natgillin/translations-raw huggingface dataset:
For 10 patients in the per-protocol set (excludes those patients who received oral vitamin D between baseline and week 24) who underwent biopsy of the trans-iliac bone crest before and after receiving asfotase alfa:
(izključeni so bolniki, ki so prejemali peroralni vitamin D med izhodiščem in 24. tednom), ki so imeli biopsijo transčrevničnega grebena, preden so prejeli asfotazo alfa, in po tem:
Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics.
Zaradi razlik v encimskih značilnostih se aktivnost asfotaze alfa ne sme razlagati enako kot meritev aktivnosti alkalne fosfataze v serumu.
Treatment should be initiated by a physician experienced in the management of patients with metabolic or bone disorders.
Zdravljenje mora uvesti zdravnik z izkušnjami pri obravnavi bolnikov s presnovnimi ali kostnimi boleznimi.
What Strensiq looks like and contents of the pack Strensiq is presented as a clear colourless to slightly yellow aqueous solution for injection in vials containing 0.8 ml of solution.
Zdravilo Strensiq je na voljo v obliki bistre in brezbarvne do rahlo rumenkaste vodne raztopine za injiciranje v vialah, ki vsebujejo po 0,8 ml raztopine.
1- Preferred terms considered as injection site reactions are presented in section below 2- Preferred terms considered as hypersensitivity are presented in the section below
2- Posamezni izrazi, obravnavani kot preobčutljivost, so predstavljeni v spodnjem poglavju.
How to use Strensiq
Kako uporabljati zdravilo Strensiq
Strensiq should be administered using sterile disposable syringes and injection needles.
Zdravilo Strensiq je treba dati s sterilno injekcijsko brizgo in injekcijsko iglo za enkratno uporabo.
29 of 80 patients required ventilation support at baseline: ∙ 16 patients required invasive ventilation support (intubation or tracheostomy) at baseline (one had a brief period of non-invasive ventilation at baseline before transfer).
∙ 16 bolnikov je potrebovalo invazivno ventilacijsko podporo (intubacija ali traheostomija) ob izhodišču (eden je imel kratko obdobje neinvazivne ventilacije ob izhodišču pred transferjem);
Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus, and oral hypaesthesia.
Druge preobčutljivostne reakcije so vključevale bruhanje, navzeo, zvišano telesno temperaturo, glavobol, pordevanje, razdražljivost, mrzlico, kožni eritem, izpuščaj, pruritus in oralno hipestezijo.
In the event that bubbles appear in the syringe, hold the syringe with the needle pointing upwards and gently tap the side of the syringe until the bubbles rise to the top.
Če se v brizgi pojavijo zračni mehurčki, držite brizgo z iglo navzgor in previdno potrkajte po valju brizge, da se bodo mehurčki dvignili navzgor.
In asfotase alfa clinical studies adverse events of craniosynostosis (associated with increased intracranial pressure), including worsening of pre-existing craniosynostosis and occurrence of Arnold-Chiari malformation, have been reported in hypophosphatasia patients < 5 years of age.
V kliničnih študijah z asfotazo alfa so kot o neželenih učinkih poročali o kraniosinostozi (povezani z povečanim intrakranialnim tlakom), vključno s poslabšanjem obstoječe kraniosinostoze in pojavom
Remove the larger bore needle pushing down and turning counterclockwise.
Odstranite iglo večjega notranjega premera, tako da jo potisnete navzdol in jo zasukate v obratni smeri urnega kazalca.
Contents of the pack and other information
Shranjevanje zdravila Strensiq Vsebina pakiranja in dodatne informacije
With the needle in the solution, pull the plunger to withdraw the correct dose into the syringe.
Z iglo v raztopini povlecite bat nazaj, da boste v brizgo izvlekli pravilni odmerek.
Injection reaction
Reakcije na injiciranje
Place a smaller bore needle (e.g. 27 or 29G) on the filled syringe and with the protective cap on, push down and turn clockwise the needle onto the syringe until it is tight.
