natgillin/translations-raw huggingface dataset:
Zoledronic acid medac 4 mg/100 ml solution for infusion 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 medac 4 mg/100 ml raztopina za infundiranje se ne sme mešati z drugimi infuzijskimi raztopinami in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
METHOD OF ADMINSTRATION Dilute before use.
POSTOPEK UPORABE Pred uporabo razredčite.
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 pojavnost atrijske fibrilacije pri bolnicah, ki so prejemale 5 mg zoledronske kisline, 2,5 % (pri 96 od 3.862 bolnic), pri bolnicah, ki so prejemale placebo, pa 1,9 % (pri 75 od 3.852 bolnic).
If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2 °C - 8 °C.
Če zdravstveni delavec raztopine ne uporabi takoj, je sam odgovoren za trajanje in pogoje shranjevanja pred uporabo in mora biti v hladilniku pri 2 ºC−8 ºC.
Patients treated with Zoledronic acid medac should be given the package leaflet and the patient reminder card.
Bolniki, zdravljeni z zdravilom Zoledronska kislina medac, morajo prejeti navodilo za uporabo in opozorilno kartico za bolnika.
If the solution is not used immediately, it should be stored in a refrigerator at 2°C - 8°C.
Če raztopine ne uporabite takoj, jo je treba shraniti v hladilnik pri temperaturi
In patients with mild to moderate renal impairment, reduced Zoledronic acid medac 4 mg/100 ml solution for infusion doses are recommended (see section “Posology” above and section 4.4).
Za bolnike z blago do zmerno okvaro ledvic so priporočeni nižji odmerki zdravila Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje (glejte poglavje "Odmerjanje" zgoraj in poglavje 4.4).
• Do not use Zoledronic acid medac after the expiry date stated on the bottle and carton after
• Zdravila Zoledronska kislina medac ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici in škatli poleg oznake Uporabno do.
Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Preglednica 6: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta
- Zoledronic acid medac must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
- Zdravilo Zoledronska kislina medac vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno) dajanje difosfonatov.
Zoledronic acid 4 mg reduced the risk of SREs by 41 % in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Pri analizi večkratnih dogodkov se je pokazalo, da je zoledronska kislina v odmerku 4 mg zmanjšala tveganje za SRE za 41 % (razmerje tveganj = 0,59, p=0,019) v primerjavi s placebom.
Zoledronic acid recommended dose*
Priporočeni odmerek zoledronske kisline*
Caution is advised when zoledronic acid is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Pri uporabi zdravila zoledronska kislina skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
Multipack: 4 x 1 bottle of 100 ml Multipack: 10 x 1 bottle of 100 ml
raztopina za infundiranje Skupno pakiranje: 4 x 1 steklenica s 100 ml
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30 - 60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
Pri bolnikih z zasevki v kosteh, ki imajo pred začetkom zdravljenja blago do zmerno okvaro ledvic (opredeljeno za to skupino bolnikov kot CLcr 30-60 ml/min), priporočajo naslednje odmerke zoledronske kisline (glejte tudi poglavje 4.4):
One bottle contains 100 ml of solution.
Ena steklenica vsebuje 100 ml raztopine.
• From a microbiological point of view, the diluted solution for infusion should be used immediately.
• Z mikrobiološkega stališča je rekonstituirano in razredčeno raztopino za infundiranje najbolje uporabiti takoj.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Pred začetkom uporabe zdravila Zoledronska kislina medac, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
After dilution: From a microbiological point of view the medicinal product should be used immediately.
Po redčenju: z mikrobiološkega stališča je razredčeno zdravilo najbolje uporabiti takoj.
Uncommon (may affect up to 1 in 100 people): - 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.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - bolečina v ustih, zobeh in/ali čeljusti, oteklina ali neceljenje ran v ustni votlini ali čeljusti, izcedek, odrevenelost ali občutek pritiska v čeljusti ali majanje zoba, kar so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
− For patients with normal baseline serum creatinine (< 1.4 mg/dl or 124 µmol/l), an increase of
- pri bolnikih z normalnim izhodiščnim serumskim kreatininom (< 1,4 mg/dl ali < 124 µmol/l),
There is preponderance of specific location (head of femur, humerus and medial condyle of femur) due to local anatomical features.
