natgillin/translations-raw huggingface dataset:
20 Blood and lymphatic system disorders
20 Bolezni krvi in limfatičnega sistema Bolezni živčevja
Uncommon:
občasna:
In one 3 year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
V enem 3- letnem randomiziranem dvojno slepem kontroliranem preskušanju, v katerem so vrednotili učinkovitost in varnost zoledronske kisline pri zdravljenju postmenopavzalne osteoporoze (PMO), in sicer v odmerku 5 mg enkrat na leto v primerjavi s placebom, je bila skupna incidenca atrijske 21 fibrilacije pri bolnikih, ki so prejemali 5 mg zoledronske kisline, 2, 5% (pri 96 od 3. 862 bolnikov), pri bolnikih, ki so prejemali placebo, pa 1, 9% (pri 75 od 3. 852 bolnikov).
The rate of atrial fibrillation serious 21 adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Delež atrijske fibrilacije, ki so jo opredelili kot resen neželen dogodek, je bil pri bolnikih, ki so prejemali 5 mg zoledronske kisline, 1, 3% (pri 51 od 3. 862 bolnikov), pri bolnikih, ki so prejemali placebo, pa 0, 6% (pri 22 od 3. 852 bolnikov).
The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with Zometa (zoledronic acid) 4 mg every 3-4 weeks in oncology patients.
Neravnovesja, ki so ga opažali v tem preskušanju, niso opažali v drugih preskušanjih z zoledronsko kislino, vključno s preskušanji z Zometo (zoledronsko kislino) v odmerku 4 mg vsake 3- 4 tedne pri onkoloških bolnikih.
Cases of osteonecrosis (primarily of the jaws) have been reported, predominantly in cancer patients treated with bisphosphonates, including Zometa.
Predvsem pri bolnikih z rakom, zdravljenih z difosfonati, med drugim tudi z Zometo, so poročali o redkih primerih osteonekroze (predvsem čeljusti).
22 Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone The first randomised, double-blind, placebo-controlled study compared Zometa to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Rezultati kliničnih preskušanj v preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti V prvi randomizirani, dvojno slepi raziskavi, kontrolirani s placebom, so primerjali Zometo s placebom za preprečevanje z okostjem povezanih dogodkov (SREs) pri bolnikih z rakom prostate.
23 Table 3:
23 Preglednica 3:
In a third phase III randomised, double-blind trial, 4 mg Zometa or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
V tretjem randomiziranem, dvojno slepem preskušanju faze III so pri bolnikih z multiplim mielomom ali rakom dojke z vsaj po eno lezijo v kosteh primerjali 4 mg Zomete in 90 mg pamidronata vsake 3 do 4 tedne.
24 Table 4:
24 Preglednica 4:
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached NA Not Applicable
* zajema vertebralne in nevertebralne zlome; ** velja za vse skeletne dogodke, tako za celotno število kot za trajanje vsakega dogodka med preskušanjem; NR ni bil dosežen; NA ne velja za ta primer.
25 Figure 1.
25 Slika 1.
In clinical trials 69 patients who relapsed or were refractory to initial treatment (Zometa 4 mg, 8 mg or pamidronate 90 mg) were retreated with Zometa 8 mg.
V kliničnih prešanjih je bilo 69 bolnikov, pri katerih se je bolezen ponovno pojavila ali so bili odporni proti začetnemu zdravljenju (Zometa 4 mg, 8 mg ali pamidronat 90 mg), ponovno zdravljenih z Zometo 8 mg.
Since those patients were retreated with the 8 mg dose only, there are no data available allowing comparison with the 4 mg dose.
26 zdravljeni samo z odmerkom 8 mg, ni na voljo podatkov, ki bi omogočali primerjavo z odmerkom 4 mg.
26 In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
V kliničnih preskušanjih, narejenih na bolnikih s tumorsko povzročeno hiperkalciemijo (TIH), je bil celotni varnostni profil v vseh treh zdravljenih skupinah (zoledronska kislina 4 in 8 mg in pamidronat 90 mg) podoben glede na vrste in izraženost.
Subchronic and chronic toxicity Zoledronic acid was well tolerated when administered subcutaneously to rats and intravenously to dogs at doses up to 0.02 mg/ kg daily for 4 weeks.
27 Subkronična in kronična toksičnost Zoledronsko kislino, dano subkutano, so dobro prenašale podgane, intravensko dano pa psi, v odmerkih do 0, 02 mg/ kg na dan 4 tedne dolgo.
27 The most frequent finding in 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.
Najpogostejša ugotovitev v študijah večkratnih odmerkov je bilo zvečanje primarne spongiozne kostne substance v metafizah dolgih kosti pri rastočih živalih pri skoraj vseh odmerkih; ta ugotovitev odseva farmakološki antiresorpcijski učinek zdravila.
Longer-term repeat administration at doses bracketing the highest intended human therapeutic dose of zoledronic acid produced toxicological effects in other organs, including the gastrointestinal tract, liver, spleen and lungs, and at intravenous injection sites.
Dolgoročnejše večkratno dajanje v odmerkih okrog največjega nameravanega humanega terapevtskega odmerka zoledronske kisline je povzročilo toksične učinke v drugih organih z gastrointestnalnim traktom, jetri, vranico in pljuči vred, in na mestih intravenskega injiciranja.
To avoid potential incompatibilities, Zometa concentrate is to be diluted with 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution.
Da se izognete možnim nezdružljivostim, razredčite koncentrat Zomete z 0, 9 -% m/ v raztopino natrijevega klorida ali 5 -% m/ v raztopino glukoze.
Zometa concentrate 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.
Koncentrata zdravila Zometa ne smete mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba aplicirati kot samostojno intravensko raztopino z ločenim infuzijskim sistemeom.
The Zometa solution is stable for 24 hours at 2°C – 8°C after further dilution in 100 ml physiological saline or 5% w/ v glucose solution.
Raztopina Zomete je stabilna 24 ur pri 2 °C – 8 °C po dodatnem razredčenju s 100 ml fiziološke raztopine ali 5- odstotne m/ v raztopine glukoze.
6.4 Special precautions for storage
28 6. 4 Posebna navodila za shranjevanje
After aseptic dilution, it is preferable to use the diluted product immediately.
Najbolje je uporabiti razredčeno zdravilo takoj po aseptičnem razredčenju.
The total time between dilution, storage in a refrigerator at 2°C – 8°C and end of administration must not exceed 24 hours.
Celotni čas od razredčenja, shranjevanja v hladilniku pri temperaturi med 2 °C – 8 °C do konca postopka dajanja zdravila ne sme preseči 24 ur.
Zometa 4 mg/ 5 ml concentrate for solution for infusion is supplied as packs containing 1, 4 or 10 vials.
Zometa 4 mg/ 5 ml koncentrat za raztopino za infundiranje je na voljo v ovojnini, v katerih je po 1 viala, 4 viale ali 10 vial.
5-ml plastic vial made of clear, colourless cycloolefine copolymer with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
5- mililitrska plastična viala, izdelana iz prozornega, brezbarvnega cikloolefinskega kopolimera, z zamaškom iz bromobutilne gume, prevlečene s fluoropolimerom, in aluminijasto zaporko s plastičnim zaščitnim pokrovčkom.
Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/ v sodium chloride solution or 5% w/ v glucose solution).
Pred uporabo je treba 5, 0 ml koncentrata iz ene viale oziroma ustrezni volumen odvzetega koncentrata dodatno razredčiti s 100 ml infuzijske raztopine v kateri ni kalcija (0, 9 -% m/ v raztopina natrijevega klorida ali 5 -% m/ v raztopina glukoze).
24.03.2003 Date of first renewal:
24. 03. 2003 Datum prvega podaljšanja:
Novartis Pharma GmbH, Roonstrasse 25, D-90420 Nüremberg, Germany.
