natgillin/translations-raw huggingface dataset:
• if the syringe has been dropped or damaged
• če je injekcijska brizga kam padla ali se poškodovala,
• 2 cotton balls or gauze pads (not included in the carton)
• 2 kosma vate ali zloženca gaze (nista priložena v škatli)
Based on population pharmacokinetic analyses, serum creatinine levels, creatinine clearance, or hepatic function markers (ALT/AST/bilirubin) did not have a meaningful impact on risankizumab clearance in subjects with psoriasis.
Na podlagi populacijskih farmakokinetičnih analiz koncentracija kreatinina v serumu, očistek kreatinina ali označevalci jetrne funkcije (ALT/AST/bilirubin) pri preiskovancih s psoriazo niso pomembno vplivali na očistek risankizumaba.
This medicinal product contains 68.0 mg sorbitol per 150 mg dose.
To zdravilo vsebuje 68,0 mg sorbitola na 150-mg odmerek.
The recommended dose is 150 mg (two 75 mg injections) administered by subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.
Priporočeni odmerek je 150 mg (dve 75-mg injekciji) v subkutani injekciji 0. teden, 4. teden in nato vsakih 12 tednov.
Subjects received treatment at week 0, week 4 and every 12 weeks thereafter.
Preiskovanci so dobili zdravilo 0. teden, 4. teden in nato vsakih 12 tednov.
For subjects who had PASI 50 to <PASI 90 with adalimumab at week 16 and were re-randomised, differences in PASI 90 response rates between switching to risankizumab and continuing adalimumab were noted 4 weeks after re-randomisation (49.1% vs 26.8%, respectively).
Pri preiskovancih, ki so imeli ob uporabi adalimumaba v 16. tednu oceno PASI od 50 do < 90 in so bili nato ponovno randomizirani, je bila razlika v deležu odziva PASI 90 med tistimi, ki so prešli na risankizumab in tistimi, ki so nadaljevali z adalimumabom, opazna 4 tedne po ponovni randomizaciji (49,1 % z risankizumabom in 26,8 % z adalimumabom).
Each pack contains 2 pre-filled syringes and 2 alcohol pads.
V vsakem pakiranju sta 2 napolnjeni injekcijski brizgi in 2 alkoholna zloženca.
At week 16, risankizumab was superior to placebo on the co-primary endpoints of sPGA of clear or almost clear (83.5% risankizumab vs 7.0% placebo) and PASI 90 (73.2% risankizumab vs 2.0% placebo).
V 16. tednu je bil risankizumab superioren placebu, kar zadeva soprimarna opazovana dogodka sPGA čisto ali skoraj čisto (83,5 % z risankizumabom in 7,0 % s placebom) in PASI 90 (73,2 % z risankizumabom in 2,0 % s placebom).
ULTIMMA-1 and ULTIMMA-2
ULTIMMA-1 in ULTIMMA-2
Risankizumab is not expected to be metabolised by cytochrome P450 enzymes.
Ni pričakovati, da bi se risankizumab presnavljal z encimi citokroma P450.
What Skyrizi looks like and contents of the pack Skyrizi is a clear and colourless to slightly yellow liquid in a pre-filled syringe with needle guard.
Izgled zdravila Skyrizi in vsebina pakiranja Zdravilo Skyrizi je bistra in brezbarvna do rumenkasta tekočina v napolnjeni injekcijski igli s ščitnikom igle.
Keep the pre-filled syringes in the original carton in order to protect from light.
Napolnjene injekcijske brizge shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Table 3: Mean changes from baseline in NAPSI, PPASI, and PSSI ULTIMMA-1
Preglednica 3: Povprečne spremembe od izhodiščne vrednosti pri NAPSI, PPASI in PSSI ULTIMMA-1
Other medicines and Skyrizi
Druga zdravila in zdravilo Skyrizi
For subcutaneous use
za subkutano uporabo
There is no relevant use of Skyrizi in children aged below 6 years for the indication of moderate to severe plaque psoriasis.
Pri otrocih, mlajših od 6 let, zdravilo Skyrizi nima relevantne uporabe za indikacijo zmerne do hude psoriaze v plakih.
