FrancophonIA/ELRC3.0 huggingface dataset:
English: Before inserting a cartridge in Terrosa Pen write down the batch (Lot) number of the cartridge and its first injection date on a calendar.
Slovenian: Preden vstavite vložek v pripomoček Terrosa Pen, morate na koledar zabeležiti številko serije (Lot) vložka in datum prvega injiciranja.
English: • Turn the dose knob clockwise until you see a droplet sign on the dose display.
Slovenian: • Gumb za odmerjanje obrnite v smeri urinega kazalca, dokler na prikazu odmerka ne vidite znaka kapljice.
English: Posology The recommended dose of Terrosa is 20 micrograms administered once daily.
Slovenian: Odmerjanje Priporočeni odmerek zdravila Terrosa je 20 mikrogramov enkrat dnevno.
English: In patients with moderate renal impairment, teriparatide should be used with caution.
Slovenian: Pri bolnikih z zmerno okvarjenim delovanjem ledvic moramo teriparatid uporabljati previdno.
English: Seek immediate medical advice if you have any health concern.
Slovenian: Če imate kakšne zdravstvene težave, nemudoma poiščite zdravniško pomoč.
English: Terrosa can be injected at meal times.
Slovenian: Zdravilo Terrosa si lahko injicirate v času obrokov.
English: Rare (may affect up to 1 in 1,000 people):
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov):
English: 5 How to store Terrosa Contents of the pack and other information
Slovenian: Shranjevanje zdravila Terrosa Vsebina pakiranja in dodatne informacije
English: Gently hold a skin fold between the thumb and index finger.
Slovenian: Med palcem in kazalcem prsta nežno držite kožno gubo.
English: Check the label of the cartridge before its insertion into the cartridge holder.
Slovenian: Preverite nalepko vložka preden ga vstavite v nosilec vložka.
English: The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in limb, headache and dizziness.
Slovenian: Najpogosteje poročane neželeni učinki pri bolnikih, zdravljenih s teriparatidom, so slabost, bolečine v okončinah, glavobol in omotica.
English: However, for the treatment initiation a cartridge and pen pack should be used containing one carton of Terrosa cartridge and one carton of Terrosa Pen.
Slovenian: Vendar je potrebno za začetek zdravljenja uporabiti komplet vložka in peresnika, ki vsebuje eno škatlo vložka Terrosa in eno škatlo s Terrosa Pen peresnikom.
English: It should be administered exclusively with the Terrosa Pen reusable, multidose medicine delivery system and the injection needles which are listed as compatible in the instructions which are provided with the pen.
Slovenian: Zdravilo se daje izključno s sistemom Terrosa Pen za dostavo zdravila v več odmerkih in za večkratno uporabo ter z injekcijskimi iglami, ki so navedene kot združljive v navodilih, priloženih peresniku.
English: Leave the cartridge in the pen.
Slovenian: Vložek pustite v peresniku.
English: Terrosa Pen parts push button; display window; threaded rod; flange; Terrosa cartridge; peel foil; pen needle; inner needle cap; outer needle cap; pen cap; cartridge holder, dosage knob, housing
Slovenian: Terrosa Pen deli pritisni gumb; zaslon; navojna palica; prirobnica; Terrosa vložek; odstranljiva folija; igla peresnika;
English: After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9% and 4% compared with placebo (p<0.001).
Slovenian: Po 19 mesecih (mediana) zdravljenja se je mineralna gostota kosti (BMD) povišala v ledvenem delu hrbtenice oziroma celem kolku, za 9 % oziroma 4 % v primerjavi s placebom (p < 0,001).
English: • Pull out the pen slowly.
Slovenian: • Počasi izvlecite iglo peresnika.
English: Insert the cartridge into the pen before the first use as detailed in the pen instructions.
Slovenian: Pred prvo uporabo vstavite vložek v peresnik, kot je podrobno opisano v navodilih za uporabo peresnika.
