natgillin/translations-raw huggingface dataset:
• Children aged from 2 years weighing 50 kg or more receive 600 mg (3 Alpivab vials).
• Otroci, starejši od dveh let in težji od 50 kg ali več, prejmejo 600 mg (3 viale zdravila Alpivab).
• chest discomfort, fatigue
• neprijeten občutek v prsnem košu, utrujenost
Renal and urinary disorders blood urea increased, blood present in urine, urobilin present in urine, blood creatinine increased, urine ketone body increased acute kidney injury*, renal impairment*
Bolezni ledvic in sečil zvišana sečnina v krvi, prisotnost krvi v urinu, urobilin v urinu, zvišan kreatinin v krvi, zvišana ketonska telesa v krvi akutna poškodba ledvic*, okvara ledvic*
NAME OF THE MEDICINAL PRODUCT Alpivab 200 mg concentrate for solution for infusion
IME ZDRAVILA Alpivab 200 mg koncentrat za raztopino za infundiranje
Peramivir is not significantly metabolised in humans.
Peramivir se pri človeku ne presnavlja v večji meri.
• Add the measured volume of peramivir concentrate into the infusion container.
• V vsebnik za infundiranje dodajte izmerjeni volumen koncentrata peramivira.
Common adverse reactions not reported in adults were injection site rash, pyrexia, tympanic membrane hyperaemia, psychomotor hyperactivity, and pruritus.
Pogosti neželeni učinki, o katerih pri odraslih niso poročali, so bili izpuščaj na mestu injiciranja, zvišana telesna temperatura, hiperemija bobniča, psihomotorična hiperaktivnost in pruritus.
The pharmacokinetics in elderly subjects was similar to non-elderly subjects.
Pri starejših preiskovancih je bila farmakokinetika podobna kot pri preiskovancih, ki niso sodili med starostnike.
Among the 93 subjects enrolled in the peramivir dose group, 43% were infected with influenza A virus (subtypes H1 and H3; 54 % and 46 %, respectively) and 27% with influenza B virus.
Od 93 preiskovancev, vključenih v skupino z odmerkom peramivira, jih je bilo 43 % okuženih z virusom influence A (54 % s podtipom H1 in 46 % s podtipom H3), 27 % pa z virusom influence B. Preiskovanci so bili randomizirani na peramivir ali oseltamivir v razmerju 4 : 1.
Cardiac disorders electrocardiogram QT prolonged
Srčne bolezni podaljšan interval Q-T
Alpivab 200 mg concentrate for solution for infusion peramivir
Alpivab 200 mg koncentrat za raztopino za infundiranje peramivir
If a patient receives 600 mg peramivir the required volume of Alpivab concentrate is 60 mL (3 vials of 20 mL each).
Če bo bolnik prejel 600 mg peramivira, je potreben volumen koncentrata zdravila Alpivab 60 ml (3 viale, vsaka z 20 ml).
The following steps should be followed to prepare a diluted solution of peramivir:
Razredčeno raztopino peramivira je treba pripraviti po naslednjih korakih:
In clinical trials, H275Y was the only resistance-associated treatment-emergent mutation in the neuraminidase gene that occurred in virus obtained from more than one peramivir-treated subject (in 9 of 481[1.9 %] infected with the A/H1N1 influenza virus).
Pojavila se je v virusu, pridobljenem od več kot enega s peramivirom zdravljenega preiskovanca (pri 9 od 481[1,9 %], okuženih z virusom influence A/H1N1).
Add the measured volume of Alpivab concentrate into the infusion container.
V vsebnik za infundiranje dodajte izmerjeni volumen koncentrata zdravila Alpivab.
Mean peak concentrations of peramivir were approximately 10 % higher in elderly subjects following administration of a single dose when compared to young adults (22,647 vs. 20,490 ng/mL, respectively).
Povprečna najvišja plazemska koncentracija peramivira po dajanju enkratnega odmerka je bila pri starejših preiskovancih za približno 10 % viška kot pri mlajših odraslih (22.647 v primerjavi z 20.490 ng/ml).
• abnormal sensation such as prickling, tingling and itchiness
• neobičajni občutki, kot so zbadanje, mravljinčenje in srbenje
The potential for interactions of peramivir with other medicines is low, based on the known elimination pathway of peramivir.
