natgillin/translations-raw huggingface dataset:
In order to substantiate correlation of the biomarker (antiFXa-activity) with haemostatic efficacy and clarify the risk of thromboses and thromboembolic events, the MAH should submit the results of a global randomised controlled clinical trial to investigate the use of andexanet versus standard of care treatment in patients with intracranial haemorrhage (ICH) taking apixaban, rivaroxaban, or edoxaban (study 18-513).
U cilju daljnjeg utvrđivanja povezanosti biomarkera (anti-FXa aktivnosti) s hemostatskom djelotvornosti i pojašnjenja rizika za nastanak tromboze i tromboemboličkih događaja, nositelj odobrenja mora podnijeti rezultate globalnog randomiziranog kontroliranog kliničkog ispitivanja primjene andeksaneta u usporedbi sa terapijskim standardom u bolesnika s intrakranijalnim krvarenjem koji primaju apiksaban, rivaroksaban ili edoksaban (ispitivanje 18-513).
When andexanet alfa was administered as a bolus followed by a continuous infusion, the maximum decrease in unbound FXa inhibitors was rapid (within two minutes of the end of the bolus) and was sustained over the course of the infusion then gradually increased over time, reaching a maximum at approximately two hours following the end of infusion.
FXa bilo je brzo (unutar 2 minute od završetka bolusa) i održalo se tijekom trajanja infuzije te se zatim razina postupno s vremenom povisivala, dosežući svoj maksimum otprilike dva sata nakon završetka infuzije.
Transfer the reconstituted solution from the syringe into an appropriate IV bag.
2. Prebaciti rekonstituiranu otopinu iz štrcaljke u odgovarajuću vrećicu za intravensku infuziju.
The primary endpoint for both Study 14-503 (apixaban) and Study 14-504 (rivaroxaban) was the percent change in anti-FXa activity from baseline to post-infusion nadir.
Primarna mjera ishoda kako u ispitivanju 14-503 (apiksaban) tako i u ispitivanju 14-504 (rivaroksaban) bila je postotna promjena anti-FXa aktivnosti od početnih vrijednosti do najniže vrijednosti nakon infuzije.
• Intravenous PO or PVC bag (150 mL or larger) to contain the final volume of reconstituted product (if administration is performed with an IV bag).
• Vrećica od polivinilklorida ili poliolefina (150 ml ili veća) u koju može stati konačni volumen rekonstituiranog lijeka (ako se lijek primjenjuje u obliku i.v. infuzije pomoću vrećice).
In order to further substantiate correlation of the biomarker (antiFXa-activity) with haemostatic efficacy and clarify the risk of thromboses and thromboembolic events, the MAH should submit the results of ANNEXA-4, an interventional non-randomized, multicentre, prospective, open-label, single-group study in patients with acute major bleeding.
U cilju daljnjeg utvrđivanja povezanosti biomarkera (anti-FXa aktivnosti) s hemostatskom djelotvornosti i pojašnjenja rizika za nastanak tromboze i tromboemboličkih događaja, nositelj odobrenja za stavljanje lijeka u promet mora podnijeti rezultate ispitivanja ANNEXA-4, intervencijskog nerandomiziranog, multicentričnog, prospektivnog, otvorenog ispitivanja jedne skupine koje se provodi u bolesnika s akutnim velikim krvarenjem.
6.6 Special precautions for disposal and other handling
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Rekonstitucija
Among the apixaban-treated subjects in Study 14-503, the percent change in anti-FXa activity was -92.34% (± 2.809%) for the andexanet alfa group and -32.70% (± 5.578%) for the placebo group (p < 0.0001), the latter reflecting the intrinsic clearance of the anticoagulant.
Među ispitanicima koji su primali apiksaban u ispitivanju 14-503, postotna promjena anti-FXa aktivnosti bila je -92,34% (± 2,809%) za skupinu koja je primila andeksanet alfa i -32,70% (± 5,578%) za skupinu koja je primila placebo (p < 0,0001); potonja vrijednost odražava intrinzični klirens antikoagulansa.
Using a 20 mL (or larger) syringe and a 20 gauge (or larger) needle, withdraw 20 mL of water for injection.
