natgillin/translations-raw huggingface dataset:
Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Neželene učinke so analizirali v 2 kliničnih s placebom kontroliranih študijah teduglutida pri 109 bolnikih s SKČ, ki so bili zdravljeni z odmerki 0,05 mg/kg/dan in 0,10/mg/kg/dan do 24 tednov.
Reconstituted product Chemical and physical in-use stablility has been demonstrated for 24 hours up to 25°C.
Rekonstituirano zdravilo Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 24 ur pri do 25 °C.
Colorectal polyp Colonic stenosis Flatulence Intestinal obstruction Pancreatic duct stenosis Pancreatitis Small intestinal stenosis
Bolezni prebavil napetost trebuha bolečine v trebuhu navzea bruhanje kolorektalni polip stenoza debelega črevesa vetrovi zapora črevesa stenoza izvodila trebušne slinavke vnetje trebušne slinavke stenoza tankega črevesa polip dvanajstnika polip želodca
If polyps are found before your treatment with Revestive, your doctor will decide whether you should use this medicine.
Če najdejo polipe, preden se začnete zdraviti z zdravilom Revestive, bo vaš zdravnik odločil, ali boste zdravilo začeli jemati.
Revestive comes in pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Zdravilo Revestive je na voljo v velikostih pakiranja po 1 vialo praška z 1 napolnjeno injekcijsko brizgo ali 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
The doctor will perform further colonoscopies if your child continues treatment with Revestive.
Če bo vaš otrok nadaljeval zdravljenje z zdravilom Revestive, bo zdravnik delal nadaljnje kolonoskopije.
If you inject more Revestive than you are told to by your child's doctor, you should contact the doctor, pharmacist or nurse.
Če ste otroku injicirali več zdravila Revestive, kot vam je naročil zdravnik, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Cases of intestinal obstruction have been reported in clinical studies.
V kliničnih študijah so poročali o primerih zapore črevesa.
There were no clinically relevant mean increases of C-reactive protein from baseline following long-term treatment with teduglutide for up to 30 months.
Po dolgotrajnem zdravljenju s teduglutidom do največ 30 mesecev niso opazili nobenega klinično relevantnega povprečnega zvišanja koncentracije C-reaktivnega proteina glede na izhodiščno raven.
No dose adjustment is necessary for paediatric patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B adult subjects.
Pri pediatričnih bolnikih z blago ali zmerno okvaro jeter na osnovi študije, izvedene na odraslih preiskovancih z jetrno okvaro stopnje B po lestvici Child-Pugh, prilagajanje odmerka ni potrebno.
No accumulation of teduglutide was observed following repeated subcutaneous administrations.
Ob ponovljenem vnosu v podkožje niso zabeležili akumulacije teduglutida.
Common (may affect up to 1 in 10 people): - Flu (influenza) or flu-like symptoms - Decreased appetite - Swelling of hands and/or feet - Problems sleeping, anxiety - Cough, shortness of breath - Polyps (small abnormal growths) in your large bowel - Passing gas (flatulence) - Narrowing or blockage of your pancreatic duct, which may cause inflammation of the pancreas - Inflammation of the gallbladder
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): - gripa (influenca) ali gripi podobni simptomi, - zmanjšan apetit, - otekanje rok in/ali nog, - nespečnost, tesnoba, - kašelj, kratka sapa, - polipi (majhne nenormalne tvorbe) v debelem črevesu, - vetrovi (flatulenca), - zožitev ali zapora izvodila trebušne slinavke, ki lahko povzroči vnetje trebušne slinavke, - vnetje trebušne slinavke.
No dose adjustment is necessary for paediatric patients with mild renal impairment.
Pri pediatričnih bolnikih z blago ledvično okvaro odmerka ni treba prilagajati.
- The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
- Druge sestavine zdravila so L-histidin, manitol, natrijev fosfat monohidrat, natrijev hidrogenfosfat heptahidrat.
One vial of powder contains 5 mg of teduglutide.
Ena viala praška vsebuje 5 mg teduglutida.
- Read the Package Leaflet before using Revestive.
