natgillin/translations-raw huggingface dataset:
The active substance in Velphoro, sucroferric oxyhydroxide, is a phosphate binder.
Zdravilna učinkovina v zdravilu Velphoro, železov(III) oksihidroksid saharozni kompleks, je fosfatni vezalec.
Velphoro sucroferric oxyhydroxide
Velphoro železov(III) oksihidroksid saharozni kompleks
How is Velphoro used?
Kako se zdravilo Velphoro uporablja?
How does Velphoro work?
Kako zdravilo Velphoro deluje?
Patients should keep to their prescribed low-phosphate diets.
Največji odmerek je 3 000 mg (6 tablet) na dan. Bolniki se morajo držati predpisane diete z majhnim vnosom fosfatov.
The average half-life is of about 1.5 hours.
Povprečna razpolovna doba je približno 1,5 ure.
The disease progresses gradually so you may not feel any symptoms at first.
Bolezen napreduje postopno tako, da sprva morda ne opazite nobenih simptomov.
• Some medic may come out - this is normal.
• Nekaj zdravila lahko izteče ven - to je normalno.
You will hear and feel a click at the end.
• Na koncu boste slišali in čutili klik.
You will hear a “click” (see picture).
Pri tem boste slišali “klik” (glejte sliko).
The results for these subjects were not different from the results in the study as a whole.
Rezultati teh preiskovank se niso razlikovali od celokupnih rezultatov študije.
• Do not share your medication with others.
• Ne delite svojega zdravila z drugimi.
Date of latest renewal: 24.04.2011
Datum zadnjega podaljšanja: 24.04.2011
Never inject more than one dose in the same day.
Nikoli si ne injicirajte več kot en odmerek v enem dnevu.
This means that it is essentially “sodium-free”.
To pomeni, da je v bistvu „brez natrija“.
• Let it sit for about one minute until the medicine is completely mixed.
• Pustite ga ležati približno eno minuto, dokler se zdravilo popolnoma ne zmeša.
Please read the information in these boxes carefully - they contain important information for you.
Prosimo vas, da skrbno preberete besedila v takšnih okvirčkih - vsebujejo za vas pomembne informacije.
• loss of appetite,
• izguba apetita,
If you feel dizzy, do not drive or operate any machines until you feel better.
Če ste omotični, ne vozite ali upravljajte strojev, dokler se ne počutite bolje.
DATE OF REVISION OF THE TEXT
10 DATUM ZADNJE REVIZIJE BESEDILA
Use each needle only once.
Vsako iglo uporabite samo enkrat.
Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor.
Zaradi razlik v fiziologiji kosti med podganami in človekom, je klinični pomen teh odkritij verjetno manjši.
Cartridge: Glass Type I.
Vložek: steklo tipa I.
DK-4000 Roskilde Denmark
DK-4000 Roskilde Danska
Until further clinical data becomes available the recommended treatment time of 24 months should not be exceeded.
Dokler ni na voljo dodatnih kliničnih podatkov, 24-mesečnega priporočenega trajanja zdravljenja ne smemo preseči.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24.04.2006
9 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 24.04.2006
To prevent one or more new vertebral fractures, 48 women had to be treated for a median of 18 months for the total population.
Za preprečitev enega ali več novih vretenčnih zlomov v celotni populaciji je bilo treba 48 žensk zdraviti z mediano trajanja 18 mesecev.
Keep using Preotact for as long as your doctor prescribes it for you - normally no longer than 24 months.
Zdravilo Preotact uporabljajte tako dolgo, kakor vam ga predpisuje zdravnik - običajno ne dlje kot 24 mesecev.
The safety and efficacy of Preotact in patients under 18 years have not been studied.
Varnost in učinkovitost zdravila Preotact pri bolnikih, mlajših od 18 let, ni raziskana.
Due to the relatively short duration of the pharmacological activity of Preotact further measures should not be necessary.
