natgillin/translations-raw huggingface dataset:
The pen and injection needles are not included with Terrosa.
Peresnik in injekcijske igle niso priloženi zdravilu Terrosa.
EU/1/16/1159/002 [3 cartridges] {Displayed in case of 1x and 3x cartridges only.
EU/1/16/1159/002 [3 vložki] {Prikazano samo v primeru 1 ali 3 vložkov.
If you are considering stopping Terrosa treatment, please discuss this with your doctor.
Če razmišljate o prenehanju jemanja zdravila Terrosa, se o tem posvetujte s svojim zdravnikom.
Rare
Redko
• To set the fixed daily dose of 80 microliters, turn the dose knob clockwise until it stops and cannot be rotated any further.
• Če želite nastaviti dnevni odmerek 80 mikrolitrov, obračajte gumb za odmerjanje v smeri urinega kazalca dokler se ne ustavi in ga ne morete več obrniti.
The recommended dose is 20 micrograms (corresponding to 80 microliters) given once a day by injection under the skin (subcutaneous injection) in the thigh or abdomen.
Priporočeni odmerek je 20 mikrogramov (kar ustreza 80 mikrolitrom), danih enkrat na dan z injiciranjem pod kožo (subkutano injiciranje) v stegno ali trebuh.
Keep the cartridge in the outer carton in order to protect from light.
Vložek shranjujte v zunanji ovojnini za zaščito pred svetlobo.
Injecting Terrosa - Before you inject Terrosa, clean your skin where you intend to inject (thigh or abdomen) as instructed by your doctor.
- Pred injiciranjem zdravila Terrosa očistite kožo na mestu, kamor si nameravate injicirati zdravilo (stegno ali trebuh) po navodilih svojega zdravnika.
If you stop using Terrosa
Če ste prenehali uporabljati zdravilo Terrosa
What Terrosa is and what it is used for What you need to know before you use Terrosa How to use Terrosa
Kaj je zdravilo Terrosa in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Terrosa Kako uporabljati zdravilo Terrosa Možni neželeni učinki
Before using the pen device for the first time, the patient should read and understand the instructions on how to use the pen which are provided with the pen.
Pred prvo uporabo peresnika mora bolnik prebrati in razumeti navodila za uporabo peresnika, ki so priložena peresniku.
The efficacy of teriparatide in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18month primary phase of a 36-month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day).
Učinkovitost teriparatida pri moških in ženskah (N = 428), ki so prejemali podaljšano sistemsko glukokortikoidno terapijo (kar ustreza 5 mg ali več prednizona v najmanj 3 mesecih) so dokazali v 18mesečni začetni fazi 36-mesečne, randomizirane, dvojno slepe, s primerjavo kontrolirane študije (alendronat 10 mg/dan).
At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study.
V izhodišču je bila povprečna starost bolnic 72,1 let, imele pa so mediano 2 predhodna zloma vretenc; 57,9 % bolnic je že prejelo zdravljenje z bisfosfonati, 18,8 % pa jih je med študijo sočasno jemalo glukokortikoide.
Use your Terrosa Pen only as prescribed by your doctor, in this instructions for use and the Terrosa package leaflet.
Uporabljajte svoj Terrosa Pen le kot vam je predpisal vaš zdravnik, kot je opisano v teh navodilih za uporabo in kot je opisano v navodilu za uporabo zdravila Terrosa.
Terrosa is a biosimilar medicinal product.
Zdravilo Terrosa je podobno biološko zdravilo.
Make sure that the pen needle is attached correctly and sits firmly on the cartridge holder.
Prepričajte se, da je igla peresnika pravilno pritrjena in trdno nameščena na nosilcu vložka.
Before disposing of the Terrosa Pen always remove the pen needle and the cartridge.
Preden odvržete Terrosa Pen, vedno odstranite iglo peresnika in vložek.
What Terrosa looks like and contents of the pack Terrosa is a colourless and clear solution.
