natgillin/translations-raw huggingface dataset:
- The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate
- Pomožne snovi so natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, natrijev klorid,
dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
glicin, polisorbat 80, klorovodikova kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH) in voda za injekcije.
195 What Abseamed looks like and contents of the pack
Izgled zdravila Abseamed in vsebina pakiranja
Abseamed 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (1000 IU) of solution.
Brizga vsebuje 0, 5 ml (1. 000 i. e.) raztopine.
Abseamed 2000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (2000 IU) of solution.
Brizga vsebuje 1 ml (2. 000 i. e.) raztopine.
Abseamed 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe The syringes contain 0.3 ml (3000 IU) of solution.
Brizga vsebuje 0, 3 ml (3. 000 i. e.) raztopine.
Abseamed 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe The syringes contain 0.4 ml (4000 IU) of solution.
Brizga vsebuje 0, 4 ml (4. 000 i. e.) raztopine.
Abseamed 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe The syringes contain 0.5 ml (5000 IU) of solution.
Brizga vsebuje 0, 5 ml (5. 000 i. e.) raztopine.
Abseamed 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe The syringes contain 0.6 ml (6000 IU) of solution.
Brizga vsebuje 0, 6 ml (6. 000 i. e.) raztopine.
Abseamed 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe The syringes contain 0.7 ml (7000 IU) of solution.
Brizga vsebuje 0, 7 ml (7. 000 i. e.) raztopine.
Abseamed 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe The syringes contain 0.8 ml (8000 IU) of solution.
Brizga vsebuje 0, 8 ml (8. 000 i. e.) raztopine.
Abseamed 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe The syringes contain 0.9 ml (9000 IU) of solution.
Brizga vsebuje 0, 9 ml (9. 000 i. e.) raztopine.
Abseamed 10 000 IU/ 1 ml solution for injection in a pre-filled syringe The syringes contain 1 ml (10 000 IU) of solution.
Brizga vsebuje 1 ml (10. 000 i. e.) raztopine.
Pack size of 1 or 6 pre-filled syringe(s).
Zdravilo je pakirano s po 1 ali 6 napolnjenimi injekcijskimi brizgami.
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn Germany
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D- 58638 Iserlohn Nemčija
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
206 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Latvija Medice Arzneimittel GmbH & Co.
207 Latvija Medice Arzneimittel GmbH & Co.
197 This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo odobreno {MM/ LLLL}.
Aclasta is a solution for infusion (drip into a vein) containing the active substance zoledronic acid (5 mg/ 100 ml).
Zdravilo Aclasta je raztopina za infudiranje (kapalna infuzija v veno), ki vsebuje zdravilno učinkovino zoledronsko kislino (5 mg/ 100 ml).
Aclasta is used for the treatment of the following diseases: • osteoporosis (a disease that makes bones fragile), both in women who have been through the menopause and in men.
Zdravilo Aclasta je namenjeno za zdravljenje naslednjih bolezni: • osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi kot tudi pri moških.
It is used in patients who are at risk of fracture (bone breaks), including patients who have recently broken their hip in a minor trauma, such as a fall; • Paget’ s disease of the bone, a disease where the normal process of bone growth is changed.
Uporablja se pri bolnikih, pri katerih obstaja tveganje za zlom kosti, vključno z bolniki, ki so nedavno doživeli manjšo poškodbo z zlomom kolka (npr. zaradi padca); • Pagetove bolezni kosti, pri kateri se je spremenil normalen proces rasti kosti.
Aclasta is given as a 100 ml infusion, lasting at least 15 minutes.
Zdravilo Aclasta se daje kot 100- mililitrska infuzija, ki traja najmanj 15 minut.
This can be repeated once a year in patients being treated for osteoporosis.
Dajanje infuzije se lahko ponovi enkrat letno pri bolnikih, ki se zdravijo za osteoporozo.
Patients who have broken their hip should receive Aclasta at least two weeks after the operation to repair the fracture.
Bolniki z zlomom kolka morajo dobiti zdravilo Aclasta najmanj dva tedna po operaciji zlomljenega kolka.
For Paget’ s disease, only one infusion of Aclasta is given.
Bolniki s Pagetovo boleznijo prejmejo samo eno infuzijo zdravila Aclasta.
The effect of the infusion lasts for a year or more.
Njen učinek traja eno leto ali več.
Patients must have adequate fluids before and after treatment.