English: The expected effects of overdose include nausea, vomiting, dizziness, and headache.
Slovenian: Pričakovani učinki prevelikega odmerjanjavključujejo slabost, bruhanje, omotico in glavobol.
English: Display does not return to start position after injection.
Slovenian: Po injiciranju se zaslon ne vrne v začetni položaj.
English: For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.290.68), p<0.0001.
Slovenian: Pri bolnicah, pri katerih so opravili radiografijo osnovnega stanja in radiografijo za spremljanje stanja, je bila incidenca novih zlomov vretenc 28/516 (5,4 %) v skupini s teriparatidom in 64/533 (12,0 %) pri bolnicah, zdravljenih z rizedronatom, relativno tveganje (95-odstotni IZ) = 0,44
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En odmerek 80 mikrolitrov vsebuje 20 mikrogramov teriparatida*.
English: Do not drop your pen and avoid knocking it against hard surfaces.
Slovenian: Ne mečite peresnika in izogibajte se udarcem s trdimi površinami.
English: Press the push button and hold it pressed in until the dose indication has returned to the start position.
Slovenian: Pritisnite gumb in ga držite pritisnjenega, dokler se prikazovalnik odmerka ne vrne v začetni položaj.
English: Terrosa contains a clear and colourless solution.
Slovenian: Zdravilo Terrosa vsebuje bistro in brezbarvno raztopino.
English: • Hold the pen with the needle pointing upwards.
Slovenian: • Držite peresnik tako, da je igla obrnjena navzgor.
English: Terrosa cartridge and pen pack: 1 carton of Terrosa cartridge (containing 1 cartridge) and 1 carton of Terrosa Pen (containing 1 pen).
Slovenian: Terrosa komplet vložka in peresnika: 1 škatla vložka Terrosa (z 1 vložkom) in 1 škatla Terrosa Pen sistema (z enim peresnikom).
English: - Prior external beam or implant radiation therapy to the skeleton.
Slovenian: - Teleradioterapija ali brahiradioterapija za zdravljenje okostja v preteklosti.
English: Abbreviations: N = number of patients randomly assigned to each treatment group; CI = confidence interval.
Slovenian: Okrajšave: N = število bolnikov, naključno vključenih v vsako skupino zdravljenja; IZ = interval zaupanja aIncidenca vretenčnih zlomov je bila ocenjena pri 448 bolnikih, ki so prejemali placebo in
English: F: Attach a new pen needle as follows: • Pull off the peel foil.
Slovenian: F: Novo iglo peresnika pritrdite na naslednji način:
English: Terrosa cartridge and pen pack: 1 Terrosa cartridge packed in a plastic tray sealed with lid foil and packed in a carton and 1 Terrosa Pen packed into a separate carton.
Slovenian: Terrosa komplet vložka in peresnika: 1 vložek Terrosa pakiran na plastičen podstavek s tesnilnim pokrovom iz folije in pakiran v škatli ter 1 pripomoček Terrosa Pen v ločeni škatli.
English: Paediatric population and young adults with open epiphyses The safety and efficacy of teriparatide in children and adolescents less than 18 years have not been established.
Slovenian: Varnost in učinkovitost teriparatida pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: One cartridge of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
Slovenian: En vložek po 2,4 ml vsebuje 600 mikrogramov teriparatida (kar ustreza 250 mikrogramom na ml).
English: One cartridge of 2.4 mL of solution contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
Slovenian: En vložek z 2,4 ml raztopine vsebuje 600 mikrogramov teriparatida (kar ustreza 250 mikrogramom na ml).
English: After 12 months, BMD had increased in the lumbar spine and total hip by 5% and 1%, respectively, compared with placebo.
Slovenian: Po 12 mesecih se je mineralna gostota kosti (BMD) v ledvenem delu hrbtenice oziroma celem kolku povišala za 5 % oziroma 1 % v primerjavi s placebom.
