natgillin/translations-raw huggingface dataset:
Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of mepivacaine (see section 4.8). 
Po uporabi mepivakaina se lahko pojavi omotica (vključno z vrtoglavico, motnjami vida in utrujenostjo) (glejte poglavje 4.8).
Gingival / oral mucosal exfoliation (sloughing) / ulceration Swelling of tongue, lip, gums Not known Stomatitis, glossitis, gingivitis Salivary hypersecretion 
Bolezni prebavil redki navzea bruhanje eksfoliacija (lupljenje)/razjede na dlesni ali ustni sluznici oteklost8 jezika, ustnic, dlesni neznana stomatitis, glositis, gingivitis preveliko izločanje sline
− ear disturbances, such as ringing in the ears, oversensitivity of hearing; 
motnje v ušesu, kot so zvonjenje v ušesih, prevelika občutljivost sluha, nezmožnost srca za učinkovito krčenje (depresija miokarda),
- If you get any side effects, talk to your doctor, dentist or pharmacist. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, zobozdravnikom ali farmacevtom.
− euphoric mood, anxiety/nervousness; 
Psihiatrične motnje neznana evforično razpoloženje anksioznost/živčnost3
How to store X 
Shranjevanje zdravila X
The medicine administration should take place immediately after the opening of the cartridge. 
Zdravilo je treba uporabiti takoj po odprtju vložka.
What X contains 
Kaj vsebuje navodilo
Mepivacaine must be used safely and effectively under appropriate conditions: The local anaesthetic effects may be reduced when {Scandonest and associated names} is injected into an inflamed or infected area. 
Lokalni anestetični učinki se lahko zmanjšajo, če se zdravilo {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika} injicira v vneto ali okuženo področje.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva redki trzanje mišic mrzlica (drgetanje)
Talk to your dentist before using X if: - You suffer from heart disorders; - You have a severe anaemia; - You suffer from high blood pressure (severe or untreated hypertension); - You suffer from a low blood pressure (hypotension); - You suffer from epilepsy; - You suffer from liver disease; - You suffer from kidney disease; - You suffer from a disease which affects the nervous system and results in neurological disorders 
imate bolezni srca, imate hudo anemijo, imate visok krvni tlak (hudo ali nezdravljeno hipertnezijo), imate nizek krvni tlak (hipotenzijo), imate epilepsijo, imate bolezen jeter, imate bolezen ledvic,
Skin and subcutaneous tissue Rare 
Bolezni kože in podkožja redki izpuščaj (izbruh)
Sodium hydroxide (for pH-adjustment) Water for injection 
6.1 Seznam pomožnih snovi natrijev klorid natrijev hidroksid (za prilagajanje pH) voda za injekcije
Each cartridge of 1.7 ml of solution for injection contains 51 mg of mepivacaine hydrochloride. 
En vložek z 1,7 ml raztopine za injiciranje vsebuje 51 mg mepivakainijevega klorida.
Contents of the pack and other information 
Shranjevanje zdravila X Vsebina pakiranja in dodatne informacije
Neuralgia (Neuropathic pain) Paresthesia (i.e., burning, prickling, itching, tingling, local sensation of heat or cold, with no apparent physical cause) of oral and perioral structures Hypoesthesia / numbness (oral and perioral) 
pekoč, mravljinčast, srbeč, gomazeč občutek, lokalen občutek toplote ali hladu brez opaznega fizičnega vzroka) v ustih in perioralno,
wheezing/asthma, hives (urticaria): these might be symptoms of hypersensitivity reactions (allergic or allergy-like reactions); 
izpuščaj, srbenje, oteklost obraza, ustnic, dlesni, jezika in/ali žrela in težave z dihanjem, piskajoče dihanje/astma, koprivnica (urtikarija): to so lahko simptomi preobčutljivostnih reakcij (alergijskih ali alergijam podobnih reakcij),
Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to efficient anaesthesia in: - elderly people, - patients with renal or hepatic impairment. 
