natgillin/translations-raw huggingface dataset:
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Študije z zoledronsko kislino pri živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic Acid Hospira.
Zdravnik vas bo verjetno prosil, da pred začetkom zdravljenja z zdravilom Zoledronska kislina Hospira opravite zobozdravstveni pregled.
ONJ can also occur after stopping treatment.
Do osteonekroze čeljustnic lahko pride tudi po zaključku zdravljenja.
The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Delež atrijske fibrilacije, ki so jo opredelili kot resen neželen učinek, je bil pri bolnikih, ki so prejemali zoledronsko kislino, višji (1,3 %) (pri 51 od 3.862 bolnikov) v primerjavi z bolniki, ki so prejemali placebo (0,6 %) (pri 22 od 3.852 bolnikov).
The following are the important identified risks with zoledronic acid in the approved indications:
Pri uporabi zoledronske kisline za odobrene indikacije so ugotovili naslednja pomembna tveganja:
Not known**
Zlomi*
All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget's disease trials (see also section 4.2).
V preskušanju zdravljenja postmenopavzalne osteoporoze, v preskušanju preventive kliničnih zlomov po zlomu kolka in v preskušanjih zdravljenja Pagetove bolezni so vsi bolniki prejemali ustrezne dodatke vitamina D in kalcija (glejte tudi poglavje 4.2).
Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
atipični subtrohanterni zlomi stegnenice in zlomi diafize stegnenice (za difosfonate značilen neželeni učinek).
Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Preglednica 3: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) Katerikoli SRE (+TIH)
Very rare Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
osteonekroza zunanjega slušnega kanala (neželeni učinek skupine difosfonatov) in osteonekroza na drugih anatomskih lokacijah, vključno s stegnenico in kolkom
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following zoledronic acid administration (see section 4.2).
Ob dajanju zoledronske kisline so priporočljivi zadostni vnosi kalcija in vitamina D. Poleg tega je pri bolnikih s Pagetovo boleznijo zelo priporočljivo zagotoviti zadosten dodatek kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, dvakrat na dan vsaj 10 dni po uporabi zoledronske kisline (glejte poglavje 4.2).
No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH), s serumskim kreatininom < 400 μmol/l ali < 4,5 mg/dl, ni potrebno prilagajanje odmerjanja (glejte poglavje 4.4).
Proportion of patients with SREs (%) p-value Median time to SRE (days)
4 mg placebo delež bolnikov s SRE (%) vrednost p 0,028 mediana časa do SRE (dnevi)
•Breast-feeding (see section 4.6).
• Dojenje (glejte poglavje 4.6).
− Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
− reakcije prebavil, na primer slabost s siljenjem na bruhanje (navzea) in bruhanje, pa tudi izguba teka,
To avoid potential incompatibilities, Zoledronic Acid Hospira is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Da se izognete možnim nezdružljivostim, razredčite koncentrat zdravila Zoledronska kislina Hospira z 9 mg/ml (0,9-odstotno) raztopino natrijevega klorida ali 5-odstotno m/v raztopino glukoze.
Uncommon (may affect up to 1 in 100 people):
Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov):
Table 4: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Preglednica 4: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate) Katerikoli SRE (+TIH)
Psychiatric disorders Uncommon: Anxiety, sleep disturbance Rare:
Bolezni prebavil Zelo pogosti: bruhanje, navzea Pogosti:
Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov) glavobol, omotičnost, slabost, bruhanje, driska, bolečine v mišicah, bolečine v kosteh in/ali sklepih, bolečine v hrbtu, rokah ali nogah, gripi podobni simptomi (na primer utrujenost, mrazenje, bolečine v sklepih in mišicah), mrazenje, občutek utrujenosti in pomanjkanje zanimanja, šibkost, bolečine, slabo počutje, oteklina in/ali bolečina na mestu injiciranja.
3.5 mg* zoledronic acid
3,5 mg* zoledronske kisline
Osteonecrosis Osteonecrosis of the jaw
Osteonekroza Osteonekroza čeljustnic
This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Zdravila ne smemo mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in ga je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Zoledronic Acid Hospira must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Zdravila Zoledronska kislina Hospira se ne sme mešati z drugimi raztopinami za infundiranje in ga je treba dati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
How to prepare and administer Zoledronic Acid Hospira
Kako pripraviti in dati bolniku zdravilo Zoledronska kislina Hospira
Zoledronic Acid Hospira is contraindicated during breast-feeding (see section 4.3).
