natgillin/translations-raw huggingface dataset:
The 2 female patients had little or no GL-3 accumulation in the superficial skin vascular endothelium at baseline, making this conclusion applicable in male patients only.
Dvije djevojčice su na početku liječenja, u endotelu površinskih krvnih žila kože, imale malo ili nimalo akumuliranog GL-3, što znači da se ovaj zaključak odnosi samo na bolesnike muškog spola.
Baseline CL was 77 ml/min with a Vss of 2.6 l; half-life was 55 min. After IgG seroconversion, CL decreased to 35 ml/min, Vss increased to 5.4 l, and half-life increased to 240 min.
Nakon serokonverzije IgG-a, CL se smanjio na 35 ml/min, Vss je porastao na 5,4 l, a poluvijek se povećao na 240 minuta.
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet
In one of these studies, performed in adult male patients, after an initial dose of 1.0 mg/kg every 2 weeks for 6 months, 0.3 mg/kg every 2 weeks may maintain clearance of GL-3 in certain cell types in some patients; however, the long term clinical relevance of these findings has not been established (see section 5.1).
dozom od 0,3 mg/kg svaka 2 tjedna može se u nekih bolesnika održati klirens GL-3 u određenim vrstama stanica; međutim, dugoročan klinički značaj tih nalaza nije utvrđen (vidjeti dio 5.1).
One vial of powder contains 5 mg of agalsidase beta.
Jedna bočica praška sadrži 5 mg agalzidaze beta.
• exacerbated difficulty in breathing
• pogoršanje tegoba s disanjem
- The treating physician will be responsible for determining which patients may be suitable for home or self-administration of Fabrazyme and for arranging for treatment at home and training the patient and/or caregiver in the appropriate skills necessary for this.
- Odgovornost je liječnika propisivača odrediti koji bolesnici su pogodni za (samostalnu) primjenu lijeka Fabrazyme kod kuće, organizirati sve za primjenu lijeka kod kuće i poučiti bolesnika i/ili njegovatelja svim vještinama potrebnima za primjenu lijeka kod kuće.
In another study with 30 paediatric patients with available pharmacokinetics data, aged 5 to 18 years, treated with two lower dose regimens of 0.5 mg/kg every 2 weeks and 1.0 mg/kg every 4 weeks, mean CL was 4.6 and 2.3 ml/min/kg, respectively, mean Vss was 0.27 and 0.22 l/kg, respectively, and mean elimination half-life was 88 and 107 minutes, respectively.
do 18 godina liječenih s dva niža režima doziranja od 0,5 mg/kg svaka 2 tjedna odnosno 1,0 mg/kg svaka 4 tjedna, srednji CL je bio redom 4,6 odnosno 2,3 ml/min/kg, srednji Vss 0,27 odnosno 0,22 l/kg i srednje poluvrijeme eliminacije 88 odnosno 107 minuta.
- That it is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Fabrazyme.
- Odgovornost je liječnika propisivača odrediti koji su bolesnici podobni za primjenu infuzije kod kuće, odnosno samostalnu primjenu lijeka Fabrazyme.
Do not use the solution if foreign particles are observed or if the solution is discoloured.
Ne smijete upotrijebiti otopinu u kojoj ima stranih čestica ili ako je promijenila boju.
- The training to be provided to the patient and /or caregiver should address the following elements: - That it is essential to follow strictly the prescribed dose and infusion rate - Method of preparation and administration of Fabrazyme - Instructions in handling possible adverse events - Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion - The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy - The need to keep a diary to document each treatment received at home and to bring it at each visit - It is the responsibility of the prescribing physician to verify that all necessary skills have been acquired by the non-healthcare professional and that Fabrazyme may be safely and effectively administered at home.
- bolesnika treba uputiti da potraži hitnu medicinsku pomoć ako ne može pristupiti veni ili ako primijeti nedovoljnu djelotvornost liječenja - potrebu vođenja dnevnika u koji treba bilježitu svako liječenje primijenjeno kod kuće i koji bolesnika mora ponijeti sa sobom pri svakom posjetu liječniku - Liječnik propisivač dužan je provjeriti je li osoba koja nije zdravstveni djelatnik savladala sve nužne vještine i jesu li zadovoljeni svi uvjeti za sigurnu i djelotvornu primjenu lijeka Fabrazyme kod kuće.
After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta.
Nakon rekonstitucije sa 7,2 ml vode za injekcije jedna bočica lijeka Fabrazyme sadrži 5 mg/ml (35 mg/7 ml)
• increased blood pressure • joint pain
• povišen krvni tlak
Use of Fabrazyme during pregnancy is not recommended.