3. Pomoću štrcaljke od 20 ml ili veće i igle od 20 G (ili veće) navucite 20 ml vode za injekciju.
Excipients: Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, polysorbate 80
POPIS POMOĆNIH TVARI Pomoćne tvari: tris baza, tris hidroklorid, L-arginin hidroklorid, saharoza, manitol, polisorbat 80
No thromboembolic events were observed in 223 healthy volunteers who received FXa inhibitors and were treated with andexanet alfa.
Izostanak tromboembolijskog događaja zabilježen je u 223 zdrava dobrovoljca koja su primila inhibitore
> 10 mg/ Unknown
> 10 mg/
Cardiac arrest uncommon
Srčani arest manje često
Limitations of use
Ograničenja u primjeni
If administration is done with a syringe driver, multiple syringes should be used to contain the final volume of reconstituted product.
Ako se primjenjuje pomoću perfuzora, potrebno je koristiti više štrcaljki koje sveukupno sadrže konačni volumen rekonstituiranog lijeka.
Use andexanet alfa within eight hours after reconstitution when stored at room temperature.
9. Nakon rekonstitucije, upotrijebite andeksanet alfa unutar 8 sati ako se čuva na sobnoj temperaturi.
Ondexxya 200 mg powder for solution for infusion andexanet alfa
Ondexxya 200 mg prašak za otopinu za infuziju andeksanet alfa
It reverses the effects of certain anticoagulants called factor Xa inhibitors (apixaban or rivaroxaban).
Ona poništava djelovanje nekih lijekova protiv zgrušavanja krvi koji se nazivaju inhibitori faktora Xa (apiksaban ili rivaroksaban).
For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Ondexxya je indicirana u odraslih bolesnika liječenih direktnim inhibitorima koagulacijskog faktora Xa (FXa) kada je potrebna reverzija antikoagulacije zbog po život opasnog ili nekontroliranog krvarenja.
Hyperhidrosis common
Hiperhidroza često
If a syringe driver is used for administration, multiple syringes should be used to contain the final volume of reconstituted product.
Ako se za primjenu koristi perfuzor, potrebno je koristiti više štrcaljki koje sveukupno sadrže konačni volumen rekonstituiranog lijeka.
Handling instructions
Upute o rukovanju
Andexanet alfa is to be reconstituted and the 10 mg/mL solution then transferred to a suitable IV bag comprised of polyolefin (PO) or polyvinyl chloride (PVC) material without further dilution prior to administration by IV infusion using a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low protein-binding filter.
Andeksanet alfa je potrebno rekonstituirati i potom otopinu u koncentraciji 10 mg/ml prenijeti u odgovarajuću vrećicu za primjenu i.v. infuzije načinjenu od poliolefina (PO) ili polivinilklorida (PVC) bez dodatnog razrjeđivanja prije intravenske primjene pomoću sustava za infuziju s filtrom od polietersulfona (PES) s veličinom pora od 0,2 ili 0,22 mikrometra s niskim vezanjem proteina ili ekvivalentnim filtrom.
No dose-limiting toxicities have been observed during clinical trials.
Tijekom kliničkih ispitivanja nije primijećena toksičnost koja bi ograničavala dozu.
In a similar study, subjects with a median age of 57 years on rivaroxaban 20 mg daily received andexanet alfa (n=26) administered as an 800 mg IV bolus immediately followed by an 8 mg per minute IV infusion for 120 minutes (960 mg) or placebo (n=13).
U sličnom ispitivanju ispitanicima s medijanom dobi od 57 godina koji su primali 20 mg rivaroksabana jedanput dnevno primijenjen je andeksanet alfa (n = 26) u obliku intravenskog bolusa od 800 mg nakon kojega je odmah uslijedila i.v. infuzija brzinom od 8 mg u minuti tijekom 120 minuta (960 mg) ili placebo (n = 13).
Headache common
Glavobolja često
Table 4: List of adverse reactions in healthy subjects and bleeding patients System organ class/ Preferred term
Tablica 4: Popis nuspojava u zdravih ispitanika i bolesnika s krvarenjem
Attach ancillary equipment (i.e., extension tubing, air filters, IV pump) in preparation for administration.
