natgillin/translations-raw huggingface dataset:
Children and adolescents Soliris has not been administered to patients less than 18 years of age.
Otroci in mladostniki Zdravilo Soliris ni bilo dajano bolnikom, mlajšim od 18 let.
Important information about some of the ingredients of Soliris This medicinal product contains 5.00 mmol sodium per dose (1 vial).
Pomembne informacije o nekaterih sestavinah zdravila Soliris To zdravilo vsebuje 5, 00 mmol natrija na odmerek (1 viala).
HOW TO USE SOLIRIS
KAKO UPORABLJATI ZDRAVILO SOLIRIS
Prior to beginning treatment, your doctor will discuss with you the importance of:
Pred začetkom zdravljenja vas bo zdravnik seznanil s pomembnostjo:
- Receiving a vaccine against meningitis,
- cepljenja proti meningitisu,
- Becoming knowledgeable about symptoms associated with infections, and
- poznavanja simptomov, povezanih z okužbami, in
- Being carefully monitored by your doctor following any discontinuation of Soliris treatment.
- pozornega spremljanja vašega stanja s strani zdravnika po prenehanju zdravljenja z zdravilom
At least 14 days before you start treatment with Soliris, your doctor will administer a vaccine against meningitis if it was not previously administered or if your vaccination is outdated.
Najkasneje 14 dni pred začetkom zdravljenja z zdravilom Soliris vam bo zdravnik dal cepivo proti meningitisu, če ga še niste prejeli ali če cepivo ne učinkuje več.
Instructions for proper use The treatment will be given by your doctor or other health care provider by infusing a dilution of the Soliris vial from a drip bag through a tube directly into one of your veins.
Navodila za pravilno uporabo Zdravilo vam bo dajal zdravnik ali drug zdravstveni delavec z infundiranjem razredčene vsebine viale zdravila Soliris iz infuzijske vrečke skozi cevko neposredno v eno od ven.
It is recommended that the beginning of your treatments, called the initial phase, will extend over 5 weeks, followed by a maintenance phase:
Priporočljivo je, da traja začetek zdravljenja, imenovan začetna faza, 5 tednov, tej fazi pa sledi faza vzdrževanja:
Initial Phase: • Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted Soliris.
Začetna faza: • Prve štiri tedne vam bo zdravnik vsak teden dal intravensko infuzijo razredčenega zdravila Soliris.
Each infusion will consist of a dose of 600 mg (2 vials of 30 ml) and will take approximately 30 minutes. • In the fifth week your doctor will administer an intravenous infusion of diluted Soliris at a dose of 900 mg (3 vials of 30 ml) over a 30 minute period.
Vsaka infuzija bo vsebovala odmerek 600 mg (2 viali po 30 ml) in bo trajala približno 30 minut. • Peti teden vam bo zdravnik dal intravensko infuzijo razredčenega zdravila Soliris v odmerku 900 mg (3 viale po 30 ml), ki bo trajala 30 minut.
Maintenance Phase: • After the fifth week, your doctor will administer 900 mg of diluted Soliris every two weeks as a long-term treatment.
Faza vzdrževanja: • Od petega tedna dalje vam bo zdravnik vsaka dva tedna dal 900 mg razredčenega zdravila Soliris kot dolgoročno zdravljenje.
If you receive more Soliris than you should If you suspect that you have been accidentally administered a higher dose of Soliris than prescribed, please contact your doctor for advice.
Če ste prejeli večji odmerek zdravila Soliris, kot bi smeli Če domnevate, da ste po pomoti prejeli večji odmerek zdravila Soliris od predpisanega, se posvetujte z zdravnikom.
If you forget an appointment to receive Soliris If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Soliris”
Če ste pozabili na termin za zdravljenje z zdravilom Soliris Če ste pozabili na termin, se takoj posvetujte z zdravnikom in si oglejte spodnje poglavje » Če ste prenehali jemati zdravilo Soliris «
If you stop using Soliris Interrupting or ending treatment with Soliris may cause your PNH symptoms to come back more severely soon after stopping Soliris treatment.