Namestite iglo manjšega notranjega premera (npr. 27 ali 29G) na napolnjeno brizgo in medtem,
Supportive safety data reflect exposure in 112 patients with perinatal/infantile (n=89), juvenile-onset (n = 22), adult onset (n = 1) HPP (age at enrollment from 1 day to 66.5 years) treated with asfotase alfa, with a treatment duration range from 1 day to 391.9 weeks [7.5 years]).
z juvenilnim začetkom (n=22) in HPP z začetkom v odrasli dobi (n=1) (starost ob vključitvi v študijo je bila od 1 dneva do 66,5 let), ki so prejemali asfotazo alfa, zdravljenje pa je trajalo od 1 dne do 391,9 tednov [7,5 let].
After the 1 mg/kg weekly subcutaneous administration in Cohort 1 the mean
Po subkutanem dajanju 1 mg/kg na teden v kohorti 1 je bila srednja (SD) vrednost AUC
Patients underwent biopsy of the trans-iliac bone crest either as part of a control group or before and after exposure to asfotase alfa: - Control group, standard of care (5 evaluable patients): mean (SD) mineralisation lag-time was 226 (248) days at baseline and 304 (211) days at week 24 - 0.3 mg/kg/day asfotase alfa group (4 evaluable patients): mean (SD) mineralisation lag-time was 1236 (1468) days at baseline and 328 (200) days at week 48 - 0.5 mg/kg/day asfotase alfa group (5 evaluable patients): mean (SD) mineralisation lag-time was 257 (146) days at baseline and 130 (142) days at week 48 After approximately 48 weeks all patients were adjusted to the recommended dose 1.0 mg/kg/day.
- kontrolna skupina, standardna oskrba (5 bolnikov, ki jih je bilo možno oceniti): srdnja vrednost (SD) časa zakasnitve mineralizacije je bila 226 (248) dni ob izhodišču in 304 (211) dni v 24. tednu; - skupina z 0,3 mg/kg/dan asfotaze alfa (4 bolniki, ki jih je bilo možno oceniti): srednja vrednost (SD) časa zakasnitve mineralizacije je bila 1236 (1468) dni ob izhodišču in 328 (200) dni v
No trends in adverse events based on antibody status were observed in clinical trials.
V kliničnih preskušanjih niso opazili trendov neželenih učinkov na podlagi statusa protiteles.
Age at inclusion in the study was between 6 and 12 years old and was between 10 and 18 years old at completion, with 9 patients who became between 13 and 17 years old during the study.
Pri vključitvi v študijo je bila starost bolnikov med 6 in 12 leti, ob zaključku pa med 10 in 18 leti.
Remove the protective plastic from the syringe to be used.
odstranite zaščitno plastiko.
Ophthalmology examination and renal ultrasounds are recommended at baseline and periodically in hypophosphatasia patients.
Pri bolnikih s hipofosfatazijo se zato priporočajo očesni pregledi v izhodišču in nato periodično in ultrazvok ledvic.
- Mean (SD) mineralisation lag-time was 93 (70) days at baseline and 119 (225) days at week 24
- srednja vrednost (SD) časa zakasnitve mineralizacije je bila 93 (70) dni ob izhodišču in
Onset of hypophosphatasia was under 6 months in all patients.
Pri vseh bolnikih je hipofosfatazija nastopila pri manj kot
The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate and water for injections.
Druge sestavine zdravila so natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat in voda za injekcije.
In asfotase alfa clinical studies ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis have been reported in patients with hypophosphatasia.
V kliničnih študijah z asfotazo alfa so pri bolnikih s hipofosfatazijo poročali o očesnih (vezničnih in roženičnih) kalcifikacijah in nefrokalcinozi.
Study ENB-006-09/ENB-008-10 was an open-label, randomised study.
Študija ENB-006-09/ENB-008-10 je bila odprta, randomizirana študija.
- 7 patients were weaned off invasive ventilation (time on ventilation from 12 to 168 weeks), 4 patients were off any ventilation support, and 3 patients were on noninvasive ventilation support.
168 tednov), 4 bolniki so bili brez ventilacijske podpore, 3 bolniki pa so bili na neinvazivni ventilacijski podpori.
9 out of 10 patients achieved a RGI-C score ≥2, only 1 with RGI-C <2.
Pet od 7 bolnikov je doseglo oceno RGI-C ≥ 2,
This is important to rotate the injection from among the following sites to reduce the risk of lipodystrophy: abdominal area, thigh, or deltoid.
Za zmanjšanje tveganja lipodistrofije je pomembno, da izmenjujete predel injiciranja: predel trebuha, stegna in nadlakta.