Uporaba zdravila Zoledronska kislina Hospira v času dojenja je kontraindicirana (glejte poglavje 4.3).
The following should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Za oceno tveganja za razvoj osteonekroze čeljustnic pri bolniku je treba upoštevati naslednje dejavnike: - jakost delovanja zdravila, ki zavira resorpcijo kosti (tveganje je večje pri močnejših zdravilih),
Cases of ONJ have been reported in the postmarketing setting for zoledronic acid.
O osteonekrozi čeljustnic so poročali tudi v okviru uporabe v času trženja zoledronske kisline.
One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Ena viala s 5 ml koncentrata vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), 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 and placebo, respectively.
V študiji HORIZON - ključni študiji zlomov (Pivotal Fracture Trial [PFT], glejte poglavje 5.1) je bila skupna incidenca atrijske fibrilacije pri bolnikih, ki so prejemali zoledronsko kislino, 2,5 % (pri 96 od 3.862 bolnikov), pri bolnikih, ki so prejemali placebo, pa 1,9 % (pri 75 od 3.852 bolnikov).
Zoledronic Acid Hospira 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.
Zdravila Zoledronska kislina Hospira se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in ga je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2
Če zdravila ne uporabite takoj, ste sami odgovorni za čas in pogoje shranjevanja pred uporabo.
Measurement of serum calcium before infusion of zoledronic acid is recommended for patients with Paget´s disease.
Bolnikom s Pagetovo boleznijo je priporočljivo izmeriti vrednost kalcija v serumu pred infuzijo zoledronske kisline.
Mannitol
Maidenhead
Flu-like symptoms including arthritis and joint swelling.
− simptomi, ki spominjajo na gripo, vključno z artritisom in oteklinami sklepov,
− Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw discharge, numbness or a feeling of heaviness in the jaw or loosening of a tooth.
− bolečina v ustih, zobeh in/ali čeljusti, oteklost ali neceljenje ran v ustni votlini ali čeljusti, izcedek, odrevelenost ali občutek pritiska v čeljusti ali majanje zoba, kar so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
− If you have any further questions, ask your doctor, pharmacist or nurse.
− Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
• Transient increase in serum creatinine may be greater in patients with underlying impaired renal function.
• Pri bolnikih s predhodno zmanjšanim delovanjem ledvic je lahko prehodno zvišanje koncentracije kreatinina v serumu bolj izrazito.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ki je naveden na pakiranju.
Hypocalcaemia has been reported in patients treated with zoledronic acid.
Pri bolnikih, ki so prejemali zoledronsko kislino, so poročali o hipokalciemiji.
The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Pri oceni tveganja za razvoj osteonekroze čeljusti pri posamezniku je treba upoštevati naslednje dejavnike tveganja: - jakost difosfonata (večje tveganje pri zelo močnih učinkovinah), pot uporabe (večje tveganje pri parenteralni uporabi) in kumulativni odmerek difosfonata; - sočasna prisotnost raka ali drugih bolezni (npr. anemije, koagulopatije, okužbe), kajenje;
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.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, ne smete dobiti zdravila Zoledronska kislina Hospira.
Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing) Uncommon: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
astenija, periferni edemi, reakcije na mestu injiciranja (vključujoč bolečino, iritacijo, otekanje, zatrdlino), bolečina v prsih, zvečanje telesne mase, anafilaktična reakcija/šok, urtikarija
- Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
- sočasno zdravljenje: kemoterapija, zaviralci angiogeneze (glejte poglavje 4.5), obsevanje vratu in glave, kortikosteroidi; - bolezni zob v anamnezi, slaba ustna higiena, parodontalna bolezen, invazivni zobozdravstveni posegi (npr. ekstrakcija zoba) in slabo prilegajoča se zobna proteza.
ONJ has been reported in the post-marketing setting in patients receiving zoledronic acid for osteoporosis (see section 4.8).
O osteonekrozi čeljustnic so poročali pri bolnikih, ki so zaradi osteoporoze prejemali zoledronsko kislino po začetku trženja zdravila (glejte poglavje 4.8).
This medicinal product contains 16 mmol (or 360 mg) sodium per dose.
Zdravilo Zoledronska kislina Hospira vsebuje natrij To zdravilo vsebuje 16 mmol (ali 360 mg) natrija na odmerek.
Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic Acid Hospira, as directed by your doctor.
Zdravilo Zoledronska kislina Hospira skupaj s hrano in pijačo Poskrbite, da boste pred odmerjanjem zdravila Zoledronska kislina Hospira in po njem popili dovolj tekočine (najmanj en do dva kozarca), kot vam naroči zdravnik.