- Pred uporabo zdravila Revestive preberite navodilo za uporabo.
Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Prašek: L-histidin, manitol, natrijev fosfat monohidrat, natrijev hidrogenfosfat heptahidrat.
If you have any further questions on the use of this medicine, ask your child's doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z otrokovim zdravnikom, farmacevtom ali medicinsko sestro.
Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Prašek: L-histidin, manitol, natrijev fosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid (uravnavanje pH), klorovodikova kislina (uravnavanje pH).
- Dispose of all needles and syringes in a sharps disposal container.
- Vse igle in injekcijske brizge zavrzite v vsebnik za ostre predmete.
Cough Dyspnoea
Zapora črevesa
If your child gets any side effects, talk to your child's doctor or pharmacist.
Če otrok opazi katerega koli izmed neželenih učinkov, se posvetujte z otrokovim zdravnikom ali farmacevtom.
- The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
- Druge sestavine zdravila so L-histidin, manitol, natrijev fosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid (uravnavanje pH), klorovodikova kislina (uravnavanje pH).
- If the child gets any side effects, talk to your child's doctor, pharmacist or nurse.
- Če pri otroku opazite kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom, farmacevtom ali medicinsko sestro.
- If you have any further questions, ask your child's doctor, pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z otrokovim zdravnikom, farmacevtom ali medicinsko sestro.
The recommended dose of Revestive in children and adolescents (aged 1 to 17 years) is 0.05 mg/kg body weight once daily.
Priporočeni odmerek zdravila Revestive za otroke in mladostnike (stare od 1 do 17 let) je 0,05 mg/kg telesne mase enkrat na dan. Injicirani volumen na telesno maso pri uporabi viale z jakostjo 1,25 mg je naveden v preglednici 1 v nadaljevanju.
The pre-filled syringe must be assembled with a reconstitution needle.
Napolnjeno injekcijsko brizgo sestavite z rekonstitucijsko iglo.
Sodium phosphate monohydrate Disodium phosphate heptahydrate Sodium hydroxide (pH adjustment) Hydrochloric acid (pH adjustment)
L-histidin manitol natrijev fosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev hidroksid (uravnavanje pH) klorovodikova kislina (uravnavanje pH)
Revestive 1.25 mg powder and solvent for solution for injection
Revestive 1,25 mg prašek in vehikel za raztopino za injiciranje
Patients with a history of malignancies in the gastrointestinal tract, including the hepatobiliary system and pancreas within the last five years.
Bolniki z anamnezo maligne bolezni prebavil, vključno z jetri, žolčnikom, žolčevodi in trebušno slinavko, v zadnjih petih letih.
Fluid overload has been observed in clinical trials.
V kliničnih preskušanjih so opažali preobremenitev s tekočino.
- Do not use Revestive after the expiry date which is stated on the carton, the vial and the pre-filled syringe.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli,
Sodium phosphate monohydrate Disodium phosphate heptahydrate
L-histidin manitol natrijev fosfat monohidrat natrijev hidrogenfosfat heptahidrat
Your child will also have a colonoscopy done (a procedure to see inside their colon and rectum to check for the presence of polyps (small abnormal growths) and have them removed) if they have unexplained blood in their bowel movements (stools).
Če ima otrok nepojasnjeno kri v blatu, mu bodo morali narediti tudi kolonoskopijo (postopek, pri katerem si zdravnik ogleda notranjost debelega črevesa in danke, da vidi, ali so prisotni polipi (majhne nenormalne rašče), in jih odstrani).
Solvent Pre-filled syringe (glass) with plungers (bromobutyl) containing 0.5 ml of solvent.
Napolnjena injekcijska brizga (steklo) z bati (bromobutil), ki vsebuje 0,5 ml vehikla.
However, chemical and physical stability has been demonstrated for 24 hours at 25°C.
Vendar pa je dokazano, da je raztopina kemijsko in fizikalno stabilna 24 ur pri 25 °C.
If you are not sure, ask the doctor, pharmacist or nurse.
Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Solvent for Revestive
Vehikel za Revestive
Pack size of 28 vials of powder with 28 pre-filled syringes.
