natgillin/translations-raw huggingface dataset:
• If you are treated with Strensiq, you may experience a reaction at the injection site (pain, nodule, rash, discoloration) during the injection of the medicine or during the hours following the injection.
• Če se zdravite z zdravilom Strensiq, boste morda imeli reakcijo na mestu injiciranja (bolečino, zatrdlino, izpuščaj, obarvanje) med injiciranjem zdravila ali v urah, ki sledijo injiciranju.
A total of 24/69 (35%) patients displayed apparent catch-up height-gain and 32/69 (46%) patients displayed apparent catch-up weight-gain, as shown by movement over time to a higher percentile on CDC growth charts.
Skupaj 24 od 69 (35 %) bolnikov je pokazalo navidezno dohitevanje pridobivanja telesne višine, 32 od 69 (46 %) bolnikov pa je pokazalo navidezno dohitevanje pridobivanja telesne mase, kot kaže gibanje v času proti naslednjemu percentilu na rastnih shemah CDC.
Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ in clinical trials (see section 4.8).
O lokalizirani lipodistrofiji, vključno z lipoatrofijo in lipohipertrofijo, na mestu injiciranja so pri bolnikih, zdravljenih z zdravilom STRENSIQ v kliničnih preskušanjih, poročali po več mesecih (glejte poglavje 4.8).
Elderly There is no evidence for special considerations when Strensiq is administered to elderly patients.
Ni dokazov o tem, da bi bila pri dajanju zdravila Strensiq starejšim bolnikom potrebna posebna previdnost.
(SD) AUC over the dosing interval (AUCτ) was 66034 (19241) and 40444 (N=1) U*h/L following the first and the third dose, respectively.
med odmernim intervalom (AUCτ) 66.034 (19.241) po prvem oz. 40.444 (N = 1) e*h/l po tretjem odmerku.
Any unused solution in the vial should be discarded.
Morebitno neuporabljeno raztopino v viali je treba zavreči.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte poglavje 5.3).
Read section 4 carefully to know what side effects can occur before using this medicine
Pred uporabo tega zdravila natančno preberite poglavje 4, da boste vedeli, kateri neželeni učinki se lahko pojavijo.
If it is the case, multiple injections should be done at different sites.
Če presega, dajte več injekcij na različnih mestih.
A few case reports of anaphylactoid/hypersensitivity reaction have been received in the clinical trial setting.
Prejeli so nekaj poročil o primerih anafilaktoidnih/preobčutljivostnih reakcij v okviru kliničnih preskušanj.
• Information on reporting side effect
• informacije o poročanju neželenih učinkov.
Not all pack sizes may be marketed in your country.
Na trgu morda ni vseh navedenih pakiranj.
Subcutaneous use.
subkutana uporaba
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB13
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi, oznaka ATC:
Serum Parathyroid Hormone and Calcium
Ravni obščitničnega hormona in kalcija v serumu
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. the product is essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
• If you are injecting this medicine yourself, you will be shown how to prepare and inject the medicine by your doctor, pharmacist or nurse.
• Če si zdravilo injicirate sami, vam bo zdravnik, farmacevt ali medicinska sestra pokazal, kako si zdravilo pripravite in injicirate.
After the 3 mg/kg for 1.08 hours intravenous infusion, the median time (Tmax) ranged between 1.25 to 1.50 hours, and the mean (SD) Cmax ranged between 42694 (8443) and 46890 (6635) U/L over the studied cohorts.
Po intravenski infuziji 3 mg/kg v 1,08-ure je bil razpon medianega časa (Tmax) od 1,25 do 1,50 ure, srednja vrednost (SD) Cmax pa je bila v proučevanih kohortah v območju med 42.694 (8.443) in 46.890 (6.635) e/l.
If you suspect that you have been accidently administered a higher dose of Strensiq than prescribed, please contact your doctor for advice.
