natgillin/translations-raw huggingface dataset:
• Each vial should be swirled gently to avoid foaming and ensure that all Orbactiv powder is completely reconstituted in solution.
• Vsako vialo je treba nežno zavrteti, da se tekočina ne peni in da se zagotovi popolna rekonstitucija praška zdravila Orbactiv v raztopini.
No mass balance study has been conducted in humans.
Študij utežnega razmerja pri ljudeh niso izvajali.
Intravenous infusions of oritavancin can cause reactions that resemble “red man syndrome”, including flushing of the upper body, urticaria, pruritis and/or rash.
Intravenske infuzije oritavancina lahko povzročijo reakcije, podobne »sindromu rdečega moža«, vključno z rdečico na zgornjem delu telesa, urtikarijo, pruritusom in/ali izpuščajem.
Reconstitution: Aseptic technique should be used to reconstitute three Orbactiv 400 mg vials.
Rekonstitucija: Za rekonstitucijo treh vial zdravila Orbactiv 400 mg je treba uporabljati aseptično tehniko.
• 40 mL of water for injections (WFI) should be added using a sterile syringe to reconstitute each vial to provide a 10 mg/mL solution per vial.
• S sterilno injekcijsko brizgo je treba vsaki viali dodati 40 ml vode za injekcije, da dobimo raztopino s koncentracijo 10 mg/ml na vialo.
In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, oritavancin should be coadministered with appropriate antibacterial agent(s).
Pri mešanih okužbah, kjer obstaja sum na gramnegativne in/ali nekatere vrste anaerobnih bakterij, je treba oritavancin dajati skupaj z drugo ustrezno protibakterijsko učinkovino ali učinkovinami.
Table 1: Coagulation tests affected by oritavancin Assay
Preglednica 1: Testi koagulacije, na katere oritavancin vpliva Test
Up to 12 hours
Do 12 ur
Orbactiv may interfere with laboratory tests or self-test that measure how well your blood is clotting (INR) and may cause a false reading up to 12 hours after the infusion.
Zdravilo Orbactiv lahko vpliva na laboratorijske teste ali osebni diagnostični test, ki meri strjevanje krvi (INR), in povzroči lažne rezultate do 12 ur po infuziji.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of oritavancin (see section 4.8).
Zato je pri bolnikih, ki imajo po dajanju oritavancina drisko, pomembno pomisliti na to diagnozo (glejte poglavje 4.8).
1,200 mg administered as a single dose by intravenous infusion over 3 hours.
1.200 mg se daje kot enkratni odmerek v obliki 3-urne intravenske infuzije.
Hypersensitivity (see sections 4.3 and 4.4) , anaphylactic reaction
Bolezni imunskega sistema občasni preobčutljivost (glejte poglavji 4.3 in 4.4), anafilaktična reakcija neznana pogostnost anafilaktični šok
Clostridioides difficile-associated diarrhoea
Driska, povezana s Clostridioides difficile
Only glucose 5% intravenous bag (D5W) should be used for dilution.
Za redčenje je dovoljeno uporabljati le vreče za intravensko infuzijo s 5-% glukozo (D5W).
Oritavancin was found to be a nonspecific, weak inhibitor (CYP2C9 and CYP2C19) or a weak inducer (CYP3A4 and CYP2D6) of several CYP isoforms.
CYP2C19) ali šibak induktor (CYP3A4 in CYP2D6) več izooblik encima CYP.
Orbactiv should be prepared under aseptic techniques in a pharmacy.
Zdravilo Orbactiv je treba pripraviti v lekarni po aseptičnem postopku.
Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to oritavancin in vitro.
Klinična učinkovitost proti specifičnim patogenom Učinkovitost je bila dokazana v kliničnih študijah za naslednje patogene, ki so bili in vitro dovzetni za oritavancin.
Moderate, dose-related increases in liver enzymes (alanine transaminase and aspartate transaminase) were observed in rats and dogs and were shown to be reversible upon cessation of treatment.
