natgillin/translations-raw huggingface dataset:
There are no other preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
Osim pretkliničkih podataka o sigurnosti već uključenih u druge dijelove Sažetka opisa svojstava lijeka, nema drugih podataka bitnih za propisivača.
INFORMATION IN BRAILLE BUCCOLAM 2.5 mg
BUCCOLAM 2,5 mg
Remove the oral syringe cap before use.
Prije uporabe uklonite zatvarač štrcaljke za usta.
BUCCOLAM 10 mg oromucosal solution midazolam
BUCCOLAM 10 mg otopina za usnu sluznicu midazolam
The frequency of adverse reactions is classified as follows:
Učestalost nuspojava klasificirana je na sljedeći način:
• Each 2.5 mg pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution.
• Svaka napunjena štrcaljka za usta od 2,5 mg sadrži 2,5 mg midazolama (u obliku midazolamklorida) u 0,5 ml otopine.
BUCCOLAM 10 mg oromucosal solution EU/1/11/709/004
BUCCOLAM 10 mg otopina za usnu sluznicu EU/1/11/709/004
• Each 5 mg pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution.
• Svaka napunjena štrcaljka za usta od 5 mg sadrži 5 mg midazolama (u obliku midazolamklorida) u 1 ml otopine.
If you have any doubt about whether any medicine the patient is taking may affect the use of BUCCOLAM, please speak to your doctor or pharmacist.
Ako ste u nedoumici može li bilo koji lijek koji uzima bolesnik utjecati na djelovanje
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 10 mg /2 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Naljepnica na plastičnoj tubi 10 mg/2 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 7.5 mg/1.5 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Plastična štrcaljka za usta 7,5 mg/1,5 ml
Strengths 5 mg, 7.5 mg and 10 mg:
Jačine od 5 mg, 7,5 mg i 10 mg: Lijek se izdaje na recept.
BUCCOLAM 7.5 mg oromucosal solution midazolam
BUCCOLAM 7,5 mg otopina za usnu sluznicu midazolam
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 2.5 mg/0.5 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Plastična štrcaljka za usta 2,5 mg/0,5 ml
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 2.5 mg /0.5 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Naljepnica na plastičnoj tubi 2,5 mg/0,5 ml
even if their signs of illness are the same as those of the child for whom this medicine has been prescribed.
Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki onima u djeteta kojemu je ovaj lijek propisan.
Nausea and vomiting Very rare:
Poremećaji probavnog sustava Često: Mučnina i povraćanje
4 pre-filled oral syringes
Otopina za usnu sluznicu 4 napunjene štrcaljke za usta
BUCCOLAM 7.5 mg oromucosal solution EU/1/11/709/003
BUCCOLAM 7,5 mg otopina za usnu sluznicu EU/1/11/709/003
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 10 mg/2 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Plastična štrcaljka za usta 10 mg/2 ml
BUCCOLAM 5 mg oromucosal solution EU/1/11/709/002
BUCCOLAM 5 mg otopina za usnu sluznicu EU/1/11/709/002
BUCCOLAM 2.5 mg oromucosal solution For children aged 3 months to less than 1 year
BUCCOLAM 2,5 mg otopina za usnu sluznicu 18 mjeseci
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 5 mg /1 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Naljepnica na plastičnoj tubi 5 mg/1 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 5 mg/1 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Plastična štrcaljka za usta 5 mg/1 ml
2 ml
10 mg 2 ml
5 years to < 10 years
5 mg plava od 5 godina do < 10 godina
1.5 ml
5 mg 1 ml
For children aged 5 years to less than 10 years For oromucosal use only
Za djecu u dobi od 1 godine do manje od 5 godina Samo za usnu sluznicu.
BUCCOLAM 2.5 mg oromucosal solution midazolam
BUCCOLAM 2,5 mg otopina za usnu sluznicu midazolam
• St John's Wort (a herbal medicine).
• gospina trava (biljni lijek).
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (2 ml) contains 10 mg midazolam (as hydrochloride)
Svaka napunjena štrcaljka za usta (2 ml) sadrži 10 mg midazolama (u obliku midazolamklorida).
Purple
BUCCOLAM.
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (1 ml) contains 5 mg midazolam (as hydrochloride)
Svaka napunjena štrcaljka za usta (1 ml) sadrži 5 mg midazolama (u obliku midazolamklorida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (1.5 ml) contains 7.5 mg midazolam (as hydrochloride)
Svaka napunjena štrcaljka za usta (1,5 ml) sadrži 7,5 mg midazolama (u obliku midazolamklorida).