Če sumite, da ste prejeli večji odmerek zdravila Strensiq, kot vam je bil predpisan, se za nasvet obrnite na zdravnika.
Asfotase alfa, a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein with enzymatic activity, promotes mineralisation of the skeleton in patients with hypophosphatasia.
Asfotaza alfa, humana rekombinantna tkivno nespecifična alkalna fosfataza-Fc-deka-aspartatni fuzijski protein z encimsko aktivnostjo spodbuja mineralizacijo skeleta pri bolnikih s hipofosfatazijo.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1015/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1015/003
Remove the needle from the vial and place back the protective cap over the needle.
Odstranite iglo iz viale in spet namestite zaščitni pokrovček na iglo.
Trained radiologists evaluated pre- and post-baseline x-rays of wrists and knees of patients for the following signs: apparent physeal widening, metaphyseal flaring, irregularity of provisional zone of calcification, metaphyseal radiolucencies, metadiaphyseal sclerosis, osteopenia, ‘popcorn' calcification in metadiaphysis, demineralization of distal metaphysis, transverse subphyseal band of lucency and tongues of radiolucency.
Usposobljeni radiologi so ocenjevali rentgenske posnetke zapestij in kolen bolnikov pred izhodiščem in po izhodišču in ugotavljali naslednje znake: navidezna fizna razširitev, metafizni izbruh, nepravilnosti začasne cone kalcifikacije, metafizne radiotransparence, metadiafizna skleroza, osteopenija, "popcorn" kalcifikacije v metadiafizi, demineralizacija distalne metafize, transverzen subfizni trak transparence in pasovi radiotransparence.
Ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis as manifestations of hypophosphatasia are documented in published literature.
Očesna (veznična in roženična) kalcifikacija in nefrokalcinoza kot manifestaciji hipofosfatazije sta dokumentirani v objavljenih virih.
Step 4: Injecting Strensiq
4. korak: Injiciranje zdravila Strensiq
Table 1 gives the adverse reactions observed from clinical trials.
V preglednici 1 so navedeni neželeni učinki, ki so jih opazili v kliničnih preskušanjih.
Any unused medicinal product or waste material should be disposed of immediately.
Morebitno neuporabljeno zdravilo ali odpadni material takoj zavrzite.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
PHARMACEUTICAL FORM Solution for injection (injection).
raztopina za injiciranje (injekcija)
Your doctor will provide dietary advice as necessary.
Zdravnik vam bo po potrebi svetoval glede prehrane.
A few case reports of anaphylactoid/hypersensitivity reaction have also been received and were associated with signs and symptoms of difficulty breathing, choking sensation, periorbital edema and dizziness.
Prejeli so tudi nekaj poročil o primerih anafilaktoidnih/preobčutljivostnih reakcij, ki so bile povezane z znaki in simptomi oteženega dihanja, občutkom dušenja, periorbitalnim edemom in omotico.
Asfotase alfa is a soluble glycoprotein comprised of two identical polypeptide chains, each with a length of 726 amino acids made from (i) the catalytic domain of human tissue-nonspecific alkaline phosphatase, (ii) the human immunoglobulin G1 Fc domain and (iii) a deca-aspartate peptide domain.
726 aminokislin, sestavljen iz (i) katalitične domene humane, tkivno nespecifične alkalne fosfataze, (ii) domene Fc humanega imunoglobulina G1 in (iii) deka-aspartat peptidne domene.
Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centers for Disease Control and Prevention (CDC), USA.
Telesno višino, telesno maso in obseg glave so vnašali v krivulje rasti (serije percentilnih krivulj, ki ponazarjajo porazdelitev), ki so na voljo v Centrih za obvladovanje in preprečevanje bolezni (Centers for Disease Control and Prevention - CDC), ZDA.
At study completion patients had received a median of over 76 months (6.3 years) of treatment (1 to 79 months).
Ob zaključku študije so bolniki prejeli mediano več kot 76 mesecev (6,3 leta) zdravljenja (1 do 79 mesecev).