Če ste prenehali jemati zdravilo Soliris Prekinitev ali prenehanje zdravljenja z zdravilom Soliris lahko povzroči, da se simptomi PNH znova pojavijo v resnejši obliki kmalu po prekinitvi zdravljenja z zdravilom Soliris.
If you stop treatment with Soliris, your doctor will
Če ste prenehali z
23 discuss the possible side effects with you and explain the risks.
23 zdravljenjem z zdravilom Soliris, vam bo zdravnik razložil morebitne neželene učinke in tveganja.
Your doctor will want to continue to monitor you closely.
Zdravnik bo želel še naprej podrobneje spremljati vaše stanje.
- A significant fall in your red blood cell counts (anaemia),
- bistven upad števila rdečih krvničk (slabokrvnost),
- You to be confused or unalert,
- zmedenost ali nepozornost,
- Chest pain, or angina,
- bolečine v prsih ali angino,
- An increase in your serum creatine level (problems with your kidneys), or
- povečanje ravni serumskega kreatina (težave z ledvicami) ali
- Thrombosis (blood clotting).
- trombozo (strjevanje krvi).
Like all medicines, Soliris can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Soliris neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The side effects caused by Soliris are usually mild or moderate.
Neželeni učinki zdravila Soliris so običajno blagi ali zmerni.
Very common side effects (occurring in at least 1 in 10 patients) include: runny nose or sore throat, urinary infection (bladder infection), headaches, dizziness, nausea, diarrhoea, back pain, pain in joints, fever, and bruise.
Zelo pogosti neželeni učinki (ki prizadenejo vsaj 1 od 10 bolnikov) so: izcedek iz nosu ali vneto žrelo, okužba sečil (okužba mehurja), glavobol, omotica, slabost (navzeja), driska, bolečine v hrbtu, bolečine v sklepih, vročina in podplutba.
Common side effects (occurring in 5 or more out of 100 patients and less than 10 in 100 patients) include: herpes simplex (cold sores), sinus infection (sinusitis), viral infection, stomach flu (gastroenteritis), lung infection, insomnia, cough, sore throat, bloody nose, abdominal pain, constipation, vomiting, upper abdominal pain, itchy skin, rash, muscle aches, pain in the limbs (arms and legs), muscle cramp, fatigue, and influenza-like illness.
Pogosti neželeni učinki (ki prizadenejo 5 ali več od 100 bolnikov in manj kot 10 od 100 bolnikov) so: herpes simpleks (ocvirki), okužba sinusov (sinuzitis), virusna okužba, trebušna gripa (gastroenteritis), okužba pljuč, nespečnost, kašelj, vneto žrelo, krvavitev iz nosu, bolečina v trebuhu, zaprtje, bruhanje, bolečina v zgornjem delu trebuha, srbeča koža, izpuščaji, bolečine v mišicah, bolečine v okončinah (rokah in nogah), mišični krči, utrujenost ter gripi podobna bolezen.
HOW TO STORE SOLIRIS
SHRANJEVANJE ZDRAVILA SOLIRIS
Keep out of the reach of children.
Zdravilo shranjujte nedosegljivo otrokom!
Store in a refrigerator (2°C – 8°C) Do not freeze.
Ne zamrzujte.
Do not use Soliris after the expiry date which is stated on the label after “EXP”.
Zdravila Soliris ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake » Uporabno do «.
After dilution, the product should be used immediately within 24 hours.
Po razredčenju je treba zdravilo uporabiti takoj v roku 24 ur.
What Soliris contains
Kaj vsebuje zdravilo Soliris
The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml).
Zdravilna učinkovina je ekulizumab (300 mg/ 30 ml v viali, kar ustreza 10 mg/ ml).
24
24 Pomožne snovi so:
- sodium phosphate monobasic
- natrijev dihidrogenfosfat
- sodium phosphate dibasic
- natrijev hidrogenfosfat
- polysorbate 80 (vegetable origin)
- polisorbat 80 (rastlinskega izvora)
Solvent: water for injections
vehikel: voda za injekcije
What Soliris looks like and contents of the pack Soliris is presented as a concentrate for solution for infusion (30 ml in a vial – pack size of 1).