Zaradi relativno kratkega trajanje farmakološke aktivnosti zdravila Preotact dodatni ukrepi niso potrebni.
• Do not use this medicine if it has not been stored correctly, even if it is not used up.
• Ne uporabljajte tega zdravila, če ni bilo pravilno shranjeno, čeprav še ni porabljeno.
Do not push it back until you are instructed to do so in this leaflet.
Ne pritiskajte ga nazaj, dokler vam tega ne svetujejo navodila v tem priročniku.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/339/003
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/06/339/003
No differences in Preotact pharmacokinetics were detected with regard to age (range 47-88 years).
Niso odkrili razlik v farmakokinetiki zdravila Preotact glede na starost (obseg 47-88 let).
If you forget to take Preotact (or cannot take Preotact at your usual time), take it as soon as possible on that day.
Če pozabite uporabiti zdravilo Preotact (ali zdravila Preotact ne morete uporabiti ob običajni uri), ga uporabite čimprej na tisti dan.
Preotact should not be used in children or adolescents under 18 years old.
Zdravilo Preotact se ne sme uporabljati pri otrocih in mladostnikih mlajših od 18 let.
Interindividual variability in systemic clearance is about 15%.
Interindividualna variabilnost sistemskega očistka je približno 15%.
Consequently, no interaction with other medicinal products would be anticipated and no specific drug-drug interactions studies were performed.
Zato se ne pričakuje interakcij z drugimi zdravili, niti niso bile opravljene specifične študije interakcij z drugimi zdravili.
Your doctor may advise you to take supplementary calcium and vitamin D. Your doctor will tell you how much you should take each day.
Zdravnik vam bo morda svetoval, da jemljete dopolnila kalcija in vitamina D. Zdravnik vam bo povedal, kakšen odmerek morate vzeti dnevno.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
The steps you have to go through for each of the 14 injections:
Za vsako od 14 injekcij morate opraviti naslednje korake:
It is especially common in women after the menopause.
Zlasti pogosta je pri ženskah po menopavzi.
Caution should be exercised in
Previdnost je potrebna pri
Osteoporosis is a disease that causes bones to become thin and fragile.
Osteoporoza je bolezen, zaradi katere postanejo kosti tanke in krhke.
• if you have high levels of alkaline phosphatase (an enzyme produced by the organism; may signal certain medical conditions, related to bones and liver);
• če imate visoke ravni alkalne fosfataze(encim, ki ga proizvaja organizem; lahko signalizira določena medicinska stanja v povezavi s kostmi in jetri);
The dose counter has now decreased by one.
Števec odmerkov se je sedaj zmanjšal za eno enoto.
• Check that the medicine is clear.
• Preverite, če je zdravilo bistro.
• pain in arms and legs (extremities),
• bolečine v rokah in nogah (okončinah),
Stopper (center and end): Bromobutyl rubber, grey.
Zamašek (osrednji in končni): bromobutilna guma, siva.
The hypercalcemia was transient and was reported most frequently in the first 3 months of treatment.
Hiperkalciemija je bila prehodna in najpogosteje poročana v prvih 3 mesecih zdravljenja.
• fast or irregular heart beats,
• hiter ali nepravilen srčni utrip,
Furthermore, parathyroid hormone is not protein bound and has a low volume of distribution.
Poleg tega se obščitnični hormon ne veže na beljakovine in ima majhen volumen porazdelitve.
Each pen should be used by only one patient.
Isti peresnik sme uporabljati samo en bolnik.
• Throw away the needle as you have been instructed by your doctor or nurse
• Zavrzite iglo, kot vam je naročil vaš zdravnik ali medicinska sestra.
It is unknown whether recombinant human parathyroid hormone is excreted in the milk of lactating animals.
Ni znano, ali se rekombinantni človeški obščitnični hormon izloča v materinem mleku živali, ki dojijo.
This leaflet was last approved in MM/YYYY
Navodilo je bilo odobreno MM/LLLL
• A small air bubble may remain in the pre-filled pen - this is normal.
