natgillin/translations-raw huggingface dataset:
Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of drug with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50– 80 ml/ min) and moderate renal impairment down to a creatinine clearance of 35 ml/ min are not necessary.
Majhno zvečanje AUC( 0- 24hr) za okrog 30 do 40%, ki so ga opazili pri bolnikih z blago do zmerno ledvično okvaro v primerjavi z bolniki z normalnim ledvičnim delovanjem, in odsotnost kopičenja zdravila ob večkratnih odmerkih, ne glede na ledvično delovanje, kažeta, da prilagajanje odmerka zoledronske kisline pri blagi (Clcr = 50 do 80 ml/ min) in zmerni ledvični okvari z znižanim očistkom kreatinina do 35 ml/ min ni potrebno.
As only limited data are available in severe renal impairment (creatinine clearance < 30 ml/ min), no dosing recommendations are possible for this population.
Ker so o hudi ledvični okvari (očistek kreatinina < 30 ml/ min) na voljo le omejeni podatki, za to skupino bolnikov ne moremo dati priporočil za odmerjanje.
11 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
Acute toxicity The highest non-lethal single intravenous dose was 10 mg/ kg body weight in mice and 0.6 mg/ kg in rats.
Akutna toksičnost Največji ne- letalen enkratni intravenski odmerek je bil 10 mg/ kg telesne mase pri miših in 0, 6 mg/ kg pri podganah.
In the single-dose dog infusion studies, 1.0 mg/ kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
V študijah, kjer so psom infundirali enkratne odmerke, so le- ti, brez učinkov na ledvice, dobro prenašali odmerek 1, 0 mg/ kg (6- krat priporočena terapevtska izpostavljenost za človeka na podlagi AUC) infundiran v času 15 minut.
Subchronic and chronic toxicity In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/ kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/ kg administered at 2– 3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
Subkronična in kronična toksičnost V študijah z intravenskim infundiranjem so dokazali ledvično prenosljivost za zoledronsko kislino pri podganah, ki so jim dajali odmerek 0, 6 mg/ kg v 15- minutnih infuzijah v 3- dnevnih presledkih (kumulativni odmerek je ustrezal ravnem AUC, ki so bile približno 6- krat večje od terapevtske izpostavljenosti pri človeku).
In the intravenous bolus studies, the doses that were well-tolerated decreased with increasing study duration:
Psi pa so dobro prenesli pet 15- minutnih infuzij po 0, 25 mg/ kg, danih v 2 - do 3- tedenskih presledkih (kumulativni odmerek, ki je ustrezal 7- kratni terapevtski izpostavljenosti pri človeku).
0.2 and 0.02 mg/ kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/ kg and 0.005 mg/ kg in rats and dogs, respectively, when given for 52 weeks.
V študijah z intravenskimi bolusi so se odmerki, ki so jih živali dobro prenašale, zmanjševali s podaljševanjem študije: odmerek 0, 2 oziroma 0, 02 mg/ kg na dan so podgane in psi dobro prenašali 4 tedne, medtem ko so tako podgane kot psi 52 tednov dolgo dajanje zdravila dobro prenašali le v odmerku 0, 01 mg/ kg oziroma 0, 005 mg/ kg.
The most frequent finding in the repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound’ s pharmacological antiresorptive activity.
Ta podatek odraža farmakološko protiresorpcijsko aktivnost učinkovine.
Reproduction toxicity Teratology studies were performed in two species, both via subcutaneous administration.
Reproduktivna toksičnost Študije teratogenosti so opravili pri dveh živalskih vrstah, pri obeh s subkutano uporabo.
Teratogenicity was observed in rats at doses ≥ 0.2 mg/ kg and was manifested by external, visceral and skeletal malformations.
Teratogenost so ugotovili pri podganah v odmerkih ≥0, 2 mg/ kg, ki se je kazala v obliki zunanjih, visceralnih in skeletnih malformacij.
Dystocia was observed at the lowest dose (0.01 mg/ kg body weight) tested in rats.
Distocijo so ugotovili pri najnižjem odmerku (0, 01 mg/ kg telesne mase), ki so ga preskušali pri podganah.
No teratological or embryo/ foetal effects were observed in rabbits, although maternal toxicity was marked at 0.1 mg/ kg due to decreased serum calcium levels.