Izgled zdravila Soliris in vsebina pakiranja Zdravilo Soliris je na voljo kot koncentrat za pripravo raztopine za infundiranje (30 ml v viali – pakiranje po 1 vialo).
Alexion Europe SAS 54-56 Avenue Hoche 75008 Paris Tel: +33 (0) 1 56 60 52 18 France
Alexion Europe SAS 54- 56 avenue Hoche 75008 Pariz Tel: +33 (0) 1 56 60 52 18 Francija
Almac Pharma Service Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom
Almac Pharma Service Seagoe Industrial Estate Craigavon BT63 5QD Velika Britanija
Danmark Alexion Pharma France 56 avenue Hoche 75008 Paris Frankrig
Danmark
Nederland Alexion Pharma France 56 avenue Hoche 75008 Paris Frankrijk
Nederland
Ireland Alexion Pharma UK 3000 Cathedral Hill Guildford Surrey GU2 7YB
Ireland Alexion Pharma UK 3000 Cathedral Hill
This leaflet was last approved in June 2007.
Navodilo je bilo odobreno Junij 2007.
27 --------------------------------------------------------------------------------------------------------------------------- -------
27 Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Instructions for Use for Healthcare Professionals Handling Soliris
Navodila za uporabo za zdravstveno osebje Ravnanje z zdravilom Soliris
1- How is Soliris supplied?
1 - Kako se zdravilo Soliris dobavlja?
Each vial of Soliris contains 300 mg of active ingredient in 30 ml of product solution.
Vsaka viala zdravila Soliris vsebuje 300 mg zdravilne učinkovine v 30 ml raztopine.
2- Before Administration Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
2 - Pred uporabo Rekonstitucijo in redčenje je treba izvajati v skladu s pravili dobre prakse, še zlasti v zvezi z asepso.
Soliris should be prepared for administration by a qualified healthcare professional using aseptic technique. • Inspect visually Soliris solution for particulate matter and discolouration • Withdraw the required amount of Soliris from the vial(s) using a sterile syringe. • Transfer the recommended dose to an infusion bag. • Dilute Soliris to a final concentration of 5 mg/ml (initial concentration divided by 2) by adding the appropriate amount of diluent to the infusion bag.
Zdravilo Soliris mora z aseptično tehniko za uporabo pripraviti strokovno usposobljen zdravstveni delavec. • Vizualno preverite, ali raztopina vsebuje delce in ali je razbarvana. • S sterilno brizgo odvzemite zahtevano količino zdravila Soliris iz viale (vial). • Priporočeni odmerek prenesite v infuzijsko vrečko. • Zdravilo Soliris razredčite do končne koncentracije 5 mg/ ml (začetna koncentracija, deljena z dva) z dodajanjem ustrezne količine vehikla za redčenje v infuzijsko vrečko.
For 600mg doses, use 60 ml of Soliris (10mg/ml) and add the same volume of diluent.
Za 600 mg odmerke uporabite 60 ml zdravila Soliris (10 mg/ ml) in dodajte enak volumen vehikla za redčenje.
For 900 mg use 90 ml of Soliris and add 90 ml of diluent.
Za 900 mg odmerke uporabite 90 ml zdravila Soliris in dodajte 90 ml vehikla za redčenje.
The final volume of a 5 mg/ml diluted Soliris solution is 120 ml for 600 mg doses or 180 ml for 900 mg doses.
Končni volumen 5 mg/ ml razredčene raztopine je 120 ml za 600 mg odmerke ali 180 ml za 900 mg odmerke.
Diluents are 0.9% Sodium chloride, 0.45% Sodium chloride or 5% Dextrose in Water • Gently agitate the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the medicinal product and diluent. • The diluted solution should be allowed to warm to room temperature [18°-25° C] prior to administration by exposure to ambient air. • Discard any unused portion left in a vial as the medicinal product contains no preservatives. • Diluted solutions of Soliris may be stored at 2°C -8° C for up to 24 hours prior to administration.
