natgillin/translations-raw huggingface dataset:
The median time to relapse (re-increase of serum albumin-corrected serum calcium above 3 mmol/l) was 1819 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.
Pyrexia, influenza-like illness**, oedema peripheral, asthenia, thirst
Splošne težave in spremembe na mestu aplikacije pireksija, gripi podobna bolezen**, periferni edem, astenija, žeja hipotermija
The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics.
Zmanjšanje bolečine je bilo skozi vso raziskavo pod vrednostjo pred začetkom zdravljenja v primerjavi s placebom, sočasno pa je bila značilno zmanjšana tudi uporaba analgezije.
How to take Iasibon
Kako jemati zdravilo Iasibon
Do not receive Iasibon
Ne jemljite zdravila Iasibon:
WHO performance score *
status učinka po SZO*
The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/l) was 1819 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 pri 2 mg in 4 mg odmerkih.
• if you have any swallowing or digestion problems
• če imate težave s požiranjem ali prebavne težave;
Therefore, with such products, including food, intake must be delayed at least 30 minutes following oral administration.
Zato po peroralnem jemanju zdravila najmanj 30 minut takih pripravkov ali hrane ne smemo zaužiti.
• The other ingredients are sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections.
• Pomožne snovi so natrijev klorid, koncentrirana ocetna kislina, natrijev acetat trihidrat in voda za injekcije.
Iasibon contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Zdravilo Iasibon vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
Sodium chloride Acetic acid, glacial Sodium acetate trihydrate Water for injections
Natrijev klorid Koncentrirana ocetna kislina Natrijev acetat trihidrat Voda za injekcije
Iasibon 6 mg is supplied as packs containing 1,5,10 vials (9 ml type I glass vial with a bromobutyl rubber stopper).
Zdravilo Iasibon 6 mg je na voljo v škatlah, v katerih je 1, 5 ali 10 vial (9 ml viala iz stekla tipa I zamaškom iz bromobutilne gume).
Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki
Dervenakion 6 153 51 Pallini, Attiki
Osteonecrosis of jaw†**, osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)
osteonekroza zunanjega slušnega kanala (neželeni učinek skupine bisfosfonatov)
Mutagenicity/Carcinogenicity:
Mutagenost in kancerogeni potencial
Albumin-corrected serum calcium (mmol/l) = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 or Albumin-corrected serum calcium (mg/dl) =serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
korigirani kalcij v serumu (mmol/l) = koncentracija kalcija v serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8
INFORMATION IN BRAILLE Iasibon 50 mg
PODATKI V BRAILLOVI PISAVI Iasibon 50 mg
Talk to your doctor first if you want to drive, use machine or tools.
Če želite voziti ali upravljati orodja ali stroje, se prej posvetujte z zdravnikom.
Neoplasms benign, malignant, and unspecified
Benigne, maligne in neopredeljene novotvorbe benigna kožna neoplazma
Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate)
Vsaka filmsko obložena tableta vsebuje 50 mg ibandronske kisline (v obliki natrijevega monohidrata).
If you have a raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 2 ampoules (2 mg) or 4 ampoules (4 mg), depending on the severity of your illness.
Če imate zaradi tumorja povečano koncentracijo kalcija v krvi, je priporočeni odmerek enkratna uporaba 2 ampul (2 mg) ali 4 ampul (4 mg), odvisno od stopnje resnosti vaše bolezni.
Hypophosphatae mia
hipofosfatem ija
A statistically significant improvement in bone pain score was shown for Ibandronate 50 mg compared to placebo.
V primerjavi s placebom se je pri ibandronski kislini (50 mg) pokazalo statistično značilno izboljšanje rezultata pri bolečinah v kosteh.
INFORMATION IN BRAILLE Iasibon 1 mg
PODATKI V BRAILLOVI PISAVI Iasibon 1 mg
• 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 kosteh dodamo k 100 ml izotonične raztopine natrijevega klorida ali k 100 ml 5-% raztopine glukoze in infundiramo vsaj 15 minut.
• problems with your parathyroid gland
• težave z obščitnično žlezo,
Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Peroralno uporabljeni difosfonati lahko povzročijo lokalno draženje sluznice zgornjega dela prebavne cevi.
You can drive and use machines as it's expected that Iasibon affectshas no or negligible effect on your ability to drive and use machines.
Lahko vozite in upravljate s stroji, saj pričakujemo, da zdravilo Iasibon ne vpliva ali ima zanemarljiv vpliv na sposobnost vaše vožnje ali upravljanja s stroji..
Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis
bolezen zob gastroenteritis, gastritis, ulceracija ust, disfagija, heilitis
The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Inhibicijo endogene resorpcije kosti so dokazali tudi s kinetičnimi raziskavami
For patients with breast cancer and bone metastases, Iasibon infusion should be administered every 3-4 weeks.
Bolniki z rakom dojke in metastazami v kosteh morajo prejeti infuzijo zdravila Iasibon vsake 3 do 4
Table 1 lists adverse drug reactions from the pivotal phase III studies (Treatment of tumour induced hypercalcaemia: 311 patients treated with ibandronic acid 2 mg or 4 mg; Prevention of skeletal events in patients with breast cancer and bone metastases: 152 patients treated with ibandronic acid 6 mg), and from post-marketing experience.
2 mg ali 4 mg; preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh: 152 bolnikov se je zdravilo z zdravilom ibandronsko kislino 6 mg) in iz obdobja po prihodu zdravila na trg.
• Keep this medicine out of the sightand reachof children.
• Zdravilo shranjujte nedosegljivo otrokom!.
- Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1.
4.3 Kontraindikacije - Preobčutljivost na ibandronsko kislino ali katerokoli pomožno snov, navedeno v poglavju 6.1.. - Hipokalciemija.
INFORMATION IN BRAILLE Iasibon 6 mg
PODATKI V BRAILLOVI PISAVI Iasibon 6 mg
• aching joints, arthritis, or other joint problems
• otekanje nog in stopal, • bolečine v sklepih, artritis ali druge težave s sklepi,
• 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.
It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Iasibon').
Priporočamo, da se razredčen pripravek uporabi takoj (glejte poglavje 5.
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 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) z rakom dojke in metastazami v kosteh, ki se zdravijo zaradi preprečevanja z okostjem povezanih dogodkov, se priporoča prilagoditev odmerka (glejte poglavje 4.2).
MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/005
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/659/005
Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.
Če imate težave z ledvicami, vam bo morda vaš zdravnik prilagodil odmerek in trajanje intravenske infuzije.
Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06
Oznaka ATC: M05BA06
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or
Pri večini bolnikov s hudo hiperkalciemijo (korigirani kalcij v serumu * ≥ 3 mmol/l ali ≥ 12 mg/dl)
Not known anaphylactic reaction/shock†
anafilaktična reakcija/šok†*
Othermedicines and Iasibon
Shranjevanje zdravila Iasibon
There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Za bolnike z jetrno okvaro za ibandronsko kislino ni farmakokinetičnih podatkov.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/659/004
INFORMATION IN BRAILLE Iasibon 2 mg
PODATKI V BRAILLOVI PISAVI Iasibon 2 mg
≥12 mg/dl) 4 mg is an adequate single dosage.
< 3 mmol/l ali < 12 mg/dl) je učinkovit odmerek 2 mg.
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).
• mouth ulcers, swollen lips (‘cheilitis'), oral thrush
• težko požiranje, • ustne razjede, otekle ustnice (heilitis), ustni oprh,
Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
Pri bolnikih zdravljenih z ibandronsko kislino, dano intravensko, so poročali o primerih resnih, včasih smrtnih, alergijskih reakcij.
Therefore dosage adjustment is not necessary in patients with hepatic impairment.
Za bolnike z jetrno okvaro prilagajanje odmerkov ni potrebno.
• 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).
• changes in your blood cells (‘anaemia')
• spremembe v številu krvnih celic (anemija), • visoka koncentracija alkalne fosfataze v krvi,
Adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
V nekaterih primerih so bili neželeni dogodki hudi in so zahtevali hospitalizacijo, redko pa so bili povezani s krvavitvijo ali spremljajočo zožitvijo ali perforacijo ezofagusa.
Prevention of skeletal events in patients with breast cancer and bone metastases with Ibandronate 6 mg administered intravenously was assessed in one randomized placebo controlled phase III trial with a duration of 96 weeks.
Preprečevanje z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh z ibandronsko kislino (6 mg), dano intravensko, so raziskovali v randomiziranem s placebom kontroliranem preskušanju faze III, ki je potekala 96 tednov.
As no clinical data are available, dose recommendations cannot be given for patients with severe hepatic insufficiency (see section 4.2).
Ker za bolnike s težko insuficienco jeter klinični podatki niso na voljo, za to skupino bolnikov ne moremo dati priporočil o odmerjanju.
Prescribers should consult the section Patients with Renal Impairment (see section 4.2) for recommendations on dosing and administration in this patient group.
