natgillin/translations-raw huggingface dataset:
In Studies I and II only, patients were required to have at least one asthma exacerbation requiring systemic corticosteroid use in the year prior to study entry.
Bolesnici su morali imati najmanje jednu egzacerbaciju astme koja je zahtijevala primjenu sistemskih kortikosteroida u godinu dana prije ulaska u ispitivanje samo u Ispitivanjima
Studies I and II were 52-week, randomised, placebo-controlled studies in patients who had at least one asthma exacerbation requiring systemic corticosteroid use over the past twelve months.
I i II bila su randomizirana, placebom kontrolirana ispitivanja u trajanju od 52 tjedna u bolesnika s najmanje jednom egzacerbacijom astme koja je zahtijevala primjenu sistemskih kortikosteroida tijekom prethodnih dvanaest mjeseci.
Clear to slightly hazy opalescent, colourless to slightly yellow solution with pH 5.5.
Bistra do blago zamućena, opalescentna, bezbojna do blago žuta otopina s pH 5,5.
CINQAERO is a clear to slightly hazy opalescent, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate).
CINQAERO je bistri do blago mutni, opalescentni, bezbojni ili blago žuti koncentrat za otopinu za infuziju (sterilni koncentrat).
The infusion must be discontinued immediately if the patient experiences a hypersensitivity reaction to reslizumab or to any of the excipients (see section 4.4).
Infuzija se mora odmah prekinuti ako bolesnik razvije reakciju preosjetljivosti na reslizumab ili neku od pomoćnih tvari (vidjeti dio 4.4).
What you need to know before you are given CINQAERO You must not receive CINQAERO:
Što morate znati prije nego primite CINQAERO
Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab antibodies.
Čini se da protutijela protiv reslizumaba ne utječu na sistemsku izloženost reslizumabu.
As reslizumab binds to a soluble target, linear non-target-mediated clearance is expected.
Kako se reslizumab veže za topljivu ciljnu molekulu, očekuje se linearni klirens koji nije posredovan ciljnom molekulom.
There was no prior asthma exacerbation requirement for this study.
Za ovo ispitivanje prethodna egzacerbacija astme nije bila uvjet.
Investigations
Ispitivanjima
CINQAERO is provided as a concentrate for solution for infusion in a single-use vial.
CINQAERO se isporučuje kao koncentrat za otopinu za infuziju u bočici za jednokratnu primjenu.
95% CI a Rate adjusted for stratification factors (baseline usage of OCS and geographical region).
a Stopa prilagođena za stratifikacijske čimbenike (početna uporaba peroralnih kortikosteroida i geografska regija).
What CINQAERO is used for
Za što se CINQAERO koristi
ACQ Mean diff (95% CI) (p-value) AQLQ Mean diff (95% CI) (p-value)
Srednja vrijednost razlike (95 % CI) (p-vrijednost) AQLQ
During controlled clinical studies, the proportion of patients who discontinued due to any adverse event was 5% for both the 3 mg/kg reslizumab and placebo groups.
Tijekom kontroliranih kliničkih ispitivanja, udio bolesnika koji su prekinuli liječenje zbog nekog štetnog događaja iznosio je 5 % i u skupini koja je primala reslizumab u dozi od 3 mg/kg i u onoj koja je primala placebo.
Numbers of each vial** Vials with 10 mL concentrate (100 mg reslizumab)
Broj bočica** Bočice s 10 ml koncentrata (100 mg reslizumaba)
Study I (n=489)
Ispitivanje I (n=489)
No significant difference in the pharmacokinetics of reslizumab was observed across these groups.
Nije opažena značajna razlika u farmakokinetici reslizumaba između ovih skupina.
CINQAERO is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) low protein binding in-line infusion filters.
CINQAERO je kompatibilan s ugrađenim infuzijskim filtrima s niskim afinitetom vezanja proteina izrađenima od polietersulfona (PES), poliviniliden fluorida (PVDF), najlona, celulozaacetata (CA).
