FrancophonIA/ELRC3.0 huggingface dataset:
English: Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000μl
Slovenian: Magnezijev klorid heksahidrat 0,3 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,02 g/1 000 ml, natrijev acetat trihidrat 4,63 g/1 000 ml, poli (0 2 hidroksietil) škrob 60 g/1 000 μl
English: Magnesium Chloride Hexahydrate 0.3g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.02g/1000ml, Sodium Acetate Trihydrate 4.63g/1000ml, Poly (0 2 Hydroxyethyl) Starch 60g/1000ml
Slovenian: Magnezijev klorid heksahidrat 0,3 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,02 g/1 000 ml, natrijev acetat trihidrat 4,63 g/1 000 ml, poli (0 2 hidroksietil) škrob 60 g/1 000 ml
English: Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Hetastarch 100g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml
Slovenian: Magnezijev klorid heksahidrat 0,2 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,25 g/1 000 ml, kalcijev klorid dihidrat 0,37 g/1 000 ml, hetaškrob 100 g/1 000 ml, natrijev acetat trihidrat 3,27 g/1 000 ml
English: Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, L-Malic Acid 0.67g/1000ml
Slovenian: Magnezijev klorid heksahidrat 0,2 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,25 g/1 000 ml, kalcijev klorid dihidrat 0,37 g/1 000 ml, natrijev acetat trihidrat 3,27 g/1 000 ml, L-jabolčna kislina 0,67 g/1 000 ml
English: Magnesium Chloride Hexahydrate 0.2g/1000ml, Potassium Chloride 0.3g/1000ml, Sodium Chloride 6.25g/1000ml, Calcium Chloride Dihydrate 0.37g/1000ml, Malic Acid 0.67g/1000ml, Sodium Acetate Trihydrate 3.27g/1000ml, Poly (0 2
Slovenian: Magnezijev klorid heksahidrat 0,2 g/1 000 ml, kalijev klorid 0,3 g/1 000 ml, natrijev klorid 6,25 g/1 000 ml, kalcijev klorid dihidrat 0,37 g/1 000 ml, natrijev acetat trihidrat 3,27 g/1 000 ml, poli (0 2 hidroksietil) škrob 60 g/1 000 ml, L-jabolčna kislina 0,67 g/1 000 ml
English: A-1121 Vienna
Slovenian: A-1121 Wien
English: Study 1 - REPLACE
Slovenian: Študija 1 - REPLACE
English: 31 December 2035.
Slovenian: 31. decembra 2035.
English: Do not clean it with any other liquids, such as alcohol.
Slovenian: Ne čistite ga z nobeno drugo tekočino, na primer z alkoholom.
English: Study 2 - RACE
Slovenian: Študija 2 - RACE
English: 30 June 2023
Slovenian: 30. junija 2023
English: Here are 4 ways to get your questions answered:
Slovenian: Odgovore na svoja vprašanja lahko dobite na 4 načine:
English: This will be the same day of the week, 2 weeks later (See Figure B).
Slovenian: To bo isti dan v tednu, 2 tedna kasneje (glejte sliko B).
English: A total of 49 patients were enrolled in the study.
Slovenian: V študiji je sodelovalo skupaj 49 bolnikov.
English: • sleep problems (feeling sleepy during the day or having trouble sleeping at night)*
Slovenian: • težave s spanjem (zaspanost podnevi ali težave s spanjem ponoči)*
English: E. Frequently Asked Questions
Slovenian: E. Pogosta vprašanja
English: Important - Read this information before getting started:
Slovenian: Pomembno - pred začetkom uporabe preberite te informacije:
English: The mean age was 47.3 years (range 19 to 74 years); 79% were females.
Slovenian: Povprečna starost je bila 47,3 leta (razpon od 19 do 74 let); 79 % je bilo žensk.
English: Patients had hypoparathyroidism for an average of 13.6 years.
Slovenian: Bolniki so imeli hipoparatiroidizem v povprečju 13,6 leta.
English: Why won't the blue button go all the way down?
Slovenian: Zakaj modri gumb ne gre do konca navzdol?
English: • Do not use this medicine if it has not been stored correctly.
Slovenian: • Zdravila ne uporabljajte, če ni bilo pravilno shranjeno.
English: Who should I contact if I am concerned about not having received a full dose or if I have symptoms of any kind?
Slovenian: Na koga naj se obrnem, če me skrbi, da nisem prejel/-a celotnega odmerka ali imam kakršne koli simptome?
English: • Get 1 alcohol pad.
Slovenian: • Priskrbite 1 alkoholno blazinico.
English: - After 2 to 4 weeks, your doctor may adjust the dose.
