FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
Slovenian: Kadar difosfonate dajemo sočasno z aminoglikozidi, kalcitoninom ali diuretiki Henlejeve zanke je priporočljiva previdnost, ker utegnejo imeti navedene učinkovine aditiven učinek, kar bi imelo za posledico nižje koncentracije serumskega kalcija za dalj časa, kot je potrebno (glejte poglavje 4.4).
English: Other medicinal products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Slovenian: Na voljo so tudi druga zdravila, ki vsebujejo zdravilno učinkovino zoledronska kislina, in se uporabljajo za zdravljenje osteoporoze in Pagetove bolezni kosti.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Teva and will check your response to treatment at regular intervals.
Slovenian: Preden začnete zdravljenje z zdravilom Zoledronska kislina Teva, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni »brez natrija«.
English: - Low level of calcium in the blood.
Slovenian: - nizka koncentracija fosfata v krvi.
English: - Severe bone, joint and/or muscle pain, occasionally incapacitating.
Slovenian: − hude bolečine v kosteh, sklepih in/ali mišicah, ki bolnika včasih onesposobijo.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic Acid Teva.
Slovenian: Vsem bolnikom je treba naročiti, naj v času zdravljenja z zdravilom Zoledronska kislina Teva skrbijo za dobro ustno higieno in redno hodijo na preglede k zobozdravniku, v primeru simptomov v ustni votlini, kot so majavost zob, bolečine, otekline ali neceljenje ran ali vnetje, pa naj takoj obvestijo zdravnika.
English: 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.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - 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).
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Slovenian: Občasni (pojavijo se lahko pri največ 1 do 100 bolnikov): - preobčutljivostne reakcije,
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Teva.
Slovenian: Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom Zoledronska kislina Teva opravite zobozdravstveni pregled.
English: Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - glavobol in gripi podoben sindrom, ki ga sestavljajo zvišana telesna temperatura, utrujenost, šibkost, zaspanost, mrazenje in bolečine v kosteh, sklepih in/ali mišicah.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Slovenian: Preglednica 4: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom)
English: abdominal pain, dry mouth.
Slovenian: stomatitis, suha usta
English: Important information about some of the ingredients in Zoledronic Acid Teva
Slovenian: Pomembne informacije o nekaterih pomožnih snoveh zdravila Zoledronska kislina Teva
English: Manufacturer Pharmachemie B.V. Swensweg 5
Slovenian: Izdelovalci Pharmachemie B.V.
English: Caution is advised when Zoledronic Acid Teva is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Slovenian: Pri dajanju zdravila Zoledronska kislina Teva skupaj z zdravili, za katera je znano, da povzročajo hipokalciemijo, je potrebna previdnost, saj lahko delujejo sinergistično in povzročijo hudo hipokalciemijo (glejte poglavje 4.5).
English: What Zoledronic Acid Teva looks like and contents of the pack Zoledronic Acid Teva is supplied as a concentrate for solution for infusion.
Slovenian: Izgled zdravila Zoledronska kislina Teva in vsebina pakiranja Zdravilo Zoledronska kislina Teva je koncentrat za raztopino za infundiranje.
English: − As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Slovenian: − zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije);
English: Diluted Solution - The readily prepared Zoledronic Acid Teva infusion solution should preferably be used immediately.
Slovenian: Pripravljena raztopina - Razredčeno raztopino zdravila Zoledroniska kislina Teva je najbolje raztopino za infundiranje uporabiti takoj.
English: Patients being treated with Zoledronic acid Teva should not be treated with such medicinal products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Slovenian: Zoledronska kislina Teva ne smejo sočasno prejemati teh zdravil ali katerega koli od drugih difosfonatov, saj učinki kombinacije navedenih učinkovin niso znani.
English: Zoledronic acid 4 mg (N=86)
Slovenian: 10. dan zoledronska kislina 4 mg (N=86)
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Slovenian: 4.3 Kontraindikacije - Preobčutljivost na zdravilno učinkovino, na druge difosfonate ali katero koli drugo pomožno snov, navedeno v poglavju 6.1.
English: Zoledronic Acid Teva should only be resumed when serum creatinine returns to within 10% of baseline.
Slovenian: Zdravljenje z zdravilom Zoledronska kislina Teva se sme spet začeti šele, ko se serumski kreatinin vrne na vrednost, ki ni za več kot 10 % večja od izhodiščne.
English: This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea arthralgia and arthritis with subsequent joint swelling.
Slovenian: Ta neželeni učinek zdravila zajema sklop simptomov, ki vključujejo zvišano telesno temperaturo, mialgijo, glavobol, bolečine v okončinah, navzeo, bruhanje, diarejo, artralgijo in artritis, ki povzroči otekline sklepov.
English: • Breast-feeding (see section 4.6)
Slovenian: - Dojenje (glejte poglavje 4.6).
English: Zoledronic Acid Teva treatment should be resumed at the same dose as that given prior to treatment interruption.
Slovenian: Zdravljenje z zdravilom Zoledronska kislina Teva je treba spet začeti z enakim odmerkom kot ga je bolnik prejemal pred prekinitvijo zdravljenja.
