natgillin/translations-raw huggingface dataset:
After administration of 1,662, 500IU twice daily for 7 days in adult, adolescent and paediatric cystic fibrosis patients mean C max values of total colistimethate of up to 455ng/ml (adult mean) were observed.
Colobreathe 1 662 500 IU dvaput na dan tijekom 7 dana u odraslih, adolescenata i djece s cističnom fibrozom, zabilježene su prosječne vrijednosti C max ukupnog kolistimetata do 455 ng/ml (prosjek u odraslih).
For inhalation use only.
Samo za primjenu inhalacijom.
If you/your child forget to use Colobreathe
Ako ste Vi/Vaše dijete zaboravili primijeniti Colobreathe
Carry on from there as instructed.
Nakon toga, nastavite prema uputama.
Warnings and precautions Tell your doctor if you/your child has ever had any of the following conditions:
Obavijestite liječnika ako ste Vi/Vaše dijete ikada imali jedno od sljedećeg:
• if you/your child are taking aminoglycoside antibiotics used to treat infections caution must be taken;
• ako Vi/Vaše dijete uzimate aminoglikozidne antibiotike koji se koriste za liječenje infekcija nužan je oprez;
Absorption of colistimethate from the gastro-intestinal tract does not occur to any appreciable extent in the normal individual.
Apsorpcija kolistimetata iz gastrointestinalnog trakta u zdravih osoba ne događa se u značajnom opsegu.
Colistimethate sodium should be used with extreme caution in patients with porphyria.
Kolistimetatnatrij je potrebno primjenjivati uz krajnji oprez u bolesnika s porfirijom.
Colobreathe is used to control persistent lung infections caused by the bacterium Pseudomonas aeruginosa in adult patients and children aged 6 years and older with cystic fibrosis.
Colobreathe se koristi za kontrolu ustrajne plućne infekcije prouzročene bakterijom Pseudomonas aeruginosa u odraslih bolesnika, i djece u dobi od 6 godina i starijih, s cističnom fibrozom.
Forced expiratory volume decreased
Smanjeni forsirani ekspiratorni volumen
− emphasise that patients should persist with the treatment.
− naglasak da bolesnik mora nastaviti s liječenjem
Currently there is no experience of overdose with the use of Colobreathe.
Trenutno nema iskustva s predoziranjem prilikom primjene lijeka Colobreathe.
Overdose is unlikely by the inhaled route but has been recognised after systemic use.
Predoziranje nije vjerojatno prilikom primjene lijekova inhaliranjem, ali je potvrđeno pri sistemskoj primjeni.
• The contents of one Colobreathe capsule should be inhaled twice a day using the Turbospin inhaler.
• Sadržaj jedne kapsule lijeka Colobreathe mora se udisati dvaput na dan inhalatorom Turbospin.
There is no experience of using Colobreathe concurrently with other inhaled antibacterial agents.
Nema iskustva s primjenom lijeka Colobreathe istodobno s drugim inhaliranim antibakterijskim lijekovima.
Do not use this medicine after the expiry date, which is stated on the outer carton and blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok valjanosti“.
8 capsules with 1 Turbospin inhaler (1 strip of 8 capsules) 56 capsules with 1 Turbospin inhaler (4 strips of 14 capsules) 56 capsules with 1 Turbospin inhaler (7 strips of 8 capsules)
8 kapsula s 1 inhalatorom Turbospin (1 blister sa 8 kapsula) 56 kapsula s 1 inhalatorom Turbospin (4 blistera sa 14 kapsula) 56 kapsula s 1 inhalatorom Turbospin (7 blistera sa 8 kapsula)
Removing the empty capsule from the Turbospin
Uklanjanje prazne kapsule iz inhalatora Turbospin
If you/your child stop using Colobreathe
Ako ste Vi/Vaše dijete prestali primjenjivati Colobreathe
Change in FEV1 (% predicted) from baseline at Week 24 (ITT Population) Patient group Colobreathe
Promjena u FEV1 (očekivani %) u odnosu na početnu vrijednost u 24. tjednu (populacija ITT)
Therefore, dose adjustment in low age groups is considered not necessary.
Stoga se smatra da nema potrebe za prilagođavanjem doze u skupinama mlađe dobi.
Care should still be taken in administering Colobreathe to patients who are known to have a propensity for nephrotoxic or neurotoxic events.