Zaradi pomanjkanja kliničnih podatkov je potrebna posebna previdnost, da bi uporabili najmanjši odmerek, ki povzroči učinkovito anestezijo, pri:
Ask your dentist, doctor or pharmacist how to throw away medicines you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z zobozdravnikom, zdravnikom ali farmacevtom.
Toxic effects are dose-dependent, comprising progressively more severe neurological manifestations, followed by vascular, respiratory and finally cardiovascular signs such as hypotension, bradycardia, arrhythmia and cardiac arrest 
dihalni in končno srčno-žilni znaki, kot so hipotenzija, bradikardija, aritmija in srčni zastoj.
Pharmacotherapeutic group: Nervous System/Anaesthetics/Local anaesthetics/Amides/Mepivacaine ATC code: N01 BB 03 
mepivakain Oznaka ATC: N01 BB 03
Confusional state, disorientation Speech disorder3 (e.g., dysarthria, logorrhea) 
presinkopa, sinkopa; stanje zmedenosti, dezorientiranost, motnje govora3 (npr., dizartrija, logoreja), nemir/agitiranost3,
Sedatives (central nervous system depressants) 
globoka depresija osrednjega živčevja:
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Vložki so namenjeni za enkratno uporabo.
If you get any side effects, talk to your doctor or dentist. 
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali zobozdravnikom.
{Scandonest and associated names} may have a minor influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika} ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
Discard unused solution. 
Neporabljeno raztopino zavrzite.
Anaphylatic / anaphylactoid reactions Angioedema (Face / tongue / lip / throat / larynx1 / periorbital oedema) Bronchospasm / asthma2 
Organski sistem po MedDRA Pogostnost Neželeni učinki Bolezni imunskega sistema redki preobčutljivost anafilaktične/anafilaktoidne reakcije angioedem (obraza/jezika/ustnic/žrela/ grla1/periorbitalni edem) bronhospazem/astma2
Marketing Authorisation Holder [See Annex I - To be completed nationally] 
Imetnik dovoljenja za promet [Glejte Prilogo I - Izpolni država članica]
This is equivalent to 1.23 % of the recommended maximum daily dietary intake of sodium for an adult. 
priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
− burning sensation, prickling skin sensation, tingling with no apparent physical cause around the mouth 
bolečina zaradi poškodbe živca (nevropatska bolečina), pekoč občutek, zbadajoč občutek na koži, mravljinčenje brez očitnega fizičnega razloga v okolici ust (parestezija),
Hyperhidrosis (sweating or perspiration) 
eritem srbenje otekanje obraza hiperhidroza (potenje ali znojenje)
Very rare side effects (may affect up to 1 in 10,000 people): − high blood pressure. 
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
Local swelling Injection site swelling Not known Chest pain Fatigue, asthenia (weakness) Feeling hot 
Splošne težave in spremembe na mestu aplikacije redki lokalna oteklost oteklost na mestu injiciranja neznana bolečina v prsnem košu utrujenost, astenija (šibkost)
Injection site pain 
občutek vročine bolečina na mestu injiciranja
PHARMACEUTICAL FORM Solution for injection. 
FARMACEVTSKA OBLIKA raztopina za injiciranje Bistra in brezbarvna raztopina.
Common side effects (may affect up to 1 in 10 people): Headache 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
NAME OF THE MEDICINAL PRODUCT {Scandonest and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally] 
IME ZDRAVILA {Scandonest in povezana imena (glejte Dodatek I) jakost farmacevtska oblika}
− excessive sweating; 
- srčno popuščanje,
The clearance of mepivacaine may be reduced when associated with propranolol and it may result in higher serum concentrations of the anaesthetic. 
To se lahko kaže v večjih koncentracijah anestetika v serumu.
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
− pain due to nerve damage (neuropathic pain); 
nevralgija (nevropatska bolečina) parestezije (t.j.
− swelling at the site of injection. 
OVOJNINAH NALEPKA NA VLOŽKU
Dysphonia (Hoarseness1) 
hiperkapnija7 disfonija (hripavost1)
Increased serum levels of amide anaesthetics have been reported after concomitant administration of cimetidine. 