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Slovenian: Teva niso znani, - antiangiogena zdravila (uporabljamo jih pri zdravljenju raka), ker kombinacijo le-teh z zoledronsko kislino povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
English: The following properties have been demonstrated in preclinical studies: - In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Slovenian: - In vivo: Inhibicijo osteoklastne resorpcije kosti, ki spremeni mikrookolje kostnega mozga, tako da je le-to manj ugodno za rast tumorskih celic, protiangiogeno aktivnost in protibolečinsko aktivnost.
English: The active substance is zoledronic acid.
Slovenian: - Zdravilna učinkovina je zoledronska kislina.
English: Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Slovenian: Takoj povejte zdravniku, če imate katerega od naslednjih resnih neželenih učinkov: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - huda okvara ledvic (običajno jo ugotovi zdravnik z določenimi specifičnimi krvnimi preiskavami), - nizka raven kalcija v krvi.
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Slovenian: V kliničnem programu so bolniki v starosti od 1 leta do < 3 leta prejeli 0,025 mg/kg zoledronske kisline (do največ 0,35 mg v enkratnem odmerku)
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Slovenian: astenija, periferni edemi, reakcije na mestu injiciranja (vključujoč bolečino, iritacijo, otekanje, zatrdlino), bolečina v prsih, zvečanje telesne mase, anafilaktična reakcija/šok,
English: Patients treated with Zoledronic Acid Teva should be given the package leaflet and the patient reminder card.
Slovenian: Bolnikom, ki prejemajo zdravilo Zoledronska kislina Teva, je treba izročiti navodilo za uporabo in opozorilno kartico za bolnika.
English: - Zoledronic acid must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Slovenian: - Zoledronsko kislino vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno) dajanje difosfonatov.
English: The refrigerated solution should then be equilibrated to room temperature before administration.
Slovenian: Ohlajeno raztopino je treba pred uporabo pustiti, da se ogreje na sobno temperaturo.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Slovenian: 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)
English: Instructions for preparing reduced doses of Zoledronic Acid Teva: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Slovenian: Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina Teva: Odvzemite ustrezni volumen tekočega koncentrata, kot sledi:
English: Do not use this medicine if you notice any particles or discoloration in the solution.
Slovenian: Ne uporabite raztopine, če je drugačne barve ali so v njej majhni delci.
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Slovenian: vrtoglavost, parestezija, disgevzija, hipestezija, hiperestezija, tremor, somnolenca konvulzije, hipestezija in tetanija (zaradi hipokalciemije)
English: Caution is indicated when Zoledronic Acid Teva is used with other potentially nephrotoxic medicinal products.
Slovenian: Kadar zdravilo Zoledronska kislina Teva dajemo z drugimi potencialno nefrotoksičnimi zdravili, je potrebna previdnost.
English: In a third phase III randomised, double-blind trial, 4 mg zoledronic acid 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.
Slovenian: NA ne velja za ta primer V tretjem randomiziranem, dvojno slepem preskušanju faze III so pri bolnicah/bolnikih z multiplim mielomom ali rakom dojke z vsaj po eno lezijo v kosteh primerjali zoledronsko kislino 4 mg in 90 mg pamidronata vsake 3 do 4 tedne.
English: You should not be given Zoledronic Acid Teva: - if you are breast-feeding.
Slovenian: Zdravila Zoledronska kislina Teva ne smete dobiti: - če dojite.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 x 5 ml vial
Slovenian: koncentrat za raztopino za infundiranje 1 x 5 ml viala
English: Zoledronic Acid Teva is not recommended for use in adolescents and children below the age of 18 years.
Slovenian: Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Zoledronska kislina Teva ni priporočena.
English: Caution is advised when Zoledronic Acid Teva 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.
Slovenian: Pri uporabi zdravila Zoledronska kislina Teva skupaj z antiangiogenimi zdravili je potrebna previdnost, saj so pri bolnikih, ki so sočasno prejemali navedena zdravila, opažali povečano pogostnost osteonekroze čeljustnic.
English: Do not mix Zoledronic Acid Teva concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Slovenian: Ne mešajte rekonstituirane raztopine zdravila Zoledronska kislina Teva z raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata.
English: - Low level of magnesium and potassium in the blood.
Slovenian: - nizka koncentracija levkocitov in trombocitov, - nizki koncentraciji magnezija in kalija v krvi.
English: 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.
Slovenian: 1,3 % (pri 51 od 3.862 bolnic), pri bolnicah, ki so prejemale placebo, pa 0,6 % (pri 22 od
English: Dyspnoea, cough, bronchoconstriction
Slovenian: dispneja, kašelj, bronhokonstrikcija intersticijska bolezen pljuč
English: There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Slovenian: Ob uporabi zoledronske kisline v zelo redkih primerih prišlo do dremavosti in zaspanosti.
English: − As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Slovenian: − zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije).
English: 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.
Slovenian: To zdravilo ne smete 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.
English: This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Slovenian: Prišlo je do poudarjenega farmakološkega delovanja, domnevno zaradi zaviranja presnove kalcija v kosteh, ki je v obdobju okrog poroda povzročalo hipokalciemijo (kar je značilno za celotno skupino difosfonatov), distocijo in predčasno prekinitev študije.
