FrancophonIA/ELRC3.0 huggingface dataset:
English: (abdomen), thigh, or upper arm.
Slovenian: (abdomnu), stegnu ali nadlakti.
English: TAKHZYRO has negligible influence on the ability to drive or use machines.
Slovenian: Zdravilo TAKHZYRO ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: • The other ingredients are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80 and water for injections - see section 2 “TAKHZYRO contains sodium” What TAKHZYRO looks like and contents of the pack
Slovenian: Druge sestavine so natrijev hidrogenfosfat dihidrat, citronska kislina monohidrat, histidin, natrijev klorid, polisorbat 80, voda za injekcije - glejte poglavje 2 »Zdravilo TAKHZYRO vsebuje natrij«.
English: The solution is colourless to slightly yellow, appearing either clear or slightly opalescent.
Slovenian: Raztopina je brezbarvna do rahlo rumenkasta ter bistrega ali nekoliko opalescentnega videza.
English: All TAKHZYRO treatment arms produced statistically significant reductions in the mean HAE attack rate compared to placebo across all primary and secondary endpoints in the Intent-to-Treat population (ITT) (Table 2).
Slovenian: Vsi kraki zdravljenja z zdravilom TAKHZYRO so pokazali statistično značilno zmanjšanje povprečne stopnje napadov HAE v primerjavi s placebom glede vseh primarnih in sekundarnih opazovanih dogodkov v populaciji z namenom zdravljenja (ITT, Intent-to-Treat) (preglednica 2).
English: It is unknown whether lanadelumab is excreted in human milk.
Slovenian: Ni znano, ali se lanadelumab izloča v materino mleko pri človeku.
English: TAKHZYRO is presented as a clear, colourless to slightly yellow solution for injection in a glass vial.
Slovenian: Zdravilo TAKHZYRO je na voljo kot bistra, brezbarvna do rahlo rumenkasta raztopina za injiciranje v stekleni viali.
English: Renal impairment is not expected to affect exposure to lanadelumab or the safety profile.
Slovenian: Ne pričakuje se, da bi ledvična okvara vplivala na izpostavljenost lanadelumabu ali na njegov varnostni profil.
English: Do not choose an area that is bruised, swollen, or painful.
Slovenian: Ne izberite predela z modrico, oteklino ali bolečega predela.
English: Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial into the syringe using an 18 gauge needle.
Slovenian: Z aseptično tehniko izvlecite predpisani odmerek zdravila TAKHZYRO iz viale v injekcijsko brizgo z iglo velikosti 18G.
English: 2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with violet flip-off cap.
Slovenian: 2 ml raztopine v viali (steklo tipa I) z zamaškom iz butilne gume in aluminijastim tesnilom z vijolično dvižno zaporko.
English: The percentage of patients who achieved a clinically meaningful improvement in AE-QoL total score was 65% (Odds ratio vs placebo, [95% CI]= 3.2 [1.1, 9.2]), 63% (2.9 [1.1, 8.1]), and 81% (7.2 [2.2, 23.4]), in TAKHZYRO 150 mg q4 wks, 300 mg q4 wks, and 300 mg q2 wks groups, respectively, compared to 37% of patients in the placebo group.
Slovenian: Odstotek bolnikov, ki so dosegli klinično pomembno izboljšanje v skupnem seštevku AE-QoL, je bil 65 % (razmerje obetov v primerjavi s placebom, [95-% IZ] = 3,2 [1,1; 9,2]), 63 % (2,9 [1,1; 8;1]) oz. 81 % (7,2 [2,2; 23,4]) za skupine z zdravilom TAKHZYRO 150 mg vsake štiri tedne, 300 mg vsake štiri tedne oz. 300 mg vsaka 2 tedna, v primerjavi s 37 % bolnikov v skupini s placebom.
English: Do not remove the vial rubber stopper.
Slovenian: Ne odstranite gumijastega zamaška z viale.
English: If a dose of TAKHZYRO is missed, the patient should be instructed to administer the dose as soon as possible ensuring at least 10 days between doses.