Prior to launch of Strensiq in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
• Dodatni ukrepi za zmanjševanje tveganj Pred prihodom zdravila Strensiq na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa,
Periodic monitoring (including fundoscopy for signs of papilloedema) and prompt intervention for increased intracranial pressure is recommended in hypophosphatasia patients below 5 years of age.
Pri bolnikih s hipofosfatazijo, starih manj kot 5 let, se priporoča obdobno spremljanje (vključno s fundoskopijo za znake papiloedema) in hitro ukrepanje pri zvečanem intrakranialnem tlaku.
If injecting 6 x per week
Ob injiciranju 6 x na teden
Strensiq 40 mg/ml solution for injection Filled volumes of the vials are: 0.3 ml, 0.45 ml, 0.7 ml and 1.0 ml
Napolnjeni volumni vial so: 0,3 ml, 0,45 ml, 0,7 ml in 1,0 ml
What Strensiq is and what it is used for
Kaj je zdravilo Strensiq in za kaj ga uporabljamo Kaj je zdravilo Strensiq
Refer to the dosing chart below for more details.
Za več podrobnosti glejte preglednico za odmerjanje.
Hypersensitivity reactions including signs and symptoms consistent with anaphylaxis have been reported in patients treated with asfotase alfa (see section 4.8).
Pri bolnikih, zdravljenih z asfotazo alfa, so poročali o preobčutljivostnih reakcijah, vključno z znaki in simptomi, skladnimi z anafilaksijo (glejte poglavje 4.8).
For storage conditions before administration of the medicinal product, see section 6.3.
Za pogoje shranjevanja pred dajanjem zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Five out of 7 patients achieved an RGI-C score ≥2 - 5 patients continued with invasive ventilation support, 4 of them with RGI-C score <2 - 3 patients died whilst on ventilation support - 1 patient withdrew consent ∙ 13 patients required non-invasive ventilation support at baseline.
9 od 10 bolnikov je doseglo oceno RGI-C ≥ 2, samo eden z oceno RGI-C - 2 bolnika sta potrebovala invazivno ventilacijsko podporo in 1 bolnik je nadaljeval z neinvazivno ventilacijsko podporo, vsi 3 bolniki so umrli in vsi so imeli oceno RGI-C < 2.
Each vial contains 40 mg of asfotase alfa (40 mg/1 ml).
Ena viala vsebuje 40 mg asfotaze alfa (40 mg/1 ml).
Dose - and time-dependent acute injection reactions that were transient and self-limiting were noted in rats at intravenous use doses of 1 to 180 mg/kg.
Pri podganah so pri intravenski uporabi odmerkov od 1 do 180 mg/kg opazili akutne reakcije na injiciranje, odvisne od odmerka in časa, ki so bile prehodne in so izzvenele same od sebe.
If injecting 3 x per week
Ob injiciranju 3 x na teden
Any unused solution should be discarded.
Neporabljeni ostanek raztopine je treba zavreči.
Always use this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you.
Pri uporabi tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila zdravnika, farmacevta ali medicinske sestre.
The central and peripheral clearance estimates for a patient with body weight of 70 kg (and 95% CI) were 15.8 (13.2, 18.9) L/day and 51.9 (44.0, 61.2) L/day, respectively.
Za bolnika s telesno maso 70 kg (in 95-odstotnim IZ) je bila ocena centralnega volumna porazdelitve 5,66 (2,76; 11,6) l in perifernega volumna porazdelitve 44,8 (33,2; 60,5) l. Za bolnika s telesno maso 70 kg (in 95-odstotnim IZ) je bila ocena centralnega očistka 15,8 (13,2; 18,9) l/dan in perifernega očistka 51,9 (44,0; 61;2) l/dan.
There is no experience with overdose of asfotase alfa.
S prevelikim odmerjanjem asfotaze alfa ni izkušenj.
Dispose the needle with the protective cap in your sharps container.
Iglo z nameščenim zaščitnim pokrovčkom vred zavrzite v vsebnik za ostre odpadke.
STRENSIQ 40 mg/ml 12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml
STRENSIQ 40 mg/ml 12 mg/0,3 ml 18 mg/0,45 ml 28 mg/0,7 ml
Each vial contains 12 mg of asfotase alfa (12 mg/0.3 ml).