Izgled zdravila Terrosa in vsebina pakiranja Zdravilo Terrosa je brezbarvna in bistra raztopina.
Disposal of Terrosa Pen and used accessories
Odstranjevanje Terrosa Pen in uporabljenih pripomočkov
Terrosa contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.
Zdravilo Terrosa vsebuje učinkovino teriparatid, ki jo uporabljamo za krepitev kosti in zmanjšanje tveganja za zlome s spodbujanjem tvorjenja kostnine.
Teriparatide increases serum uric acid concentrations.
Teriparatid zvišuje serumske koncentracije sečne kisline.
If you forget an injection or cannot use your medicine at your usual time, inject it as soon as possible on that day.
Če ste pozabili uporabiti zdravilo Terrosa Če ste pozabili ali ne morete uporabiti svojega zdravila ob vaši običajni uri, si ga injicirajte, kakor hitro morete, še ta dan. Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek.
Some drops of medicine must be expelled from the needle tip.
Nekaj kapljic zdravila mora priteči iz konice igle.
You should inject Terrosa shortly after you take the pen with inserted cartridge out of the refrigerator.
Zdravilo Terrosa si vbrizgajte kmalu po tem, ko vzamete peresnik z vstavljenim vložkom iz hladilnika.
Do not remove the cartridge from the pen after first use.
Ne odstranjujte vložka iz peresnika po prvi uporabi.
• Put the Terrosa Pen, with the cartridge inserted, back into the refrigerator between 2 and 8 °C immediately after use.
• Takoj po uporabi shranite Terrosa Pen z vstavljenim vložkom nazaj v hladilnik s temperaturo med 2 in 8° C.
- After inserting a new cartridge and before the first injection from this cartridge prime the pen according to the instructions which are provided.
- Po vstavitvi novega vložka in pred prvim injiciranjem iz tega vložka pripravite peresnik za uporabo v skladu s priloženimi navodili.
Write down the first injection date of each new cartridge.
Zapišite prvi datum prvega injiciranja za vsak nov vložek.
From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days within its shelf life at 2 °C to 8 °C.
Po odprtju zdravila ga lahko, v času njegovega roka uporabnosti, z mikrobiološkega vidika shranjujemo največ 28 dni pri temperaturi med 2 °C in 8 °C.
Preparing the pen for use - To ensure the correct administration of Terrosa always read the Instructions for Use of Terrosa Pen, which is included in the carton of the pen.
Priprava peresnika za uporabo - Da boste zagotovili pravilno dajanje zdravila Terrosa, vedno preberite Navodila za uporabo pripomočka Terrosa Pen, ki so priložena v škatli s peresnikom.
In this case, remove the pen needle, change the cartridge and proceed with priming according the pen preparation steps.
V tem primeru odstranite iglo peresnika, zamenjajte vložek in nadaljujte s pripravo v skladu s postopki za pripravo peresnika.
If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Terrosa.
Če ste ženska, ki bi lahko zanosila, morate med uporabo zdravila Terrosa uporabljati učinkovito metodo kontracepcije.
• Remove the outer needle cap and save it.
• Odstranite zunanji pokrovček igle ter ga shranite.
Nausea, vomiting, hiatus hernia, gastrooesophageal reflux disease
Bolezni prebavil navzea, bruhanje, hiatalna hernija, gastroezofagealna refluksna bolezen hemoroidi
• a puncture-resistant sharps disposal container for used needles.
• na predrtje odporen zabojnik ostrih predmetov za odlaganje uporabljenih igel.
Terrosa may increase calcium in your blood or urine.
Opozorila in previdnostni ukrepi Zdravilo Terrosa lahko zviša količino kalcija v vaši krvi ali urinu.
Contact customer service if the second needle cannot be attached.
Obrnite se na podporno službo, če tudi druge igle ni mogoče pritrditi.