Glede na znano pot izločanja peramivira je potencial za medsebojno delovanje peramivira z drugimi zdravili majhen.
If refrigerated, allow the diluted Alpivab solution to reach room temperature, then administer immediately.
Če ste razredčeno raztopino zdravila Alpivab shranili v hladilniku, počakajte, da se segreje na sobno temperaturo, nato pa jo takoj uporabite.
4.5 mg/mL (0.45 %) solution for infusion, 5 % dextrose or Ringer lactate solution to a volume of
(0,9 %) ali 4,5 mg/ml (0,45 %) za infundiranje, 5-odstotni dekstrozi ali Ringerjevem laktatu do prostornine 100 ml.
Peramivir was not mutagenic or clastogenic in a battery of in-vitro and in-vivo assays.
Peramivir v bateriji analiz in vitro in in vivo poskusov ni bil mutagen ali klastogen.
It is first diluted and then given into a vein by infusion (drip), over 15 to 30 minutes.
Najprej se razredči, nato pa se od 15 do 30 minut z infundiranjem (kapalno infuzijo) daje v veno.
• liver disorder
• motnja delovanja jeter
• urobilin presented in the urine
• urobilin v urinu
Live attenuated influenza vaccines are not recommended to be used until 48 hours following Alpivab administration due to a theoretical risk that peramivir could reduce the immunogenicity of the vaccine.
Živega oslabljenega cepiva proti gripi ne smete prejeti 48 ur po zdravljenju z zdravilom Alpivab, ker lahko zdravilo Alpivab prepreči zadostno učinkovitost teh cepiv.
• inflammation of stomach lining
• vnetje sluznice želodca
1 mL concentrate for solution for infusion contains 10 mg peramivir (anhydrous base).
1 ml koncentrata za raztopino za infundiranje vsebuje 10 mg peramivira (brezvodnega).
Intravenous use after dilution
Intravenska uporaba po redčenju
Clear glass vial (Type I) with a coated bromobutyl-rubber stopper, aluminium overseal and flip-off cap.
Viala iz prozornega stekla (tipa I), zaprta s klorobutilnim gumijastim zamaškom in aluminijasto zapiralno obrobo z zaporko.
• restlessness
• nespečnost
Alpivab is administered via intravenous infusion for 15 to 30 minutes.
Zdravilo Alpivab se daje s 15- do 30-minutno intravensko infuzijo.
Rare
Pogost
In the case of a 300 mg peramivir dose, 30 mL (1½ vials) of Alpivab concentrate is needed and for a 200 mg dose, only 20 mL (1 vial).
Za odmerek 300 mg peramivira je potrebnih 30 ml (1½ viale) koncentrata zdravila Alpivab, za odmerek 200 mg pa le 20 ml (1 viala).
Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
natrijev klorid voda za injekcije natrijev hidroksid (za prilagoditev pH) klorovodikova kislina (za prilagoditev pH)
• blood tests showing decreased levels of albumin, glucose, lactate dehydrogenase
• znižana raven albumina, glukoze ali laktat-dehidrogenaze pri preiskavah krvi
2 years - <7 years
2 leti-< 7 let
Peramivir had no effects on mating or fertility in animal studies (see section 5.3).
Pri študijah na živalih peramivir ni vplival na parjenje ali plodnost (glejte poglavje 5.3).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL
PODATKI NA PRIMARNI OVOJNINI OZNAKA NA VIALI
13 years - <18
13 let-< 18 let
• Once a diluted peramivir solution has been prepared, administer immediately or store in a refrigerator (2 °C to 8 °C) for up to 24 hours.
• Ko je razredčena raztopina peramivira pripravljena, jo dajte takoj; sicer jo za največ 24 ur shranite v hladilniku (pri 2 °C do 8 °C).
Fractions of a vial may be needed for appropriate dose adjustments in children with a bodyweight of less than 50 kg.
Za ustrezno prilagojen odmerek pri otrocih s telesno maso manj kot 50 kg je lahko potreben le del vsebine ene viale.
No clinically relevant alterations to peramivir pharmacokinetics are expected in patients with hepatic impairment based on the route of peramivir elimination.
Glede na pot izločanja peramivira ni pri bolnikih z okvaro jeter pričakovati nobene klinično pomembne spremembe farmakokinetike peramivira.
• Administer the diluted solution via intravenous infusion for 15 to 30 minutes.
• Razredčeno raztopino dajajte z intravensko infuzijo 15 do 30 minut.
Immune system disorders anaphylactic reaction*, anaphylactic shock*
Bolezni imunskega sistema alergijske reakcije*,
Among the 97 subjects enrolled in the peramivir 600 mg dose group, 99 % were infected with influenza A virus (subtypes H1 and H3; 71 % and 26 %, respectively) and 1 % with influenza B virus.
Od 97 preiskovancev, vključenih v skupino z odmerkom 600 mg peramivira, jih je bilo 99 % okuženih z virusom influence A (71 % s podtipom H1 in 26 % s podtipom H3), 1 % pa z virusom influence B. Ob vključitvi je imelo sestavljeno oceno simptomov influence < 15 85 % od 296 preiskovancev.
Gastrointestinal disorders nausea, vomiting abdominal pain upper, abdominal discomfort, gastritis
Bolezni prebavil navzea, bruhanje bolečina v zgornjem delu trebuha, neprijeten občutek v trebuhu, gastritis
It is provided in a clear glass vial with a coated rubber stopper, aluminium overseal and flip-off cap.
Dobavljeno je v prozorni stekleni viali z gumijastim zamaškom in aluminijasto zapiralno obrobo z zaporko.
How Alpivab is given
Kako se daje zdravilo Alpivab
These events were reported primarily among paediatric patients and often had an abrupt onset and rapid resolution.
O teh dogodkih, ki so se nenadoma začeli in hitro končali, so poročali predvsem pri pediatričnih bolnikih.
Administer the diluted solution via intravenous infusion over 15 to 30 minutes.
Razredčeno raztopino dajajte z intravensko infuzijo 15 do 30 minut.
2 years - <18 years
2 leti-< 18 let
Delirium, hallucinations and abnormal behaviour have been reported in patients with influenza who were receiving peramivir.
Pri bolnikih z influenco, ki so prejemali peramivir, so poročali o deliriju, halucinacijah in nenormalnem vedenju.
Hepatobiliary disorders increased gammaglutamyltransferase liver disorder*, alanine aminotransferase increased*, aspartate aminotransferase increased*
Bolezni jeter, žolčnika in žolčevodov zvišana gamaglutamiltransferaza motnja v delovanju jeter*, zvišana alaninaminotransferaza *, zvišana aspartataminotransferaza
Acute renal failure, renal failure, pre-renal failure, renal disorder, anuria, nephritis, and increased blood creatinine have been reported in patients with influenza who were receiving peramivir.
Pri bolnikih z influenco, ki so prejemali peramivir, so poročali o akutni odpovedi ledvic, odpovedi ledvic, prerenalni odpovedi ledvic, motnji delovanja ledvic, anuriji, nefritisu in povečani koncentraciji kreatinina v krvi.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL concentrate contains 10 mg peramivir (anhydrous basis).
NAVEDBA ENE ALI VEČ UČINKOVIN 1 mililiter koncentrata vsebuje 10 mg peramivira (brezvodne baze).
How to store Alpivab
Shranjevanje zdravila Alpivab
Once a diluted Alpivab solution has been prepared, administer immediately or store in a refrigerator (2 °C to 8 °C) for up to 24 hours.
Ko je razredčena raztopina zdravila Alpivab pripravljena, jo dajte takoj; sicer jo za največ 24 ur shranite v hladilniku (pri 2 °C do 8 °C).
Eye disorders vision blurred
Očesne bolezni zamegljen vid
• sleeplessness
• srbenje
What Alpivab contains
Kaj vsebuje zdravilo Alpivab
If refrigerated, allow the diluted peramivir solution to reach room temperature, then administer immediately.
počakajte, da se segreje na sobno temperaturo, nato pa jo takoj uporabite.
Follow the steps below in the provided order to prepare a diluted solution of Alpivab:
Razredčeno raztopino zdravila Alpivab pripravite po naslednjih korakih:
Once diluted, administer the prepared Alpivab solution immediately; otherwise, store in a refrigerator (2 °C - 8 °C) for up to 24 hours.
Raztopino zdravila Alpivab uporabite takoj po redčenju; sicer jo za največ 24 ur shranite v hladilniku (pri 2 °C do 8 °C).
Hepatic impairment
anafilaktični šok*
• upper abdominal pain, abdominal discomfort
• bolečina v zgornjem delu trebuha, neprijeten občutek v trebuhu
Alpivab contains sodium
Zdravilo Alpivab vsebuje natrij
• blood tests showing increased levels of chloride, potassium, sodium, uric acid, protein total,
• zvišana raven klorida, kalija, natrija, sečne kisline, celotnih beljakovin, gama glutamiltransferaze, kreatin-fosfokinaze, sečnine ali kreatinina pri preiskavah krvi
• itching
• nemir
• blood tests showing increased levels of lactate dehydrogenase
• zvišana raven laktat-dehidrogenaze pri preiskavah krvi
• very severe skin reactions, including Steven-Johnson syndrome and dermatitis exfoliative These skin reactions are life-threatening rashes with fever and blisters and can effect the lining of the mouth and genitals.
Te kožne reakcije so življenjsko nevarni izpuščaji z vročino in mehurji ter lahko prizadenejo sluznico ust in spolovila.
PHARMACEUTICAL FORM Concentrate for solution for infusion.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje Bistra, brezbarvna raztopina.
• skin inflammation, eczema, rash, nettle-rash
• vnetje kože, ekcem, izpuščaj, koprivnica
General disorders and administration site conditions chest discomfort, fatigue *These events reported from post-authorization use occurred with different dosage and dosing schedule to that described in the SmPC.
* Ti neželeni učinki, o katerih so poročali pri uporabi po izdaji dovoljenja za promet, so se pojavili pri drugačnem odmerku in shemi odmerjanja, kot sta opisana v povzetku glavnih značilnosti zdravila.
Talk to your doctor or pharmacist before you are given Alpivab if you have reduced kidney function.
Če imate okvaro delovanja ledvic, se pred prejemom zdravila Alpivab posvetujte z zdravnikom ali farmacevtom.
In the case of a 300 mg peramivir dose, 30 mL (1½ vials) of peramivir concentrate is needed and for a 200 mg dose, only 20 mL (1 vial).
Za odmerek 300 mg peramivira je potrebnih 30 ml (1½ viale)
Posology
ODGOVOREN
Excipients
Izdelovalec
Contact your doctor immediately if any of the following side effects occur:
Če opazite katerega od naslednjih neželenih učinkov, se čim prej posvetujte z zdravnikom:
Do not use water.
Ne uporabljajte vode.
3 years.
3 let
You/your child must not take 2 doses within 12 hours.
Vi/vaš otrok ne smete vzeti 2 odmerkov v 12 urah.
• Unpleasant taste
• neprijeten okus.
Some people will get this infection whilst very young but for others it will be much later.
Nekateri se okužijo zelo mladi, pri drugih pa se to zgodi veliko kasneje.
Date of first authorisation: 13/02/2012 Date of latest renewal: 26/09/2016
Datum prve odobritve: 13/02/2012 Datum zadnjega podaljšanja: 26/09/2016
Explain that the device should be discarded after 28 days.
Razlaga, da je treba pripomoček po 28 dneh zavreči.
• If this happens, you may be able to feel these pieces on your tongue or in your airways.
• Če se to zgodi, boste te delce morda občutili na jeziku ali v dihalnih poteh.
Capsules: no special requirements for disposal.
Kapsule: ni posebnih zahtev za odstranjevanje.
Protein binding is low.
Vezava beljakovin je nizka.
Do not drive or use any machines until the symptoms have gone away.
Ne vozite in ne upravljajte s stroji, dokler ti simptomi ne izginejo.
If it is not empty, repeat steps 7, 8 and 9 until you have inhaled all of the contents.
Če ni prazna, ponavljajte korake 7, 8 in 9, dokler ne vdihnete vse vsebine.
Breathe out slowly.
Počasi izdihnite.
• Information on the need to comply with the treatment in order to maximise the potential benefits.
• Podatki o potrebi upoštevanja načina zdravljenja, da se možne koristi kar najbolj povečajo.
• Ringing or buzzing noises in the ear, problems with balance
• zvonjenje ali brenčanje v ušesu, težave z ravnotežjem,
Adjusted Treatment difference
Prilagojena razlika zdravljenja
Consideration should be given to official guidance on the appropriate use of antibacterial active substances.
Upoštevati je treba uradna navodila glede ustrezne uporabe antibakterijskih učinkovin.
Place the mouthpiece between your lips and teeth.
Postavite ustnik med ustnice in zobe.
ATC Code: J01XB01
Oznaka ATC: J01XB01
The results of the Intent-To-Treat (ITT) population for the primary efficacy outcome are shown below:
Rezultati vključenih bolnikov (ITT - Intent-To-Treat) glede glavnega merila učinkovitosti so prikazani spodaj:
However, overdose may possibly result in higher systemic exposure.
Vendar pa lahko preveliko odmerjanje morda povzroči večjo sistemsko izpostavljenost.
There is no specific antidote, therefore management should be done by supportive treatment.
Specifičnega antidota ni, zato je treba uvesti podporno zdravljenje.
Adults and children 6 years of age and older
Odrasli in otroci, stari 6 let in več
The subjects were aged 6 years and above and had an FEV1% predicted of 25-75%.
Osebe so bile stare 6 let in več in so imele napovedano vrednost FEV1 25-75 %.
Patients should be warned not to drive or operate machines if this occurs.
Bolnike je treba opozoriti, da naj v tem primeru ne vozijo in upravljajo s stroji.
Explanation that using inhaled antibiotics can reduce the need for intravenous antibiotics.
Razlaga o tem, da lahko inhalirani antibiotiki zmanjšajo potrebo po intravenskih antibiotikih.
The first dose should be given under medical supervision.
Prvi odmerek se da pod zdravniškim nadzorom.
It should be noted that treatment was not interrupted when patients received concomitant parenteral antibacterial active substances.
Dodati je treba, da zdravljenje ni bilo prekinjeno, ko so bolniki sočasno parenteralno prejeli protibakterijske učinkovine.
The ITT population excluded patients who had been treated but demonstrated no evidence of chronic infection.
Iz populacije ITT so bili izključeni bolniki, ki so bili zdravljeni, vendar niso kazali znakov kronične infekcije.
• Hoarse or weak, or even loss of the voice
• hripav ali šibek glas, ali celo izguba glasu,
• Discussion about common side effects and in particular cough and taste abnormality: Explanation that:
• Razprava o pogostih neželenih učinkih in zlasti o kašlju ter nenavadnem okusu: Razlaga, da:
No in-vivo interaction studies have been performed.
Študij medsebojnega delovanja in vivo niso izvedli.
Then, breathe in slowly and deeply through your mouth at a rate sufficient for you to hear or feel the capsule spinning.
Nato počasi in globoko vdihnite skozi usta dovolj hitro, da boste slišali ali čutili vrtenje kapsule.
2031 GA Haarlem The Netherlands.
2031 GA Haarlem Nizozemska.
Safety and efficacy have been assessed in controlled studies for up to 24 weeks.
Varnost in učinkovitost so ocenili v kontroliranih študijah, ki so trajale do 24 tednov (glejte poglavje
The data from the primary outcome parameter, change in FEV1 % predicted, are not normally distributed.
Podatki parametrov primarnega dogodka, sprememba napovedanih odstotkov FEV1, niso normalno porazdeljeni.
• Do not pierce the capsule more than once.
• Kapsule ne smete prebosti več kot enkrat.
Acute respiratory exacerbation
Akutno respiratorno poslabšanje
• The chances of the capsule breaking into pieces are increased if the capsule is pierced more than once during Step 6.
• Možnost, da se bo kapsula razlomila na koščke, je večja, če jo v 6. koraku prebodete več kot enkrat.
The efficacy of Colobreathe has been demonstrated in a study of 24-weeks duration.
Učinkovitost zdravila Colobreathe je bila dokazana v 24 tednov trajajoči študiji.
If bronchospasm or coughing remain problematic, withdrawal of treatment should be considered.
Če bronhospazem ali kašelj ostajata problematična, je treba premisliti o prenehanju zdravljenja.
− that cough decreases with repeated use of the product and should stabilize after the first month or so.
− se kašelj zmanjšuje s ponavljajočo uporabo zdravila in se bo približno po prvem mesecu stabiliziral.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Znotraj vsake skupine pogostosti so neželeni učinki navedeni po padajoči resnosti.
If this infection is not properly controlled it will cause damage to the lungs.
Okužba, ki ni pravilno nadzorovana, lahko poškoduje pljuča.
• Protein in the urine (found by testing)
• beljakovine v urinu (ugotovijo se s testiranjem),
Treatment may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
Zdravnik lahko z zdravljenjem nadaljuje tako dolgo, dokler meni, da ima bolnik od tega klinične koristi.
The capsules are packed in blister packs supplied in cartons containing:
Kapsule so pakirane v pretisne omote v kartonskih škatlah, ki vsebujejo:
− emphasise that patients should persist with the treatment.
− poudarjajo, da mora bolnik z zdravljenjem nadaljevati,
Oral fungal super-infection
Ustna glivična superinfekcija
Treatment with colistimethate sodium or colistin did not induce the activity of any enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5).
Zdravljenje z natrijevim kolistimetatom ali kolistinom ni spodbudilo aktivnosti nobenega testiranega encima (CYP1A2, 2B6, 2C8, 2C9, 2C19 in 3A4/5).
− these are only of nuisance value for most patients
− predstavljajo za večino bolnikov le neprijetnost,
• There should be a 12 hour gap between doses.
• Med odmerki naj bo 12-urni presledek.
It can also result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest.
Povzroči lahko tudi živčno-mišično blokado, ki lahko vodi v oslabelost mišic, apnejo in možni dihalni zastoj.
• Detailed instructions about how to use the medication: starting from unpacking of the product and finishing with disposal of the used capsule and device.
• Podrobna navodila o uporabi zdravila: kako se odpre ovojnina zdravila in kako ob koncu zavrže porabljene kapsule in pripomoček.
Colobreathe is available in packs containing either 8 or 56 hard capsules.
Zdravilo Colobreathe je na voljo v pakiranjih, ki vsebujejo 8 ali 56 trdih kapsul.
An allergic reaction with Colobreathe is possible (typically serious allergic reactions may cause rashes, swelling of the face, tongue and neck, inability to breathe due to narrowing of the airways and loss of consciousness).
Alergijska reakcija na zdravilo Colobreathe je možna (običajno lahko hude alergijske reakcije povzročijo izpuščaje, oteklost obraza, jezika in vratu ter nezmožnost dihati zaradi zoženja dihalnih poti in izgubo zavesti).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden uporabite to zdravilo.
• Introduction to the product: provide information on the contents of the box ie that 28 days treatment is 56 capsules and 1 device.
• Predstavitev zdravila: podatki o vsebini škatle, tj. da je za 28-dnevno zdravljenje v škatli 56 kapsul in 1 pripomoček.
This may be related to Candida albicans infection or hypersensitivity.
To je lahko povezano z okužbo z organizmom Candida albicans ali preobčutljivostjo.
Efficacy was measured by the change in FEV1 % predicted compared to baseline after a 24-week treatment period.
Učinkovitost je bila merjena glede na spremembo napovedane vrednosti FEV1 v primerjavi z vrednostjo ob izhodišču po 24-tedenskem obdobju zdravljenja.
Tmax for total colistimethate occurred between 0.5 and 1 hour post-dose.
Vrednost Tmax celotnega kolistimetata je nastopila od 0,5 do 1 ure po odmerjanju.
The Marketing Authorisation Holder shall agree the format and content of the healthcare professional and patient educational pack with the National Competent Authority prior to launch in the Member State.
Imetnik dovoljenja za promet z zdravilom se bo o obliki in vsebini paketa izobraževalnega gradiva za zdravstvenega delavca in bolnika dogovoril s pristojnim nacionalnim organom pred začetkom prodaje zdravila v državi članici.
Penn Pharmaceutical Services Ltd. 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA United Kingdom
Penn Pharmaceutical Services Ltd. 23-24 Tafarnaubach Industrial Estate Tredegar, Gwent NP2 3AA Velika Britanija
Frequencies are defined as: 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).
V 24-tedenski klinični študiji so pri vseh starostih skupinah opazili naslednje neželene učinke: Pogostnosti so opredeljene kot: 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).