Driving and using machines Skyrizi is not likely to affect your driving and use of machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Skyrizi vplivalo na vašo sposobnost upravljanja vozil ali strojev.
Skyrizi is available in packs containing 2 pre-filled syringes and 2 alcohol pads.
Zdravilo Skyrizi je na voljo v pakiranjih, ki vsebujejo 2 napolnjeni injekcijski brizgi in 2 alkoholna zloženca.
How much Skyrizi to use
Koliko zdravila Skyrizi uporabiti
- The other ingredients are disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate
- Druge sestavine zdravila so dinatrijev sukcinat heksahidrat, sukcinska kislina, sorbitol,
Co-primary endpoints versus placebo No impact on health-related quality of life c Psoriasis Symptom Scale (PSS) of 0 means no symptoms of pain, itching, redness, and burning during the last 24 hours
c Lestvica simptomov psoriaze (Psoriasis Symptom Scale, PSS) 0 pomeni, da ni simptomov bolečine, srbenja, pordelosti in pekočega občutka v zadnjih 24 urah.
Choose from these 3 areas to inject:
Za injiciranje izberite enega izmed 3 predelov:
• your belly (abdomen) at least 5 cm from your belly button (navel)
• trebuh, vendar najmanj 5 cm proč od popka
The liquid may contain tiny white or clear particles.
Tekočina lahko vsebuje drobne bele ali prozorne delce.
The mean (±standard deviation) systemic clearance (CL) of risankizumab was 0.3 (±0.1) L/day in Phase 3 studies in subjects with psoriasis.
Povprečni (± standardni odklon) sistemski očistek (CL) risankizumaba je bil v študijah 3. faze pri preiskovancih s psoriazo 0,3 (± 0,1) l/dan.
Figure 1: Time course of mean percent change from baseline of PASI in ULTIMMA-1 and ULTIMMA-2
Slika 1: Časovni potek povprečne odstotne spremembe PASI od izhodišča v študijah ULTIMMA-1 in ULTIMMA-2
The two co-primary endpoints in ULTIMMA-1 and ULTIMMA-2 were the proportion of subjects who achieved 1) PASI 90 response and 2) sPGA score of clear or almost clear (sPGA 0 or 1) at week 16 versus placebo.
Soprimarna opazovana dogodka v študijah ULTIMMA-1 in ULTIMMA-2 sta bila deleža bolnikov, ki so po v 16. tednu v primerjavi s placebom dosegli (1) odziv PASI 90 in (2) oceno sPGA čisto ali skoraj čisto (sPGA 0 ali 1).
• Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
• Ne injicirajte v kožo, ki je ranjena, podpluta, pordela, zatrdela, zabrazgotinjena ali so na njej strije.
In an integrated analysis of subjects receiving risankizumab in ULTIMMA-1 and ULTIMMA-2 for PASI 100 responders at week 16, 79.8% (206/258) of the subjects who continued on risankizumab maintained the response at week 52.
V združeni analizi preiskovancev, ki so prejemali risankizumab v študijah ULTIMMA-1 in ULTIMMA-2 in so imeli v 16. tednu odziv PASI 100 , se je pri preiskovancih, ki so nadaljevali zdravljenje z risankizumabom, odziv v 52. tednu ohranil pri 79,8 % (206/258).
As an IgG1 monoclonal antibody, risankizumab is mainly eliminated via intracellular catabolism and is not expected to undergo metabolism via hepatic cytochrome P450 enzymes or renal elimination.
Risankizumab je monoklonsko protitelo IgG1 in se v glavnem odstrani z znotrajcelično razgradnjo ter ni pričakovati, da bi bil podvržen presnovi z jetrnimi encimi citokroma P450 ali izločanju skozi ledvice.
If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.
Če se bolniku pojavi takšna okužba, ali če se ne odzove na običajno zdravljenje okužbe, ga je potrebno skrbno nadzirati.
• difficulty breathing or swallowing
• težko dihanje ali požiranje,
The mean (±standard deviation) steady-state volume of distribution (Vss) of risankizumab was 11.4 (±2.7) L in Phase 3 studies in subjects with psoriasis, indicating that the distribution of risankizumab is primarily confined to the vascular and interstitial spaces.