Potreban je oprez kada se Colobreathe daje bolesnicima za koje je poznato da imaju sklonost ka nefrotoksičnim i neurotoksičnim događajima.
Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older (see section 5.1).
Colobreathe je indiciran za zbrinjavanje kronične plućne infekcije prouzročene s Pseudomonas aeruginosa u bolesnika s cističnom fibrozom (CF) u dobi od 6 godina i starijih (vidjeti dio 5.1).
Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium.
Polimiksini djeluju tako što razaraju staničnu membranu i rezultirajući fiziološki učinci su smrt za bakteriju.
Colistimethate sodium has no notable effects on fertility in male or female rats or mice.
Kolistimetatnatrij nema primjetnih učinaka na plodnost mužjaka ili ženki štakora ili miševa.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ili OTPADNIH
The Turbospin is an inspiratory flow driven dry powder inhaler made of polypropylene and stainless steel.
Turbospin je inhalator za suhi prašak koji se aktivira zračnim tokom udisaja, a izrađen je od polipropilena i nehrđajućeg čelika.
Very common: may affect more than 1 in 10 people
Često: mogu se javiti u manje od 1 na 10 osoba
If you/your child use more Colobreathe than you/your child should, or have accidentally swallowed the capsule, contact your doctor immediately for advice.
Ako ste Vi/Vaše dijete primijenili više lijeka Colobreathe nego što ste smjeli, ili ste nehotice progutali kapsulu, odmah se posavjetujte s Vašim liječnikom.
Use as directed by the physician.
Primijenite prema uputama liječnika.
Physico-chemical data suggest excretion of colistimethate sodium in human milk.
Fizikalno-kemijski podaci ukazuju da se kolistimetatnatrij izlučuje u majčino mlijeko.
Colobreathe inhalation powder, hard capsule (inhalation powder) is supplied as small, hard, transparent gelatin capsules containing a fine white powder.
Colobreathe prašak inhalata, tvrda kapsula (prašak inhalata) isporučuje se u malim, tvrdim, prozirnim želatinskim kapsulama koje sadrže fini bijeli prašak.
Clean the chamber using a tissue or cotton bud.
Komoru očistite papirnatom maramicom ili komadićem vate.
The other ingredients are: Capsule Shell Gelatin polyethylene glycol sodium lauryl sulfate purified water
Drugi sastojci su: Ovojnica kapsule želatina polietilenglikol natrijev laurilsulfat pročišćena voda
Vomiting, nausea Diarrhoea, toothache, salivary hypersecretion, flatulence
zubobolja, hipersekrecija sline, flatulencija
There is very low transpulmonary absorption of colistimethate after inhalation of Colobreathe (see section 5.2).
Nakon inhalacije lijeka Colobreathe, dolazi do vrlo niske transpulmonalne apsorpcije (vidjeti dio 5.2).
• Other inhaled medicines
• Drugi inhalacijski lijekovi
• The “Physician DVD”
• „DVD za liječnika“
All subjects were also required to have successfully completed a minimum of two cycles of nebulised tobramycin solution run-in prior to randomisation.
Svi su ispitanici morali prije randomizacije uspješno dovršiti uvodno razdoblje s najmanje dva ciklusa otopine tobramicina u atomizatoru.
• Cough, throat irritation
• kašalj, nadražaj grla
Remove a single capsule from the blister.
Izvadite jednu kapsulu iz blistera.
To inhale Colobreathe from the capsule through the Turbospin inhaler follow the procedure described below.
Za inhaliranje lijeka Colobreathe iz kapsule kroz inhalator Turbospin pridržavajte se postupka opisanog u nastavku.
• Vomiting, nausea
• povraćanje, mučnina
If bronchospasm or coughing remain problematic, withdrawal of treatment should be considered.
Ako bronhospazam ili kašljanje ostanu problematični,
Subjects were randomised to receive either one 1,662,500 IU capsule of colistimethate sodium twice daily, or 300 mg of tobramycin, twice daily.
Ispitanici su bili randomizirani tako da su dobivali jednu kapsulu s 1 662 500 IU kolistimetatnatrija dvaput dnevno, ili 300 mg tobramicina dvaput dnevno.
Caution should be taken with concomitant use of Colobreathe and parenteral or nebulised colistimethate sodium.