Po sočasni uporabi cimetidina so poročali o povišani ravni amidnih anestetikov v serumu.
− fatigue, feeling of weakness, feeling hot, pain at the site of injection; 
oteklost ust, ustnic, jezika in dlesni, veliko izločanje sline, utrujenost, občutek šibkosti, občutek vročine, bolečina na mestu injiciranja,
DATE OF REVISION OF THE TEXT [To be completed nationally] 
NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica]
Package leaflet: Information for the patient {Scandonest and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally] 
Navodilo za uporabo {Scandonest in povezana imena (glejte Prilogo I) jakost farmacevtska oblika}
Contains sodium, see package leaflet for further information. 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo X
Amaurosis (blindness) Mydriasis 
Hornerjev sindrom ptoza veke enoftalmos diplopija (paraliza of okulomotoričnih mišic) amavroza (slepota) midriaza mioza
Accommodation disorder Not known Horner's syndrome Eyelid ptosis 
Očesne bolezni redki okvara vida zamegljen vid motnja akomodacije neznana
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION [See Annex I - To be completed nationally] 
IME ZDRAVILA IN POT(I) UPORABE [Glejte Prilogo I - jakost farmacevtska oblika] mepivakainijev klorid infiltriranje in perinevralna uporaba
Erythema 
Antiaritmiki
Common Headache Rare 
glavobol.
Precautions to be taken before administering the medicinal product The medicinal product should not be used if cloudy and discoloured. 
Zdravila se ne sme uporabiti, če je motno in spremeni barvo.
Possible side effects (frequency cannot be estimated from the available data): 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): evforično razpoloženje, zaskrbljenost/živčnost,
Miosis 
Odmerjanje
This review was carried out under an ‘Article 31' referral1. 
Pregled je bil opravljen v skladu z napotitvenim postopkom po „ lenu 31“
The dose of bromocriptine should also be limited to 30 mg a day. 
Tudi odmerek bromokriptina je treba omejiti na 30 mg dnevno.
All five medicines are authorised by regulatory authorities in Member States. 
Regulativni organi v državah lanicah so odobrili vseh pet zdravil.
What are the recommendations for patients and prescribers? 
Kakšna so priporo ila za bolnike in zdravnike, ki zdravila predpisujejo?
• a reduction of the maximum recommended dose to 3 mg per day; 
• zmanjšanje najve jega priporo enega odmerka na 3 mg dnevno;
However, restrictions on the way these medicines are used should be introduced, to reduce the risk of fibrosis developing. 
Vendar je treba uvesti omejitve na inov uporabe teh zdravil, da se zmanjša tveganje razvoja fibroze.
• Patients or their carers who have any questions or concerns should speak to their doctor or pharmacist. 
• Bolniki ali njihovi negovalci se lahko z morebitnimi vprašanji ali zadržki obrnejo na svojega zdravnika ali farmacevta.
Fibrosis can affect a number of body structures such as the heart, the lungs or the abdomen. 
Fibroza lahko vpliva na številne telesne strukture, kot so srce, plju a ali trebuh.
There was not enough information available to allow the Committee to recommend a similar contraindication for lisuride. 
Odbor ni imel dovolj razpoložljivih podatkov, da bi podobno kontraindikacijo priporo il za lisurid.
The Committee noted that there is a plausible mechanism for how these medicines may cause fibrosis, through activation of ‘5-HT2B receptors', leading to cell division and formation of fibrous tissue, although other mechanisms might be involved. 
Odbor je izpostavil, da obstaja verjeten mehanizem, kako ta zdravila lahko povzro ijo fibrozo, in sicer prek aktivacije „receptorjev 5-HT2B“, kar povzro i delitev celic in nastajanje fibroznega tkiva, eprav morda sodelujejo tudi drugi mehanizmi.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for these medicines should be maintained. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri EMEA je zaklju il, da naj se dovoljenja za promet s temi zdravili ohranijo.