Pri podganah in psih so opazili zmerno, od odmerka odvisno povišanje vrednosti jetrnih encimov (alanin transaminaze in aspartat transaminaze), ki je bilo po prenehanju dajanja reverzibilno.
This yields a concentration of 1.2 mg/mL of oritavancin.
Tako dobite koncentracijo oritavancina 1,2 mg/ml.
• Heart racing or beating fast;
• razbijanje ali hitro utripanje srca
Oritavancin is a type of antibiotic (a lipoglycopeptide antibiotic) that can kill or stop the growth of certain bacteria.
(lipoglikopeptidni antibiotik), ki lahko ubije nekatere bakterije ali ustavi njihovo rast.
There were no relevant changes in pharmacokinetics of oritavancin in subjects with moderate hepatic impairment.
Pomembnih sprememb v farmakokinetiki oritavancina pri osebah z zmerno jetrno okvaro ni bilo.
• Increased blood bilirubin levels ;
• zvišane ravni bilirubina v krvi
These effects result from oritavancin binding to and preventing the action of the phospholipid reagents which activate coagulation in commonly used laboratory coagulation tests.
Ti učinki so posledica vezave oritavancina na fosfolipidne reagente, ki aktivirajo koagulacijo pri pogosto uporabljenih laboratorijskih testih koagulacije, in preprečitve njihovega delovanja.
The appearance of the eosinophilic granules did not occur following single dose administration and did not significantly affect innate macrophage function in vitro at intracellular levels anticipated from a single 1,200 mg dose.
Eozinofilne granule se niso pojavile po dajanju enega odmerka in in vitro niso bistveno vplivale na naravno delovanje makrofagov pri predvidenih znotrajceličnih ravneh od enkratnega odmerka
The recommended dose for Orbactiv is one single infusion of 1,200 mg administered into a vein over 3 hours.
Priporočeni odmerek zdravila Orbactiv je ena 3-urna infuzija 1.200 mg v veno.
Orbactiv may interfere with laboratory tests that measure how well your blood is clotting and may cause a false reading.
Zdravilo Orbactiv lahko vpliva na laboratorijske teste za merjenje strjevanja krvi in povzroči napačne odčitke.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/<in na spletni strani {ime agencije v državi članici (povezava)}>.
No metabolites were observed in plasma or bile from oritavancin treated dogs and rats, respectively.
V plazmi ali žolču psov in podgan, ki so jim dajali oritavancin, niso opazili presnovkov.
• To avoid excessive foaming, it is recommended that WFI should be added carefully, along the walls of the vials.
• Da se tekočina na peni preveč, je treba vodo za injekcije dodajati previdno vzdolž sten viale.
Dilute Russell's viper venom time (DRVVT)
Russellovega gada (DRVVT)
Parenteral medicinal products should be inspected visually for particulate matter after reconstitution.
Parenteralna zdravila je treba po rekonstituciji in pred uporabo vizualno pregledati, ali vsebujejo delce.
No dosage adjustment is needed in patients with mild or moderate renal impairment (see section 5.2).
Prilagajanje odmerka pri bolnikih z blago ali zmerno okvaro ledvic ni potrebno (glejte poglavje 5.2).
If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C for Orbactiv diluted in glucose 5% intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Običajno naj bi čas shranjevanja ne bil daljši od 12 ur pri 25 ºC in 24 ur pri 2 do 8 ºC za zdravilo Orbactiv, razredčeno v vreči za intravensko infuzijo z glukozo, razen če je rekonstitucija ali redčenje potekalo pod nadziranimi in validiranimi aseptičnimi pogoji.
Up to 24 hours
Do 24 ur
In humans, less than 1% to 5% of the dose was recovered as parent drug in faeces and urine respectively after 2 weeks of collection indicating that oritavancin is slowly excreted unchanged.
1 % izhodiščne učinkovine v blatu in manj kot 5 % v urinu, kar kaže, da se oritavancin počasi izloča v nespremenjeni obliki.