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic Acid Hospira.
Zdravnik mora pred vsakim odmerkom zdravila Zoledronska kislina Hospira opraviti krvne preiskave, da preveri delovanje vaših ledvic (raven kreatinina).
Pain in extremities, arthralgia, musculoskeletal pain General disorders and administration site conditions Very common:
bolečine v okončinah, bolečine v sklepih, mišično-skeletne bolečine Splošne težave in spremembe na mestu aplikacije Zelo pogosti: pireksija, utrujenost Pogosti:
In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Bolniki s serumskim kreatininom > 265 μmol/l ali > 3,0 mg/dl so bili iz kliničnih preskušanj z zoledronsko kislino izključeni.
− The bag does not require any specific storage conditions.
− Za shranjevanje vrečke niso potrebna posebna navodila.
− High blood pressure, shortness of breath, dizziness,anxiety,sleep disturbances,taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhea, constipation, abdominal pain, dry mouth.
− visok krvni tlak, zadihanost, omotičnost, tesnoba, motnje spanja, motnje okušanja, tresenje,
Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Hospira.
Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom Zoledronska kislina Hospira opravite zobozdravstveni pregled.
- The unopened bag does not require any special storage conditions.
- Za shranjevanje neodprtih vreč niso potrebna posebna navodila.
- If you have any further questions, ask your doctor, pharmacist or nurse.
− Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid (see section 4.8).
Pri bolnikih, ki jemljejo difosfonate, vključno zoledronsko kislino, so redko poročali o hudih bolečinah v kosteh, sklepih in/ali mišicah, ki so bolnike občasno onesposobile (glejte poglavje 4.8).
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic Acid Hospira in patients with concomitant risk factors.
Pri bolnikih s spremljajočimi dejavniki tveganja je pred začetkom zdravljenja z zdravilom Zoledronska kislina Hospira priporočeno opraviti zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in oceniti razmerje med koristmi in tveganji pri vsakem posameznem bolniku.
Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with zoledronic acid.
Pri bolnikih, ki so se zdravili z zoledronsko kislino, so poročali o znižani koncentraciji kalcija v krvi (hipokalciemiji), zaradi katere v nekaterih primerih lahko pride do mišičnih krčev, suhe kože in pekočega občutka.
3.0 mg* zoledronic acid
3,0 mg* zoledronske kisline
CARTON FOR 1 VIAL AS UNIT PACK
ŠKATLA ZA 1 VIALO ZA POSAMIČNO PAKIRANJE
Adequate calcium and vitamin D intake are recommended in association with Zoledronic Acid Hospira administration.
Skupaj z dajanjem zdravila Zoledronska kislina Hospira se priporoča zadostno uživanje kalcija in vitamina D.
What Zoledronic Acid Hospira 5 mg/100 ml solution for infusion contains - The active substance is zoledronic acid.
Kaj vsebuje zdravilo Zoledronska kislina Hospira 5 mg/100 ml raztopina za infundiranje - Učinkovina je zoledronska kislina.
Osteonecrosis of the jaw has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
O osteonekrozi čeljustnic so občasno poročali pri bolnikih, ki so prejemali zoledronsko kislino v kliničnih preskušanjih ali so se z njo zdravili po začetku trženja zdravila.
The recommended dose in hypercalcaemia (albumin-corrected serum calcium 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Priporočeni odmerek za hiperkalciemijo (za albumin korigirani serumski kalcij ≥ 12,0 mg/dl ali
Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia) Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea, cough, bronchoconstriction Rare
bradikardija, srčna aritmija (zaradi hipokalciemije) Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni:
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Po začetku zdravljenja z zoledronsko kislino moramo skrbno spremljati standardne presnovne parametre, povezane s hiperkalciemijo, kot so: serumske koncentracije kalcija, fosfata in magnezija.
Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion
Zoledronska kislina Hospira 4 mg/5 ml koncentrat za raztopino za infundiranje
Renal function impairment
Okvarjeno delovanje ledvic
Sodium citrate Sodium chloride Water for injections
6.1 Seznam pomožnih snovi manitol natrijev citrat natrijev klorid voda za injekcije
The onset time is 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Omenjeno reakcijo opisujejo tudi z izrazoma "gripi podobni simptomi" in "simptomi po odmerjanju".
3.3 mg* zoledronic acid
3,3 mg* zoledronske kisline
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Čas shranjevanja naj praviloma ne presega 24 ur pri 2°C - 8°C.
