natgillin/translations-raw huggingface dataset:
PhotoBarr 15 mg powder for solution for injection Porfimer sodium
PhotoBarr 15 mg prašek za raztopino za injiciranje Porfimer- natrij
One vial contains 15 mg porfimer sodium.
Ena viala vsebuje 15 mg porfimer- natrija.
Hydrochloric acid, sodium hydroxide (for pH adjustment).
Klorovodikova kislina, natrijev hidroksid (za uravnavanje pH- vrednosti).
Intravenous use Read the package leaflet before use.
Pred uporabo natančno preberite navodilo.
Engelenkampstraat 72 6131JJ Sittard The Netherlands
Engelenkampstraat 72
35 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
35/ 52 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PhotoBarr 15 mg powder for solution for injection Porfimer sodium Intravenous use
PhotoBarr 15 mg prašek za raztopino za injiciranje Porfimer- natrij Za intravensko uporabo
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
36/ 52 PODATKI NA ZUNANJI OVOJNINI
PhotoBarr 75 mg powder for solution for injection Porfimer sodium
PhotoBarr 75 mg prašek za raztopino za injiciranje Porfimer- natrij
One vial contains 75 mg porfimer sodium After reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Po pripravi vsebuje vsak ml raztopine 2, 5 mg porfimer- natrija.
Powder for solution for injection.1 vial
1 viala
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 zaščitite zdravilo pred svetlobo in uporabite v 3 urah.
Axcan Pharma International B.V.
37/ 52 Axcan Pharma International B. V.
37 Engelenkampstraat 72 6131JJ Sittard The Netherlands
Engelenkampstraat 72 NL- 6131JJ Sittard Nizozemska
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
38/ 52 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PhotoBarr 75 mg powder for solution for injection Porfimer sodium Intravenous use
PhotoBarr 75 mg prašek za raztopino za injiciranje Porfimer- natrij Za intravensko uporabo
39 B.
39/ 52 B.
INFORMATION FOR THE USER
40/ 52 NAVODILO ZA UPORABO
Possible side effects 5 How to store PhotoBarr 6.
Shranjevanje zdravila PhotoBarr 6.
PhotoBarr is a light -activated medicine used in photodynamic therapy (PDT) in combination with a non-burning red laser light.
PhotoBarr je zdravilo, ki ga aktivira svetloba, in se uporablja za fotodinamično zdravljenje (PDT) (photodynamic therapy) v kombinaciji z rdečo nevročo lasersko svetlobo.
PhotoBarr is used to remove high -grade dysplasia (cells with atypical changes that increase the risk of developing cancer) in patients with Barrett's oesophagus (gullet).
PhotoBarr se uporablja za odpravo displazije (celice z netipičnimi spremembami, ki povečujejo tveganje za razvoj raka) visoke stopnje pri bolnikih z Barrettovim požiralnikom.
Do not use PhotoBarr
Ne uporabljajte PhotoBarra
- if you are allergic (hypersensitive) to porfimer sodium, other porphyrins or any of the other
- če ste alergični (preobčutljivi) na porfimer- natrij ali druge porfirine ali katero koli drugo sestavino
ingredients of PhotoBarr (listed in section 6, ‘What PhotoBarr contains’)
PhotoBarra (naštetih v poglavju 6, » Kaj vsebuje zdravilo PhotoBarr «),
- if you have porphyria
- če imate porfirijo,
- if you have an opening (fistula) between the oesophagus and the airways
- če imate odprtino (fistulo) med požiralnikom in dihalnimi potmi,
- if you suffer from varices of your oesophageal veins or erosion of other major blood vessels
- če imate varice v venah požiralnika ali razjedo (erozijo) drugih velikih krvnih žil,
- if you have ulcers in your oesophagus
- če imate razjede v požiralniku,
- if you have severe liver or kidney problems
- če imate hudo motnjo v delovanju jeter ali ledvic.