Ena viala vsebuje 12 mg asfotaze alfa (12 mg/0,3 ml).
7/11 patients in the full analysis set achieved Radiographic Global Impression of Change scores of +2 at Week 24 compared to baseline radiographs.
7 od 11 bolnikov v celotni skupini za analizo je v 24. tednu v primerjavi z rentgenogrami ob izhodišču doseglo rezultat +2 po lestvici RGI-C.
• Localized lipodystrophy (fatty lumps or deceased fatty tissue on the surface of the skin) have been reported at injection sites after several months in patients using Strensiq.
• Pri bolnikih, ki so uporabljali zdravilo Strensiq, so po več mesecih poročali o lokalizirani lipodistrofiji (maščobnih zatrdlinah ali pomanjkanju maščobnega tkiva na površini kože).
Each vial contains 18 mg of asfotase alfa (18 mg/0.45 ml).
Ena viala vsebuje 18 mg asfotaze alfa (18 mg/0,45 ml).
If injecting 3x per week
Pri injiciranju 3x na teden
Each vial contains 28 mg of asfotase alfa (28 mg/0.7 ml).
Ena viala vsebuje 28 mg asfotaze alfa (28 mg/0,7 ml).
It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with asfotase alfa.
Pri bolnikih, zdravljenih z asfotazo alfa, se priporoča spremljanje koncentracije obščitničnega hormona in kalcija v serum.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 mg/ml
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA 40 mg/ml
- 10 patients were weaned off any ventilation support (time on ventilation from 3 to 216 weeks).
- 7 bolnikov je bilo odvajenih od invazivne ventilacije (čas na ventilaciji od 12 do
• Warning and precautions on the potential risk of medication errors and injection site reactions associated with the use of Strensiq
Izobraževalna gradiva za bolnike in skrbnike morajo vsebovati naslednja ključna sporočila: • opozorila in previdnostne ukrepe glede možnega tveganja napak pri uporabi zdravila in o reakcijah na mestu injiciranja, povezanih z uporabo zdravila Strensiq,
Hypoaesthesia oral Nausea
Bolezni prebavil pogosti oralna hipestezija navzea
Hypophosphatasia is associated with multiple bone manifestations including rickets / osteomalacia, altered calcium and phosphate metabolism, impaired growth and mobility, respiratory compromise that may require ventilation, and vitamin B6-responsive seizures.
Hipofosfatazija je povezana z več kostnimi manifestacijami, vključno z rahitisom/osteomalacijo, spremenjeno presnovo kalcija in fosfata,
Alternative assays (i.e. not utilizing an ALP-conjugated reporter system) may be considered in patients treated with Strensiq.
(tj. takih, kjer se ne uporablja sistem poročevalskih molekul, konjugiranih z AF).
40/69 patients and 32/69 patients did not show apparent catch-up gain in height and in weight, respectively.
40 od 69 bolnikov ni pokazalo navideznega dohitevanja pridobivanja telesne višine, 32 od 69 bolnikov pa ni pokazalo navideznega dohitevanja pridobivanja telesne mase.
Each vial of 0.8 ml solution (100 mg/ml) contains 80 mg of asfotase alfa.
Ena viala z 0,8 ml raztopine (100 mg/ml) vsebuje 80 mg asfotaze alfa.
After the 2 mg/kg weekly subcutaneous administration in Cohort 2 the mean (SD) AUCτ was 138595 (6958) and 136109 (41875) following the first and the third dose, respectively.
138.595 (6.958) po prvem oz. 136.109 (41.875) po tretjem odmerku.
In nonclinical safety testing in rats, no body system-specific adverse effects were noted at any dose or route of administration.
5.3 Predklinični podatki o varnosti Predklinično testiranje varnosti pri podganah ni pokazalo neželenih učinkov, specifičnih za telesni sistem,
Gently pinch the skin of the chosen injection area between your thumb and index finger.
S palcem in kazalcem nežno primite izbrano mesto injiciranja.
Remove the protective cap from the Strensiq vial.
Z viale zdravila Strensiq odstranite zaščitni pokrovček.