Pri kuncih niso opazili teratogenih učinkov ali učinkov na zarodek ali plod, čeprav je bila toksičnost za mater pri odmerku 0, 1 mg/ kg znatna zaradi znižanih koncentracij kalcija v serumu.
Mutagenicity and carcinogenic potential Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Mutagenost in kancerogeni potencial Zoledronska kislina v opravljenih testih mutagenosti ni bila mutagena, testiranje kancerogenosti pa ni dalo nikakršnih dokazov o kancerogenem potencialu.
Mannitol Sodium citrate Water for injections
manitol natrijev citrat voda za injekcije
Aclasta must not be allowed to come into contact with any calcium-containing solutions.
Zdravilo Aclasta ne sme priti v stik z raztopinami, ki vsebujejo kalcij.
Aclasta must not be mixed or given intravenously with any other medicinal products.
Ne smete ga mešati ali dajati intravensko skupaj z drugimi zdravili.
Unopened bottle:
Neodprta steklenica:
After opening:
Po odpiranju:
24 hours at 2°C - 8°C
24 ur pri 2°C - 8°C.
12 From a microbiological point of view, the product should be used immediately.
Če ga uporabnik ne uporabi takoj, je sam odgovoren za čas in pogoje shranjevanja pred uporabo.
100 ml transparent plastic (cycloolefinic polymer) bottle closed with a fluoro-polymer coated bromobutyl rubber stopper and an aluminium/ polypropylene cap with a flip component.
100- mililitrska prosojna plastična (cikloolefinski polimer) steklenica, zaprta z zamaškom iz bromobutilne gume, prevlečene s fluoropolimerom, in pokrovčkom iz aluminija/ polipropilena z zaporko.
Aclasta is supplied in packs containing one bottle as unit pack or in multi-packs comprising 5 packs, each containing 1 bottle.
Zdravilo Aclasta je na voljo v škatlah, ki vsebujejo po eno steklenico kot posamično pakiranje ali skupno pakiranje s 5 škatlami po 1 steklenico.
Any unused solution should be discarded.
Morebitno neuporabljeno raztopino morate zavreči.
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Velika Britanija
14 A.
14 DODATEK II
Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Novartis Pharma GmbH Roonstraße 25 D- 90429 Nürnberg Nemčija
(See Annex I:
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I:
Summary of Product Characteristics, section 4.2)
Povzetek glavnih značilnosti zdravila, poglavje 4. 2).
The Marketing Authorisation Holder (MAH) shall ensure that the educational programme implemented for the authorised indication of treatment of post-menopausal osteoporosis, is extended to the potential prescribers concerned by the new indication: treatment of osteoporosis in post- menopausal women and men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo izobraževalni program, ki ga je izvajal za odobreno indikacijo zdravljenja postmenopavzalne osteoporoze, razširil na zdravnike, ki bi zdravilo lahko predpisovali v okviru nove indikacije: zdravljenje osteoporoze pri postmenopavzalnih ženskah in moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi.
The educational programme contains the following: • Physician educational material • Patient information pack
Izobraževalni program vsebuje naslednje: • Izobraževalni material za zdravnika • Komplet podatkov o zdravilu za bolnika
The physician educational material should contain the following key elements: • The Summary of Product Characteristics • Reminder card with the following key messages: o Need to measure serum creatinine before treatment with Aclasta o Recommendation not to use Aclasta in patients with creatinine clearance < 35 ml/ min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient o Need to infuse Aclasta slowly over a period of no less than 15 minutes o One-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration o Need for appropriate physical activity, non-smoking and healthy diet • Patient information pack
Izobraževalni material za zdravnika mora vsebovati naslednje ključne sestavine: • Povzetek glavnih značilnosti zdravila; • Opomnik z naslednjimi ključnimi sporočili: o potrebnost meritve kreatinina v serumu pred zdravljenjem z zdravilom Aclasta, o priporočilo, da se zdravila Aclasta ne sme uporabljati pri bolnikih z očistkom kreatinina < 35 ml/ min, o kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti, o potrebo po zagotovitvi primerne hidriranosti bolnika, o potrebnost počasnega infundiranja zdravila Aclasta v času, ki ni krajši od 15 minut, o shemo odmerjanja enkrat letno, o priporočilo o zadostnem vnosu kalcija in vitamina D v zvezi z uporabo zdravila Aclasta, o potrebnost ustrezne telesne dejavnosti in zdrave prehrane ter odsotnosti kajenja; • Komplet podatkov o zdravilu za bolnika.
