natgillin/translations-raw huggingface dataset:
It is given to cats with a pre-filled spot-on pipette, a small plastic container which is already filled with the correct amount of ProMeris needed to treat one cat (ProMeris is available in 2 different sizes for various cat weights). 
Daje se mačkam na kožo s predhodno napolnjeno merilno kapalko, majhno plastično cevko, ki je že napolnjena z ustrezno količino zdravila ProMeris, potrebno za zdravljenje ene mačke (zdravilo ProMeris je na voljo v 2 različnih velikostih za različno težke mačke).
Data were provided on the pharmaceutical quality, the safety of the product in cats and the safety in humans (people in contact with the product) and the environment. 
Predloženi so bili podatki o farmacevtski kakovosti, varnosti zdravila za mačke ter njegovi varnosti za ljudi (za ljudi, ki pridejo v stik z zdravilom) in okolje.
When administering ProMeris, the user should not smoke, eat or drink. 
Med dajanjem zdravila ProMeris je prepovedano kaditi, piti ali jesti.
This product is specifically developed for cats and should not be used in any other animal species. 
To zdravilo je bilo razvito posebej za mačke in se ga ne sme uporabljati pri drugih živalskih vrstah.
ProMeris should not be used in cats less than 8 weeks old since it has not been sufficiently studied in these animals. 
Zdravila ProMeris se ne sme uporabljati pri mačkah, ki so stare manj kot 8 tednov, saj pri tej skupini živali zdravilo ni bilo zadostno raziskano.
As other products of this group, ProMeris should not be used in sick animals or cats that have just recovered from illness. 
Kot to velja za ostala zdravila iz te skupine zdravil, se zdravila ProMeris ne sme uporabljati pri bolnih živalih ali mačkah, ki so pravkar okrevale od bolezni.
As a precautionary measure, direct contact with the treated cat should be avoided and children should not be allowed to play with a treated animal until the application site is dry. 
Kot preventivni ukrep se je treba izogibati direktnemu stiku z zdravljeno mačko in preprečiti otrokom igranje z zdravljeno živaljo, dokler področje nanosa ni suho.
The medicine killed fleas within 24 hours after treatment and its effectiveness lasted 6 weeks. 
Zdravilo ubije bolhe v 24 urah po uporabi zdravila, njegov učinek pa traja najmanj 6 tednov.
Cats from various breeds (mainly European shorthair), age groups and weight that were infested with fleas were either treated with ProMeris or with other products authorised in the EU for this indication. 
Mačke različnih ras (večinoma evropske kratkodlake mačke), starostnih skupin in z različnimi telesnimi masami, ki so bile bolhave, so zdravili bodisi z zdravilom ProMeris ali z drugimi zdravili, ki so bila v EU odobrena za to indikacijo.
What is the risk associated with ProMeris? 
Kakšna tveganja so povezana z zdravilom ProMeris?
ProMeris is an “ectoparasiticide”, this means that it will kill parasites that live on the skin or in the fur of animals, such as fleas and ticks. 
ProMeris je “ektoparaziticid”, to pomeni, da uničuje zajedalce, ki živijo na koži ali v dlaki živali, kot so denimo bolhe in klopi.
What benefit has ProMeris shown during the studies? 
Kakšne koristi je zdravilo ProMeris izkazalo med raziskavami?
The effectiveness of metaflumizone against flea infestations in cats was investigated in laboratory studies and in a field trial. 
Učinkovitost metaflumizona zoper bolhavost pri mačkah je bila raziskana v laboratorijskih raziskavah in preskušanju na terenu.
The Committee recommended that ProMeris be given a marketing authorisation. 
Zato je priporočil, da se za zdravilo ProMeris odobri dovoljenje za promet.
The effectiveness was measured looking at the number of fleas on the cat at various times up to 2 months after application. 
Učinkovitost so merili z ugotavljanjem števila živih bolh na mački ob različnih časovnih obdobjih, in sicer do 2 mesecev po uporabi zdravila.