• V napolnjenem injekcijskem peresniku lahko ostane majhen zračni mehurček - to je normalno.
Precautions to be taken before handling or administering the medicinal product For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Previdnostni ukrepi potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Za navodila glede rekonstitucije zdravila pred dajanjem, glejte poglavje 6.6.
• Use a new needle for each injection and throw the needle away after each use.
• Za vsako injiciranje uporabite novo iglo in zavrzite iglo po vsaki uporabi.
The needle pre-filled pen is full number of index outer needle cover needle inner needle cover
Igla pre-filled pen is full number of doses left pre-filled pen is empty index outer needle cover needle inner needle cover
• The pre-filled pen has an expiration date printed on it; do not use the medicine after this date.
• Na napolnjenem injekcijskem peresniku je odtisnjen rok uporabnosti; ne uporabljajte zdravila po tem datumu.
Continued treatment for up to 24 months in an open-label extension of this study resulted in a continued increase in BMD.
Pri nadaljevanju zdravljenja do 24 mesecev v odprtem podaljšanju te študije je prišlo do nadaljnjega povečevanja BMD.
• The medicine should not be used for more than 28 days after it has been mixed.
• Zdravila se ne sme uporabljati več kot 28 dni potem, ko je bilo zmešano.
Inclusion criteria were; women between 55 and 85 years of age with BMD T-scores below -2.5 or below -2 and at least one additional risk factor for fracture.
Vključitveni kriterij so bile ženske med 55. in 85. letom starosti s T-točkovanjem BMD pod -2,5 oziroma pod -2 in najmanj enim dodatnim dejavnikom tveganja za zlom.
Patients receiving cardiac glucosides
Bolnice, ki prejemajo srčne glukozide
As some episodes of dizziness have been described in patients treated with Preotact, patients should refrain from driving or using machines until symptoms have subsided.
Poročali so nekaj primerih omotice pri bolnikih, ki so se zdravili z zdravilom Preotact, zato bolniki ne smejo voziti ali upravljati strojev, dokler simptomi ne izzvenijo.
Similarly, volumetric trabecular BMD at the total hip increased by 4.7%.
Podobno se je volumetrični trabekularni BMD celotnega kolka povečal za 4,7%.
All women were given calcium (400-500 mg) and vitamin D (400 IU) supplements.
Vse ženske so prejemale dodatke kalcija (400-500 mg) in vitamina D (400 i.e.).
• If you have just mixed a new pre-filled pen you can use the needle already on.
• Če ste pravkar zmešali nov napolnjen injekcijski peresnik, lahko uporabite že nameščeno iglo.
Do not take a double dose to make up for a forgotten dose.
Ne uporabite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists.
Vendar če imate osteoporozo, se bolj nagnjeni k zlomom kosti, zlasti v hrbtenici, kolku in zapestjih.
What Preotact is and what it is used for
Kaj je zdravilo Preotact in za kaj ga uporabljamo
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu /
In these women with a positive titre, there was no evidence of hypersensitivity reactions, allergic reactions, effects on bone mineral density response, or effects on serum calcium.
Pri ženskah s pozitivnim titrom ni bilo dokazov o preobčutljivostni reakciji, alergijski reakciji, učinkih na odziv mineralne gostote kosti ali učinkih na serumske ravni kalcija.
Reconstituted solution: 28 days
EXP Pripravljena raztopina: 28 dni
In general, serum calcium levels return to baseline levels 24 hours after dosing.
Na splošno se serumske ravni kalcija vrnejo na izhodiščne ravni 24 ur po odmerjanju.
Sodium chloride, mannitol, citric acid monohydrate, hydrochloric acid, metacresol, sodium hydroxide, water for injections.
Natrijev klorid, manitol, citronska kislina monohidrat, klorovodikova kislina, metakrezol, natrijev hidroksid, voda za injekcije.