5. Spojite dodatni pribor (npr. produžne infuzijske linije, zračne filtre, infuzomat) i pripremite za primjenu.
• if you are allergic to andexanet alfa or any of the other ingredients of this medicine (listed in section 6).
Nemojte primjenjivati Ondexxyu: - ako ste alergični na andeksanet alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste alergični na proteine hrčka
Change from baseline in free FXa inhibitor concentration at nadir The mean unbound concentrations of apixaban and rivaroxaban were < 3.5 ng/mL and 4 ng/mL, respectively, after bolus andexanet alfa administration and were maintained throughout the continuous infusion.
Nakon primjene bolusa andeksaneta alfa, srednja vrijednost koncentracije nevezanog apiksabana iznosila je < 3,5 ng/ml odnosno 4 ng/ml za rivaroksaban, a održana je sve vrijeme trajanja infuzije.
Patients being treated with FXa inhibitor therapy have underlying disease states that predispose them to thromboembolic events.
Bolesnici koji primaju terapiju inhibitorima FXa boluju od osnovne bolesti koja predstavlja predispoziciju za nastanak tromboembolijskog događaja.
Use within eight hours after reconstitution when stored at room temperature.
9. Nakon rekonstitucije, upotrijebiti unutar 8 sati ako se čuva na sobnoj temperaturi.
Treatment of patients with more severe ICH with andexanet alfa has not been studied.
Liječenje andeksanetom alfa u bolesnika s težim intrakranijalnim krvarenjem nije ispitano.
Animal reproductive and developmental studies have not been conducted with andexanet alfa.
Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti andeksaneta alfa na životinjama.
C/ La Relba s/n
Lonza Biologics Porrino, S.L. C/ La Relba s/n
Wipe the rubber stopper of each vial with an alcohol swab.
Obrisati gumeni čep bočice alkoholnim tupferom.
Very common (may affect more than 1 in 10 people)
Vrlo često (mogu se javiti u više od 1 na 10 osoba) - navale crvenila ili osjećaj vrućine
Reversal of anticoagulation in healthy subjects aged 50-75 (Studies 14-503 and 14-504) In a prospective, randomized, placebo-controlled study, healthy subjects with a median age of 56.5 years on apixaban 5 mg twice daily received andexanet alfa (n=24) administered as a 400 mg IV bolus immediately followed by a 4 mg per minute IV infusion for 120 minutes (480 mg) or placebo (n=8).
U prospektivnom, randomiziranom, placebom kontroliranom ispitivanju u zdravih ispitanika s medijanom dobi od 56,5 godina koji su primali 5 mg apiksabana dva puta dnevno primijenjen je andeksanet alfa (n = 24) u obliku intravenskog bolusa od 400 mg nakon kojega je odmah uslijedila i.v. infuzija brzinom od 4 mg u minuti tijekom 120 minuta (480 mg) ili placebo (n = 8).
• Same number of 20 mL (or larger) solvent syringes equipped with a 20 gauge (or larger) needle.
• Jednaki broj štrcaljki otapala od 20 ml ili većih s iglom od 20 G ili većom.
4 mg/min for 120 minutes (480 mg)
4 mg/min tijekom 120 minuta
The 30-day mortality rates were 20.1% (44/219) in patients aged > 75 years old and 7.6% (10/132) in patients aged ≤ 75 years.
Stopa smrtnosti u 30-dnevnom razdoblju bila je 20,1% (44/219) u bolesnika u dobi
No clinical evaluation for apixabantreated subjects with high-dose andexanet alfa and no evaluation for rivaroxaban-treated subjects with low-dose andexanet alfa was performed in these studies.
U ovim ispitivanjima nisu se radile kliničke procjene za ispitanike liječene apiksabanom koji su primili visoke doze andeksaneta alfa, kao ni bolesnika na rivaroksabanu koji su primili nisku dozu andeksaneta alfa.
• The other ingredients are Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose,
- Drugi sastojci su: tris baza, tris hidroklorid, L-arginin hidroklorid, saharoza, manitol i polisorbat 80.
Gently swirl each vial, until all of the powder is completely dissolved.