Ne preporučuje se primjena lijeka Fabrazyme tijekom trudnoće.
One vial of powder contains 35 mg of agalsidase beta.
Jedna bočica praška sadrži 35 mg agalzidaze beta.
Fabrazyme 5 mg powder for concentrate for solution for infusion Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju Prije dodavanja rekonstituiranog volumena lijeka Fabrazyme potrebnog za dozu za bolesnika, preporučuje se iz infuzijske vrećice ukloniti jednaki volumen 0,9% otopine natrijevog klorida za intravensku primjenu.
EU/1/01/188/001 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 10 vials of powder for concentrate for solution for infusion
EU/1/01/188/002 5 bočica s praškom za koncentrat za otopinu za infuziju EU/1/01/188/003 10 bočica s praškom za koncentrat za otopinu za infuziju
• pain at the extremities
• bol u udovima
Genzyme Europe B.V. Paasheuvelweg 25
Genzyme Europe B.V.-NL
No unexpected safety issues were encountered in patients with an increase in exposure after seroconversion.
U bolesnika u kojih se nakon serokonverzije povećala izloženost lijeku nisu zabilježene neočekivane poteškoće povezane sa sigurnošću.
Fabrazyme 5 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase beta.
Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju Jedna bočica lijeka Fabrazyme sadrži nominalnu vrijednost od 5 mg agalzidaze beta.
Limited information from clinical trials suggests that the safety profile of Fabrazyme treatment in paediatric patients ages 5-7, treated with either 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks is similar to that of patients (above the age of 7) treated at 1.0 mg/kg every 2 weeks.
Malobrojni podaci iz kliničkih ispitivanja upućuju da je sigurnosni profil liječenja lijekom Fabrazyme u pedijatrijskih bolesnika u dobi od 5 do 7 godina liječenih dozom od 0,5 mg/kg svaka 2 tjedna ili dozom od
Incidence of adverse reactions with Fabrazyme treatment System organ class
Incidencija nuspojava kod liječenja lijekom Fabrazyme Organski sustav Vrlo često Često
Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion
Fabrazyme 35 mg prašak za koncentrat za otopinu za infuziju Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju
• itching eyes
• svrbež očiju
The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α-galactosidase A.
Niz aminokiselina rekombinantnog oblika, kao i niz nukleotida koji ga kodira,
Very common Common
Manje često
Gastrointestinal Disorders nausea, vomiting abdominal pain, abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea dyspepsia, dysphagia --
Poremećaji probavnog sustava mučnina, povraćanje bol u abdomenu, bol u gornjem dijelu abdomena, nelagoda u abdomenu, nelagoda u želucu, oralna hipoestezija, proljev dispepsija, disfagija --
Use of Fabrazyme during breastfeeding is not recommended.
Ne preporučuje se primjena lijeka Fabrazyme tijekom dojenja.
• red rash
• crveni osip
Patients experiencing mild or moderate infusion-associated reactions when treated with agalsidase beta during clinical trials have continued therapy after a reduction in the infusion rate (~0.15 mg/min; 10 mg/hr) and/or pre-treatment with antihistamines, paracetamol, ibuprofen and/or corticosteroids.
(~0,15 mg/min; 10 mg/sat) i/ili prethodne primjene antihistaminika, paracetamola, ibuprofena i/ili kortikosteroida.
Respiratory, thoracic and mediastinal disorders dyspnoea, nasal congestion, throat tightness, wheezing, cough, dyspnoea exacerbated bronchospasm, pharyngolaryngeal pain, rhinnorhoea, tachypnoea, upper respiratory tract congestion hypoxia
Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, kongestija nosa, stezanje u grlu, piskanje pri disanju, kašalj, egzacerbacija dispneje bronhospazam, faringolaringealna bol, rinoreja, tahipneja, kongestija gornjeg dišnog sustava hipoksija
Skin and subcutaneous tissue disorders pruritus, urticaria, rash, erythema, pruritus generalized, angioneurotic oedema, swelling face, rash maculo-papular livedo reticularis, rash erythematous, rash pruritic, skin discolouration, skin discomfort leukocytoclastic vasculitis
Poremećaji kože i potkožnog tkiva pruritus, urtikarija, osip, eritem, generalizirani pruritus, angioneurotski edem, oticanje lica, makulopapularni osip retikularni livedo, eritematozni osip,
- The active substance is agalsidase beta, one vial contains 35 mg. - The other ingredients are:
- Djelatna tvar je agalzidaza beta, jedna bočica sadrži 35 mg.