Slovenian: Če bolnik izpusti odmerek zdravila TAKHZYRO, mu je treba naročiti, naj si odmerek da čim prej, pri čemer pa mora med dvema odmerkoma preteči vsaj 10 dni.
English: Important: Be sure to keep the tip of the needle in the liquid to avoid drawing air in as you pull back the plunger.
Slovenian: Pomembno: Konica igle mora ostati v tekočini, da ne posesate zraka, ko vlečete za bat.
English: Lanadelumab's effect on fertility has not been evaluated in humans.
Slovenian: Učinka lanadelumaba na plodnost pri ljudeh niso ocenili.
English: - placebo vs TAKHZYRO at week 26 in HELP study
Slovenian: Sprememba rezultata a po AE-QoL - placebo v primerjavi z zdravilom TAKHZYRO v 26. tednu v študiji HELP.
English: Change the needle on the syringe to a 27 gauge needle or other needle suitable for SC injection.
Slovenian: Iglo na injekcijski brizgi zamenjajte z iglo velikosti 27G ali drugo iglo, primerno za s.c. injiciranje.
English: This medicinal product should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE).
Slovenian: Zdravljenje s tem zdravilom se lahko uvede le pod nadzorom zdravnika z izkušnjami v obravnavi bolnikov s hereditarnim angioedemom (HAE).
English: As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy and breast-feeding.
Slovenian: Kot previdnostni ukrep se je med nosečnostjo in dojenjem uporabi lanadelumaba bolje izogniti.
English: • One empty 3 ml syringe.
Slovenian: • Eno prazno 3-ml injekcijsko brizgo.
English: Slowly push the plunger, allowing air to go back into the vial, until the solution reaches the top of the syringe.
Slovenian: Bat počasi potiskajte in pustite, da se zrak vrne v vialo, dokler raztopina ne doseže vrha injekcijske brizge.
English: Multipack: 6 vials (6 packs of 1 vial) of 2 ml.
Slovenian: Skupno pakiranje: 1 viala (6 pakiranj z 1 vialo) z 2 ml.
English: If you use more TAKHZYRO than you should
Slovenian: Če ste uporabili večji odmerek zdravila TAKHZYRO, kot bi smeli
English: Pull back on the plunger to withdraw the full dose in the vial.
Slovenian: Bat povlecite nazaj, da izvlečete polni odmerek v vialo.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: What you need to know before you use TAKHZYRO
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo TAKHZYRO
English: As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy.
Slovenian: Kot previdnostni ukrep pa se je uporabi lanadelumaba med nosečnostjo bolje izogniti.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: The medicine contains less than 1 mmol sodium (23 mg) per ml of solution, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na ml raztopine, kar v bistvu pomeni ‘brez natrija'.
English: If you are not sure when to inject TAKHZYRO after a missed dose, ask your doctor, pharmacist or nurse.
Slovenian: Če niste prepričani, kdaj naj si po izpuščenem odmerku zdravilo TAKHZYRO injicirate, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: h) Place the vial on a flat surface.
Slovenian: h) Vialo položite na ravno površino.
English: Name and address of the manufacturer(s) of the biological active substance(s) Rentschler Biopharma SE
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin) Rentschler Biopharma SE
English: • TAKHZYRO is for injection under the skin (‘subcutaneous injection').
Slovenian: Zdravilo TAKHZYRO je za podkožno injiciranje (‘subkutana injekcija').
English: Store in a refrigerator (2C to 8C).
Slovenian: Shranjujte v hladilniku (2 C do 8 C).
English: Concentration-dependent inhibition of plasma kallikrein, measured as reduction of cHMWK levels, was demonstrated after SC administration of TAKHZYRO 150 mg every 4 weeks, 300 mg every 4 weeks or 300 mg every 2 weeks in subjects with HAE.
Slovenian: Od koncentracije odvisno zaviranje plazemskega kalikreina, izmerjeno kot zmanjšanje ravni cHMWK, je bilo dokazano po s.c. dajanju zdravila TAKHZYRO 150 mg vsake 4 tedne, 300 mg vsake 4 tedne ali 300 mg vsaka 2 tedna pri preiskovancih s HAE.
