natgillin/translations-raw huggingface dataset:
In addition, one group of six ferrets were immunized with vaccine candidate containing 3.75 µg H5N1 + full dose of AS03 and one control group included ferrets immunized with non-adjuvanted vaccine (3.75 micrograms HA).
Razen tega pa so eno skupino šestih belih dihurjev cepili s kandidatnim cepivom, ki je vsebovalo 3,75 H5N1 + celoten odmerek AS03.
Very common: • Pain at the injection site
• bolečina na mestu injiciranja
• Limited safety and immunogenicity data obtained three weeks after administration of a single dose to healthy adults aged 18-79 years.
• Malo podatkov o varnosti in imunogenosti, dobljenih tri tedne po uporabi enega odmerka cepiva Pandemrix (H1N1) pri zdravih odraslih, starih od 18 do 79 let.
• Limited immunogenicity data obtained three weeks after administration of a single dose of 0.25 ml or 0.5 ml to healthy children aged 10-17 years.
• Malo podatkov o imunogenosti, dobljenih tri tedne po uporabi enega 0,25-ml odmerka ali 0,5ml odmerka cepiva Pandemrix (H1N1) pri zdravih otrocih, starih od 10 do 17 let.
Immunogenicity data obtained at three weeks after administration of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in clinical studies suggest that a single dose may be sufficient.
Podatki o imunogenosti, dobljeni tri tedne po uporabi cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, v kliničnih študijah kažejo, da morda lahko zadošča en sam odmerek.
- abridged report for post dose 3 (immuno & solicited and unsolicited symptoms, SAEs)
- skrajšano poročilo po 3. odmerku (imunološki podatki ter spontano in nespontano zabeleženi simptomi, resni neželeni učinki)
• Being sick, stomach pain, acid indigestion
• slabost, bolečine v želodcu, dispepsija
• Limited safety data obtained after administration of 0.25 ml or two doses of 0.5 ml to healthy children aged 10-17 years.
• Malo podatkov o varnosti, dobljenih po uporabi 0,25-ml ali dveh 0,5-ml odmerkov cepiva Pandemrix (H1N1) pri zdravih otrocih, starih od 10 do 17 let.
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde and sodium deoxycholate) of this vaccine.
Anafilaktična reakcija v anamnezi (tj. življenjsko nevarna) na katerokoli sestavino cepiva ali ostanke v sledeh (jajčne in piščančje beljakovine, ovalbumin, formaldehid in natrijev deoksiholat).
• Fits due to fever
• zvišana telesna temperatura
STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to: 3.75 micrograms haemagglutinin/dose *Antigen: A/California/7/2009 (H1N1)v-like strain (X-179A)
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN inaktivirani delci virusa gripe, ki vsebujejo antigene*, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek *Antigen: sev A/California/7/2009 (X-179A) podoben sevu A/California/7/2009 (H1N1)v
Total enrolled subjects N=120 [95% CI]
Skupno vključeni preiskovanci n=120 [95% IZ]
Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Pomožne snovi: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, voda za injekcije
In a clinical study that evaluated the reactogenicity in children 10 to 17 years of age who received two 0.5 ml doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process, there was no increase in reactogenicity after the second dose compared to the first dose.
V klinični študiji, s katero so ocenili reaktogenost pri otrocih, starih od 10 do 17 let, ki so dobili dva 0,5-ml odmerka (21 dni narazen) cepiva cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, po drugem odmerku niso opazili povečanja reaktogenosti v primerjavi s prvim odmerkom.
Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Kako uporabljati cepivo Arepanrix V skladu z uradnimi priporočili vas bo cepil zdravnik ali medicinska sestra.
• Post-marketing surveillance
• Spremljanje cepiva po pridobitvi dovoljenja za promet
• Diarrhoea, feeling sick
• driska, siljenje na bruhanje
Additional data on reactogenicity are available from clinical studies in healthy subjects of various age groups from 6 months of age upwards who received an AS03-containing vaccine containing HA from H1N1v manufactured using a different process.
Iz kliničnih študij pri zdravih preiskovancih različnih starostnih skupin od 6 mesecev starosti dalje, ki so prejeli cepivo z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, so na voljo dodatni podatki o reaktogenosti.
Immune response to A/California/7/2009 (H1N1)v-like 61-70 years
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 61-70 let
Seronegative subjects prior to vaccination N=61 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=61 [95% IZ]
Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Zvišana telesna temperatura >39°C
• Clinical studies in healthy subjects (including elderly subjects) who received two doses of a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Dodatni podatki o varnosti in imunogenosti pri zdravih odraslih, vključno s starejšimi so na voljo iz kliničnih študij z različico cepiva Arepanrix z vsebnostjo 3,75 µg HA pridobljenega iz A/Indonesia/05/2005 (H5N1).
However, in another clinical study which evaluated reactogenicity in children 3 to 9 years who received two adult (i.e. 0.5 ml) doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose.
Toda v drugi klinični študiji, ki je ocenjevala reaktogenost pri otrocih, starih od 3 do 9 let po dveh odmerkih (tj. 0,5 ml) za odrasle (21 dni narazen) cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, so po drugem odmerku v primerjavi s prvim odmerkom opazili več reakcij na mestu injiciranja in splošnih simptomov.
Arepanrix may be used in lactating women.
Cepivo Arepanrix se lahko uporabi v obdobju dojenja.
Immune response to A/California/7/2009 (H1N1)v-like 6-11 months
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 6-11 mesecev
Split influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms** per 0.5 ml dose *propagated in eggs ** expressed in microgram haemagglutinin
• Zdravilna učinkovina: inaktivirani delci virusa gripe, ki vsebujejo antigene*, ki ustrezajo: sevu A/California/7/2009 (X-179A) podobnemu sevu A/California/7/2009 (H1N1)v 3,75 mikrogramov**na 0,5 ml odmerek
Immune response to A/California/7/2009 (H1N1)v-like Half dose
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu Polovični odmerek
Total enrolled subjects [95% CI]
Skupno vključeni preiskovanci [95% IZ]
2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre);
2Delež serokonverzije (delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra); 3Faktor serokonverzije (razmerje med geometrično sredino (GMT - geometric mean titre) titra po cepljenju in GMT titra pred cepljenjem).
Immune response to A/California/7/2009 (H1N1)v-like 3-5 years
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 3-5 let
Total enrolled subjects N=75 [95% CI]
Skupno vključeni preiskovanci n=75 [95% IZ]
There are no data with Arepanrix using the subcutaneous route.
Podatkov o subkutani uporabi cepiva Arepanrix ni.
Total enrolled subjects N=40 [95% CI]
Skupno vključeni preiskovanci n=40 [95% CI]
Seronegative subjects prior to vaccination N=76 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=76 [95% IZ]
Total enrolled subjects N=97 [95% CI]
Skupno vključeni preiskovanci n=97 [95% IZ]
• Dizziness
• drgetanje
Before you are given Arepanrix
Kaj morate vedeti, preden boste dobili cepivo Arepanrix
Total enrolled subjects N=60 [95% CI]
Skupno vključeni preiskovanci n=60 [95% IZ]
Seronegative subjects prior to vaccination N=40 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=40 [95% IZ]
After mixing: Use within 24 hours and do not store above 25°C.
Po premešanju: Uporabite v 24 urah.
Seronegative subjects prior to vaccination N=29 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=29 [95% IZ]
Posology
Pordelost
NA= not available
NP= ni podatka
Seronegative subjects prior to vaccination N=38 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=38 [95% IZ]
Total enrolled subjects N=58 [95% CI]
Skupno vključeni preiskovanci n=58 [95% IZ]
Ferrets immunized with the non adjuvanted H5N1 influenza vaccine were not protected from death and showed similar lung viral loads and degree of viral shedding in the upper respiratory tract as those exhibited by ferrets immunized with the adjuvant alone.
Pri njih je bilo virusno breme v pljučih in izločanje virusa iz zgornjih dihal podobno kot pri belih dihurjih, ki so bili cepljeni le z adjuvansom.
Seronegative subjects prior to vaccination N=43 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=43 [95% IZ]
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo odobreno
Seronegative subjects prior to vaccination N=23 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=23 [95% IZ]
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Arepanrix Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Suspenzija za emulzijo za injiciranje za cepivo Arepanrix cepivo proti pandemski gripi (H1N1) z delci virionov, inaktivirano (z adjuvansom)
Total enrolled subjects N=30 [95% CI]
Skupno vključeni preiskovanci n=30 [95% IZ]
• On-going clinical studies in healthy subjects who received a single dose or two doses of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process
potekajočih kliničnih študij pri zdravih preiskovancih, ki so dobili en odmerek ali dva odmerka cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, kliničnih študij pri zdravih preiskovancih, ki so dobili dva odmerka cepiva z AS03 z vsebnostjo HA iz H5N1, pridobljenega z drugačnim postopkom.
What Arepanrix contains
Dodatne informacije Kaj vsebuje cepivo Arepanrix
Seronegative subjects prior to vaccination N=27 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=27 [95% IZ]
Total enrolled subjects N=59 [95% CI]
Skupno vključeni preiskovanci n=59 [95% IZ]
Seronegative subjects prior to vaccination N=3 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=3 [95% IZ]
Post dose 1 Post dose
Po 1. odmerku Po 1. odmerku
• Aching muscles, joint pain
• bolečine v mišicah, bolečine v sklepih
Total enrolled subjects N=5 [95% CI]
Skupno vključeni preiskovanci n=5 [95% IZ]
Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity
Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: bolečina v sklepih, bolečine v mišicah Občasni: bolečina v hrbtu, okorelost mišično-skeletnega sistema, bolečina v vratu, mišični krči, bolečina v okončinah
The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections What Arepanrix looks like and contents of the pack
Pomožne snovi so: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid in voda za injekcije.
Thiomersal
* hemaglutinin
Medicinal product subject to medical prescription.
Izdaja cepiva je le na recept.
Pain
NP
In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process:
Cepivo z AS03 z vsebnostjo HA iz H1N1v, pridobljeno z drugačnim postopkom Poleg neželenih učinkov, opisanih v kliničnih preskušanjih, so bili po pridobitvi dovoljenja za promet s cepivom z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom opisani tudi naslednji neželeni učinki:
• Swollen glands in the axilla
• otekle podpazdušne bezgavke
Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Pomožne snovi: natrijev klorid natrijev hidrogenfosfat kalijev dihidrogenfosfat kalijev klorid voda za injekcije
Split influenza virus, inactivated, containing antigen* equivalent to:
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Po premešanju 1 odmerek (0,5 ml) vsebuje: inaktivirane delce virusa gripe, ki vsebujejo antigene, ki ustrezajo:
The following information is intended for medical or healthcare professionals only: Arepanrix consists of two containers:
Naslednje informacije so namenjene samo zdravstvenemu osebju:
In a clinical study that evaluated reactogenicity in healthy adults aged 18-60 years who received two 0.5 ml doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process, there were higher rates of most general solicited symptoms (such as fatigue, headache, arthralgia, shivering, sweating and fever) after the second dose compared to the first dose.
V klinični študiji, s katero so ocenili reaktogenost pri zdravih odraslih, starih od 18 do 60 let, ki so dobili dva 0,5-ml odmerka (21 dni narazen) cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, so bili deleži večine splošnih spodbujeno poročanih simptomov (npr.
Timelines described in the RMP
Časovnica je opisana v načrtu za obvladovanje tveganja.
Study Q-Pan H1N1-003 (6 months-8 yrs, Dose finding,)
študija Q-Pan H1N1-003 (6 mesecev do 8 let, določitev odmerka) - skrajšano poročilo po 1. odmerku 1. vala uporabe (imunološki podatki, spontano in nespontano zabeleženi simptomi ter resni neželeni učinki)
Ear and labyrinth disorders Uncommon: vertigo
Ušesne bolezni, vključno z motnjami labirinta Občasni: vrtoglavica
After mixing, use the vaccine within 24 hours and do not store above 25°C.
Cepivo uporabite v 24 urah po premešanju.
It is available as a concentrate (4 mg/5 ml) to be used to make a solution for infusion (drip) into a vein, and as a solution for infusion (4 mg/100 ml).
Na voljo je kot koncentrat (4 mg/5 ml) za pripravo raztopine za infundiranje (kapalne infuzije) v veno ter kot raztopina za infundiranje (4 mg/100 ml).
The full EPAR for Zoledronic acid Teva 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 Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For more information about treatment with Zoledronic acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zoledronska kislina Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva on 16 August 2012.
Evropska komisija je dovoljenje za promet z zdravilom Zoledronska kislina Teva, veljavno po vsej Evropski uniji, izdala 16. avgusta 2012.
This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Teva.
The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva has been shown to be comparable to Zometa.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Zoledronska kislina Teva primerljivo zdravilu Zometa.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Ta zavira delovanje osteoklastov, tj. celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
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, pri katerih je potrebna radioterapija (zdravljenje z obsevanjem) ali operacija, ter hiperkalciemija (visoke ravni kalcija v krvi).
This means that Zoledronic acid Teva 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.
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 Teva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zoledronska kislina Teva?
This leads to less bone loss.
S tem se zmanjša izguba kostne mase.
Because Zoledronic acid Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Zoledronska kislina Teva generično zdravilo, so koristi in tveganja enaki kot pri referenčnem zdravilu.
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 zapletov, povezanih z okostjem, 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 Teva is one infusion of 4 mg over at least 15 minutes.
Običajni odmerek zdravila Zoledronska kislina Teva je ena 4-miligramska infuzija, ki traja najmanj 15 minut.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the benefits and risks of Zoledronic acid Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Zoledronska kislina Teva?
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.
Zmanjšanje izgube kostne mase pripomore k manjši verjetnosti zloma, kar prispeva k preprečevanju zlomov pri bolnikih z rakom in metastazami v kosteh.
Zoledronic acid Teva can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Zdravilo Zoledronska kislina Teva se lahko uporablja za preprečevanje zapletov, povezanih z okostjem, pri odraslih z napredovalim rakom, ki vpliva na kosti.
Zoledronic acid Teva 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 Teva smejo uporabljati le zdravniki, ki imajo izkušnje z uporabo te vrste zdravil za intravensko uporabo.
Zoledronic acid Teva can also be used to treat the hypercalcaemia caused by tumours.
Zdravilo Zoledronska kislina Teva se lahko uporablja tudi za zdravljenje hiperkalcemije, ki jo povzročajo tumorji.
A risk management plan has been developed to ensure that Zoledronic acid Teva is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Zoledronska kislina Teva je bil pripravljen načrt obvladovanja tveganj.
Other information about Zoledronic acid Teva
Druge informacije o zdravilu Zoledronska kislina Teva
Zoledronic acid Teva is a ‘generic medicine'.
Zdravilo Zoledronska kislina Teva je „generično zdravilo“.
By preventing the breakdown of bones, Zoledronic acid Teva also helps to reduce the amount of calcium released into the blood.
Zdravilo Zoledronska kislina Teva s preprečevanjem razgradnje kosti pripomore tudi k znižanju ravni kalcija, ki se sprosti v kri.
Zoledronic acid Teva is a medicine that contains the active substance zoledronic acid.
Zoledronska kislina Teva je zdravilo, ki vsebuje zdravilno učinkovino zoledronska kislina.
The Committee recommended that Zoledronic acid Teva be given marketing authorisation.
Priporočil je, da se za zdravilo Zoledronska kislina Teva izda dovoljenje za promet.
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.
The active substance in Zoledronic acid Teva, zoledronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Zoledronska kislina Teva, zoledronska kislina, je difosfonat.
Zoledronic acid Teva zoledronic acid
Zoledronska kislina Teva zoledronska kislina
Why has Zoledronic acid Teva been approved?
Zakaj je bilo zdravilo Zoledronska kislina Teva odobreno?
No additional studies were needed as Zoledronic acid Teva 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 Teva 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 Teva been studied?
Kako je bilo zdravilo Zoledronska kislina Teva raziskano?
What is Zoledronic acid Teva?
Kaj je zdravilo Zoledronska kislina Teva?
How is Zoledronic acid Teva used?
Kako se zdravilo Zoledronska kislina Teva uporablja?
What is Zoledronic acid Teva used for?
Za kaj se zdravilo Zoledronska kislina Teva uporablja?
How does Zoledronic acid Teva work?
Kako zdravilo Zoledronska kislina Teva deluje?
EU Number
Številka EU Izmišljeno ime
Invented name Strength Pharmaceutical Form
Farmacevtska oblika
Route of Administration
Način uporabe zdravila
The majority of these reactions were mild or moderate and of short duration.
Reakcije so bile večinoma blage ali zmerne in kratkotrajne.
It is available as tablets (18 mg).
Na voljo je v obliki tablet (18 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Selincro on 25 February 2013.
Evropska komisija je dovoljenje za promet z zdravilom Selincro, veljavno po vsej Evropski uniji, odobrila dne 25. Februarja 2013.
Data on the use of Selincro from standard clinical studies are available for a period of six months to one year.
Podatki o uporabi zdravila Selincro iz standardnih kliničnih študij so na voljo za obdobje od šestih mesecev do enega leta.
Only one tablet can be taken on any given day and it should preferably be taken one to two hours before they are likely to start drinking.
Vzame lahko samo eno tableto katerikoli dan, po možnosti eno do dve uri pred verjetnim začetkom pitja.