Nježno kružeći oko uzdužne osi bočice miješati sadržaj sve dok se prašak potpuno ne otopi.
Apixaban
Doziranje
Reversal of FXa inhibitor anticoagulation in patients with acute major bleeding In Study 14-505 (ANNEXA-4), a Phase IIIb/IV multinational, prospective, single-arm, open-label study, Ondexxya was administered to 352 patients on FXa inhibitors who presented with acute major bleeding.
U ispitivanju 14-505 (ANNEXA-4), međunarodnom, prospektivnom, otvorenom ispitivanju faze IIIb/IV s jednom skupinom, lijek Ondexxya je primijenjen u 352 bolesnika koji primaju inhibitore FXa a kod kojih se pojavilo veliko akutno krvarenje.
Ondexxya 200 mg powder for solution for infusion
NAZIV LIJEKA Ondexxya 200 mg prašak za otopinu za infuziju
Pyrexia common
Pireksija često
Median change from baseline to nadir in anti-FXa activity was -93.4% (95% CI -94.3%, -92.4%) for apixaban, and -92.5% (95% CI -94.2%, -90.3%) for rivaroxaban.
(95% CI -94,3%; -92,4%) za apiksaban, odnosno -92,5% (95% CI -94,2%; -90,3%) za rivaroksaban.
FXa inhibitor last dose
Posljednja doza inhibitora FXa
Timing of FXa inhibitor last dose before andexanet alfa initiation
FXa prije početka primjene andeksaneta alfa
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja Kašalj često
Package Leaflet: Information for the patient and user Ondexxya 200 mg powder for solution for infusion andexanet alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ondexxya 200 mg prašak za otopinu za infuziju andeksanet alfa
How Ondexxya is used
Kako primjenjivati Ondexxyu
Insert the syringe needle through the centre of the rubber stopper.
4. Probosti iglom štrcaljke sredinu gumenog čepa.
Once all required vials are reconstituted, withdraw the reconstituted solution from each vial, using the large volume (60 mL or larger) syringe equipped with a 20 gauge (or larger) needle.
Nakon što su rekonstituirane sve potrebne bočice, navući rekonstituiranu otopinu iz svake bočice pomoću štrcaljke velikog volumena (60 ml ili veće) s iglom od 20 G (ili većom).
Ondexxya is administered as an IV bolus at a target rate of approximately 30 mg/min over 15 to 30 minutes, followed by administration of a continuous infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1).
Ondexxya se primjenjuje kao i.v. bolus brzinom od otprilike 30 mg/min tijekom 15 do 30 minuta nakon kojeg slijedi kontinuirana infuzija od 4 mg (niska doza) ili 8 mg (visoka doza) u minuti tijekom 120 minuta (vidjeti tablicu 1).
Flushing very common
Navale crvenila vrlo često
Palpitations common
Palpitacije često
Andexanet alfa is administered as an intravenous bolus at a target rate of approximately 30 mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed by administration of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high dose) for 120 minutes (see table 1).
Andeksanet alfa primjenjuje se kao intravenski bolus ciljnom brzinom od otprilike 30 mg/min tijekom 15 minuta (niska doza) ili 30 minuta (visoka doza) nakon kojeg slijedi kontinuirana infuzija od 4 mg/min (niska doza) ili 8 mg/min (visoka doza) tijekom 120 minuta (vidjeti tablicu 1).
How Ondexxya is stored
Kako čuvati Ondexxyu
Peripheral coldness common
Hladne okrajine često
No trials have been conducted to investigate the pharmacokinetics of andexanet alfa in patients with hepatic impairment.
Nisu provedena ispitivanja farmakokinetike andeksaneta alfa u bolesnika s oštećenom funkcijom bubrega.
Cerebrovascular accident uncommon
Cerebrovaskularni incident manje često
Once all required vials are reconstituted, the reconstituted solution is withdrawn from each vial, using the large volume (60 mL or larger) syringe equipped with a 20 gauge (or larger) needle.
Nakon što je rekonstituiran potreban broj bočica, otopina rekonstituiranog lijeka navlači se iz svake bočice pomoću štrcaljke velikog volumena (60 ml ili veće) s iglom od 20 G (ili većom).