Each vial contains 80 mg of asfotase alfa (80 mg/0.8 ml)
Ena viala vsebuje 80 mg asfotaze alfa (80 mg/0,8 ml).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg/ml
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA 100 mg/ml
Lonza Biologics 101 International Drive Pease International Tradeport 03801 Portsmouth United States
03801 Portsmouth
Irritability
Preobčutljivost
Skin discolouration Skin disorder (stretched skin)
Bolezni kože in podkožja zelo pogosti eritem pogosti obarvanje kože bolezen kože (raztegnjena koža)
Injection site reactions (including injection site atrophy, abscess, erythema, discolouration, pain, pruritus, macule, swelling, contusion, bruising, lipodystrophy (lipoatrophy or lipohypertrophy), induration, reaction, nodule, rash, papule, haematoma, inflammation, urticarial, calcification, warmth, haemorrhage,
makulo, oteklino, kontuzijo, modrico, lipodistrofijo (lipoatrofijo ali lipohipertrofijo), zatrdlino, reakcijo,
Each vial contains 0.8 ml solution and 80 mg of asfotase alfa (100 mg/ml).
Ena viala vsebuje 0,8 ml raztopine in 80 mg asfotaze alfa (100 mg/ml).
12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml
DRUGI PODATKI 12 mg/0,3 ml 18 mg/0,45 ml 28 mg/0,7 ml
Each vial of 0.7 ml solution (40 mg/ml) contains 28 mg of asfotase alfa.
Ena viala z 0,7 ml raztopine (40 mg/ml) vsebuje 28 mg asfotaze alfa.
Sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, water for injections.
natrijev klorid, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, voda za injekcije Za nadaljnje podatke glejte navodilo za uporabo.
Each vial contains 0.45 ml solution and 18 mg of asfotase alfa (40 mg/ml).
Ena viala vsebuje 0,45 ml raztopine in 18 mg asfotaze alfa (40 mg/ml).
Each vial of 0.3 ml solution (40 mg/ml) contains 12 mg of asfotase alfa.
Ena viala z 0,3 ml raztopine (40 mg/ml) vsebuje 12 mg asfotaze alfa.
Each vial of 0.45 ml solution (40 mg/ml) contains 18 mg of asfotase alfa.
Ena viala z 0,45 ml raztopine (40 mg/ml) vsebuje 18 mg asfotaze alfa.
Each vial contains 0.3 ml solution and 12 mg of asfotase alfa (40 mg/ml).
Ena viala vsebuje 0,3 ml raztopine in 12 mg asfotaze alfa (40 mg/ml).
Each ml of solution contains 100 mg of asfotase alfa.
En ml raztopine vsebuje 100 mg asfotaze alfa.
Each vial of 1 ml solution (40 mg/ml) contains 40 mg of asfotase alfa.
Ena viala z 1 ml raztopine (40 mg/ml) vsebuje 40 mg asfotaze alfa.
Each ml of solution contains 40 mg of asfotase alfa.
En ml raztopine vsebuje 40 mg asfotaze alfa.
Each vial contains 0.7 ml solution and 28 mg of asfotase alfa (40 mg/ml).
Ena viala vsebuje 0,7 ml raztopine in 28 mg asfotaze alfa (40 mg/ml).
Each vial contains 1.0 ml solution and 40 mg of asfotase alfa (40 mg/ml).
Ena viala vsebuje 1,0 ml raztopine in 40 mg asfotaze alfa (40 mg/ml).
Hypersensitivity reactions include erythema/redness, pyrexia/fever, rash, pruritis, irritability, nausea, vomiting, pain, rigor/chills, hypaesthesia oral, headache, flushing, tachycardia, cough, and signs and symptoms consistent with anaphylaxis (see section 4.4).
Preobčutljivostne reakcije vključujejo eritem/rdečino, pireksijo/zvišano telesno temperaturo, izpuščaj, pruritus, razdražljivost, navzeo, bruhanje, bolečino, rigor/mrzlico, oralno hipestezijo, glavobol,
What is Strensiq used for
Za kaj uporabljamo zdravilo Strensiq
OTHER
Eden od
- Mean (SD) osteoid volume / bone volume was 11.8 (5.9)% at baseline and 8.6 (7.2)% at week 24
24. tednu; - srednja vrednost (SD) osteoidnegai volumna/kostnega volumna je bila 11,8 (5,9) % ob izhodišču in
The active substance is asfotase alfa.
Učinkovina je asfotaza alfa.