Potreban je oprez kada se Colobreathe primjenjuje istodobno kad i kolistimetatnatrij parenteralno ili nebulizacijom.
• Then Colobreathe
• Zatim Colobreathe.
Colistimethate sodium may be secreted in the breast milk.
Kolistimetatnatrij može se izlučiti u mlijeko dojilja.
How it works Colobreathe works by destroying the bacterial cell membrane, having a lethal effect on them.
Colobreathe djeluje tako što razara staničnu membranu bakterija, što za njih ima smrtonosan učinak.
Inhalation powder, hard capsule (inhalation powder) Hard transparent PEG-gelatin capsules containing a fine white powder.
Prašak inhalata, tvrda kapsula (prašak inhalata) Tvrde i prozirne PEG-želatinske kapsule koje sadrže fini bijeli prašak.
Tobramycin ( Mean)
Tobramicin (prosjek)
Haemoptysis, bronchospasm, asthma, wheezing, chest discomfort, lower respiratory tract infection, productive cough, crackles lung
Hemoptiza, bronhospazam, astma, piskanje, nelagoda u prsištu, infekcija donjih dišnih puteva, produktivni kašalj,
There are no or limited amount of data from the use of inhaled colistimethate sodium in pregnant women.
Nema podataka ili su podaci o primjeni inhaliranog kolistimetatnatrija u trudnica ograničeni.
The above side effects have been seen in people of all ages with similar frequency.
Navedene nuspojave pojavile su se sa sličnom učestalosti u bolesnika svih dobi.
The tiny particles of medicine in the capsule are picked up by the airflow and carried down your airway into your lungs.
Protok zraka prikuplja sitne čestice lijeka prisutne u kapsuli i dovodi ih kroz dišne puteve u pluća.
Deeply press the piston a few times whilst keeping the chamber turned upside down.
Klip nekoliko puta pritisnite do kraja dok držite komoru okrenutu naopako.
You/your child should confirm the order of your treatments with your doctor.
Za Vas/Vaše dijete neka navedeni redoslijed liječenja potvrdi liječnik.
Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis (see section 4.4).
Nužno je primijeniti oprez u bolesnika s miastenijom gravis prilikom istodobnog liječenja kolistimetatnatrijem i makrolidima, kao što su azitromicin i klaritromicin, ili fluorokinolonima, kao što su norfloksacin i ciprofloksacin (vidjeti dio 4.4).
Each 8 capsule pack contains one Turbospin powder inhaler device and 1 blister of 8 hard capsules sufficient for 4 days use.
Svako pakiranje od 8 kapsula sadrži jedan inhalator za prašak Turbospin i 1 blister sa 8 tvrdih kapsula, što je dovoljno za 4 dana primjene.
• 56 hard capsules and one Turbospin powder inhaler device sufficient for 4 weeks use.
• 56 tvrdih kapsula i jedan inhalator za prašak Turbospin, što je dovoljno za 4 tjedna primjene.
• already have a muscle condition known as myasthenia gravis or the inherited condition,
• bolest mišića koja se naziva miastenija gravis ili naslijeđenu bolest koja se naziva porfirija
Dyspnoea, cough, dysphonia, throat irritation
Dispneja, kašalj, disfonija, nadražaj grla
Please discuss the use of Colobreathe with your doctor.
Posavjetujte se sa svojim liječnikom o primjeni lijeka Colobreathe.
Sore throat or mouth has been reported with nebulised colistimethate sodium and may occur with Colobreathe.
Prilikom primjene nebuliziranog kolistimetatnatrija prijavljena je grlobolja ili bol u ustima, pa se mogu pojaviti i s lijekom Colobreathe.
Each 56 capsule pack contains one Turbospin powder inhaler device and 7 blisters of 8 capsules or one Turbospin powder inhaler device and 4 blisters of 14 capsules (56 hard capsules) sufficient for 4 weeks use.
Svako pakiranje od 56 kapsula sadrži jedan inhalator za prašak Turbospin i 7 blistera sa 8 kapsula ili 4 blistera sa 14 kapsula (56 tvrdih kapsula), što je dovoljno za 4 tjedna primjene.
