natgillin/translations-raw huggingface dataset:
The use of this veterinary medicnal product is only allowed under the particular conditions established by the European Community legislation on the control of Avian Influenza. 
Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena samo v posebnih razmerah, ki so opredeljene v zakonodaji Evropske skupnosti za nadzor nad aviarno influenco.
PACKAGE SIZE 250 ml 
VELIKOST PAKIRANJA 250 ml
No information is available on vaccination in the presence of maternally derived antibodies. 
Ni podatkov o cepljenju v prisotnosti materinih protiteles.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. 
Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
Allow the vaccine to reach a temperature of 15°C - 25°C and shake well before use. 
Cepivo ogrejte na 15 °C - 25 °C in ga pred uporabo dobro pretresite.
All food producing species All food producing species 
vse živali za proizvodnjo živil vse živali za proizvodnjo živil glicin vse živali za proizvodnjo živil
The Applicant should agree to specify the NZ-Amine(s) used in production and only to source Tryptose and these specified NZ-Amine(s) from specified companies from whom suitable ‘milk statements' have been submitted in the dossier, together with details of the countries of origin of the source animals. 
Predlagatelj mora soglašati, da bo podrobno navedel NZ-amin(e), ki jih bo uporabil v proizvodnji in kot vir za triptozo in podrobno naveden(e) NZamin(e) uporabljal samo podjetja, za katera so v dokumentaciji primerne 'izjave o mleku' in podrobni podatki o državah izvora živali, ki služijo kot vir.
ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use. 
NASVET O PRAVILNI UPORABI ZDRAVILA Cepivo ogrejte na 15 °C-25 °C in ga pred uporabo dobro pretresite.
Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. 
Pokazalo se je, da trajajo pri piščancih zaščitne ravni protiteles v serumu najmanj 7 mesecev, študije z drugimi cepnimi sevi pa so pokazale, da bi bila pri piščancih po dveh odmerkih cepiva protitelesa v serumu predvidoma prisotna najmanj 12 mesecev.
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N6 emulsion for injection for chickens 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobilis Influenza H5N6, emulzija za injiciranje za piščance
This vaccine has been tested for safety in chickens and only some supportive data for safety in ducks are available. 
Varnost cepiva je testirana pri piščancih, o njegovi varnosti pri racah pa je na voljo nekaj spremljajočih podatkov.
SPECIAL STORAGE CONDITIONS Store refrigerated (2°C to +8°C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C do +8 °C).
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 250 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 250 ml
E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER 
E. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect neuraminidase antibodies. 
Če ima divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N6 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
From 8-14 days old: 0.25 ml subcutaneously 
Od 8 do 14 dni starosti: 0,25 ml subkutano
ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous injection Read the package leaflet before use. 
POT(I) UPORABE ZDRAVILA Intramuskularno ali subkutano Pred uporabo preberite navodilo za uporabo.
From 14 days to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly 6 weeks and older: 0.5 ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination. 
Od 14 dni do 6 tednov starosti: 0,25 ali 0,5 ml subkutano ali intramuskularno Stari 6 tednov in starejši: 0,5 ml subkutano ali intramuskularno Pri bodočih nesnicah in matičnih jatah moramo cepljenje ponoviti 4 do 6 tednov po prvem cepljenju.
Liquid light paraffin 234.8 mg/0.5 ml 
Redko tekoči parafin, 234,8 mg/0,5 ml
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous injection of 0.25 or 0.5 ml, depending on the age. 
Intramuskularno ali subkutano odmerek po 0,25 ali 0,5 ml, glede na starost.
Adjuvant: Liquid light paraffin 234.8 mg/0.5 ml 
Adjuvans: Redko tekoči parafin, 234,8 mg/0,5 ml
The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/90: 
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Naslednje snovi, ki jih vsebuje končni izdelek, so vključene v Dodatek II Uredbe Sveta (ES) št.
250 or 500 ml multidose glass bottle 250 or 500 ml multidose PET bottle The bottles are closed with a rubber stopper and an aluminium cap. 