Subcutaneous use {1x} SC
DRUGI PODATKI subkutana uporaba {1x} s.c.
Each cartridge contains 2.4 mL of solution, enough for 28 doses.
Vsak vložek vsebuje 2,4 ml raztopine, kar zadošča za 28 odmerkov.
Do not use this pen; contact customer service.
Ne uporabljajte tega Peresnika; kontaktirajte podporo strankam.
BMD T score of −2.7, median prednisone equivalent dose of 7.5 mg/day, and 34% had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of −2.5, median prednisone equivalent dose of 10 mg/day, and 9% had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD
V osnovi so imele ženske po menopavzi povprečno starost 61 let, srednjo T-vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice -2,7, srednji ustrezni odmerek prednizona 7,5 mg/dan in 34 % jih je imelo enega ali več radiografskih zlomov; ženske pred menopavzo so imele povprečno starost 37 let, srednjo T-vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice -2,5, srednji ustrezni odmerek prednizona 10 mg/dan in 9 % jih je imelo enega ali več radiografskih zlomov; moški so imeli povprečno starost 57 let, srednjo T-vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice -2,2, srednji ustrezni odmerek prednizona 10 mg/dan in 24 % jih je imelo enega ali več radiografskih zlomov.
Weight increased, cardiac murmur, alkaline phosphatase increased *Serious cases of back cramp or pain have been reported within minutes of the injection.
Preiskave zvišana telesna masa, šum na srcu, zvišana alkalna fosfataza *Nekaj minut po injiciranju so poročali o resnih primerih krča ali bolečine v hrbtu.
After each injection, the pen should be returned to the refrigerator.
Po vsakem injiciranju morate injekcijski peresnik shraniti nazaj v hladilnik.
Women of childbearing potential should use effective methods of contraception during use of teriparatide.
Ženske, ki bi lahko zanosile, morajo med uporabo teriparatida uporabljati učinkovito metodo kontracepcije.
- As soon as you have finished the injection, attach the outer needle protective cap on the pen needle and screw the cap anti-clockwise to remove the pen needle.
- Takoj ko končate z injiciranjem, namestite zunanji zaščitni pokrovček igle na iglo peresnika in privijte pokrovček v obratni smeri urinega kazalca, da boste odstranili iglo peresnika.
No needles are supplied with this medicinal product.
Igle temu zdravilu niso priložene.
What Terrosa contains - The active substance is teriparatide.
Kaj vsebuje zdravilo Terrosa - Učinkovina je teriparatid.
Small air bubbles are visible in the cartridge.
V vložku so vidni majhni zračni mehurčki.
Rarely, patients may suffer allergic reactions consisting of breathlessness, swelling of the face, rash and chest pain.
Pri bolnikih lahko v redkih primerih pride do alergijske reakcije, ki jo vključuje zadihanost, zatekanje obraza, izpuščaj in bolečine v prsnem košu.
........................{the grey-shaded text refers to the 3x pack size}
........................{sivooznačeno besedilo se nanaša na pakiranje s 3 vložki}
The pen can be used with compatible pen needles.
Peresnik je mogoče uporabljati z združljivimi iglami za peresnik.
Of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo patients reported at least 1 adverse event.
Od bolnikov v preskušanjih teriparatida je o vsaj 1 neželenem dogodku poročalo 82,8 % bolnikov, ki so prejemali teriparatid, in 84,5 % bolnikov, ki so prejemali placebo.
Hypercalcaemia greater than 2.76 mmol/L, hyperuricaemia
Hiperholesterolemija hiperkalcemija, višja od 2,76 mmol/l, hiperurikemija hiperkalcemija, višja od 3,25 mmol/l
In addition, 15 of 214 patients in the alendronate group (7.0%) had experienced a non-vertebral fracture compared with 16 of 214 patients in the teriparatide group (7.5%) (p=0.84).