Določene lokacije prevladujejo zaradi lokalnih anatomskih lastnosti (glava stegnenice, nadlahtnica in medialni kondil stegnenice).
Zoledronic acid medac contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodium-free'.
Zdravilo Zoledronska kisilna medac vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Pri bolnikih s spremljajočimi dejavniki tveganja sta pred začetkom zdravljenja z difosfonati priporočljiva zobozdravniški pregled z ustreznimi preventivnimi zobozdravstvenimi ukrepi in individualna ocena razmerja med koristjo in tveganjem.
Talk to your doctor before you are given Zoledronic acid medac, if you - have or have had a kidney problem.
Preden vam dajo zdravilo Zoledronska kislina medac, se posvetujte z zdravnikom, če: - imate ali ste imeli težave z ledvicami,
- The other ingredients are: mannitol, sodium citrate, water for injections.
- Druge sestavine zdravila so manitol, natrijev citrat, voda za injekcije.
Zoledronic acid medac is not recommended for use in adolescents and children below the age of 18 years.
Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Zoledronska kislina medac ni priporočena.
Plastic vial made of clear, colourless cycloolefine copolymer with Type I bromobutyl rubber stopper and sealed with aluminium polypropylene flip-off seal.
Plastična viala, izdelana iz prozornega, brezbarvnega cikloolefinskega kopolimera tipa I, z zamaškom iz bromobutilne gume, prevlečena z aluminijasto polipropilensko odtržno zaporko.
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Osteonekroza čeljustnic O osteonekrozi čeljustnic so občasno poročali v kliničnih preskušanjih in po začetku trženja zdravila pri bolnikih, ki so prejemali zoledronsko kislino.
Respiratory, thoracic and mediastinal disorders Uncommon: Rare:
zamegljen vid, skleritis in orbitalno vnetje redki: zelo redki:
After first opening, Zoledronic acid medac solution for infusion should preferably be used immediately.
Raztopino za infundiranje Zoledronska kislina medac je najbolje uporabiti takoj po prvem odpiranju.
NA Not applicable
NR ni bil dosežen
Zoledronic acid medac 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Zdravilo Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje je treba dajati v obliki ene same intravenske infuzije, ki traja najmanj 15 minut.
What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as a concentrate for solution for infusion in a 5 ml plastic vial made of clear, colourless plastic (cycloolefine copolymer) with rubber stopper (type I bromobutyl) and sealed with flip-off seal (aluminium and polypropylene).
Zdravilo Zoledronska kislina medac je v obliki koncentrata za raztopino za infundiranje v 5 ml plastični viali, narejeni iz prozorne, brezbarvne plastike (cikloolefinski kopolimer) z gumijastim zamaškom (tip 1 bromobutil), prevlečena z odtržno zaporko (aluminij ali polipropilen).
Table 6: Proportion of complete responders by day in the combined TIH studies
Preglednica 6: Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah tumorsko povzročene hiperkalciemije (TIH)
Zoledronic acid 4 mg
Zoledronska kislina 4 mg 
Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Pri uvajanju zdravljenja z zoledronsko kislino pri bolnikih z multiplim mielomom ali metastatičnimi kostnimi lezijami zaradi čvrstih tumorjev je treba določiti serumski kreatinin in očistek kreatinina (CLcr).
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Po pregledu podatkov kliničnih preskušanj in primerov, ki so jih opažali po prihodu zdravila na trg, je na voljo dovolj dokazov, ki povezujejo zdravljenje z zdravilom zoledronska kislina, opisane primere hipokalciemije in posledičen razvoj aritmije.
6.6 Special precautions for disposal and other handling Additional information on handling of Zoledronic acid medac 4 mg/100 ml solution for infusion, including guidance on the preparation of reduced doses using the Zoledronic acid medac ready-to-use bottle, is provided in section 4.2.
Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina medac 4 mg/100 ml raztopina za infundiranje, vključno z navodili za pripravo nižjih odmerkov iz plastenke z že pripravljeno raztopino zdravila Zoledronska kislina medac, so navedene v poglavju 4.2.