− The active substance of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion is zoledronic acid.
− Učinkovina v zdravilu Zoledronska kislina Hospira 4 mg/100 ml raztopina za infundiranje je zoledronska kislina.
Uncommon Influenza, nasopharyngitis
Preglednica 1 Infekcijske in parazitske bolezni občasni gripa, nazofaringitis
− The other ingredients are: mannitol, sodium citrate, sodium chloride and water for injections.
−Druge sestavine zdravila so: manitol, natrijev citrat, natrijev klorid in voda za injekcije.
After opening: 24 hours at 2
EXP Po odprtju: 24 ur pri 2 oC - 8 oC.
Zoledronic acid is eliminated by renal excretion.
Zoledronska kislina se izloča iz telesa skozi ledvice.
How Zoledronic Acid Hospira is given
Kako se daje zdravilo Zoledronska kislina Hospira
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
Iz postmarketinških izkušenj pri bolnikih, ki so dobivali zoledronsko kislino, so poročali o hudih bolečinah v kosteh, sklepih in/ali mišicah.
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Preglednica 4: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom) Katerikoli SRE (+TIH)
Common Atrial fibrillation Uncommon Palpitations
Srčne bolezni pogosti atrijska fibrilacija občasni palpitacije
- The other ingredients are mannitol, sodium citrate and water for injections.
- Druge sestavine zdravila so manitol, natrijev citrat in voda za injekcije.
Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), the majority of whom received a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Po uporabi zoledronske kisline so opazili okvaro ledvic, posebno pri bolnikih s predhodno ledvično disfunkcijo ali z dodatnimi dejavniki tveganja (npr. višja starost bolnika, onkološki bolniki s kemoterapijo, spremljajoča nefrotoksična zdravila, spremljajoče diuretično zdravljenje, huda dehidracija).
Tachycardia Respiratory, thoracic and mediastinal disorders Common:
tahikardija Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti:
(to appear in roundel)
(v okencu)
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Hospira.
Vpliv na sposobnost upravljanja vozil in strojev Ob uporabi zdravila Zoledronska kislina Hospira je v zelo redkih primerih prišlo do dremavosti in zaspanosti.
Allow the refrigerated solution to reach room temperature before administration.
Če je raztopina zdravila ohlajena, pustite, da se pred uporabo segreje na sobno temperaturo.
Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Pri doječih materah je uporaba zoledronske kisline kontraindicirana (glejte poglavje 4.3).
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Zoledronska kislina Hospira Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Zoledronska kislina Hospira 4mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
You must not be given Zoledronic Acid Hospira: - if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
− če ste alergični na zoledronsko kislino, druge difosfonate ali katerokoli sestavino tega zdravila
− 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).
Patients were evenly distributed between zoledronic acid -treated and placebo groups.
V obe skupini, zdravljeni bodisi z zoledronsko kislino bodisi s placebom, so bile bolnice razporejene enakomerno.
One ml solution contains 0.05 mg zoledronic acid (as monohydrate).
En ml raztopine vsebuje 0,05 mg zoledronske kisline (v obliki monohidrata).
Zoledronic Acid Hospira 5 mg/100 ml solution for infusion
Zoledronska kislina Hospira 5 mg/100 ml raztopina za infundiranje
Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Zoledronska kislina Hospira 4 mg/100 ml raztopina za infundiranje
Patients must be maintained well hydrated prior to and following administration of Zoledronic Acid Hospira.
Bolniki morajo biti pred dajanjem zdravila Zoledronska kislina Hospira in po njem dobro hidrirani.
− The other ingredients are: mannitol, sodium citrate, water for injections.
− Druge sestavine zdravila so: manitol, natrijev citrat in voda za injekcije.
Uncommon Blood creatinine increased, pollakiuria, proteinuria
Bolezni sečil občasni zvišana vrednost kreatinina v krvi, polakisurija, proteinurija pogostnost neznana*
Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Pogosto so poročali o reakciji akutne faze, do katere pride v prvih treh dneh po vnosu zoledronske kisline, simptomi pa vključujejo bolečine v kosteh, zvišano telesno temperaturo, utrujenost, artralgijo, mialgijo, okorelost in artritis, ki povzroči otekline sklepov.
Zoledronic Acid Hospira 5 mg/100 ml solution for infusion Zoledronic acid
Zoledronska kislina Hospira 5 mg/100 ml raztopina za infundiranje zoledronska kislina