Bolniki morajo pred zdravljenjem in po njem popiti dovolj tekočine.
Adequate supplements of vitamin D and calcium are also recommended for all patients receiving Aclasta.
Za vse bolnike, ki prejemajo zdravilo Aclasta, so priporočljivi tudi ustrezni dodatki vitamina D in kalcija.
In addition, patients with Paget’ s disease should take at least 500 mg calcium twice a day for at least 10 days following treatment, and patients who have broken their hip should receive a large dose of vitamin D (50,000 to 125,000 international units) by mouth or by injection into a muscle before their first infusion.
Poleg tega morajo bolniki s Pagetovo boleznijo jemati najmanj 500 mg kalcija dvakrat dnevno, in sicer najmanj 10 dni po uporabi zdravila, medtem ko morajo bolniki z zlomom kolka pred prvim infundiranjem prejeti visok odmerek vitamina D (od 50. 000 do 125. 000 mednarodnih enot) bodisi peroralno ali z injekcijo v mišico.
Using paracetamol or ibuprofen (anti-inflammation medicines) shortly after Aclasta can reduce symptoms such as fever, muscle pain, flu-like symptoms, joint pain and headache in the three days following the infusion.
Uporaba paracetamola ali ibuprofena (protivnetnih zdravil) takoj po aplikaciji zdravila Aclasta lahko v treh dneh po infuziji zmanjša simptome, kot so povišana telesna temperatura, bolečine v mišicah, gripi podobni simptomi, bolečine v sklepih in glavobol.
Aclasta is not recommended for use in patients who have severe problems with their kidneys.
Uporaba zdravila Aclasta pri bolnikih, ki imajo hude težave z ledvicami, ni priporočljiva.
In the treatment of Paget’ s disease of the bone, Aclasta must only be used by a doctor who has experience in the treatment of the disease.
Pri zdravljenju Pagetove bolezni kosti lahko zdravilo Aclasta predpiše le zdravnik, ki ima izkušnje z zdravljenjem te bolezni.
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Do osteoporoze pride, ko se ne tvori več dovolj nove kostne mase, ki bi nadomestila naravno razgradnjo kostnega tkiva.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Pri ženskah je osteoporoza pogostejša po menopavzi, ko se raven ženskega hormona estrogena zniža.
In Paget’ s disease the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Pri Pagetovi bolezni poteka razgradnja kosti hitreje, ko pa kostno tkivo ponovno zraste, je šibkejše od normalnega kostnega tkiva.
This leads to less bone loss in osteoporosis and less disease activity in Paget’ s disease.
To zmanjša izgubo kostne mase pri osteoporozi in bolezensko aktivnost pri Pagetovi bolezni.
Because the active substance in Aclasta is the same as the active substance in Zometa, some of the data presented for Zometa were taken into account when assessing Aclasta.
Ker je zdravilna učinkovina zdravila Aclasta enaka zdravilni učinkovini zdravila Zometa, so bili pri vrednotenju zdravila Aclasta upoštevani nekateri podatki, ki so bili predloženi za zdravilo Zometa.
For the treatment of osteoporosis, the effects of Aclasta given once a year have been compared with those of placebo (a dummy treatment) in two main studies.
V dveh glavnih študijah zdravljenja osteoporoze so učinke zdravila Aclasta, dajanega enkrat na leto, primerjali z učinki placeba (zdravila brez zdravilne učinkovine).
The first involved almost 8,000 elderly women with osteoporosis, looking at the number of spine and hip fractures over three years.
Prva študija, ki je vključevala skoraj 8. 000 starejših žensk z osteoporozo, je preučevala število zlomov hrbtenice in kolka v obdobju treh let.
The second involved 2,127 men and women with osteoporosis who were aged over 50 years and had recently broken their hip, and looked at the number of fractures over up to five years.
Druga študija je vključevala 2. 127 moških in žensk z osteoporozo, starejših od 50 let, ki so si nedavno zlomili kolk, preučevala pa je število zlomov v obdobju do pet let.
In both studies, the patients were allowed to take other medicines for osteoporosis, but not other bisphosphonates.
V obeh študijah so bolnikom dovolili uporabljati tudi druga zdravila za zdravljenje osteoporoze, vendar ne drugih difosfonatov.
In Paget’ s disease, Aclasta has been studied in a total of 357 patients in two studies, where it was compared with risedronate (another bisphosphonate) over six months.