• Patients should be monitored for the signs of fibrosis in the heart and elsewhere in the body throughout treatment, using blood tests or chest X-rays as appropriate. 
• Bolnike je treba med zdravljenjem spremljati za znake fibroze v srcu in drugje po telesu s preiskavami krvi ali rentgenskim slikanjem prsnega koša, kakor je ustrezno.
This suggested that cardiac fibrosis may be more common that previously thought. 
To nakazuje, da je morda sr na fibroza veliko pogostejša, kot se je prej predvidevalo.
When it affects the heart valves, it can lead to problems with the flow of blood around the heart and, eventually, heart failure (an inability of the heart to pump enough blood around the body). 
e vpliva na sr ne zaklopke, lahko povzro i težave s pretokom krvi pri srcu in na koncu sr no odpovedovanje (nezmožnost srca, da po telesu pre rpa dovolj krvi).
However, two studies published in scientific journals using echocardiography (ultrasound scans of the heart) have shown that fibrosis of the heart valves can begin to develop well before symptoms start to appear. 
Vendar so v dveh študijah, objavljenih v znanstvenih revijah, z ehokardiografijo (ultrazvo nimi preiskavami srca) dokazali, da se fibroza sr nih zaklopk lahko za ne razvijati precej pred pojavom simptomov.
They are also used to treat conditions including hyperprolactinaemia (high levels of the hormone prolactin in the blood) and prolactinoma (a non-cancerous tumour of the pituitary gland at the base of the brain), and to prevent lactation (production of breast milk) and migraine. 
Uporabljajo se tudi za zdravljenje drugih bolezni, med drugim hiperprolaktinemije (visokih ravni hormona prolaktina v krvi) in prolaktinoma (nerakavega tumorja hipofize v bazi možganov), ter za prepre evanje laktacije (nastajanje materinega mleka) in migrene.
• a warning stating that patients must be monitored for signs of fibrosis with echocardiography before treatment is started and regularly during treatment; 
• opozorilo, da je treba bolnike pred za etkom zdravljenja pregledati za znake fibroze z ehokardiografijo ter jih redno spremljati med zdravljenjem;
• Doctors should prescribe ergot-derived dopamine agonists according to the updated prescribing information. 
• Zdravniki morajo predpisovati agoniste dopamina, ki so derivati ergot alkaloidov, skladno s posodobljenimi podatki o predpisovanju.
They have been available on the market for many years and are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines. 
V prometu so že ve let in se ve inoma uporabljajo za zdravljenje Parkinsonove bolezni kot samostojna zdravila ali v kombinaciji z drugimi zdravili.
The CHMP also concluded that the risk of fibrosis, including fibrosis of the heart valves, does not appear to be the same for all five medicines in the class. 
Poleg tega je CHMP zaklju il, da se tveganje fibroze, vklju no s fibrozo sr nih zaklopk, ne zdi enako pri vseh petih zdravilih v tej skupini.
However, since such a risk cannot completely be excluded, the Committee recommended that warnings on the possible risk of fibrosis in patients taking these medicines at high doses for long periods should be included in their prescribing information. 
Ker takšnega tveganja ni mogo e popolnoma izklju iti, je Odbor priporo il, da je treba za ta zdravila v podatke o predpisovanju vklju iti opozorila o možnem tveganju fibroze pri bolnikih, ki dolgo asa jemljejo velike odmerke omenjenih zdravil.
• To reduce the risk of cardiac fibrosis, patients should be prescribed a daily maximum of 3 mg pergolide or cabergoline, or 30 mg bromocriptine. 
• Za zmanjšanje tveganja sr ne fibroze je najve ji dnevni odmerek, ki se lahko predpiše bolnikom, 3 mg za pergolid ali kabergolin ali 30 mg za bromokriptin.
QUESTIONS AND ANSWERS ON THE REVIEW OF ERGOT-DERIVED DOPAMINE AGONISTS 
VPRAŠANJA IN ODGOVORI V ZVEZI S PREGLEDOM AGONISTOV DOPAMINA, KI SO DERIVATI ERGOT ALKALOIDOV
For cabergoline and pergolide, the Committee noted that the risk of fibrosis of the heart valves is well established, that the prescribing information for both products already includes contraindications stating that patients with evidence of heart valve problems should not take them, and that the medicines should only be used for Parkinson's disease in patients who have already taken or cannot take other treatments. 