It can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis, an allergic reaction of cats to flea bites. 
Lahko se uporablja tudi kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe, t.j.
Why has ProMeris been approved? 
Zakaj je bilo zdravilo ProMeris odobreno?
ProMeris is a clear yellow to amber solution that contains metaflumizone as active substance. 
ProMeris je bistra, rumena do jantarna raztopina, ki vsebuje zdravilno učinkovino metaflumizon.
There may be a change in appearance of the fur (oily appearance and clumping or spiking of hair) at the application site. 
Na mestu nanosa se lahko pojavijo spremembe dlake (masten izgled, vozlanje in zlepljanje dlake).
The active substance of ProMeris, metaflumizone, interferes with the neural activity of the fleas and consequently leads to the death of these parasites. 
Metaflumizon, zdravilna učinkovina v zdravilu ProMeris, ovira živčne funkcije bolh, čemur posledično sledi smrt teh zajedalcev.
If a cat licks the application area, the cat might salivate considerably for a short period. 
Če mačka liže mesto nanosa, se lahko pojavi kratko obdobje prekomernega slinjenja.
What is ProMeris used for? 
Za kaj se zdravilo ProMeris uporablja?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProMeris exceed the risks for the treatment and prevention of flea infestations in cats. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila ProMeris za zdravljenje in preprečevanje bolhavosti pri mačkah večje od z njim povezanih tveganj.
The results of the field trial showed that ProMeris is effective in the treatment and prevention of flea infestations in cats. 
Rezultati preskušanj na terenu so pokazali, da je zdravilo Pro Meris učinkovito pri zdravljenju in preprečevanju bolhavosti pri mačkah.
ProMeris is used to treat and to prevent flea infestations in cats. 
Zdravilo ProMeris se uporablja za zdravljenje in preprečevanje bolhavosti pri mačkah.
What is ProMeris? 
Kaj je zdravilo ProMeris?
How does ProMeris work? 
Kako zdravilo ProMeris deluje?
Skin should be washed and eyes should be rinsed with water, if accidental exposure occurred. 
V primeru nehotenega stika je treba kožo in oči sprati z vodo.
How has ProMeris been studied? 
Kako je bilo zdravilo ProMeris raziskano?
Skin contact with the pipette content should be avoided. 
Pazite, da kapalka ne pride v stik s kožo.
The content of the pipette is squeezed onto the skin after parting the fur between the shoulder blades of the cat. 
Mački razmaknemo dlako med lopaticama, da se prikaže koža, in na to mesto stisnemo vsebino merilne kapalke.
Once applied, it remains active for up to 6 weeks. 
Učinek zdravila traja najmanj 6 tednov po njegovi uporabi.
Other pharmaceutical forms/strengths may be more appropriate for this population. 
Druge farmacevtske oblike/jakosti so morda bolj primerne za to populacijo.
This medicinal product is authorised in the Member States of the EEA under the following names: {As currently approved}. 
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: {Kot trenutno odobreno}.
This medicine is available as 5 mg, 10 mg, 20 mg and 40 mg chewable tablets and 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets. 
To zdravilo je na voljo kot 5 mg, 10, mg, 20 mg in 40 mg žvečljive tablete in 10 mg, 20 mg, 40 mg in 80 mg filmsko obložene tablete.
4.7 Effects on ability to drive and use machines {As currently approved}. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji {Kot trenutno odobreno}.
4.5 Interaction with other medicinal products and other forms of interaction {As currently approved}. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij {Kot trenutno odobreno}.
QUALITATIVE AND QUANTITATIVE COMPOSITION {As currently approved}. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA {Kot trenutno odobreno}.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Special populations {As currently approved}. 
Posebne populacije {Kot trenutno odobreno}.
PHARMACEUTICAL FORM {As currently approved}. 
FARMACEVTSKA OBLIKA {Kot trenutno odobreno}.