Any unused solution should be discarded.
Neupotrijebljena otopina mora se zbrinuti.
Musculoskeletal and connective tissue disorders pain in extremity, myalgia, back pain, muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness musculoskeletal pain --
bol u leđima, grčevi u mišićima, artralgija, stezanje u mišićima, mišićno-koštana ukočenost mišićno-koštana bol --
Fabrazyme 35 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Fabrazyme 35 mg prašak za koncentrat za otopinu za infuziju Jednu bočicu lijeka Fabrazyme od 35 mg rekonstituirajte sa 7,2 ml vode za injekcije.
Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Prije dodavanja rekonstituiranog volumena lijeka Fabrazyme potrebnog za dozu za bolesnika, preporučuje se iz infuzijske vrećice ukloniti jednaki volumen 0,9% otopine natrijevog klorida za intravensku primjenu.
It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles which will not lead to any loss of agalsidase beta activity.
Da bi se uklonile čestice proteina preporučuje se razrijeđenu otopinu primjenjivati kroz “in-line” filtar male sposobnosti vezanja proteina s porama veličine 0,2 µm.
Common (may affect up to 1 in 10 people): • chest pain
Česte (mogu se javiti u manje od 1 na 10 osoba):
Fabrazyme 5 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju Jednu bočicu lijeka Fabrazyme od 5 mg rekonstituirajte s 1,1 ml vode za injekcije.
• skin discoloration
• promjena boje kože
However, at the lower dose, IgG antibodies may play a role with respect to GL-3 clearance in some patients.
IgG protutijela mogu utjecati na klirens GL-3.
In this trial, the initial rechallenge administration was at a low dose and a lower infusion rate (1/2 the therapeutic dose at 1/25 the initial standard recommended rate).
(1/2 terapijske doze uz 1/25 početne standardne preporučene brzine).
• difficulty in breathing
• otežano disanje
Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Jednu bočicu lijeka Fabrazyme od 35 mg rekonstituirajte sa 7,2 ml vode za injekcije.
• burning sensation
• osjećaj žarenja
• urticaria
• koprivnjača
The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to clear the accumulating substrate in the organ tissues; thereby, preventing, stabilizing or reversing the progressive decline in function of these organs before irreversible damage has occurred.
Time se sprječava, stabilizira ili popravlja progresivno smanjenje funkcije tih organa prije nastanka nepopravljivih oštećenja.
• feeling hot
• navala vrućine
- The active substance is agalsidase beta, one vial contains 5 mg. - The other ingredients are:
- Djelatna tvar je agalzidaza beta, jedna bočica sadrži 5 mg.
Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Jednu bočicu lijeka Fabrazyme od 5 mg rekonstituirajte s 1,1 ml vode za injekcije.
• injection site blood clotting
• zgrušavanje krvi na mjestu primjene injekcije
Intravenous use.
Za primjenu u venu.
5 vials of powder for concentrate for solution for infusion.
5 bočica s praškom za koncentrat za otopinu za infuziju.
Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta
Fabrazyme 35 mg prašak za koncentrat za otopinu za infuziju agalzidaza beta
Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials.
Fabrazyme 35 mg je dostupan u prozirnim staklenim bočicama od 20 ml (staklo tipa I).
10 vials of powder for concentrate for solution for infusion.
10 bočica s praškom za koncentrat za otopinu za infuziju.
• (mottled purplish) skin discoloration
• promjena boje kože (ljubičaste šare)
Nervous system disorders headache, paraesthesia dizziness, somnolence, hypoaesthesia, burning sensation, lethargy, syncope hyperaesthesia, tremor
hipoestezija, osjećaj žarenja, letargija, sinkopa hiperestezija, tremor --
No changes in dose are necessary for patients with kidney disease.
U bolesnika s bolešću bubrega nije potrebno mijenjati dozu.
• lower blood oxygen levels • serious inflammation of the vessels
• niže razine kisika u krvi
Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta
Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju agalzidaza beta
• oedema
• omaglica
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of patients (see section
U malog su broja bolesnika prijavljene reakcije koje upućuju na akutnu preosjetljivost (tipa I) (vidjeti dio 4.4).