Odbor je izpostavil, da je tveganje fibroze sr nih zaklopk pri kabergolinu in pergolidu dobro poznano, da podatki o predpisovanju za obe zdravili že vsebujejo kontraindikacije, in sicer da ju bolniki z dokazanimi težavami s sr nimi zaklopkami ne smejo jemati, ter da se lahko zdravili uporabljata za Parkinsonovo bolezen le pri bolnikih, ki so ju že jemali, ali bolnikih, ki ne morejo jemati drugih zdravil.
Ergot-derived dopamine agonists are a group of medicines consisting of bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide. 
Agonisti dopamina, ki so derivati ergot alkaloidov, so skupina zdravil, kamor spadajo bromokriptin, kabergolin, dihidroergokriptin, lisurid in pergolid.
In contrast, there is not enough evidence to determine whether there is an increased risk of fibrosis of the heart valves in patients taking bromocriptine, dihydroergocryptine or lisuride. 
Ni pa dovolj dokazov, da bi ugotovili, ali obstaja pove ano tveganje fibroze sr nih zaklopk pri bolnikih, ki jemljejo bromokriptin, dihidroergokriptin ali lisurid.
• Ergot-derived dopamine agonists should not be taken by patients who have had fibrosis in the heart, lungs or abdomen. 
• Agoniste dopamina, ki so derivati ergot alkaloidov, ne smejo jemati bolniki, ki so v preteklosti imeli fibrozo v srcu, plju ih ali trebuhu.
The absence of fibrosis in the heart should be verified before treatment is started. 
Pred za etkom zdravljenja je treba potrditi odsotnost fibroze v srcu.
Based on the information available, the CHMP has concluded that the marketing authorisations for the ergot-derived dopamine agonists should be maintained, but changes to the prescribing information for the medicines should be introduced to reduce the risk of fibrosis. 
CHMP je na podlagi razpoložljivih podatkov zaklju il, da naj se dovoljenja za promet z agonisti dopamina, ki so derivati ergot alkaloidov, ohranijo, vendar je za ta zdravila potrebno uvesti spremembe podatkov o predpisovanju, da bi se zmanjšalo tveganje fibroze.
The review focused on the risk of fibrosis (the formation of fibrous tissue in some body structures) in patients taking these medicines for long periods, particularly cardiac fibrosis (abnormal thickening of the heart valves). 
Pri pregledu so se osredoto ili na tveganje fibroze (nastanka fibroznega tkiva v dolo enih telesnih strukturah) pri bolnikih, ki jemljejo ta zdravila dolgo asa, zlasti pa sr ne fibroze (nenormalne odebelitve sr nih zaklopk).
This group of dopamine agonists are called ‘ergotderived', because they were first produced from a type of fungus called ergot. 
To skupino agonistov dopamina imenujemo „derivati ergot alkaloidov“, ker so jih prvi pridobili iz plesni, imenovane ergot.
Consequently, the United Kingdom's medicines regulatory authority asked the CHMP to review the risk of fibrosis, including cardiac fibrosis, associated with the use of ergot-derived dopamine agonists. 
Zato je regulativni organ za zdravila v Združenem kraljestvu prosil CHMP za pregled tveganja fibroze, vklju no s sr no fibrozo, ki je povezano z jemanjem agonistov dopamina, ki so derivati ergot alkaloidov.
Therefore, the CHMP recommended that the prescribing information for these two medicines should be updated to include: 
Zato je CHMP priporo il, da se podatki o predpisovanju za zdravili posodobijo, tako da vklju ujejo naslednje:
Why have ergot-derived dopamine agonists been reviewed? 
Zakaj so bili agonisti dopamina, ki so derivati ergot alkaloidov, pregledani?
