Patients who have received doses higher than those recommended should be carefully monitored.
Bolnike, ki so dobili večje odmerke od priporočenih, je treba skrbno spremljati.
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.
Pomembno je, da ta nasvet natančno upoštevate, da se raven kalcija v vaši krvi v obdobju po infuziji ne zniža preveč.
Each pack contains one bag.
Vsako pakiranje vsebuje eno vrečo.
Hypotension (some of the patients had underlying risk factors)
hipotenzija (pri nekaterih od the bolnikov so bili že prej prisotni dejavniki tveganja)
This process is called remodelling.
Ta proces se imenuje kostna premena (remodeliranje).
There is no evidence to suggest that any extra precautions are needed.
Ni dokazov, ki bi nakazovali, da so potrebni posebni previdnostni ukrepi.
The infusion must be conducted according to standard medical practice.
Postopek infundiranja morate opraviti v skladu s standardno medicinsko prakso.
It is normal that old bone is removed and is replaced with new bone material.
Normalno je, da se stara kost odstranjuje in da jo nadomešča nova kostnina.
Each pack contains one vial with concentrate.
Vsako pakiranje vsebuje eno vialo s koncentratom.
Most patients had relief of symptoms after stopping treatment.
Pri večini bolnikov je prišlo do olajšanja simptomov po prekinitvi zdravljenja.
After opening: 24 hours at 2°C - 8°C
Po odprtju: 24 ur pri 2 °C - 8 °C
Your doctor will monitor this and take any necessary measures.
Zdravnik bo spremljal te vrednosti in ustrezno ukrepal,
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Tell your doctor if you are or think that you may be pregnant.
Povejte zdravniku, če ste noseči ali menite, da bi lahko bili noseči.
The frequency of hypocalcaemia was much lower following subsequent infusions.
Pogostnost hipokalciemije je bila pri nadaljnjih infuzijah precej nižja.
As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Ker so za bolnike s hudo insuficienco jeter na voljo le omejeni klinični podatki, za to skupino bolnikov ne moremo dati specifičnih priporočil.
No interaction studies with other medicinal products have been performed.
Študij medsebojnega delovanja z drugimi zdravili niso izvedli.
The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse.
Običajni odmerek je 5 mg, ki vam ga v obliki enkratne infuzije da vaš zdravnik ali medicinska sestra.
Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Zdravnik vas bo poučil o simptomih, povezanih s hipokalciemijo.
Physicians should consider clinical monitoring for these patients.
Zdravniki naj pretehtajo potrebo po kliničnem spremljanju teh bolnikov.
- if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
− če imate hipokalciemijo (to pomeni, da je koncentracija kalcija v vaši krvi prenizka),
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
To je zlasti pomembno pri bolnikih, ki prejemajo diuretike (tablete za odvajanje vode), in pri starejših bolnikih.
− Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
− Zdravnik vam bo priporočil, da pred vsako infuzijo spijete dovolj vode, kar bo pomagalo preprečiti dehidracijo.
Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
V prvih 24 urah se izloči v urin 39 ± 16 % danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
No symptomatic cases of hypocalcaemia were observed.
Simptomatskih primerov hipokalciemije niso opažali.
If the disease is not treated, bones may become deformed and painful, and may break.
Če bolezni ne zdravimo, se kost lahko deformira in začne boleti, lahko se tudi zlomi.
- if you are unable to take daily calcium supplements.
− če ne morete vsak dan jemati nadomestkov kalcija,
Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
Neželeni učinki, povezani s prvo infuzijo, so zelo pogosti (pojavijo se pri več kot 30 % bolnikov), pri naslednjih infuzijah pa so manj pogosti.
Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
Bolniki, ki so prejemali zoledronsko kislino 4 mg, so poročali o manjšem povečanju bolečine, kot bolniki, ki so prejemali placebo, razlika pa je postala pomembna v 3., 9., 21. in 24 mesecu.
− Low level of red blood cells (anaemia).
− nizko število rdečih krvnih celic (anemija).
The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Večina poročil se nanaša na bolnike z rakom po ekstrakciji zoba ali drugih zobozdravstvenih operativnih posegih.
- if you have severe kidney problems.
− če imate hude težave z ledvicami,
No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Prilagajanje odmerjanja ni potrebno, ker so vrednosti biološke uporabnosti, porazdelitve in izločanja iz telesa pri starejših bolnikih in mlajših preskušancih podobne.
Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
Bolnike je treba poučiti o simptomih hipokalciemije in jim med obdobjem tveganja nuditi ustrezno klinično spremljanje.
Zoledronic Acid Hospira may work for longer than one year, and your doctor will let you know if you need to be treated again.
Zdravilo Zoledronska kislina Hospira lahko učinkuje dlje kot eno leto, zato vam bo zdravnik povedal, če vas je treba ponovno zdraviti.
− Increased sweating
− zvečano znojenje,
Risk reduction of suffering from multiple events** (%)
zmanjšanje tveganja za pojav večkratnih dogodkov** (%)
* Common in Paget's disease only.
* pogosto samo pri Pagetovi bolezni.
Stable for 24 hours at 2
EXP Po redčenju stabilno 24 ur pri 2
− Fainting due to low blood pressure.
− izguba zavesti zaradi nizkega krvnega tlaka,
Teratology studies were performed in two species, both via subcutaneous administration.
Študije teratogenosti so opravili pri dveh živalskih vrstah, pri obeh s subkutano uporabo.
The symptoms are usually mild to moderate and go away within three days.
Simptomi so običajno blagi do zmerni in izzvenijo v treh dneh.