Pri tej skupini bolnikov morajo predpisovalci upoštevati navodila za odmerjanje in način uporabe iz poglavja Bolniki z ledvično okvaro (glejte poglavje 4.2).
MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/659/003
There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with Ibandronate that was statistically significant compared to placebo.
V primerjavi s placebom se je pri bolnikih, zdravljenih z ibandronsko kislino, v urinu pojavilo statistično značilno izrazito zmanjšanje označevalcev kostne resorpcije (piridinolina in deoksipiridinolina).
Calcium containing solutions should not be mixed with Iasibon concentrate for solution for infusion.
Koncentrata za raztopino za infundiranje Iasibon ne smemo mešati z drugimi raztopinami, ki vsebujejo kalcij.
NAME OF THE MEDICINAL PRODUCT Iasibon 50 mg film-coated tablets ibandronic acid
Navodilo za uporabo Iasibon 50 mg filmsko obložene tablete ibandronska kislina
Sleep disorder, anxiety, affection lability
Psihiatrične motnje motnje spanca, anksioznost,
- Hypocalcaemia - Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes
- Nepravilnosti ezofagusa, ki upočasnjujejo praznjenje, kot sta zožitev ali ahalazija ezofagusa.
Myocardial ischaemia, cardiovascular disorder, palpitations
Srčne bolezni kračni blok srčnomišična ishemija, kardiovaskular na bolezen, palpitacije
− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − Hypocalcaemia
- Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1
NAME OF THE MEDICINAL PRODUCT Iasibon 6 mg concentrate for solution for infusion
IME ZDRAVILA Iasibon 6 mg koncentrat za raztopino za infundiranje
Sodium chloride
Očistek kreatinina
Infection Cystitis, vaginitis, oral candidiasis
Infekcijske in parazitske bolezni okužba cistitis, vaginitis, kandidoza v ustih
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Pri bolnikih s sočasnimi dejavniki tveganja (npr. rak, kemoterapija, radioterapija, kortikosteroidi, slaba ustna higiena) je treba pred začetkom zdravljenja z difosfonati razmisliti o pregledu zobovja in primernih preventivnih zobozdravstvenih posegih.
Talk to your doctor, pharmacist or nurse before receiving Iasibon:
Pred začetkom uporabe zdravila Iasibon se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
In patients with moderate hypercalcaemia (albumincorrected 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.
No evidence of direct foetal toxicity or teratogenic effects were observed for ibandronic acid in intravenously treated rats and rabbits.
Po intravenskem zdravljenju z ibandronsko kislino pri podganah in kuncih niso opazili neposrednih škodljivih vplivov na plod ali teratogenih učinkov.
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:
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:
METHOD AND ROUTE(S) OF ADMINISTRATION Do not suck, chew or crush tablets Read the package leaflet before use Oral use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Sekundarni rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti)
Ocular inflammation Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Vnetje oči Pri zdravljenju z ibandronsko kislino so poročali o vnetnih stanjih oči, kot so uveitis, episkleritis in skleritis.
How to store Iasibon.
Shranjevanje zdravila Iasibon).
NAME OF THE MEDICINAL PRODUCT Iasibon 2 mg concentrate for solution for infusion
IME ZDRAVILA Iasibon 2 mg koncentrat za raztopino za infundiranje
Uncommon Rare
Redka dedna intoleranca
Frequency categories are defined using the following convention: very common (>1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare
Neželeni učinki so navedeni po organskih sistemih in pogostnosti po MedDRA. Glede na pogostnost so neželeni učinki opredeljeni kot zelo pogosti (≥1/10), pogosti (≥ 1/100 do < 1/10), občasni
Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate.
morajo bolniki prejeti dodatke kalcija ali vitamina D ali oboje.
Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Pri bolnikih z rakom, ki so prejemali zdravljenje, ki je prvenstveno vključevalo difosfonate, dane intravensko, so poročali o osteonekrozi čeljustnic, po navadi povezani z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
Medicinal product -Food Interactions
PROMET Z ZDRAVILOM
Iasibon works by reducing the amount of calcium that is lost from your bones.
Zdravilo Iasibon zavira izločanje kalcija iz kosti.
Skin and subcutaneous tissue disorders
Ni znano kože in podkožja
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Bolniki z motnjo kosti in presnovo mineralov
In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dosage.
Pri večini bolnikov s hudo hiperkalciemijo (korigirani kalcij v serumu* ≥ 3 mmol/l ali ≥ 12 mg/dl) zadošča enkratni odmerek 4 mg.
Marketing Authorisation Holder Pharmathen S.A.
Imetnik dovoljenja za promet z zdravilom Pharmathen S.A.