Vehikli za redčenje so 0, 9% raztopina natrijevega klorida, 0, 45% raztopina natrijeva klorida ali 5% raztopina dekstroze v vodi. • Infuzijsko vrečko z razredčenim zdravilom Soliris rahlo pretresite, da zagotovite temeljito mešanje zdravila in vehikla za redčenje. • Pred uporabo razredčeno raztopino izpostavite temperaturi v okolici in počakajte, da se ogreje na sobno temperaturo [18°- 25 °C]. • Neuporabljene ostanke v viali zavrzite, saj zdravilo ne vsebuje konzervansov. • Razredčene raztopine zdravila Soliris lahko hranite pri temperaturi 2 °C – 8 °C največ 24 ur pred uporabo.
3- Administration • Do not administer Soliris as an intravenous Push or Bolus Injection • Soliris should only be administered via intravenous infusion and must be diluted to a final concentration of 5 mg/ml prior to administration..
3 - Uporaba • Zdravila Soliris ni dovoljeno dajati v obliki hitre intravenske ali bolusne injekcije. • Zdravilo Soliris se daje samo kot intravenska infuzija in ga je pred uporabo treba razredčiti do končne koncentracije 5 mg/ ml.
Diluted solutions of Soliris are stable for 24 hours at 2°C-8°C.
Razredčene raztopine zdravila Soliris so stabilne 24 ur pri temperaturi 2 °C – 8 °C.
Prior to administration, the diluted solution should be allowed to warm to room temperature by exposure to ambient air.
Pred uporabo razredčeno raztopino izpostavite temperaturi v okolici in počakajte, da se ogreje na sobno temperaturo.
The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature. • The diluted solution of Soliris should be administered by intravenous infusion over 25 to 45 minutes via gravity feed, a syringe-type pump, or an infusion pump.
Razredčene raztopine ne grejte v mikrovalovni pečici ali z drugim virom toplote; ogreti se sme samo s toploto zraka pri temperaturi okolice. • Razredčena raztopina zdravila Soliris se daje v obliki 25 – 45- minutne intravenske infuzije s pomočjo kapalnega sistema, brizgalne črpalke ali infuzijske črpalke.
4- Special Handling and Storage Soliris vials must be stored in the original carton until time of use under refrigerated conditions at 2- 8ºC and protected from light.
4 - Posebno ravnanje in shranjevanje Zdravilo Soliris mora biti do trenutka uporabe shranjeno v originalni ovojnini v hladilniku pri temperaturi 2 - 8 ºC in zaščiteno pred svetlobo.
Do not use beyond the expiration date stamped on the carton.
Ne uporabljajte ga po preteku roka uporabe, ki je vtisnjen na ovojnini.
What is SOMAVERT?
Kaj je zdravilo SOMAVERT?
SOMAVERT is a powder and solvent that are mixed together to make up a solution for injection.
Zdravilo SOMAVERT sestavljata prašek in vehikel, ki se zmešata v raztopino za injiciranje.
It contains the active substance pegvisomant (10, 15 or 20 mg/ ml).
Vsebuje zdravilno učinkovino pegvisomant (10, 15 ali 20 mg/ ml).
What is SOMAVERT used for?
Za kaj se zdravilo SOMAVERT uporablja?
SOMAVERT is used to treat patients with acromegaly (a rare hormonal disorder that usually occurs in middle-aged adults, which is caused by the pituitary gland producing excess growth hormone).
Povzroči jo hipofiza, ki izloča preveč rastnega hormona).
SOMAVERT is used in patients who did not respond well to surgery or radiation therapy, or to treatment with somatostatin analogues (another type of medicine used in acromegaly).
Zdravilo SOMAVERT se uporablja pri bolnikih, ki se na operacijo, obsevanje ali zdravljenje z analogi somatostatina (drugo vrsto zdravila, ki se uporablja pri akromegaliji) niso ustrezno odzvali.
Because the number of patients with acromegaly is low, the disease is considered ‘ rare’, and SOMAVERT was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 14 February 2001.