V študijah 3. faze je bil povprečni (± standardni odklon) volumen porazdelitve risankizumaba v stanju dinamičnega ravnovesja (Vss) pri preiskovancih s psoriazo 11,4 (± 2,7) l; to kaže, da je porazdelitev risankizumaba v prvi vrsti omejena na žilni in intersticijski prostor.
Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse.
Zdravila si ne injicirajte, dokler vas zdravnik, farmacevt ali medicinska sestra ne nauči, kako to naredite.
Read section 7 ‘Instructions for use' at the end of this leaflet before injecting Skyrizi yourself.
Preden si zdravilo Skyrizi injicirate sami, preberite poglavje 7, "Navodila za uporabo", na koncu tega navodila.
• if you have recently had or are going to have a vaccination.
• če ste se pred kratkim cepili ali imate predvideno kakšno cepljenje.
The solution is colourless to slightly yellow and clear to slightly opalescent.
Raztopina je brezbarvna do rahlo rumenkasta in bistra do rahlo opalescentna.
PASI Percent Change from Baseline
Odstotek spremembe PASI od izhodišča
• Throw away the needle cover
• Pokrovček igle zavrzite.
• The liquid should look clear to slightly yellow and may contain tiny white or clear particles
• Tekočina mora biti bistra do rumenkasta in lahko vsebuje drobne bele ali prozorne delce.
It is unknown whether risankizumab is excreted in human milk.
Ni znano, ali se zdravilo risankizumab izloča v materino mleko.
Other side effects Tell your doctor, pharmacist or nurse if you get any of the following side effects
Obvestite zdravnika, farmacevta ali medicinsko sestro, če se vam pojavi kateri od naslednjih neželenih učinkov
No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of risankizumab.
Specifičnih študij za ugotavljanje vpliva okvare ledvic ali jeter na farmakokinetiko risankizumaba niso izvedli.
The solution should be colourless to slightly yellow and clear to slightly opalescent.
Raztopina mora biti brezbarvna do rahlo rumenkasta in bistra do rahlo opalescentna.
Of the 31 subjects from the IMMHANCE study with latent tuberculosis (TB) who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on risankizumab.
Aktivna tuberkuloza (TB) se med povprečno 55-tedenskim spremljanjem zdravljenja z risankizumabom ni pojavila pri nobenem od 31 preiskovancev v študiji IMMHANCE, ki so imeli latentno tuberkulozo (TB) in med študijo niso prejemali profilakse.
Two pre-filled syringes should be injected for the full 150 mg dose.
Za celoten 150-mg odmerek je treba injicirati dve napolnjeni injekcijski brizgi.
Week 16 109 (35.9) Week 52 171 (56.3) DLQI 0 or 1
16. teden 109 (35,9) 52. teden 171 (56,3)
• Do not inject if the liquid is cloudy or contains flakes or large particles.
• Ne injicirajte, če je tekočina motna ali vsebuje kosme ali velike delce.
No clinically meaningful differences in risankizumab exposure were observed in Chinese or Japanese subjects compared to Caucasian subjects in a clinical pharmacokinetic study.
V klinični študiji farmakokinetike niso ugotovili klinično pomembnih razlik v izpostavljenosti risankizumabu pri kitajskih ali japonskih preiskovancih v primerjavi z belci.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se s posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
2D barcode carrying the unique identifier included.
<Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako>.
Body of syringe
Telo injekcijske brizge
If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Če dojite ali nameravate dojiti, se posvetujte z zdravnikom, preden uporabite to zdravilo.
Among subjects with sPGA of clear or almost clear at week 28 in IMMHANCE, 81.1% (90/111) of subjects re-randomised to continued treatment with risankizumab maintained this response at week 104 compared to 7.1% (16/225) who were re-randomised to withdrawal from risankizumab.