(dead bone tissue) in the jaw bone).
(nekroza (odmrtje kostnega tkiva) čeljustnice);
Pruritus
Odmerek
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Pri bolnikih, zdravljenih z intravensko ibandronsko kislino, so poročali o primerih anafilaktične reakcije/šoku, vključno z dogodki s smrtnim izidom.
The number of SREs was also significantly reduced with Ibandronate 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
SRE pa 40 % manjše (relativno tveganje 0,6, p = 0,003) v primerjavi s placebom.
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 5.2):
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):
NAME OF THE MEDICINAL PRODUCT Iasibon 1 mg concentrate for solution for infusion
IME ZDRAVILA Iasibon 1 mg koncentrat za raztopino za infundiranje
Endocrine disorders
Bolezni endokrinega sistema okvara ščitnice
Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Osteonekroza čeljustnic Pri bolnikih, zdravljenih z difosfonati, so poročali o osteonekrozi čeljustnic.
<50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) se priporoča prilagajanje odmerkov
One ampoule with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Ena ampula z 2 ml koncentrata za raztopino za infundiranje vsebuje 2 mg ibandronske kisline (v obliki natrijevega monohidrata).
Anaemia, blood dyscrasia
Bolezni krvi in limfatičnega sistema anemija, diskrazija krvi
One ampoule with 1 ml of a concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate)
Ena ampula z 1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg ibandronske kisline (v obliki natrijevega monohidrata).
The following information is intended for healthcare professionals only Dose: 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.
Naslednje informacije so namenjene samo zdravstvenemu osebju Odmerjanje: preprečevanje dogodkov, povezanih z okostjem pri bolnikih z rakom dojke in metastazami v kosteh
Ear and labyrinth disorders
vključno z motnjami labirinta gluhota
Iasibon concentrate for solution for infusion should be administered as an intravenous infusion.
Koncentrat za raztopino za infundiranje Iasibon damo kot intravensko infuzijo.
NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Pharmathen S.A.
Iasibon 6 mg concentrate for solution for infusion ibandronic acid
Iasibon 6 mg koncentrat za raztopino za infundiranje ibandronska kislina
Iasibon 2 mg concentrate for solution for infusion ibandronic acid
Iasibon 2 mg koncentrat za raztopino za infundiranje ibandronska kislina
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 6 mg concentrate for solution for infusion ibandronic acid
IME ZDRAVILA IN POT(I) UPORABE Iasibon 6 mg koncentrat za raztopino za infundiranje ibandronska kislina i.v.
Iasibon 1 mg is supplied as pack containing 1 ampoule (2 ml type I glass ampoule).
Zdravilo Iasibon 1 mg je na voljo v škatlah, v katerih je 1 ampula (2 ml ampula iz stekla tipa I).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister foil
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
A.
Sre.
This medicinal product does not require any special storage conditions prior to reconstitution.After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca Po razredčitvi je infuzijska raztopina stabilna 24 ur pri temperaturi med 2 °C in 8 °C
Iasibon 1 mg concentrate for solution for infusion ibandronic acid
Iasibon 1 mg koncentrat za raztopino za infundiranje ibandronska kislina
Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder
Bolezni prebavil diareja, bruhanje, dispepsija, gastrointestina lna bolečina,
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 2 mg concentrate for solution for infusion ibandronic acid
IME ZDRAVILA IN POT(I) UPORABE Iasibon 2 mg koncentrat za raztopino za infundiranje ibandronska kislina i.v.
Iasibon 2mg is supplied as pack containing 1 ampoule (4 ml type I glass ampoule).
Zdravilo Iasibon 2 mg je na voljo v škatlah, v katerih je 1 ampula (4 ml ampula iz stekla tipa I).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Iasibon 1 mg concentrate for solution for infusion ibandronic acid
IME ZDRAVILA IN POT(I) UPORABE Iasibon 1 mg koncentrat za raztopino za infundiranje ibandronska kislina i.v.
One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Ena viala z 6 ml koncentrata za raztopino za infundiranje vsebuje 6 mg ibandronske kisline (v obliki natrijevega monohidrata).
Ocular inflammat ion†**
anafilaktična reakcija/šok†**
Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Rezultati učinkovitosti (bolniki z rakom dojke z metastatično boleznijo kosti)
A statistically significant improvement in bone pain score was shown for intravenous Ibandronate 6 mg compared to placebo.
V primerjavi s placebom se je pri ibandronski kislini (6 mg), dani intravensko, pokazalo statistično značilno izboljšanje rezultata pri bolečini v kosteh.