Slovenian: - Po 2 do 4 tednih vam bo zdravnik morda prilagodil odmerek.
English: The needle may not be attached correctly.
Slovenian: Morda igla ni pravilno pritrjena.
English: Monitoring of patients during treatment
Slovenian: Spremljanje bolnikov med zdravljenjem
English: I'm trying to push it, but I can only partially push it down.
Slovenian: Ko nanj pritiskam, gre le delno navzdol.
English: For example, if you give your first injection on a Tuesday, you will need to discard your pen 2 weeks later on a Tuesday.
Slovenian: Če si na primer daste prvo injekcijo v torek, boste morali peresnik zavreči 2 tedna kasneje v torek.
English: Interruption or discontinuation of treatment
Slovenian: Prekinitev ali opustitev zdravljenja
English: This leaflet was last revised in 07/2019.
Slovenian: Navodilo je bilo nazadnje revidirano dne 07/2019.
English: If your symptoms are severe, your doctor may give you additional medical treatment.
Slovenian: Če so vaši simptomi hudi, vam bo zdravnik morda predpisal dodatno zdravljenje.
English: You will need the following supplies for your injection:
Slovenian: Za svojo injekcijo boste potrebovali naslednje potrebščine:
English: • Otherwise, go to “Daily Injection” (Section C).
Slovenian: • Sicer pojdite na »Dnevno injiciranje« (poglavje C).
English: • Prepare a new pen every 14 days.
Slovenian: • Vsakih 14 dni pripravite nov peresnik.
English: Call your doctor.
Slovenian: Pokličite zdravnika.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
English: Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is unknown.
Slovenian: Zaradi razlik v fiziologiji kosti pri podganah in ljudeh klinična pomembnost teh ugotovitev ni znana.
English: This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Slovenian: Te informacije ne nadomestijo pogovora z zdravnikom ali medicinsko sestro glede vašega zdravstvenega stanja ali vašega zdravljenja.
English: No change, or decrease if active vitamin D was already discontinued before this titration step
Slovenian: Ne spremenite ali zmanjšajte, če je bil aktivni vitamin D že ukinjen pred tem korakom titriranja.
English: This medicinal product must not be mixed with other medicinal products.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili.
English: 19 How to discard your empty pens
Slovenian: 19 Kako odstraniti prazne peresnike
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 April 2017
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 24. april 2017
English: • Call your doctor or nurse.
Slovenian: • Pokličite zdravnika ali medicinsko sestro.
English: Your doctor will check how you respond to the treatment: - during the first 7 days of starting treatment and - if your dose is changed.
Slovenian: Zdravnik bo preveril, kako se odzivate na zdravljenje: - v prvih 7 dneh po začetku zdravljenja in - ob morebitnih spremembah odmerka.
English: Call your doctor for advice.
Slovenian: Za nasvet pokličite zdravnika.
English: A. Getting Started
Slovenian: A. Kako začeti
English: This may mean that you did not hold the needle in your thigh for the full 10 seconds.
Slovenian: To lahko pomeni, da igle niste držali v stegnu polnih 10 sekund.
English: Use in young adults
Slovenian: Uporaba pri mladih odraslih
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh poznejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Take your next dose of Natpar at the usual time the next day.
Slovenian: Naslednji odmerek zdravila Natpar vzemite ob običajni uri naslednji dan.
English: C. Daily Injection
Slovenian: C. Dnevno injiciranje
English: Each pen must be used by only one patient.
Slovenian: Vsak peresnik sme uporabljati samo en bolnik.
English: • high blood pressure*
Slovenian: • visok krvni tlak*
English: No change
Slovenian: Ne spremenite
English: • Wash your hands with soap and water and dry them with a clean towel.
Slovenian: • Roke si umijte z milom in vodo ter jih osušite s čisto brisačo.
English: Date of latest renewal: 29 April 2019
Slovenian: Datum zadnjega podaljšanja : 29. april 2019
English: When you give your next scheduled injection, be sure that you hold the needle in your thigh for at least 10 seconds.
Slovenian: Ko si daste svojo naslednjo načrtovano injekcijo, držite iglo v stegnu vsaj 10 sekund.
English: • In the Medicine Tracker below (See Figure C):
Slovenian: • Spodaj v Sledilniku zdravila (glejte sliko C):
English: In the powder:
Slovenian: V prašku:
English: You may have used all the doses in your pen.
Slovenian: Morda ste porabili vse odmerke v peresniku.
English: Symptoms related to high or low calcium levels are included in the list below.
Slovenian: Simptomi, povezani z visokimi ali nizkimi ravnmi kalcija, so navedeni v seznamu spodaj.