39 paediatric asthma patients from 12 to 17 years were randomised to reslizumab 0.3 mg/kg, reslizumab 3 mg/kg or placebo as part of two 52-week exacerbation studies (Studies I and II) and one 16-week lung function study (Study III).
Trideset devet pedijatrijskih bolesnika s astmom u dobi od 12 do 17 godina bilo je randomizirano da prima reslizumab u dozi 0,3 mg/kg, reslizumab u dozi od 3 mg/kg ili placebo u sklopu dva ispitivanja egzacerbacije u trajanju od 52 tjedna (Ispitivanja I i II) i jednog ispitivanja funkcije pluća u trajanju od
Maintenance OCS (up to 10 mg per day prednisone equivalent) were allowed.
Bila je dopuštena terapija održavanja peroralnim kortikosteroidima (ekvivalent prednizonu u dozi do10 mg na dan).
Blood creatine phosphokinase increased*
Pretrage često povišena kreatin fosfokinaza u krvi*
Vials with 2.5 mL concentrate (25 mg reslizumab)
Bočice s 2,5 ml koncentrata (25 mg reslizumaba)
CINQAERO 10 mg/mL sterile concentrate reslizumab
CINQAERO 10 mg/ml sterilni koncentrat reslizumab
Patients with refractory asthmad
Bolesnici s refrakternom astmom d
Asthma-related symptoms or exacerbations may occur during treatment.
Tijekom liječenja mogu nastupiti simptomi vezani uz astmu ili egzacerbacije astme.
The appropriate volume of CINQAERO should be dispensed into an infusion bag containing 50 mL sodium chloride 9 mg/mL (0.9%) solution for infusion.
Odgovarajući volumen lijeka CINQAERO treba dodati u infuzijsku vrećicu koja sadrži 50 ml otopine natrijevog klorida za infuziju od 9 mg/ml (0,9 %).
Excipients: sodium acetate trihydrate, acetic acid glacial, sucrose, water for injections.
POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev acetat trihidrat, ledena acetatna kiselina, saharoza, voda za injekcije.
Common (may affect up to 1 in 10 people) • Increase of an enzyme in your blood (blood creatine phosphokinase).
• povišenje jednog enzima u krvi (kreatin fosfokinaze u krvi)
GINA step 5 patients received in addition, as an add-on, maintenance OCS.
Bolesnici u koraku 5 prema klasifikaciji GINA dodatno su primili, kao dodatnu terapiju, peroralne kortikosteroide kao terapiju održavanja.
How CINQAERO works
Kako CINQUAERO djeluje
Serious allergic reactions can happen uncommonly (may affect up to 1 in 100 people) while receiving CINQAERO or afterwards.
Dok primate CINQAERO ili nakon toga, manje često (mogu se javiti u do 1 na 100 osoba) mogu nastupiti ozbiljne alergijske reakcije.
Table 3: Demographics and baseline characteristics of asthma studies I - III Demographic or baseline characteristic
Tablica 3: Demografske i početne značajke Ispitivanja astme
In phase 3 placebo-controlled studies with a duration of 16 to 52 weeks, low-titre, frequently transient anti-reslizumab antibodies were detected in 53 out of 983 asthma patients (5%) receiving reslizumab at 3 mg/kg.
U placebom kontroliranim ispitivanjima faze 3 u trajanju od 16 do 52 tjedna, u 53 od 983 bolesnika s astmom (5 %) koji su primali reslizumab u dozi od 3 mg/kg otkriven je niski titar često prolaznih protutijela protiv reslizumaba.
CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4).
CINQAERO treba primjenjivati zdravstveni radnik pripremljen za liječenje reakcija preosjetljivosti uključujući anafilaksiju (vidjeti dio 4.4).
Each vial of 2.5 mL contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab.
Jedna bočica od 2,5 ml sadrži 25 mg reslizumaba, a jedna bočica od 10 ml sadrži 100 mg reslizumaba.
Reslizumab has not been studied in patients with severe renal impairment or end stage renal disease.
