natgillin/translations-raw huggingface dataset:
Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a physician with experience in endoscopic laser procedures.
Fotodinamično zdravljenje s PhotoBarrom mora opraviti zdravnik, ki ima izkušnje z endoskopskimi laserskimi postopki oz. se lahko opravi le pod nadzorom takega zdravnika.
Frequency not known side effects lung infection lower number of red cells in your blood cataract lesion in intestine, abnormal opening between the wind pipe and the food pipe allergic reaction blood clots in your vessels, blockage of blood arteries, inflammation of a vein
- okužba pljuč - manjše število rdečih krvnih celic v vaši krvi - očesna mrena - razjeda na črevesju, nenormalna odprtina med sapnikom in požiralnikom - alergijska reakcija - krvni strdki v žilah, blokada arterij, vnetje vene
- Hypersensitivity to the active substance, other porphyrins or to any of the excipients.
- Preobčutljivost za zdravilno učinkovino, druge porfirine ali katero koli pomožno snov.
− There are a number of potential side effects that patients should be aware of.
− Bolniki morajo biti seznanjenimi z možnimi neželenimi učinki.
affects less than 1 user in 10,000
prizadene manj kot 1 od 10.000 bolnikov
Short fibre optic diffusers to be used without a centering balloon to deliver 50 J/cm of diffuser length at a light intensity of 400 mW/cm
Difuzorji z majhno dolžino optičnih vlaken, ki se uporabljajo brez centrirnega balona za oddajanje 50 J/cm dolžine difuzorja pri jakosti svetlobe 400 mW/cm
PhotoBarr PDT plus omeprazole (PDT + OM) treatment was compared to a group treated with omeprazole alone (OM only), in the BO with HGD controlled clinical trial.
Zdravljenje bolnikov s PhotoBarrom PDT in omeprazolom (PDT + OM) so primerjali s skupino bolnikov, zdravljenih samo z omeprazolom (samo OM) pri BP s HGD v nadzorovanem kliničnem preskušanju.
The laser light application will induce difficulties with swallowing (pain, nausea and vomiting).
Uporaba zdravila PhotoBarr skupaj s hrano in pijačo Uporaba laserske svetlobe povzroči težave pri požiranju (bolečino, slabost in bruhanje).
For this treatment, the fibre optic diffuser is used without a balloon, and a light intensity of 400 mW/cm should be used.
Za to zdravljenje se uporablja difuzor z optičnimi vlakni brez balona ter moč svetlobe 400 mW/cm.
Increased symptoms and damage to normal tissue might be expected following an overdose of light.
Po prevelikem odmerku svetlobe se lahko pričakuje povečano število simptomov in poškodba zdravega tkiva.
Preclinical studies indicate that the excretion of porfimer sodium components occurs primarily via the faecal route.
Predklinične študije kažejo, da se sestavine porfimer-natrija izločajo predvsem z blatom.
Laser Light Application
Uporaba laserske svetlobe
After reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Po pripravi vsebuje vsak ml raztopine 2,5 mg porfimer-natrija.
General disorders and administration site conditions Very common: Pyrexia
Splošne težave in spremembe na mestu aplikacije Zelo pogoste: Vročica (pireksija) Pogoste:
affects more than 1 user in 10
prizadene več kot 1 od 10 bolnikov
Also, whenever possible, the BO segment selected for the first light applications should include normal tissue margin of a few millimetre at the proximal and distal ends.
Kadar je možno, naj izbrani segment BP za prve uporabe (laserske) svetlobe zajema tudi običajni, nekaj milimetrski rob tkiva na proksimalnih in distalnih koncih.
In a controlled clinical trial, a PhotoBarr PDT + OM (omeprazole) patient group (n=183)was compared to a group of patients receiving OM only (n=70).
V nadzorovanem kliničnem preskušanju so primerjali skupino bolnikov, zdravljenih s PhotoBarrom PDT + OM (omeprazol), s skupino bolnikov (n=183), ki so dobivali samo OM (n=70).