Ker je število bolnikov z akromegalijo majhno, velja ta bolezen za „ redko “, zato je bilo zdravilo SOMAVERT dne 14. februarja 2001 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
How is SOMAVERT used?
Kako se zdravilo SOMAVERT uporablja?
SOMAVERT treatment should be initiated by a doctor who has experience in the treatment of acromegaly.
Zdravljenje z zdravilom SOMAVERT mora uvesti zdravnik z izkušnjami z zdravljenjem akromegalije.
SOMAVERT is given by subcutaneous injection (under the skin).
Zdravilo SOMAVERT se daje s subkutano injekcijo (pod kožo).
The patient first receives a loading dose of 80 mg under medical supervision.
Bolnik prejme najprej udarni odmerek 80 mg pod zdravniškim nadzorom.
Following this, SOMAVERT is given as a subcutaneous injection of 10 mg once a day.
Zatem se zdravilo SOMAVERT daje s subkutano injekcijo v odmerku 10 mg enkrat dnevno.
The patient or caregiver can inject SOMAVERT, after training by a doctor or a nurse.
Po ustreznem usposabljanju, ki ga vodi zdravnik ali medicinska sestra, lahko bolnik ali negovalec injicirata zdravilo SOMAVERT sama.
The doctor should check the response every four to six weeks and adjust the dose if needed.
Zdravnik mora preveriti odziv vsake štiri do šest tednov in po potrebi prilagoditi odmerek.
The maximum dose is 30 mg per day.
Največji odmerek je 30 mg na dan.
How does SOMAVERT work?
Kako zdravilo SOMAVERT deluje?
Acromegaly happens because the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour.
Akromegalija se razvije, če hipofiza, ki se nahaja na možganskem dnu, izloča preveč rastnega hormona, običajno zaradi benignega (nerakastega) tumorja.
Growth hormone promotes growth during childhood and adolescence.
Rastni hormon vzpodbuja rast v otroštvu in adolescenci.
In acromegaly, this overproduction causes overgrowth of bone, swelling of soft tissue (such as the hands and feet), heart disease and other disorders.
Pri akromegaliji izzove to prekomerno izločanje čezmerno rast kosti, otekanje mehkih tkiv (npr. dlani in stopal), bolezen srca in druge motnje.
The active substance in SOMAVERT, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally fixes itself.
Zdravilna učinkovina v zdravilu SOMAVERT, pegvisomant, je zelo podobna človeškemu rastnemu hormonu, vendar je bila oblikovana tako, da blokira receptorje, na katere se običajno veže rastni hormon.
By blocking the receptors, it prevents growth hormone from having an effect.
Z blokiranjem receptorjev prepreči učinkovanje rastnega hormona.
This helps SOMAVERT prevent the unwanted growth and other disorders seen in acromegaly.
S tem zdravilo SOMAVERT preprečuje neželeno rast in druge motnje, opažene pri akromegaliji.
Pegvisomant is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA) that makes it able to produce the substance.
Pegvisomant se proizvaja po metodi, imenovani „ tehnologija rekombinantne DNA “: tvori ga bakterija, ki je prejela gen (DNA), s katerim postane sposobna tvoriti snov.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has SOMAVERT been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo SOMAVERT raziskano?
SOMAVERT has been studied in 112 patients with acromegaly in a 12-week study.
Zdravilo SOMAVERT so v okviru 12 tedenske študije preučevali pri 112 bolnikih z akromegalijo.
Three different doses of the medicine (10, 15 or 20 mg/ day) were compared with placebo (a dummy treatment).
Pri tem so tri različne odmerke (10, 15 ali 20 mg/ dan) primerjali s placebom (zdravilom brez zdravilne učinkovine).
The effectiveness was measured by comparing the levels of insulin-like growth factor-I (IGF-I) before and at the end of the study.
Učinkovitost so merili s primerjavo ravni insulinu podobnega rastnega faktorja I (IGF- I) pred in ob koncu študije.
IGF-I is regulated by human growth hormone and causes growth in the body.