Dopamine agonists work by stimulating brain and nerve cells in a similar way to dopamine, a messenger substance in the nervous system. 
Agonisti dopamina delujejo tako, da stimulirajo možgane in živ ne celice podobno kot dopamin, ki je sporo ilna snov v živ evju.
• ‘cardiac fibrosis' as a ‘very common' side effect (seen in more than 1 patient in 10 taking either medicine). 
• „sr na fibroza“ se ozna i kot „zelo pogost“ neželen u inek (opažen pri ve kot 1 bolniku izmed
The development of the symptoms of fibrosis has been known as a side effect of ergot-derived dopamine agonists for many years, particularly when the medicines are used for long periods. 
Pojav simptomov fibroze je že ve let znan neželeni u inek agonistov dopamina, ki so derivati ergot alkaloidov, zlasti e jih bolniki jemljejo dolgo asa.
Among the ergot-derived dopamine agonists, cabergoline and pergolide activate these receptors most strongly, possibly explaining the greater risk of fibrosis seen with these medicines. 
Med agonisti dopamina, ki so derivati ergot alkaloidov, te receptorje najmo neje aktivirata kabergolin in pergolid, kar je možna razlaga ve jega tveganja fibroze pri uporabi teh dveh zdravil.
The CHMP also recommended that companies that make these two medicines should conduct studies to look at how closely doctors follow the updated prescribing information and the impact that these changes have on the incidence of fibrosis of the heart valves. 
Poleg tega je CHMP priporo il, da družbe, ki izdelujejo zdravili, izvedejo študije, s katerimi bi ugotovili, kako natan no zdravniki upoštevajo posodobljene podatke o predpisovanju ter u inek teh sprememb na pojavnost fibroze sr nih zaklopk.
What are ergot-derived dopamine agonists? 
Kaj so agonisti dopamina, ki so derivati ergot alkaloidov?
The European Medicines Agency (EMEA) has completed a review of the safety of the ergot-derived dopamine agonists, a group of medicines that are mainly used to treat Parkinson's disease. 
Evropska agencija za zdravila (EMEA) je zaklju ila pregled varnosti agonistov dopamina, ki so derivati ergot alkaloidov.
The CHMP reviewed all of the available information on the risk of fibrosis and valve problems from clinical trials, observational studies (studies looking at the effects of medicines as they are used by patients) and ‘spontaneous reports' of side effects made by patients or doctors to the companies that make the medicines or to health authorities. 
CHMP je pregledal vse razpoložljive podatke o tveganju fibroze ter težav z zaklopkami iz klini nih preskušanj, opazovalnih študij (študij, v katerih preu ujejo u inke zdravil med njihovo uporabo pri len 31 Direktive 2001/83/ES, kakor je bila spremenjena, napotitveni postopek v interesu Skupnosti.
In addition, the CHMP recommended that a contraindication for patients with pre-existing valve problems should be included in the prescribing information for bromocriptine and dihydroergocryptine-containing medicines. 
CHMP je priporo il tudi, da se za zdravila, ki vsebujejo bromokriptin in dihidroergokriptin, v podatke o predpisovanju vklju i kontraindikacija za bolnike z obstoje imi težavami s sr nimi zaklopkami.
--1 ≥ 394AU/ml (Antigenic units determined by ELISA) (1400 AU corresponding to ≥ 492 AU in the potency test) 
--1 ≥ 492 AU/ml (Antigenske enote določene z ELISA testom) (1400 AU ustreza ≥ 492 AU v testu potentnost)
Vial (type I glass) closed with a rubber stopper secured with aluminium cap 
Intramuskularno Viala (steklo tipa I) zaprta z gumijastim zamaškom zatesnjenim z aluminijasto zaporko
10 vials Zero days 
10 vial
Strength Pharmaceutical form 
Način uporabe zdravila
EU Number 
Ovojnina
Invented name 
EU številka Izmišljeno ime Jakost Farmacevtska oblika
It was to be available as 10 mg tablets. 
Na voljo naj bi bilo v obliki 10-miligramskih tablet.