• musculoskeletal stiffness
• stezanje mišića
General disorders and administration site conditions chills, pyrexia, feeling cold fatigue, chest discomfort, feeling hot, oedema peripheral, pain, asthenia, chest pain, face oedema, hyperthermia feeling hot and cold, influenza-like illness, infusion site pain, infusion site reaction, injection site thrombosis, malaise, oedema
osjećaj vrućine, periferni edem, bol, astenija, bol u prsištu, oticanje lica, hipertermija osjećaj vrućine i hladnoće, bolest nalik gripi, bol na mjestu primjene infuzije, reakcija na mjestu primjene infuzije, tromboza na mjestu injekcije, malaksalost, edem
Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
manitol natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat
Due to the limitations of the study design (small number of patients), no definitive conclusion regarding the dose maintenance regimen can be drawn, but these findings suggest that, after an initial debulking dose of 1.0 mg/kg every 2 weeks, 0.3 mg/kg every 2 weeks may be sufficient in some patients to maintain clearance of GL-3.
Ipak, nalazi pokazuju da nakon početne doze od 1,0 mg/kg svaka 2 tjedna doza od 0,3 mg/kg svaka 2 tjedna može u nekih bolesnika biti dovoljna za održavanje klirensa GL-3.
Hepatic impairment Studies in patients with hepatic insufficiency have not been performed.
Nisu provedena ispitivanja u bolesnika sa zatajivanjem jetre.
Ear and labyrinth disorders tinnitus, vertigo auricular swelling, ear pain
Poremećaji uha i labirinta tinitus, vrtoglavica oticanje ušne školjke, bol u uhu
• increased heart beat
• ubrzani otkucaji srca
Additional symptoms included mild or moderate dyspnoea, hypoxia (oxygen saturation decreased), throat tightness, chest discomfort, flushing, pruritus, urticaria, face oedema, angioneurotic oedema, rhinitis, bronchospasm, tachypnoea, wheezing, hypertension, hypotension, tachycardia, palpitations, abdominal pain, nausea, vomiting, infusion-related pain including pain at the extremities, myalgia, and headache.
Ostali simptomi uključivali su blagu do umjerenu dispneju, hipoksiju (smanjenu saturaciju kisikom), stezanje u grlu, nelagodu u prsištu, crvenilo praćeno osjećajem užarenosti, pruritus, urtikariju, edem lica, angioneurotski edem, rinitis, bronhospazam,
Infusion of Fabrazyme at home may be considered for patients who are tolerating their infusions well.
U bolesnika koji dobro podnose infuzije može se razmotriti mogućnost primjene infuzije lijeka Fabrazyme kod kuće.
• decreased blood pressure • hot flush
• naglo oticanje lica ili grla • snižen krvni tlak
EU/1/01/188/004 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 10 vials of powder for concentrate for solution for infusion
EU/1/01/188/004 1 bočica s praškom za koncentrat za otopinu za infuziju
Fabry disease
FARMAKOLOŠKA SVOJSTVA
• sudden swelling of the face or throat
• upala nosa ili ždrijela
• low heart rate
• spori otkucaji srca
Fabrazyme 5 mg powder for concentrate for solution for infusion Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials.
Fabrazyme 5 mg je dostupan u prozirnim staklenim bočicama od 5 ml (staklo tipa I).
In the postmarketing setting, experience was gained in patients who initiated treatment at a dose of 1 mg/kg every 2 weeks and subsequently received a reduced dose for an extended period.
1 mg/kg svaka 2 tjedna, a nakon toga su dulje vrijeme primali smanjenu dozu.
Anaphylactoid reactions have been reported in the postmarketing setting.
Nakon stavljanja lijeka u promet prijavljene su anafilaktičke reakcije.
- Necessary skills have to be acquired by non-healthcare professionals before Fabrazyme may be safely and effectively administered at home. - Their prescribing physician will provide training on the following elements: - That it is essential to follow strictly the prescribed dose and infusion rate - Method of preparation and administration of Fabrazyme - Instructions in handling possible adverse events - Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion
- način pripreme i primjene lijeka Fabrazyme - upute za postupanje u slučaju mogućih nuspojava - bolesnika treba uputiti da potraži hitnu medicinsku pomoć u slučaju pojave nuspojava tijekom primjene infuzije
• rhinitis
• nesvjestica
• upper respiratory tract congestion
• opstrukcija gornjeg dijela dišnog sustava
Package leaflet: Information for the user Fabrazyme 5 mg powder for concentrate for solution for infusion
Uputa o lijeku: Informacije za korisnika Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju agalzidaza beta
• musculoskeletal pain
• ukočenost mišića i kostiju
Package leaflet: Information for the user Fabrazyme 35 mg powder for concentrate for solution for infusion
Uputa o lijeku: Informacije za korisnika Fabrazyme 35 mg prašak za koncentrat za otopinu za infuziju agalzidaza beta
The level of support required for home infusion will be discussed and agreed by the patient and/or caregiver with the prescribing physician.