Pri Pagetovi bolezni so zdravilo Aclasta preučevali v dveh študijah pri skupno 357 bolnikih, pri čemer so ga v obdobju šest mesecev primerjali z rizedronatom (drugim difosfonatom).
The patients received one infusion of Aclasta or they received risedronate once a day for two months.
Bolniki so prejeli bodisi eno infuzijo zdravila Aclasta ali pa so enkrat dnevno prejemali rizedronat v obdobju dveh mesecev.
The main measure of effectiveness was whether blood levels of serum alkaline phosphatase (an enzyme involved in the breakdown of bone) returned to normal or fell by at least 75% of the way back to normal levels.
Glavno merilo učinkovitosti je bilo, ali se je koncentracija serumske alkalne fosfataze v krvi (encima, ki sodeluje pri razgradnji kostnega tkiva) vrnila na normalno vrednost ali se znižala za najmanj 75% presežka glede na normalno raven.
In osteoporosis, Aclasta was more effective than placebo at reducing the number of fractures.
Pri zdravljenju osteoporoze je bilo zdravilo Aclasta pri zniževanju števila zlomov učinkovitejše od placeba.
In the study of elderly women, the risk of spine fractures was reduced by 70% in patients taking Aclasta (without any other medicines for osteoporosis) over three years, compared with those taking placebo.
V študiji s starejšimi bolnicami se je pri bolnicah, ki so prejemale zdravilo Aclasta (brez dodajanja drugih zdravil za zdravljenje osteoporoze), tveganje za zlom hrbtenice v obdobju treh let zmanjšalo za 70% v primerjavi z bolnicami, ki so prejemale placebo.
There was a 41% risk reduction in hip fractures, when comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking placebo.
Pri primerjavi rezultatov za vse ženske, ki so prejemale zdravilo Aclasta (z dodajanjem drugih zdravil za zdravljenje osteoporoze ali brez njih), z rezultati za ženske, ki so prejemale placebo, se je tveganje za zlome kolkov zmanjšalo za 41%.
In the study of men and women who had broken their hip, 9% of the patients receiving Aclasta had a fracture (92 out of 1,065), compared with 13% of the patients receiving placebo (139 out of 1,062).
V študiji, v kateri so sodelovali moški in ženske z zlomom kolka, je do zloma prišlo pri 9% bolnikov (pri 92 od skupno 1. 065), ki so prejemali zdravilo Aclasta, v primerjavi s 13% bolnikov, ki so prejemali placebo (pri 139 od skupno 1062).
This represents a 35% reduction in the risk of fracture in patients receiving Aclasta.
To predstavlja 35- odstotno zmanjšanje tveganja za zlome pri bolnikih, ki so prejemali zdravilo Aclasta.
In Paget’ s disease, Aclasta was more effective than risedronate.
Pri Pagetovi bolezni je bilo zdravilo Aclasta učinkovitejše od rizedronata.
After six months, the proportion of patients who had responded to treatment was 95% in one study and 97% in the other, compared with 75% and 73% of the patients who received risedronate.
Po šestih mesecih je bil delež bolnikov, ki so se odzvali na zdravljenje, v prvi študiji 95%, v drugi pa 97%, v primerjavi s 75% in 73% pri bolnikih, ki so prejemali rizedronat.
Most side effects with Aclasta tend to occur within the first three days after infusion, becoming less common with repeated infusions.
Večina neželenih učinkov zdravila Aclasta se pojavi v prvih treh dneh po infuziji, vendar pa s ponavljanjem infuzij postajajo čedalje manj pogosti.
The most common side effect with Aclasta (seen in more than 1 patient in 10) is fever.
Najpogostejši neželeni učinek zdravila Aclasta (opažen pri več kot 1 izmed 10 bolnikov) je povišana telesna temperatura.
For the full list of all side effects reported with Aclasta, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aclasta, glejte navodilo za uporabo.
Aclasta should not be used in people who may be hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients.
Zdravila Aclasta ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zoledronsko kislino, druge difosfonate ali katero koli drugo sestavino zdravila.
Aclasta should not be used in patients with hypocalcaemia (low blood calcium levels) or in pregnant or breast-feeding women.
Zdravila Aclasta ne smejo uporabljati bolniki s hipokalcemijo (nizkimi ravnmi kalcija v krvi) ali nosečnice ali doječe matere.