15 • OTHER CONDITIONS
16 • DRUGI POGOJI
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in the version 3.0 dated 13 July 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora vzpostaviti in zagotoviti delovanje sistema farmakovigilance preden je zdravilo dostopno na tržišču in dokler je trženo zdravilo v uporabi, kot je navedeno v modulu 1. 8. 1 verzije 3. 0 vloge za pridobitev dovoljenja za promet z zdravilom z dne 13. julija 2007.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 004 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt obvladovanja tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil raziskave in dodatne dejavnosti v okviru farmakovigilance, opisane v Farmakovigilančnem načrtu, kot je sprejeto v verziji 004 Načrta obvladovanja tveganja v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih dopolnilih Načrta obvladovanja tveganja, ki jih sprejme Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s Smernicami glede sistemov za obvladovanje tveganja pri zdravilih za uporabo v humani medicini Odbora za zdravila za uporabo v humani medicini (CHMP), je treba dopolnjen Načrt obvladovanja tveganja predložiti istočasno z naslednjim Periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba predložiti dopolnjen Načrt obvladovanja tveganja: • po prejetju novih informacij, ki bi lahko vplivale na zadnjo Varnostno specifikacijo, Farmakovigilančni načrt ali na ukrepe za zmanjševanje tveganja, • v 60 dneh po doseženem pomembnem mejniku (glede farmakovigilance ali zmanjševanja tveganja), • na zahtevo Evropske agencije za zdravila (EMEA).
17 A.
17 DODATEK III
LABELLING
OZNAČEVANJE IN NAVODILO ZA UPORABO
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
OZNAČEVANJE
FOLDING BOX (WITH BLUE BOX) AND BOTTLE LABEL FOR UNIT PACK
ŠKATLA (Z ” BLUE BOX ” PODATKI) IN NALEPKA NA STEKLENICI ZA POSAMIČNO PAKIRANJE
1 bottle contains 5 mg zoledronic acid (anhydrous).
1 steklenica vsebuje 5 mg brezvodne zoledronske kisline.
1 bottle – 100 ml
1 steklenica – 100 ml
EXP After opening:
EXP Po odpiranju:
24 hours at 2°C - 8°C.
24 ur pri 2°C - 8°C.
20 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
21 PODATKI NA VMESNI OVOJNINI
FOLDING BOX (WITH BLUE BOX) AND BOTTLE LABEL FOR INTERMEDIATE PACK
ŠKATLA Z ” BLUE BOX ” PODATKI IN NALEPKA NA STEKLENICI ZA VMESNO PAKIRANJE
1 bottle - 100 ml Component of a multi-pack comprising 5 bottles, each bottle of 100 ml.
1 steklenica – 100 ml Del skupnega pakiranja s 5 steklenicami po 100 ml.
22 PARTICULARS TO APPEAR ON THE OUTER CARTON OF MULTI-PACK (INCLUDING BLUE BOX)
23 PODATKI NA ZUNANJI ŠKATLI SKUPNEGA PAKIRANJA (VKLJUČNO Z ” BLUE BOX ” PODATKI)
Multi-pack comprising 5 bottles, each bottle of 100 ml.
Skupno pakiranje s 5 steklenicami po 100 ml.
INFORMATION FOR THE USER
NAVODILO ZA UPORABO
Read all of this leaflet carefully before you are given this medicine.
Preden vam bodo dali to zdravilo, natančno preberite navodilo!
please tell your doctor, pharmacist or nurse.
omenjen v tem navodilu, obvestite svojega zdravnika, farmacevta ali medicinsko sestro.
What Aclasta is and what it is used for 2.
Kaj je zdravilo Aclasta in za kaj ga uporabljamo 2.
Before you are given Aclasta 3.
Kaj morate vedeti, preden vam dajo zdravilo Aclasta 3.
How Aclasta is given 4.
Kako se daje zdravilo Aclasta 4.
How to store Aclasta 6.
Shranjevanje zdravila Aclasta 6.