Take special care with PhotoBarr Tell your doctor if any of the following applies to you:
Bodite posebno pozorni pri uporabi zdravila PhotoBarr Obvestite svojega zdravnika, če se pojavi kar koli od naštetega:
- you are taking any other medicines (see below),
- kadar jemljete druga zdravila (glejte spodaj),
- you have a liver or kidney problems
- če imate težave z jetri ali ledvicami,
- you have a family history of cataracts
- če imate očesno mreno v družinski anamnezi,
- you are 75 years or older,
- če ste stari 75 let ali več,
- you have or have had heart or lung disease
- če imate ali ste imeli resno bolezen srca ali pljuč.
41 Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
41/ 52 Obvestite svojega zdravnika ali farmacevta, če uporabljate ali ste pred kratkim uporabljali katero koli zdravilo, tudi če ste ga dobili brez recepta.
Using PhotoBarr with food and drink 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).
Pregnancy and breast-feeding PhotoBarr should not be used during pregnancy unless clearly necessary.
Nosečnost in dojenje PhotoBarra ne smete uporabljati med nosečnostjo, razen v nujnih primerih.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Raziskave o vplivu zdravila na sposobnost vožnje in upravljanje s stroji niso bile izvedene.
PhotoBarr injection:
Injiciranje zdravila PhotoBarr:
You will receive one intravenous injection of PhotoBarr (2 mg per kg of body weight), 40 to 50 hours before laser light treatment.
Prejeli boste eno intravensko injekcijo PhotoBarra (2 mg na kg telesne mase) 40 do 50 ur pred zdravljenjem z lasersko svetlobo.
Laser light treatment:
Zdravljenje z lasersko svetlobo:
Your doctor will apply the red laser light (not a burning laser) to the involved area using an endoscope (a device used to see inside certain parts of the body).
Zdravnik vam bo z endoskopom (pripravo, ki se uporablja za vpogled v določene dele telesa) apliciral rdečo lasersko svetlobo (ne vročega laserja) na zadevno mesto.
You may receive a second laser light treatment 96-120 hours after the initial injection of PhotoBarr.
Prejmete lahko tudi drugo zdravljenje z lasersko svetlobo 96- 120 ur po začetnem vbrizganem odmerku PhotoBarra.
If you miss the laser light treatment Both the medicine and laser light are necessary for the therapy to work.
Če ste izpustili zdravljenje z lasersko svetlobo Za uspešnost zdravljenja sta potrebna tako zdravilo kot laserska svetloba.
How to prevent a photosensitivity reaction Photosensitivity reactions are very common side effects of PhotoBarr (affecting more than 2 users in 3).
Fotosenzitivne reakcije so zelo pogost neželeni učinek PhotoBarra (prizadenejo več kot 2 bolnika od 3).
They consist mainly of sunburn -like reactions, mild redness on exposed skin, usually the face and hands.
Predstavljajo jih predvsem reakcije, podobne sončnim opeklinam, blaga rdečina na izpostavljeni koži, navadno na obrazu in rokah.
42 Before you go to receive your PhotoBarr injection, check that there are adequate shades and curtains in your home to keep out bright sunlight.
42/ 52 Preden greste po injekcijo PhotoBarra, se prepričajte, da so v vašem domu nameščeni ustrezni senčniki in zavese, ki vas ščitijo pred močno sončno svetlobo.
- cover as much skin as possible by wearing a long-sleeved shirt, trousers, socks, shoes, gloves
- zakrijte si čim večji del kože tako, da nosite srajco z dolgimi rokavi, hlače, nogavice, čevlje,
and a wide brimmed hat
rokavice in širokokrajni klobuk,
- protect your eyes with dark sunglasses.
- oči si zavarujte s temnimi sončnimi očali,
- remember to take protective clothing and sunglasses with you to your appointment, as you will
- ne pozabite vzeti k zdravniku zaščitnih oblačil in sončnih očal, ker boste po aplikaciji injekcije
be photosensitive once the injection has been given.
postali občutljivi na svetlobo.