Based on population PK analysis, the population mean total volume of distribution is estimated to be approximately 87.6 L, indicating oritavancin is extensively distributed into the tissues.
87,6 l, kar kaže, da se oritavancin obsežno porazdeljuje po tkivih.
The pharmacokinetics of oritavancin was examined in the single dose Phase 3 ABSSSI studies in patients with normal renal function, CrCL ≥90 mL/min (n=213), mild renal impairment, CrCL 60-89 mL/min (n=59), moderate renal impairment, CrCL 30-59 mL/min (n=22), and severe renal impairment CrCL <30 mL/min (n=3).
blago ledvično okvaro, CrCL 60-89 ml/min (n = 59), zmerno ledvično okvaro, CrCL 30-59 ml/min
The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated.
Farmakokinetike oritavancina pri bolnikih s hudo okvaro ledvic niso ovrednotili.
Exposures (AUC0-24) of oritavancin in skin blister fluid were 20% of those in plasma after a single 800 mg dose in healthy subjects.
Izpostavljenosti (AUC0-24) oritavancinu v tekočini kožnih mehurjev so bile enake 20 %
Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of ill effects.
Če dobite večji odmerek zdravila Orbactiv, kot bi smeli Vaš zdravnik se bo odločil o tem, kako vas bo zdravil, vključno z ustavitvijo zdravljenja in spremljanje bolezenskih znakov.
patients is 138 (23) μg/ml and 2,800 (28.6) μg•h/mL respectively.
Pri bolnikih, ki so prejeli en odmerek 1.200 mg zaradi ABSSSI, je povprečna (CV %) največja koncentracija oritavancina (Cmax) 138 (23) μg/ml, AUC0-∞ pa 2.800 (28,6) μg•h/ml.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Urticaria, rash, pruritis
ekstravazacija, induracija, pruritis, izpuščaj,
The pharmacokinetics of oritavancin in patients with severe hepatic impairment has not been studied.
Farmakokinetike oritavancina pri bolnikih s hudo okvaro jeter niso preučili.
Single-use 50 ml Type 1 glass vials with rubber stoppers and aluminium flip off cap. 3 individual vials are packaged in a carton.
50 ml steklena viala iz stekla tipa 1 za enkratno uporabo z gumijastim zamaškom in aluminijasto zaporko na poteg.
After reconstitution, 1 ml of the solution contains 10 mg oritavancin.
Po rekonstituciji vsebuje 1 ml raztopine 10 mg oritavancina.
The area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC) ratio of oritavancin for the infecting organism has been shown to be the parameter that best correlates with efficacy.
Farmakokinetično/farmakodinamično (FK/FD) razmerje Pokazalo se je, da je parameter, ki najboljše korelira z učinkovitostjo, razmerje med površino pod krivuljo koncentracija-čas (AUC-area under the concentration-time curve) in minimalno inhibitorno koncentracijo (MIC-minimum inhibitory concentration) oritavancina za povzročitelje okužbe.
Aseptic procedures should be used for the preparation of Orbactiv.
Priprava zdravila Orbactiv mora potekati po aseptičnih postopkih.
No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Prilagajanje odmerka pri bolnikih z blago ali zmerno okvaro jeter (razred B po Child-Pughu) ni potrebno (glejte poglavje 5.2).
Serious hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock have been reported with the use of oritavancin.
Pri uporabi oritavancina so poročali o resnih preobčutljivostnih reakcijah, vključno z anafilaktičnimi reakcijami in anafilaktičnim šokom.
How you will be given Orbactiv
Kako boste dobili zdravilo Orbactiv
Interference with assay for coagulation tests
Vplivi na koagulacijske teste
After reconstitution and dilution, 1 ml solution for infusion contains 1.2 mg oritavancin.
Po rekonstituciji in redčenju vsebuje 1 ml raztopine za infundiranje 1,2 mg oritavancina.
