natgillin/translations-raw huggingface dataset:
Talk to your doctor, pharmacist or nurse before you are given Zoledronic acid Teva Pharma: - if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Zoledronic acid Teva Pharma (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
Preden dobite zdravilo Zoledronska kislina Teva Pharma, povejte zdravniku, farmacevtu ali medicinski sestri: - če se zdravite z zdravilom, ki vsebuje zoledronsko kislino, ki je zdravilna učinkovina tudi v zdravilu Zoledronska kislina Teva Pharma (zoledronsko kislino uporabljamo za preprečevanje zapletov na kosteh ali za zmanjševanje količine kalcija pri odraslih bolnikih, ki imajo določene
Re-treatment consists of an additional intravenous infusion of 5 mg Zoledronic acid Teva Pharma after an interval of one year or longer from initial treatment in patients who have relapsed.
Ponovno zdravljene Pagetove bolezni kosti pomeni dodatno intravensko infuzijo zdravila Zolendronska kislina Teva Pharma 5 mg eno leto ali več po začetnem zdravljenju bolnikov, pri katerih pride do ponovitve bolezni.
What you need to know before you are given Zoledronic acid Teva Pharma
Kaj morate vedeti, preden vam dajo zdravilo Zoledronska kislina Teva Pharma
At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in postmenopausal women in the HORIZON-PFT study.
Po 24 mesecih so pri bolnikih, ki so prejemali zoledronsko kislino, opažali pomembno 3,6-odstotno povečanje mineralne gostote kosti celotnega kolka, kar je podobno učinkom, ki so jih opažali pri postmenopavzalnih ženskah v študiji HORIZON-PFT.
Solution for infusion Multipack: 5 bags of 100 ml Multipack: 10 bags of 100 ml
raztopina za infundiranje Skupno pakiranje: 5 vreč s 100 ml Skupno pakiranje: 10 vreč s 100 ml
In case you recently broke your hip, it is recommended that Zoledronic acid Teva Pharma is administered two or more weeks after your hip repair surgery.
Če ste si pred kratkim zlomili kolk, je priporočljivo, da dobite zdravilo Zoledronska kislina Teva Pharma dva ali več tednov po operativnem zdravljenju kolka.
Hypocalcaemia* Uncommon Decreased appetite
Presnovne in prehranske motnje hipokalciemija* zmanjšan apetit
Placebo (N=1,062) event rate
placebo (N=1.062) delež dogodkov (%)
Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
osteonekroza čeljustnic (glejte poglavji 4.4 in 4.8 odstavek Učinki po skupinah)
• Need to infuse Zoledronic acid Teva Pharma slowly over a period of no less than 15 minutes
• potrebnost počasnega infundiranja zdravila Zoledronska kislina Teva Pharma v času, ki ni krajši
The zoledronic acid group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
V skupini z zoledronsko kislino je bilo zniževanje telesne višine za približno 2,5 mm manjše kot v skupini s placebom (95 % IZ: 1,6 mm, 3,5 mm) [p < 0,0001].
Non-vertebral fracture (1) *p-value <0.001, **p-value <0.0001 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
kateri koli klinični zlom (1) klinični zlom vretenca (2) nevretenčni zlom (1) *vrednost p < 0,001, **vrednost p < 0,0001 (1) brez zlomov prstov rok in nog ter zlomov na področju obraza (2) vključno s kliničnimi zlomi prsnih in ledvenih vretenc
Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov Gripa, okužbe zgornjih dihal, znižano število eritrocitov, izguba apetita, nespečnost, zaspanost, ki lahko vključuje upad pozornosti in zavesti, občutek mravljinčenja ali otrplosti, izjemna utrujenost, tresenje, začasna izguba zavesti, okužba ali draženje ali vnetje očesa z bolečino in rdečino, vrtoglavica, zvišan krvni tlak, navali rdečice, kašelj, zadihanost, razdražen želodec, bolečine v trebuhu, zapeka, suha usta, zgaga, izpuščaj, čezmerno znojenje, srbenje, rdečina kože, bolečine v vratu, okorelost mišic, kosti in/ali sklepov, otekanje sklepov, mišični krči, bolečine v rami, bolečine v mišicah prsnega koša in v rebrih, vnetje sklepov, šibkost mišic, nenormalni izvidi preiskav ledvic, nenormalno pogosto uriniranje, otekanje rok, gležnjev ali stopal, žeja, zobobol, motnje okušanja.
How to store Zoledronic acid Teva Pharma Contents of the pack and other information
Shranjevanje zdravila Zoledronska kislina Teva Pharma Vsebina pakiranja in dodatne informacije
Before stopping Zoledronic acid Teva Pharma therapy If you are considering stopping Zoledronic acid Teva Pharma treatment, please go to your next appointment and discuss this with your doctor.