Andexanet alfa is administered as an intravenous (IV) bolus at a target rate of approximately 30 mg/min over 15 (low dose) or 30 minutes (high dose), immediately followed by administration of a continuous infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1).
Andeksanet alfa se primjenjuje kao intravenski (i.v.) bolus brzinom od otprilike 30 mg/min tijekom 15 (niska doza) ili 30 minuta (visoka doza), nakon čega odmah slijedi kontinuirana infuzija od 4 mg (niska doza) ili 8 mg (visoka doza) u minuti tijekom 120 minuta (vidjeti tablicu 1).
Acute myocardial infarction uncommon
Srčani poremećaji Akutni infarkt miokarda manje često
Administration using a syringe pump
Primjena pomoću perfuzora (infuzijske pumpe sa štrcaljkom)
Each vial contains 200 mg of andexanet alfa*.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 200 mg andeksaneta alfa*.
High dose
nepoznato visoka doza
Mannitol
Intravenski
Abdominal pain common
Bol u abdomenu često
Each vial contains 200 mg of andexanet alfa.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 200 mg andeksaneta alfa.
Myocardial infarction uncommon
Infarkt miokarda manje često
The recommended dose regimen of Ondexxya is based on the dose of rivaroxaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of rivaroxaban (see table 3).
Preporučeni režim doziranja Ondexxye temelji se na dozi rivaroksabana koju bolesnik uzima u trenutku potrebe reverzije antikoagulacije, kao i o vremenu proteklom od zadnje doze rivaroksabana koju je bolesnik primio (vidjeti tablicu 3).
The reconstituted solution should be inspected for particulate matter and/or discolouration prior to administration.
7. Prije primjene potrebno je provjeriti ima li u rekonstituiranoj otopini vidljivih čestica i/ili promjene boje.
Hepatic impairment
Završetak bolusa
Pulmonary embolism uncommon
Plućna embolija manje često
• If you get any side effects, talk to your doctor or nurse.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
The recommended dose regimen of andexanet alfa is based on the dose of rivaroxaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of rivaroxaban (see table 3).
Preporučeni režim doziranja andeksaneta alfa temelji se na dozi rivaroksabana koju bolesnik uzima u trenutku potrebe reverzije antikoagulacije, kao i o vremenu proteklom od zadnje doze rivaroksabana koju je bolesnik primio (vidjeti tablicu 3).
Reversing FXa inhibitor therapy exposes patients to the thrombotic risk of their underlying disease.
FXa ti se bolesnici izlažu riziku od tromboze uzrokovane osnovnom bolešću.
Powder for solution for infusion 4 x 1 vial of 200 mg
4 x1 bočica od 200 mg
The recommended dose regimen of Ondexxya is based on the dose of apixaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of apixaban (see table 2).
Preporučeni režim doziranja Ondexxye temelji se na dozi apiksabana koju bolesnik uzima u trenutku potrebe reverzije antikoagulacije, kao i o vremenu proteklom od zadnje doze apiksabana koju je bolesnik primio (vidjeti tablicu 2).
Submission of the final CSR by 30
Podnošenje konačnog izvješća o kliničkom ispitivanju do 30. rujna
The occurrence of thromboembolic events was generally comparable between patients > 75 years (11.0%; 24/219) and those ≤ 75 years of age (9.1%; 12/132).
> 75 godina (11,0%: 24/219) i onih u dobi
Pruritus generalised common
Generalizirani svrbež često
PK/PD modelling
Farmakokinetičko/farmakodinamičko modeliranje
The recommended dose regimen of andexanet alfa is based on the dose of apixaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of apixaban (see table 2).
Preporučeni režim doziranja andeksaneta alfa temelji se na dozi apiksabana koju bolesnik uzima u trenutku potrebe reverzije antikoagulacije, kao i na vremenu proteklom od zadnje doze apiksabana koju je bolesnik primio (vidjeti tablicu 2).
Reporting suspected adverse reactions after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.
Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.