Med preiskovanci, ki so imeli v študiji IMMHANCE v 28. tednu sPGA čisto ali skoraj čisto in so jih ponovno randomizirali na nadaljevanje zdravljenja z risankizumabom, se je ta odziv v 104. tednu ohranil pri 81,1 % (90/111) preiskovancev; med tistimi, ki so bili ob ponovni randomizaciji razvrščeni na prenehanje zdravljenja, pa je bil ta delež 7,1 % (16/225).
• You should receive training on how to inject Skyrizi before giving an injection.
• Preden boste injicirali zdravilo Skyrizi, morate za to opraviti usposabljanje.
Risankizumab exhibited linear pharmacokinetics with approximately dose-proportional increases in systemic exposure (Cmax and AUC) in the evaluated dose ranges of 18 to 300 mg or 0.25 to 1 mg/kg subcutaneous administration in healthy subjects or subjects with psoriasis.
Pri zdravih preiskovancih in preiskovancih s psoriazo je imel risankizumab linearno farmakokinetiko s približno odmerku sorazmernim povečanjem sistemske izpostavljenosti (Cmax in AUC) v ocenjenem razponu odmerkov od 18 do 300 mg ali od 0,25 do 1 mg/kg subkutano.
Subjects randomised to risankizumab received 150 mg of treatment at week 0, week 4 and every 12 weeks thereafter.
Preiskovanci, randomizirani na risankizumab, so prejeli 150 mg zdravila 0. teden, 4. teden in nato vsakih 12 tednov.
The liquid should look clear to slightly yellow and may contain tiny white or clear particles
Tekočina mora biti bistra do rumenkasta in lahko vsebuje drobne bele ali prozorne delce.
No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of Skyrizi.
Specifičnih študij za oceno vpliva okvare jeter ali ledvic na farmakokinetiko zdravila Skyrizi niso izvedli.
Skyrizi is used to treat adults with moderate to severe plaque psoriasis.
Zdravilo Skyrizi uporabljamo za zdravljenje odraslih, ki imajo zmerno do hudo psoriazo v plakih.
The pharmacokinetics of risankizumab in paediatric subjects has not been established.
Farmakokinetika risankizumaba pri pediatričnih preiskovancih ni ugotovljena.
Of these subjects, 63.1% (70/111) of subjects re-randomised to continued treatment with risankizumab achieved a sPGA clear response at week 104 compared to 2.2% (5/225) who were re-randomised to withdrawal from risankizumab.
Od teh preiskovancev, ki so bili ponovno randomizirani na nadaljevanje zdravljenja z risankizumabom, jih je v 104. tednu 63,1 % (70/111) doseglo odziv sPGA čisto; med tistimi, ki so bili ob ponovni randomizaciji razvrščeni na prenehanje zdravljenja, pa je bil ta delež 2,2 % (5/225).
Administration of Skyrizi in the upper, outer arm may only be performed by a healthcare professional or caregiver.
V zunanji del nadlakti sme zdravilo Skyrizi injicirati le zdravstveni delavec ali bolnikov negovalec.
Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, onychomycosis Includes: headache, tension headache, sinus headache Includes: fatigue, asthenia Includes: injection site bruising, erythema, haematoma, haemorrhage, irritation, pain, pruritus, reaction, swelling
Vključuje: okužbe dihal (virusne, bakterijske ali neopredeljene), sinuzitis (tudi akutni), rinitis, nazofaringitis, faringitis (tudi virusni), tonzilitis.
How to use Skyrizi
Kako uporabljati zdravilo Skyrizi
Check liquid
Preverite tekočino
Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination.
Ni pričakovati, da bi bil risankizumab podvržen presnovi z jetrnimi encimi ali izločanju skozi ledvice.
One pre-filled syringe contains 75 mg risankizumab.
Ena napolnjena injekcijska brizga vsebuje 75 mg risankizumaba.
• front of left thigh
• sprednji del levega stegna
Continued on Adalimumab (N=56) n (%)
Nadaljevanje adalimumaba (N = 56) n (%)
150 mg (two 75 mg injections) 4 weeks after 1
150 mg (dve 75-mg injekciji) Na 12 tednov z začetkom po 2. odmerku
Do not use this medicine if the liquid is cloudy or contains flakes or large particles.