Velikost pakiranja 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
No dose adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects.
Pri bolnikih z blago ali zmerno okvaro jeter na osnovi študije, izvedene na preiskovancih z jetrno okvaro stopnje B po lestvici Child-Pugh, prilagajanje odmerka ni potrebno.
Materials provided in the pack: - 1 or 28 vials with 5 mg teduglutide as a powder - 1 or 28 pre-filled syringes with solvent
- 1 ali 28 vial s po 5 mg teduglutida v obliki praška, - 1 ali 28 napolnjenih injekcijskih brizg z vehiklom.
At Week 12, there was a -35.11% (±53.04) mean change from baseline in parenteral nutrition calorie consumption in the ITT population based on physician-prescribed data.
V 12. tednu je bila srednja sprememba od izhodišča porabe kalorij parenteralne prehrane v populaciji ITT na podlagi podatkov o parenteralni prehrani, ki jo je predpisal zdravnik, -35,11 % (±53,04).
Revestive comes in pack sizes of 28 vials of powder with 28 pre-filled syringes.
Zdravilo Revestive je na voljo v pakiranju po 28 vial praška z 28 napolnjenimi injekcijskimi brizgami.
Driving, cycling and using machines
Vpliv na sposobnost upravljanja vozil, kolesarjenja in upravljanja strojev
In case of pancreatic adverse events, the need for continued Revestive treatment should be reassessed.
Če pride do neželenih dogodkov v zvezi s trebušno slinavko, je treba ponovno pretehtati potrebo po nadaljevanju zdravljenja z zdravilom Revestive.
However, chemical and physical stability has been demonstrated for 3 hours at 25°C.
Vendar pa je dokazano, da je raztopina kemijsko in fizikalno stabilna 3 ure pri 25 °C.
Revestive 5 mg powder and solvent for solution for injection
Revestive 5 mg prašek in vehikel za raztopino za injiciranje
Dispose of all needles and syringes in a sharps disposal container.
Odvrzite vse igle in injekcijske brizge v vsebnik za ostre predmete.
The naturally occurring human glucagon-like peptide-2 (GLP-2) is a peptide secreted by L cells of the intestine which is known to increase intestinal and portal blood flow, inhibit gastric acid secretion, and decrease intestinal motility.
Naravni človeški glukagonu podoben peptid-2 (GLP-2) je peptid, ki ga izločajo celice L v črevesu.
Use the 5 mg strength vial
>20 kg uporabljajte viale z jakostjo 5 mg
- After reconstitution, from a microbiological point of view, the solution should be used immediately.
- Z mikrobiološkega vidika je treba zdravilo uporabiti takoj po rekonstituciji.
Your doctor will perform further colonoscopies if you continue treatment with Revestive.
Če boste nadaljevali zdravljenje z zdravilom Revestive, vam bo zdravnik delal nadaljnje kolonoskopije.
If you are not sure, ask your doctor, pharmacist or nurse.
Če ste negotovi, se posvetujte s svojim z zdravnikom, farmacevtom ali medicinsko sestro.
Anxiety Insomnia
Psihiatrične motnje tesnoba nespečnost
Revestive 5 mg powder and solvent for solution for injection Teduglutide
Revestive 5 mg prašek in vehikel za raztopino za injiciranje teduglutid
How to store Revestive
Shranjevanje zdravila Revestive
Contact the doctor or the emergency unit if your child experiences severe stomach ache and fever - Intestinal obstruction (blockage of the bowel).
Posvetujte se z zdravnikom ali z urgentno enoto, če ima otrok hude bolečine v trebuhu, bruha in je zaprt.
Contact the doctor if your child experiences tiredness, shortness of breath or swelling of ankles or legs - Inflammation of the pancreas (pancreatitis).
Posvetujte se z zdravnikom, če vaš otrok občuti utrujenost, kratko sapo ali otekanje gležnjev ali nog.
Cholecystitis Cholecystitis acute
Bolezni jeter, žolčnika in žolčevodov holecistitis akutni holecistitis
CARTON
Vehikel
Contact your doctor or the emergency unit if you experience severe stomach ache and fever - Intestinal obstruction (blockage of the bowel).