English: In repeat-dose studies evaluating once weekly SC injection in both rats (up to 28 days) and cynomolgus monkeys (up to 6 months) lanadelumab was well-tolerated at doses of up to and including 50 mg/kg (highest dose tested) with no organs of toxicity identified.
Slovenian: V študijah ponavljajočih odmerkov za ocenitev s.c. injiciranja lanadelumaba enkrat na teden podganam (do 28 dni) in opicam cynomolgus (do 6 mesecev) so živali odmerke do vključno 50 mg/kg (največji testirani odmerek) dobro prenašale, brez ugotovljenih toksičnosti za organe.
English: **Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.
Slovenian: **Reakcije na mestu injiciranja vključujejo: bolečino, eritem, modrice, nelagodje, hematom, krvavitev, pruritus, oteklino, otrdlino, parestezijo, reakcijo, toploto, edem in izpuščaj.
English: Percentage of subjects who were attack free through treatment
Slovenian: Odstotek preiskovancev, ki ves čas zdravljenja niso imeli napadov Kriterij
English: Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm (see section 4.2).
Slovenian: Zdravilo TAKHZYRO injicirajte subkutano v trebuh, stegno ali nadlaket (glejte poglavje 4.2).
English: Multipack: 2 vials (2 packs of 1 vial) of 2 ml.
Slovenian: Skupno pakiranje: 1 viala (2 pakiranji z 1 vialo) z 2 ml.
English: The mean reduction in HAE attack rate was consistently higher across the TAKHZYRO treatment arms compared to placebo regardless of the baseline history of LTP, laryngeal attacks, or attack rate during the run-in period.
Slovenian: Povprečno zmanjšanje stopnje napadov HAE je bilo dosledno večje v vseh krakih zdravljenja z zdravilom TAKHZYRO v primerjavi s placebom, ne glede na izhodiščno anamnezo dolgoročne profilakse ali laringealnih napadov ali glede na stopnjo napadov v uvajalnem obdobju.
English: In a 13-week study, once weekly SC administration of lanadelumab had no effects on male or female fertility at doses of 10 or 50 mg/kg (highest dose tested).
Slovenian: V 13-tedenski študiji s.c. dajanje lanadelumaba enkrat na teden ni vplivalo na plodnost samcev ali samic pri odmerkih 10 ali 50 mg/kg (največji testirani odmerek).
English: No dose adjustment is required for patients above 65 years of age (see section 5.2).
Slovenian: Pri bolnikih, starih več kot 65 let, odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Do not touch any surface or your body, especially your face, after washing your hands before injection.
Slovenian: Po tem, ko ste si pred injiciranjem umili roke, se ne dotikajte površine svojega telesa, zlasti obraza.
English: • Insert the needle into the fatty tissue in the tummy (abdomen), thigh or upper arm.
Slovenian: Iglo si vstavite v maščobno tkivo trebuha (abdomna), stegna ali nadlakti.
English: No studies have been conducted in patients with severe renal impairment.
Slovenian: Študij pri bolnikih s hudo ledvično okvaro niso izvedli.
English: Only use the syringes, blunt-tip vial access needles and pointed-tip injection needles in this pack or which your doctor has prescribed.
Slovenian: Uporabljajte samo injekcijske brizge, igle za dostop do viale s topo konico in igle za injiciranje z ostro konico, ki so priložene temu pakiranju ali jih je predpisal zdravnik.
English: Other medicines and TAKHZYRO
Slovenian: Druga zdravila in zdravilo TAKHZYRO
English: • 18G vial access needle
Slovenian: • iglo velikosti 18G za dostop do viale
English: The ADA response was transient in 20% (2/10) of ADA positive subjects.
Slovenian: Odziv protiteles proti zdravilu je bil prehoden pri 20 % (2/10) preiskovancev, pozitivnih na protitelesa proti zdravilu.
English: The single and multiple dose pharmacokinetics of lanadelumab have been studied in patients with HAE.
Slovenian: Farmakokinetiko lanadelumaba pri enkratnem in večkratnem odmerjanju so preučili pri bolnikih s HAE.