Novartis Pharma GmbH, Roonstrasse 25, D- 90420 Nürnberg, Nemčija
Manufacturing authorisation issued on 1 August 1997 by Regierungspräsidium Freiburg, Germany.
Regierungspräsidium Freiburg, Nemčija.
Medicinal product subject to restricted medical prescription (See Annex I:
Zdravilo z omejitvijo predpisovanja (Glejte dodatek I:
FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AND 4 AMPOULES AS UNIT PACK (INCLUDING BLUE BOX
ŠKATLA ZA 1 VIALO IN 1 AMPULO KOT ENOTA PAKIRANJA (VKLJUČENI PODATKI ZA “ BLUE BOX ”) ŠKATLA ZA 4 VIALE IN 4 AMPULE KOT ENOTA PAKIRANJA (VKLJUČENI PODATKI ZA “ BLUE BOX ”)
Zometa 4 mg Powder and solvent for solution for infusion Zoledronic acid
Zometa 4 mg prašek in vehikel za raztopino za infundiranje zoledronska kislina
One vial contains 4 mg of zoledronic acid (anhydrous).
Ena viala vsebuje 4 mg zoledronske kisline (brezvodne).
One vial 4 mg One ampoule of solvent 5 ml Four vials 4 mg Four ampoules of solvent 5 ml
Ena viala po 4 mg Ena ampula vehikla po 5 ml Štiri viale po 4 mg Štiri ampule vehikla po 5 ml
The reconstituted solution is stable for 24 hours at 2°C – 8°C.
Rekonstituirana raztopina je stabilna 24 ur pri 2 °C – 8 °C.
1 vial and 1 ampoule 4 vials and 4 ampoules
1 viala in 1 ampula 4 viale in 4 ampule
FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS INTERMEDIATE PACK (WITHOUT BLUE BOX)
ŠKATLA ZA 1 VIALO IN 1 AMPULO KOT VMESNO PAKIRANJE (BREZ PODATKOV ZA “ BLUE BOX ”)
One vial 4 mg One ampoule of solvent 5 ml Component of a multipack comprising ten packs, each containing one vial and one ampoule
Ena viala po 4 mg Ena ampula vehikla po 5 ml Sestavni del ovojnine z več ovojninami, ki obsega deset ovojnin, od katerih vsaka vsebuje eno vialo in eno ampulo
WRAPPER LABEL ON MULTIPACKS WRAPPED IN NON-TRANSPARENT FOIL (INCLUDING BLUE BOX)
ZAVOJI Z VEČ ŠKATLAMI, ZAVITIMI V NEPROZORNO FOLIJO (VKLJUČENI PODATKI ZA “ BLUE BOX ”)
Multipack comprising ten packs, each containing one vial and one ampoule of solvent 5 ml.
Zavoj z več ovojninami obsega deset ovojnin, od katerih vsaka vsebuje eno vialo in eno ampulo vehikla po 5 ml.
38 The reconstituted solution is stable for 24 hours at 2°C – 8°C.
Rekonstituirana raztopina je stabilna 24 ur pri 2 °C – 8 °C.
Zometa 4 mg Powder for solution for infusion Zoledronic acid For intravenous use only
Zometa 4 mg prašek za raztopino za infundiranje zoledronska kislina Samo za intravensko uporabo.
MAH logo
logotip imetnika dovoljenja za promet z zdravilom
FOLDING BOX FOR 1 VIAL AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AS UNIT PACK (INCLUDING BLUE BOX)
ŠKATLA ZA 1 VIALO KOT ENOTA PAKIRANJA (VKLJUČENI PODATKI ZA “ BLUE BOX ”) ŠKATLA ZA 4 VIALE KOT ENOTA PAKIRANJA (VKLJUČENI PODATKI ZA “ BLUE BOX ”)
Zometa 4 mg/ 5 ml concentrate for solution for infusion Zoledronic acid
Zometa 4 mg/ 5 ml koncentrat za raztopino za infundiranje zoledronska kislina
One vial with 5 ml concentrate for solution for infusion Four vials with 5 ml concentrate for solution for infusion
Ena viala po 5 ml koncentrata za raztopino za infundiranje Štiri viale s po 5 ml koncentrata za raztopino za infundiranje
Stable for 24 hours at 2°C – 8°C after further dilution in 100 ml physiological saline or 5% w/ v glucose solution.