Preden prenehate prejemati zdravilo Zoledronska kislina Teva Pharma Če nameravate prenehati z zdravljenjem z zdravilom Zoledronska kislina Teva Pharma, se pri naslednjem pregledu o tem pogovorite z zdravnikom.
Zoledronic acid Teva Pharma is supplied in multipacks of 5 (5 x 1) or 10 (10 x 1) bags .
Zoledronska kislina Teva Pharma je na voljo v skupnem pakiranju po 5 (5 x 1) ali 10 (10 x 1) vreč.
What Zoledronic acid Teva Pharma is and what it is used for
Kaj je zdravilo Zoledronska kislina Teva Pharma in za kaj ga uporabljamo
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Zdravnika in zobozdravnika morate obvestiti takoj, če pride do kakršnih koli težav v ustih oziroma z zobmi, na primer do majanja zoba, bolečin ali otekline, slabega celjenja ustnih razjed ali vnetja, saj so to lahko znaki osteonekroze čeljustnic.
Multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Večplastna vreča iz poliolefin/stiren-etilen-butilena (SEB) z SFC propilenskim nastavkom za infundiranje, zaprtim z gumijastim zamaškom in snemno zaporko.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
(glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Zoledronic acid-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001).
Pri bolnikih, ki so bili stari 75 let ali starejši in so prejemali zoledronsko kislino, je bilo tveganje za zlome vretenc za 60 % manjše v primerjavi z bolniki, ki so prejemali placebo (p < 0,0001).
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4).
O osteonekrozi čeljustnic so poročali predvsem pri bolnikih z rakom, zdravljenih z zdravili, ki zavirajo resorpcijo kosti, vključno z zoledronsko kislino (glejte poglavje 4.4).
The patient educational material should contain the following key messages:
Pripraviti je treba Komplet podatkov o zdravilu za bolnika, ki mora vsebovati naslednja ključna sporočila:
Not known (frequency cannot be estimated from the available data) Pain in the mouth, and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth; these could be signs of bone damage in the jaw (osteonecrosis).
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Bolečine v ustih in/ali čeljustnic, oteklina ali slabo celjenje ranic v ustni votlini ali čeljustnic, vnetje, odrevenelost ali občutek pritiska v čeljustnic ali majanje zoba so lahko znaki odmiranja kosti v čeljustnic (osteonekroze).
Zoledronic acid Teva Pharma is supplied in packs of 1 bottle and multipacks of 5 (5 x 1) or 10 (10 x 1) bottles.
Zoledronska kislina Teva Pharma je na voljo v posamičnih pakiranjih po 1 plastenko in skupnih pakiranjih po 5 (5 x 1) ali 10 (10 x 1) plastenk.
Pharmacodynamic effects The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone.
Farmakodinamični učinki Difosfonati delujejo selektivno na kosti zaradi svoje velike afinitete do mineralizirane kosti.
Excipients: Mannitol, sodium citrate and water for injections.
Pomožne snovi: manitol, natrijev citrat in voda za injekcije.
The hip fracture event rate was 1.44% for zoledronic acidtreated patients compared to 2.49% for placebo-treated patients.
Delež zlomov kolka je bil 1,44 % v skupini z zoledronsko kislino v primerjavi z 2,49 % v skupini s placebom.
The recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma.
Priporočeni odmerek je ena intravenska infuzija s 5 mg zdravila Zoledronska kislina Teva Pharma.
Not known (frequency cannot be estimated from the available data) Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea.
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) hude alergijske reakcije, vključno z omotičnostjo in oteženim dihanjem, otekanje predvsem v obraz in grlo oziroma žrelo, znižan krvni tlak, dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in diareja.
- The other ingredients are mannitol, sodium citrate and water for injections.
- Druge sestavine zdravila so: manitol, natrijev citrat in voda za injekcije.
Osteonecrosis of the external auditory canal† (bisphosphonate class adverse reaction)
zelo redki osteonekroza zunanjega slušnega kanala† (neželeni učinek skupine disfosfonatov)
Zoledronic acid Teva Pharma contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Zdravilo Zoledronska kislina Teva Pharma vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml, kar v bistvu pomeni »brez natrija«.
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 Teva Pharma administration (see section 4.4).
Pri bolnikih s Pagetovo boleznijo je zelo priporočeno zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, in sicer dvakrat na dan vsaj 10 dni po uporabi zdravila Zoledronska kislina Teva Pharma (glejte poglavje 4.4).
Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic acid Teva Pharma.
Zdravnik vas bo verjetno prosil, da pred začetkom zdravljenja z zdravilom Zoledronska kislina Teva Pharma opravite zobozdravstveni pregled.