Photosensitivity skin test About 90 days after the PhotoBarr injection, you should test the photosensitivity of your skin as follows:
Kožni preskus preobčutljivosti na svetlobo Po približno 90- tih dneh po injekciji PhotoBarra je treba preskusiti občutljivost kože na svetlobo, kot sledi:
- if none of these appear on the exposed area, then you can gradually return to your normal
- Če se ti znaki ne pojavijo, lahko postopno začnete opravljati običajne dejavnosti na prostem in
outdoor activities, limiting exposure to the sun during the midday hours.
zmanjšate izpostavljenost soncu v opoldanskih urah.
- if any of these signs are seen, then continue to protect yourself from bright light for 2 more
- Če opazite katere od teh znakov, se še naprej zaščitite pred močno svetlobo v naslednjih 2
weeks, then repeat the skin test.
tednih, zatem pa kožni preskus ponovite.
All patients who receive PhotoBarr will be photosensitive (sensitive to light) and must observe precautions to avoid direct sunlight and bright indoor light (see above ‘How to prevent a photosensitivity reaction’).
Vsi bolniki, ki dobivajo PhotoBarr, so fotosenzitivni (občutljivi na svetlobo) in morajo upoštevati posebna opozorila, da se izognejo neposredni sončni svetlobi in močni notranji svetlobi (glejte zgoraj » Kako preprečimo fotosenzitivne reakcije «).
Tell your doctor immediately:
Nemudoma obvestite svojega zdravnika:
- if you notice a change in your eyesight.
- če opazite spremembe vida.
- if you are not able to swallow at all or repeated vomiting occurs
- če sploh ne morete požirati ali če se bruhanje ponavlja.
Side effects may occur with certain frequencies, which are defined as follows:
Razvrstitev pogostosti neželenih učinkov:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data.
prizadene več kot 1 od 10 bolnikov prizadene 1 do 10 od 100 bolnikov prizadene 1 do 10 od 1. 000 bolnikov prizadene 1 do 10 od 10. 000 bolnikov prizadene manj kot 1 od 10. 000 bolnikov pogostosti na podlagi obstoječih podatkov ni možno oceniti
- fever
43/ 52
- photosensitivity reactions (see section 3)
- fotosenzitivni odzivi (glejte poglavje 3),
- vomiting, nausea
- bruhanje, slabost,
- tightening of the gullet (oesophagus), difficulty in swallowing that may cause pain
- zoženje požiralnika, težave pri požiranju, ki je lahko boleče,
- constipation, dehydration
- zaprtje, dehidracija.
- back pain, pain in arms and legs, pain due to treatment
- bolečine v hrbtu, bolečine v okončinah, bolečina, ki je posledica zdravljenja.
- headache, feeling nervous, tingling feeling, problems sleeping
- glavoboli, nervoza, občutek mravljincev, nespečnost.
- abdominal stiffness, stomach pain, vomiting blood
- trd trebuh, bolečine v trebuhu, krvavo bruhanje,
- disorders of the gullet such as ulcer, irritation or constriction
- motnje v požiralniku, kot so razjede ali občutek zožanja in draženje,
- loose stools, passing dark tarry stool, sore throat, hiccups, belching
- mehko blato, začasna temna katranasta stolica (blato), vnetje grla, kolcanje, spahovanje.
- fluid in chest, chest pain, fast heart beat, shortness of breath, shakes due to high fever, chills
- tekočina v prsih, bolečina v prsih, pospešeno bitje srca, kratka sapa, tresavica zaradi visoke
- loss of weight, decrease in appetite, feeling tired, loss of taste
- izguba teže, zmanjšanje apetita, občutek utrujenosti, izguba okusa.
- skin ulcer, rash, itchiness, hives, change in skin colour, scratch, scar, abnormal tissue, bump on
- razjeda na koži, kožni izpuščaj, srbečica, koprivnica, sprememba barve kože, majhne kožne
the skin, very small cysts in the skin, dry and fragile skin
ranice, brazgotina, nenormalno tkivo, kožne bule, zelo majhne kožne ciste, suha in krhka koža.
