natgillin/translations-raw huggingface dataset:
The Stocrin combination was more effective than the combination without Stocrin: 70% and 30% of the patients, respectively, had viral loads below 500 copies/ml after 48 weeks;
Kombinacija z zdravilom Stocrin je bila učinkovitejša od kombinacije brez njega: 70 % oziroma 30 % bolnikov je imelo po 48 tednih virusno breme nižje od 500 kopij/ml;
The most common side effect with Stocrin (seen in more than 1 patient in 10) is rash.
Najpogostejši neželeni učinek zdravila Stocrin (ki se je pojavil pri več kot 1 bolniku od 10) je izpuščaj.
For patients who are unable to swallow the capsules or tablets, Stocrin can be given using the oral solution.
Pri bolnikih, ki ne morejo pogoltniti kapsul ali tablet, se zdravilo Stocrin lahko daje v obliki peroralne raztopine.
Stocrin can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Predpisovanje in izdaja zdravila Stocrin je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z obvladovanjem okužbe z virusom HIV.
For more information about treatment with Stocrin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Stocrin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In all of the studies, the main measure of effectiveness was the number of patients with undetectable levels of HIV-1 in their blood (viral loads) after 24 or 48 weeks of treatment:
V vseh študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so imeli po 24 ali 48 tednih zdravljenja v krvi nezaznavno raven virusa HIV-1 (virusno breme):
Stocrin is also commonly associated with dizziness, headache, nausea (feeling sick) and tiredness.
Zdravilo Stocrin pogosto povezujejo tudi z omotico, glavobolom, navzejo (siljenjem na bruhanje) in utrujenostjo.
For practical information about using Stocrin, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Stocrin naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The Agency noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Ugotovila je, da zdravilo Stocrin ni bilo ustrezno raziskano pri bolnikih z napredovalo boleznijo (številom celic CD4, nižjim od 50 celic/mm3) ali po zdravljenju z zaviralci proteaze (drugo vrsto protivirusnega zdravila), ki ni bilo uspešno.
• in the first study, Stocrin in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine.
• v prvi študiji so zdravilo Stocrin v kombinaciji z lamivudinom in zidovudinom ali z indinavirjem (drugimi protivirusnimi zdravili) primerjali s kombinacijo indinavirja, lamivudina in zidovudina.
67% of the adults treated with Stocrin in combination with zidovudine and lamivudine had viral loads below 400 copies/ml after 48 weeks, compared with 54% of the patients treated with Stocrin and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;
Prva študija je pokazala, da je imelo po 48 tednih virusno breme nižje od 400 kopij/ml 67 % odraslih, zdravljenih z zdravilom Stocrin v kombinaciji z zidovudinom in lamivudinom, 54 % bolnikov, zdravljenih z zdravilom Stocrin in indinavirjem, ter 45 % bolnikov, zdravljenih z indinavirjem, lamivudinom in zidovudinom;
How does Stocrin work?
Kako zdravilo Stocrin deluje?
For the full list of side effects reported with Stocrin, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Stocrin, glejte navodilo za uporabo.
• the third study compared adding Stocrin or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
• v tretji študiji so primerjali dodajanje zdravila Stocrin ali placeba (zdravila brez zdravilne učinkovine) kombinaciji protivirusnih zdravil, ki je vključevala indinavir in dve drugi protivirusni zdravili, pri bolnikih, ki so se že zdravili zaradi okužbe z virusom HIV.
How is Stocrin used?
Kako se zdravilo Stocrin uporablja?
• the second study compared Stocrin in combination with nelfinavir and two other antiviral medicines with the same combination without Stocrin.
• v drugi študiji so zdravilo Stocrin v kombinaciji z nelfinavirjem in dvema drugima protivirusnima zdraviloma primerjali z enako kombinacijo, vendar brez zdravila Stocrin.
The dose of Stocrin may need to be adjusted in patients taking certain other medicines at the same time.
Poleg tega je pri sočasnem jemanju določenih drugih zdravil včasih treba prilagoditi odmerek zdravila Stocrin.
More patients receiving Stocrin had viral loads below 400 copies/ml than those taking placebo after 24 weeks
Tretja študija je pokazala, da je imelo po 24 tednih virusno breme nižje od 400 kopij/ml več bolnikov, ki so prejemali zdravilo Stocrin, kot bolnikov, ki so prejemali placebo.
To investigate this further the Agency recommended that a study be carried out.
Da bi to vprašanje nadalje proučili, priporoča, da se izvede študija.