0.5 ml
2,5 mg 0,5 ml
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (0.5 ml) contains 2.5 mg midazolam (as hydrochloride)
Svaka napunjena štrcaljka za usta (0,5 ml) sadrži 2,5 mg midazolama (u obliku midazolamklorida).
• If you see any side effects, talk to your doctor or pharmacist.
• Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Each pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution BUCCOLAM 5 mg oromucosal solution
Svaka napunjena štrcaljka za usta sadrži 2,5 mg midazolama (u obliku midazolamklorida) u 0,5 ml otopine.
1 year to < 5 years
3 ml od 1 godine do < 5 godina plava
MARKETING AUTHORISATION NUMBER(S) EU/1/11/709/004
EU/1/11/709/004
Uncommon side effects (may affect up to 1 in 100 people): • Rash, hives (lumpy rash), itchiness
Česte nuspojave (mogu se javiti u do 1 na 10 osoba): • osjećaj mučnine i povraćanje
Biotransformation
Biljni pripravci
MARKETING AUTHORISATION NUMBER(S) EU/1/11/709/003
EU/1/11/709/003
NAME OF THE MEDICINAL PRODUCT BUCCOLAM 5 mg oromucosal solution midazolam
BUCCOLAM 5 mg otopina za usnu sluznicu midazolam
Respiratory insufficiency
Oštećenje jetre
Each pre-filled oral syringe contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution BUCCOLAM 10 mg oromucosal solution
Svaka napunjena štrcaljka za usta sadrži 7,5 mg midazolama (u obliku midazolamklorida) u 1,5 ml otopine.
BUCCOLAM 10 mg oromucosal solution For children aged 10 years to less than 18 years
3 ml od 10 godina do < 18 godina narančasta BUCCOLAM se isporučuje u kutijama koje sadrže 4 napunjene štrcaljke
MARKETING AUTHORISATION NUMBER(S) EU/1/11/709/002
EU/1/11/709/002
Do not attach a needle to the syringe The dose is the full contents of one syringe.
Dozu čini cjelokupni sadržaj jedne štrcaljke.
Marketing Authorisation Holder
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
BUCCOLAM 5 mg oromucosal solution For children aged 1 year to less than 5 years
BUCCOLAM 5 mg otopina za usnu sluznicu
7.5 mg 5 yrs <10 yrs
7,5 mg 5 god <10 god AUC0-inf (ng.h/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION BUCCOLAM 2.5 mg oromucosal solution
BUCCOLAM 2,5 mg otopina za usnu sluznicu
Skin and subcutaneous tissue disorders
Konstipacija**, suha usta** Poremećaji kože i potkožnog tkiva Manje često:
Each pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution BUCCOLAM 7.5 mg oromucosal solution
Svaka napunjena štrcaljka za usta sadrži 5 mg midazolama (u obliku midazolamklorida) u 1 ml otopine.
BUCCOLAM 7.5 mg oromucosal solution For children aged 5 years to less than 10 years
7,5 mg ljubičasta od 10 godina do < 18 godina
• Dizziness
posakonazol
Erythromycin resulted in an increase in the plasma concentrations of intravenous midazolam by about 1.6 to 2 -fold associated with an increase of the terminal half-life of midazolam by 1.5 to 1.8-fold.
Eritromicin je uzrokovao povećanje plazmatskih koncentracija intravenskog midazolama otprilike 1,6
MARKETING AUTHORISATION NUMBER(S) BUCCOLAM 2.5 mg oromucosal solution EU/1/11/709/001
BUCCOLAM 2,5 mg otopina za usnu sluznicu EU/1/11/709/001
MARKETING AUTHORISATION NUMBER(S) EU/1/11/709/001
EU/1/11/709/001
• Constipation
Doziranje
Not known (frequency cannot be estimated from the available data): • dysgeusia (strange taste)
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): • disgeuzija (čudan okus)
Rare (may affect up to 1 in 1,000 users):
Rijetko (mogu se javiti u do 1 na 1000 korisnika):
Frequencies have been evaluated according to the following convention: very common: (1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Učestalost je procijenjena prema sljedećoj konvenciji: vrlo često: (≥1/10), (često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Take special care with Helixate NexGen and talk to your doctor or pharmacist if:
Budite posebno oprezni s lijekom Helixate NexGen te se obratite svom liječniku ili ljekarniku ako:
Common may affect up to 1 in 10 users):
Često (mogu se javiti u do 1 na 10 korisnika):
This medicine is intended for injection into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after preparing the solution.