- difficulty breathing, decrease in level of oxygen, choking, swelling of the airways, fluid in
- oteženo dihanje, izkašljevanje krvi, znižanje ravni kisika, dušenje, zatekanje dihalnih poti,
airways, shortness of breath during physical activity, wheezing, coughing up more phlegm, coughing up blood, stuffy nose
tekočina v dihalnih poteh, kratka sapa med naporom, sopenje, izkašljevanje več sluzi, izkašljevanje krvi, zamašen nos.
- lung infection, sinus infection
- vnetje pljuč, vnetje sinusov.
- chest pain or heart attack, high blood pressure or low blood pressure, chest discomfort
- bolečina v prsih ali srčna kap, visok ali nizek krvni tlak, nelagodje v prsnem košu.
- abnormal blood test results, including increase in white blood cells, low potassium levels
- nenavadni rezultati krvnih preiskav, vključno povečano število belih krvničk, nizke ravni kalija,
- bleeding, loss of blood, increased tendency to bruise
- krvavenje, izguba krvi, večje nagnjenje k podpludbam.
- overdevelopment of breasts in men, inability to urinate, temperature intolerance, cold sweats,
- povečanje prsi pri moških, nezmožnost uriniranja, preobčutljivost za temperaturo, hladen pot,
night sweats
nočno potenje.
- general swelling, general pain, musculoskeletal chest pain, stiffness of joint, inflammation of the
- splošna zatečenost, splošne bolečine, mišično- skeletne bolečine v prsnem košu, otrdelost
heel
sklepov, vnetje pete.
- shakes, restlessness, dizziness, numbness, flushes, feeling weak, feeling unwell
- tresavica, nemir, občutek omotičnosti, otopelost, oblivanje vročine, občutek slabosti, občutek
- loss of hearing, ringing in the ears, swelling of the eye, eye pain
strahu.
- rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin,
- izguba sluha, zvonjenje v ušesih, otekanje oči, bolečina v očeh.
overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal hair growth
- izpuščaj, rdečina na mestu injiciranja, glivične okužbe nohtov, infekcije kože, žulji, srbeča koža,
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
keloidna brazgotina, boleča brazgotina, krastavost, pojav kožnih znamenj, neobičajna poraščenost.
44 What PhotoBarr contains
44/ 52 Kaj vsebuje zdravilo PhotoBarr
- The active substance is porfimer sodium.
- Zdravilna učinkovina je porfimer- natrij.
Each vial contains 15 mg of porfimer sodium.
Ena viala vsebuje 15 mg porfimer- natrija.
After
Po pripravi
reconstitution, each ml solution contains 2.5 mg porfimer sodium.
vsebuje vsak ml raztopine 2, 5 mg/ ml porfimer- natrija.
- The other ingredients are hydrochloric acid and sodium hydroxide (for pH adjustment).
- Ostale učinkovine so klorovodikova kislina in natrijev hidroksid (za uravnavanje pH- vrednosti).
Marketing Authorisation Holder Axcan Pharma International B.V., Engelenkampstraat 72, NL -6131JJ Sittard, The Netherlands
Axcan Pharma International B. V., Engelenkampstraat 72, NL- 6131JJ Sittard, Nizozemska
Manufacturer Axcan Pharma S.A., Route de Bû, 78550 Houdan, France
Axcan Pharma S. A., Route de Bû, 78550 Houdan, Francija
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
INFORMATION FOR THE USER
45/ 52 NAVODILO ZA UPORABO
PhotoBarr is a light -activated medicine used photodynamic therapy (PDT)in combination with a non-burning, red laser light.
PhotoBarr je zdravilo, ki ga aktivira svetloba, in se uporablja za fotodinamično zdravljenje (PDT) (photodynamic therapy) v kombinaciji z rdečo nevročo lasersko svetlobo.