The Chromogenic Factor Xa Assay, the Thrombin Time (TT) assay and the assays used for the diagnosis of Heparin Induced Thrombocytopenia (HIT) are not affected by oritavancin.
Oritavancin ne vpliva na kromogeni preizkus določanja aktivnosti faktorja Xa, določanje trombinskega časa (TT-thrombin Time) in preizkus trombocitopenije, izzvane s heparinom (HITheparin induced thrombocytopenia).
Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours after oritavancin administration (see sections 4.4 and 4.5).
Uporaba intravenskega nefrakcioniranega natrijevega heparinata je kontraindicirana 120 ur (5 dni) po dajanju oritavancina, saj so lahko rezultati testov aktiviranega delnega tromboplastinskega časa
If you get any side effects, talk to your doctor or nurse.
Če opazite kateregakoli izmed neželenih učinovk, se posvetujte z zdravnikom ali medicinsko sestro.
Nausea, vomiting, diarrhoea, constipation
Bolezni prebavil pogosti navzea, bruhanje, driska, zaprtje
After reconstitution
3 leta Po rekonstituciji
• More enzymes produced by your liver (as shown in blood tests);
• povišane vrednosti jetrnih encimov (spremenjene vrednosti jetrnih testov)
• Muscle pain;
• bolečina v mišicah
How to store Orbactiv
Shranjevanje zdravila Orbactiv
• Headache;
• glavobol
Cellulitis, abscess (limb and subcutaneous)
Infekcijske in parazitske bolezni pogosti celulitis, abscesi (okončine in podkožni)
• Feeling sick (nausea) or being sick (vomiting);
• siljenje na bruhanje (navzea) ali bruhanje
• Beta-haemolytic streptococci of Group G
• Betahemolitični streptokoki skupine G
It is particularly important to tell your doctor if you are using medicines that prevent blood from clotting (oral anticoagulants, e.g.coumarin anticoagulants ).
Zlasti pomembno je, da zdravniku poveste, če jemljete zdravila za preprečevanje strjevanja krvi
- Orbactiv is a powder for concentrate for solution for infusion - Orbactiv is a white to off white powder, supplied in a 50 ml glass vial.
- Zdravilo Orbactiv je bel do umazano bel prašek v 50 ml stekleni viali.
Lifetime studies in animals have not been conducted to evaluate the carcinogenic potential of oritavancin.
Študij za ugotavljanje kancerogenega potenciala oritavancina, pri katerih bi živali spremljali vse življenje, niso izvedli.
The reconstituted solution should be further diluted in glucose 5% intravenous infusion bag immediately.
Rekonstituirano raztopino nadalje takoj razredčite v vreči za intravensko infuzijo z glukozo (5-%).
Bronchospasm, wheezing
multiformni eritem, oblivanje
Three Orbactiv 400 mg vials need to be reconstituted and diluted to prepare a single once-only 1,200 mg IV dose.
Rekonstituirati in razredčiti je treba tri viale zdravila Orbactiv 400 mg, da pripravite en i.v.
• Withdraw and discard 120 mL from a 1,000 mL D5W intravenous bag.
Redčenje: • Iz 1.000 ml vreče za intravensko infuzijo D5W izvlecite 120 ml tekočine in jo zavrzite.
Orbactiv 400 mg powder for concentrate oritavancin
Orbactiv 400 mg prašek za koncentrat oritavancin
The reconstituted solution should be further diluted in glucose 50 mg/ml (5%) intravenous infusion bag immediately.
Rekonstituirano raztopino nadalje takoj razredčite v vreči za intravensko infuzijo z glukozo 50 mg/ml
A study to assess the drug-drug interaction effect of a single 1,200mg dose of oritavancin on the pharmacokinetics of S-warfarin following a single dose was conducted in 36 healthy subjects.
Pri 36 zdravih osebah so izvedli študijo za oceno, kako pri medsebojnem delovanju med zdravili posamezen 1200 mg odmerek oritavancina učinkuje na farmakokinetiko S-varfarina.