• If elevated levels continue, Preotact therapy should be stopped and the patient monitored until the abnormal values have reverted to normal
• Če so vrednosti še naprej zvišane, moramo prekiniti zdravljenje z zdravilom Preotact in bolnico spremljati, dokler se nenormalne vrednosti ne vrnejo v normalno območje.
Similar increases occurred at the femoral neck, trochanter, and intertrochanter.
Podobne povečke so opazili za femoralni vrat, trohanter in intertrohanter.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE
• Calcium and vitamin D supplementation should be withdrawn
• Dopolnjevanja kalcija in vitamina D je treba prekiniti.
Parathyroid hormone is the principal regulator of serum calcium homeostasis.
Obščitnični hormon je poglavitni regulator homeostaze serumskega kalcija.
If no underlying condition is found, the following management procedures should be followed:
Če ne odkrijemo osnovne bolezni, moramo upoštevati naslednje postopke obravnave bolnice:
The effects of overdose that might be expected include delayed hypercalcemia, nausea, vomiting, dizziness and headache.
Učinki prevelikega odmerjanja, ki jih lahko pričakujemo, vključujejo zakasnjeno hiperkalciemijo, slabost, bruhanje, omotico in glavobol.
• if you have other bone disease (including hyperparathyroidism or Paget's disease);
• če imate druge bolezni kosti (vključno s hiperparatiroidizmom in Pagetovo boleznijo);
• receive heart medicine (e.g. digoxin also known as digitalis).
• prejemate zdravila za srce (npr.: digoksin, znan tudi kot digitalis).
It may also cause back pain, loss of height, and a curved back.
Lahko povzroči tudi bolečine v hrbtu, nižanje telesne višine in ukrivljen hrbet.
Only mix one pen at the time.
Zmešajte samo po en peresnik naenkrat.
A user manual is included in the box to instruct patients on the correct use of the pen.
V škatli so priložena navodila za uporabo, ki bolnice poučijo o pravilni uporabi peresnika.
The pre-filled pen contains medicine for 14 days.
Napolnjen injekcijski peresnik vsebuje zdravilo za 14 dni.
INFORMATION ON BRAILLE Preotact
PODATKI V BRAILLOVI PISAVI Preotact
These carboxy-terminal fragments are thought to play a role in the regulation of parathyroid hormone activity.
Ti fragmenti s karboksi-koncem naj bi imeli vlogo pri uravnavanju aktivnosti obščitničnega hormona.
The pharmacokinetics of parathyroid hormone in patients with severe renal impairment (creatinine clearance of less than 30 ml/min) has not been investigated.
Farmakokinetika obščitničnega hormona pri bolnikih s hudo okvaro ledvic (očistek kreatinina manj kot 30 ml/min) ni raziskana.
Patients must be trained to use the proper injection techniques (see section 6.6).
Bolnice je treba usposobiti za pravilno izvajanje tehnike injiciranja (glejte poglavje 6.6).
Preotact has been administered in single doses up to 5 micrograms/kg and in repeated doses of up to 3 micrograms/kg/day for 3 days and up to 2.5 micrograms/kg/day for 7 days.
Zdravilo Preotact je bilo uporabljeno v posameznih odmerkih do 5 µg/kg ter v ponavljajočih se odmerkih do 3 µg/kg/dan za 3 dni in do 2,5 µg/kg/dan za 7 dni.
• Do not use this medicine if you notice that it became cloudy or coloured.
• Ne uporabljajte tega zdravila, če opazite, da je postalo motno ali obarvano.
Point the needle straight up and press the blue injection button until it is fully depressed.
Usmerite iglo naravnost navzgor in pritisnite na modri injekcijski gumb, dokler se popolnoma ne pogrezne.
Like all medicines, Preotact can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The effects of Preotact on bone architecture were evaluated using quantitative computed tomography (QCT) and peripheral QCT.
Učinki zdravila Preotact na arhitekturo kosti so ovrednotili s kvantitativno računalniško tomografijo (quantitative computed tomography, QCT) in periferno QCT.