English: The mean increase in BMD from 18 to 24 months was 1.4%, 1.2%, and 1.6% at the lumbar spine, total hip and femoral neck, respectively.
Slovenian: Povprečno povečanje BMD od 18. do 24. meseca je bilo v ledvenem delu hrbtenice 1,4 %, celem kolku 1,2 % in vratu stegnenice 1,6 %.
English: • Press the push button until the dose indication has returned to the start position.
Slovenian: • Pritisnite gumb, dokler se indikator odmerka ne vrne v začetni položaj.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1159/001 [1 cartridge]
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/16/1159/001 [1 vložek]
English: Read the patient information leaflet for Terrosa cartridge provided separately.
Slovenian: Preberite navodila za uporabo bolnikom za vložek Terrosa, ki so priložena ločeno.
English: - The other ingredients are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Slovenian: - Druge sestavine zdravila so: koncentrirana ocetna kislina (ledocet), manitol, metakrezol in natrijev acetat trihidrat, klorovodikova kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH), voda za injekcije.
English: Terrosa is contraindicated for use during breast-feeding.
Slovenian: Zdravilo Terrosa je med dojenjem kontraindicirano.
English: Studies in rabbits have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na kuncih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: C: Remove the empty cartridge, in the case of changing cartridge.
Slovenian: C: Odstranite prazen vložek, če menjate vložek.
English: These are listed in the instruction for use for the pen.
Slovenian: Te so navedene kot združljive v navodilih za uporabo peresnika.
English: • Do not remove the cartridge from the Terrosa Pen before it is empty.
Slovenian: Ponovno pritrdite pokrovček za pero • Ne odstranite vložka iz Terrosa Pen preden se izprazni.
English: Detailed and updated information on this product is available by scanning the QR code included below or the outer carton with a smartphone.The same information is also available on the following URL: www.terrosapatient.com
Slovenian: Podrobni in posodobljeni podatki o tem zdravilu so na voljo s skeniranjem spodnje kode QR alin zunanje ovojnine s pomočjo pametnega telefona.
English: Read both the package leaflet of Terrosa cartridge and the instructions for use of the Terrosa Pen before use.
Slovenian: Pred uporabo preberite priloženo navodilo za vložek Terrosa in navodila za uporabo pripomočka Terrosa Pen!
English: The threaded rod cannot be pushed back to the pen housing entirely.
Slovenian: Navojne palice ni mogoče v celoti potisniti nazaj v ohišje peresnika.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu .
English: Teriparatide is a bone formation agent to treat osteoporosis.
Slovenian: Teriparatid je zdravilo za tvorbo kostnine za zdravljenje osteoporoze.
English: Each cartridge and pen should be used by only one patient.
Slovenian: Vsak vložek in vsak injekcijski peresnik sta namenjena za uporabo pri samo enem bolniku.
English: Do not use the pen if the cartridge is cloudy, discoloured or contains particles.
Slovenian: Peresnika ne uporabljajte, če je vložek moten, obarvan ali vsebuje delce.
English: Terrosa cartridges are to be used in Terrosa Pen reusable, multidose pen device exclusively and must not be used with any other pen.
Slovenian: Vložki zdravila Terrosa se uporabljajo izključno s peresnikom Terrosa Pen za dostavo več odmerkov in za večkratno uporabo in se jih ne sme uporabljati z nobenim drugim peresnikom.
English: Do not use this medicine after the expiry date which is stated on the carton and the cartridge after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in injekcijskem peresniku po oznaki EXP/Uporabno doRok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1159/001 [1 cartridge] EU/1/16/1159/002 [3 cartridges] EU/1/16/1159/003 [cartridge and pen pack]
Slovenian: EU/1/16/1159/001 [1 vložek] EU/1/16/1159/002 [3 vložki] EU/1/16/1159/003 [komplet vložka in peresnika]
English: In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7%, 0.9%, and 0.4%, respectively.