WHAT ACLASTA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ACLASTA IN ZA KAJ GA UPORABLJAMO
Aclasta is given as a single infusion into a vein by a doctor or nurse.
Zdravilo Aclasta vam vbrizga zdravnik ali medicinska sestra v veno, v obliki enkratne infuzije.
It belongs to a group of medicines called bisphosphonates and is used to treat osteoporosis in post-menopausal women, osteoporosis in men and Paget’ s disease of the bone.
Pripada skupini zdravil, ki se imenujejo difosfonati in jih uporabljamo za zdravljenje osteoporoze pri postmenopavzalnih ženskah, osteoporoze pri moških in Pagetove bolezni kosti.
Osteoporosis Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after the menopause, but can also occur in men.
Osteoporoza Osteoporoza je bolezen, pri kateri kosti postajajo bolj porozne in krhke, in je pogosta pri ženskah po menopavzi, vendar se lahko pojavi tudi pri moških.
At the menopause, a woman’ s ovaries stop producing the female hormone oestrogen, which helps keep bones healthy.
Pri ženski po menopavzi jajčniki ne tvorijo več ženskega hormona estrogena, ki pomaga ohranjati kosti zdrave.
Because Aclasta works for a long time, you will not need another dose of Aclasta for a year.
Ker zdravilo Aclasta deluje dolgo časa, eno leto ne boste potrebovali naslednjega odmerka.
Paget’ s disease of the bone It is normal that old bone is removed and is replaced with new bone material.
Pagetova bolezen kosti Normalno je, da se stara kost odstranjuje in da jo nadomešča nova kostnina.
In Paget’ s disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal.
Pri Pagetovi bolezni je kostna pregradnja prehitra, nova kostnina pa se tvori nepravilno, zato je šibkejša od normalne.
Aclasta works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Aclasta deluje tako, da normalizira proces kostne pregradnje, omogoči tvorbo normalne kostnine in tako kostem povrne čvrstost.
BEFORE YOU ARE GIVEN ACLASTA
KAJ MORATE VEDETI, PREDEN VAM DAJO ZDRAVILO ACLASTA
Follow all instructions given to you by your doctor carefully before you are given Aclasta.
Skrbno se ravnajte po vseh zdravnikovih navodilih, preden vam dajo zdravilo Aclasta.
You should not be given Aclasta
Zdravila Aclasta ne smete dobiti
- if you are allergic (hypersensitive) to zoledronic acid, other bisphosphonates or any of the other
- če ste alergični (preobčutljivi) na zoledronsko kislino, druge difosfonate ali katerokoli sestavino
ingredients of Aclasta.
zdravila Aclasta,
- 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),
- if you are pregnant or plan to become pregnant.
- če ste noseči ali nameravate zanositi,
26 Take special care with Aclasta Tell your doctor before you are given Aclasta:
27 Bodite posebno pozorni pri uporabi zdravila Aclasta Preden dobite zdravilo Aclasta, povejte zdravniku:
- if you are being treated with Zometa, which contains the same active substance as Aclasta.
- če se zdravite z zdravilom Zometa, ki vsebuje isto učinkovino kot zdravilo Aclasta,
- if you have a kidney problem, or used to have one.
- če imate ali ste kdaj prej imeli težave z ledvicami,
- if you are unable to take daily calcium supplements.
- če ne morete vsak dan jemati nadomestkov kalcija,
- if you have had some or all of the parathyroid glands in your neck surgically removed.
- če so vam deloma ali v celoti kirurško odstranili žleze obščitnice,
- if you have had sections of your intestine removed.
- če so vam odstranili dele črevesa,
- if you had or have pain, swelling or numbness of the jaw or a loosening of the tooth.
- če imate ali ste kdaj prej imeli bolečino, oteklino, občutek odrevenelosti v čeljusti ali majavost
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Aclasta.
Če ste v postopku zdravljenja zob ali načrtujete stomatološko operacijo, zobozdravniku povejte, da se zdravite z zdravilom Aclasta.
Taking other medicines Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
It is especially important for your doctor to know if you are taking any medicines known to be harmful to your kidneys.
Posebno pomembno je, da vaš zdravnik ve, če jemljete zdravila, za katera je znano, da lahko škodujejo ledvicam.
Using Aclasta with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Aclasta, as directed by your doctor.