What you need to know before you use Colobreathe Do not use Colobreathe:
Što morate znati prije nego počnete primjenjivati Colobreathe
Of these, 187 patients aged 6 years and above were exposed to Colobreathe one capsule twice daily in a 24-week, phase 3 comparative study.
izloženo jednoj kapsuli lijeka Colobreathe dvaput dnevno u 24-tjednom komparativnom ispitivanju faze III.
• Changes in how your lungs function (found by testing)
• promjene u radu pluća (ustanove se pretragama)
Explanation of the Turbospin and how it works.
Turbospin i njegovog rada.
• 8 hard capsules and one Turbospin inhaler device sufficient for 4 days use.
• 8 tvrdih kapsula i jedan inhalator za prašak Turbospin, što je dovoljno za 4 dana primjene.
The Physician and patient “DVDs/leaflet forms” should contain the following key elements and messages:
• Podatke „DVD za bolesnika“ u „obliku uputa" za bolesnike koji nemaju pristup čitaču DVD-a „DVD/podaci u obliku uputa“ za liječnike i bolesnike moraju sadržati sljedeće glavne stavke i poruke:
Clean the Turbospin inhaler after each dose using the following procedure: 1.
Čišćenje inhalatora Turbospin Inhalator Turbospin očistite nakon svake doze na sljedeći način:
If you/your child are taking other treatments for cystic fibrosis you/your child should take them in the following order:
Redoslijed kojim se moraju uzimati ili izvoditi drugi oblici liječenja Ako Vi/Vaše dijete liječite cističnu fibrozu još na koji način, redoslijed liječenja za Vas/Vaše dijete je sljedeći:
• Coughing up blood, wheezing, chest discomfort, asthma, productive cough (a cough which brings up mucus), infection of the lungs, lung crackles (your doctor would hear this when listening to your lungs using a stethoscope)
(kašalj kojim se iskašljava sluz), plućna infekcija, pucketanja na plućima (čuje ih Vaš liječnik kada sluša pluća stetoskopom)
Preparing the Turbospin
Priprema inhalatora Turbospin
It is possible while using Colobreathe that you may experience dizziness, confusion or have problems with your sight.
Prilikom primjene lijeka Colobreathe može se pojaviti omaglica, smetenost, ili poteškoće s vidom.
The rinse should not be swallowed.
Voda od ispiranja ne smije se progutati.
• The capsule is now pierced and the contents can be inhaled.
• Time probijate kapsulu, što omogućuje udisanje njenog sadržaja.
For use with the Turbospin inhaler only.
Samo za primjenu uz inhalator Turbospin.
Taking Colobreathe using the Turbospin inhaler Preparing the Turbospin
Uzimanje lijeka Colobreathe koristeći inhalator Turbospin Priprema inhalatora Turbospin
How to use Colobreathe
Kako primjenjivati lijek Colobreathe
Acute respiratory exacerbation
Akutna respiratorna egzacerbacija
Colobreathe is inhaled into the lungs as a powder from the capsule using the hand-held inhaler called the Turbospin.
Način primjene Colobreathe se u obliku praška iz kapsule udiše u pluća pomoću ručnog inhalatora, koji se naziva
Each capsule contains 1,662,500 IU, which is approximately equal to 125 mg of colistimethate sodium.
Jedna kapsula sadrži 1 662 500 IU, što je približno jednako 125 mg kolistimetatnatrija.
Colobreathe capsules are to be used only with the Turbospin powder inhaler.
Colobreathe kapsule smiju se primjenjivati samo uz pomoć Turbospin inhalatora za prašak.
Taking Colobreathe using the Turbospin inhaler
Uzimanje lijeka Colobreathe koristeći inhalator Turbospin
• Chest physiotherapy
• Respiratorna fizioterapija
player
Serija
• blood in your sputum (the substance you cough up)
• krv u ispljuvku (iskašljaju)
Package leaflet: Information for the user Colobreathe 1,662,500 IU inhalation powder, hard capsules
Uputa o lijeku: Informacije za korisnika Colobreathe 1 662 500 IU prašak inhalata, tvrde kapsule kolistimetatnatrij
All patients using LOCF
Forward, LOCF)
If other treatments are being taken, they should be taken in the following order: Inhaled bronchodilators
U slučaju primjene drugih istodobnih liječenja, terapije se moraju se provoditi sljedećim redoslijedom:
Each capsule contains 1,662,500 IU (approximately equivalent to 125 mg) of colistimethate sodium.