Reslizumab nije ispitan u bolesnika s teškim oštećenjem funkcije bubrega i završnim stadijem bolesti bubrega.
The antibodies had no impact on clinical pharmacodynamics, efficacy or safety.
Ta protutijela nisu utjecala na kliničku farmakodinamiku,
How to store CINQAERO
Kako čuvati CINQAERO
Myalgia was reported in 0.97% of patients (10 out of 1,028) in the 3 mg/kg reslizumab group of the placebo-controlled asthma studies compared with 0.55% of patients (4 out of 730) in the placebo group.
U placebom kontroliranim ispitivanjima astme, mijalgija je bila zabilježena u 0,97 % bolesnika (10 od 1028) u skupini koja je primala reslizumab u dozi od 3 mg/kg u usporedbi s 0,55 % bolesnika (4 od 730) u skupini koja je primala placebo.
The proportion of patients who did not experience an asthma exacerbation during the 52-week treatment period was higher in the reslizumab 3 mg/kg group (62% and 75%) compared with the placebo group (46% and 55%), in Studies I and II, respectively.
I i II, udio bolesnika koji nisu imali egzacerbaciju astme tijekom 52 tjedna liječenja bio je veći u skupini koja je primala reslizumab u dozi od 3 mg/kg (62 % odnosno 75 %) nego u skupini koja je primala placebo (46 % odnosno 55 %).
Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion.
Polako ubrizgajte sadržaj štrcaljke(i) u infuzijsku vrećicu koja sadrži 50 ml otopine natrijevog klorida za infuziju od 9 mg/ml (0,9 %).
CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4 of Summary of Product Characteristics).
CINQAERO treba primjenjivati zdravstveni radnik pripremljen za liječenje reakcija preosjetljivosti uključujući anafilaksiju (vidjeti dio 4.4 Sažetak opisa svojstava lijeka).
10 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a blue plastic flip-off cap.
I zatvorenoj čepom od butilne gume obložene poli(etilen-ko-tetrafluoroetilenom) pokrivenim aluminijskim prstenom i plavim plastičnim zatvaračem.
1 vial of 2.5 mL 2 vials of 2.5 mL 1 vial of 10 mL 2 vials of 10 mL
1 bočica od 2,5 ml 2 bočice od 2,5 ml 1 bočica od 10 ml 2 bočice od 10 ml
The medicinal product should be inspected visually before use.
Prije primjene treba pregledati izgled lijeka.
2.5 mL of concentrate in a clear type I glass vial closed by a poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on aluminium ring and a white plastic flip-off cap.
I zatvorenoj čepom od butilne gume obložene poli(etilen-ko-tetrafluoroetilenom) pokrivenim aluminijskim prstenom i bijelim plastičnim zatvaračem.
Tell your doctor or nurse straight away if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin rash, redness or swelling).
Odmah obavijestite liječnika ili medicinsku sestru ako imate bilo kakve simptome alergijske reakcije (npr. svrbež, otežano disanje, piskanje pri disanju,
An infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 µm) should be used for infusion.
Za infuziju treba upotrijebiti infuzijski set s ugrađenim sterilnim, nepirogenim, infuzijskim filtrom s niskim afinitetom vezanja proteina (pora veličine 0,2 µm).
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
In Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (50% and 59%, respectively) compared to placebo (see Table 4).
I i II, bolesnici koji su primali reslizumab u dozi od 3 mg/kg imali su značajno smanjenje egzacerbacija astme (50 % odnosno 59 %) u usporedbi s placebom (vidjeti tablicu 4).
No noteworthy differences in the pharmacokinetics of reslizumab were observed across these renal function groups.
Nisu bile opažene nikakve znatnije razlike u farmakokinetici reslizumaba između ovih skupina s različitom funkcijom bubrega.
Data by study Study I
Podaci po pojedinom ispitivanju Ispitivanje
In integrated Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (56% for subgroup GINA 4 and 5) compared to placebo.