42 Po dodatnem razredčenju v 100 ml fiziološke raztopine ali 5 -% m/ v raztopine glukoze stabilno 24 ur pri 2 °C – 8 °C.
1 vial 4 vials
1 viala 4 viale
FOLDING BOX FOR 1 VIAL AS INTERMEDIATE PACK (WITHOUT BLUE BOX)
ŠKATLA ZA 1 VIALO KOT VMESNO PAKIRANJE (BREZ PODATKOV ZA “ BLUE BOX ”)
One vial with 5 ml concentrate for solution for infusion Component of a multipack comprising ten packs, each containing one vial
Ena viala po 5 ml koncentrata za raztopino za infundiranje Sestavni del zavoja z več ovojninami, ki obsega deset ovojnin, od katerih vsaka vsebuje eno vialo
Stable for 24 hours at 2°C – 8°C after further dilution in 100 ml physiological saline or 5% w/ v glucose solution.
Po dodatnem razredčenju v 100 ml fiziološke raztopine ali 5 -% m/ v raztopine glukoze stabilno 24 ur pri 2 °C – 8 °C.
WRAPPER LABEL ON MULTIPACKS WRAPPED IN NON-TRANSPARENT FOIL (INCLUDING BLUE BOX)
ZAVOJI Z VEČ ŠKATLAMI, ZAVITIMI V NEPROZORNO FOLIJO (VKLJUČNO S PODATKI ZA “ BLUE BOX ”)
One vial with 5 ml concentrate for solution for infusion.
Ena viala po 5 ml koncentrata za raztopino za infundiranje.
Multipack comprising ten packs, each containing one vial.
Zavoj z več ovojninami, ki obsega deset ovojnin, od katerih vsak vsebuje eno vialo.
Zometa 4 mg/ 5 ml concentrate for solution for infusion Zoledronic acid For intravenous use only
Zometa 4 mg/ 5 ml koncentrat za raztopino za infundiranje zoledronska kislina Samo za intravensko uporabo.
INFORMATION FOR THE USER
Natančno preberite navodilo, preden vam dajo zdravilo Zometa.
Zometa 4 mg powder and solvent for solution for infusion Zoledronic acid
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom.
Read all of this leaflet carefully before you are given Zometa. − Ask your doctor, nurse or pharmacist if you have further questions. − Keep this leaflet.
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
You may need to read it again. − If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
What Zometa is and what it is used for 2.
Kaj je zdravilo Zometa in za kaj ga uporabljamo 2.
Before you are given Zometa 3.
Kaj morate vedeti, preden vam bodo dali zdravilo Zometa 3.
How Zometa is used 4.
Kako se zdravilo Zometa uporablja 4.
How to store Zometa 6.
Shranjevanje zdravila Zometa 6.
WHAT ZOMETA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ZOMETA IN ZA KAJ GA UPORABLJAMO
Zometa is given as an infusion into a vein.
Zometa se daje kot infuzija v veno.
Zoledronic acid is a member of a group of substances called bisphosphonates.
Zoledronska kislina spada v skupino snovi, ki se imenujejo difosfonati.
It is used to treat bone metastases (spread of cancer), to prevent bone complications, e. g. fractures, and to lower the amount of calcium in the blood in patients with tumour-induced hypercalcaemia (TIH).
Uporablja se za zdravljenje metastaz (rakastih zasevkov) v kosteh, za preprečevanje zapletov na kosteh, na primer zlomov, in za zniževanje količine kalcija v krvi bolnikov s tumorsko povzročeno hiperkalciemijo (TIH).
Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Zoledronska kislina deluje tako, da se pripne na kost in upočasni povprečno hitrost spreminjanja kosti.
It is used to reduce the amount of calcium in the blood in cases where it is too high due to the presence of a tumour.
Uporablja se za zmanjševanje količine kalcija v krvi v primerih, ko je le- ta previsoka zaradi tumorja.
Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased.
Tumorji lahko pospešijo normalno spreminjanje kosti na tak način, da se zveča sproščanje kalcija iz kosti.
This condition is known as tumour-induced hypercalcaemia.
To stanje poznamo pod imenom tumorsko povzročena hiperkalciemija.
BEFORE YOU ARE GIVEN ZOMETA
KAJ MORATE VEDETI, PREDEN VAM BODO DALI ZDRAVILO ZOMETA
You should not be given Zometa: − if you are breast-feeding. − if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to which Zometa belongs), or any of the other ingredients of Zometa.
- če ste alergični na (preobčutljivi za) zoledronsko kislino, kak drug difosfonat (skupina snovi, ki
Before you are given Zometa, tell your doctor: − if you have or have had a liver problem. − if you have or have had a kidney problem. − if you have or have had a heart problem. − if you have or have had pain, swelling or numbness of the jaw or a “ heavy jaw feeling” or loosening of a tooth.
- če imate ali ste imeli bolečino, oteklino ali odrevenelost čeljusti ali “ občutek težke čeljusti ” ali
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Zometa.
Če si zdravite zobe ali če boste imeli zobozdravstveno operacijo, povejte svojemu zobozdravniku, da se zdravite z Zometo.
Your doctor will check your response to treatment at regular intervals.
Zdravnik bo v rednih presledkih kontroliral vaš odziv na zdravljenje.
He or she must perform blood tests prior to your treatment with Zometa.
Preden začnete z zdravljenjem z Zometo, bo moral opraviti preiskave vaše krvi.
50 Ensure sufficient intake of liquids prior to infusions as directed by your doctor as this will help to prevent dehydration.
50 Poskrbite, da boste pred infuzijami zaužili dovolj tekočin, tako kot vam bo naročil zdravnik, ker bo to pomagalo preprečiti dehidracijo.
Using other medicines Tell your doctor about any other medicines you are taking or have recently been taking, including any you have bought without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
It is particularly important that your doctor knows if you are also taking aminoglycosides (a type of medicine used to treat severe infections), since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Posebno pomembno je, da vaš zdravnik ve, ali jemljete tudi aminoglikozide (vrsta zdravila, ki se uporablja za zdravljenje težkih okužb), ker kombinacija le- teh z difosfonati lahko preveč zniža koncentracijo kalcija v krvi.
Tell your doctor if you are taking thalidomide or medicines known to be harmful to your kidneys.
Povejte svojemu zdravniku, če jemljete talidomid ali zdravila, za katera je znano, da škodujejo ledvicam.
Use in the elderly Zometa can be given to elderly people.
Uporaba pri starejših bolnikih Zometo lahko dajemo starejšim osebam.
There is no evidence to suggest that any additional precautions are needed.
Ni dokazov, ki bi kazali, da so potrebni kakšni dodatni varnostni ukrepi.
Use in children The use of Zometa in children has not been studied and therefore it is not recommended.
Uporaba pri otrocih Uporabe Zomete pri otrocih niso raziskovali in je zato ne priporočamo.
Pregnancy and breast-feeding You should not be given Zometa if you are pregnant.
Nosečnost in dojenje Če ste noseči, vam ne bi smeli dati Zomete.
You must not be given Zometa if you are breast-feeding.
Če dojite, vam ne smejo dati Zomete.
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Če ste noseči ali če dojite, vprašajte za nasvet zdravnika, preden vzamete katerokoli zdravilo.
Driving and using machines The effects of Zometa on driving, using machines and performing other tasks that need your full attention have not been studied.