Poleg tega se je nevretenčen zlom pojavil pri 15 od 214 bolnikov v skupini z alendronatom (7,0 %) in pri 16 od 214 bolnikov v skupini s teriparatidom (7,5 %) (p = 0,84).
Teriparatide increased BMD at the total hip (3.6%) compared with alendronate (2.2%) (p<0.01), as well as at the femoral neck (3.7%) compared with alendronate (2.1%) (p<0.05).
Teriparatid je zvišal mineralno gostoto kosti (BMD) v celem kolku (7,2 %) v primerjavi z alendronatom (2,2 %) (p < 0,01), kot tudi v vratu stegnenice (3,7 %) v primerjavi z alendronatom (2,1 %) (p < 0,05).
Dispose of it correctly, for example, in a puncture-resistant sharps disposal container.
Iglo ustrezno zavrzite, na primer v na predrtje odporen zabojnik ostrih predmetov.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v
Chemical in-use stability has been demonstrated for 28 days at 2 - 8 °C.
Pri temperaturi 2 do 8 °C so dokazali 28-dnevno kemijsko stabilnost med uporabo zdravila.
Instructions for use Terrosa Pen
Navodila za uporabo Terrosa Pen
In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving teriparatide.
V velikem kliničnem preskušanju so pri 2,8 % žensk, ki so prejemale teriparatid, zaznali protitelesa, ki so navzkrižno reagirala s teriparatidom.
Do not try to force the dose knob any further.
Ne poskušajte več na silo obračati gumba za odmerjanje.
Needle cannot be attached.
Igle ni mogoče pritrditi.
If still no medicine is expelled, do not use this pen; contact customer service.
Če še vedno iz igle ne pride zdravilo, peresnika ne uporabljajte; kontaktirajte podporo strankam.
After the first use, the cartridge should not be removed from the pen during the 28 days of usage.
Po prvi uporabi vložka ga ne smete odstraniti iz peresnika v 28-dnevnem obdobju uporabe.
• increased sweating
• zvečano znojenje
Teriparatide has not been studied in patients with active urolithiasis.
Teriparatida pri bolnikih z aktivno urolitiazo niso preučevali.
Co-administration of raloxifene or hormone replacement therapy with teriparatide did not alter the effects of teriparatide on serum or urine calcium or on clinical adverse events.
Sočasno dajanje teriparatida in raloksifena ali hormonske nadomestne terapije s teriparatidom ni spremenilo učinkov teriparatida na serumske koncentracije kalcija, koncentracije kalcija v seču ali na klinične neželene dogodke.
Teriparatide must not be used in patients with severe renal impairment (see section 4.3).
Teriparatida pri bolnikih s hudo okvarjenim delovanjem ledvic ne smemo uporabljati (glejte poglavje 4.3).
This will keep the remaining Terrosa sterile and prevent leaking from the pen.
Na ta način bo preostala količina zdravila Terrosa ostala sterilna, obenem pa boste preprečili iztekanje zdravila iz peresnika.
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and rare (≥1/10,000 to
Za klasifikacijo neželenih reakcij smo uporabili naslednji dogovor: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000 do < 1/100) in redko (≥ 1/10.000 do < 1/1.000).
Warning: Prevent the pen needle from bending or breaking.
Opozorilo: Preprečite upogibanje in zlom igle.
- Wash your hands before handling the cartridge or pen.
- Pred rokovanjem z vložkom ali peresnikom si umijte roke.
Therefore, teriparatide should be used with caution.
Pri uporabi teriparatida je zato potrebna previdnost.
Once-daily administration of teriparatide increases apposition of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Dajanje teriparatida enkrat dnevno poveča apozicijo nove kostnine na trabekularne in kortikalne površine kosti s prednostno stimulacijo osteoblastnega delovanja proti osteoklastnimu delovanju.
How to use Terrosa
Kako uporabljati zdravilo Terrosa
Setting the dose and injection
Nastavitev odmerka ter injiciranje
If pregnancy occurs, teriparatide should be discontinued.