Slovenian: Pri bolnikih zdravljenih s teriparatidom, se je BMD ledvenega dela hrbtenice od 18. do 24. meseca dodatno povečala za 1,7 %, celega kolka za 0,9 % in vratu stegnenice za 0,4 %.
English: Each cartridge contains 2.4 mL of solution corresponding to 28 doses of 20 micrograms (per 80 microliters).
Slovenian: En vložek vsebuje 2,4 ml raztopine, kar ustreza 28 odmerkom po 20 mikrogramov (na 80 mikrolitrov).
English: The pen is customised for use with Terrosa only.
Slovenian: Peresnik je prilagojen izključno za uporabo z zdravilom Terrosa.
English: At the 18 month endpoint, teriparatide significantly increased lumbar spine BMD (7.2%) compared with alendronate (3.4%) (p<0.001).
Slovenian: V končni točki po 18 mesecih je teriparatid značilno zvišal mineralno gostoto kosti (BMD) v ledvenem delu hrbtenice (7,2 %) v primerjavi z alendronatom (3,6 %) (p < 0,01).
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja povečano znojenje
English: • Remove and dispose the inner needle cap.
Slovenian: • Odstranite in zavrzite notranji pokrovček igle.
English: • Pull off the peel foil.
Slovenian: • Odstranite folijo.
English: Change the cartridge and the pen needle and perform priming according to the pen preparation.
Slovenian: Zamenjajte vložek in iglo peresnika ter pripravite peresnik v skladu z navodili za pripravo.
English: Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Slovenian: Koncentrirana ocetna kislina (ledocet), natrijev acetat trihidrat, manitol, metakrezol, voda za injekcije, klorovodikova kislina (za uravnavanje pH) in natrijev hidroksid (za uravnavanje pH).
English: a The incidence of vertebral fractures was assessed in 448 placebo and 444 teriparatide patients who had baseline and follow-up spine radiographs.
Slovenian: 444 bolnikih, ki so prejemali teriparatid in so imeli radiografijo osnovnega stanja in ponovne ocene hrbtenice.
English: An instruction for use which is included in the carton of the delivery system is also available to instruct patients on the correct use of the pen.
Slovenian: Za navodila bolnikom o pravilni uporabi injekcijskega peresnika so na voljo tudi Navodila za uporabo, ki so priložena v škatli dostavnega sistema.
English: Terrosa should not be used if the solution is cloudy, coloured or contains visible particles.
Slovenian: Zdravila Terrosa ne smete uporabiti, če je raztopina motna, obarvana ali vsebuje vidne trdne delce.
English: Use a new needle for every injection.
Slovenian: Za vsako injiciranje uporabite novo iglo.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Terrosa 20 mcg/80 mcL injection teriparatide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Terrosa 20 mcg/80 mcl, injekcija teriparatid s.c.
English: Terrosa must not be used with any other pen.
Slovenian: Zdravila Terrosa ne smete uporabljati z drugimi peresniki.
English: Hold it pressed in until the dose indication has turned back to the start position.
Slovenian: Držite ga pritisnjenega, dokler se kazalo odmerka ne vrne v začetni položaj.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not remove the cartridge from the pen during the 28 days of use.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA V 28-dnevnem obdobju uporabe, vložka ne smete odstraniti iz peresnika.
English: After insertion of the cartridge into the pen, the combined pen and cartridge should be returned to the refrigerator immediately after use.
Slovenian: Po vstavitvi vložka v peresnik morate peresnik z vložkom takoj po uporabi shraniti nazaj v hladilnik.
English: Do not use Terrosa if solid particles appear or if the solution is cloudy or coloured.
Slovenian: Ne uporabljajte zdravila Terrosa, če opazite trdne delce v raztopini ali je raztopina videti motna ali obarvana.
English: If pregnancy occurs, Terrosa should be discontinued.
Slovenian: Če zanosijo, mora biti zdravilo Terrosa ukinjeno.
English: Write down the batch (Lot) number of each cartridge and its first injection date on a calendar.