Liječnik propisivač u dogovoru s bolesnikom i/ili njegovateljem određuje razinu potpore nužnu za primjenu infuzije kod kuće.
Agalsidase beta clearance was not influenced by weight in this population.
U toj populaciji tjelesna težina nije utjecala na klirens agalzidaze beta.
Vascular disorders flushing, hypertension, pallor, hypotension, hot flush peripheral coldness --
tahipneju, piskanje pri disanju, hipertenziju, hipotenziju, tahikardiju, palpitacije, bol u abdomenu,
1 vial of powder for concentrate for solution for infusion.
1 bočica s praškom za koncentrat za otopinu za infuziju.
• nasopharyngitis
• grlobolja
• dizziness
• bljedilo
The reconstituted solution contains 5 mg agalsidase beta per ml, and appears as a clear colourless solution.
Rekonstituirana otopina je bistra, bezbojna otopina koja sadrži 5 mg agalzidaze beta po ml. pH vrijednost rekonstituirane otopine je otprilike 7,0.
• throat pain
• bol u prsima
• malaise
• vrtoglavica
• lethargy
• proljev
• Summary of Product Characteristics and Package Leaflet
• Sažetak opisa svojstava lijeka i Uputu o lijeku
Excipients: mannitol sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate See the leaflet for further information.
Drugi sastojci su: manitol natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat
Genzyme Europe B.V.- NL Store in a refrigerator (2°C - 8°C)
POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2°C - 8°C).
• redness
• svrbež
• abdominal discomfort
• prekomjerno suzenje
Elderly
Trudnoća
• chest discomfort
• bezvoljnost
Both cases resolved.
Oba su slučaja bila uspješno riješena.
Older people (≥ 65 years)
Starije osobe(≥ 65 godina)
This process is called remodelling.
Taj se proces naziva preoblikovanje.
- if you are pregnant.
- ako ste trudni. - ako dojite.
• Key signs and symptoms of serious adverse events
• Ključni znakovi i simptomi ozbiljnih štetnih događaja
The infusion must be conducted according to standard medical practice.
Infuzija se mora provoditi u skladu sa standardnom medicinskom praksom.
Tell your dentist immediately if you experience such symptoms.
Odmah se obratite svom zubaru ako primijetite takve simptome.
The duration of the trial was one year.
Ispitivanje je trajalo godinu dana.
Mutagenicity and carcinogenic potential
Mutagenost i karcinogeni potencijal
The clinical relevance of these findings is unknown.
Kliničko značenje tih nalaza nije poznato.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego što počnete primati ovaj lijek jer sadrži Vama važne podatke.
Clinical experience with acute overdose is limited.
Klinička iskustva s akutnim predoziranjem su ograničena.
Check with your doctor or nurse if you are not sure.
Provjerite sa svojim liječnikom ili medicinskom sestrom ako niste sigurni.
- Do not throw away any medicines via wastewater (or household waste).
Nikada nemojte nikakve lijekove bacati u otpadne vode (ili kućni otpad).
- The unopened bottle does not require any special storage conditions.
- Neotvorena bočica ne zahtijeva posebne uvjete čuvanja.
All clinical fractures were verified based on the radiographic and/or clinical evidence.
Svi klinički prijelom bili su potvrđeni na osnovi radiološkog i/ili kliničkog dokaza.
Your doctor will let you know when to return for your next dose.
Vaš će Vam liječnik objasniti kada trebate primiti sljedeću dozu.
Effect on height
Učinak na visinu
Clinical efficacy in men
Klinička djelotvornost u muškaraca
This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
To se podudara s 28% smanjenjem rizika za sve uzroke smrtnosti (p=0,01).
Patients who have received doses higher than those recommended should be carefully monitored.
Bolesnike koji su primali doze više od preporučenih potrebno je pažljivo pratiti.
Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Liječnik će Vas upoznati sa simptomima koji su povezani s hipokalcijemijom.
- After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
- Nakon otvaranja bočice, lijek treba odmah primijeniti kako bi se izbjeglo mikrobiološko onečišćenje.
Follow carefully all instructions given to you by your doctor or nurse.
Pažljivo slijedite sve upute koje Vam je dao liječnik ili medicinska sestra.
The infusion will take at least 15 minutes.
Infuzija traje najmanje 15 minuta.