Ovaj lijek se primjenjuje injekcijom u venu tijekom 2 do 5 minuta, ovisno o ukupnom volumenu i Vašoj razini podnošljivosti te se treba primijeniti u roku od 3 h nakon pripreme otopine.
What Helixate NexGen is and what it is used for What you need to know before you use Helixate NexGen How to use Helixate NexGen Possible side effects
Što je Helixate NexGen i za što se koristi Što morate znati prije nego počnete primjenjivati Helixate NexGen Kako primjenjivati Helixate NexGen Moguće nuspojave
• an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
• dodatno pakovanje koje sadrži sljedeće: - 1 uređaj za prijenos s filtrom 20/20 [Mix2Vial] - 1 set za venepunkciju - 1 jednokratnu 5-mililitarsku štrcaljku - 2 tupfera natopljena alkoholom za jednokratnu primjenu
Make sure that you only pull away the blister package and not the Mix2Vial set.
Pazite da povučete samo blister pakiranje, a ne i komplet uređaja Mix2Vial.
* Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
* Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTPs = prethodno liječeni bolesnici (engl. previously-treated patients), PUPs = prethodno neliječeni bolesnici (engl. previously-untreated patients)
Helixate NexGen should be injected intravenously over 2 to 5 minutes.
Helixate NexGen injicira se intravenski tijekom 2 do 5 minuta.
Data show that Helixate NexGen has been used to induce immune tolerance.
Podaci pokazuju da se Helixate NexGen primjenjivao za izazivanje imunološke tolerancije.
Use in children and adolescents Helixate NexGen can be used in children of all ages.
Primjena u djece i adolescenata Helixate NexGen se može koristiti u djece svih dobi.
If you use more Helixate NexGen than you should No cases of overdose with recombinant coagulation factor VIII have been reported.
Ako primijenite više lijeka Helixate NexGen nego što ste trebali Nije zabilježen niti jedan slučaj predoziranja rekombinantnim koagulacijskim faktorom VIII.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2 °C - 8 °C).
What Helixate NexGen is and what it is used for
Što je Helixate NexGen i za što se koristi
The speed of injection should be based on your comfort, but should not be faster than 2.0 mL per minute.
Brzina injiciranja određuje se prema tome koju brzinu bolesnik može podnijeti, ali ne smije biti veća od 2,0 ml/min.
It is strongly recommended that every time that Helixate NexGen is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Snažno se preporučuje da se pri svakoj primjeni lijeka Helixate NexGen zabilježi naziv i serijski broj lijeka kako bi se održala veza između bolesnika i serije lijeka.
It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen can be used for continuous infusion in surgeries (pre-, during and postoperative).
Kliničko ispitivanje provedenu u odraslih bolesnika s hemofilijom A u kojih se radi veliki kirurški zahvat pokazalo je da se Helixate NexGen može koristiti za kontinuiranu infuziju kod operacije (prije, tijekom i poslije operacije).
If the inhibitor is present at levels less than 10 Bethesda Units (BU) per mL, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with Helixate NexGen.
Ako je prisutna razina inhibitora manja od 10 Bethesda jedinica (BU) po ml, dodatna primjena rekombinantnog koagulacijskog faktora VIII mogla bi neutralizirati inhibitor te omogućiti nastavak klinički učinkovite terapije lijekom Helixate NexGen.
No interactions of Helixate NexGen with other medicinal products have been reported.
Nisu zabilježene interakcije lijeka Helixate NexGen s drugim lijekovima.
The degree and duration of aPTT normalisation observed after administration of Helixate NexGen is similar to that achieved with plasma-derived factor VIII.
Stupanj i vrijeme normalizacije APTV-a zabilježeni nakon primjene lijeka Helixate NexGen slični su vrijednostima postignutima primjenom faktora VIII dobivenog iz plazme.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH 2.5 mL or 5 mL WATER FOR INJECTIONS
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S 2,5 ml ili 5 ml VODE ZA INJEKCIJE
Helixate NexGen contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Helixate NexGen kao pomoćnu tvar sadrži malu količinu polisorbata 80, za koji je poznato da povećava brzinu ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih (PVC) materijala.