Do not use PhotoBarr
Ne uporabljajte PhotoBarra:
- if you are allergic (hypersensitive) to porfimer sodium other porphyrins or to any other
- če ste alergični (preobčutljivi) na porfimer- natrij ali druge porfirine ali katero koli drugo sestavino
ingredients of PhotoBarr (listed in section 6 “What PhotoBarr contains”)
PhotoBarra (naštete v poglavju 6, » Kaj vsebuje zdravilo PhotoBarr «), o če imate porfirijo,
- if you have severe liver of kidney problems
- če imate hudo motnjo v delovanju jeter ali ledvic.
Take special care with PhotoBarr Tell your doctor if any of the following applies to you:
Obvestite svojega zdravnika, če se pojavi kar koli od naštetega:
- you have liver or kidney problems
- če imate težave z jetri ali ledvicami,
- you have a family history of cataracts,
- če imate očesno mreno v družinski anamnezi,
- have or have had heart or lung disease
Pri otrocih in mladostnikih, mlajših od 18 let, se zdravilo PhotoBarr zaradi pomanjkanja izkušenj ne priporoča.
46 Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
46/ 52 Obvestite svojega zdravnika ali farmacevta, če uporabljate ali ste pred kratkim uporabljali katero koli zdravilo, tudi če ste ga dobili brez recepta.
No studies on the effects on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Raziskave o vplivu zdravila na sposobnost vožnje in upravljanje s stroji niso bile izvedene.
You will receive one intravenous injection of PhotoBarr (2 mg per kg of body weight) 40 to 50 hours before laser light treatment.
Prejeli boste eno intravensko injekcijo PhotoBarra (2 mg na kg telesne mase) 40 do 50 ur pred zdravljenjem z lasersko svetlobo.
Your doctor will apply the red laser light(not a burning laser) to the involved area using an endoscope (a device used to see inside certain parts of the body)..
Zdravnik vam bo z endoskopom (pripravo, ki se uporablja za vpogled v določene dele telesa) apliciral rdečo lasersko svetlobo (ne vročega laserja) na zadevno mesto.
47 Before you go to receive your PhotoBarr injection, check that there are adequate shades and curtains in your home to keep out bright sunlight.
47/ 52 Preden greste po injekcijo PhotoBarra, se prepričajte, da so v vašem domu nameščeni ustrezni senčniki in zavese, ki vas ščitijo pred močno sončno svetlobo.
and a wide brimmed hat
rokavice in širokokrajni klobuk.
- protect your eyes with dark sunglasses.
- oči si zavarujte s temnimi sončnimi očali.
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data.
prizadene več kot 1 od 10 bolnikov prizadene 1 do 10od 100 bolnikov prizadene 1 do 10od 1. 000 bolnikov prizadene 1 do 10od 10. 000 bolnikov prizadene manj kot 1 od 10. 000 bolnikov pogostosti na podlagi obstoječih podatkov ni možno oceniti
- fever
48/ 52
- over development of breasts in men, inability to urinate, temperature intolerance, cold sweats,
- povečanje prsi pri moških, nezmožnost uriniranja, preobčutljivost za temperaturo, hladen pot,
- loss of hearing, ringing in the ears, swelling of the eye, eye pain
- izguba sluha, zvonjenje v ušesih, otekanje oči, bolečina v očeh.
- rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin,
- izpuščaj, rdečina na mestu injiciranja, glivične okužbe nohtov, infekcije kože, žulji, srbeča koža,
overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal hair growth
keloidna brazgotina, boleča brazgotina, krastavost, pojav kožnih znamenj, neobičajna poraščenost.
Chemical and physical in -use stability has been demonstrated for 3 hours at 23°C.
Kemično in fizikalno stabilnost med uporabo so dokazovali 3 ure pri 23°C.
From a microbiological point of view, the product should be used immediately.
49/ 52 takoj uporabiti.
49 What PhotoBarr contains
Kaj vsebuje zdravilo PhotoBarr
Each vial contains 75 mg of porfimer sodium.