Posvetujte se s svojim zdravnikom ali z urgentno enoto, če imate hude bolečine v trebuhu, bruhate in ste zaprti.
- Do not use Revestive if you notice that the solution is cloudy or contains particulate matter.
- Zdravila Revestive ne smete uporabiti, če je raztopina motna ali če vsebuje delce.
In case of recurrent intestinal obstructions, the need for continued Revestive treatment should be reassessed.
Če se zapore črevesa ponavljajo, je treba ponovno pretehtati potrebo po nadaljevanju zdravljenja z zdravilom Revestive.
Revestive 1.25 mg powder for solution for injection teduglutide
Revestive 1,25 mg prašek in vehikel za raztopino za injiciranje teduglutid subkutana uporaba
The recommended dose of Revestive is 0.05 mg/kg body weight once daily.
Priporočen odmerek zdravila Revestive je 0,05 mg/kg telesne mase enkrat na dan. Injicirani volumen na telesno maso je naveden v preglednici 1 v nadaljevanju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Pripomočki, ki so na voljo v pakiranju:
Treatment should be initiated under the supervision of a medical professional with experience in the treatment of paediatric SBS.
Pediatrična populacija (≥1 leto) Zdravljenje se mora začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem SKČ pri otrocih.
SOLVENT PREFILLED SYRINGE LABEL
Žilne bolezni sinkopa
Hyperplasia in the gall bladder, hepatic biliary ducts, and pancreatic ducts were observed in subchronic and chronic toxicology studies.
V subkroničnih in kroničnih toksikoloških študijah so opazili hiperplazijo žolčnika, jetrnih žolčevodov in voda trebušne slinavke.
Pancreatitis Small intestinal stenosis
polipi (majhne nenormalne tvorbe) v želodcu.
One vial of powder contains 1.25 mg of teduglutide*.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala praška vsebuje 1,25 mg teduglutida*.
Contact your doctor if you experience tiredness, shortness of breath or swelling of ankles or legs - Inflammation of the pancreas (pancreatitis).
Posvetujte se s svojim zdravnikom, če občutite utrujenost, kratko sapo ali otekanje gležnjev ali nog.
EU/1/12/787/002 1 vial EU/1/12/787/001 28 vials
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/787/003 28 vial
Revestive 5 mg powder for solution for injection teduglutide
Revestive 5 mg prašek in vehikel za raztopino za injiciranje teduglutid subkutana uporaba
Assemble the pre-filled syringe
Sestavite napolnjeno injekcijsko brizgo
Subcutaneous use vial (glass)
Velikost pakiranja subkutana ali intravenska uporaba intarvenska uporaba
The full EPAR for Zoledronic acid medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zoledronska kislina medac je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is available as a 4mg/100ml solution for infusion (drip into a vein) and as a 4mg/5ml concentrate for solution for infusion.
Na voljo je v obliki 4 mg/100 ml raztopine za infundiranje (kapalne infuzije v veno) in 4 mg/5 ml koncentrata za pripravo raztopine za infundiranje.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid medac on 03 August 2012.
Evropska komisija je dovoljenje za promet z zdravilom Zoledronska kislina medac, veljavno po vsej Evropski uniji, izdala 3. avgusta 2012.
For more information about treatment with Zoledronic acid medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zoledronska kislina medac preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid medac.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoledronska kislina medac.
In addition, the company that markets Zoledronic acid medac will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Poleg tega bo družba, ki trži zdravilo Zoledronska kislina medac pripravila izobraževalno kartico, s katero bo bolnike seznanila s tveganji osteonekroze čeljustnice (poškodbi čeljustne kosti, ki lahko povzroči bolečine, oteklost v ustih ali majanje zob) in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid medac has been shown to have comparable quality and to be bioequivalent to Zometa.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Zoledronska kislina medac primerljivo raven kakovosti kot zdravilo Zometa ter da mu je biološko enakovredno.
Because Zoledronic acid medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Zoledronska kislina medac generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so z njim povezane koristi in tveganja enaki kot pri referenčnem zdravilu.