I i II, a primarni ishod djelotvornosti prikazan je u tablici 4. U integriranim Ispitivanjima I i II, bolesnici koji su primali reslizumab u dozi od 3 mg/kg imali su značajno smanjenje egzacerbacija astme (56% u podskupini GINA 4 i 5) u usporedbi s onima koji su primali placebo.
Effect on sputum eosinophils
Učinak na eozinofile u sputumu
Sodium acetate trihydrate Acetic acid glacial Sucrose
6.1 Popis pomoćnih tvari natrijev acetat trihidrat ledena acetatna kiselina saharoza voda za injekcije
Patients with severe eosinophilic asthma
Bolesnici s teškom eozinofilnom astmom
Baseline mean blood eosinophil count, µL-1
Početna srednja vrijednost broja eozinofila u krvi, µl-1
One vial of 2.5 mL contains 25 mg reslizumab.
Jedna bočica od 2,5 ml sadrži 25 mg reslizumaba.
One vial of 10 mL contains 100 mg reslizumab.
Jedna bočica od 10 ml sadrži 100 mg reslizumaba.
GINA step 4 patients received medium- to high-dose ICS plus another controller.
Global Initiative for Asthma - GINA): Bolesnici u koraku 4 prema klasifikaciji GINA primali su srednje do visoke doze inhalacijskih kortikosteroida plus drugi lijek za kontrolu bolesti.
A suitable injection syringe should be used to withdraw the needed amount of concentrate from the vial(s) (see section 4.2 of Summary of Product Characteristics).
Za izvlačenje potrebne količine koncentrata iz bočice(a), potrebno je upotrijebiti prikladnu štrcaljku za injekcije (vidjeti dio 4.2 Sažetka opisa svojstava lijeka).
Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
The serious adverse reaction of anaphylactic reaction was reported and considered related to reslizumab in 3 patients (0.19%) during placebo-controlled and open-label asthma studies.
Tijekom placebom kontroliranih i otvorenih ispitivanja astme zabilježena je ozbiljna nuspojava anafilaktičke reakcije a smatrala se povezanom s reslizumabom u 3 bolesnika (0,19 %).
[ATS]/European Respiratory Society [ERS] 2000 workshop definition for refractory asthma) from Studies I and II was analysed post hoc.
European Respiratory Society - ERS] 2000. godine) u Ispitivanjima
CINQAERO 10 mg/mL concentrate for solution for infusion
CINQAERO 10 mg/ml koncentrat za otopinu za infuziju
FEV1 (mL) Mean diff (95% CIb) (p-value)
Srednja vrijednost razlike (95 % CIb) (p-vrijednost)
CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab
CINQAERO 10 mg/ml koncentrat za otopinu za infuziju reslizumab
Asthma exacerbations were evaluated only in the exacerbation studies (Studies I and II: reslizumab
Egzacerbacija astme bila je procijenjena samo u ispitivanjima egzacerbacije (Ispitivanja I i II: reslizumab u dozi od 3 mg/kg [n=14] i placebo [n=11]).
A suitable injection syringe should be used to withdraw the needed amount of the concentrate from the vial(s) (see section 4.2).
Za izvlačenje potrebne količine koncentrata iz bočice(a), potrebno je upotrijebiti prikladnu štrcaljku za injekcije (vidjeti dio 4.2).
No treatment effect on asthma exacerbations was observed for this age group (asthma exacerbation rate ratio [reslizumab/placebo] of 2.09).
Nije bio opažen terapijski učinak na egzacerbacije astme u ovoj dobnoj skupini (omjer stopa egzacerbacije astme
Table 4: Frequency of asthma exacerbations during the 52-week treatment period - Studies I and II, integrated data (Studies I and II) for the overall population and subgroup GINA 4 and 5 Treatment arms (n)
integrirani podaci (Ispitivanja I i II) za ukupnu populaciju i podskupinu GINA 4 i 5 Terapijske skupine (n)
Each mL of concentrate contains 10 mg of reslizumab.
Jedan ml koncentrata sadrži 10 mg reslizumaba.
