natgillin/translations-raw huggingface dataset:
You must empty the remaining doses of PecFent from the bottle by aiming the nasal spray away from you (and any other people) and pressing and releasing the grips until the red number “8” appears in the counting window.
• Preostale odmerke zdravila PecFent morate odstraniti iz steklenice, tako da usmerite pršilo za nos proč od sebe (in drugih ljudi) ter pritiskate in spuščate sprožilec, dokler se v okencu s števcem ne prikaže rdeče število “8”.
What PecFent is used for
Za kaj se zdravilo PecFent uporablja
• Drug abuse
• zloraba zdravil.
How to use PecFent
Kako uporabljati zdravilo PecFent
Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Dose readjustment
Popravek odmerka
The concomitant use of PecFent with strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.
CYP3A4 (npr. ritonavir, ketokonazol, itrakonazol, troleandomicin, klaritromicin in nelfinavir) ali zmernimi inhibitorji CYP3A4 (npr. amprenavir, aprepitant, diltiazem, eritromicin, flukonazol,
PecFent should, therefore, be used with caution in patients with previous or pre-existing bradyarrhythmias.
Pri bolnikih s prejšnjo ali obstoječo bradiaritmijo je treba zdravilo PecFent dajati previdno.
• change in taste
• sprememba čuta za okus, • omotičnost,
8 spray bottle:
Steklenica z 8 vpihi:
Also contains: pectin (E440), mannitol (E421), phenylethyl alcohol, propylparahydroxybenzoate (E216), sucrose, purified water and hydrochloric acid (0.36%) or sodium hydroxide for pH adjustment.
Vsebuje tudi: pektin (E440), manitol (E421), feniletilalkohol, propilparahidroksibenzoat (E216),
Pharmacokinetic parameters (mean (%CV))
(povprečje (%VK))
Nasal use Read the package leaflet before use.
nazalna uporaba Pred uporabo preberite priloženo navodilo!
Bottles in their child resistant containers are supplied in cartons containing: For 2 spray bottle: 1 bottle.
Steklenice v vsebnikih z zaporko, varno za otroke, so na voljo v škatlah z: za steklenico z 2 vpihoma: 1 steklenico; za steklenico z 8 vpihi: 1, 4 ali 12 steklenicami.
The bottle should be removed from the child resistant container immediately prior to use and the protective cap removed.
Tik pred uporabo vzemite steklenico iz vsebnika z zaporko, varno za otroke, in snemite zaščitno zaporko.
Method of administration PecFent is for nasal use only.
Zdravilo PecFent je namenjeno samo za nazalno uporabo.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja pruritus hiperhidroza koprivnica
Check that there is a green bar or a number showing in the counting window (Figure 4): this confirms that the PecFent bottle has been primed (see ‘Preparing the PecFent bottle for use' above).
To potrjuje, da je bila steklenica zdravila PecFent ‘aktivirana' (glejte ‘Priprava steklenice zdravila PecFent za uporabo' zgoraj).
One spray administered into each nostril
En vpih v vsako nosnico.
The other ingredients (excipients) are pectin (E440), mannitol (E421), phenylethyl alcohol, propylparahydroxybenzoate (E216), sucrose, purified water and hydrochloric acid or sodium hydroxide for pH adjustment.
Druge sestavine zdravila (pomožne snovi) so pektin (E440), manitol (E421), feniletilalkohol,
One spray administered into one nostril
En vpih v eno nosnico.
• chest infection
• okužba pljuč,
Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl.
Pri uporabi transmukoznega fentanila so opazili simptome odtegnitve opioidov, na primer navzea, bruhanje, driska, anksioznost, mrzlica, tremor in znojenje.
EXP After first-use, use within 60 days.
Porabite v 60 dneh po prvi uporabi.
• memory loss
• izguba spomina, • vznesenost,
• you take antidepressants or antipsychotics, please refer to the section ‘Other medicines and
To bi namreč lahko vplivalo na način, na katerega vaše telo razgrajuje zdravilo; • jemljete antidepresive ali antipsihotike, glejte poglavje 'Druga zdravila in zdravilo PecFent'.