Slovenian: Zabeležite številko serije (Lot) vsakega vložka in datum prvega injiciranja na koledar.
English: • piles (haemorrhoids)
Slovenian: • hemoroidi (zlata žila)
English: 1 Terrosa cartridge
Slovenian: 1 vložek Terrosa
English: 1103 Budapest Hungary
Slovenian: 1103 Budapest MADŽARSKA
English: Each dose of 80 microliters contains 20 micrograms of teriparatide.
Slovenian: En odmerek 80 mikrolitrov vsebuje 20 mikrogramov teriparatida.
English: Dizziness, headache, sciatica, syncope
Slovenian: Bolezni živčevja omotica, glavobol, išias, sinkopa
English: Compatible pen needles
Slovenian: Združljive igle za peresnik
English: Terrosa cartridges are designed to be used only with the Terrosa Pen reusable, multidose delivery system and compatible pen needles.
Slovenian: Vložki zdravila Terrosa so zasnovani izključno za uporabo z iglami, združljivimi s peresnikom Terrosa Pen za dostavo več odmerkov in za večkratno uporabo.
English: Reset the pen by simply turning back the dose knob anticlockwise to the start position.
Slovenian: Ponastavite peresnik tako, da preprosto zavrtite gumb za odmerjanje v nasprotni smeri urinega kazalca v začetni položaj.
English: Use a new injection needle for each injection to prevent contamination and safely dispose of the needle after use.
Slovenian: Za vsako injiciranje uporabite novo injekcijsko iglo, da boste preprečili kontaminacijo.
English: The date of first injection should also be recorded on the outer carton of Terrosa (see the provided space on the box: {First use:}) (see section 3.
Slovenian: Datum prvega injiciranja morate zabeležiti tudi na zunanjo ovojnino zdravila Terrosa (glejte za to namenjeno okence na škatli {Prva uporaba:}) (glejte poglavje 3).
English: The date of first injection should also be recorded on the outer carton of Terrosa (see the provided space on the box: {First use:}).
Slovenian: Datum prvega injiciranja je treba zabeležiti tudi na zunanjo ovojnino zdravila Terrosa (glejte za to namenjeno okence na škatli {Prva uporaba:}).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1159/003 [cartridge and pen pack]
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/16/1159/003 [komplet vložka in peresnika]
English: INFORMATION IN BRAILLE Terrosa cartridge and pen
Slovenian: PODATKI V BRAILLOVI PISAVI Terrosa vložek in peresnik
English: • a compatible pen needle
Slovenian: • združljivo iglo za pero
English: • spinning sensation
Slovenian: • občutek vrtenja
English: 1103 Budapest, Hungary
Slovenian: 1103 Budimpešta, Madžarska
English: If you become pregnant while using Terrosa, Terrosa should be discontinued.
Slovenian: Če zanosite med uporabo zdravila Terrosa, vam morajo zdravilo Terrosa ukiniti.
English: 3401 Burgdorf, Switzerland
Slovenian: Pravni proizvajalec: Ypsomed AG Brunnmattstrasse 6 3401 Burgdorf, Švica
English: The date of first injection should also be written on the outer carton of Terrosa (see the provided space on the box: {First use:}).
Slovenian: Datum prvega injiciranja mora biti zabeležen tudi na zunanji ovojnini zdravila Terrosa (glejte za to namenjeno okence na škatli {Prva uporaba:}).
English: A new, sterile pen needle must be used for every injection.
Slovenian: Za vsako injiciranje morate uporabiti novo, sterilno iglo za peresnik.
English: • Press the push button fully in.
Slovenian: • Do konca pritisnite gumb.
English: • Handle your pen with care.
Slovenian: • S peresnikom ravnajte pazljivo.
English: For the correct use of this medicine it is very important to closely follow the detailed Instructions for Use of your pen which are provided with the pen.