• Healthcare professionals administration and monitoring guide
• Navodila za zdravstveno osebje za odmerjanje zdravila in spremljanje zdravljenja
Summary of adverse reactions with porfimer sodium Infections and infestations
Povzetek neželenih učinkov s pofrimer-natrijem Infekcijske in parazitske bolezni Občasne:
Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory
Dušenje, oteženo dihanje po naporu, hemoptiza, hipoksija, nazalna kongestija, aspiracijska pljučnica, produktivni kašelj, respiratorna depresija, kongestija
In clinical trials, PhotoBarr PDT has only been tested in patients being treatment naive concerning mucosal ablative therapy.
V kliničnih preskušanjih PhotoBarra je bila PDT preizkušena le pri bolnikih, ki še niso bili zdravljeni z ablativnim zdravljenjem sluznice.
After reconstitution, protect from light and use within 3 hours.
Po pripravi zaščitite zdravilo pred svetlobo in uporabite v 3 urah.
What PhotoBarr contains The active substance is porfimer sodium.
Kaj vsebuje zdravilo PhotoBarr - Zdravilna učinkovina je porfimer-natrij.
Non Cardiac Chest Pain
Nekardiogena prsna bolečina
Uptake of photosensitiser
Absorpcija v fotosenzibilizatorju
Treatment of "skip" areas only aDiscrete nodules will receive an initial light application of 50 J/cm (using short diffuser) before the balloon light application.
Samo zdravljenje »izpuščenih« področij a Pri posameznih vozličih uporabimo začetni odmerek svetlobe 50 J/cm (pri difuzorju s kratkimi vlakni) pred uporabo svetlobe iz balona.
Angina pectoris, atrial fibrillation, atrial flutter, chest discomfort Vascular disorders
Angina pektoris, atrijska fibrilacija, atrijska undulacija, pritisk v prsih
Pulmonary or cardiac disorders
Bolezni pljuč in srca
Follow-up procedure
Spremljanje postopka
- Tracheo-oesophageal or broncho-oesophageal fistula.
- Fistule sapnika in požiralnika ali fistule bronhijev in požiralnika.
As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Kot je bilo izmerjeno s potopitvijo difuzorja v kiveto v merilniku jakosti in ob postopnem povečevanju moči laserja.
The reddish-brown solution is slowly injected, over 3 to 5 minutes, into a vein.
Rdečkastorjavo raztopino počasi injicirajo v veno na vaši roki 3 do 5 minut.
Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Fotodinamično zdravljenje (PDT, photodynamic therapy) s PhotoBarrom je indicirano v primeru odprave displazije visoke stopnje (HGD, high-grade dysplasia) pri bolnikih z Barrettovim požiralnikom (BP).
Common:
Pogoste:
Healthcare professionals administration and monitoring guide
Navodila za zdravstveno osebje za odmerjanje zdravila in spremljanje zdravljenja
Side effects may occur with certain frequencies, which are defined as follows: Very common:
Razvrstitev pogostosti neželenih učinkov: Zelo pogosto:
aAs measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Izmerjeno s potopitvijo difuzorja v kiveto v merilniku jakosti in ob postopnem povečevanju moči laserja.
Very common: Photosensitivity reaction Common:
Bolezni kože in podkožja Zelo pogoste: Fotosenzitivna reakcija Pogoste:
In patients, the mean peak plasma concentration (Cmax) was 79.6 μg/ml (CV 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
61%, razpon 39-222), pri prostovoljcih pa je bil Cmax 40 μg/ml in AUCinf 2400 μg/h/ml.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 75 mg porfimer sodium.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 75 mg porfimer-natrija.
The influence of hepatic impairment on exposure to porfimer sodium has not been evaluated (see section 4.3 and 4.4).
Vpliv jetrne okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavji 4.3 in 4.4).
Do not use PhotoBarr if you are allergic (hypersensitive) to porfimer sodium, other porphyrins or any of the other ingredients of PhotoBarr (listed in section 6, ‘What PhotoBarr contains') if you have porphyria if you have an opening (fistula) between the oesophagus and the airways if you suffer from varices of your oesophageal veins or erosion of other major blood vessels if you have ulcers in your oesophagus if you have severe liver or kidney problems
PhotoBarra (naštetih v poglavju 6, »Kaj vsebuje zdravilo PhotoBarr«), - če imate porfirijo, - če imate odprtino (fistulo) med požiralnikom in dihalnimi potmi, - če imate varice v venah požiralnika ali razjedo (erozijo) drugih velikih krvnih žil, - če imate razjede v požiralniku, - če imate hudo motnjo v delovanju jeter ali ledvic.