Further information on Laventair Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Laventair Ellipta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Recommendations and precautions to be followed by healthcare professionals and patients have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
In all 4 studies, involving over 4,700 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
V vseh štirih študijah, v katerih je sodelovalo več kot 4 700 bolnikov, je bilo glavno merilo učinkovitosti sprememba bolnikovega forsiranega ekspiracijskega volumna (FEV1 - največja količina zraka, ki jo oseba lahko izdihne v eni sekundi).
For detailed information on using the inhaler correctly, see the instructions in the package leaflet or contact your doctor and pharmacist.
Za podrobnejše informacije o pravilni uporabi inhalatorja glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
As medicines of the same class as Laventair Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets the medicine will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Ker lahko zdravila istega razreda kot zdravilo Laventair Ellipta vplivajo na srce in krvne žile v možganih, bo podjetje, ki trži zdravilo, izvedlo dolgoročno študijo pri bolnikih, da bo zbralo dodatne informacije o njegovi varnosti v primerjavi s tiotropijem.
Previously known as Laventair.
Predhodno znano kot zdravilo Laventair.
The most common side effects with Laventair Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.
Najpogostejši neželeni učinki zdravila Laventair Ellipta (ki se lahko pojavijo pri največ 1 bolniku od 10) so okužbe zgornjih dihal (okužbe nosu in žrela), okužbe sečil (okužbe struktur za odvajanje urina), faringitis (vnetje žrela), sinuzitis (vnetje sinusov), nazofaringitis (vnetje nosu in žrela), glavobol, kašelj, orofaringealna bolečina (bolečina v ustih in žrelu), zaprtje in suha usta.
Laventair Ellipta1 (umeclidinium bromide / vilanterol)
Laventair Ellipta1 (umeklidinijev bromid/vilanterol)
Laventair Ellipta received a marketing authorisation valid throughout the EU on 8 May 2014.
Za zdravilo Laventair Ellipta je bilo 8. maja 2014 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Laventair Ellipta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Laventair Ellipta?
The European Medicines Agency decided that Laventair Ellipta's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Laventair Ellipta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Side effects reported with Laventair Ellipta are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Laventair Ellipta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The Agency also noted that there were no major safety concerns with Laventair Ellipta, with side effects being manageable, although the longterm safety data so far are limited.
Ugotovila je tudi, da ni večjih pomislekov glede varnosti zdravila Laventair Ellipta, saj so njegovi neželeni učinki obvladljivi, čeprav so podatki o dolgoročni varnosti zdravila trenutno omejeni.
As for all medicines, data on the use of Laventair Ellipta are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Laventair Ellipta stalno spremljajo.
It works by attaching to beta-2 receptors found in the muscle cells of many organs including the airways in the lungs.
Deluje tako, da se veže na receptorje beta2, ki so v mišičnih celicah številnih organov, vključno z dihalnimi potmi v pljučih.
Laventair Ellipta is used for maintenance (regular) treatment.
Zdravilo Laventair Ellipta se uporablja za vzdrževalno (redno) zdravljenje.
The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Kombinirano delovanje obeh učinkovin pomaga ohranjati dihalne poti prehodne in bolniku olajša dihanje.
It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles.
Deluje tako, da zavira druge receptorje, imenovane muskarinski receptorji, ki nadzorujejo krčenje mišic.
Each inhalation provides 65 micrograms of umeclidinium bromide (equivalent to 55 micrograms of umeclidinium) and 22 micrograms of vilanterol.
Z enim vdihom se dovede 65 mikrogramov umeklidinijevega bromida (kar je enakovredno 55 mikrogramom umeklidinija) in 22 mikrogramov vilanterola.
Other information about Laventair Ellipta
Druge informacije o zdravilu Laventair Ellipta
Laventair Ellipta contains two active substances.
Zdravilo Laventair Ellipta vsebuje dve učinkovini.
The results for the higher dose combination of umeclidinium bromide and vilanterol did not consistently show relevant improvements in lung function to justify its use.
Rezultati kombinacije z večjim odmerkom umeklidinijevega bromida in vilanterola ni vedno privedla do večjega izboljšanja delovanja pljuč, zaradi česar ni mogoče upravičiti njene uporabe.
Why is Laventair Ellipta authorised in the EU?
Zakaj je bilo zdravilo Laventair Ellipta odobreno v EU?
Laventair Ellipta also increased FEV1 by an average of 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone.
Zdravilo Laventair Ellipta je tudi povečalo vrednost FEV1 za povprečno 95 ml več kot sam vilanterol in za 52 ml več kot sam umeklidinijev bromid.
An overview of Laventair Ellipta and why it is authorised for use in the EU
Pregled zdravila Laventair Ellipta in zakaj je odobreno v EU
Laventair Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Zdravilo Laventair Ellipta se uporablja za lajšanje simptomov kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
What benefits of Laventair Ellipta have been shown in studies?
Kakšne koristi zdravila Laventair Ellipta so se pokazale v študijah?