English: Important: Small air bubbles in the liquid may not rise to the top.
Slovenian: Pomembno: Morda majhni zračni mehurčki v tekočini ne bodo prišli do površja.
English: These medicines include calcium or vitamin D.
Slovenian: Ta zdravila vključujejo kalcij in vitamin D.
English: 17 Discard your used needles:
Slovenian: 17 Odstranjevanje uporabljenih igel:
English: If you still cannot screw it down all the way, use a new needle.
Slovenian: Če ga še vedno ne morete popolnoma priviti, uporabite novo iglo.
English: Can I use different needles?
Slovenian: Lahko uporabim druge igle?
English: Natpar should not be used in children or adolescents under 18 years old.
Slovenian: Zdravilo Natpar se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: If you do not think you received your full dose, do not take another dose.
Slovenian: Če menite, da niste prejeli celotnega odmerka, ne uporabite drugega odmerka.
English: Consider increase after at least 2-4 weeks at a stable dose
Slovenian: Razmislite o povečanju po vsaj 2-4 tednih stabilnega odmerjanja.
English: Important: Carefully read Step 10 through Step 14 before injecting.
Slovenian: Pomembno: Pred injiciranjem natančno preberite korake 10 do 14.
English: If the expiration date is before today's date or is in the next two weeks, discard the pen and use a new pen.
Slovenian: Če je datum roka uporabnosti pred današnjim datumom ali je v naslednjih dveh tednih, peresnik zavrzite in uporabite nov peresnik.
English: Do not blow on it or fan it with your hand.
Slovenian: Ne pihajte vanj in ne mahajte z roko.
English: The safety and efficacy of Natpar in children less than 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Natpar pri otrocih, mlajših od 18 let, še nista dokazani.
English: For the efficacy analysis, subjects that fulfilled three components of a three-part response criterion were considered responders.
Slovenian: Za analizo učinkovitosti so bili upoštevani kot odzivni tisti preskušanci, ki so izpolnjevali tri komponente tridelnega merila odzivnosti.
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in serijsko številko uporabljenega zdravila.
English: • Refer to the following Frequently Asked Questions.
Slovenian: • Glejte poglavje Pogosta vprašanja.
English: The other ingredients in the medicine (for all strengths) are:
Slovenian: Pomožne snovi v zdravilu (za vse jakosti) so:
English: Three of these patients had antibodies with neutralising activity; these patients maintained a clinical response with no evidence of immune-related adverse reactions.
Slovenian: Trije od teh bolnikov so imeli protitelesa z nevtralizacijsko aktivnostjo; ti bolniki so ohranili klinični odziv brez znakov neželenih učinkov, povezanih z imunostjo.
English: • need to pass urine often
Slovenian: • pogosta potreba po uriniranju
English: • Let go of the blue button.
Slovenian: • Spustite modri gumb.
English: • in blood tests, your doctor may see decreased levels of vitamin D and magnesium
Slovenian: • zdravnik lahko pri krvnih preiskavah ugotovi znižane ravni vitamina D in magnezija
English: Adjust first
Slovenian: Prilagodite najprej
English: • water for injections
Slovenian: • voda za injekcije
English: • feeling nervous or anxious
Slovenian: • občutek živčnosti ali tesnobe
English: Tests and checks
Slovenian: Preiskave in pregledi
English: • fast or uneven heart beat*,
Slovenian: • hitro ali neenakomerno bitje srca*
English: • Confirm 25-OH vitamin D stores are sufficient.
Slovenian: • prepričajte se, da so zaloge 25-OH vitamina D dovolj velike;
English: Paediatric population Pharmacokinetic data in paediatric patients are not available.
Slovenian: Pediatrična populacija Farmakokinetični podatki pri pediatričnih bolnikih niso na voljo.
English: • Do not use this medicine for more than 14 days after it has been mixed.
Slovenian: • Po mešanju zdravila ne uporabljajte več kot 14 dni.
English: Very common (1/10) Common (1/100 to
Slovenian: Organski sistem Zelo pogosti (1/10) Pogosti (od 1/100 do
English: This confirms that your pen has not been primed yet.
Slovenian: To potrjuje, da peresnik še ni bil aktiviran.
English: Patients should be monitored until signs and symptoms resolve (see sections 4.3 and 4.8).
Slovenian: Bolnike je treba spremljati, dokler znaki in simptomi ne izzvenijo (glejte poglavji 4.3 in 4.8).
English: If you do not wait 10 seconds after pressing the blue button, you may not receive your full dose.