As with all bisphosphonates, patients taking Aclasta may also be at risk of kidney problems, reactions at the site of infusion and osteonecrosis (death of bone tissue) in the jaw.
Tako kot pri uporabi vseh difosfonatov obstaja tudi pri bolnikih, ki jemljejo zdravilo Aclasta, tveganje za težave z ledvicami, reakcije na mestu infundiranja in osteonekrozo (odmiranje kostnega tkiva) čeljusti.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aclasta’ s benefits are greater than its risks for the treatment of osteoporosis in post-menopausal women and in men, at increased risk of fracture including those with a recent low-trauma hip fracture, and of Paget’ s disease of the bone.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Aclasta pri zdravljenju osteoporoze pri ženskah po menopavzi in moških, pri katerih obstaja povečano tveganje za zlome, vključno z bolniki z nedavno manjšo poškodbo z zlomom kolka, ter Pagetove bolezni kosti, večje od z njim povezanih tveganj.
The Committee recommended that Aclasta be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Aclasta odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Aclasta?
2/ 3 Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Aclasta?
The company that makes Aclasta will provide educational packs for doctors who prescribe Aclasta for osteoporosis, reminding them how the medicine should be used, and similar packs for patients, which explain the medicine’ s side effects and when they should contact their doctor.
Družba, ki izdeluje zdravilo Aclasta, bo pripravila informativne brošure za zdravnike, ki predpisujejo zdravilo Aclasta za osteoporozo, v katerih bo opisan predvideni način uporabe zdravila, ter podobne brošure za bolnike, v katerih bodo razloženi neželeni učinki zdravila in primeri, ko morajo obvestiti zdravnika.
The European Commission granted a marketing authorisation valid throughout the European Union for Aclasta to Novartis Europharm Limited on 15 April 2005.
Evropska komisija je dovoljenje za promet z zdravilom Aclasta, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 15. aprila 2005.
2/ 3 The full EPAR for Aclasta is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aclasta je na voljo tukaj.
This summary was last updated in 09-2008.
Povzetek je bil nazadnje posodobljen 09- 2008.
bottle (plastic)
steklenica (plastična)
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO VZPOSTAVITI DRŽAVE ČLANICE • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO VZPOSTAVITI DRŽAVE ČLANICE
The Member States shall ensure that the educational programme implemented for the authorised indication of treatment of post-menopausal osteoporosis, is extended to the potential prescribers concerned by the new indication: treatment of osteoporosis in post-menopausal women and men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Država članica mora zagotoviti, da bo izobraževalni program, ki ga je izvajala za odobreno indikacijo zdravljenja postmenopavzalne osteoporoze, razširila na zdravnike, ki bi zdravilo lahko predpisovali v okviru nove indikacije: zdravljenje osteoporoze pri postmenopavzalnih ženskah in moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi.
The physician educational material should contain the following key elements: • The Summary of Product Characteristics • Reminder card with the following key messages: o Need to measure serum creatinine before treatment with Aclasta o Recommendation not to use Aclasta in patients with creatinine clearance < 35 ml/ min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient o Need to infuse Aclasta slowly over a period of no less than 15 minutes o One-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration. o Need for appropriate physical activity, non-smoking and healthy diet • Patient information pack
Izobraževalni material za zdravnika mora vsebovati naslednje ključne sestavine: • Povzetek glavnih značilnosti zdravila; • Opomnik z naslednjimi ključnimi sporočili: o potrebnost meritve kreatinina v serumu pred zdravljenjem z zdravilom Aclasta, o priporočilo, da se zdravila Aclasta ne sme uporabljati pri bolnikih z očistkom kreatinina < 35 ml/ min, o kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti, o potrebo po zagotovitvi primerne hidriranosti bolnika, o potrebnost počasnega infundiranja zdravila Aclasta v času, ki ni krajši od 15 minut, o shemo odmerjanja enkrat letno, o priporočilo o zadostnem vnosu kalcija in vitamina D v zvezi z uporabo zdravila Aclasta, o potrebnost ustrezne telesne dejavnosti in zdrave prehrane ter odsotnosti kajenja; • Komplet podatkov o zdravilu za bolnika.