Zdravila ne uporabite, če je tekočina motna, ali vsebuje kosme ali velike delce.
Skyrizi 75 mg solution for injection in pre-filled syringe
Skyrizi 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
• <PASI 50 were switched to risankizumab
• < PASI 50 so prešli na risankizumab,
Talk to your doctor if you are not sure what to do.
Če ste negotovi kaj storiti, se posvetujte z zdravnikom.
Improvements were observed in psoriasis involving the scalp, the nails, and the palms and soles at week 16 and week 52 in subjects treated with risankizumab.
Pri preiskovancih, zdravljenih z risankizumabom, so v 16. in 52. tednu opažali izboljšanja psoriaze lasišča, nohtov ter dlani in stopal.
Skyrizi should not be used if the solution is cloudy or discoloured, or contains large particles.
Zdravila Skyrizi se ne sme uporabiti, če je raztopina motna, spremenjene barve ali vsebuje velike delce.
• front of right thigh
• sprednji del desnega stegna
What Skyrizi contains
Kaj vsebuje zdravilo Skyrizi
Follow the steps below each time you use Skyrizi
Pri vsaki uporabi zdravila Skyrizi sledite spodaj opisanim korakom.
The clearance of risankizumab was not significantly influenced by gender or race in adult subjects with plaque psoriasis.
Spol in rasa odraslih preiskovancev s psoriazo v plakih nista pomembno vplivala na očistek risankizumaba.
Water for injections
Predeli za injiciranje
You may have slight bleeding from where you injected.
Mesto, kamor ste injicirali, lahko rahlo zakrvavi.
Needle cover
Pokrovček igle
With dosing of 150 mg at week 0, week 4 and every 12 weeks thereafter, estimated steady-state peak and trough plasma concentrations are 12 and 2 µg/mL, respectively.
teden in nato vsakih 12 tednov sta bili ocenjena največja in najmanjša koncentracija v plazmi v stanju dinamičnega ravnovesja 12 µg/ml (največja) in 2 µg/ml (najmanjša).
How Skyrizi works
Kako deluje zdravilo Skyrizi
Week 16 200 (65.8) Week 52 229 (75.3) PSS 0 (symptom-free)
16. teden 200 (65,8) 52. teden 229 (75,3)
Plunger rod Finger grip
Držalo za prste
Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Pri bolnikih z anamnezo latentne ali aktivne TB, pri katerih ni mogoče potrditi, da so opravili ustrezen ciklus zdravljenja, je treba pred uvedbo risankizumaba razmisliti o protituberkuloznem zdravljenju.
Week 16 89 (29.3) Week 52 173 (56.9) All comparisons of risankizumab versus ustekinumab and placebo achieved p<0.001 except for PASI 75 at week 52 in ULTIMMA-2 where p=0.001
Vse primerjave risankizumaba z ustekinumabom in placebom so dosegle p < 0,001, razen za PASI 75 v 52. tednu študije ULTIMMA-2, kjer je bila vrednost p = 0,001.
Do not use Skyrizi
Ne uporabljajte zdravila Skyrizi
Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml.
Ena napolnjena injekcijska brizga vsebuje 75 mg risankizumaba v 0,83 ml.
Tinea infections
Okužbe s tineo
Skyrizi 75 mg solution for injection in pre-filled syringe risankizumab
Skyrizi 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi risankizumab
No overall differences in risankizumab exposure were observed between older and younger subjects who received risankizumab.
Med starejšimi in mlajšimi preiskovanci, ki so prejemali risankizumab, na splošno niso opazili razlik v izpostavljenosti risankizumabu.
Each pre-filled syringe contains 75 mg of risankizumab in 0.83 ml solution.
Ena napolnjena injekcijska brizga vsebuje 75 mg risankizumaba v 0,83 ml raztopine.
Folliculitis
Folikulitis
Drug interactions
Medsebojno delovanje z zdravili
150 mg (two 75 mg injections) When your doctor tells you nd dose
1. odmerek 150 mg (dve 75-mg injekciji) Ko vam naroči zdravnik 2. odmerek 150 mg (dve 75-mg injekciji) 4 tedne po 1.odmerku Nadaljnji odmerki
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants / marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe, predlagateljev, imetnikov dovoljenj za promet z zdravilom v državah članicah
This summary was last updated in April 2013.