English: • Reactions where the injection is given - symptoms include pain, skin redness, bruising, discomfort, swelling, bleeding, itching, hardening of skin, tingling, warmth and rash.
Slovenian: Reakcije na mestu injiciranja - simptomi vključujejo bolečino, rdečino kože, modrice, nelagodje, oteklino, krvavitev, srbenje, kožno zatrdlino, mravljinčenje, toploto in izpuščaj.
English: Lanadelumab had no effect on male or female fertility in cynomolgus monkeys (see section 5.3).
Slovenian: Lanadelumab pri opicah cynomolgus ni vplival na plodnost samcev in samic (glejte poglavje 5.3).
English: Rotation of the injection site is recommended.
Slovenian: Priporočljivo je menjavati mesta injiciranja.
English: TAKHZYRO should be administered within 2 hours of preparing the dosing syringe.
Slovenian: Zdravilo TAKHZYRO je treba dati v 2 urah po pripravi injekcijske brizge za dajanje zdravila.
English: Step 5: Inject TAKHZYRO
Slovenian: 5. korak: Injicirajte zdravilo TAKHZYRO
English: If you forget to use TAKHZYRO
Slovenian: Če ste pozabili uporabiti zdravilo TAKHZYRO
English: TAKHZYRO is intended for subcutaneous (SC) administration only.
Slovenian: Zdravilo TAKHZYRO je namenjeno samo za subkutano (s.c.) uporabo.
English: As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor (see section 5.1).
Slovenian: Po pričakovanju povzroči sočasna uporaba rešilnega zdravila, zaviralca esteraze C1, aditivni učinek lanadelumaba na raven odcepljenega visokomolekularnega kininogena (cHMWK, cleaved high molecular weight kininogen) na podlagi mehanizma delovanja lanadelumaba in zaviralca esteraze C1 (glejte poglavje 5.1).
English: The recommended starting dose is 300 mg lanadelumab every 2 weeks.
Slovenian: Priporočeni začetni odmerek je 300 mg lanadelumaba vsaka 2 tedna.
English: What TAKHZYRO is and what it is used for
Slovenian: Kaj je zdravilo TAKHZYRO in za kaj ga uporabljamo
English: Aspartate aminotransferase increased Common *Hypersensitivity includes: pruritus, discomfort and tingling of tongue.
Slovenian: Preiskave zvišanje ravni alaninaminotransferaze pogosti zvišanje ravni aspartataminotransferaze pogosti *Preobčutljivostne reakcije vključujejo: pruritus, nelagodje in mravljinčenje v jeziku.
English: There are no or limited data from the use of lanadelumab in pregnant women.
Slovenian: Podatkov o uporabi lanadelumaba pri nosečnicah ni oziroma so omejeni.
English: *Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Slovenian: *Lanadelumab je pridobljen s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
English: In the HELP study, patients treated with 300 mg q2 wks presented mean (SD) area under the curve over the dosing interval at steady-state (AUCtau,ss), maximum concentration at steady-state (Cmax,ss) and minimum concentration at steady-state (Cmin,ss) of 408 µg*day/ml (138), 34.4 µg/mL (11.2), and 25.4 µg/mL (9.18), respectively.
Slovenian: V študiji HELP so imeli bolniki, zdravljeni z 300 mg dvakrat na teden, povprečno (SD) površino pod krivuljo v intervalu odmerjanja v stanju dinamičnega ravnovesja (AUCtau,ss) 408 µg*dan/ml (138), največjo koncentracijo v stanju dinamičnega ravnovesja (Cmax,ss) 34,4 µg/ml (11,2) in najmanjšo koncentracijo v stanju dinamičnega ravnovesja (Cmin,ss) 25,4 µg/ml (9,18).
English: • 27G x ½ inch (0.4 x 13 mm) injection needle 6.6 Special precautions for disposal and other handling
Slovenian: • injekcijsko iglo velikosti 27G x ½ palca (0,4 x 13 mm) 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Lanadelumab je na voljo v vialah za enkratno uporabo.
English: TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.
Slovenian: Zdravilo TAKHZYRO si lahko bolnik injicira sam ali mu ga injicira negovalec, če ga zdravstveni delavec pred tem usposobi za s.c. injiciranje.