Overall population Reslizumab 3 mg/kg (n=477)
Ukupna populacija Reslizumab 3 mg/kg (n=477)
Most patients in the population pharmacokinetic analysis had normal renal function (estimated glomerular filtration rate [eGFR]) greater than or equal to 90 mL/min/1.73 m2; n=294, approximately 37%), mild renal impairment (eGFR 60-89 mL/min/1.73 m2; n=446, approximately 56%), or moderate renal impairment (eGFR 30-59 mL/min/1.73 m2; n=63, approximately 8%).
56 %) ili umjereno oštećenu funkciju bubrega (eGFR 30-59 ml/min/1,73 m2; n=63, približno 8 %).
The effect of reslizumab 3 mg/kg administered once every 4 weeks on secondary endpoints, including FEV1, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and Asthma Symptom Utility Index (ASUI), further supports the efficacy of reslizumab 3 mg/kg compared to placebo.
Učinak reslizumaba, primijenjenog u dozi od 3 mg/kg jedanput svaka 4 tjedna, na sekundarne mjere ishoda, uključujući FEV1, Upitnik o kvaliteti života s astmom (engl.
The patients received either four doses of placebo or reslizumab 0.3 mg/kg or 3 mg/kg administered once every 4 weeks.
0,3 mg/kg ili 3 mg/kg koje su se davale jedanput svaka 4 tjedna.
Based on the similar reslizumab exposure observed in patients older than 65 years of age as compared to patients 18 to <65 years of age, no dose adjustment is recommended (see section 5.2).
Na temelju slične izloženosti reslizumabu u bolesnika starijih od 65 godina u usporedbi s bolesnicima u dobi od
Package leaflet: Information for the patient CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika CINQAERO 10 mg/ml koncentrat za otopinu za infuziju reslizumab
The primary efficacy measure for both Studies I and II was the frequency of asthma exacerbations for each patient during the 52-week treatment period.
I i II bila je učestalost egzacerbacija astme u svakog bolesnika tijekom razdoblja liječenja od 52 tjedna.
Studies I and II
I i II
Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany
3 89079 Ulm
CINQAERO should be prescribed by physicians experienced in the diagnosis and treatment of the above-mentioned indication (see section 4.1).
4.2 Doziranje i način primjene CINQAERO trebaju propisivati liječnici s iskustvom u dijagnozi i liječenju gore navedene indikacije
Reslizumab has not been studied in patients with hepatic impairment.
Reslizumab nije ispitan u bolesnika s oštećenjem funkcije jetre.
What are the benefits of using CINQAERO
Koje su koristi primjene lijeka CINQAERO
The concentrate is clear to slightly hazy opalescent, colourless to slightly yellow.
opalescentan, bezbojan do blago žut.
Musculoskeletal and connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često mijalgija*
Maintenance OCS was not allowed.
Nije bila dopuštena terapija održavanja peroralnim kortikosteroidima.
In Study III, patients receiving reslizumab 3 mg/kg had significantly larger increases in FEV1 from baseline compared to placebo (treatment difference: 160 mL, p=0.0018).
Ispitivanju III, bolesnici koji su primali reslizumab u dozi od 3 mg/kg imali su značajno veće povećanje FEV1 u odnosu na početnu vrijednost u usporedbi s onima koji su primali placebo
In Studies I and II, severe eosinophilic asthma is defined as any patients falling into GINA steps 4 and 5 (medium- to high-dose ICS [≥ 440 µg fluticasone propionate] plus another controller, with or without maintenance OCS) with a blood eosinophil count of ≥400 µL-1 at start of treatment.
I i II, teška eozinofilna astma definirana je kao astma kod svakog bolesnika u koracima 4 i 5 prema klasifikaciji GINA (srednje do visoke doze inhalacijskih kortikosteroida [≥
Preparation of solution for infusion
Priprema otopine za infuziju
Asthma exacerbation ratea
Stopa egzacerbacije astmea
CINQAERO is a medicine containing the active substance reslizumab, a monoclonal antibody, a type of protein that recognises and binds to a specific target substance in the body.
vrsta proteina koja prepoznaje određenu ciljnu tvar u tijelu i veže se za nju.
cohort of 763 patients within Studies I and II met this criterion; the primary efficacy outcome is presented in Table 4.
