natgillin/translations-raw huggingface dataset:
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.
0.5 mg/dl or 44 µmol/l;
zvišanje za 0,5 mg/dl ali 44 µmol/l;
Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
so poročali o manjšem porastu bolečin kot tisti, ki so dobivali placebo, ta razlika pa je dosegla statistično značilnost v 3., 9., 21. in 24. mesecu.
Healthcare professionals are advised not to dispose of unused Zoledronic acid medac via the domestic sewage system.
Zdravstvenim delavcem svetujemo, da neporabljenega zdravila Zoledronska kislina medac ne izlijejo v gospodinjske odplake.
Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Zdravljenje z zoledronsko kislino pri bolnikih s TIH, ki imajo tudi težko ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
After first opening: Chemical and physical in-use stability has been demonstrated for 4 days at 2 - 8°C and 25°C.
Po prvem odprtju: dokazana je bila 4-dnevna kemična in fizična stabilnost razredčenega zdravila pri 2-8 °C in 25 °C.
There are no site specific risk factors for osteonecrosis apart from additional oral risk factors for osteonecrosis of the jaw.
Dejavniki tveganja za osteonekrozo niso specifični glede na lokacijo z izjemo dodatnih oralnih dejavnikov tveganja za osteonekrozo čeljustnice.
• Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
• potentnost difosfonatov (večje tveganje pri visoko potentnih učinkovinah), pot uporabe (večje tveganje pri parenteralni uporabi) in kumulativni odmerek difosfonata.
Increasing the infusion time from 5 to 15 minutes caused a 30 % decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Podaljšanje časa infundiranja s 5 na 15 minut je povzročilo 30-odstotno znižanje koncentracije zoledronske kisline ob koncu infuzije, ni pa vplivalo na površino pod krivuljo plazemske koncentracije proti času.
Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.
Pri bolnikih, ki se zdravijo s kemoterapijo in/ali obsevanjem, jemljejo steroide, imajo operativen poseg na zobeh, niso deležni redne zobozdravstvene oskrbe, imajo bolezen dlesni, kadijo ali so se prej zdravili z difosfonati (ki se uporabljajo za zdravljenje ali preprečevanje bolezni kosti), je lahko tveganje nastanka osteonekroze čeljustnic večje.
Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Odvzemite ustrezni volumen potrebnega koncentrata, kot sledi: 4,4 ml za odmerek 3,5 mg,
• Breast-feeding (see section 4.6).
• Dojenje (glejte poglavje 4.6)
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
• Preprečevanje z okostjem povezanih dogodkov (patološki zlomi, spinalna kompresija, obsevanje ali operacija kosti ali tumorsko povzročena hiperkalciemija) pri odraslih bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti.
- Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
- Osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Intravensko dana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t1/2α 0,24 ure in t1/2β 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t1/2γ 146 ur.
Therefore, the product information should be updated to reflect in sections 4.4 and 4.8 of the SmPC a warning on osteonecrosis of other anatomical sites and add this adverse reaction with a frequency very rare.
Informacije o zdravilu je zato treba posodobiti z vključitvijo opozorila o pojavu osteonekroze na drugih anatomskih lokacijah in dodatkom tega neželenega učinka s pogostnostjo zelo redek v poglavji 4.4 in 4.8 povzetka glavnih značilnosti zdravila.
The cases from safety database did report multiple risk factors including underlying malignancy, bone metastases; concomitant therapy with steroids, angiogenesis inhibitors, radiotherapy but the exact underlying cause for the osteonecrosis was not ascertained.
Primeri iz podatkovne baze o varnosti zdravila kažejo več dejavnikov tveganja vključno z osnovno rakavo boleznijo, kostnimi zasevki, sočasnim zdravljenjem s steroidi, zaviralci angiogeneze ali radioterapijo, vendar pa natančen vzrok za pojav osteonekroze ni ugotovljen.
- have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
- imate ali ste imeli bolečino, oteklino ali odrevenelost čeljusti, občutek pritiska v čeljusti ali če se vam maje zob.
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Študije razmnoževanja pri živalih z zoledronsko kislino so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• From a microbiological point of view, the solution for infusion should be used immediately, after first opening.
• Z mikrobiološkega stališča je raztopino za infundiranje najbolje uporabiti takoj po prvem odpiranju.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje zoledronsko kislino za vse podskupine pediatrične populacije glede zdravljenja tumorsko povzročene hiperkalciemije in preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).