Če zanosijo, mora biti teriparatid ukinjen.
• A damp cloth is sufficient to clean the Terrosa Pen.
• Za čiščenje peresnika Terrosa je zadostna vlažna krpa.
- Severe renal impairment.
- Hudo okvarjeno delovanje ledvic.
The dose knob cannot be turned clockwise up to the arrow sign.
Gumba za odmerjanje ni mogoče obrniti v smeri urinega kazalca do oznake puščice.
680 subjects were randomised to teriparatide and 680 subjects were randomised to oral risedronate 35 mg/week.
680 bolnic je bilo randomiziranih v skupino s teriparatidom, 680 bolnic pa je bilo randomiziranih v skupino s peroralnim rizedronatom 35
• Transport and store the Terrosa Pen with inserted cartridge at temperatures specified in the Terrosa package leaflet, provided separately.
• Terrosa Pen z vstavljenim vložkom prenašajte in shranjujte pri temperaturah navedenih v navodilu za uporabo zdravila Terrosa, ki so priložena ločeno.
At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 teriparatide patients showed that 13 patients in the alendronate group (7.7%) had experienced a new vertebral fracture compared with 3 patients in the teriparatide group (1.7%) (p=0.01).
Analiza rentgenskih posnetkov 169 bolnikov, ki so dobivali alendronat, in 173 bolnikov, ki so dobivali teriparatid, je po 36 mesecih pokazala nov zlom vretenc pri 13 bolnikih v skupini z alendronatom (7,7 %) in pri 3 bolnikih v skupini s teriparatidom (1,7 %) (p = 0,01).
However, foetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 micrograms/kg.
Vendar se je pojavila resorpcija ploda in zmanjšanje zaroda pri brejih kuncih, ki so prejemali dnevne odmerke od 3 do 100 mikrogramov/kg.
Relative risk (95% CI) vs. placebo
Relativno tveganje (95 % IZ) v primerjavi s
QR code to be included
Vključiti kodo QR
The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8% in teriparatide and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), p=0.0009.
Kumulativna incidenca kliničnih zlomov (klinični vretenčni in nevretenčni zlomi) je bila 4,8 % v skupini s teriparatidom in 9,8 % pri bolnicah, zdravljenih z rizedronatom, razmerje tveganja (95-odstotni IZ) = 0,48 (0,32-0,74), p = 0,0009.
During a median of 18 months following discontinuation of teriparatide, there was a 41% reduction (p=0.004) compared with placebo in the number of patients with a minimum of one new vertebral fracture.
V času po ukinitvi teriparatida (mediana 18 mesecev) je za 41 % (p = 0,004) manj bolnikov imelo najmanj en novi zlom vretenca v primerjavi z bolniki, ki so prejemali placebo.
Cases of fainting have occured after teriparatide use.
Po uporabi teriparatida je prihajalo do primerov omedlevice.
PHARMACEUTICAL FORM Solution for injection.
FARMACEVTSKA OBLIKA raztopina za injiciranje
If the display still does not return to start position after injection, do not use this pen; contact customer service.
Če se zaslon po injiciranju še vedno ne vrne v začetni položaj, tega peresnika ne uporabljajte;
• increase in an enzyme called alkaline phosphatase.
• zvišanje encima, imenovanega alkalna fosfataza
Terrosa is used to treat osteoporosis in adults.
Zdravilo Terrosa uporabljamo za zdravljenje osteoporoze pri odraslih.
Do not transfer the medicine into a syringe.
Zdravila ne prenašajte v injekcijsko brizgo.
Before the first use, insert the cartridge into the pen.
Pred prvo uporabo vstavite vložek v peresnik.
Terrosa 20 micrograms/80 microliters solution for injection: 1 or 3 cartridge(s) packed in a plastic tray sealed with lid foil and packed in a carton.