Večodmerna steklenička po 250 ali 500 ml Večodmerna plastenka iz PET po 250 ali 500 ml Steklenička in plastenka sta zaprti z gumijastim zamaškom in aluminijasto zaporko.
250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET). 
Stekleničke po 250 ml ali 500 ml iz stekla tipa II ali plastenke po 250 ml ali 500 ml iz polietilen tereftalata (PET).
Test for identification: A final product batch test should be introduced to identify the neuraminidase component and confirm that the vaccine has the correct composition. 
KONTROLA KAKOVOSTI KONČNEGA IZDELKA II.E.2 Istovetnost in vsebnost zdravilnih učinkovin Preskus istovetnosti: Vpeljati je treba končni preskus serije izdelka za istovetnost sestavine nevraminidaze in potrditev, da ima cepivo pravilno sestavo.
Polysorbate 80 Sorbitan mono oleate (E494) 
Druge določbe redko tekoči parafin vse živali za proizvodnjo živil polisorbat 80 sorbitan monooleat (E494)
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H5. 
Cepivo vzbudi aktivno imunost proti virusu aviarne influence tipa A, podtip H5.
Adjuvant: Liquid paraffin 
Adjuvans: redko tekoči parafin
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5ml contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA En odmerek po 0,5 ml vsebuje:
Liquid light paraffin Polysorbate 80 
Seznam pomožnih snovi redko tekoči parafin polisorbat 80 sorbitan monooleat glicin
Intervet International BV Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands 
Intervet International BV Wim de Korverstraat 35 NL-5831 AN Boxmeer Nizozemska
Manufacturer for the batch release: 
Izdelovalec, odgovoren za sproščanje serije:
INDICATION(S) Active immunisation against avian influenza type A, subtype H5. 
INDIKACIJA(E) Aktivna imunizacija proti aviarni influenci tipa A, podtip H5
No information is available on the safety of this vaccine for birds in lay. 
Ni podatkov o varnosti cepiva pri pticah v obdobju nesnosti.
Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands 
Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer Nizozemska
Tryptose and NZ-Amines: The use of unspecified countries of origin of the cows providing the milk and unspecified suppliers of the tryptose and NZ-Amine is not considered acceptable. 
in nenavajanje dobaviteljev triptoze in NZ-aminov je nesprejemljivo.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE
Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35 
Imetnik dovoljenja za promet z zdravilom: Intervet International B.V.
Store at +2°C to +8°C. 
Shranjujte pri temperaturi 2 °C do 8 °C.
EXPIRY DATE <EXP {month/year}> Once broached, use within 8 hours. 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA <EXP {mesec/leto}>
Results should be provided for final product tests on three batches of Nobilis Influenza H5N6, to demonstrate batch consistency. 
II.E.9 Konsistentnost serij Kot dokazilo konsistentnosti serij je treba predložiti rezultate preskusov končnega izdelka za tri serije Nobilisa Influenza H5N6.
QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 0.5 ml contains: 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN En odmerek po 0,5 ml vsebuje:
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON {250ml Bottle / 500ml Bottle} 
NALEPKA NA STEKLENIČKI {250 ml/500 ml}
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH 
C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION For subcutaneous or intramuscular use. 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
4.8 Interactions with other medicinal products and other forms of interaction No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
4.9 Amounts to be administered and administration route For subcutaneous or intramuscular use. 
Za subkutano ali intramuskularno uporabo.
{250ml/500ml} 
ŠKATLA {steklenička po 250 ml / steklenička po 500 ml }
This summary was last updated in 02-2012. 
Povzetek je bil nazadnje posodobljen 02-2012.
Temodal capsules have been studied in four main studies. 
Kapsule zdravila Temodal so raziskovali v štirih glavnih študijah.
The European Commission granted a marketing authorisation valid throughout the European Union for Temodal on 26 January 1999. 
Evropska komisija je dovoljenje za promet z zdravilom Temodal, veljavno po vsej Evropski uniji, odobrila dne 26. januarja 1999.
The full EPAR for Temodal 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 Temodal je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is available as capsules (5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg) and as a powder to be made up into a solution for infusion (drip into a vein). 
Na voljo je v obliki kapsul (5 mg, 20 mg, 100 mg, 140 mg, 180 mg in 250 mg) in praška za pripravo raztopine za infundiranje (kapalne infuzije v veno).
If the solution for infusion is used, it should be given over a period of 90 minutes. 
Kadar se uporablja raztopina za infundiranje, jo je treba bolniku dovajati v obdobju 90 minut.
MTIC binds to the DNA of cells while they are reproducing, which stops cell division. 
MTIC se veže na celice DNK, medtem ko se te razmnožujejo, kar prepreči njihovo delitev.
• adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour). 
• odraslih z novo diagnosticiranim multiformnim glioblastomom (vrsto zelo agresivnega možganskega tumorja).
EPAR summary for the public temozolomide 
Povzetek EPAR za javnost temozolomid
Temodal capsules should be taken whole without food. 
Kapsule zdravila Temodal je treba zaužiti cele, brez hrane.
The dose of Temodal depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day. 
Odmerek zdravila Temodal je odvisen od telesne površine (izračunane glede na telesno višino in maso bolnika) in znaša od 75 do 200 mg na kvadratni meter, enkrat na dan.
A further two studies were carried out in a total of 35 patients with brain tumours to show that the capsules and solution for infusion produce the same levels of temozolomide in the blood. 
Nadaljnji dve študiji sta bili izvedeni pri skupno 35 bolnikih z možganskim tumorjem, da bi dokazali, da kapsule in raztopina za infundiranje zagotovijo enake ravni temozolomida v krvi.
The CHMP decided that Temodal's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Temodal večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Temodal. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Temodal.
What benefit has Temodal shown during the studies? 
Kakšne koristi je zdravilo Temodal izkazalo med študijami?
• adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment. 
• odraslih in otrok, starih tri leta in več, z malignim gliomom, kakršna sta multiformni glioblastom ali anaplastični astrocitom, če se je tumor po standardnem zdravljenju ponovil ali poslabšal.
Other information about Temodal 
Druge informacije o zdravilu Temodal
The other three main studies involved patients with malignant glioma that had come back or got worse after previous treatment. 
V ostale tri glavne študije so bili vključeni bolniki z malignim gliomom, ki se je po predhodnem zdravljenju ponovil ali poslabšal.
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 Temodal. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Temodal, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Treatment with Temodal should be prescribed by a doctor with experience in the treatment of brain tumours. 
Zdravljenje z zdravilom Temodal mora predpisati zdravnik, ki ima izkušnje z zdravljenjem možganskih tumorjev.
The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temodal is being used alone or with radiotherapy, and how the patient responds to treatment. 
Višina odmerka in število odmerkov sta odvisna od vrste zdravljenega tumorja, ali je bil bolnik že zdravljen, ali se zdravilo Temodal uporablja kot samostojno zdravilo ali v kombinaciji z obsevanjem in od tega, kako se bolnik odziva na zdravljenje.
Patients receiving the solution for infusion may also have injection site reactions, such as pain, irritation, itching, warmth, swelling and redness, as well as bruising. 
Pri bolnikih, ki prejemajo raztopino za infundiranje, se lahko pojavijo reakcije na mestu injiciranja, kot so bolečina, vzdraženost, srbenje, toplota, otekanje in rdečina ter podplutbe.
For more information about treatment with Temodal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Temodal preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Temodal (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, constipation, loss of appetite, alopecia (hair loss), headache, fatigue (tiredness), convulsions (fits), rash, neutropenia or lymphopenia (low white blood cell counts), and thrombocytopenia (low blood platelet counts). 
Najpogostejši neželeni učinki zdravila Temodal (opaženi pri več kot 1 od 10 bolnikov) so slabost, bruhanje, zaprtje, izguba teka, alopecija (izpadanje las), glavobol, utrujenost, konvulzije (krči), izpuščaji, nevtropenija ali limfopenija (nizko število belih krvničk) ter trombocitopenija (nizko število trombocitov).
What is the risk associated with Temodal? 
Kakšna tveganja so povezana z zdravilom Temodal?
Temodal must not be used in people who are hypersensitive (allergic) to temozolomide, any of the other ingredients or dacarbazine (another anticancer medicine). 
Zdravila Temodal ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) temozolomid, katero koli drugo sestavino zdravila ali dakarbazin (drugo zdravilo proti raku).
Temodal must not be used in patients with severe myelosuppression (a condition in which the bone marrow cannot make enough blood cells). 
Ne smejo ga uporabljati osebe s hudo mielosupresijo (obolenjem, pri katerem kostni mozeg ne tvori dovolj krvnih celic).
The main measures of effectiveness were how long the patients survived or the length of time before the patient's cancer started to get worse. 
Glavno merilo učinkovitosti sta bila čas preživetja ali čas do poslabšanja rakavega obolenja.
Two of these studies involved patients with glioblastoma multiforme: one looked at the effects of Temodal in 138 patients and the other compared Temodal with procarbazine (another anticancer medicine) in 225 patients. 
Dve od teh študij sta zajeli bolnike z multiformnim glioblastomom: v prvi so proučevali učinke zdravila Temodal pri 138 bolnikih, v drugi pa so zdravilo Temodal pri 225 bolnikih primerjali s prokarbazinom (drugim zdravilom proti raku).
In the comparative study of glioblastoma multiforme that had come back or got worse after previous treatment, it took an average of 2.9 months until the cancer got worse in patients taking Temodal, compared with 1.9 months in the patients taking procarbazine. 
V primerjalni študiji multiformnega glioblastoma, ki se je po predhodnem zdravljenju ponovil ali poslabšal, je čas do poslabšanja rakavega obolenja pri bolnikih, ki so jemali Temodal, znašal 2,9 meseca, v primerjavi z 1,9 meseca pri bolnikih, ki so jemali prokarbazin.
The final study looked at the safety and effectiveness of Temodal in the treatment of 162 patients with anaplastic astrocytoma who were in their first relapse. 
V zadnji študiji so proučevali varnost in učinkovitost zdravila Temodal pri zdravljenju 162 bolnikov z anaplastičnim astrocitomom, pri katerih se je bolezen prvič ponovila.
For the full list of all side effects reported with Temodal, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Temodal, glejte navodilo za uporabo.
Why has Temodal been approved? 
Zakaj je bilo zdravilo Temodal odobreno?
In the study of newly diagnosed glioblastoma multiforme, patients survived for an average of 14.6 months when they received Temodal and radiotherapy, compared with 12.1 months with radiotherapy alone. 
V študiji na novo diagnosticiranega multiformnega glioblastoma je povprečni čas preživetja znašal 14,6 meseca pri bolnikih, ki so prejemali zdravilo Temodal in se obenem zdravili z obsevanjem, v primerjavi z 12,1 meseca pri zdravljenju le z obsevanjem.
The first study compared the effectiveness of Temodal and radiotherapy with that of radiotherapy on its own in 573 patients with newly diagnosed glioblastoma multiforme. 
V prvi študiji so učinkovitost zdravila Temodal v kombinaciji z obsevanjem primerjali z zdravljenjem samo z obsevanjem pri 573 bolnikih, ki so imeli na novo diagnosticirani multiformni glioblastom.
The active substance in Temodal, temozolomide, belongs to a group of anticancer medicines called alkylating agents. 
Zdravilna učinkovina zdravila Temodal je temozolomid, ki spada v skupino zdravil proti raku, imenovanih alkilirajoči citostatiki.
Patients may also need to take medicines to prevent vomiting before taking Temodal. 
Preden bo bolnik vzel zdravilo Temodal, bo morda potreboval tudi zdravilo za preprečevanje bruhanja.
Temodal is used first with radiotherapy and then on its own; 
Zdravilo Temodal se najprej uporabi v kombinaciji z obsevanjem, nato pa kot samostojno zdravilo;
What is Temodal used for? 
Za kaj se zdravilo Temodal uporablja?
Temodal is used on its own in these patients. 
Pri teh bolnikih se zdravilo Temodal uporablja kot samostojno zdravilo.
Temodal is a medicine that contains the active substance temozolomide. 
Temodal je zdravilo, ki vsebuje zdravilno učinkovino temozolomid.
How has Temodal been studied? 
Kako je bilo zdravilo Temodal raziskano?
In anaplastic astrocytoma, it took an average of 5.4 months for the cancer to get worse in patients taking Temodal. 
Pri bolnikih z anaplastičnim astrocitomom, ki so jemali zdravilo Temodal, se je rakavo obolenje poslabšalo v povprečju po 5,4 meseca.
Temodal is an anticancer medicine. 
Zdravilo Temodal je zdravilo proti raku.
How does Temodal work? 
Kako zdravilo Temodal deluje?
How is Temodal used? 
Kako se zdravilo Temodal uporablja?
What is Temodal? 
Kaj je zdravilo Temodal?
Efficacy was evaluated in 2,928 patients. 
Učinkovitost so proučevali pri 2.928 bolnicah.
Other things that can increase the risk of fractures include: 
Drugi dejavniki, ki lahko povečajo tveganje za zlome, so:
• you are a smoker (as this may increase the risk of dental problems) 
• ste kadilec (to lahko poveča tveganje za zobozdravstvene težave),
This includes: 
To vključuje:
Please consult your doctor 
posvetujte se z zdravnikom;
Please see the summary of product characteristics for more information. 
Prosimo, glejte Povzetek glavnih značilnosti zdravila za več informacij.
• Placing used sharps containers in the household waste should be avoided. 
• dajanju uporabljenih zabojnikov za ostre predmete v gospodinjske odpadke se je treba izogibati;
Specific studies for the 3-monthly dosing regimen have not been performed. 
Specifičnih študij za 3-mesečno odmerjanje niso izvajali.
This was demonstrated in both the primary analysis at one year and in the confirmatory analysis at two years endpoint (Table 2). 
To je bilo dokazano v primarni analizi po enem letu in v potrditveni analizi v končni točki po dveh letih (preglednica 2).
• Needles and syringes should never be reused. 
• injekcijske igle in injekcijske brizge se nikoli ne smejo uporabiti ponovno;
This also applies to solutions used to flush butterfly and other devices. 
To velja tudi za raztopine, ki se uporabljajo za spiranje metuljčka in drugih naprav.
• Dispose of the full container according to local requirements or as instructed by your healthcare professional. 
• poln zabojnik odstranite v skladu z lokalnimi predpisi ali kot vam je naročil zdravstveni delavec.
Date of first authorisation: 19 November 2012 Date of latest renewal: 18 September 2017 
Datum prve odobritve : 19. november 2012 Datum zadnjega podaljšanja: 18. septembra 2017
• smoking cigarettes, or drinking too much alcohol 
• kajenje cigaret ali čezmerno pitje alkohola,
Your doctor may take steps to correct such changes and may give you an injection containing these minerals. 
Vaš zdravnik lahko popravi te spremembe, tako da vam da injekcijo s temi minerali.
General advice 
Splošni nasveti
• you don't receive routine dental care or have not had a dental check up for a long time 
• niste deležni redne zobozdravstvene oskrbe ali dlje časa niste opravili zobozdravniškega pregleda,
Do not use this medicine if you notice that the solution is not clear or contains particles. 
Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra ali vsebuje vidne delce.
The injection should be given into the vein by a physician or qualified/trained health care worker. 
Injekcije mora v veno dajati zdravnik ali usposobljeni zdravstveni delavec.
Two year data in study BM 16550 
Dveletni podatki iz študije BM 16550
• If you have any disturbance of mineral metabolism (such as vitamin D deficiency) 
• če imate kakršne koli motnje presnove mineralov (kot je pomanjkanje vitamina D).
• serious, potentially life-threatening allergic reaction (see section 2). 
• resna, možno življenjsko ogrožujoča alergična reakcija (glejte poglavje 2).
The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis. 
Prej ko nastopi menopavza, večje je tveganje za zlome pri osteoporozi.