Slovenian: da natančno upoštevate podrobna Navodila za uporabo vašega peresnika, ki so priložena peresniku.
English: Each cartridge contains 28 doses of 20 micrograms (per 80 microliters).
Slovenian: En vložek vsebuje 28 odmerkov po 20 mikrogramov (na 80 mikrolitrov).
English: Each Terrosa cartridge contains 28 doses of fixed 80 microlitres Terrosa.
Slovenian: Vsak od vložkov Terrosa vsebuje 28 nespremenljivih odmerkov po 80 mikrolitrov zdravila Terrosa.
English: - Replace the cap on your pen.
Slovenian: - Znova namestite pokrovček na vaš peresnik.
English: NN: {Not applicable in case of cartridge and pen pack.}
Slovenian: NN: { Ne pride v poštev v primeru kompleta vložka in peresnika}
English: Terrosa must not be transferred to a syringe.
Slovenian: Zdravila Terrosa ne smete prenesti v injekcijsko brizgo.
English: Terrosa is supplied in a cartridge.
Slovenian: Zdravilo Terrosa je na voljo v napolnjenem vložku.
English: Make sure that there are at least 28 days remaining before its expiry date.
Slovenian: Prepričajte se, da je zdravilo v vložku uporabno še najmanj 28 dni.
English: Sodium acetate trihydrate Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi koncentrirana ocetna kislina (ledocet) manitol metakrezol natrijev acetat trihidrat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: Do not tilt the pen after the needle has been inserted into the skin.
Slovenian: Po vbodu igle v kožo ne nagibajte peresnika.
English: Terrosa contains sodium
Slovenian: Zdravilo Terrosa vsebuje natrij
English: Attach the pen needle
Slovenian: Pritrdite iglo peresnika
English: INFORMATION IN BRAILLE Terrosa cartridge
Slovenian: PODATKI V BRAILLOVI PISAVI Terrosa vložek
English: Some patients may feel dizzy after injecting Terrosa.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri bolniki lahko po injiciranju zdravila Terrosa čutijo omotico.
English: At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5%, 2.6 % and 3.9% respectively.
Slovenian: Po 24 mesecih se jim je mineralna gostota kosti (BMD) v ledvenem delu hrbtenice v povprečju povečala za 10,5 %, v celem kolku za 2,6 % in v vratu stegnenice za 3,9 %.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.4 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritus and minor bleeding at injection site
Slovenian: bolečina v prsnem košu, astenija, blagi in prehodni učinki na mestu injiciranja,
English: NAME OF THE MEDICINAL PRODUCT Terrosa 20 micrograms/80 microliters solution for injection
Slovenian: IME ZDRAVILA Terrosa 20 mikrogramov/80 mikrolitrov raztopina za injiciranje
English: • irregular heartbeats
Slovenian: • nepravilni srčni utripi
English: • increase in blood calcium level
Slovenian: • zvišan nivo kalcija v krvi
English: Terrosa 20 micrograms/80 microliters solution for injection Teriparatide
Slovenian: Terrosa 20 mikrogramov/80 mikrolitrov raztopina za injiciranje teriparatid
English: Use a new needle for your injection on the following day.
Slovenian: Ne ponovite injiciranja isti dan. Naslednji dan uporabite novo iglo za injiciranje.
English: Do not refill the cartridge.
Slovenian: Vložka ne polnite znova.
English: Spillage from pen is observed.
Slovenian: Opazno je razlitje iz peresnika.
English: • increased need to pass water
Slovenian: • zvečana potreba po mokrenju
English: 1 Terrosa Pen
Slovenian: 1 pripomoček Terrosa Pen
English: 3 mL cartridge (siliconised Type I glass), with a plunger stopper (bromobutyl) and disc seal (aluminium and rubber liner seals), packed in a plastic tray sealed with lid foil and packed in a carton.
Slovenian: 3-mililitrski vložek (silikonizirano steklo tipa I) z batom, zaporko (bromobutil) in zaporno ploščico