Zoledronic acid medac contains sodium
Zdravilo Zoledronska kislina medac vsebuje natrij
Muscle spasms, osteonecrosis of the jaw 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
Remove the following amount of Zoledronic acid medac solution for infusion (ml)
Odvzemite navedeni volumen zdravila Zoledronska kislina medac raztopina za infundiranje (ml)
The following conventional classification is used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Zoledronsko kislino 4 mg so proučevali tudi v dvojno slepem, randomiziranem, s placebom kontroliranem preskušanju pri 228 bolnicah z dokazanimi kostnimi zasevki raka dojke, da bi ocenili učinek 4 mg zoledronske kisline na razmerje pogostnosti z okostjem povezanih dogodkov (SRE
• Do not use Zoledronic acid medac after the expiry date stated on the vial and carton after EXP.
• Zdravila Zoledronska kislina medac ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake Uporabno do.
Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Povprečne spremembe od izhodišča na BPI lestvici, označene so statistično značilne vrednosti p (*p<0,05) za primerjavo med obema vrstama zdravljenja (4 mg zoledronska kislina v primerjavi s placebom)
Prior to administration, 5 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 (sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution).
Pred uporabo je treba 5,0 ml koncentrata iz ene viale oziroma ustrezni volumen odvzetega koncentrata dodatno redčiti s 100 ml infuzijske raztopine v kateri ni kalcija (9 mg/ml (0,9-odstotna) raztopina natrijevega klorida ali 5-odstotna m/v raztopina glukoze).
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100),
Neželeni učinki so razvrščeni glede na pogostnost, najprej najpogostejši, in to po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
CARTON FOR 4 VIALS
ŠKATLA ZA 1 VIALO ŠKATLA ZA 4 VIALE
≥ 4.5 mg/dl for patients with TIH and ≥ 265 µmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
Glede na možni vpliv zoledronske kisline na delovanje ledvic ob pomanjkanju kliničnih podatkov o varnosti pri bolnikih s težko izhodiščno okvaro ledvic (v kliničnih preskušanjih opredeljeno s serumskim kreatininom ≥ 400 µmol/l ali ≥ 4,5 mg/dl za bolnike s tumorsko povzročeno hiperkalciemijo - TIH - oziroma s serumskim kreatininom ≥ 265 µmol/l ali ≥ 3,0 mg/dl za bolnike z rakom in zasevki v kosteh) in glede na samo omejene farmakokinetične podatke pri bolnikih s težko izhodiščno ledvično okvaro (očistek kreatinina < 30 ml/min), uporabe zoledronske kisline pri bolnikih s težko ledvično okvaro ne priporočamo.
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) kateri koli SRE (+TIH) zlomi*
Do not mix Zoledronic acid medac with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Ne mešajte zdravila Zoledronska kislina medac z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
trembling, tingling or numbness of the hands or feet, diarrhoea, abdominal pain, dry mouth.
mravljinčenje ali odrevenelost rok ali stopal, driska, bolečine v trebuhu, suha usta,
The active substance in Zoledronic acid medac is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Kaj je zdravilo Zoledronska kislina medac in za kaj ga uporabljamo Zdravilna učinkovina v zdravilu Zoledronska kislina medac je zoledronska kislina, ki sodi v skupino snovi, ki se imenujejo difosfonati.
Table 5: Efficacy results (breast cancer and multiple myeloma patients)
Preglednica 5: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom)
The rate of atrial fibrillation serious 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 bolnicah, ki so prejemale 5 mg zoledronske kisline, 1,3 % (pri 51 od 3.862 bolnic), pri bolnicah, ki so prejemale placebo, pa 0,6 % (pri 22 od 3.852 bolnic).
Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders Common:
Preglednica 7: Neželeni učinki, ki so jih opažali pri pediatričnih bolnikih s hudo obliko osteogenesis imperfecta
Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing) 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,
Multipack: 4 x 1 vial of 5 ml Multipack: 10 x 1 vial of 5 ml
Skupno pakiranje: 4 x 1 viala s 5 ml.
Austria medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
2491 Neufeld/Leitha Avstrija medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate, water for injections.
SEZNAM POMOŽNIH SNOVI Pomožne snovi: manitol, natrijev citrat, voda za injekcije.
Remove the volume of Zoledronic acid medac 4 mg/100 ml solution indicated from the bottle and replace with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% glucose.