Uporaba zdravila Aclasta skupaj s hrano in pijačo Poskrbite, da boste pred zdravljenjem z zdravilom Aclasta in po njem pili dovolj tekočine (vsaj en do dva kozarca), kot vam bo naročil zdravnik.
You may eat normally on the day you are treated with Aclasta.
Na dan, ko dobite zdravilo Aclasta, lahko jeste normalno.
Elderly patients (age 65 years and over) Aclasta can be given to older patients.
Starejši bolniki (stari 65 let ali več) Starejši bolniki lahko dobijo zdravilo Aclasta.
Pregnancy and breast-feeding You should not be given Aclasta if you are pregnant or plan to become pregnant.
Nosečnost in dojenje Če ste noseči ali nameravate zanositi, ne smete dobiti zdravila Aclasta.
You should not be given Aclasta if you are breast-feeding.
Če dojite, ne smete dobiti zdravila Aclasta.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Posvetujte se z zdravnikom, s farmacevtom ali z medicinsko sestro, preden vzamete katerokoli zdravilo.
Driving and using machines Aclasta has no known effects on the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Aclasta nima znanih učinkov na sposobnost upravljanja vozil in strojev.
HOW ACLASTA IS GIVEN
KAKO SE DAJE ZDRAVILO ACLASTA
Osteoporosis The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse.
Osteoporoza Običajni odmerek je 5 mg, in sicer vam ga da vaš zdravnik ali medicinska sestra enkrat na leto v obliki enkratne infuzije v veno.
Follow carefully all instructions given to you by your doctor or nurse.
Skrbno se ravnajte po vseh zdravnikovih navodilih ali navodilih medicinske sestre.
For osteoporosis, Aclasta works for one year and you will need the next dose after one year.
Čez eno leto boste potrebovali naslednji odmerek.
27 Paget’ s disease The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse.
28 Pagetova bolezen Običajni odmerek je 5 mg in sicer vam ga da vaš zdravnik ali medicinska sestra v obliki enkratne infuzije v veno.
As Aclasta works for a long time, you may not need another dose of Aclasta for a year or longer.
Ker zdravilo Aclasta deluje dolgo časa, mogoče ne boste potrebovali njenega naslednjega odmerka eno leto ali še dlje časa.
Your doctor may advise you to take calcium and vitamin D supplements (e. g. tablets) for at least the first ten days after being given Aclasta.
Mogoče vam bo zdravnik svetoval, da vsaj prvih deset dni po prejemu zdravila Aclasta jemljete dodatke kalcija in vitamina D (na primer v obliki tablet).
For Paget’ s disease Aclasta may work for longer than one year, and your doctor will let you know if you need to be treated again.
Zdravnik vam bo povedal, če se boste morali ponovno zdraviti.
If a dose of Aclasta is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Če niste prejeli načrtovanega odmerka zdravila Aclasta Čimprej pokličite zdravnika oziroma v bolnišnico, da se dogovorite za nov datum.
Before stopping Aclasta therapy If you are considering stopping Aclasta treatment, please go to your next appointment and discuss this with your doctor.
Preden prenehate prejemati zdravilo Aclasta Če nameravate prenehati z zdravljenjem z zdravilom Aclasta, se pri naslednjem pregledu o tem pogovorite z zdravnikom.
If you have any questions on the use of this product, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
Like all medicines, Aclasta can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Aclasta neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In most cases, no specific treatment is required.
V večini primerov posebno zdravljenje ni potrebno.
Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
V povezavi s prvo infuzijo so neželeni učinki zelo pogosti (nastopijo pri več kot 30% bolnikov), manj pogosti pa so po naslednjih infuzijah.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Aclasta for post- menopausal osteoporosis.
Pri bolnicah, ki so prejemale zdravilo Aclasta zaradi postmenopavzalne osteoporoze, so opažali nepravilno bitje srca (atrijsko fibrilacijo).
It is currently unclear whether Aclasta causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Aclasta.
Zaenkrat ni jasno, ali to nepravilno bitje srca povzroča zdravilo Aclasta, kljub temu pa morate zdravniku sporočiti, če pri vas pride do takih simptomov po tem, ko ste prejeli zdravilo Aclasta.
Fever
Zelo pogosti neželeni učinki (do katerih pride pri 10 ali več na vsakih 100 bolnikov): vročina