Strensiq is a medicine used to treat the inherited disease hypophosphatasia.
Zdravilo Strensiq se uporablja za zdravljenje dedne bolezni hipofosfatazije.
• Patients receiving asfotase alfa have had allergic reactions including life threatening allergic reactions requiring medical treatment similar to anaphylaxis.
Opozorila in previdnostni ukrepi • Bolniki, ki so prejemali asfotazo alfa, so imeli alergijske reakcije, vključno z življenje ogrožajočimi alergijskimi reakcijami, zaradi katerih je bilo potrebno podobno zdravljenje kot pri anafilaksiji.
Nineteen patients were enrolled, 14 completed, and 5 discontinued.
Vključenih je bilo 19 bolnikov, 14 bolnikov je študijo zaključilo, 5 bolnikov pa prekinilo.
There are insufficient data from the use of asfotase alfa in pregnant women.
Podatkov o uporabi asfotaze alfa pri nosečnicah ni dovolj.
Hold the syringe with the needle pointing up and tap the barrel of the syringe with your finger to remove any air bubbles.
Držite brizgo z iglo navzgor in s prstom potrkajte po valju brizge, da boste odstranili morebitne zračne mehurčke.
• The maximum volume per injection should not exceed 1 ml.
• Največji volumen na injekcijo ne sme preseči 1 ml.
5/11 subjects displayed apparent catch-up height-gain.
Pri 5 od 11 oseb se je pokazalo navidezno dohitevanje v pridobivanju višine.
Remove the needle, release the skin fold and gently place a piece of cotton wool or gauze over the injection site for a few seconds.
Injekcijsko iglo odstranite, izpustite kožno gubo in na mesto injiciranja za nekaj sekund nežno položite kosem vate ali gazo.
Step 3: Placing the needle for injection on the syringe 1.
3. korak: Pritrditev igle za injiciranje na brizgo
The extrinsic factors affecting asfotase alfa pharmacokinetic exposures were formulation specific activity and total sialic acid content.
Ekstrinzični dejavniki, ki so vplivali na farmakokinetično izpostavljenost asfotazi alfa, so bili aktivnost, specifična za zdravilo, in skupna vsebnost sialne kisline.
No interaction studies have been performed with asfotase alfa.
Študij medsebojnega delovanja z asfotazo alfa niso izvedli.
Upon removal of the vial(s) from refrigeration, Strensiq should be used within 3 hours maximum.
Potem, ko viale vzamete iz hladilnika, morate zdravilo Strensiq porabiti najkasneje v 3 urah.
These symptoms included difficulty breathing, choking sensation, periorbital edema, and dizziness.
Ti simptomi so vključevali težave z dihanjem, občutek dušenja, periorbitalni edem in omotičnost.
Pull the plunger back to draw air into the syringe equal to your dose.
Povlecite bat nazaj, da boste posrkali v brizgo toliko zraka, kolikor ustreza vašemu odmerku.
How to use Strensiq will be explained to you by a doctor who is experienced in the management of patients with metabolic or bone related diseases.
Uporabo zdravila Strensiq vam bo razložil zdravnik z izkušnjami pri obravnavi bolnikov s presnovnimi boleznimi ali boleznimi, povezanimi s kostmi.
Height, weight and head circumference were plotted on growth charts (series of percentile curves that illustrate distribution) available from the Centers for Disease Control and Prevention, USA.
Rast Višina, telesna masa in obseg glave so bili izrisani na tablicah rasti (serije percentilnih krivulj, ki ponazarjajo porazdelitev), in so na voljo pri Centrih za nadzor in preprečevanje bolezni (Centers for Disease Control and Prevention) v ZDA.
All patients began the study on a dose of asfotase alfa 6 mg/kg per week.
Vsi bolniki so začeli študijo z odmerkom 6 mg/kg asfotaze alfa na teden.
If asfotase alfa is present in clinical laboratory samples, aberrant values could be reported.