If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C following dilution in a glucose 5% intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Običajno naj bi čas shranjevanja ne bil daljši od 12 ur pri 25 ºC in 24 ur pri 2 do 8 ºC po razredčitvi v vreči za intravensko infuzijo s 5
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
Myalgia
odmerek
Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin.
Ena viala vsebuje 400 mg oritavancina v obliki oritavancin difosfata.
Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to oritavancin in the absence of acquired mechanisms of resistance:
Klinične učinkovitosti proti naslednjim patogenom niso ugotovili, čeprav študije in vitro nakazujejo,
After dilution, 1 ml of the solution for infusion contains 1.2 mg oritavancin.
Po redčenju vsebuje 1 ml raztopine za infundiranje 1,2 mg oritavancina.
Your doctor will treat you as necessary.
Zdravnik vas bo po potrebi zdravil.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti mialgija občasni tenosinovitis
No effect of oritavancin on the in vivo coagulation system was observed in nonclinical and clinical studies.
V nekliničnih in kliničnih študijah ni bilo opaziti vpliva oritavancina na sistem strjevanja krvi in vivo.
Extramedullary haematopoiesis in the spleen was observed in rats.
Pri podganah so opazili ekstramedularno hematopoezo vranice.
Dilution: Three reconstituted vials are needed for dilution for administration of a single 1,200 mg intravenous infusion.
Redčenje: Za eno 1.200 mg intravensko infuzijo je treba razredčiti tri rekonstituirane viale.
Beta-haemolytic streptococci Groups A, B, C, G 0.25 Viridans group streptococci (S. anginosus group only)
Beta-hemolitični streptokoki skupin A, B, C, G
• Pain or irritation where the injection was given;
• bolečina ali draženje na mestu dajanja injekcije • srbenje, kožni izpuščaj
Blood bilirubin increased
občasni povečana raven bilirubina v krvi
Powder for concentrate for solution for infusion (powder for concentrate).
prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Bel do umazano bel prašek.
A screening drug-drug interaction study was conducted in healthy volunteers (n=16) evaluating the concomitant administration of a single 1,200 mg dose of oritavancin with probe substrates for several CYP450 enzymes.
za ocenitev sočasnega dajanja enega odmerka 1.200 mg oritavancina s preiskovalnimi substrati za več encimov CYP450.
Dosage adjustment of oritavancin is not needed in patients with mild or moderate renal impairment.
Pri bolnikih z blago ali zmerno ledvično okvaro odmerka oritavancina ni treba prilagajati.
Mannitol Phosphoric acid (for pH-adjustment)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol fosforna kislina (za uravnavanje pH)
Headache, dizziness
• hud izpuščaj • vročinski oblivi
• Shivering or trembling;
• tresenje ali drgetanje
• Reduced blood platelet count below the normal lower limit (known as thrombocytopenia).
• zmanjšano število krvnih ploščic (trombocitopenija)
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora občasni bronhospazem, sopenje
• Constipation;
• vrtoglavica
Leucocytoclastic vasculitis, angioedema, erythema multiforme, flushing
Bolezni kože in podkožja pogosti urtikarija, izpuščaj, pruritus občasni levkocitoklastični vaskulitis, angioedem,
Orbactiv 400 mg powder for concentrate for solution for infusion
Orbactiv 400 mg prašek za koncentrat za raztopino za infundiranje
6.5 Nature and contents of container
6.5 Vrsta ovojnine in vsebina <ter posebna oprema za uporabo, dajanje ali implantacijo>
Infusion site reactions, including the following symptoms infusion site phlebitis, infusion site erythema, extravasation, induration, pruritis, rash, oedema peripheral
Splošne težave in spremembe na mestu aplikacije pogosti reakcije na mestu infundiranja, vključno z naslednjimi simptomi: flebitis na mestu infundiranja, eritem na mestu infundiranja,
There was no evidence of transplacental transfer of oritavancin in pregnant rats.