When umeclidinium bromide is inhaled, it relaxes the muscles of the airways.
Ko bolnik vdihne umeklidinijev bromid, ta sprosti mišice dihalnih poti.
What is Laventair Ellipta and what is it used for?
Kaj je zdravilo Laventair Ellipta in za kaj se uporablja?
Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Kombinacija antagonistov muskarinskih receptorjev in dolgodelujočih agonistov receptorjev beta2 se pogosto uporablja za obvladovanje KOPB.
What are the risks associated with Laventair Ellipta?
Kakšna tveganja so povezana z zdravilom Laventair Ellipta?
Laventair Ellipta was also shown to improve symptoms such as breathlessness and wheezing.
Zdravilo Laventair Ellipta prav tako dokazano lajšalo simptome, kot je težko ali piskajoče dihanje.
The Agency concluded that Laventair Ellipta was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Zaključila je, da se je zdravilo Laventair Ellipta izkazalo za učinkovito pri izboljševanju delovanja pljuč in simptomov KOPB v primerjavi s placebom, posameznima učinkovinama in tiotropijem.
Laventair Ellipta and a higher-dose combination of umeclidinium bromide and vilanterol were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium bromide alone and another COPD medicine called tiotropium in 4 main studies.
V štirih glavnih študijah so zdravilo Laventair Ellipta in kombinacijo z večjim odmerkom umeklidinijevega bromida in vilanterola primerjali s placebom (zdravilom brez učinkovine), vilanterolom samim, umeklidinijevim bromidom samim in drugim zdravilom za zdravljenje KOPB, imenovanim tiotropij.
Results showed that Laventair Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment.
Rezultati so pokazali, da je zdravilo Laventair Ellipta po 24 tednih zdravljenja izboljšalo delovanje pljuč v smislu povečanja povprečne vrednosti FEV1 za 167 ml več kot placebo.
When inhaled, vilanterol reaches the receptors in the airways and activates them.
Ko bolnik vdihne vilanterol, ta doseže receptorje v dihalnih poteh in jih aktivira, zaradi česar se mišice dihalnih poti sprostijo.
Laventair Ellipta contains the active substances umeclidinium bromide and vilanterol.
Zdravilo vsebuje učinkovini umeklidinijev bromid in vilanterol.
Laventair Ellipta can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Laventair Ellipta je le na recept.
The average increase in FEV1 with Laventair Ellipta was 90 ml more than with tiotropium after 24 weeks of treatment.
Po 24 tednih zdravljenja se je povprečna vrednost FEV1 ob uporabi zdravila Laventair Ellipta povečala za 90 ml več kot pri zdravljenju s tiotropijem.
How is Laventair Ellipta used?
Kako se zdravilo Laventair Ellipta uporablja?
How does Laventair Ellipta work?
Kako zdravilo Laventair Ellipta deluje?
< PC: {number} SN: {number} NN: {number} >
< PC: {številka} SN: {številka} NN: {številka} >
The response rate in these patients was about 52%.
Delež odziva pri teh bolnikih je bil okrog 52%.
Date of first authorisation: 20 April 2012 Date of latest renewal: 09 Desember 2016
Datum prve odobritve: 20. april 2012 Datum zadnjega podaljašnja: 9. december 2016
However, such reports have been infrequent.
Vendar so bili takšni primeri redki.
In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Še zlasti ni bilo jasnih dokazov o učinkovitost glede incidence zlomov ali bolečin.
Any SRE (+TIH)
Katerikoli SRE (+TIH)
You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Zato morate biti previdni pri upravljanju motornih vozil, uporabi strojev in opravljanju drugih nalog, ki zahtevajo popolno pozornost.
Median time to normocalcaemia was 4 days.
Mediani čas do normokalciemije je bil 4 dni.
Your doctor will monitor this and take any necessary measures.
Zdravnik vas bo kontroliral in bo ustrezno ukrepal.
In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
V večini primerov ni potrebno kakšno posebno zdravljenje in simptomi v kratkem (čez nekaj ur ali dni) izginejo.
The frequencies for each of these identified risks are shown in Table 1.
Pogostnosti vsakega od teh ugotovljenih tveganj prikazuje Preglednica 1.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse informacije o tem zdravilu se obrnite na lokalnega predstavnika imetnika dovoljenja za promet:
There is no evidence to suggest that any extra precautions are needed.
Ni dokazov, da bi bili potrebni posebni previdnostni ukrepi.
- Increased sweating.
- Povečano znojenje.
Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Podatki, ki so trenutno na voljo, so opisani v poglavju 5.1, a priporočil za odmerjanje ni mogoče dati.
- if you have or have had a kidney problem.