4.8 Undesirable effects {As currently approved}. 
4.8 Neželeni učinki {Kot trenutno odobreno}.
4.6 Pregnancy and lactation {As currently approved}. 
4.6 Nosečnost in dojenje {Kot trenutno odobreno}.
WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR {As currently approved}. 
KAJ JE ZDRAVILO X IN ZA KAJ GA UPORABLJAMO {Kot trenutno odobreno}.
6.5 Nature and contents of container {As currently approved}. 
6.5 Vrsta ovojnine in vsebina {Kot trenutno odobreno}.
− {As currently approved}. 
− {Kot trenutno odobreno}.
4.3 Contraindications {As currently approved}. 
4.3 Kontraindikacije {Kot trenutno odobreno}.
MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}> 
IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica] [Glejte Dodatek I - Izpolni država članica] {Ime in naslov} <{tel.}> <{fax}> <{e-mail}>
{PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. 
Zdravilo {(Lastniško) ime} je indicirano kot dodatek k dieti za znižanje zvišanega celotnega holesterola, holesterola LDL, apolipoproteina B in trigliceridov pri bolnikih odraslih, mladostnikih in otrocih starejših od 10 let s primarno hiperholesterolemijo, vključno s familiarno hiperholesterolemijo (heterozigotna oblika) ali kombinirano (mešano) hiperlipidemijo (kar ustreza tipoma IIa in IIb po Fredricksonovi klasifikaciji), kadar odziv na dieto in druge nefarmakološke ukrepe ni zadosten.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients {As currently approved}. 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi {Kot trenutno odobreno}.
{As currently approved}. 
{Kot trenutno odobreno}.
POSSIBLE SIDE EFFECTS {As currently approved}. 
MOŽNI NEŽELENI UČINKI {Kot trenutno odobreno}.
6.2 Incompatibilities {As currently approved}. 
6.2 Inkompatibilnosti {Kot trenutno odobreno}.
4.9 Overdose {As currently approved}. 
4.9 Preveliko odmerjanje {Kot trenutno odobreno}.
4.4 Special warnings and precautions for use {As currently approved}. 
4.4 Posebna opozorila in previdnostni ukrepi {Kot trenutno odobreno}.
6.6 Special precautions for disposal {As currently approved}. 
6.6 Posebni varnostni ukrepi za odstranjevanje {Kot trenutno odobreno}.
6.4 Special precautions for storage {As currently approved}. 
6.4 Posebna navodila za shranjevanje {Kot trenutno odobreno}.
LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase. 
Povprečne vrednosti holesterola LDL, trigliceridov, holesterola VLDL in apolipoproteina B so se pri vseh preiskovancih zmanjšale do 2. tedna.
What {PRODUCT NAME} contains {As currently approved}. 
Kaj vsebuje zdravilo X {Kot trenutno odobreno}.
{PRODUCT NAME} 80 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally] 
NAVODILO ZA UPORABO {(Lastniško) ime} 80 mg filmsko obložene tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 10 mg film-coated tablet 
IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime}10 mg filmsko obložena tableta
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 80 mg film-coated tablet 
IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 80 mg filmsko obložena tableta
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 20 mg film-coated tablet 
IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 20 mg filmsko obložena tableta
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 40 mg film-coated tablet 
IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 40 mg filmsko obložena tableta
6.3 Shelf life {As currently approved}. 
6.3 Rok uporabnosti {Kot trenutno odobreno}.
{PRODUCT NAME} 10 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally] 
NAVODILO ZA UPORABO {(Lastniško) ime} 10 mg filmsko obložene tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
{PRODUCT NAME} 40 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally] 
NAVODILO ZA UPORABO {(Lastniško) ime} 40 mg filmsko obložene tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
BEFORE YOU TAKE {PRODUCT NAME} {As currently approved}. 
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO X {Kot trenutno odobreno}.
{PRODUCT NAME} 20 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally] 
NAVODILO ZA UPORABO {(Lastniško) ime} 20 mg filmsko obložene tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
-1 Live non-pathogenic Escherichia coli O8:K87: 
-1 Živ nepatogeni sev Escherichia coli O8:K87: 1.3∙108 do 9.0∙108 k.e.