Vpliv na sposobnost upravljanja vozil in strojev Učinkov Zomete na upravljanje motornih vozil, uporabo strojev in opravljanje drugih nalog, ki zahtevajo vašo celotno pozornost, niso proučevali.
However, there have been very rare cases of drowsiness with the use of Zometa.
Vendar je ob uporabi zdravila Zometa v zelo redkih primerih prišlo do zaspanosti.
HOW ZOMETA IS USED
KAKO SE ZDRAVILO ZOMETA UPORABLJA
Follow carefully all instructions given to you by your doctor, nurse or pharmacist.
Skrbno se ravnajte po vseh navodilih, ki jih dobite od svojega zdravnika, medicinske sestre ali farmacevta.
How much is given The usual dose given is 4 mg.
Koliko zdravila se daje Običajni odmerek, ki se daje, je 4 mg.
How Zometa is given Zometa is given as an infusion into a vein which should last no less than 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Kako se zdravilo Zometa daje Zometa se daje v veno v obliki infuzije, ki ne sme trajati manj od 15 minut, in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
In addition, patients without hypercalcaemia will also receive supplementary doses of calcium and vitamin D daily.
Poleg tega bolniki brez hiperkalciemije dobijo vsak dan tudi odmerke za nadomeščanje kalcija in vitamina D.
When Zometa is given Your doctor will determine when you will be given Zometa.
Kdaj se zdravilo Zometa daje Vaš zdravnik bo odločil o tem, kdaj boste prejeli Zometo.
How long to use Zometa If you are being treated for bone metastases, you will be given one infusion of Zometa every three to four weeks.
Kako dolgo se zdravilo Zometa uporablja Če vas zdravijo zaradi zasevkov v kosteh, boste prejeli po eno infuzijo Zomete na tri do štiri tedne.
Your doctor will decide how often you should receive the infusions.
Vaš zdravnik bo odločil o tem, kako pogosto morate dobivati infuzije.
If you are being treated for TIH, you will normally only be given one infusion of Zometa.
Če se zdravite zaradi tumorsko povzročene hiperkalciemije (TIH), boste normalno prejeli samo eno infuzijo Zomete.
This is because you may develop serum electrolyte abnormalities (e. g. abnormal levels of calcium, phosphorus and magnesium) and/ or changes in kidney function, including severe kidney impairment.
51 Če ste prejeli večji odmerek zdravila Zometa, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
Like all medicines, Zometa can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Zometa neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Rise in body temperature.
Dvig telesne temperature.
One third of the patients on Zometa have reported headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/ or muscle ache.
Tretjina bolnikov, ki dobivajo Zometo, poroča o glavobolu in gripi podobnem sindromu, ki ga sestavljajo vročina, utrujenost, šibkost, zaspanost, mrzlica in bolečine v kosteh, sklepih in/ ali mišicah.
In most cases no specific treatment is required and the symptoms subside after a couple of hours or days.
V večini primerov ni potrebno nikakršno specifično zdravljenje in simptomi čez nekaj ur ali dni izzvenijo.
Very rare cases of severe bone, joint, and/ or muscle pain, occasionally incapacitating, have been reported.
Poročali so o zelo redkih primerih hudih bolečin v kosteh, sklepih in/ ali mišicah, ki so bolnike občasno onesposobile.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Pri bolnicah, ki so prejemale zoledronsko kislino zaradi postmenopavzalne osteoporoze, so opažali nepravilno bitje srca (atrijsko fibrilacijo).
Uncommonly, in some patients bone damage in the jaw (osteonecrosis) may occur.
Občasno lahko pri nekaterih bolnikih pride do poškodbe kosti v čeljusti (osteonekroza).
Signs of this condition can be pain in the mouth, teeth and/ or jaw, swelling or sores inside the mouth, numbness or a “ heavy jaw feeling”, or loosening of a tooth.
Znaki tega stanja so lahko bolečine v ustih, zobeh in/ ali čeljusti, otekline ali rane v ustni votlini, odrevenelost ali občutek pritiska v čeljusti ali majavost zob.