Povzetek je bil nazadnje posodobljen dne 04-2013.
Other information about TruScient:
Druge informacije o zdravilu TruScient:
TruScient should only be used by a veterinarian.
Zdravilo TruScient lahko uporablja samo veterinar.
The European Commission granted a marketing authorisation valid throughout the European Union, for TruScient on 14 December 2011.
Evropska komisija je dovoljenje za promet z zdravilom TruScient, veljavno po vsej Evropski uniji, odobrila dne 14. 12. 2011.
TruScient has been developed for use in dogs based on the approved use of the InductOs product in humans (EU/1/02/226/001).
Zdravilo TruScient je bilo razvito za uporabo pri psih na podlagi odobrene uporabe zdravila InductOs pri ljudeh (EU/1/02/226/001).
The main side effects with TruScient (seen in more than 1 dog in 10) were lameness, and firm and soft swelling during the first three weeks after surgery.
Glavni neželeni učinki zdravila TruScient (opaženi pri več kot 1 od 10 psov) so bili šepanje ter čvrste in mehke otekline v prvih treh tednih po operaciji.
The prepared collagen sponges are then cut, if needed, to the correct size before use.
Pripravljeni kolagenski gobici se nato po potrebi razrežeta, tako da sta pred uporabo ustrezne velikosti.
It must not be used in young dogs whose bones are not fully developed, have an active infection at the site of operation, pathological fracture (caused by a disease), or any active malignancy (cancerous growth).
Ne sme se uporabljati pri mladih psih, katerih kosti še niso povsem razvite, ter pri psih z aktivno okužbo na mestu operacije, s patološkimi zlomi (ki jih povzročajo bolezni) ali s katerim koli aktivnim malignim obolenjem (rakasta rast).
What benefit has TruScient shown during the studies?
Kakšne koristi je zdravilo TruScient izkazalo med študijami?
TruScient was investigated in one main field study in 126 dogs with fractures of the diaphysis.
Zdravilo TruScient je bilo raziskano v eni glavni terenski študiji pri 126 psih z diafiznimi zlomi.
Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Dibotermin alfa se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“: tvorijo ga celice, ki so prejele gen (DNK), s katerim lahko tvorijo dibotermin alfa.
After 18 weeks, the fractures of all the dogs treated with TruScient together with standard surgical care (84) were seen to have healed, compared with 95% of the dogs treated with standard surgical care alone (40 out of 42).
Po 18 tednih so bili zlomi vseh psov, ki so jih zdravili z zdravilom TruScient skupaj s standardno kirurško oskrbo (84), vidno ozdravljeni, medtem ko je bilo pri psih, ki so jih zdravili samo s standardno kirurško oskrbo, takih primerov samo 95 % (40 od 42).
TruScient is available as a kit for implant.
Zdravilo TruScient je na voljo kot komplet za implantacijo.
The replacement dibotermin alfa acts in the same way as BMP-2 produced naturally by the body.
Nadomestni dibotermin alfa deluje na enak način kot BMP-2, ki ga naravno tvori telo.
It is a copy of a protein called ‘bone morphogenetic protein 2' (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Učinkovina je kopija beljakovine, imenovane „protein za morfogenezo kosti 2“ (BMP-2), ki se naravno tvori v telesu in pomaga pri tvorjenju novega kostnega tkiva.
What is the risk associated with TruScient?
Kakšna tveganja so povezana z zdravilom TruScient?
TruScient is made up into a solution before use, applied to the collagen sponges and left for at least 15 minutes (but no more than two hours).
Zdravilo TruScient se pred uporabo pripravi v raztopino ter nanese na kolagenski gobici, nato je treba počakati najmanj 15 minut (vendar ne več kot dve uri).
Why has TruScient been approved?
Zakaj je bilo zdravilo TruScient odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of TruScient exceed the risks for the treatment of diaphyseal bone fractures in dogs and recommended that TruScient be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila TruScient za zdravljenje diafiznih zlomov pri psih večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.