This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Ti zapleti so zlomi kosti, spinalna kompresija (ko hrbtenjačo stisne kost), kostna obolenja, ki zahtevajo radioterapijo (zdravljenje z obsevanjem) ali operacijo, ter hiperkalciemija (visoke ravni kalcija v krvi).
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Pri uporabi za preprečevanje z okostjem povezanih zapletov se infundiranje lahko ponovi vsake tri do štiri tedne, bolniki pa morajo prejemati tudi dodatek kalcija in vitamina D. Pri bolnikih s kostnimi metastazami (rakom, ki se je razširil na kosti), ki imajo blage do zmerne težave z ledvicami, je priporočljiv nižji odmerek zdravila.
The usual dose of Zoledronic acid medac is one infusion of 4 mg over at least 15 minutes.
Običajni odmerek zdravila Zoledronska kislina medac je ena 4-miligramska infuzija v trajanju vsaj 15 minut.
This means that Zoledronic acid medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Zometa.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid medac, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What measures are being taken to ensure the safe and effective use of Zoledronic acid medac?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zoledronska kislina medac?
The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Zmanjševanje izgubljanja kostnine vpliva na manjšo lomljivost kosti, kar je koristno pri preprečevanju zlomov pri bolnikih z rakom, z metastazami v kosteh.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid medac.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zoledronska kilsina medac, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Zoledronic acid medac can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Zdravilo Zoledronska kislina medac se lahko uporablja za preprečevanje z okostjem povezanih zapletov pri odraslih z napredovalim rakom, ki prizadene kosti.
What are the benefits and risks of Zoledronic acid medac?
Kakšne so koristi in tveganja, povezani z zdravilom Zoledronska kislina medac?
A risk management plan has been developed to ensure that Zoledronic acid medac is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Zoledronska kislina medac je bil pripravljen načrt obvladovanja tveganj.
Zoledronic acid medac must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Zdravilo Zoledronska kislina medac smejo uporabljati le zdravniki z izkušnjami z uporabo te vrste zdravil za intravensko uporabo.
Zoledronic acid medac can also be used to treat the hypercalcaemia caused by tumours.
Zdravilo Zoledronska kislina medac se lahko uporablja tudi za zdravljenje hiperkalciemije, ki jo povzročajo tumorji.
Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilu Zometa, odtehtajo znana tveganja.
Other information about Zoledronic acid medac
Druge informacije o zdravilu Zoledronska kislina medac
The Committee recommended that Zoledronic acid medac be given marketing authorisation.
Priporočil je, da se za zdravilo Zoledronska kislina medac izda dovoljenje za promet.
By preventing the breakdown of bones, Zoledronic acid medac also helps to reduce the amount of calcium released into the blood.
Zdravilo Zoledronska kislina medac s preprečevanjem razgradnje kosti pripomore tudi k znižanju ravni kalcija, ki se sprosti v kri.
Zoledronic acid medac is a ‘generic medicine'.
Zdravilo Zoledronska kislina medac je „generično zdravilo“.
Zoledronic acid medac is a medicine that contains the active substance zoledronic acid.
Zoledronska kislina medac je zdravilo, ki vsebuje zdravilno učinkovino zoledronska kislina.
Zoledronic acid medac zoledronic acid
Zoledronska kislina medac zoledronska kislina
The active substance in Zoledronic acid medac, zoledronic acid, is a bisphosphonate.
Zdravilna učinkovina zdravila Zoledronska kislina medac, zoledronska kislina, je difosfonat.
Why has Zoledronic acid medac been approved?
Zakaj je bilo zdravilo Zoledronska kislina medac odobreno?
No additional studies were needed as Zoledronic acid medac is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Ker je zdravilo Zoledronska kislina medac generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Zometa, niso bile potrebne nobene dodatne študije.
How has Zoledronic acid medac been studied?
Kako je bilo zdravilo Zoledronska kislina medac raziskano?
How does Zoledronic acid medac work?
Kako zdravilo Zoledronska kislina medac deluje?
What is Zoledronic acid medac?
Kaj je zdravilo Zoledronska kislina medac?