Slovenian: Če po tem, ko pritisnete na modri gumb, ne boste počakali 10 sekund, morda ne boste prejeli celotnega odmerka.
English: Decrease or discontinue**
Slovenian: Zmanjšajte ali opustite**
English: Figure C Medicine Tracker
Slovenian: Slika C Sledilnik zdravila
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: If your ability to concentrate is impaired, you should not drive or use machines until your ability to concentrate is improved.
Slovenian: Če je vaša sposobnost koncentracije oslabljena, ne smete voziti ali uporabljati strojev, dokler se ne izboljša.
English: Your doctor will check your calcium levels.
Slovenian: Zdravnik bo izmeril vaše ravni kalcija.
English: Your doctor may tell you to change the amount of calcium or vitamin D you take (in any form, including foods rich in calcium).
Slovenian: Zdravnik vam bo morda naročil, da spremenite količino kalcija in vitamina D, ki ju jemljete (v kakršni koli obliki, tudi hrane, bogate s kalcijem).
English: Other medicines and Natpar
Slovenian: Druga zdravila in zdravilo Natpar
English: Do not place the pen under water.
Slovenian: Peresnika ne dajajte pod vodo.
English: • pain in your arms and legs
Slovenian: • bolečine v rokah in nogah
English: What Natpar is and what it is used for 2.
Slovenian: Kaj je zdravilo Natpar in za kaj ga uporabljamo 2.
English: PTH (1-84) is the principal regulator of plasma calcium homeostasis.
Slovenian: PTH (1-84) je glavni regulator homeostaze kalcija v plazmi.
English: Natpar is not protein bound and has a low volume of distribution.
Slovenian: Zdravilo Natpar se ne veže na beljakovine in ima majhen volumen porazdelitve.
English: These 17 patients had low titre anti-PTH antibodies and, of these, 3 subsequently became antibody negative.
Slovenian: Teh 17 bolnikov je imelo nizke titre protiteles anti-PTH in 3 med njimi so pozneje imeli negativne teste protiteles.
English: Treatment should be supervised by a physician or other qualified healthcare professional experienced in the management of patients with hypoparathyroidism.
Slovenian: Zdravljenje mora nadzorovati zdravnik ali drug usposobljen zdravstveni delavec z izkušnjami pri zdravljenju bolnikov s hipoparatiroidizmom.
English: Continue following the instructions, being careful not to press the blue button until instructed to do so.
Slovenian: Še naprej upoštevajte navodila in bodite previdni, da ne pritisnete modrega gumba, dokler navodila tako ne velevajo.
English: If you forget to use Natpar (or cannot inject it at your usual time), use your injection as soon as you can but do not inject more than one dose in the same day.
Slovenian: Če ste pozabili uporabiti zdravilo Natpar (ali ga niste mogli uporabiti ob običajni uri), si ga injicirajte, takoj ko se spomnite, vendar ne injicirajte več kot enega odmerka v enem dnevu.
English: Active vitamin D
Slovenian: Aktivni vitamin D
English: Try re-tightening the needle.
Slovenian: Iglo poskušajte ponovno pritrditi.
English: • When your sharps disposal container is two thirds full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
Slovenian: • Ko je vaš vsebnik za odlaganje ostrih predmetov do dveh tretjin poln, sledite lokalnim smernicam glede pravilnega načina za odstranjevanje vsebnika za odlaganje ostrih predmetov.
English: Do not touch the needle or the inside of the needle cap.
Slovenian: Ne dotikajte se igle ali notranjosti pokrovčka igle.
English: The apparent transient nature of antibodies to PTH is likely due to the low titre.
Slovenian: Navidezna prehodna narava protiteles proti PTH je verjetno posledica nizkega titra.
English: • Confirm serum magnesium is within the reference range.
Slovenian: • prepričajte se, da je koncentracija magnezija v serumu znotraj referenčnega razpona.
English: • Follow these instructions each time you use your pen to ensure that you do not skip any steps.
Slovenian: • Uporabite ta navodila za uporabo vsakič, ko uporabljate peresnik, da ne pozabite kakšnega koraka.
English: This means that further evidence on this medicinal product is awaited.
Slovenian: To pomeni, da se pričakujejo dodatni dokazi o zdravilu.
English: The final clinical study report should be submitted by:
Slovenian: Končno poročilo o klinični študiji je treba predložiti do:
English: These effects are more likely to occur: - when first starting Natpar, - if you change your Natpar dose, - if you miss one of your daily injections, - if you stop taking Natpar for a short time or altogether.