Če je v vzorcih za klinične laboratorije prisotna asfotaza alfa, to lahko povzroči nepravilne rezultate.
Place a larger bore needle (e.g. 25G) on the empty syringe and with the protective cap on, push down and turn clockwise the needle onto the syringe until it is tight.
Namestite iglo večjega notranjega premera (npr. 25G) na prazno brizgo in medtem, ko je zaščitni pokrovček na igli, iglo pritisnite navzdol na brizgo in jo zasukajte v smeri urnega kazalca, da bo čvrsto pritrjena.
- Mean (SD) osteoid thickness was 12.8 (3.5) µm at baseline and 9.5 (5.1) µm at week 24
- srednja vrednost (SD) osteoidne debeline je bila 12,8 (3,5) µm ob izhodišču in 9,5 (5,1) µm v
Before removing the needle from the vial, check the syringe for air bubbles.
Preden odstranite iglo iz viale, se prepričajte, da v brizgi ni zračnih mehurčkov.
Step 2: Withdrawing Strensiq solution from the vial
2. korak: Odvzem raztopine zdravila Strensiq iz viale
Ectopic calcifications and injection site reactions were observed in monkeys when asfotase alfa was administered subcutaneously at daily doses up to 10 mg/kg through 26 weeks.
Pri opicah so opazili ektopične kalcifikacije in reakcije na mestu injiciranja, ko so jim 26 tednov asfotazo alfa dajali subkutano v dnevnih odmerkih do 10 mg/kg.
Study ENB-010-10
Študija ENB-010-10
Recommended dosage regimen of asfotase alfa is 2 mg/kg of body weight administered subcutaneously three times per week, or a dosage regimen of 1 mg/kg of body weight administered subcutaneously six times per week.
Odmerjanje Priporočeni režim odmerjanja asfotaze alfa je 2 mg/kg telesne mase subkutano trikrat na teden ali režim odmerjanja 1 mg/kg telesne mase subkutano šestkrat na teden.
Patients who experienced anaphalaxis-like symptoms had difficulty breathing, choking sensation, nausea, swelling around the eyes, and dizziness.
Bolniki, ki so imeli podobne simptome kot pri anafilaksiji, so imeli težave z dihanjem, občutek dušenja, navzeo, oteklino okrog oči in omotico.
• Early fusion of the bones of the head in children below 5 years of age has been reported in clinical studies of infants with hypophosphatasia, with and without use of Strensiq.
• V kliničnih študijah na dojenčkih s hipofosfatazijo so pri otrocih, starih manj kot 5 let, poročali o zgodnjem zraščanju kosti lobanje pri uporabi zdravila Strensiq in brez nje.
• Risk management plan (RMP) The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 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 EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
There are insufficient data to establish a causal relationship between exposure to Strensiq and progression of craniosynostosis.
Ni dovolj podatkov za dokaz vzročne povezave med izpostavljenostjo zdravilu Strensiq in napredovanjem kraniosinostoze.
Strensiq administration should be interrupted in any patient experiencing severe injection reactions and appropriate medical therapy administered.
Dajanje zdravila Strensiq je treba prekiniti pri bolnikih, ki doživijo hude reakcije na mestu injiciranja, in uvesti ustrezno zdravljenje z zdravili.
Once all the bubbles are at the top of the syringe, gently push on the plunger to force the bubbles out of the syringe and back into the vial.
Ko bodo vsi mehurčki na vrhu brizge, previdno potisnite bat in iztisnite mehurčke iz brizge nazaj v vialo.
Bone biopsy
Biopsija kosti
These have been generally assessed as non-serious, mild to moderate in severity and self-limiting.
Običajno so bile ocenjene kot neresne, blage do zmerne po resnosti in so izzvenele brez zdravljenja.
The volume per injection should not exceed 1 ml.
Volumen na injekcijo ne sme preseči 1 ml.
Study ENB-009-10 was an open-label, randomised study.
Študija ENB-009-10 je bila odprta, randomizirana študija.
It contains the active substance asfotase alfa.
Vsebuje učinkovino asfotazo alfa.
12 vials of 0.8 mL
12 vial z 0,8 ml
For management of adverse reactions, see sections 4.4 and 4.8.
Za obravnavo neželenih učinkov glejte poglavji 4.4 in
The active substance in Strensiq can replace the missing enzyme (alkaline phosphatase) in hypophosphatasia.
Učinkovina v zdravilu Strensiq lahko pri hipofosfataziji nadomesti manjkajoči encim (alkalno fosfatazo).
Holding the syringe and vial, insert the needle through the sterile rubber seal and into the vial.
Medtem ko držite brizgo in vialo, zabodite iglo skozi sterilno gumijasto zaporko v vialo.
The absolute bioavailability and absorption rate following subcutaneous administration were estimated to be 0.602 (95% CI: 0.567, 0.638) or 60.2% and 0.572 (95%CI: 0.338, 0.967)/day or 57.2%, respectively.
0,567; 0,638) oz. 60,2 %, in hitrost absorpcije po subkutanem dajanju pa 0,572 (95-odstotni IZ: 0,338; 0,967)/dan oziroma 57,2 %.
1/13 patients did not display apparent catch-up height-gain and 1 patient did not have enough data to permit judgement.
13 bolnikov ni kazal opaznega dohitevanja v pridobivanju višine in za 1 bolnika ni bilo dovolj podatkov, da bi bila možna ocena.
What benefits of Strensiq have been shown in clinical studies Strensiq has shown benefits for patients' mineralization of the skeleton and growth.
Pokazalo se je, da zdravilo Strensiq bolnikom koristi pri mineralizaciji skeleta in rasti.
OTHER 80 mg/0.8 ml
DRUGI PODATKI 80 mg/0,8 ml
Asfotase alfa is a human recombinant tissue-nonspecific alkaline phosphatase-Fc-deca-aspartate fusion protein that is expressed in an engineered Chinese hamster ovary cell line.
Asfotaza alfa je humana rekombinantna tkivno nespecifična alkalna fosfataza-Fc-deka-aspartatni fuzijski protein, izražena v liniji ovarijskih celic kitajskega hrčka, pridobljeni z genskim inženiringom.
Infection of skin at injection site (injection site cellulitis) Reduced levels of calcium in the blood (hypocalcaemia) Kidney stones (nephrolithiasis)
brazgotina večja nagnjenost k modricam vročinski valovi okužba kože na mestu injiciranja (celulitis na mestu injiciranja) znižana raven kalcija v krvi (hipokalciemija) ledvični kamni (nefrolitiaza)
Cohort 2 (n=3) received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 2 mg/kg subcutaneous at weekly intervals from weeks 2 to 4.
Kohorta 2 (n = 3) je prvi teden intravensko dobivala asfotazo alfa 3 mg/kg, nato pa so sledili 3 odmerki po 2 mg/kg subkutano v tedenskih intervalih od 2. do 4. tedna.
The mean age at sign/symptom onset was 1.49 months.
Povprečna starost ob nastopu znakov/simptomov je bila
Choose an injection site (thighs, abdomen, arms (deltoids), buttocks).
Izberite mesto injiciranja (stegna, trebuh, roke (deltoidne mišice), zadnjica).
Ventilation support In studies ENB-002-08/ENB-003-08 (11 patients) and ENB-010-10 (69 patients), both open-label, nonrandomised, non-controlled studies of patients aged 0.1 to 312 weeks at baseline.
Ventilacijska podpora V študijah ENB-002-08/ENB-003-08 (11 bolnikov) in ENB-010-10 (69 bolnikov), obe odprti,
• Self-injection guide for patients
• Vodnik za samoinjiciranje za bolnike,
Control visually that the volume contained into the syringe is correct.