Ovaj je kriterij zadovoljila kohorta od 763 bolesnika u Ispitivanjima
Patients with severe refractory eosinophilic asthma Reslizumab produced significant reductions in asthma exacerbations relative to placebo in the refractory population (59%) and non-refractory population (49%).
U populaciji s refraktornom (59 %) i onoj s nerefraktornom (49 %) bolešću reslizumab je značajno smanjio egzacerbacije astme u odnosu na placebo.
The effect of reslizumab in patients with asthma and elevated sputum eosinophil counts (at least 3%) was evaluated in a 15-week, phase 2, randomised, double-blind, placebo-controlled clinical study with reslizumab 3 mg/kg.
bio je procijenjen u 15-tjednom, randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze 2 u kojem se davao u dozi od 3 mg/kg.
Of these subjects, 1,006 asthma patients were exposed for at least 6 months, 759 exposed for at least 1 year and 237 exposed for longer than 2 years (up to 3 years).The following adverse reactions have been reported with reslizumab during placebo-controlled asthma studies for up to 52 weeks of treatment with a 3 mg/kg dose given intravenously (1,028 patients).
1006 bolesnika s astmom bilo izloženo lijeku najmanje 6 mjeseci, 759 najmanje 1 godinu, a 237 dulje od 2 godine (do 3 godine).
CINQAERO is used to treat severe eosinophilic asthma in adult patients (18 years of age and over) when the condition is not well controlled despite treatment with high-dose inhaled corticosteroids together with another asthma medicine.
18 godina i više) kada bolest nije dobro kontrolirana unatoč liječenju visokim dozama inhalacijskih kortikosteroida zajedno s drugim lijekom za astmu.
Eosinophils began to return towards baseline in those reslizumab patients completing a 90-day follow-up assessment (394 µL-1, n=36).
Broj eozinofila počeo se vraćati prema početnim vrijednostima u bolesnika liječenih reslizumabom u kojih je završena procjena nakon
Description of selected adverse reactions
Reakcije preosjetljivosti i reakcije povezane s primjenom
How CINQAERO is given
Kako primjenjivati CINQAERO
Exacerbation history
Prijavljivanje nuspojava
Eosinophil counts
Broj eozinofila
Pliva Hrvatska d.o.o.
Merckle GmbH Graf-Arco-Str.
Placebo (n=380)
Placebo (n=380) 95 % CI
The significance of these changes is unknown.
Važnost ovih promjena nije poznata.
It is therefore difficult to recommend an optimum method.
Stoga je teško preporučiti optimalnu metodu.
• are planning to have a baby.
• planirate imati dijete.
• think you may be pregnant; or
• mislite da biste mogli biti trudni; ili
Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Iako ova interakcija nije formalno ispitana, ne postoji dokaz da je takva interakcija štetna.
The usual dose varies depending on your illness and weight.
Uobičajena doza varira ovisno o Vašoj bolesti i težini.
These can be taken from you or from a donor.
One se mogu prikupiti od Vas ili davatelja.
It is important to tell your doctor if you:
Važno je da kažete svom liječniku ako:
These changes all reversed after discontinuation of treatment.
Sve te promjene povukle su se nakon prekida liječenja.
You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home.
Vi, ili osobe koje Vas njeguju, možete naučiti kako davati potkožne injekcije tako da možete nastaviti s terapijom kod kuće.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Čimbenici rasta su proteini koji se prirodno proizvode u tijelu, ali se mogu proizvesti i pomoću biotehnologije za primjenu kao lijek.
When the response has been obtained, the minimal effective dose to maintain this level should be established.
Kad se postigne odgovor, treba odrediti minimalnu učinkovitu dozu za održavanje te razine.
This medicine may cause dizziness.
Ovaj lijek može prouzročiti omaglicu.
Instructions on how to inject yourself
Upute kako da sami sebi date injekciju