Skin redness (erythema)
skeleče mišice (mialgija)
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema pogosti večja nagnjenost k modricam
Strensiq 40 mg/ml solution for injection (12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml) asfotase alfa
Navodilo za uporabo Strensiq 40 mg/ml raztopina za injiciranje (12 mg/0,3 ml 18 mg/0,45 ml 28 mg/0,7 ml 40 mg/1 ml)
Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat monohidrat voda za injekcije
NAME OF THE MEDICINAL PRODUCT Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection
Strensiq 40 mg/ml raztopina za injiciranje Strensiq 100 mg/ml raztopina za injiciranje
System Organ Class
let] Organski sistem
Cohort 1 (n=3) of the study received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 1 mg/kg subcutaneous at weekly intervals from weeks 2 to 4.
3 mg/kg, nato pa so sledili 3 odmerki po 1 mg/kg subkutano v tedenskih intervalih od 2. do 4. tedna.
• Areas with a good amount of fat below the skin (thighs, arms (deltoids), abdomen and buttocks) are the most suitable areas to inject.
• Za injiciranje so najbolj primerni predeli z zadostno količino maščobe pod kožo (stegna, roke
Invert the vial and syringe.
Zasukajte vialo in brizgo na glavo.
Anaphylactoid reactions Hypersensitivity
Bolezni imunskega sistema pogosti anafilaktoidne reakcije preobčutljivost2
NAME OF THE MEDICINAL PRODUCT Strensiq 40 mg/ml solution for injection asfotase alfa
Strensiq 40 mg/ml raztopina za injiciranje asfotaza alfa
Stretched skin, skin discolouration Feeling sick (nausea), numbness of the mouth (hypoaesthesia oral) Aching muscles (myalgia)
zvišana telesna temperatura (pireksija), razdražljivost rdečina kože (eritem) bolečine v dlaneh in stopalih kontuzija (modrica) glavobol
Supplements of calcium and oral vitamin D may be required.
Morda bo treba dodajati kalcij in peroralni vitamin D. Glejte poglavje 5.1.
NAME OF THE MEDICINAL PRODUCT Strensiq 100 mg/ml solution for injection asfotase alfa
Strensiq 100 mg/ml raztopina za injiciranje asfotaza alfa
After being trained by the doctor or specialized nurse, you can inject Strensiq yourself at home.
Zdravilo Strensiq si lahko injicirate sami doma po tem, ko vas bo o pravilni uporabi zdravila poučil zdravnik ali specializirana medicinska sestra.
Volume to be injected
ki ga je treba injicirati
Metabolism and nutrition disorders
Presnovne in prehranske motnje pogosti hipokalciemija
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 100 mg of asfotase alfa.
NAVEDBA ENE ALI VEČ UČINKOVIN En ml raztopine vsebuje 100 mg asfotaze alfa.
How to store Strensiq
Shranjevanje zdravila Strensiq
Dark blue
Alexion Europe SAS
• Weight gain may occur during your treatment with Strensiq.
• Pri bolniku se lahko telesna masa med zdravljenjem poveča.
Injection site cellulitis
Infekcijske in parazitske bolezni pogosti celulitis na mestu injiciranja
At study completion patients had received a median of over 60 months of treatment (24 to 68 months).
Ob zaključku študije so bolniki prejeli mediano prek 60 mesecev
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC {number}
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
Strensiq 100 mg/ml solution for injection Filled volumes of the vials are: 0.8 ml
Napolnjeni volumni vial so: 0,8 ml
PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Izgled zdravila Strensiq in vsebina pakiranja
Talk to your doctor in case of problems with your vision.
Če imate težave z vidom, se posvetujte z zdravnikom.
MARKETING AUTHORISATION HOLDER
Imetnik dovoljenja za promet z zdravilom
BATCH NUMBER Lot
PC {številka}
At study completion, patients had received a median of over 79 months (6.6 years) of treatment (1 to >84 months).
(6,6 let) zdravljenja (od 1 do > 84 mesecev).
Date of first authorisation: 10 November 2017
Datum prve odobritve: 10 november 2017
This may appear several days after birth.
Ti se lahko pojavijo nekaj dni po rojstvu.
Less than daily dosing
Manj kot dnevno odmerjanje
• Children and adolescents
• Otroci in mladostniki
This medicine should not be taken by those under 15 years of age.
Tega zdravila ne smejo jemati osebe, mlajše od 15 let.