Cardiac disease
Bolezni nosu
• Do not use more than the dose your doctor prescribes for any single breakthrough pain episode.
• Za posamezno epizodo prebijajoče bolečine ne uporabite večjega odmerka od tistega, ki vam ga predpiše zdravnik.
• Do not use PecFent if you are breast-feeding.
• Ne uporabljajte zdravila PecFent, če dojite.
Special populations
pri zdravih osebah
PecFent 100 micrograms/spray nasal spray, solution PecFent 400 micrograms/spray nasal spray, solution
PecFent 100 mikrogramov/vpih pršilo za nos, raztopina PecFent 400 mikrogramov/vpih pršilo za nos, raztopina
• Insomnia
• zapora sapnika,
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih padec namerna zloraba zdravil uporaba napačnega zdravila
• Severe breathing problems
• resne težave z dihanjem, • zardevanje,
Store the PecFent bottle in the child resistant container at all times, even when finished.
Steklenico zdravila PecFent vedno shranjujte v vsebniku z zaporko, varno za otroke, tudi če je prazna.
Hepatic or renal impairment
Okvarjeno delovanje jeter ali ledvic
AUC (pg.hour/ml) 2460.5 (17.9 4359.9 (29.8) 7513.4 (26.7) 17272 (48.9) 3735.0 (32.8) t1/2 (hour) *Data for Tmax presented as median (range).
AUC (pg.uro/ml) t1/2 (ure) *Podatki za Tmax so predstavljeni kot mediana (razpon).
• Patients should be prescribed an initial titration supply of one bottle (2 sprays or 8 sprays) of PecFent 100 micrograms/spray.
Način titracije • Bolnikom predpišemo začetno količino za titracijo, ki je ena steklenica (2 vpiha ali 8 vpihov)
Put the bottle back in the child-resistant container after each use.
Po vsaki uporabi shranite steklenico nazaj v vsebnik z zaporko, varno za otroke.
• PecFent 400 micrograms/spray nasal spray, solution Each ml of solution contains 4,000 micrograms fentanyl (as citrate).
• PecFent 400 mikrogramov/vpih pršilo za nos, raztopina En ml raztopine vsebuje 4.000 mikrogramov fentanila (v obliki citrata).
1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate).
1 vpih(100 mikrolitrov) vsebuje 400 mikrogramovfentanila (v obliki citrata).
Package leaflet: Information for the user PecFent 100 micrograms/spray nasal spray, solution - two-spray bottle
Navodilo za uporabo PecFent 100 mikrogramov/vpih pršilo za nos, raztopina, steklenica z 2 vpihoma fentanil
Do not use more than the dose that your doctor prescribes to treat any single pain episode.
Za zdravljenje nobene bolečinske epizode ne prekoračite odmerka, ki vam ga je predpisal zdravnik.
1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate).
1 vpih (100 mikrolitrov) vsebuje 100 mikrogramov fentanila (v obliki citrata).
• PecFent 100 micrograms/spray nasal spray, solution Each ml of solution contains 1,000 micrograms fentanyl (as citrate).
• PecFent 100 mikrogramov/vpih pršilo za nos, raztopina En ml raztopine vsebuje 1.000 mikrogramov fentanila (v obliki citrata).
Store the bottle in the child resistant container at all times, even when finished.
Steklenico vedno shranjujte v vsebniku z zaporko, varno za otroke, tudi če je že prazna.
The medicine is a clear to almost clear, colourless nasal spray, solution.
Zdravilo je bistra do skoraj bistra, brezbarvna raztopina za pršilo za nos. Na voljo je v steklenici iz prozornega stekla, ki ji je dodana črpalka za odmerjanje.
vomiting, diarrhoea, anxiety, chills, tremor, and sweating)
navzea, bruhanje, driska).
PecFent 100 micrograms/spray nasal spray, solution Each ml of solution contains 1,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate)
PecFent 100 mikrogramov/vpih pršilo za nos, raztopina En ml raztopine vsebuje 1.000 mikrogramov fentanila (v obliki citrata).
PecFent 400 micrograms/spray nasal spray Fentanyl
PecFent 400 mikrogramov/vpih pršilo za nos, raztopina fentanil
Nasal congestion Intranasal hypoaesthesia Throat irritiation Postnasal drip Nasal dryness
Bolezni živčevja disgevzija omotica somnolenca glavobol nezavest motnje zavesti konvulzije agevzija anozmija motnje spomina parozmija motnje govora sedacija letargija tremor
PARTICULARS TO APPEAR ON THE CHILD RESISTANT CONTAINER (CRC)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA VSEBNIKU Z ZAPORKO, VARNO ZA OTROKE
PecFent 100 micrograms/spray nasal spray Fentanyl
PecFent 100 mikrogramov/vpih pršilo za nos, raztopina fentanil
Intentional drug misuse Medication error
Shranjevanje zdravila PecFent
PecFent 400 micrograms/spray nasal spray, solution Each ml of solution contains 4,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate)
PecFent 400 mikrogramov/vpih pršilo za nos, raztopina En ml raztopine vsebuje 4.000 mikrogramov fentanila (v obliki citrata).
Your doctor will decide if your PecFent dose needs to be changed.
ali bo treba spremeniti odmerek zdravila PecFent.
Concomitant use of nasally administered oxymetazoline has been shown to decrease the absorption of PecFent (see section 5.2).
Dokazali so, da sočasna uporaba nazalno uporabljenega oksimetazolina zmanjša absorpcijo zdravila
Each spray contains 400 micrograms of fentanyl (as citrate)
En vpih vsebuje 400 mikrogramov fentanila (v obliki citrata).
The metabolic pathways following nasal administration of PecFent have not been characterised in clinical studies.
V kliničnih študijah niso podrobno opisali presnovnih poti po nazalni uporabi zdravila PecFent.
STATEMENT OF ACTIVE SUBSTANCE(S)
čas od odmerjanja (minute)
It is recommended that you prime the bottle immediately before use rather than in advance (Note: This 2 spray bottle cannot be re-primed.
To se imenuje aktiviranje.Priporočamo vam, da steklenico aktivirate tik pred uporabo namesto vnaprej.
The pump has a spray counter that clicks, so you can hear as well as see that the spray has been given.
Črpalka ima števec vpihov, ki slišno klika,
Each spray contains 100 micrograms of fentanyl (as citrate)
En vpih vsebuje 100 mikrogramov fentanila (v obliki citrata).
• Withdrawal syndrome (may manifest by the occurrence of the following side effects nausea,
• nespečnost, • odtegnitveni sindrom (lahko se pokaže s pojavom naslednjih neželenih učinkov: siljenje na bruhanje, bruhanje, driska, tesnobnost, mrzlica, tresavica in znojenje),
B. PecFent 200 µg dose
A. PecFent 100 µg dose B. PecFent 200 µg dose C. PecFent 400 µg dose D. PecFent 800 µg dose E. OTFC 200 µg dose fentanil v plazmi (pg/ml)
Pregnancy, breast-feeding and fertility
Motnje v času nosečnosti, puerperija in perinatalnem obdobju krvavitev iz nožnice
Platelet count decreased Weight increased
Preiskave znižana koncentracija trombocitov zvečana telesna masa
Patients should wait at least 4 hours after a dose before treating another BTP episode with PecFent.
preden vzamejo nov odmerek zdravila PecFent za zdravljenje naslednje epizode BTP.
Proteinuria Urinary hesitation
Bolezni sečil anurija dizurija proteinurija zamaknjen začetek mikcije
• chest pain
• kratka sapa,
The pump has a spray counter that clicks, so you can hear as well as see that the spray has been given and a protective cap. After the PecFent bottle has been primed (prepared for use) it delivers 8 full sprays.
Potem ko je bila steklenica z zdravilom PecFent ‘aktivirana' (pripravljena za uporabo), odda 8 polnih vpihov.
You can do this by holding them in your hands until they feel as warm as your hands.
To lahko storite tako, da jih držite v rokah, dokler nista tako topla kot vaše roke.
This will be checked by your doctor.
To bo preveril vaš zdravnik.
This is particularly important if you are having major surgery.
To je še posebej pomembno, če boste imeli večjo operacijo.
Of these patients, 34 (85%) were treated twice weekly or less.
Od teh bolnikov jih je bilo 34 (85%) zdravljenih dvakrat tedensko ali manj.
Severe symptoms require prompt emergency treatment.
Hudi simptomi zahtevajo takojšnje urgentno zdravljenje.
This is of importance particularly when changing the laboratory and/or reagents used in the assay.
To je zlasti pomembno pri menjavi laboratorija in/ali reagentov, ki se uporabljajo v testu.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 February 2017
Datum prve odobritve: 13. februar 2017
The result was positive only at dilution factor 1 and the antibody titre was very low.
Rezultat je bil pozitiven samo pri faktorju razredčitve 1 in titer protiteles je bil zelo nizek.
Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels.
Zdravnik bo opravil ustrezne laboratorijske preiskave, da se prepriča, da imate ustrezno raven faktorja VIII.
The regimen may be adjusted based on patient response.
Režim je možno prilagoditi glede na bolnikov odziv.
Frequency of doses (hours)/ Duration of therapy (days)
Pogostnost odmerkov (ure)/trajanje terapije (dnevi)
Taken out of refrigerator: _____________
Zdravilo je bilo vzeto iz hladilnika: _____________
Adult and adolescent population 12 - 65 years of age
Odrasli in mladostniki, stari 12 - 65 let
If you use more than one vial of powder for one treatment, you may use the same injection needle again.
Če boste za zdravljenje uporabili več kot eno vialo s praškom, lahko isto injekcijsko iglo uporabite še enkrat.
It is recommended that not more than 4 ml per minute be administered.
Priporoča se, da se ne uporabi več kot 4 ml zdravila na minuto.
The sample was tested by the central laboratory at eight dilutions.
Vzorec je bil testiran v osrednjem laboratoriju v osmih razredčitvah.
This temperature should be maintained during reconstitution.
Takšno temperaturo je treba ohranjati tudi med rekonstitucijo.
Inject the solution into the vein at a slow speed, not faster than 4 ml per minute.
Raztopino injicirajte v veno počasi, ne hitreje kot 4 ml na minuto.
Allow the alcohol to dry.
Počakajte, da se alkohol posuši.
There are no fertility data available.
Podatki o vplivu na plodnost niso na voljo.
You should be aware of the early signs of allergic reactions.
Treba se je zavedati zgodnjih znakov alergijskih reakcij.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Če ste noseči, dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Wait until all the powder dissolves completely.
Počakajte, da se ves prašek popolnoma raztopi.
If severe, sudden allergic reactions (anaphylactic) occur (very rare, up to 1 in 10,000), the injection must be stopped immediately.
Če se pojavijo hude, nenadne alergijske (anafilaktične) reakcije (zelo redko, največ 1 na 10.000), morate injiciranje zdravila takoj ustaviti.
In case of shock, standard medical treatment for shock should be implemented.
V primeru šoka je treba izvajati standardne ukrepe za zdravljenje šoka.
You should be aware of the early signs of allergic reactions as they are listed in section 4 “Allergic reactions”.
Zavedati se morate zgodnjih znakov alergijskih reakcij, kot so navedeni v poglavju 4 - "Alergijske reakcije".
These symptoms can be early symptoms of an anaphylactic shock.
Ti simptomi so lahko zgodnji simptomi anafilaktičnega šoka.
• if you are allergic to the active substance simoctocog alfa or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na učinkovino simoktokog alfa ali katerokoli sestavino tega zdravila (navedene v poglavju 6).
The solution is now prepared for immediate use.
Raztopina je pripravljena za takojšnjo uporabo.
Proceed with the next dose immediately and continue as advised by your doctor or pharmacist.
Takoj nadaljujte z naslednjim odmerkom in nadaljujte, kot vam je svetoval zdravnik ali farmacevt.
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
Pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za kakršne koli informacije o zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Every 24 hours, at least 1 day, until healing is achieved.
Na vsakih 24 h, najmanj 1 dan, dokler se ne začne celjenje.
Data have been obtained in 29 previously treated children between 2 and 5 years of age, 31 children between 6 and 12 years of age and one adolescent of 14 years.
Podatki so bili pridobljeni pri 29 predhodno zdravljenih otrocih, starih od 2 do 5 let, 31 otrocih, starih od 6 do 12 let, in enem mladostniku, starem 14 let.
None of the patients developed inhibitors.
Nobeden izmed bolnikov ni razvil zaviralcev.
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Kot pri vsakem intravenskem beljakovinskem zdravilu so možne alergijske preobčutljivostne reakcije.
How often you need an injection will depend on how well Vihuma is working for you.
Kako pogosto potrebujete injekcijo, je odvisno od tega, kako dobro zdravilo Vihuma deluje v vašem primeru.
No animal or human derived materials are added during the manufacturing process or to the final medicinal product.
Med proizvodnim procesom ali v končno zdravilo se ne dodaja nikakršnih beljakovin humanega ali živalskega izvora.
Your doctor will calculate your dose of Vihuma (in international units = IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Zdravnik bo izračunal velikost odmerka zdravila Vihuma (v mednarodnih enotah = i.e.) glede na vaše stanje in telesno maso ter v skladu s tem, ali se uporablja za preprečevanje ali zdravljenje krvavitev.
Hold the plunger rod at the end and do not touch the shaft.
Držite ročaj bata na koncu in se ne dotikajte cevi.
33 (82.5%) patients did not experience any bleeds and 36 (90.0%) patients had no spontaneous bleeds.
Pri 33 (82,5%) bolnikih pa ni prišlo do nobenih krvavitev, pri 36 (90,0%) bolnikih ni prišlo do spontanih krvavitev.
Vihuma can be used for all age groups.
Zdravilo Vihuma se lahko uporablja za vse starostne skupine.
Repeat every 12 to 24 hours.
Infuzije ponavljajte na vsakih 12 do 24
The way Vihuma is used in children does not differ from the way it is used in adults.
Način uporabe zdravila Vihuma pri otrocih se ne razlikuje od načina uporabe pri odraslih.
For storage at room temperature and storage conditions after reconstitution of the medicinal product, see section 6.3.
Za shranjevanje pri sobni temperaturi in pogoje shranjevanja po pripravi zdravila glejte poglavje 6.3.
What you need to know before you use Vihuma 3.
Kaj morate vedeti, preden boste uporabili zdravilo Vihuma 3.
Do not use the product in case you notice visible signs of deterioration of the tamper proof of packaging especially of the syringe and/or the vial.
Ne uporabljajte tega zdravila, če opazite vidne znake poškodbe varnostnega zapirala pakiranja, še posebej tistega na brizgi in/ali viali.
Paediatric population Frequency, type and severity of adverse reactions in children are assumed to be the same as in adults.
Domneva se, da so pogostnost, vrsta in resnost neželenih učinkov pri otrocih enaki kot pri odraslih.
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenim delavcem: Zdravljenje po potrebi
Do not remove the gray stopper or metal ring around the top of the vial.
Ne odstranjujte sivega zamaška ali kovinskega obročka okrog vrha viale.
As known from the literature, recovery and half-life was lower in young children than in adults and clearance higher, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Kot je znano iz literature, sta povečanje aktivnosti in razpolovna doba pri majhnih otrocih nižja kot pri odraslih, očistek pa je višji, kar je lahko delno posledica znanega večjega volumna plazme na kilogram telesne mase pri mlajših bolnikih.
For intravenous use after reconstitution.
Za intravensko uporabo po rekonstituciji.
You might need a higher dose of Vihuma or a different product to control bleedings.
Morda boste potrebovali večji odmerek zdravila Vihuma ali drugo zdravilo za nadzor krvavitev.
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Aktivirani faktor VIII deluje kot kofaktor za aktivirani faktor IX in pospešuje pretvorbo faktorja X v aktivirani faktor X. Aktivirani faktor X pretvarja protrombin v trombin.
The reconstituted medicinal product is a clear, colourless solution, free from foreign particles and has a pH of 6.5 to 7.5.
Rekonstituirano zdravilo je bistra, brezbarvna raztopina brez trdnih delcev in s pH-vrednostjo med 6,5 in 7,5.
Pharmacotherapeutic group: Antihaemorrhagics: blood coagulation factor VIII, ATC code: B02BD02.
Farmakoterapevtska skupina: Antihemoragiki: koagulacijski faktor VIII, oznaka ATC: B02BD02.
Do not increase the total dose of Vihuma to control your bleeding without consulting your doctor.
Ne povečujte skupnega odmerka zdravila Vihuma za nadzor vaše krvavitve, ne da bi se posvetovali z zdravnikom.
Repeat infusion every 8 to 24 hours until threat is resolved.
Infuzijo ponavljajte na vsakih 8 do 24 h, dokler ogroženost ne mine.
All (n=20)
Vsi (n=20)
Minor surgery including tooth extraction
Kirurški poseg Manjši kirurški poseg vključno z ekstrakcijo zoba
No blood must flow into the syringe due to the risk of formation of fibrin clots.
V brizgo ne sme priteči kri zaradi tveganja za nastanek fibrinskih strdkov.
Inhibitory activity, as measured by the modified Bethesda assay, was not detected in this patient.
Inhibitorna aktivnost, merjena z modificiranim preizkusom Bethesda, pri tem bolniku ni bila odkrita.
Make sure that the entire content of the vial is transferred to the syringe.
Prepričajte se, da se je celotna vsebina viale prenesla v brizgo.
Do not store Vihuma in the refrigerator again after it has been stored at room temperature.
Zdravila Vihuma ne hranite znova v hladilniku, potem ko je že bilo shranjeno pri sobni temperaturi.
There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Vihuma.
Obstaja majhna verjetnost, da pride do anafilaktične reakcije (huda, nenadna alergijska reakcija) na zdravilo Vihuma.
Vihuma is for intravenous use.
Zdravilo Vihuma je namenjeno intravenski uporabi.
Do not use any other way to heat the vial and pre-filled syringe.
Ne uporabljajte nobenega drugega načina za segrevanje viale in napolnjene injekcijske brizge.
Factor VIII is necessary for the blood to form clots and stop bleeding.
Faktor VIII je potreben, da se v krvi tvorijo strdki in ustavijo krvavitev.
These data were corroborated by a long-term follow-up of 49 of these children who were treated for an additional median period of approximately 30 months (range from 9.5 to 52 months); during this period 45% of children had no spontaneous bleeds
izmed teh otrok, ki so jih nadalje zdravili v obdobju z mediano približno 30 mesecev (razpon od 9,5 do 52 mesecev); v tem obdobju 45% otrok ni imelo spontanih krvavitev.
In general, minor bleeds required slightly lower, and more severe bleeds required up to three-fold higher median doses.
Manjše krvavitve so zahtevale nekoliko manjšo, hujše krvavitve pa do trikrat večjo mediano odmerkov.
If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Če se pojavijo simptomi preobčutljivosti, je treba bolnikom svetovati, naj takoj nehajo uporabljati zdravilo in se posvetujejo z zdravnikom.