S prostim očesom preverite, ali je količina v injekcijski brizgi pravilna.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction and development.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih ali vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Study ENB-006-09/ENB-008-10
Študija ENB-006-09/ENB-008-10
Very common: may affect more than 1 in 10 people Reactions at the injection site during the injection of the medicine or during the hours following the injection (which can lead to redness, discolorations, itching, pain, fatty lumps or decreased fatty tissue on the surface of the skin, skin hypopigmentation, and/or swelling) Fever (pyrexia), irritability
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov reakcije na mestu injiciranja med injiciranjem zdravila ali v urah, ki sledijo injiciranju (povzročijo lahko rdečino, obarvanje, srbenje, bolečino, maščobne zatrdline ali pomanjkanje maščobnega tkiva na površini kože, kožno hipopigmentacijo in/ali oteklino)
While continuing to hold the skin, push the syringe plunger to inject the medicine slowly, and steadily all the way in. 5.
Medtem ko držite kožo, potisnite bat injekcijske brizge in si počasi in enakomerno injicirajte zdravilo.
Dose to be injected
ki se injicira
Administration of asfotase alfa may result in local injection site reactions (including, but not limited to, erythema, rash, discoloration, pruritus, pain, papule, nodule, atrophy) defined as any related adverse event occurring during the injection or until the end of the injection day (see section 4.8).
Dajanje asfotaze alfa lahko povzroči lokalne reakcije na mestu injiciranja (med drugim lahko vključujejo eritem, izpuščaj, obarvanje, pruritus, bolečino, papule, vozliče, atrofijo), opredeljene kot kateri koli z injiciranjem povezani neželeni učinek, ki je nastopil med injiciranjem ali do konca dneva injiciranja
At Week 48, 50/69 patients (72.5%) in the full analysis set achieved Radiographic Global Impression of
V 48. tednu je 50 od 69 bolnikov (72,5 %) v celotni skupini za analizo doseglo rezultate ≥ 2 na lestvici radiografskega globalnega vtisa sprememb (Radiographic Global Impression of Change) in so jih obravnavali kot bolnike, ki so se klinično pomembno odzvali na zdravljenje.
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 0.3 ml, 0.45 ml, 0.7 ml and 1 ml of solution.
Zdravilo Strensiq je na voljo v obliki bistre in brezbarvne do rahlo rumenkaste vodne raztopine za injiciranje v vialah, ki vsebujejo 0,3 ml, 0,45 ml, 0,7 ml in 1 ml raztopine.
There is insufficient information on the excretion of asfotase alfa in human milk.
Dojenje Ni dovolj podatkov o izločanju asfotaze alfa v materino mleko.
Study ENB-009-10
Študija ENB-009-10
Please collect your syringes, vials and needle in a sharps container.
Injekcijske brizge, viale in igle odlagajte v vsebnik za ostre odpadke.
The reactions have occurred within minutes after subcutaneous administration of Strensiq and can occur in patients on treatment for more than 1 year.
Do teh reakcij je prišlo v času nekaj minut po subkutanem dajanju zdravila Strensiq, pojavijo pa se lahko tudi pri bolnikih, ki prejemajo zdravilo več kot
Study ENB-002-08/ENB-003-08 was an open-label, non-randomised, non-controlled study.
Študija ENB-002-08/ENB-003-08 Študija ENB-002-08/ENB-003-08 je bila odprta, nerandomizirana, nekontrolirana študija.
Talk to your doctor if you notice any change in the shape of your infant's head.
Če opazite kakršne koli spremembe oblike dojenčkove glave, se posvetujte z zdravnikom.
If you forget to use Strensiq Do not inject a double dose to make up for a forgotten dose and contact your doctor for advice.
Ne injicirajte dvojnega odmerka, če ste pozabili injicirati prejšnji odmerek, in za nasvet vprašajte zdravnika.
The maximum volume of medicinal product per injection should not exceed 1 ml.
Največja količina zdravila na injekcijo ne sme preseči 1 ml.