Deep vein thrombosis uncommon
Krvožilni poremećaji Duboka venska tromboza manje često
Tris hydrochloride L-arginine hydrochloride Sucrose
6.1 Popis pomoćnih tvari tris baza tris hidroklorid L-arginin hidroklorid saharoza manitol polisorbat 80 6.2 Inkompatibilnosti
Administration using a syringe pump 1.
Prašak za otopinu za infuziju.
Iliac artery occlusion uncommon
Okluzija ilijačne arterije manje često
• itching
(engl.
METHOD AND ROUTE(S) OF ADMINISTRATION
Anti-FXa (ng/ml)
Based on data from 352 patients from the Phase IIIb/IV ANNEXA-4 study treated with an FXa inhibitor and experiencing an acute major bleeding episode, one patient experienced a serious or severe infusion-related reaction.
Na temelju podataka prikupljenih na 352 bolesnika u fazi IIIb/IV ispitivanja ANNEXA-4 liječenih inhibitorom
• nausea (feeling sick)
Vrijeme nakon bolusa (sati)
Ischaemic stroke common
Ishemijski moždani udar često
Cerebral infarction uncommon
Promjena koncentracije nevezanog inhibitora
Musculoskeletal and connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Bol u leđima često
Remove the flip-top from each vial.
Skinite poklopac s bočice.
Nausea common
Mučnina često
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
• Uvjetno odobrenje za stavljanje lijeka u promet
Deaths
Dojenje
Name and address of the manufacturer of the biological active substance Lonza Biologics Porrino, S.L.
Naziv i adresa proizvođača biološke djelatne tvari
(2) Produced in human diploid lung (WI-38) fibroblasts.
(2) Umnožen na ljudskim diploidnim plućnim (WI-38) fibroblastima.
(1) Produced in chick embryo cells.
(1) Umnožen na stanicama pilećeg embrija.
(3) Produced in human diploid (MRC-5) cells.
(3) Umnožen na ljudskim diploidnim (MRC-5) stanicama.
*50% cell culture infectious dose **plaque-forming units
*količina virusa kojom se zarazi 50% kulture stanica (50% cell culture infectious dose) **jedinice stvaranja plakova
Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated) not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/3 strain (live, attenuated)
§ živi, atenuirani virus morbila1, soj Enders' Edmonston ne manje od 3,00 log10 CCID50* živi, atenuirani virus parotitisa1, soj Jeryl Lynn™ [Razina B] ne manje od 4,30 log10 CCID50* živi, atenuirani virus rubele2, soj Wistar RA 27/3 ne manje od 3,00 log10 CCID50* živi, atenuirani virus varičele3, soj Oka/Merck ne manje od 3,99 log10 PFU**
10 vials + 10 pre-filled syringes with attached needle
10 bočica + 10 napunjenih štrcaljki sa spojenom iglom
1 vial + 1 pre-filled syringe with attached needle
1 bočica + 1 napunjena štrcaljka sa spojenom iglom
In such case, treatment must be stopped immediately.
U ovakvom se slučaju liječenje mora odmah prekinuti.
The timetable for the implementation of the agreement is set out in Annex V.
Raspored provedbe sporazuma naveden je u Dodatku V.
The PRAC noted that others studies will become available.
PRAC je napomenuo da će druga ispitivanja postati dostupna.
The studies and their limitations were considered together with the overall evidence available to date.
Ispitivanja i njihova ograničenja razmotrena su zajedno s cjelokupnim trenutno dostupnim dokazima.
• The PRAC noted that some of the studies have methodological limitations.
• je PRAC napomenuo da pojedina ispitivanja imaju metodološka ograničenja.
Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Nakon što je pregledao preporuku PRAC-a, CMDh je suglasan s cjelokupnim znanstvenim zaključcima i razlozima za preporuku.
• The PRAC considered the procedure under Article 31 of directive 2001/83/EC for testosteronecontaining medicinal products.
• je PRAC razmotrio postupak u skladu s člankom 31. Direktive 2001/83/EC za lijekove koji sadrže testosteron.
In addition, there is limited experience on the safety and efficacy of the use of testosterone in patients over 65 years of age.
Nadalje, postoji ograničeno iskustvo o sigurnosti i djelotvornosti primjene testosterona u bolesnika starijih od 65 godina.