The safety and efficacy of Helixate NexGen in children of all ages have been established.
Sigurnost i djelotvornost lijeka Helixate NexGen ustanovljena je u djece svih dobi.
Each vial of Helixate NexGen contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Svaka bočica lijeka Helixate NexGen sadrži nominalnu količinu od 250, 500, 1000, 2000 ili 3000 IU oktokoga alfa.
Other medicines and Helixate NexGen
Drugi lijekovi i Helixate NexGen
If you have used more Helixate NexGen than you should, please inform your doctor.
Ako uzmete više lijeka Helixate NexGen 250 IU nego što ste trebali, obavijestite svojeg liječnika.
What you need to know before you use Helixate NexGen
Što morate znati prije nego počnete primjenjivati Helixate NexGen
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Helixate NexGen.
Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući Helixate NexGen.
Helixate NexGen is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Nije vjerojatno da Helixate NexGen utječe na plodnost bolesnika i bolesnica, s obzirom na to da je djelatna tvar normalno prisutna u organizmu.
• you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a socalled anaphylactic reaction) to this medicine.
• osjetite stezanje u prsima, omaglicu, mučninu ili nesvjesticu ili pak omaglicu prilikom ustajanja jer to mogu biti znakovi rijetke, ali teške i iznenadne alergijske reakcije (takozvane anafilaktičke reakcije) na ovaj lijek.
Detailed instructions for reconstitution and administration of Helixate NexGen using the Mix2Vial adapter:
Detaljne upute za pripremu za primjenu i primjenu lijeka HelixateNexGen uz primjenu adaptera Mix2Vial:
Helixate NexGencontains the active substance human recombinant coagulation factor VIII (octocog alfa).
Helixate NexGen kao djelatnu tvar sadrži ljudski rekombinantni koagulacijski faktor VIII (oktokog alfa).
2 http://www.bloodjournal.org/content/109/11/4648.full.pdf 3 Gouw SC et al. PedNet and RODIN Study Group.
2 http://www.bloodjournal.org/content/109/11/4648.full.pdf
Detailed instructions for preparation and administration are contained in the package leaflet provided with Helixate NexGen.
Detaljne upute za pripremu i primjenu lijeka navedene su u uputi o lijeku koja se isporučuje uz Helixate NexGen.
Helixate NexGen powder should only be reconstituted with the supplied solvent (2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 3000 IU) water for injections) using the supplied sterile Mix2Vial filter transfer device.
Prašak Helixate NexGen smije se pripremati samo otapalom (2,5 ml (za 250 IU, 500 IU i 1000 IU) ili 5 ml (za 2000 IU i 3000 IU) vode za injekcije) priloženim u sterilnom uređaju za prijenos s filtrom Mix2Vial.
What Helixate NexGen looks like and content of the pack
Kako Helixate NexGen izgleda i sadržaj pakiranja
With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew counter clockwise the set carefully into two pieces.
Jednom rukom primite komplet uređaja Mix2Vial za onu stranu na kojoj je lijek, a drugom za stranu na kojoj je otapalo te oprezno odvijte komplet u smjeru suprotnom od kazaljke na satu u dva komada.
If your or your child's bleeding is not being controlled with Helixate NexGen, tell your doctor immediately.
Vašeg djeteta ne može kontrolirati pomoću lijeka Helixate NexGen, odmah se obratite liječniku.
• one vial with solvent (6 mL clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
• jednu bočicu s otapalom (6-mililitarska bočica od prozirnog stakla tipa 1 sa sivim gumenim čepom klorobutila bez lateksa i aluminijskim prstenom)
CSL Behring sp. z o.o.
CSL Behring sp. z o.o. Tel.
• your weight
• tjelesna težina,
PHARMACEUTICAL FORM AND CONTENTS 1 vial with powder for solution for injection.
OBLIK I SADRŽAJ 1 bočica s praškom za otopinu za injekciju.
If you want to stop using Helixate NexGen Do not stop using Helixate NexGen without consulting your doctor.
Nemojte prestati uzimati Helixate NexGen bez savjetovanja s liječnikom.
Helixate NexGen contains sodium
Helixate NexGen sadrži natrij
1 F. Peyvandi et al. “A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A” N Engl J Med. 2016 May 26;374(21):2054-64)
A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A. The New England journal of medicine 2016 May 26;374(21):2054-64
It is recommended that every time that you use Helixate NexGen, the name and batch number of the product are documented.
Dokumentiranje Preporučuje se da se pri svakoj primjeni lijeka Helixate NexGen zabilježe naziv i broj serije lijeka.
This trial, known as the SIPPET study (“Survey of Inhibitors in Plasma-Product Exposed Toddlers”) was conducted to evaluate the relative risk of inhibitors in patients treated with pdFVIII compared to rFVIII.
Ovo ispitivanje, poznato kao SIPPET ispitivanje (Survey of Inhibitors in Plasma-Product Exposed Toddlers - ispitivanje inhibitora u male djece izložene lijekovima proizvedenima iz plazme), provedeno je kako bi se ocijenio relativni rizik od inhibitora u bolesnika liječenih faktorom VIII
What Helixate NexGen contains
Što Helixate NexGen sadrži
Hold a pad firmly over the injection site on your outstretched arm for about 2 minutes.
Otprilike 2 minute na ispruženoj ruci čvrsto držite rupčić na mjestu injiciranja.
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: sažetak opisa svojstava lijeka, dio 4.2).
If you forget to use Helixate NexGen
Ako ste zaboravili primijeniti Helixate NexGen
Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution.
16 Pustite da krv poteče u otvoreni kraj kompleta za venepunkciju te priključite štrcaljku s otopinom.
Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.http://www.bloodjournal.org/content/121/20/4046.full.pdf study, the FranceCoag study also found no statistically significant increased risk for any rFVIII products vs Advate when French patients (also in the RODIN/Pednet study) were excluded.
Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9. - http://www.bloodjournal.org/content/121/20/4046.full.pdf trećom generacijom rekombinantnog faktora VIII oktokog alfa (isključivo prema podatcima za lijek Advate).
Do not use Helixate NexGen
Nemojte primjenjivati Helixate NexGen
Solvent Water for injections
Otapalo Voda za injekcije.
It found that patients treated with rFVIII products had an 87% higher incidence of all inhibitors than those treated with pdFVIII (which contained VWF) (hazard ratio, 1.87; 95% CI, 1.17 to 2.96).
Ispitivanje jepokazalo da je incidencija svih inhibitora bila veća za 87 % u bolesnika liječenih lijekovima s rekombinantnim faktorom VIII u odnosu na one liječene lijekovima s faktorom VIII dobivenim iz plazme (koji su sadržavali VWF) (omjer rizika 1,87; 95 % CI, 1,17 do 2,96).
You are filtering by using the Mix2Vial adapter.
Filtrirajte uz pomoć adaptera Mix2Vial.
Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 mL/h.Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 mL/h corresponding to 3.0 mL/h/kg (range 1.6-4.6 mL/h/kg).
Srednji ishodni klirens 14 odraslih bolesnika podvrgnutih opsežnim kirurškim zahvatima uz kontinuiranu infuziju iznosio je 188 ml/h, što odgovara 3,0 ml/h/kg (raspon od 1,6 do 4,6 ml/h/kg).
However, the study found evidence of an increased risk of inhibitors (all and high titre) for 2nd generation rFVIII octocog alfa (Kogenate FS/Helixate NexGen) compared with 3rd generation rFVIII octocog alfa (which was driven solely by data for Advate).
Međutim, u ispitivanju su utvrđeni dokazi povećanog rizika od inhibitora (svih i visokog titra) kod druge generacije rekombinantnog faktora VIII oktokog alfa (lijekovi Kogenate FS / Helixate NexGen) u usporedbi s
Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counter clockwise.
Kada je otopina prenesena u štrcaljku, čvrsto primite cilindar štrcaljke (s klipom okrenutim prema dolje) te odvojite prozirni adapter uređaja
You may be at risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted.
• Vam treba postaviti centralni venski kateter za primjenu lijeka Helixate NexGen . Možete imati rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterije u krvi (bakterijemija) i stvaranje krvnog ugruška u krvnoj žili (tromboza) u koju je uveden kateter.
METHOD OF ADMINISTRATION Read the package leaflet before use.
NAČIN PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku.
How much Helixate NexGen you should use and how often you should use it depends on many factors such as:
Količina i učestalost uzimanja lijeka Helixate NexGen ovise o brojnim čimbenicima kao što su:
Helixate NexGen 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Helixate NexGen 250 IU sadržava (250 IU / 2,5 ml) = 100 IU oktokoga alfa po ml nakon pripreme za primjenu.