- če imate ali ste imeli kakšne težave z ledvicami.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur na temperaturi od 2°C - 8°C.
Poor healing of these fractures has also been reported.
Opisano je tudi slabo celjenje teh zlomov.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Če datum predložitve PSUR in posodobitve RMP sovpadata, se lahko predložita sočasno.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Preden dobite to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
Risk reduction of suffering from multiple events**
Zmanjšanje tveganja za pojav multiplih dogodkov** (%)
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Celotni telesni očistek je 5,04 ± 2,5 l/h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa in telesna masa.
NR 714
ND 714
The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Mehanizem večje incidence atrijske fibrilacije v tem enem kliničnem preskušanju ni znan.
Most patients had relief of symptoms after stopping treatment.
Pri večini bolnikov so simptomi po prenehanju zdravljenja minili.
CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
CLcr se izračuna iz vrednosti serumskega kreatinina po Cockcroft-Gaultovi formuli.
EU/1/12/759/001 1vial EU/1/12/759/002 4 vials EU/1/12/759/003 10 vials
EU/1/12/759/001 1viala EU/1/12/759/002 4 viale EU/1/12/759/003 10 vial
The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Varnost in učinkovitost zoledronske kisline pri otrocih od 1 do 17 let starosti nista ugotovljeni.
The time to onset of symptoms varied from one day to several months after starting treatment.
Simptomi so se pojavili v času od enega dneva do več mesecev po začetku zdravljenja.
- Confusion.
- Zmedenost.
• To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
• Za znižanje količine kalcija v krvi pri odraslih, kadar je ta zaradi prisotnosti tumorja prevelika.
In some instances, the hypocalcaemia may be life-threatening (see section 4.8).
Hipokalciemija je v nekaterih primerih lahko življenjsko ogrožajoča (glejte poglavje 4.8).
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached
* Vključuje vretenčne in nevretenčne zlome ** Upošteva vse skeletne dogodke, njihovo celotno število in čas do vsakega dogodka med preskušanjem.
Baseline Creatinine Clearance (ml/min)
Izhodiščni očistek kreatinina (ml/min)
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
Tell your doctor if you are or think that you may be pregnant.
Zdravniku morate povedati, če ste noseči, ali če mislite, da ste noseči.
Pack sizes: 1, 4 or 10 vials.
Pakiranja po 1, 4 ali 10 vial.
The following response rates were observed:
Ugotovili so naslednje deleže odziva:
Table 5: Proportion of complete responders by day in the combined TIH studies Day 4
Preglednica 5: Delež bolnikov s popolnim odzivom po dnevih v združenih raziskavah TIH
Acute phase reaction, pain
Reakcija akutne faze, bolečina
If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Če se pojavi hipokalciemija, hipofosfatemija ali hipomagneziemija, je lahko potrebno kratkotrajno zdravljenje z dodajanjem.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP .
- Sleepiness.
- Zaspanost.
- Low level of red blood cells (anaemia).
- Nizko število rdečih krvnih celic (anemija).
Nausea, vomiting, decreased appetite
Navzea, bruhanje, zmanjšan apetit
- The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
- Običajni posamezni odmerek je 4 mg. - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, odvisno od tega, kako izrazite so vaše težave z ledvicami.
Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Starost, telesna masa, spol in očistek kreatinina ne vplivajo na sistemsko izpostavljenost zoledronski kislini.
In long-term animal studies, zoledronic acid inhibits bone resorption without adversely affecting the formation, mineralisation or mechanical properties of bone.
V dolgoročnih študijah na živalih zoledronska kislina zavira resorpcijo kosti, ne da bi neugodno vplivala na nastajanje, mineralizacijo ali mehanske lastnosti kosti.
Pyrexia, fatigue
Pireksija, utrujenost
These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Ti prečni ali kratki poševni zlomi se lahko pojavijo kjerkoli na stegnenici, od tik pod malim trohantrom do tik nad suprakondilarno razširitvijo.
Zoledronic acid Actavis is supplied as packs containing 1, 4 or 10 vials.
Zdravilo Zoledronska kislina Actavis je opremljeno v pakiranjih, ki vsebujejo 1, 4 ali 10 vial.
The most frequent finding in repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound's pharmacological antiresorptive activity.
Najpogostejša ugotovitev v študijah večkratnih odmerkov je bilo povečanje primarne spongioze v metafizah dolgih kosti pri rastočih živalih pri skoraj vseh odmerkih; ta ugotovitev odraža farmakološki antiresorpcijski učinek zdravila.
Additional information on handling of Zoledronic acid Actavis, including guidance on preparation of reduced doses, is provided in section 4.2.
Dodatne informacije o ravnanju z zdravilom Zoledronska kislina Actavis, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.