Pri brejih podganjih samicah ni bilo znakov prehajanja oritavancina skozi placento.
Antibacterial-associated colitis and pseudomembranous colitis have been reported for oritavancin and may range in severity from mild to life threatening diarrhoea.
Pri uporabi oritavancina so poročali o kolitisu in o psevdo-membranskem kolitisu, povezanem s protibakterijskimi zdravili, ki sta lahko blaga do življenjsko nevarna.
Hypoglycaemia, hyperuricaemia
Presnovne in prehranske motnje občasni hipoglikemija, hiperurikemija
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema pogosti anemija občasni eozinofilija, trombocitopenija
Dosage adjustment of oritavancin is not needed in patients with mild and moderate hepatic impairment.
Pri bolnikih z blago in zmerno jetrno okvaro odmerka oritavancina ni treba prilagajati.
Orbactiv 400 mg powder for concentrate for solution for infusion oritavancin
Orbactiv 400 mg prašek za koncentrat za raztopino za infundiranje oritavancin
Tachycardia
• driska
In Phase 3 ABSSSI clinical trials, more cases of osteomyelitis were reported in the oritavancin-treated arm than in the vancomycin-treated arm (see section 4.8).
zdravljenih z oritavancinom, kot v kraku bolnikov, zdravljenih z vankomicinom (glejte poglavje 4.8).
Susceptibility testing break points
Mejne vrednosti testiranja dovzetnosti
Orbactiv is intended for intravenous (IV) administration, only after reconstitution and dilution.
Zdravilo Orbactiv je namenjeno intravenskemu (i.v.)
It is important that your hands and items you use be as clean as possible.
Pomembno je, da so vaše roke in predmeti, ki jih uporabljate, čim bolj čisti.
Children and adolescents (< 18 years)
Otroci in adolescenti (<18 let)
None of those events was serious and less than 5% were considered severe.
Nobeden od teh dogodkov ni bil resen in manj kot 5 % so ocenili kot hude.
It is for single use only.
Je samo za enkratno uporabo.
Generally reconstitution takes less than 5 minutes.
Na splošno traja rekonstitucija manj kot 5 minut.
The duration of therapy is 12 weeks.
Trajanje zdravljenja je 12 tednov.
This may occur rarely in particular at
To se lahko redko pojavi, zlasti na začetku
These reactions were largely mild to moderate.
Te reakcije so bile večinoma blage do zmerne.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2004
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 20. september 2004
It is important that you tell your doctor if you have had or you have any of the above.
Pomembno je, da poveste zdravniku, če ste imeli ali imate karkoli od zgoraj navedenega.
These changes, which may be associated with the use of Raptiva, can usually only be detected with blood tests.
Te spremembe, ki so lahko povezane z uporabo zdravila Raptiva, se običajno lahko ugotovi le s krvnimi preiskavami.
Only at 25 weeks of age was this decrease no longer significant.
Šele pri 25 tednih starosti, ni bilo zmanjšanje več klinično pomembno.
Steady state was achieved at week 4.
Stanje dinamičnega ravnovesja je bilo doseženo v 4 tednu.
Your doctor will tell you how much you should inject.
Vaš zdravnik vam bo povedal koliko zdravila si morate injicirati.
EXP Use immediately after reconstitution.
EXP Uporabite takoj po rekonstituciji.
Elevation of alkaline phosphatase:
Dvig ravni alkaline fosfataze:
Over 600 patients have been treated for more than 1 year including 166 patients treated for more than 2 years and up to 3 years.
Več kot 600 bolnikov se je zdravilo več kot 1 leto, vključno s 166 bolniki, ki so se zdravili več kot 2 leti in do 3 let.
The injection can be self-administered or given by another person, for example a family member or your doctor.
Injekcijo si lahko dajete sami ali vam jo da kdo drug, na primer družinski član ali vaš zdravnik.
In such cases, it is recommended to
V teh primerih je priporočljivo prekiniti