English: b) Pull back the plunger to fill the syringe with air equal to the amount of solution in the vial.
Slovenian: b) Bat povlecite nazaj, da injekcijsko brizgo napolnite s količino zraka, ki ustreza količini raztopine v viali.
English: If you stop using TAKHZYRO
Slovenian: Če ste prenehali uporabljati zdravilo TAKHZYRO
English: 100% of the subjects on 300 mg q2wks or q4wks and 89% on 150 mg q4wks achieved at least a 50% reduction in HAE attack rate compared to the run-in period.
Slovenian: 100 % preiskovancev, ki so prejemali 300 mg vsaka 2 tedna ali vsake 4 tedne, in 89 % preiskovancev, ki so prejemali 150 mg vsake 4 tedne, je doseglo vsaj 50-odstotno zmanjšanje stopenj napadov HAE v primerjavi z uvajalnim obdobjem.
English: How much TAKHZYRO to use
Slovenian: Koliko zdravila TAKHZYRO je treba uporabiti
English: Table 1: Adverse reactions reported with lanadelumab
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali pri lanadelumabu
English: TAKHZYRO 300 mg solution for injection lanadelumab
Slovenian: TAKHZYRO 300 mg raztopina za injiciranje lanadelumab
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Ob vsaki uporabi je treba zabeležiti ime zdravila in številko serije, da se zagotovi sledljivost bioloških zdravil.
English: f) Place the 18 gauge blunt-tip vial access needle and the vial in a sharps container.
Slovenian: f) Iglo velikosti 18 s topo konico za dostop in vialo odložite v vsebnik za ostre odpadke.
English: Step 3: Transfer TAKHZYRO into syringe and switch to the pointed-tip injection needle a) Insert the needle into the centre of the rubber stopper.
Slovenian: 3. korak: Zdravilo TAKHZYRO prenesite v injekcijsko brizgo in iglo za dostop do viale zamenjajte z iglo za injiciranje a) Iglo potisnite v sredino gumijastega zamaška.
English: Do not pull on the plunger.
Slovenian: Ne vlecite za bat.
English: MULTIPACK OUTER CARTON (INCLUDING BLUE-BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA ZA SKUPNO PAKIRANJE (Z MODRIM OKENCEM (BLUE-BOX))
English: Used for injection under the skin (subcutaneous).
Slovenian: Uporablja se za podkožno (subkutano) injiciranje.
English: Secondary endpoint - Number of moderate or severe HAE attacks from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Slovenian: Sekundarni opazovani dogodek - število zmernih ali hudih napadov HAE od 0. do 182. dneva Povprečje LS (95-% IZ) mesečne stopnje napadov b
English: Injection site reactions**
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja**
English: Functioning score
Slovenian: Rezultat za funkcioniranje
English: c) Slowly turn the vial upside down with needle and syringe attached.
Slovenian: c) Vialo počasi obrnite na glavo s pritrjeno iglo in injekcijsko brizgo.
English: Keep vial in the outer carton in order to protect from light.
Slovenian: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Exposures in the ePPND study were approximately 32-fold greater than that noted at 300 mg q2 wks based on AUC.
Slovenian: Izpostavljenosti v študiji ePPND so bile približno 32-krat večje, kot so jih opazili pri odmerku 300 mg vsaka 2 tedna na podlagi vrednosti AUC.
English: The injection should be given subcutaneously.
Slovenian: Zdravilo si injicirajte podkožno.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija pogosti
English: Endpoint statistics a
Slovenian: Statistika opazovanih dogodkov a
English: No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z ledvično okvaro odmerka ni treba prilagajati (glejte poglavje 5.2).
English: c) Pull off the needle cap straight from the syringe without touching the needle.
Slovenian: c) Pokrovček igle povlecite naravnost z injekcijske brizge, ne da bi se dotaknili igle.