• Gently rotate the pre-filled pen back and forth a few times to mix the medicine.
• Nežno zavrtite napolnjen peresnik nekajkrat naprej in nazaj, zato da zmešate zdravilo
Overall, approximately 19% of the subjects in each treatment group had at least 1 prevalent vertebral fracture at baseline.
Na splošno je imelo v izhodišču približno 19% preiskovank v vsaki skupini najmanj 1 prevladujoč vretenčni zlom.
Metacresol Water for injections
Metakrezol Voda za injekcije
• The frequency of Preotact dosing should be changed to 100 micrograms every other day
• Pogostnost odmerjanja zdravila Preotact je treba spremeniti na 100 µg vsake 2 dni.
• water for injections
• vodo za injekcije.
There is no specific antidote for Preotact.
Proti zdravilu Preotact ni specifičnega antidota.
uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (<1/10,000), including isolated reports.
(≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000) in zelo redki
Before taking your first injection with a new pre-filled pen you have to add a needle and mix the medicine by following the instructions in this leaflet.
Pred prvo injekcijo z novim napolnjenim injekcijskim peresnikom morate dodati iglo in zmešati zdravilo v skladu z navodili v tej brošuri.
• with pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism
• s predhodno obstoječo hiperkalciemijo in drugimi motnjami fosfokalcijeve presnove
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
When the dose counter is at 0, the pre-filled pen is empty and you must take a new pre-filled pen.
Ko je števec odmerkov na 0, je peresnik prazen in morate vzeti nov napolnjen injekcijski peresnik.
The skeletal effects of parathyroid hormone depend upon the pattern of systemic exposure.
Farmakodinamični učinki Učinki obščitničnega hormona na okostje so odvisni od vzorca sistemske izpostavljenosti.
In the 24-month alendronate combination therapy study (PaTH), the effects of Preotact on bone architecture were also evaluated using QCT.
V 24-mesečni študiji zdravljenja s kombinacijo z alendronatom (PaTH) so učinke zdravila Preotact na arhitekturo prav tako ovrednotili s QCT.
Preotact reduces the risk of breaking spinal bones because it increases your bone quality and strength.
Zdravilo Preotact zmanjša tveganje zloma hrbteničnih kosti, ker izboljša kakovost in moč kostnine.
• if you have cancer of the bones;
• če imate kostnega raka;
Other medicines and Preotact
Druga zdravila in zdravilo Preotact:
Data support continuous treatment with Preotact for up to 24 months (see section 4.4).
Podatki podpirajo neprekinjeno zdravljenje z zdravilom Preotact do 24 mesecev (glejte poglavje 4.4).
Parathyroid hormone is not excreted from the body in its intact form.
Obščitnični hormon se iz telesa ne izloča v nespremenjeni obliki.
The dose counter now shows 14 and the pre-filled pen is ready to use.
Števec odmerkov zdaj kaže 14 in napolnjen injekcijski peresnik je pripravljen za uporabo.
Reconstituted solution: chemical and physical in-use stability has been demonstrated for 28 days at 28°C.
Pripravljena raztopina: kemijska in fizikalna obstojnost je dokazana za 28 dni pri 2 °C -8 °C.
DO NOT SHAKE; shaking may cause denaturation of the active substance.
NE STRESAJTE; stresanje lahko povzroči denaturacijo zdravilne učinkovine.
There was no significant difference between the treatment groups in the incidence of any non-vertebral clinical fracture: 5.52% for Preotact vs. 5.86% for placebo.
Med skupinama preiskovank ni bilo statistično značilnih razlik v pojavnosti kakršnegakoli nevretenčnega kliničnega zloma: 5,52% za zdravilo Preotact v primerjavi s 5,86% za placebo.
After you do this, the Preotact pre-filled pen is ready for use and the medicine is ready to be injected into the abdomen (under the skin).