* colony forming units 
* kolonijske enote
Vial (glass) 50 doses 4 vials Zero days 
4 viale Nič dni
EU (MA) Number Invented name 
Številka (dovoljenja za promet z zdravilom) EU
Date of latest renewal: 28 April 2017. 
Datum zadnjega podaljšanja: 28 april 2017.
Unopened bottle: 3 years. 
Neodprta steklenica: 3 leta.
A-2491 Neufeld/Leitha 
2491 Neufeld/Leitha
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2012. 
Datum prve odobritve: 3. avgust 2012.
Manufacturer Sanochemia Pharmazeutika AG 
Sanochemia Pharmazeutika AG
The occurrence of osteonecrosis is multifactorial and is associated with various risk factors. 
Pojav osteonekroze je odvisen od več dejavnikov in je povezan z različnimi dejavniki tveganja.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali če dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z svojim zdravnikom, preden vzamete to zdravilo.
- to reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour. 
- zniževanje količine kalcija v krvi pri odraslih, kadar je ta prevelika zaradi prisotnosti tumorja.
The contributive role of zoledronic acid therapy in these cases could not be excluded. 
Dodatnega vpliva zdravljenja z zoledronsko kislino v teh primerih ni bilo mogoče izključiti.
The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth except in medical emergency situations. 
Začetek zdravljenja ali nov ciklus zdravljenja je treba odložiti pri bolnikih z nezaceljenimi odprtimi lezijami mehkih tkiv v ustih, razen v medicinskih nujnih primerih.
Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis. 
Izmed teh bolnikov so številni prejemali tudi kemoterapijo in kortikosteroide in imeli znake lokalne infekcije,
Pamidronate 90 mg (N=99) *p-values compared to pamidronate. 
pamidronat 90 mg (N=99) *vrednosti p v primerjavi s pamidronatom.
• The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours. 
• Skupni čas med redčenjem, shranjevanjem v hladilniku in koncem dajanja ne sme prekoračiti
- Painful redness and/or swelling of the eye. 
- boleča rdečina in/ali oteklina očesa.
- Sleepiness. 
- zaspanost,
Zoledronic acid medac can be given to people aged 65 years and over. 
Zdravilo Zoledronska kislina medac lahko dajemo ljudem, ki so stari 65 let ali več.
Any SRE (+TIH) 
kateri koli SRE (+TIH) zlomi*
• Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1. 
• Preobčutljivost na učinkovino, na druge difosfonate ali katero koli pomožno snov, navedeno v poglavju 6.1
Your doctor, pharmacist or nurse knows how to store Zoledronic acid medac properly (see section 6). 
Zdravnik, farmacevt ali medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina medac pravilno shranjevati (glejte poglavje 6).
If a lower dose of Zoledronic acid medac is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution. 
• Če je potreben manjši odmerek zdravila Zoledronska kislina medac, najprej odvzemite ustrezni volumen, kot je navedeno spodaj, in ga nato dodatno razredčite s 100 ml infuzijske raztopine.
Proportion of patients with SREs (%) p-value 
delež bolnic/bolnikov s SREs (%) vrednost p mediana časa do
Over the first 24 hours, 39 ± 16 % of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue. 
V prvih 24 urah se izloči v urin 39 ± 16 % danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
After first opening and dilution: From a microbiological point of view the medicinal product should be used immediately. 
Po prvem odprtju in redčenju: z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
- If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic acid medac. 
- Če prejemate zdravilo za zniževanje količine kalcija v krvi, boste običajno prejeli samo eno infuzijo zdravila Zoledronska kislina medac.
The time to onset for occurrence of osteonecrosis also has similar pattern when compared to osteonecrosis of the jaw/external auditory canal. 
Tudi čas do pojava osteonekroze sledi podobnemu vzorcu kot pri osteonekrozi čeljustnice/zunanjega slušnega kanala.