English: TAKHZYRO 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI TAKHZYRO 300 mg
English: TAKHZYRO 300 mg solution for injection
Slovenian: IME ZDRAVILA TAKHZYRO 300 mg raztopina za injiciranje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA POSAMIČNO PAKIRANJE
English: Subjects were randomized into 1 of 4 parallel treatment arms, stratified by baseline attack rate, in a 3:2:2:2 ratio (placebo, lanadelumab 150 mg every 4 weeks [q4wks], lanadelumab 300 mg every 4 weeks [q4wks], or lanadelumab 300 mg every 2 weeks [q2wks] by SC injection) for the 26-week treatment period.
Slovenian: Preiskovanci so bili randomizirani v 1 od 4 krakov vzporednega zdravljenja, stratificiranih glede na stopnjo napadov ob izhodišču, v razmerju 3:2:2:2 (placebo, lanadelumab 150 mg vsake 4 tedne, lanadelumab 300 mg vsake 4 tedne ali lanadelumab 300 mg vsaka 2 tedna s s.c. injekcijo), za 26-tedensko obdobje zdravljenja.
English: Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay.
Slovenian: Zaviranje plazemskega kalikreina, ki ga povzroči lanadelumab, lahko pri tem testu podaljša aPTČ.
English: Posology
Slovenian: Beleženje
English: Exposures in sexually mature cynomolgus monkeys in the fertility study were approximately 20-and 22-fold greater than that noted at 300 mg q2 wks based on Cmax and AUC, respectively.
Slovenian: Izpostavljenosti spolno zrelih opic cynomolgus v študiji plodnosti so bile približno 20- oz. 22-krat večje, kot so jih opazili pri odmerjanju 300 mg vsaka dva tedna na podlagi vrednosti Cmax oz. AUC.
English: Primary endpoint - Number of HAE attacks from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Slovenian: Primarni opazovani dogodek - število napadov HAE od 0. do 182. dneva Povprečje LS (95-% IZ) mesečne stopnje napadov b
English: Age is not expected to affect exposure to lanadelumab.
Slovenian: Ne pričakuje se, da bi starost vplivala na izpostavljenost lanadelumabu.
English: TAKHZYRO is provided in single-use vials as ready-to-use solution.
Slovenian: Zravilo TAKHZYRO je na voljo kot raztopina, pripravljena za uporabo, v viali za enkratno uporabo.
English: 300 mg q2wks (N=27)
Slovenian: 300 mg vsaka 2 tedna (N = 27)
English: Important: Do not remove the needle cap from the needle when attaching to the syringe.
Slovenian: Pomembno: Pri pritrjevanju na injekcijsko brizgo z igle ne odstranite pokrovčka.
English: Do not use any syringes, blunt-tip vial access needles and pointed-tip injection needles that appear damaged.
Slovenian: Ne uporabljajte injekcijskih brizg, igel s topo konico za dostop do viale in injekcijskih igel s konico za injiciranje, če so poškodovane.
English: TAKHZYRO is not recommended for use in children under 12 years of age.
Slovenian: Uporaba zdravila TAKHZYRO pri otrocih, starih manj kot 12 let, ni priporočljiva.
English: Lanadelumab inhibits active plasma kallikrein proteolytic activity.
Slovenian: Lanadelumab zavira aktivno proteolitično aktivnost plazemskega kalikreina.
English: Solutions that are discoloured or contain particles should not be used.
Slovenian: Ne uporabljajte raztopin, ki so drugače obarvane ali vsebujejo delce.
English: Hepatic impairment is not expected to affect exposure to lanadelumab.
Slovenian: Ne pričakuje se, da bi jetrna okvara vplivala na izpostavljenost lanadelumabu.
English: Skin and subcutaneous tissue disorders Rash maculo-papular
Slovenian: Bolezni kože in podkožja makulopapulozni izpuščaj pogosti
English: Exposures in cynomolgus monkeys following 6 months of administration were approximately 23-fold greater than that noted at 300 mg q2 wks based on AUC.
Slovenian: Izpostavljenost opic cynomolgus po 6-mesečnem dajanju je bila približno 23-krat večja, kot so jo opazili pri 300 mg vsaka 2 tedna na podlagi vrednosti AUC.
English: Each vial contains 300 mg of lanadelumab in 2mL.
Slovenian: Ena viala vsebuje 300 mg lanadelumaba v 2 ml.