Zoledronic acid Teva Pharma is administered via a vented infusion line and given slowly at a constant infusion rate.
Zdravilo Zoledronska kislina Teva Pharma se aplicira prek infuzijskega sistema s prezračevanjem in sicer počasi s stalno hitrostjo infundiranja.
Clinical efficacy in osteoporosis associated with long-term systemic glucocorticoid therapy The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, doubleblind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent).
Klinična učinkovitost pri osteoporozi zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi Učinkovitost in varnost zdravila pri zdravljenju in preprečevanju osteoporoze, do katere pride zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi, so ocenjevali v randomizirani, multicentrični, dvojno slepi, stratificirani, aktivno kontrolirani študiji z 833 moškimi in ženskami, starimi od 18 do 85 let (s povprečno starostjo 56,4 leta pri moških in 53,5 let pri ženskah), ki so peroralno jemali več kot 7,5 mg prednizona na dan (ali ekvivalent).
Uncommon Influenza, nasopharyngitis
Infekcijske in parazitske bolezni gripa, nazofaringitis
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Pomožne snovi To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 ml, kar v bistvu pomeni “brez natrija”.
Table 2 Summary of vertebral fracture efficacy at 12, 24 and 36 months Outcome
Preglednica 2 Pregled učinkovitosti glede zlomov vretenc po 12, 24 in 36 mesecih Izid absolutno znižanje odstotka zlomov % (IZ)
Solution for infusion Multipack: 5 bottles of 100 ml Multipack: 10 bottles of 100 ml
raztopina za infundiranje Skupno pakiranje: 5 plastenk po 100 ml Skupno pakiranje: 10 plastenk po 100 ml
Cyclic olefin polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc.
Plastenka iz cikloolefinskega polimera z zamaškom iz klorobutila/butila in pečatom iz aluminija z vijolično plastično dvižno zaporko.
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Pri zdravljenju z disfosfonati so poročali o osteonekrozi zunanjega slušnega kanala, večinoma pri dolgoročnem zdravljenju.
You must not be given Zoledronic acid Teva Pharma:
Zdravila Zoledronska kislina Teva Pharma ne smete dobiti:
Zoledronic acid Teva Pharma is contraindicated during pregnancy (see section 4.3).
Uporaba zdravila Zoledronska kislina Teva Pharma v nosečnosti je kontraindicirana (glejte poglavje 4.3).
Zoledronic acid Teva Pharma must not be allowed to come into contact with any calcium-containing solutions.
Ne smete dovoliti, da bi zdravilo Zoledronska kislina Teva Pharma prišla v stik z raztopino, ki vsebuje kalcij.
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients, listed in section 6.1.
- Preobčutljivost na zdravilno učinkovino, katerega od difosfonatov ali katero koli pomožno snov, navedeno v poglavju 6.1.
Zoledronic acid Teva Pharma with food and drink Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Pharma, as directed by your doctor.
Zdravilo Zoledronska kislina Teva Pharma s hrano in pijačo Poskrbite, da boste pred zdravljenjem z zdravilom Zoledronska kislina Teva Pharma in po njem pili dovolj tekočine (vsaj en do dva kozarca), kot vam bo naročil zdravnik.
For osteoporosis, Zoledronic acid Teva Pharma works for one year.
Za zdravljenje osteoporoze deluje zdravilo Zoledronska kislina Teva Pharma eno leto.
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
- Preobčutljivost na zdravilno učinkovino, katerega od difosfonatov ali katero koli pomožno snov navedeno v poglavju 6.1.
- 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 katero koli sestavino zdravila
Patients treated with Zoledronic acid Teva Pharma should be given the package leaflet and the patient reminder card.
Bolnikom, ki prejemajo zdravilo Zoledronska kislina Teva Pharma, je treba izročiti Navodilo za uporabo in Opozorilno kartico za bolnika.
• Zoledronic acid Teva Pharma should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
• Pri sočasni uporabi zdravila Zoledronska kislina Teva Pharma z drugimi zdravili, ki lahko vplivajo na delovanje ledvic, je potrebna previdnost (glejte poglavje 4.5).
After opening: 24 hours at 2°C - 8°C
EXP: Po odprtju: 24 ur pri 2 °C - 8 °C.
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: - moč delovanja zdravila, ki zavira resorpcijo kosti (tveganje je večje pri močnejših zdravilih),
Caution is indicated when Zoledronic acid Teva Pharma is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Kadar uporabljamo zdravilo Zoledronska kislina Teva Pharma skupaj z zdravili, ki lahko znatno vplivajo na delovanje ledvic (npr. z aminoglikozidi ali diuretiki, ki lahko povzročijo dehidracijo), je potrebna previdnost (glejte poglavje 4.4).