Terrosa 20 mikrogramov/80 mikrolitrov raztopina za injiciranje: 1 ali 3 vložki, pakirani na plastičen podstavek s tesnilnim pokrovom iz folije in pakirani v škatli.
Make sure the display shows an arrow sign and the two indicator stripes are aligned.
Prepričajte se, da je na zaslonu prikazana puščica in poravnani indikatorski črti.
Insert a new Terrosa cartridge into the cartridge holder, with the metal crimped cap of the cartridge first.
Vstavite nov vložek Terrosa v nosilec vložka tako, da najprej vstavite kovinsko pokrivno kapico vložka.
• increase in blood cholesterol levels
• zvišanje koncentracij holesterola v krvi
If, by mistake, you have used more Terrosa than you should, contact your doctor or pharmacist.
Če ste uporabili večji odmerek zdravila Terrosa, kot bi smeli Če ste pomotoma uporabili višji odmerek zdravila Terrosa, kot bi smeli, pokličite svojega zdravnika ali farmacevta.
Before inserting a cartridge in Terrosa Pen write down the batch (Lot) number of the cartridge and its first injection date on a calendar.
Preden vstavite vložek v pripomoček Terrosa Pen, morate na koledar zabeležiti številko serije (Lot) vložka in datum prvega injiciranja.
• Turn the dose knob clockwise until you see a droplet sign on the dose display.
• Gumb za odmerjanje obrnite v smeri urinega kazalca, dokler na prikazu odmerka ne vidite znaka kapljice.
Posology The recommended dose of Terrosa is 20 micrograms administered once daily.
Odmerjanje Priporočeni odmerek zdravila Terrosa je 20 mikrogramov enkrat dnevno.
In patients with moderate renal impairment, teriparatide should be used with caution.
Pri bolnikih z zmerno okvarjenim delovanjem ledvic moramo teriparatid uporabljati previdno.
Seek immediate medical advice if you have any health concern.
Če imate kakšne zdravstvene težave, nemudoma poiščite zdravniško pomoč.
Terrosa can be injected at meal times.
Zdravilo Terrosa si lahko injicirate v času obrokov.
Rare (may affect up to 1 in 1,000 people):
Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov):
5 How to store Terrosa Contents of the pack and other information
Shranjevanje zdravila Terrosa Vsebina pakiranja in dodatne informacije
Gently hold a skin fold between the thumb and index finger.
Med palcem in kazalcem prsta nežno držite kožno gubo.
Check the label of the cartridge before its insertion into the cartridge holder.
Preverite nalepko vložka preden ga vstavite v nosilec vložka.
The most commonly reported adverse reactions in patients treated with teriparatide are nausea, pain in limb, headache and dizziness.
Najpogosteje poročane neželeni učinki pri bolnikih, zdravljenih s teriparatidom, so slabost, bolečine v okončinah, glavobol in omotica.
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.
Vendar je potrebno za začetek zdravljenja uporabiti komplet vložka in peresnika, ki vsebuje eno škatlo vložka Terrosa in eno škatlo s Terrosa Pen peresnikom.
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.
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.
Leave the cartridge in the pen.
Vložek pustite v peresniku.
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
Terrosa Pen deli pritisni gumb; zaslon; navojna palica; prirobnica; Terrosa vložek; odstranljiva folija; igla peresnika;
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).
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).
• Pull out the pen slowly.
• Počasi izvlecite iglo peresnika.
Insert the cartridge into the pen before the first use as detailed in the pen instructions.
Pred prvo uporabo vstavite vložek v peresnik, kot je podrobno opisano v navodilih za uporabo peresnika.
The expected effects of overdose include nausea, vomiting, dizziness, and headache.
Pričakovani učinki prevelikega odmerjanjavključujejo slabost, bruhanje, omotico in glavobol.
Display does not return to start position after injection.
Po injiciranju se zaslon ne vrne v začetni položaj.