English: It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Slovenian: Posebno pomembno je, da zdravniku poveste, če jemljete tudi naslednja zdravila: - aminoglikozide (zdravila, ki jih uporabljamo za zdravljenje težkih okužb), kalcitonin (vrsta zdravila, ki ga uporabljamo za zdravljenje pri postmenopavzalni osteoporozi in hiperkalciemiji),
English: Zoledronic Acid Teva 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.
Slovenian: Koncentrat zdravila Zoledronska kislina Teva 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.
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Slovenian: Poročali so o razvoju aritmij in nevroloških neželenih učinkov (vključno s konvulzijami, hipestezijo in tetanijo), do katerih je prišlo zaradi hude hipokalciemije.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Slovenian: zvišana telesna temperatura, gripi podoben sindrom (z utrujenostjo, okorelostjo, občutkom slabosti in napadi rdečice)
English: Patients should be adequately supplemented with calcium and vitamin D.
Slovenian: Bolniki morajo prejemati zadostno količino kalcija in vitamina D. Pomožne snovi
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Slovenian: NA ne velja za ta primer Preglednica 3: Rezultati učinkovitosti (čvrsti tumorji, razen raka dojke in prostate)
English: 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.
Slovenian: NA ne velja za ta primer 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),
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic Acid Teva is used in combination with thalidomide.
Slovenian: Pri bolnikih z multiplim mielomom se utegne zvečati tveganje za disfunkcijo ledvic, kadar zdravilo
English: 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.
Slovenian: Priporočeni odmerek za hiperkalciemijo (za albumin korigirani serumski kalcij ≥ 12,0 mg/dl ali
English: - 4.1 ml for 3.3 mg dose
Slovenian: 4,4 ml za odmerek 3,5 mg 4,1 ml za odmerek 3,3 mg 3,8 ml za odmerek 3,0 mg
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Slovenian: moteno delovanje ledvic, osteonekrozo čeljustnic, reakcijo akutne faze, hipokalciemijo, atrijsko fibrilacijo, anafilaksijo, intersticijsko bolezen pljuč.
English: In the clinical studies, patients with serum creatinine > 400 μmol/l or > 4.5 mg/dl were excluded.
Slovenian: Bolnike s serumskim kreatininom > 400 μmol/l ali > 4,5 mg/dl so izključili iz kliničnih študij.
English: Patients must be assessed prior to administration of Zoledronic Acid Teva to ensure that they are adequately hydrated.
Slovenian: Pred uporabo zdravila Zoledronska kislina Teva moramo bolnike pregledati, da zagotovimo, da so ustrezno hidrirani.
English: Zoledronic Acid Teva recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Slovenian: 4,0 mg zoledronske kisline 3,5 mg* zoledronske kisline 3,3 mg* zoledronske kisline 3,0 mg* zoledronske kisline
English: Danmark Teva Denmark A/S Tlf: +45 44 98 55 11
Slovenian: Tlf: +45 44 98 55 11
English: Zoledronic Acid Teva is contraindicated in breast-feeding women (see section 4.3).
Slovenian: Pri doječih materah je uporaba zdravila Zoledronska kislina Teva kontraindicirana (glejte poglavje 4.3).
English: 6.6 Special precautions for disposal and other handling 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 for injection or 5% w/v glucose solution).
Slovenian: 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 (9 mg/ml (0,9-odstotna) raztopina natrijevega klorida ali 5-odstotna m/v raztopina glukoze).
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Slovenian: Analiza večkratnih dogodkov je pokazala za 30,7 % zmanjšano tveganje za razvoj z okostjem povezanih dogodkov (SREs) v skupini, ki je prejemala zoledronsko kislino 4 mg,
English: 5 ml
Slovenian: 4 mg/5 ml
English: How Zoledronic Acid Teva is given
Slovenian: Kako se zdravilo Zoledronska kislina Teva daje
English: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Slovenian: mravljinčenje ali odrevenelost rok ali stopal, driska, zaprtje bolečine v trebuhu, suha usta,
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Teva and inform your doctor about your dental treatment.
Slovenian: da prejemate zdravilo Zoledronska kislina Teva in obvestite svojega zdravnika o zdravljenju zob.
English: 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 Teva dose is recommended (see also section 4.4):
Slovenian: (opredeljeno za to skupino bolnikov kot CLcr 30-60 ml/min), priporočajo naslednji odmerek zdravila Zoledronska kislina Teva (glejte tudi poglavje 4.4):
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, difosfonati, oznaka
English: Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Slovenian: pamidronat 90 mg (N=99)
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Slovenian: (neželeni učinek skupine difosfonatov) in osteonekroza na drugih anatomskih lokacijah, vključno s stegnenico in kolkom
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Slovenian: hipertenzija, hipotenzija, atrijska fibrilacija,
English: Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Slovenian: Če ste noseči ali če dojite, se posvetujte z zdravnikom, preden vzamete katero koli zdravilo.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat) bistra in brezbarvna raztopina
English: - Weight increase.
Slovenian: 0,1 % maksimalne koncentracije.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE