natgillin/translations-raw huggingface dataset:
Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bondronat for oncology indications (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo Bondronat za indikacije v onkologiji, so v obdobju po prihodu zdravila na trg zelo redko poročali o osteonekrozi čeljustnic (glejte poglavje 4.8).
angioedema†, anaphylactic reaction/shock†
bronhospazem†, angioedem†, anafilaktična reakcija/šok†**
• It helps to prevent your bones from breaking (fractures) • It also helps to prevent other bone problems that may need surgery or radiotherapy
• Pomaga preprečiti druge težave s kostmi, zaradi česar bi potrebovali operacijo ali radioterapijo.
• If you have any further questions, ask your doctor, pharmacist or nurse
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Hypocalcaemia
- Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Hypocalcaemia** Hypophosphataemia
Presnovne in prehranske motnje hipokalciemija** hipofosfatemija
You can drive and use machines as it's expected that Bondronat has no or negligible effect on your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Lahko vozite in upravljate s stroji, saj pričakujemo, da zdravilo Bondronat ne vpliva ali ima zanemarljiv vpliv na sposobnost vaše vožnje ali upravljanja s stroji.
This is because the medicine will only work if it is taken all the time.
Zdravilo Bondronat jemljite, dokler vam je to naročil zdravnik, ker deluje samo, če ga jemljemo stalno.
= serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)] To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by
= koncentracija kalcija v serumu (mg/dl) + 0,8 x [4 - albumin (g/dl)] Če želimo korigirani kalcij v serumu, izražen v mmol/l pretvoriti v mg/dl, vrednost pomnožimo s 4.
Albumin-corrected serum calcium (mg/dl)
ali korigirani kalcij v serumu (mg/dl)
Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh s tabletami Bondronat 50 mg so raziskovali v dveh randomiziranih, s placebom kontroliranih preskušanjih faze III, ki so potekala 96 tednov.
The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/l) was 18 - 19 days for the 2 mg and 4 mg doses.
Mediana časa do relapsa (ponovnega zvišanja korigiranega kalcija v serumu nad 3 mmol/l) je bila 18 do 19 dni za 2 mg in 4 mg odmerke.
• kidney cyst (fluid-filled sac in the kidney)
• ledvična cista (vrečka v ledvicah napolnjena s tekočino).
Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat therapy.
Pred začetkom zdravljenja metastatične bolezni kosti z zdravilom Bondronat je potrebno učinkovito zdraviti hipokalciemijo in druge motnje kosti in presnove mineralov.
How to receive Bondronat
Kako jemati zdravilo Bondronat
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
osteonekroza čeljustnic†**, osteonekroza zunanjega sluhovoda (neželeni učinek skupine difosfonatov)†
Film-coated tablets.
Filmsko obložene tablete
Ocular inflammation†**
Očesne bolezni vnetje oči†**
• if you have kidney problems
• če imate težave z ledvicami,
Data from this study demonstrated a significant advantage for intravenous Bondronat 6 mg over placebo in the reduction in SREs measured by the time-adjusted SMPR (p=0.004).
Podatki raziskave so pokazali signifikantno prednost zdravila Bondronat 6 mg, danega intravensko, pred placebom v zmanjšanju SRE, ki so jih merili s SMPR (p = 0,004).
There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Če vzamemo ibandronsko kislino 60 minut pred obrokom, biološka uporabnost ni pomembno zmanjšana.
Bondronat works by reducing the amount of calcium that is lost from your bones.
Zdravilo Bondronat zavira izločanje kalcija iz kosti.
Blood parathyroid hormone increased
Preiskave zvišane vrednosti paratiroidnega hormona v krvi
MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/009: 28film-coated tablets EU/1/96/012/010: 84 film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/012/009: 28 filmsko obloženih tablet
Posology Prevention of skeletal events in patients with breast cancer and bone metastases
Odmerjanje Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh
If you are not sure, talk to your doctor or pharmacist before having Bondronat.
Če ste negotovi, se, preden boste prejeli zdravilo Bondronat, posvetujte z zdravnikom ali farmacevtom.
• Prevention of Skeletal Events - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
• preprečevanje z okostjem povezanih dogodkov - dodamo k 100 ml izotonične raztopine natrijevega klorida ali k 100 ml 5-% raztopine dekstroze in infundiramo najmanj 15 minut.
Clear, colourless solution.
Bistra, brezbarvna raztopina
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intravenous use, for infusion after dilution
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo Za intravensko uporabo.
In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose.
Pri bolnikih z zmerno hiperkalciemijo (korigirani kalcij v serumu < 3 mmol/l ali < 12 mg/dl) je učinkovit odmerek 2 mg.
Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate.
Za vse bolnike je pomemben zadosten vnos kalcija in vitamina D. Če je vnos s hrano nezadosten, morajo bolniki prejeti dodatke kalcija ali vitamina D ali oboje.
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) se priporoča prilagajanje odmerkov (glejte poglavje 4.2).
After reconstitution: Store at 2°C - 8°C (in a refrigerator).
Po rekonstituciji: shranjujte pri temperaturi med 2 C in 8 C (v hladilniku).
The medicine should be administered as an infusion in your vein over two hours.
Zdravilo mora biti dano v veno v obliki dvourne infuzije.
• Keep this medicine out of the sight and reach of children• Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega monohidrata).
Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vial with a bromobutyl rubber stopper).
Zdravilo Bondronat je na voljo v pakiranju po 1, 5 in 10 vial (6 ml viala iz stekla tipa I z zamaškom iz bromobutilne gume).
• Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
• preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in zasevki v kostehdodamo k 100 ml izotonične raztopine natrijevega klorida ali k 100 ml 5-% raztopine glukoze in infundiramo vsaj 15 minut.
Blood alkaline phosphatase increase, weight decrease
Preiskave zvišana γ-GT, zvišan kreatinin zvišane koncentracije alkalne fosfataze v krvi, znižanje telesne mase
• Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours
• zdravljenje tumorsko povzročene hiperkalciemije -dodamo k 500 ml izotonične raztopine natrijevega klorida ali k 500 ml 5-% raztopine dekstroze in infundiramo 2 uri.
Injury, injection site pain
bolečina na mestu injiciranja
Method and route of administration Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Način in pot dajanja Koncentrat za raztopino za infundiranje Bondronat damo kot intravensko infuzijo.
A statistically significant improvement in bone pain score was shown for Bondronat 50 mg compared to placebo.
V primerjavi s placebom se je pri zdravilu Bondronat 50 mg pokazalo statistično značilno izboljšanje rezultata pri bolečinah v kosteh.
Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Pri bolnikih, zdravljenih z intravensko ibandronsko kislino, so poročali o primerih resnih, včasih smrtnih, alergijskih reakcij.
Eye disorders
Vnetje oči
NAME OF THE MEDICINAL PRODUCT Bondronat 50 mg film-coated tablets ibandronic acid
Navodilo za uporabo Bondronat 50 mg filmsko obložene tablete ibandronska kislina
There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with Bondronat that was statistically significant compared to placebo.
V primerjavi s placebom se je pri bolnikih, zdravljenih z zdravilom Bondronat, v urinu pojavilo statistično značilno izrazito zmanjšanje označevalcev kostne resorpcije (piridinolina in deoksipiridinolina).
Dosage: Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh Priporočeni odmerek za preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh je 6 mg v obliki intravenske injekcije in ga damo vsake 3 do 4 tedne.
After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
Po razredčitvi je infuzijska raztopina stabilna 24 ur pri temperaturi med 2 C in 8 °C (v hladilniku)
The deterioration in Quality of Life and WHO performance status was significantly less in Bondronat treated patients compared with placebo.
Poslabšanje kakovosti življenja in status učinka po klasifikaciji Svetovne zdravstvene organizacije (SZO) sta bila pri bolnikih, zdravljenih z zdravilom Bondronat, v primerjavi s placebom značilno manjša.
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* 3 mmol/l or 12 mg/dl) 4 mg is an adequate single dose.
Pri večini bolnikov s hudo hiperkalciemijo (korigirani kalcij v serumu*  3 mmol/l ali  12 mg/dl) zadošča enkratni odmerek 4 mg.
Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with duration of 96 weeks.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh z zdravilom Bondronat 6 mg, danim intravensko, so raziskovali v randomiziranem s placebom kontroliranem preskušanju faze III, ki je potekala 96 tednov.
Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial with a bromobutyl rubber stopper).
Zdravilo Bondronat je na voljo v škatlah, v katerih je 1 viala (2 ml viala iz stekla tipa I z zamaškom iz bromobutilne gume).
Talk to your doctor first if you want to drive, use machine or tools.
Če želite voziti ali upravljati s stroji, se prej posvetujte z zdravnikom.
Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06.
Oznaka ATC: M05BA06
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala z 2 ml koncentrata za raztopino za infundiranje vsebuje 2 mg ibandronske kisline (v obliki natrijevega monohidrata).
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dose adjustment is necessary.
Bolniki z ledvično okvaro Pri bolnikih z blago ledvično okvaro (CLcr ≥ 50 in < 80 ml/min) prilagajanje odmerkov ni potrebno.
Rare (may affect up to 1 in 1,000 people)
Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov):
• if you have any swallowing or digestion problems
• če imate težave s požiranjem ali prebavne težave,
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala s 6 ml koncentrata za raztopino za infundiranje vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložene tablete 28 filmsko obloženih tablet 84 filmsko obloženih tablet
Talk to your doctor or pharmacist before taking Bondronat:
Pred začetkom uporabe zdravila Bondronat se posvetujte z zdravnikom ali farmacevtom:
Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Bondronat 6 mg koncentrat za raztopino za infundiranje ibandronska kislina
• After dilution the infusion solution is stable for 24 hours at 2-8°C (in a refrigerator)
• Po razredčitvi je infuzijska raztopina stabilna 24 ur pri temperaturi med 2 °C in 8 °C (v hladilniku).
• if you have or ever had low calcium in your blood Do not take this medicine if any of the above apply to you.
• če imate ali ste kadar koli imeli nizke koncentracije kalcija v krvi.
Marketing Authorisation Holder Atnahs Pharma Netherlands B.V. Strawinskylaan 3127
Imetnik dovoljenja za promet z zdravilom Atnahs Pharma Netherlands B.V.
Cellulose, microcrystalline Crospovidone Stearic acid
Jedro tablete: monohidrat laktoze povidon mikrokristalna celuloza krospovidon stearinska kislina brezvoden koloidni silicijev dioksid
How to store Bondronat
Shranjevanje zdravila Bondronat
Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Bondronat 2 mg koncentrat za raztopino za infundiranje ibandronska kislina
To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by
Če želimo korigirani kalcij v serumu, izražen v mmol/l, pretvoriti v mg/dl, vrednost pomnožimo s 4.
MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/009
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/96/012/009 EU/1/96/012/010
Calcium containing solutions should not be mixed with Bondronat concentrate for solution for infusion.
Koncentrata za raztopino za infundiranje Bondronat ne smemo mešati z drugimi raztopinami, ki vsebujejo kalcij.
One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate)
Ena viala s 6 ml koncentrata za raztopino za infundiranje vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate)
Ena viala z 2 ml koncentrata za raztopino za infundiranje vsebuje 2 mg ibandronske kisline (v obliki natrijevega monohidrata).
Table 3 Secondary Efficacy Results (Breast cancer Patients with Metastatic Bone Disease)
Sekundarni rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti)
Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder
Bolezni prebavil diareja, bruhanje, dispepsija, gastrointestinaln a bolečina, bolezen zob gastroenteritis, gastritis, ulceracija ust, disfagija, heilitis
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bondronat 6 mg concentrate for solution for infusion ibandronic acid
IME ZDRAVILA IN POT(I) UPORABE Bondronat 6 mg koncentrat za raztopino za infundiranje ibandronska kislina i.v.
• It helps to prevent other bone problems that may need surgery or radiotherapy Bondronat can also be prescribed if you have a raised calcium level in your blood due to a tumour.
Zdravilo Bondronat vam bodo lahko predpisali tudi, če imate zvišano koncentracijo kalcija v krvi zaradi tumorja.
It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Bondronat').
Priporočamo, da se razredčen pripravek uporabi takoj (glejte poglavje 5.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bondronat for cancer-related conditions.
Pri bolnikih, ki so prejemali zdravilo Bondronat za zdravljenje bolezenskih stanj, povezanih z rakom, so v obdobju po prihodu zdravila na trg zelo redko poročali o neželenem učinku, imenovanem osteonekroza čeljustnic (poškodba kosti v čeljusti).
NAME OF THE MEDICINAL PRODUCT Bondronat 2 mg concentrate for solution for infusion.
IME ZDRAVILA Bondronat 2 mg koncentrat za raztopino za infundiranje
Batch
Čet.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bondronat 2 mg concentrate for solution for infusion ibandronic acid
IME ZDRAVILA IN POT(I) UPORABE Bondronat 2 mg koncentrat za raztopino za infundiranje ibandronska kislina i.v.
Chest pain, influenza-like illness, malaise, pain
Splošne težave in spremembe na mestu aplikacije astenija bolečina v prsih, gripi podobna bolezen, občutek slabosti, bolečina
MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU71/96/012/004
NAME OF THE MEDICINAL PRODUCT Bondronat 6 mg concentrate for solution for infusion.
IME ZDRAVILA Bondronat 6 mg koncentrat za raztopino za infundiranje
Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Pri zdravljenju z ibandronsko kislino so poročali o vnetnih stanjih oči, kot so uveitis, episkleritis in skleritis.
Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.
Če imate težave z ledvicami, bo zdravnik morda prilagodil odmerek in čas intravenske infuzije.
A statistically significant improvement in bone pain score was shown for intravenous Bondronat 6 mg compared to placebo.
V primerjavi s placebom se je pri zdravilu Bondronat 6 mg, danim intravensko, pokazalo statistično značilno izboljšanje rezultata pri bolečini v kosteh.
Talk to your doctor, pharmacist or nurse before receiving Bondronat:
Pred začetkom uporabe zdravila Bondronat se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2 mg of ibandronic acid (as sodium monohydrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka viala vsebuje 2 mg ibandronske kisline (v obliki natrijevega monohidrata).
(dead bone tissue) in the jaw bone)
(nekroza (odmrtje kostnega tkiva) čeljustnice);
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka viala vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
Talk to a nurse or a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment:
Če opazite katere od naštetih resnih neželenih učinkov, se takoj posvetujte z medicinsko sestro ali zdravnikom - morda boste potrebovali nujno medicinsko zdravljenje: Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov):
• it is given as an infusion into your vein
• Zdravilo Bondronat boste prejeli v obliki infuzije v veno.
Do not take Bondronat if you are pregnant, planning to get pregnant or if you are breast-feeding.
Če ste noseči, poskušate zanositi ali dojite, zdravila Bondronat ne smete jemati.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega monohidrata).
EU/1/96/012/012
EU/1/96/012/011 EU/1/96/012/012 EU/1/96/012/013
The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Najbolj resni neželeni učinki so anafilaktične reakcije/šok, atipični zlomi stegnenice, osteonekroza čeljustnic, draženje prebavil in vnetje oči (glejte odstavek “Opis izbranih neželenih učinkov” in poglavje 4.4).
Rare hereditary problems
Redka dedna intoleranca
• fluid build up and swelling (‘lymphoedema')
• zastajanje tekočin in otekanje (limfni edem),
Cases of ONJ have been reported in the post marketing setting for ibandronic acid.
Pri zdravljenju z ibandronsko kislino so poročali o primerih osteonekroze čeljustnic v obdobju po prihodu zdravila na trg.
For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section
Pri bolnikih z zmerno ledvično okvaro (CLcr ≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) z rakom dojke in metastazami v kosteh je treba upoštevati naslednja priporočila za odmerjanje, da se prepreči z okostjem povezane dogodke (glejte poglavje 5.2):
Respiratory, thoracic, and mediastinal disorders
Bolezni jeter, žolčnika in žolčevodov holelitiaza
NAME OF THE MEDICINAL PRODUCT Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Navodilo za uporabo Bondronat 2 mg koncentrat za raztopino za infundiranje ibandronska kislina
Haemorrage, duodenal ulcer, gastritis, dysphagia, dry mouth
Bolezni prebavil esofagitis, bolečina v trebuhu, dispepsija, navzea krvavitev, razjeda na dvanajstniku, gastritis, disfagija, suha usta
• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints.
občutjem nelagodja, utrujenostjo, bolečino v kosteh, mišicah in sklepih.
Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Koncentrat za raztopino za infundiranje Bondronat damo v obliki intravenske infuzije.
Immune system disorders
Bolezni imunskega sistema preobčutljivost†
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta gluhota
• stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
• bolečina v želodcu in trebuhu, slaba prebava, slabost, bruhanje ali driska,
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
To so lahko znaki poškodbe ušesnih kosti; • srbenje, otekanje obraza, ustnic, jezika in žrela s težkim dihanjem.
Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Starejši bolniki (> 65 let) Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
• gallstones
• žolčni kamni,
I.V.
Sre.
Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Bondronat and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Zdravniki morajo biti pozorni na kakršne koli znake ali simptome, ki kažejo na možno ezofagalno reakcijo.
The marketing authorisation was renewed on 14 February 2002 and 14 February 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 14. februarja 2002 in 14. februarja 2007.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je prav tako del