The patient information pack should be provided and contain the following key messages: • Package leaflet • Contraindication in pregnancy and in breast-feeding women • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non- smoking and healthy diet • Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
Pripraviti je treba Komplet podatkov o zdravilu za bolnika, ki mora vsebovati naslednja ključna sporočila: • Navodilo za uporabo, • kontraindikacije med nosečnostjo in dojenjem, • potrebnost zadostnega nadomeščanja kalcija in vitamina D, ustrezne telesne dejavnosti in zdrave prehrane ter odsotnosti kajenja, • ključne znake in simptome resnih neželenih dogodkov, • navodila o tem, kdaj je treba poiskati zdravniško pomoč.
Each bottle with 100 ml of solution contains 5 mg zoledronic acid anhydrous, corresponding to 5.330 mg zoledronic acid monohydrate.
Vsaka steklenica s 100 ml raztopine vsebuje 5 mg brezvodne zoledronske kisline, kar ustreza 5, 330 mg zoledronske kisline monohidrata.
One ml solution contains 0.05 mg zoledronic acid anhydrous, corresponding to 0.0533 mg zoledronic acid monohydrate.
En ml raztopine vsebuje 0, 05 mg brezvodne zoledronske kisline, kar ustreza 0, 0533 mg zoledronske kisline monohidrata.
Treatment of osteoporosis • in post-menopausal women • in men at increased risk of fracture, including those with a recent low-trauma hip fracture.
- pri moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po
Treatment of Paget’ s disease of the bone.
Zdravljenje Pagetove bolezni kosti.
For the treatment of post-menopausal osteoporosis and osteoporosis in men, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.
Za zdravljenje postmenopavzalne osteoporoze in osteoporoze pri moških je priporočeni odmerek ena intravenska infuzija s 5 mg zdravila Aclasta enkrat na leto.
In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair (see section 5.1).
Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je pripročeno dati infuzijo zdravila Aclasta dva ali več tednov po zacelitvi zloma kolka (glejte poglavje 5. 1).
For the treatment of Paget’ s disease, Aclasta should be prescribed only by physicians with experience in treatment of Paget’ s disease of the bone.
Za zdravljenje Pagetove bolezni smejo zdravilo Aclasta predpisovati samo zdravniki, ki imajo izkušnje z zdravljenjem Pagetove bolezni kosti.
Retreatment of Paget’ s disease: specific retreatment data are not available.
Ponovno zdravljenje Pagetove bolezni: specifičnih podatkov o ponovnem zdravljenju ni na voljo.
After a single treatment with Aclasta in Paget’ s disease, an extended remission period is observed in responding patients (see section 5.1).
Po enkratnem zdravljenju Pagetove bolezni z zdravilom Aclasta opažajo pri bolnikih, ki se odzovejo na zdravljenje, obdobje dolgotrajne remisije (glejte poglavje 5. 1).
Aclasta (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate.
Zdravilo Aclasta (5 mg v 100 ml raztopine, pripravljene za infuzijo) se aplicira prek infuzijskega sistema s prezračevanjem in sicer s stalno hitrostjo infundiranja.
For information on the infusion of Aclasta, see section 6.6.
Za informacije o infundiranju zdravila Aclasta glejte poglavje 6. 6.
2 Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
2 Skupaj z dajanjem zdravila Aclasta priporočajo zadostno uživanje kalcija in vitamina D.
In addition, in patients with Paget’ s disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.4).
Poleg tega je zelo priporočeno, da bolnikom s Pagetovo boleznijo zagotovimo zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, dvakrat na dan vsaj 10 dni po uporabi zdravila Aclasta (glejte poglavje 4. 4).
In patients with a recent low-trauma hip fracture, a loading dose of 50,000 to 125,000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.
Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je pred prvo infuzijo zdravila Aclasta priporočen večji začetni odmerek vitamina D 50. 000 do 125. 000 i. e. peroralno ali intramuskularno.
Patients with renal impairment (see section 4.4) Use of Aclasta in patients with creatinine clearance < 35 ml/ min is not recommended due to limited clinical experience in this population.
Bolniki z ledvično okvaro (glejte poglavje 4. 4) Uporabe zdravila Aclasta pri bolnikih z očistkom kreatinina < 35 ml/ min ne priporočajo zaradi omejenega obsega kliničnih izkušenj pri tej skupini bolnikov.
No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/ min.
Za bolnike z očistkom kreatinina ≥ 35 ml/ min ni potrebno prilagajanje odmerjanja.
Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Bolniki z jetrno okvaro Prilagajanje odmerjanja ni potrebno (glejte poglavje 5. 2).