Navedeni volumen raztopine Zoledronska kislina medac 4 mg/100 ml odvzemite iz plastenke in ga nadomestite z enakim volumnom sterilne raztopine natrijevega klorida za injiciranje 9 mg/ml (0,9-odstotne) ali 5-odstotne raztopine glukoze za injiciranje.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/001<1 vial>
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/779/001<1 vial>
Pyrexia, fatigue Acute phase reaction, pain
reakcija akutne faze, bolečina
Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): - zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije) - okvara v delovanju ledvic, imenovana Fanconijev sindrom (običajno jo ugotovi zdravnik s pomočjo določenih preiskav urina).
Risk reduction of suffering from multiple events**
vrednost p stopnja obolevnosti skeleta vrednost p zmanjšanje tveganja za pojav večkratnih dogodkov** (%)
• The readily prepared Zoledronic acid medac infusion solution should preferably be used immediately.
• Razredčeno infuzijsko raztopino zdravila Zoledronska kislina medac morate po možnosti porabiti takoj.
What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as solution for infusion in a 100 ml colourless glass bottle (type I) with rubber stoppers (halobutyl, fluoropolymer coated) and aluminium flip-off caps.
Zdravilo Zoledronska kislina medac je v obliki raztopine za infundiranje v 100 ml steklenice, narejeni iz brezbarvnega, prozornega stekla (tipa 1) z gumijastimi zamaški (halobutilna guma, prevlečena s fluoropolimerom) in z aluminijasto odtržno zaporko.
Colourless glass bottle type I with fluoropolymer coated halobutyl rubber stopper and aluminium flipoff cap.
Brezbarvna steklenica iz stekla tipa I, zaprti z zamaškom iz halobutilne gume, prevlečene s fluoropolimerom, in z aluminijasto odtržno zaporko.
Hypocalcaemia has been reported in patients treated with zoledronic acid.
Pri bolnikih, ki so prejemali zdravilo z zoledronsko kislino, so poročali o hipokalciemiji.
- 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,
Zoledronic acid medac 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 medac se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
Very rare:
urtikarija redki:
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 jih je treba dajati kot samostojne intravenske raztopine z ločenim infuzijskim sistemom.
Zoledronic acid medac 4mg/5ml concentrate for solution for infusion Sanochemia Pharmazeutika AG
Zoledronska kislina medac 4 mg/5 ml koncentrat za raztopino za infundiranje Sanochemia Pharmazeutika AG
Replace with the following volume of sterile sodium chloride 9 mg/ml (0.9%), or 5% glucose solution for injection (ml)
Nadomestite z navedenim volumnom sterilne raztopine natrijevega klorida 9 mg/ml (0,9-odstotne) ali 5-odstotne raztopine glukoze za injiciranje (ml)
Very common: Common:
Preiskave zelo pogosti:
• Keep Zoledronic acid medac out of the sight and reach of children.
• Zdravilo Zoledronska kislina medac shranjujte nedosegljivo otrokom!
Table 1: Preparation of reduced doses of Zoledronic acid medac 4 mg/100 ml solution for infusion
Preglednica 1: Pripravljanje nižjih odmerkov zdravila Zoledronska kislina medac 4 mg/100 ml raztopine za infundiranje
• Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Imetnik dovoljenja za promet z zdravilom bo zagotovil opozorilno kartico za bolnika glede osteonekroze čeljustnic.
The withdrawn amount of the concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution.
Odvzeto količino koncentrata morate dodatno redčiti v 100 ml sterilne 9 mg/ml (0,9-odstotne) raztopine natrijevega klorida ali 5
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking bisphosphonates, including zoledronic acid.
Iz izkušenj v obdobju trženja pri bolnikih, ki so dobivali difosfonate, vključno z zoledronsko kislino, so poročali o hudih bolečinah v kosteh, sklepih in/ali mišicah.
Hypersensitivity reaction Angioneurotic oedema
angionevrotični edem
How to store Zoledronic acid medac Contents of the pack and other information
Izgled zdravila Zoledronska kislina medac in vsebina pakiranja
PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless solution.
koncentrat za raztopino za infundiranje bistra in brezbarvna raztopina
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 zdravilom zoledronska kislina, so poročali o znižani koncentraciji kalcija v krvi (hipokalciemiji), zaradi katere v nekaterih primerih lahko pride do mišičnih krčev, suhe kože in pekočega občutka.