Ena viala vsebuje 75 mg porfimer- natrija.
- reconstitution, each ml solution contains 2.5 mg porfimer sodium.
vsebuje vsak ml raztopine 2, 5 mg/ ml porfimer- natrija.
The other ingredients are hydrochloric acid and/or sodium hydroxide (for pH adjustment).
- Ostale učinkovine so klorovodikova kislina in/ ali natrijev hidroksid (za uravnavanje pH -
What PhotoBarr looks like and contents of the pack
Izgled zdravila PhotoBarr in vsebina pakiranja
PhotoBarr is a reddish brown powder for solution for injection.
PhotoBarr je rdečkastorjav prašek za raztopino za injiciranje.
Axcan Pharma International B.V., Engelenkampstraat 72, NL-6131JJ Sittard, The Netherlands
Axcan Pharma International B. V., Engelenkampstraat 72, NL- 6131JJ Sittard, Nizozemska
Axcan Pharma S.A., Route de Bû, 78550 Houdan, France
Axcan Pharma S. A., Route de Bû, 78550 Houdan, Francija
50 ANNEX IV
50/ 52 DODATEK IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
RAZLOGI ZA DODATNO OBNOVITEV DOVOLJENJA ZA PROMET
51 GROUNDS FOR ONE ADDITIONAL RENEWAL
51/ 52 RAZLOGI ZA DODATNO OBNOVITEV DOVOLJENJA ZA PROMET
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of PhotoBarr remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Na podlagi podatkov, ki so bili zbrani po prvi pridobitvi dovoljenja za promet, Odbor za zdravila za uporabo v humani medicini (CHMP) ugotavlja, da se ohranja pozitivno razmerje koristi in tveganj uporabe zdravila PhotoBarr, vendar ocenjuje, da naslednji razlogi zahtevajo skrbno spremljanje varnostnih lastnosti zdravila:
− Several follow-up measures in terms of clinical trials aiming to address several identified risks of PhotoBarr (i.e. prevention of photosensitivity, oesophageal stenosis and oesophageal perforation) are still ongoing: two clinical trials (PHOEST07-01 and PHOTB05-01) have been initiated only recently. − In addition and further to the ongoing status of these clinical trials, the CHMP considered that there was a need to have a risk management plan for this medicinal product, including education materials as risk minimisation activities in order to lower identified and potential risks related to the use of this medicinal product.
− Klinična preskušanja, namenjena spremljanju ukrepov za zmanjšanje ugotovljenih tveganj pri uporabi zdravila PhotoBarr (tj. preprečevanje preobčutljivosti na svetlobo, ezofagealne stenoze in perforacije požiralnika), se še izvajajo: dve klinični študiji (PHOEST07- 01 in PHOTB05- 01) sta se komaj začeli. − V skladu z dosedanjimi ugotovitvami in trenutnim statusom omenjenih kliničnih preskušanj, CHMP meni, da je treba za to zdravilo predložiti načrt upravljanja tveganj ter izobraževalno gradivo o možnih ukrepih za zmanjševanje tveganj, katerih namen je zmanjšati pojavnost ugotovljenih in možnih tveganj, povezanih z uporabo tega zdravila.
Therefore, based upon the safety profile of PhotoBarr, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Na podlagi varnostnih lastnosti zdravila PhotoBarr CHMP odreja, da mora imetnik dovoljenja za promet z zdravilom v roku 5 let od prve pridobitve dovoljenja obnoviti vlogo.
52
52/ 52
Plavix are pink tablets.
Zdravilo Plavix so tablete rožnate barve.
Plavix contains the active ingredient clopidogrel (75 mg).
Zdravilo Plavix vsebuje zdravilno učinkovino klopidogrel (75 mg).
Plavix is used in adult patients to prevent atherothrombotic events (problems caused by blood clots and hardening of arteries).
Zdravilo Plavix se uporablja pri odraslih bolnikih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdevanje arterij).