• Patient reminder card on osteonecrosis of the jaw
• Opozorilno kartico za bolnika z opozorili glede osteonekroze čeljustnic.
Component of a multipack, can't be sold separately.
raztopina za infundiranje Ena plastenka s 100 ml. Del skupnega pakiranja - ne more se prodajati ločeno.
In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001).
V podskupini bolnikov, ki so prejemali glukokortikoide več kot 3 mesece pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 4,06 % v primerjavi z 2,71 % pri uporabi risedronata (z razliko povprečij: 1,36 %; p < 0,001).
In patients with a recent low trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion.
Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je pred prvo infuzijo zoledronske kisline priporočen večji začetni odmerek vitamina D 50.000 do 125.000 i.e. peroralno ali intramuskularno.
After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Po odpiranju: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
Table 4 Between treatment comparisons of the incidence of key clinical fracture variables Outcome
Preglednica 4 Primerjava incidenc ključnih kliničnih zlomov med obema načinoma
MARKETING AUTHORISATION NUMBER(S) EU/1/12/772/005 1 bottle
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/772/005 1 plastenka
What Zoledronic acid Teva Pharma looks like and contents of the pack Zoledronic acid Teva Pharma is a clear and colourless solution.
Izgled zdravila Zoledronska kislina Teva Pharma in vsebina pakiranja Zdravilo Zoledronska kislina Teva Pharma je bistra brezbarvna raztopina.
ONJ has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis (see section 4.8).
O osteonekrozi čeljustnic so po začetku trženja zdravila poročali pri bolnikih, ki so zaradi osteoporoze prejemali zdravilo Zoledronska kislina Teva Pharma (glejte poglavje 4.8).
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Pharma.
Verjetnost, da pride do teh neželenih učinkov, se pri nadaljnjih odmerjanjih zdravila Zoledronska kislina Teva Pharma zmanjšuje.
The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055).
V skupini z zoledronsko kislino je bila incidenca zlomov 8 v primerjavi z incidenco 7 v skupini z risedronatom (p = 0,8055).
• Patient educational material
• Komplet podatkov o zdravilu za bolnika
Solution for infusion 1 bag of 100 ml.
raztopina za infundiranje Ena plastenka s 100 ml.
It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Pharma, as directed by your healthcare provider.
Pomembno je, da v nekaj urah pred prejemom zdravila Zoledronska kislina Teva Pharma popijete vsaj 2 kozarca tekočine (na primer vode), kakor vam naroči zdravstveni delavec, s katerim sodelujete.
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: pojavijo se lahko 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, otekanje in/ali bolečina na mestu infundiranja.
At least one new vertebral fracture (0-1 year)
vsaj en nov zlom vretenca (v prvem letu)
In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96%; p<0.001).
V podskupini bolnikov, ki so prejemali glukokortikoide 3 mesece ali manj pred randomizacijo, je zoledronska kislina povečala mineralno gostoto kosti ledvene hrbtenice za 2,60 % v primerjavi z 0,64 % pri uporabi risedronata (z razliko povprečij: 1,96 %; p < 0,001).
Table 3 Between treatment comparisons of the incidence of key clinical fracture variables over 3 years
Preglednica 3 Primerjava incidenc ključnih kliničnih zlomov med obema načinoma
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 Zoledronic acid Teva Pharma.
Mogoče vam bo zdravnik svetoval, da vsaj prvih deset dni po prejemu zdravila Zoledronska kislina Teva Pharma jemljete dodatke kalcija in vitamina D (na primer v obliki tablet).
- Zoledronic acid Teva Pharma 5 mg solution for infusion is ready for use.
- Zdravilo Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vialah je že pripravljena za uporabo.
It comes in a polyolefin/styreneethylene-butylene (SEB) foil bag with a foil over pouch.
Pakirana je v 100 ml večplastno, vrečo iz poliolefin/stiren-etilen-butilena (SEB) obdano s folijsko vrečo.
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic acid Teva Pharma in patients with concomitant risk factors.
Pri bolnikih s spremljajočimi dejavniki tveganja je pred začetkom zdravljenja z zdravilom Zoledronska kislina Teva Pharma priporočeno opraviti zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in oceniti razmerje med koristmi in tveganji pri vsakem posameznem bolniku.
- After opening the bag, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
- Po odprtju vreče sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
Each bag contains 100 ml of solution.
Vsaka vreča vsebuje 100 ml raztopine.
Not known** Renal impairment.
neznana**
Zoledronic acid Teva Pharma is contraindicated during breast-feeding (see section 4.3).
Uporaba zdravila Zoledronska kislina Teva Pharma v času dojenja je kontraindicirana (glejte poglavje 4.3).