Jedna kapsula sadrži 1 662 500 IU (približno jednako 125 mg) kolistimetatnatrija.
Each capsule contains 1,662,500 IU (approximately equal to 125 mg) of colistimethate sodium
Jedna kapsula sadrži 1 662 500 IU (približno jednako 125 mg) kolistimetatnatrija
Overdose can also cause acute renal failure characterised by decreased urine output and increased serum concentrations of BUN and creatinine.
karakterizirano smanjenim izlučivanjem mokraće i povećanim koncentracijama BUN-a i keratinina u serumu.
• Weight fluctuations, decreased appetite
• oscilacije težine, smanjeni apetit • tjeskoba
Actavis Group PTC ehf.
Actavis Ltd.
Other possible side effects
Duge moguće nuspojave
The Turbospin device should be discarded after completion of the treatment pack.
Inhalator Turbospin valja zbrinuti kada se iskoristi sav lijek u pakiranju.
Polyethylene glycol Purified water Sodium lauryl sulfate
Sastojci PEG-želatinskih tvrdih kapsula: želatina polietilenglikol pročišćena voda natrijev laurilsulfat
Pyrexia, asthenia, fatigue
Pireksija, astenija, umor
Colobreathe 1,662,500 IU inhalation powder, hard capsules
Colobreathe 1 662 500 IU prašak inhalata, tvrde kapsule
Bronchospasm or coughing may occur on inhalation.
Prilikom inhaliranja može doći do bronhospazma ili kašljanja.
Colobreathe capsules should only be administered using the Turbospin inhaler device.
Kapsule Colobreathe smiju se primjenjivati samo pomoću inhalatora Turbospin.
When you/your child start using Colobreathe, you/your child may find they have cough, breathlessness, tightness of chest or wheezing.
Kada Vi/Vaše dijete započnete primjenjivati Colobreathe, može se dogoditi da se razvije kašalj,
Unscrew the mouthpiece, exposing the chamber of the Turbospin inhaler.
Odvijte nastavak za usta, otkriva se komorica inhalatora Turbospin.
Keep this medicine out of the sight and reach of children.
Kako čuvati Colobreathe Lijek čuvajte izvan pogleda i dohvata djece.
The active substance is colistimethate sodium.
Djelatna tvar je kolistimetatnatrij.
Ear congestion
Kongestija uha
• Nose bleeds, catarrh (mucus in your nose, which may make you feel blocked up),
• krvarenje iz nosa, katar (sluz u nosu, zbog koje osjećate da je začepljen), iskašljavanje guste zelene sluzi, bol u grlu i sinusima
patients
FARMACEUTSKI
High concentrations of total free colistin (mean 23.5mg/L) and total colistimethate (mean 178mg/L) were observed in sputum at 1 hour post-dose on Day 8 following BID dosing for 7 days across all age groups.
Visoke koncentracije ukupnog slobodnog kolistina (prosjek 23,5 mg/l) i ukupnog kolistimetata (prosjek
Colobreathe 1,662,500 IU inhalation powder colistimethate sodium
Colobreathe 1 662 500 IU prašak inhalata kolistimetatnatrij
Discard the Turbospin inhaler after the completion of a treatment pack.
Inhalator Turbospin bacite kada iskoristite sav lijek u pakiranju.
Completed
Zatvarač
Colobreathe 1,662,500 IU inhalation powder, hard capsules colistimethate sodium
Colobreathe 1 662 500 IU prašak inhalata, tvrde kapsule kolistimetatnatrij
If you/your child needs to have other forms of colistimethate either by injection or nebulisation caution should be used but your doctor should be aware of this.
Ako Vi/Vaše dijete trebate primiti druge oblike kolistimetata, bilo u obliku injekcije ili nebulizacijom,
Chest pain, dyspnoea exacerbated, pharyngolaryngeal pain, epistaxis, sputum purulent, abnormal chest sound, increased upper airway secretion
Bol u prsištu, egzacerbacija dispneje, bol u ždrijelu i grkljanu, epistaksa, gnojni sputum,
• if you/your child need to have a general anaesthetic caution must be taken.
• ako Vi/Vaše dijete uzimate kolistimetat u obliku injekcije ili nebulizacijom nužan je oprez; • ako se Vi/Vaše dijete trebate podvrgnuti općoj anesteziji, nužan je oprez.