IGF- I, ki povzroča rast v telesu, uravnava človeški rastni hormon.
What benefit has SOMAVERT shown during the studies?
Kakšne koristi je zdravilo SOMAVERT izkazalo med raziskavami?
SOMAVERT lowered IGF-I levels at all of the doses tested.
IGF- I je bil ob koncu študije (12. teden) normalen pri 38, 5%, 75% oz.
IGF-I was normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/ day SOMAVERT, respectively, compared with 9.7% of the patients treated with placebo.
20 mg/ dan zdravila SOMAVERT (v primerjavi z 9, 7% bolnikov, zdravljenih s placebom).
What is the risk associated with SOMAVERT?
Kakšna tveganja so povezana z zdravilom SOMAVERT?
The most common side effects of SOMAVERT during the clinical study were injection site reactions (seen in 11% of the patients), sweating (7%), headache (6%) and asthenia (loss of strength and energy, 6%).
Najpogostejši neželeni učinki zdravila SOMAVERT med kliničnimi študijami so bile reakcije na mestu injiciranja (opažene pri 11% bolnikov), potenje (7%), glavobol (6%) in astenija (izguba moči in energije, 6%).
Some patients who received SOMAVERT developed anti-growth hormone antibodies (proteins that are produced in response to SOMAVERT).
Pri nekaterih bolnikih, ki so prejemali zdravilo SOMAVERT, so se razvila protitelesa proti rastnemu hormonu (beljakovine, ki se tvorijo kot odziv na zdravilo SOMAVERT).
For the full list of all side effects reported with SOMAVERT, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila SOMAVERT, glejte Navodilo za uporabo.
SOMAVERT should not be used in people who may be hypersensitive (allergic) to pegvisomant or any of the other ingredients.
Zdravila SOMAVERT se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) pegvisomant ali katerokoli drugo sestavino zdravila.
Diabetic patients using the medicine have a risk of hypoglycaemia (low blood sugar), and their antidiabetes treatment may need to be adjusted.
Pri bolnikih s sladkorno boleznijo, ki uporabljajo to zdravilo, obstaja tveganje za hipoglikemijo (nizko koncentracijo sladkorja v krvi), zaradi česar bo morda potrebno prilagoditi zdravljenje sladkorne bolezni.
Why has SOMAVERT been approved?
Zakaj je bilo zdravilo SOMAVERT odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that SOMAVERT’ S benefits are greater than its risks for the treatment of patients with acromegaly who have had an inadequate response to surgery and/ or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-I concentrations or was not tolerated.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila SOMAVERT pri zdravljenju bolnikov z akromegalijo, ki se na operacijo in/ ali obsevanje niso ustrezno odzvali in pri katerih ustrezna farmakoterapija z analogi somatostatina ni normalizirala koncentracije IGF- I oz. takšne farmakoterapije niso prenašali, večje od z njim povezanih tveganj.
The Committee recommended that SOMAVERT be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo SOMAVERT podeli dovoljenje za promet.
Other information about Somavert:
Druge informacije o zdravilu Somavert:
The European Commission granted a marketing authorisation valid throughout the European Union for SOMAVERT to Pfizer Limited on 13 November 2002.
Evropska komisija je dovoljenje za promet z zdravilom SOMAVERT, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 13. novembra 2002.
The marketing authorisation was renewed on 13 November 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 13. novembra 2007.
The record of SOMAVERT’ s designation as an orphan medicine is available here.
Zapis o določitvi zdravila SOMAVERT kot zdravila sirote najdete tukaj.
The full EPAR for SOMAVERT is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo SOMAVERT je na voljo tukaj.
Pharmaceutical Form
farmacevtska olbika
Powder: vial (glass) Solvent: vial (glass)
Prašek: viala (steklena) Vehikel: viala (steklena)
10 mg; Solvent:
10 mg; Vehikel:
30 vials + 30 vials
30 vial + 30 vial
15 mg; Solvent:
15 mg; Vehikel:
20 mg; Solvent:
20 mg; Vehikel: