natgillin/translations-raw huggingface dataset:
Gastrointestinal haemorrhage (G3/4:
Očesne bolezni motnja solzenja (S3/4:
Onycholysis (G3/4: 1%)
Pogosti neželeni učinki oniholiza (S3/4: 1 %)
Abdominal pain (G3/4:
Bolezni prebavil bolečine v trebuhu (S3/4:
Intravenous use.
viala za enkratno uporabo intravenska uporaba
The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane on 7 October 2002.
Evropska komisija je dovoljenje za promet z zdravilom Protaphane, veljavno po vsej Evropski uniji, odobrila dne 7. oktobra 2002.
What measures are being taken to ensure the safe and effective use of Protaphane?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Protaphane?
The full EPAR for Protaphane is available ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protaphane je na voljo na: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Protaphane
Druge informacije o zdravilu Protaphane
This is a summary of the European public assessment report (EPAR) for Protaphane.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Protaphane.
A risk management plan has been developed to ensure that Protaphane is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Protaphane je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Protaphane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Protaphane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Protaphane's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Protaphane večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Protaphane, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Protaphane in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What benefit has Protaphane shown during the studies?
Kakšne koristi je zdravilo Protaphane izkazalo med študijami?
Protaphane has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Zdravilo Protaphane so preučili v štirih glavnih kliničnih preskušanjih, v katere je bilo vključenih skupno 557 bolnikov s sladkorno boleznijo tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina (dve študiji, 81 bolnikov), ali s sladkorno boleznijo tipa 2, pri kateri telo ne more učinkovito izrabiti insulina (dve študiji, 476 bolnikov).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protaphane.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Protaphane, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In most patients, Protaphane was compared with other types of human insulin or insulin analogues.
Pri večini bolnikov so zdravilo Protaphane primerjali z drugimi vrstami humanega insulina ali analogi insulina.
The most common side effect with Protaphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Najpogostejši neželeni učinek zdravila Protaphane (opažen pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
What is the risk associated with Protaphane?
Kakšna tveganja so povezana z zdravilom Protaphane?
The active substance in Protaphane, human insulin, is produced by a method known as ‘recombinant technology': it is made by yeast cells into which a gene (DNA) has been introduced which makes them able to produce insulin.
Zdravilna učinkovina v zdravilu Protaphane, humani insulin, se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri se v celice kvasovk vstavi gen (DNK), ki jim daje sposobnost tvorjenja insulina.
The studies measured the level of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
V študijah so merili raven glukoze v krvi na tešče ali glikoziliranega hemoglobina (HbA1c, tj. hemoglobina v krvi, na katerega se je vezala glukoza).
Protaphane contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
V zdravilu Protaphane je insulin zmešan z drugo snovjo, tj. protaminom, v obliki „izofan“, ki se čez dan absorbira mnogo počasneje.
Protaphane is used to treat diabetes.
Zdravilo Protaphane se uporablja za zdravljenje sladkorne bolezni.
Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
Zdravilo Protaphane se je izkazalo kot učinkovito tako pri sladkorni bolezni tipa 1 kot pri sladkorni bolezni tipa 2, in sicer pri uporabi običajne injekcijske brizge ali enega od napolnjenih peresnikov.
Protaphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Zdravilo Protaphane je privedlo do znižanja ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kot pri drugih humanih insulinih.
Protaphane is a suspension for injection that contains the active substance human insulin.
Zdravilo Protaphane je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino humani insulin.
Why has Protaphane been approved?
Zakaj je bilo zdravilo Protaphane odobreno?
Protaphane is a replacement insulin which is very similar to the insulin made by the pancreas.
Zdravilo Protaphane je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
Protaphane is given by injection under the skin, usually in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Zdravilo Protaphane se injicira v podkožje stegna, trebušne stene (sprednjega dela trebuha), glutealnega predela (zadnjice) ali deltoidnega predela (ramena).
Further studies were also carried out in 225 patients comparing injecting Protaphane using a syringe, or using a pre-filled pen (InnoLet or FlexPen).
V dodatnih študijah zdravila Protaphane, ki so jih opravili na 225 bolnikih, so injiciranje zdravila Protaphane z injekcijsko brizgo primerjali z injiciranjem tega zdravila z napolnjenim peresnikom (InnoLet ali FlexPen).
Protaphane is a long-acting insulin.
Zdravilo Protaphane je dolgodelujoči insulin.
How has Protaphane been studied?
Kako je bilo zdravilo Protaphane raziskano?
This gives Protaphane a longer duration of action.
To podaljša čas delovanja zdravila Protaphane.
What is Protaphane used for?
Za kaj se zdravilo Protaphane uporablja?
How does Protaphane work?
Kako zdravilo Protaphane deluje?
What is Protaphane?
Kaj je zdravilo Protaphane?
Pack size l t o r
Pot uporabe Stična ovojnina Velikost pakiranja o č
Via Virgilio Maroso, 50, 00142 Rome, Italy
Via Virgilio Maroso, 50, 00142 Rome, Italija
Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Vienna, Austria
Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Vienna, Avstrija
Budějovická 778/3, Michle 140 00 Prague 4, Czech Republic
Budějovická 778/3, Michle 140 00 Prague 4, Češka republika
Budějovická 778/3, Michle, 140 00 Prague, Czech Republic
Budějovická 778/3, Michle, 140 00 Prague, Češka republika
Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Spain
Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Španija
Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Ireland
Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Irska kapsule, mehke
Arnulfstrasse 29, München, 80636,Germany
Bristol-Myers Squibb GmbH & Co. KGaA Arnulfstrasse 29, München, 80636, Nemčija
300 MBq/ml Solution for injection
300 MBq/ml Raztopina za injiciranje
What SOMAC Control is and what it is used for
Kaj je zdravilo SOMAC Control in za kaj ga uporabljamo
To avoid this interference, SOMAC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Da bi to preprečili, je treba vsaj pet dni pred meritvami CgA prekiniti zdravljenje z zdravilom SOMAC Control (glejte poglavje 5.1).
What SOMAC Control is and what it is used for What you need to know before you take SOMAC Control How to take SOMAC Control Possible side effects
Kaj je zdravilo SOMAC Control in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo SOMAC Control Kako jemati zdravilo SOMAC Control Možni neželeni učinki
If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping SOMAC Control.
Če se pojavijo lezije, zlasti na koži, ki je izpostavljena soncu, in sočasna artralgija, mora bolnik takoj poiskati zdravniško pomoč, zdravstveni delavec pa mora razmisliti o prekinitvi zdravljenja z zdravilom SOMAC Control.
What you need to know before you take SOMAC Control
Kaj morate vedeti, preden boste vzeli zdravilo SOMAC Control
Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg
Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Nemčija
How to store SOMAC Control Contents of the pack and other information
Shranjevanje zdravila SOMAC Control Vsebina pakiranja in dodatne informacije
You must not use SOMAC Control if you are taking HIV protease inhibitors.
Zdravila SOMAC Control ne smete uporabljati, če jemljete zaviralce proteaze
SOMAC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Zdravilo SOMAC Control vsebuje zdravilno učinkovino pantoprazol, ki zavira “črpalko”, ki proizvaja želodčno kislino.
SOMAC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Zdravilo SOMAC Control je na voljo v Alu/Alu pretisnih omotih s kartonsko oporo ali brez nje.
However, you may take SOMAC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Zdravilo SOMAC Control lahko po potrebi jemljete skupaj z antacidi (npr. magaldrat, alginska kislina, natrijev hidrogenkarbonat, aluminijev hidroksid, magnezijev karbonat ali kombinacije naštetih).
The following additional risks are considered relevant for long-term use
Pri dolgotrajni uporabi je treba upoštevati naslednja dodatna tveganja:
You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with SOMAC Control, but this medicine is not meant to bring immediate relief.
Simptomi kislega refluksa in zgage se lahko ublažijo že po enem dnevu zdravljenja z zdravilom SOMAC Control, vendar pa to zdravilo ni namenjeno za dosego takojšnjega olajšanja.
Other medicines and SOMAC Control
Druga zdravila in zdravilo SOMAC Control
- reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body stores of Vitamin B12 - fracture of your hip, wrist or spine, especially if you already suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Če zdravilo SOMAC Control prejemate daljše obdobje, lahko to povzroči dodatna tveganja, kot so: - zmanjšana absorpcija vitamina B12 in pomanjkanje vitamina B12, če že imate nizke telesne zaloge vitamina B12 - zlom kolka, zapestja ali hrbtenice, še posebej, če že trpite zaradi osteoporoze ali če jemljete kortikosteroide (ki lahko povečajo tveganje za osteoporozo).
What SOMAC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Izgled zdravila SOMAC Control in vsebina pakiranja Gastrorezistentne tablete so rumene, ovalne, obojestransko izbočene filmsko obložene tablete z oznako “P20” na eni strani.
SOMAC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Zdravilo SOMAC Control lahko zmanjša absorpcijo zdravilnih učinkovin, katerih biološka uporabnost je odvisna od pH želodčnega soka (npr. ketokonazol).
See ‘Other medicines and SOMAC Control'.
Glejte “Druga zdravila in zdravilo SOMAC Control” v nadaljevanju.
SOMAC Control should not be used during breast-feeding.
Zdravila Somac Control se med dojenjem ne sme uporabljati
Do not take SOMAC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Ne jemljite zdravila SOMAC Control z drugimi zdravili, ki zavirajo izločanje želodčne kisline, kot so drugi zaviralci protonske črpalke (omeprazol, lansoprazol ali rabeprazol) ali antagonisti histaminskih receptorjev H2 (npr. ranitidin, famotidin).
What SOMAC Control contains - The active substance is pantoprazole.
Kaj vsebuje zdravilo SOMAC Control - Zdravilna učinkovina je pantoprazol.
SOMAC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila SOMAC Control pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
If you take more SOMAC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Če ste vzeli večji odmerek zdravila SOMAC Control, kot bi smeli Če ste vzeli večji odmerek zdravila SOMAC Control, kot bi smeli, o tem obvestite svojega zdravnika ali farmacevta.
Do not take a double dose to make up for the forgotten dose.
Če ste pozabili vzeti zdravilo SOMAC Control Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
- You should not take SOMAC Control tablets for more than 4 weeks without consulting a doctor.
- SOMAC Control tablet ne smete jemati dlje kot 4 tedne brez posveta z zdravnikom.
How to take SOMAC Control
Kako jemati zdravilo SOMAC Control
SOMAC Control 20 mg gastro-resistant tablets Pantoprazole
SOMAC Control 20 mg gastrorezistentne tablete pantoprazol
SOMAC Control 20 mg gastro-resistant tablets
SOMAC Control 20 mg gastrorezistentne tablete
SOMAC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
SOMAC Control 20 mg gastrorezistentnih tablet se ne sme žvečiti ali drobiti.
Do not take SOMAC Control tablets for more than 4 weeks without consulting your doctor.
Ne jemljite tablet SOMAC Control več kot 4 tedne brez posveta pri zdravniku.
SOMAC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Zdravilo SOMAC Control uporabljamo za kratkotrajno zdravljenje simptomov refluksa (na primer zgaga, regurgitacija kisline) pri odraslih.
SOMAC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Zdravilo SOMAC Control je indicirano za kratkotrajno zdravljenje simptomov refluksa (npr. zgaga, regurgitacija kisline) pri odraslih.
SOMAC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
Zdravila SOMAC Control ne smejo jemati otroci in mladostniki, mlajši od 18 let.
Agranulocytosis Thrombocytopenia; Leukopenia,
Bolezni krvi in limfatičnega sistema agranulocito za trombocitop enija, levkopenija, pancitopenij
Especially medicines containing one of the following active substances: - HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection).
Zdravilo SOMAC Control lahko vpliva na delovanje nekaterih drugih zdravil, še posebej zdravil, ki vsebujejo naslednje zdravilne učinkovine: - če jemljete zaviralce proteaze HIV, kot sta atazanavir; nelfinavir (za zdravljenje okužbe z virusom HIV).
Do not take SOMAC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Ne jemljite zdravila SOMAC Control - če ste alergični na pantoprazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
How to store SOMAC Control
Shranjevanje zdravila SOMAC Control
Liver enzymes increased (transaminases , γ-GT)
Bolezni jeter, žolčnika in žolčevodov zvišana vrednost jetrnih encimov (aminotransfera ze, γ-GT)
However adverse reactions such as dizziness and visual disturbances may occur (see section 4.8).
Zdravilo SOMAC Control nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev, vendar pa se lahko pojavijo neželeni učinki, kot so omotica in motnje vida (glejte poglavje 4.8).
Hyperlipidaemias and lipid increases (triglycerides, cholesterol);
Presnovne in prehranske motnje hiperilipide mije in zvišana vrednost lipidov (trigliceridi, holesterol), spremembe telesne mase hiponatriemija, hipomagneziemija, hipokalciemija
anaphylactic reactions and anaphylactic shock)
Bolezni imunskega sistema preobčutljiv ost (vključno z anafilaktični mi reakcijami in anafilaktični m šokom)
Reproductive system and breast disorders
Motnje reprodukcije in dojk ginekomastij
- methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your SOMAC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Če jemljete metotreksat, lahko zdravnik začasno prekine zdravljenje z zdravilom SOMAC Control,
Stop taking SOMAC Control when you are completely symptom-free.
Ko simptomi bolezni popolnoma minejo, zdravilo SOMAC Control nehajte jemati.
SOMAC Control may stop certain other medicines from working properly.
saj boste morda morali prekiniti zdravljenje z zdravilom SOMAC Control.
National Competent Authorities of Member State(s) or Reference Member State(s) if applicable shall ensure that the following conditions are fulfilled by the MAH(s):
Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic bodo zagotovili, kadar je to ustrezno, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
ATCvet code: QP51AX08.
Oznaka ATCvet: QP51AX08.
The product should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Zdravilo ne sme priti v vodotoke, ker je lahko nevarno za ribe in druge vodne organizme.
Do not use in case of diarrhoea established for more than 24 hours and in weak animals.
Ne uporabite pri driskah, ki trajajo dlje kot 24 ur, in pri oslabelih živalih.
0.03 mg For the full list of excipients, see section 6.1.
0,03 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3) If the metering pump is used for the first time (or hasn't been used for a few days), carefully pump till a drop of solution is formed on top of the nozzle.
3) Če merilno črpalko uporabljate prvič (ali je niste uporabljali nekaj dni), previdno črpajte, dokler se na vrhu šobe ne pojavi kaplja raztopine.
Adverse reactions (frequency and seriousness)
4.6 Neželeni učinki (pogostost in resnost)
Not for use in animals from which milk is produced for human consumption
Ne uporablja se za živali, katerih mleko je namenjeno za prehrano ljudi
Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.
Po dajanju zdravila prvemu teletu ga moramo sistematično dajati vsem naslednjim novorojenim teletom, vse dokler traja nevarnost driske, ki jo povzroča C. parvum.
The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 μg/ml and IC90 of 4.5
Koncentraciji, potrebni za 50- in 90-odstotno zaviranje parazitov v preskusu in vitro, sta: IC50 < 0,1 µg/ml in IC90 4,5 µg/ml.
1) Screw the metering pump on the bottle.
1) Merilno črpalko navijte na steklenico.
The bioavailability of the drug in the calf following single oral administration is about 80%.
Biološka razpoložljivost zdravila je pri teletih po enkratnem peroralnem odmerku približno 80 %.
Date of first authorisation: 13/12/2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 13/12/2016
In very rare cases, an increase in the level of diarrhoea has been observed in treated animals.
Zelo redko se lahko pri zdravljenih živalih poveča pojavnost driske.
Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Halofuginon laktat je sol, katere učinek proti protozojem in Cryptosporidium parvum so dokazali in vitro ter pri umetnih in naravnih okužbah.
Benzoic acid (E210)
Benzojska kislina (E210)
Should clinical signs of overdosing occur, the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer.
Če se pojavijo znaki, ki jih povzroča prevelik odmerek, moramo zdravljenje nemudoma prekiniti in žival hraniti z mlekom ali mlečnim nadomestkom brez dodanega zdravila.
In case of skin and eye contact wash the exposed area thoroughly with clean water.
V primeru nenamernega razlitja po koži ali stika z očmi kožo ali oči temeljito sperite s čisto vodo.
It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
Pretežno je učinkovita proti prostim oblikam parazita (sporozoitom,
Each bottle is sealed with a polypropylene cap. Each package also contains a 4 ml metering pump that consists of several components made out of high, low and linear low density polyethylene, polypropylene, stainless steel and silicone.
Vsako pakiranje vsebuje tudi merilno črpalko za odmerjanje 4 ml z več sestavnimi deli iz polietilena visoke in nizke gostote ter linearnega polietilena nizke gostote, polipropilena, nerjavnega jekla in silikona.
For smaller or higher weights, a precise calculation should be performed (4 ml/20 kg).
Za teleta z manjšo ali večjo telesno maso je treba odmerek natančno izračunati (4 ml/20 kg).
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Ne uporabite v primeru preobčutljivosti za zdravilno učinkovino ali za katero koli pomožno snov.
Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone.
Farmakoterapevtska skupina: drugi antiprotozoiki, halofuginon.
71 08503 Gurb-Vic, Barcelona Spain
71 08503 Gurb-Vic, Barcelona Španija
5) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.
5) Sprožilec merilne črpalke potegnite do konca, da odmerite odmerek, ki ustreza 4 ml raztopine.
Wear protective gloves while handling the product.
Uporabljajte zaščitne rokavice.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
(EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu, niso vključene v Uredbo (ES) št. 470/2009.
Active substance:
Pomožni snovi:
0.50 mg Equivalent to 0.6086 mg of halofuginone lactate
0,50 mg Enakovredno 0,6086 mg halofuginonovega laktata.
Shelf-life after first opening the container: 6 months.
EXP {mesec/leto} Rok uporabnosti po prvem odpiranju vsebnika: 6 mesecev.