One single-use vial per pack.
Viala za enkratno uporabo.
Hydrochloric acid, sodium hydroxide (for pH adjustment).
Klorovodikova kislina, natrijev hidroksid (za uravnavanje pH-vrednosti).
By the end of the minimum follow-up of two years, 13% in the PhotoBarr PDT + OM group had progressed to cancer compared to 28% in the OM only group in the intent-to-treat (ITT) population.
Do konca najmanj dveletnega obdobja kontrolnih pregledov se je rak razvil pri 13% bolnikov v skupini, zdravljeni s PhotoBarrom PDT + OM, medtem ko je bilo v skupini, zdravljeni samo z OM, v populaciji bolnikov, ki so čakali na zdravljenje (ITT), 28% takih primerov.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 mg porfimer sodium.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 15 mg porfimer-natrija.
After reconstitution, PhotoBarr is a dark red to reddish brown, opaque solution.
Po pripravi je PhotoBarr temno rdeča do rdečkastorjava motna raztopina.
Congenital and familial and genetic disorders Uncommon:
Vrojene, dedne in genetske okvare Občasne:
Light doses
Odmerki svetlobe
Photodynamic therapy (PDT) with PhotoBarr is indicated for: - ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Fotodinamično zdravljenje (PDT, photodynamic therapy) s PhotoBarrom je indicirano v primeru odprave displazije visoke stopnje (HGD, 'high-grade dysplasia) pri bolnikih z Barrettovim požiralnikom (BP).
Ocular sensitivity
Občutljivost oči
However, because of its potential to induce photosensitivity, PhotoBarr might be an eye and/or skin irritant in the presence of bright light.
PhotoBarr lahko draži oči in/ali kožo na močni svetlobi, ker lahko povzroči fotosenzitivnost.
Accidental exposure
Nenamerna izpostavljenost zdravilu
Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Občutek vročine, rdečina na mestu injiciranja, letargija, slabost, periferni edem, bolečina, edem vdolbinice, neprenašanje toplote, oslabelost
Joint contracture, joint range of motion decreased, musculoskeletal chest pain,
Kontraktura sklepa, zmanjšani obseg gibljivosti sklepa, mišično-kostna bolečina v prsih, plantarni fascitis
The other ingredients are hydrochloric acid and/or sodium hydroxide (for pH adjustment).
- Ostale učinkovine so klorovodikova kislina in/ali natrijev hidroksid (za uravnavanje pHvrednosti).
Each vial contains 15 mg of porfimer sodium.
Ena viala vsebuje 15 mg porfimer-natrija.
affects 1 to 10 users in 100
prizadene 1 do 10od 100 bolnikov
Cardiac disorders Common:
Srčne bolezni Pogoste:
Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, The Netherlands
Imetnik dovoljenja za promet z zdravilom Axcan Pharma International B.V., Engelenkampstraat 72, NL-6131JJ Sittard, Nizozemska
Each vial contains 75 mg of porfimer sodium.
Ena viala vsebuje 75 mg porfimer-natrija.
NAME OF THE MEDICINAL PRODUCT PhotoBarr 15 mg powder for solution for injection
IME ZDRAVILA PhotoBarr 15 mg prašek za raztopino za injiciranje
Pruritus, rash, skin fragility, skin discolouration, skin ulcer, dermatitis exfoliative, dry skin, milia, rash maculo-papular, rash papular, scar, skin hyperpigmentation, skin lesion, skin nodule, urticaria
Pruritus, kožni izpuščaj, krhkost kože, obarvanje kože, razjeda na koži, eksfoliativni dermatitis, suha koža, kožni izpuščaj, makulo-papulozni izpuščaj, papulozni izpuščaj, brazgotina, hiperpigmentacija kože, razjeda na koži, živčni vozlički na koži, urtikarija.
Photosensitivity
Preobčutljivost
One or 2 laser light treatments were administered following PhotoBarr injection.
Po injiciranju PhotoBarra je sledilo eno do 2 zdravljenji z lasersko svetlobo.
affects 1 to 10 users in 1,000
prizadene 1 do 10od 1.000 bolnikov
Prescriber guide and Prescriber slide kit − The educational tools are designed to aid physicians in optimising the benefit-risk
− Izobraževalna orodja so namenjena zdravnikom za optimiziranje razmerja koristi in
Oesophageal Stenosis
Stenoza požiralnika
NAME OF THE MEDICINAL PRODUCT PhotoBarr 75 mg powder for solution for injection.
IME ZDRAVILA PhotoBarr 75 mg prašek za raztopino za injiciranje.
HOW TO STORE PHOTOBARR
SHRANJEVANJE ZDRAVILA PHOTOBARR
Hydrochloric acid (for pH-adjustment)
Klorovodikova kislina (za uravnavanje pH-vrednosti) Natrijev hidroksid (za uravnavanje pH-vrednosti)
Hypersensitivity to the active substance, other porphyrins or to any of the excipients.
4.3 Kontraindikacije - Preobčutljivost za zdravilno učinkovino, druge porfirine ali katero koli pomožno snov.
The other ingredients are hydrochloric acid and sodium hydroxide (for pH adjustment).
- Ostale učinkovine so klorovodikova kislina in natrijev hidroksid (za uravnavanje pH-vrednosti).
cover as much skin as possible by wearing a long-sleeved shirt, trousers, socks, shoes, gloves and a wide brimmed hat protect your eyes with dark sunglasses.
Če greste podnevi na prosto (tudi v oblačnem vremenu in med vožnjo z avtomobilom), se zaščitite, kot sledi: zakrijte si čim večji del kože tako, da nosite srajco z dolgimi rokavi, hlače, nogavice, čevlje, rokavice in širokokrajni klobuk, oči si zavarujte s temnimi sončnimi očali, ne pozabite vzeti k zdravniku zaščitnih oblačil in sončnih očal, ker boste po aplikaciji injekcije postali občutljivi na svetlobo.
− Caution should be exercised if patients have moderate hepatic disease
− Pri bolnikih z zmerno okvaro jeter je potrebna previdnost.
Instructions for reconstitution
Navodilo za pripravo zdravila
affects 1 to 10 users in 10,000
prizadene 1 do 10od 10.000 bolnikov
− Before initiating therapy, o The patient should be screened for skin type o Patients should be aware of the long half-life of porfimer and that the compound gets activated by light.
− Pred začetkom zdravljenja: o Potrebno je preveriti bolnikov tip kože.
78550 Houdan
Axcan Pharma SAS Route de Bû 78550 Houdan Francija
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION PhotoBarr 75 mg powder for solution for injection Porfimer sodium
IME ZDRAVILA IN POT UPORABE PhotoBarr 75 mg prašek za raztopino za injiciranje Porfimer-natrij
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 15 mg porfimer sodium.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 15 mg porfimer-natrija.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Ime in naslov izdelovalca, odgovornega za sproščanje serije
Renal impairment The influence of renal impairment on exposure to porfimer sodium has not been evaluated (see section
Okvara ledvic Vpliv ledvične okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavje 4.3).
The light dose administered will be 130 Joules/cm (J/cm) of diffuser length using a centring balloon.
Cilj je osvetliti in zdraviti vsa področja HGD ter celotno dolžino BP. Uporabljeni odmerek svetlobe je 130 joulov/cm (J/cm) dolžine difuzorja z uporabo balona za centriranje.
Nervous system disorders Common:
Bolezni živčevja Pogoste:
b Tabulated summary of adverse events
b. Povzetek neželenih učinkov, prikazan v preglednici
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 75 mg - 40 ml
Viala 75 mg - 40 ml
Loose stools, oesophagitis ulcerative, abdominal discomfort, abdominal distension, abdominal pain lower, acquired pylori stenosis, chapped lips, colitis, flatulence, gastritis, gastrointestinal haemorrhage, halitosis, oesophageal haemorrhage, oesophageal perforation.
Mehko blato, ulcerativni ezofagitis, bolečine v trebuhu, abdominalno napenjanje, bolečine s spodnjem delu trebuha, pridobljena pilorična stenoza, razpokane ustnice, kolitis, napenjanje v črevesju, gastritis, gastro-intestinalna krvavitev, halitoza, krvavitev v požiralniku, perforacija požiralnika.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 15 mg - 7 ml
Viala 15 mg - 7 ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION PhotoBarr 15 mg powder for solution for injection Porfimer sodium
IME ZDRAVILA IN POT UPORABE PhotoBarr 15 mg prašek za raztopino za injiciranje Porfimer-natrij
Orlyplein 10, 1043 DP Amsterdam The Netherlands
NL-6131JJ Sittard Nizozemska
Cold sweat, dermatitis, hair growth abnormal, increased tendency to bruise, keloid scar, night sweats, photosensitive rash, rash macular, rash scaly, scab, scar pain, vitiligo.
Mrzel pot, dermatitis, neobičajna poraščenost, večje nagnjenje k podplutbam, keloidna brazgotina, nočno potenje, izpuščaj, ki nastane kot posledica izpostavljenosti svetlobi, makularni izpuščaj, luskasti izpuščaj, krastavost, boleča brazgotina, vitiligo.
Porfimer sodium2.
Shranjevanje zdravila PhotoBarr 6.
Common side effects back pain, pain in arms and legs, pain due to treatment headache, feeling nervous, tingling feeling, problems sleeping abdominal stiffness, stomach pain, vomiting blood disorders of the gullet such as ulcer, irritation or constriction loose stools, passing dark tarry stool, sore throat, hiccups, belching fluid in chest, chest pain, fast heart beat, shortness of breath, shakes due to high fever, chills loss of weight, decrease in appetite, feeling tired, loss of taste skin ulcer, rash, itchiness, hives, change in skin colour, scratch, scar, abnormal tissue, bump on the skin, very small cysts in the skin, dry and fragile skin
- trd trebuh, bolečine v trebuhu, krvavo bruhanje, - motnje v požiralniku, kot so razjede ali občutek zožanja in draženje, - mehko blato, začasna temna katranasta stolica (blato), vnetje grla, kolcanje, spahovanje.
Balloon window length (cm)
Dolžina odprtine za balon (cm)
− Patients should inform their doctor before they start treatment if they have severe o Remains in your body for 60-90 days after receiving the injection o There is an increased risk of photosensitivity (sensitivity to light) o Exposed skin will become red and cause discomfort in most cases but severe o Commercially available sun blocks are not effective in preventing sensitivity due to light
− Bolniki morajo zdravnika pred pričetkom zdravljenja obvestiti o morebitni hudi o se v telesu zadržuje 60-90 dni po prejemu injekcije.
BEFORE YOU USE PHOTOBARR
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PHOTOBARR
Study day Light delivery devices Treatment intent
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
POSTOPEK IN POT UPORABE ZDRAVILA Za intravensko uporabo.
PACKAGE LEAFLET: INFORMATION FOR THE USER PhotoBarr 15 mg powder for solution for injection Porfimer sodium
NAVODILO ZA UPORABO PhotoBarr 15 mg prašek za raztopino za injiciranje Porfimer-natrij
Balloon Window Size (cm)
Velikost odprtine za balon (cm)
Uncommon side effects difficulty breathing, decrease in level of oxygen, choking, swelling of the airways, fluid in airways, shortness of breath during physical activity, wheezing, coughing up more phlegm, coughing up blood, stuffy nose lung infection, sinus infection chest pain or heart attack, high blood pressure or low blood pressure, chest discomfort abnormal blood test results, including increase in white blood cells, low potassium levels bleeding, loss of blood, increased tendency to bruise over development of breasts in men, inability to urinate, temperature intolerance, cold sweats, night sweats general swelling, general pain, musculoskeletal chest pain, stiffness of joint, inflammation of the heel shakes, restlessness, dizziness, numbness, flushes, feeling weak, feeling unwell loss of hearing, ringing in the ears, swelling of the eye, eye pain rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin, overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal hair growth
- oteženo dihanje, izkašljevanje krvi, znižanje ravni kisika, dušenje, zatekanje dihalnih poti, tekočina v dihalnih poteh, kratka sapa med naporom, sopenje, izkašljevanje več sluzi, izkašljevanje krvi, zamašen nos. - vnetje pljuč, vnetje sinusov.
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 75 mg porfimer sodium
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 75 mg porfimer-natrija.
− Area in card for physician to record skin type and date of injection.
− V bolnikovi izkaznici je predviden prostor, v katerega zdravnik vnese tip kože in
Keep the vial in the outer carton in order to protect from light After reconstitution, protect from light and use immediately within 3 hours.
Po pripravi je treba raztopino PhotoBarra zaščititi pred svetlobo in uporabiti v 3 urah.
Hiccups, odynophagia, diarrhoea, dyspepsia, oesophageal ulcer, abdominal pain upper*, abdominal pain, haematemesis, oesophageal pain, eructation, melaena (haematocheznia), oesophageal disorder, regurgitation of food, abdominal rigidity, oesophageal spasm, oesophagitis.
Kolcanje, odinofagija, diareja, dispepsija, razjeda požiralnika, bolečine v zgornjem delu trebuha*, bolečine v trebuhu, hematemeza, bolečina v požiralniku, kolcanje, melena, bolezen požiralnika, bljuvanje hrane, trd trebuh, krč požiralnika, vnetje požiralnika (ezofagitis).
PACKAGE LEAFLET: INFORMATION FOR THE USER PhotoBarr 75 mg powder for solution for injection Porfimer sodium
PhotoBarr 75 mg prašek za raztopino za injiciranje Porfimer-natrij
Ear and labyrinth disorders Uncommon:
Ušesne bolezni, vključno z motnjami labirinta Občasne:
Embolism, Deep vein thrombosis, Phlebitis Respiratory, thoracic and mediastinal disorders Common:
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogoste:
Reproductive system and breast disorders Uncommon:
Motnje reprodukcije in dojk Občasne:
EXPIRY DATE
Zahtevana izhodna
In patients,the mean peak plasma concentration (Cmax) was 79.6 μg/ml (C.V. 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
Pri bolnikih je bila največja /koncentracija v plazmi (Cmax) takoj po injiciranju 79,6 μg/ml (C.V.
Do not use after the expiry date stated on the carton and vial after the EXP. Do not store above 25°C.
Zravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in viali za oznako EXP.
The European Commission granted a marketing authorisation valid throughout the European Union for ProteqFlu on 6 March 2003.
Evropska komisija je dovoljenje za promet z zdravilom ProteqFlu, veljavno po vsej Evropski uniji, izdala 6. marca 2003.
Equine influenza is a highly contagious disease that is very common in horses but rarely causes death.
Konjska influenca je zelo nalezljiva bolezen, ki je zelo pogosta pri konjih, vendar redko povzroči pogin.
The effectiveness of ProteqFlu was first assessed in several laboratory and field studies.
Učinkovitost cepiva ProteqFlu so najprej ocenili v več laboratorijskih in terenskih študijah.
The duration of protection was 5 months after primary vaccination and one year after the third vaccination.
Trajanje zaščite je bilo 5 mesecev po primarnem cepljenju in eno leto po tretjem cepljenju.
The immunogenicity of the current formulation of the vaccine was confirmed in 15 foals.
Imunogenost trenutne formulacije cepiva je bila potrjena pri 15 žrebetih.
In case of increased risk of infection or insufficient intake of colostrum (first milk), an additional initial injection can be given at the age of 4 months, followed by the full vaccination programme (primary vaccination and following revaccinations).
V primeru povečanega tveganja okužbe ali nezadostnega zaužitja kolostruma (prvega mleka), se lahko injicira dodatni začetni odmerek pri starosti 4 mesecev, ki mu sledi popoln program cepljenja (primarno cepljenje, ki mu sledijo ponovitve).
Horses should receive a primary vaccination, consisting of two injections at 5-6 months of age, given 4-6 weeks apart.
Konji potrebujejo primarno cepljenje, ki vključuje dve injiciranji pri starosti 5-6 mesecev in se ju izvede 4-6 tednov narazen.