Ko to storite, je Preotact napolnjen injekcijski peresnik pripravljen za uporabo in zdravilo je pripravljeno za injiciranje v trebuh (pod kožo).
The occurrence of osteosarcoma only occurred at doses that produced systemic exposures > 27-times higher than that observed in humans at the 100 micrograms dose.
Osteosarkom se je pojavil le pri odmerkih, ki so povzročili sistemsko izpostavitev, ki je bila ≥ 27-krat večja od izpostavitve pri človeku po odmerku 100 µg.
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Dokazano je bilo zmanjšanje pojavnosti vretenčnih zlomov, ne pa zlomov kolka.
Pharmacotherapeutic group: Calcium homeostatis, parathyroid hormones and analogues, ATC code: H05AA03.
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Zdravila za uravnavanje homeostaze kalcija, obščitnični hormoni in analogi, oznaka ATC: H05AA03.
• Do not shake the pre-filled pen (neither before nor after injection) as it may destroy the effect of the medicine.
• Ne stresajte napolnjenega injekcijskega peresnika (bodisi pred injiciranjem bodisi po injiciranju), saj se lahko izniči delovanje zdravila.
After reconstitution the liquid should be clear and colourless.
Po pripravi mora nastati tekočina, ki je bistra in brez barve.
Effects on serum calcium concentrations
Učinki na serumske koncentracije kalcija
Animal studies of reproductive toxicity are incomplete (see section 5.3).
Študije vpliva na sposobnost razmnoževanja pri živalih so nepopolne (glejte poglavje 5.3).
The absolute bioavailability of 100 micrograms of parathyroid hormone after subcutaneous administration in the abdomen is 55%.
Absolutna biološka dostopnost 100 µg obščitničnega hormona po podkožnem dajanju v trebuh je 55%.
The recommended dose of Preotact is 100 micrograms per day.
Priporočeni odmerek zdravila Preotact je 100 mikrogramov na dan.
Serum calcium concentrations reach a maximum between 6 and 8 hours post dose and normally return to baseline by 20 to 24 hours after each administration of parathyroid hormone.
Serumske koncentracije kalcija dosežejo najvišjo vrednost od 6 do 8 ur po odmerku, nato pa se običajno vrnejo na izhodiščno raven 20 do 24 ur po prejemu obščitničnega hormona.
Urine calcium/creatinine ratio increased Urine calcium increased
Zvišano razmerje urinskega kalcija/kreatinina Zvišana raven kalcija v urinu
Parathyroid hormone N=1341
N=1341
Therefore if any blood samples are taken from a patient for monitoring of calcium levels, this should be done at least 20 hours after the most recent injection.
To pomeni, da je treba vse vzorce krvi bolnic za spremljanje ravni kalcija odvzeti najmanj 20 ur po zadnjem injiciranju.
Hypercalcemia was reported in 25.3% of patients and hypercalciuria in 39.3% of patients treated with Preotact.
O hiperkalciemiji so poročali pri 25,3% bolnic, o hiperkalciuriji pa pri 39,3% bolnic, ki so prejemale Preotact.
If you forget to use Preotact
Če ste pozabili uporabiti zdravilo Preotact
The Preotact pre-filled pen has been designed especially to make it easy for you to take your osteoporosis treatment.
Preotact napolnjen injekcijski peresnik je posebno oblikovan z namenom, da vam olajša zdravljenje osteoporoze.
Dosage adjustment based on age is not required.
Odmerka ni treba prilagajati glede na starost.
• Take your daily dose or store the pre-filled pen
• Vzamete svoj dnevni odmerek ali shranite napolnjen injekcijski peresnik
• with skeletal malignancies or bone metastases.
• s skeletnimi malignostmi ali kostnimi metastazami
• with hypersensitivity to parathyroid hormone or to any of the excipients (see section 6.1)
• s preobčutljivostjo za obščitnični hormon ali katerokoli pomožno snov (glejte poglavje 6.1)