Check with your doctor if you/your child are not sure.
Ako Vi/Vaše dijete niste sigurni, posavjetujte se sa svojim liječnikom.
• Allergic (hypersensitivity) reactions, the signs may include rash and itching
Manje često: mogu se javiti u manje od 1 na 100 osoba • alergijske reakcije (reakcije preosjetljivost), znakovi mogu uključivati osip i svrbež
Colistimethate sodium is converted to the base in vivo.
Biotransformacija Kolistimetatnatrij se in vivo pretvara u kolistin.
Balance disorder, headache
Poremećaj ravnoteže,
Screw the mouthpiece firmly back into place, put the cap back on and the inhaler is ready to be used for your next dose.
Nastavak za usta čvrsto zavijte natrag na mjesto i vratite zatvarač.
• Shortness of breath
• bol u prsnom košu • nedostatak zraka
Gastrointestinal disorders
Inhalacijski bronhodilatatori
One capsule to be inhaled twice daily.
Odrasli i djeca u dobi od 6 godina ili starija Dvaput dnevno inhalirati po jednu kapsulu.
• Chest pain
• napadaji • pospanost
Vpriv velaglucerase alfa
Vpriv velagluceraza alfa
This summary was last updated in 06-2016.
Ovaj sažetak je posljednji put ažuriran u 06. 2016.
The main measure of effectiveness was the improvement in anaemia, one of the symptoms of the disease, after 41 weeks.
Glavna mjera učinkovitosti bilo je poboljšanje anemije, jednog od simptoma bolesti, nakon 41 tjedna.
The first three infusions are given in hospital, but subsequent infusions may be given at home in patients who tolerate the medicine well.
Prve tri infuzije primjenjuju se u bolnici, ali se naknadne infuzije mogu primijeniti kod kuće u onih bolesnika koji dobro podnose lijek.
The dose can be adjusted according to each patient's symptoms and response to treatment.
Doza se može prilagoditi u skladu sa simptomima i reakcijom na liječenje svakog pacijenta zasebno.
Vpriv increased the amount of haemoglobin (the protein in red blood cells that carries oxygen) by an average of 1.6 grams per decilitre (from 11.4 g/dl) while imiglucerase increased the amount of haemoglobin by an average of 1.5 g/dl (from 10.6 g/dl).
Vpriv je povećao količinu hemoglobina (proteina u crvenim krvnim stanicama koji prenosi kisik) za prosječno 1,6 grama po decilitru (od 11,4 g/dl), dok je imigluceraza povećala količinu hemoglobina za prosječno 1,5 g/dl (od 10,6 g/dl).
What measures are being taken to ensure the safe and effective use of Vpriv?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vpriv?
The European Commission granted a marketing authorisation valid throughout the European Union for Vpriv on 26 August 2010.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vpriv na snazi u Europskoj uniji od 26. kolovoza 2010.
Why has Vpriv been approved?
Zašto je Vpriv odobren?
It is available as a powder that is made up into a solution for infusion (drip) into a vein.
Dostupan je kao prašak koji se koristi za pripremu otopine za infuziju (drip u venu).
The recommended dose of Vpriv is 60 units/kg bodyweight, which is given as a one-hour infusion once every two weeks.
Preporučena doza lijeka Vpriv je 60 jedinica/kg tjelesne težine koja se primjenjuje kao jednosatna infuzija svaka dva tjedna.
Vpriv must not be used in people who have a severe allergic reaction to velaglucerase alfa or any of the other ingredients.
Vpriv se ne smije upotrebljavati u osoba koje imaju teške alergijske reakcije na velaglucerazu alfa ili bilo koji drugi sastojak.
Vpriv was as effective as imiglucerase at reducing anaemia.
Vpriv je bio učinkovit kao i imigluceraza pri smanjenju anemije.
Home infusions should be supervised by a healthcare professional trained in emergency measures.
Infuzije kod kuće trebao bi nadgledati zdravstveni djelatnik uvježban u primjeni hitnih mjera.
Other information about Vpriv
Ostale informacije o lijeku Vpriv
The full EPAR for Vpriv can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Vpriv nalazi se na internetskim stranicama Agencije: EMA website/Find medicine/Human medicines/European Public Assessment Reports.