Slovenian: Ti učinki so verjetnejši: - ko začnete uporabljati zdravilo Natpar, - če spremenite odmerek zdravila Natpar, - če izpustite eno od dnevnih injekcij, - če zdravilo Natpar prenehate uporabljati za krajši čas ali popolnoma.
English: What should I do if I heard a click when I pushed the blue button to give the injection, but the blue button did not stay down?
Slovenian: Kaj naj naredim, če sem zaslišal/-a klik, ko sem modri gumb potisnil/-a navzdol za injiciranje, vendar modri gumb ni ostal pritisnjen?
English: The MAH shall plan to include regular progress reports of the registry in the PSUR.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora načrtovati, da bo redna poročila o napredku registra vključeval v PSUR.
English: Do not use this medicine after the expiry date which is stated on the pen and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na peresniku in škatli poleg oznake »EXP«.
English: This step mixes the powder and liquid.
Slovenian: S tem korakom se prašek in tekočina zmešata.
English: • Set your pen down and wait until the powder is dissolved and the liquid is colourless, or until 5 minutes have passed.
Slovenian: • Peresnik položite in počakajte, da se prašek raztopi in je tekočina brezbarvna, ali da mine 5 minut.
English: After reconstitution, the liquid must be colourless and practically free of foreign particles; parathyroid hormone (rDNA) must not be used if the reconstituted solution is cloudy, coloured, or contains visible particles.
Slovenian: Po rekonstituciji mora biti tekočina brezbarvna in praktično brez delcev; paratiroidni hormon (rDNA) se ne sme uporabljati, če je rekonstituirana raztopina motna ali obarvana, ali če vsebuje vidne delce.
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 osebi od 10):
English: • Leave the needle cap on until you are ready to inject your medicine.
Slovenian: • Pokrovček igle pustite na igli, dokler niste pripravljeni na injiciranje zdravila.
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14-a(4) Uredbe (ES) št. 726/2004 mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
English: • Gather your pen and other supplies needed as shown in the figure below and set them on a clean, flat surface.
Slovenian: • Peresnik in druge potrebščine zberite, kot je prikazano na spodnji sliki, in jih položite na čisto ter ravno površino.
English: What should I do if the medicine in the pen is frozen?
Slovenian: Kaj naj naredim, če je zdravilo v peresniku zamrznjeno?
English: • You may want to also write down the ”Date Mixed” and “Discard On” date in a place where you will remember, like a personal calendar or mobile device.
Slovenian: • Dobro je, če si »Datum mešanja« in datum »Zavrzite dne« zapišete tudi na mesto, kjer se boste tega spomnili, na primer v osebni koledar ali mobilno napravo.
English: • Store your pen away from heat and light.
Slovenian: • Peresnik shranjujte ločeno od vročine in svetlobe.
English: • fatigue and lack of energy*
Slovenian: • utrujenost in pomanjkanje energije*
English: Why does the dose counter show “14” after I have given an injection using a newly mixed pen?
Slovenian: Zakaj števec odmerkov kaže »14« po injiciranju z na novo zmešanim peresnikom?
English: After reconstitution, chemical and physical in-use stability of the solution has been demonstrated for up to 14 days when stored in a refrigerator (2°C - 8°C) and for up to 3 days when stored outside the refrigerator not above 25°C during the 14-day use period.
Slovenian: Po rekonstituciji raztopina ostane kemično in fizično stabilna do 14 dni, če je shranjena v hladilniku (2 °C-8 °C), in do 3 dni, če je v 14-dnevnem obdobju uporabe shranjena zunaj hladilnika pri temperaturi, ki ne presega 25 °C.
English: • allergic reactions (hypersensitivity), such as: swelling of the face, lips, mouth, or tongue;
Slovenian: • alergijske reakcije (preobčutljivost), kot so: otekanje obraza, ustnic, ust ali jezika, zasoplost,
English: Across all clinical studies in patients with hypoparathyroidism following treatment with Natpar for up to 4 years, the immunogenicity incidence rate was 17/87 (19.5%) and did not appear to increase over time.
Slovenian: V vseh kliničnih študijah pri bolnikih s hipoparatiroidizmom po zdravljenju z zdravilom Natpar, ki je trajalo do 4 leta, je bila stopnja pojavnosti imunogenosti 17/87 (19,5 %) in ni bilo videti, da bi se sčasoma povečala.
English: The clinical study report should be submitted by:
Slovenian: Poročilo o klinični študiji je treba predložiti do:
English: 1 • If you just completed “New Pen Setup & Mixing” (Section B), go to Step 8 below.
Slovenian: 1 • Če ste pravkar končali s »Pripravo novega injekcijskega peresnika in mešanjem zdravila« (poglavje B), pojdite na spodnji korak 8.