Treatment of TIH 
Zdravljenje TIH
While being treated with Zoledronic acid medac, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. 
Med zdravljenjem z zdravilom Zoledronska kislina medac, morate skrbeti za dobro ustno higieno (vključno z rednim ščetkanjem zob) in hoditi na redne zobozdravstvene preglede.
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic acid medac. 
Vse bolnike je treba spodbujati, da skrbijo za dobro ustno higieno, imajo redne zobozdravstvene preglede in takoj poročajo o kakršnih koli ustnih simptomih, na primer majanju zob, bolečini ali otekanju, neceljenju ran ali izcedku med zdravljenjem z zdravilom Zoledronska kislina medac.
Other medicines and Zoledronic acid medac Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo Zoledronska kislina medac Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
* 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 
* zajema vertebralne in nevertebralne zlome ** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem NR ni bil dosežen
Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome 
akutna odpoved ledvic, hematurija, proteinurija pridobljen Fanconijev sindrom
How much Zoledronic acid medac is given - 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. 
Koliko zdravila Zoledronska kislina medac se daje - Običajni posamezni odmerek je 4 mg. - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, ki bo odvisen od tega, kako hude so vaše težave z ledvicami.
The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo. 
Pogostnost SRE (dogodki/oseba-let) je bila 0,628 z zoledronsko kislino in 1,096 s placebom.
Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of zoledronic acid along with driving and operating of machinery. 
Neželeni učinki, kot na primer vrtoglavost in somnolenca, lahko vplivajo na sposobnost vožnje in upravljanja s stroji, zato je ob uporabi zoledronske kisline potrebna previdnost pri vožnji in upravljanju strojev.
How often Zoledronic acid medac is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid medac every three to four weeks. 
Kako pogosto se daje zdravilo Zoledronska kislina medac - Če prejemate zdravilo za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste prejeli eno infuzijo zdravila Zoledronska kislina medac vsake tri do štiri tedne.
Other medicinal products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone. 
Druga zdravila, ki vsebujejo zoledronsko kislino kot zdravilno učinkovino, so na voljo za osteoporozo in za zdravljenje Pagetove bolezni kosti.
- Low level of red blood cells (anaemia). 
- konjunktivitis (vnetje očesne veznice), - nizka koncentracija rdečih krvnih celic (anemija).
Zoledronic acid medac belongs), or any of the other ingredients of this medicine (listed in section 6). 
Zoledronska kislina medac) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures. 
• zobozdravstvene bolezni v anamnezi, slaba ustna higiena, peridontalne bolezni, invazivni zobozdravstveni postopki (npr. ekstrakcije zob) in slabo prileganje protez.
− In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity. 
- In vivo: inhibicijo osteoklastne resorpcije kosti, ki spremeni mikrookolje kostnega mozga, tako da je le-to manj ugodno za rast tumorskih celic, protiangiogeno aktivnost in protibolečinsko aktivnost.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
After dilution of the concentrate the prepared solution should be clear, colourless and free of visible particles. 
Po redčenju koncentrata mora biti pripravljena raztopina bistra, brezbarvna in brez vidnih delcev.
• Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids. 
• sočasna zdravljenja: kemoterapija, inhibitorji angiogeneze (glejte poglavje 4.5), radioterapija glave in vratu, kortikosteroidi.
The reports of osteonecrosis at other sites with zoledronic acid suggest similarity in reporting frequency (femur>knee>humerus) as compared to the commonly affected sites of osteonecrosis based on anatomical factors. 
Poročila o osteonekrozi v povezavi z zoledronsko kislino na drugih lokacijah kažejo podobno pogostnost (stegnenica>koleno>nadlahtnica) kot pri z osteonekrozo običajno prizadetih lokacijah zaradi anatomskih dejavnikov.
Additional information on handling of Zoledronic acid medac, including guidance on preparation of reduced doses, is provided in section 4.2. 
Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina medac, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
Can't be sold separately. 
Prodaja posamezne enote ni možna.