natgillin/translations-raw huggingface dataset:
Very rarely (may affect up to 1 in 10,000 people) Decreased sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (hypoaesthesia), excessive sweating (hyperhidrosis), itching, chest pain, chills, fever (pyrexia).
Zelo redki (pojavijo se lahko največ pri 1 od 10.000 bolnikov) zmanjšan občutek na dotik, kot je pekoč občutek, mravljinčenje ali občutek otrplosti v dlaneh, rokah, nogah ali stopalih (hipestezija), pretirano znojenje (hiperhidroza), srbenje, bolečine v prsnem košu, mrzlica, zvišana telesna temperatura (pireksija).
Do NOT take Respreeza
NE uporabljajte zdravila Respreeza
There are no data concerning the effect on fertility but as alpha1-proteinase inhibitor is a normal component of human blood, no adverse effects on fertility are expected if you use Respreeza at the recommended dose.
Ni podatkov o učinku na plodnost, vendar je zaviralec alfa1-proteinaze normalna sestavina človeške krvi, zato neželenih učinkov na plodnost pri uporabi priporočenega odmerka zdravila Respreeza ni za pričakovati.
Post authorisation efficacy study (PAES): A randomized, long-term PAES has been agreed to study the dose-relationship if the higher API levels achieved in the blood might influence the rate of lung density decline and whether that would support an increased dose of 120mg/kg the MAH should conduct and submit the results of a randomized, long term, efficacy study conducted according to an agreed protocol.
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Dogovorjena je bila randomizirana, dolgotrajna študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom za preučitev razmerja odmerka, če lahko višje ravniučinkovin, dosežene v krvi, vplivajo na stopnjo upada pljučne gostote, in ali to podpira večji odmerek 120 mg/kg.
Place the Respreeza vial on an even and firm surface.
Vialo z zdravilom Respreeza postavite na ravno in trdno podlago.
The total protein content is approximately 4,400 mg per vial.
Skupna vsebnost beljakovine je približno 4.400 mg na vialo.
Tell your doctor or healthcare professional immediately if you notice any sign of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands,
Zdravniku ali zdravstvenemu delavcu takoj povejte, če med apliciranjem zdravila Respreeza opazite kakršne koli znake alergijske reakcije (na primer mrzlico, vročinske oblive, hitrejše bitje srca, padec krvnega tlaka, občutek vrtoglavosti, izpuščaj, koprivnico, srbenje, težave z dihanjem ali požiranjem ter oteklost rok, obraza ali ust).
Using this medicine regularly increases the blood and lung levels of alpha1-proteinase inhibitor, thus slowing the progression of emphysema.
Redna uporaba tega zdravila poveča raven zaviralca alfa1-proteinaze v krvi in pljučih, kar upočasni napredovanje emfizema.
Non-clinical data reveal no special risk for humans based on safety pharmacology and short term toxicity studies.
Predklinični podatki na osnovi študij farmakološke varnosti in kratkotrajnih študij toksičnosti ne kažejo posebnega tveganja za človeka.
Epithelial lining fluid measurements (ELF) of alpha1-proteinase inhibitor levels showed a consistent increase following treatment.
Izmerjene vrednosti zaviralca alfa1-proteinaze v epitelijski tekočini so pokazale konsistentno povečanje po zdravljenju.
The total protein content is approximately 1,100 mg per vial.
Skupna vsebnost beljakovine je približno 1.100 mg na vialo.
Close the roller clamp.
Stišček zaprite.
This infusion rate may be adjusted, based upon patient tolerability.
Hitrost infundiranja se lahko prilagodi glede na to, kako bolnik prenaša zdravilo.
The active substance is alpha1-proteinase inhibitor.
Učinkovina je zaviralec alfa1-proteinaze.
Commonly (may affect up to 1 in 10 people) Dizziness, headache, shortness of breath (dyspnea), nausea.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) omotica, glavobol, zasoplost (dispneja), slabost (navzea).
Urticaria, rash (including exfoliative and generalized)
Bolezni kože in podkožja urtikarija, izpuščaj (vključno z eksfoliativnim in generaliziranim)
Wipe the rubber stopper of the water for injections vial with antiseptic solution and allow it to dry.
Gumijasti zamašek viale z vodo za injekcije obrišite z antiseptično raztopino in počakajte, da se posuši.
The solvent is a clear and colourless solution.
Vehikel je prozorna in brezbarvna raztopina.
Chest pain, chills, pyrexia
bolečine v prsnem košu, mrzlica, pireksija
• The reconstituted solution should be clear, colorless to slightly yellow, and free from visible particles.
• Rekonstituirana raztopina mora biti bistra, brezbarvna do rahlo rumenkasta in brez vidnih delcev.
SOLVENT VIAL
VIALA Z VEHIKLOM
Excipients : Sodium chloride, sodium dihydrogen phosphate monohydrate, mannitol.
Pomožne snovi: natrijev klorid, natrijev dihidrogenfosfat monohidrat, manitol.
Respreeza contains approximately 1.9 mg (<1 mmol) sodium per ml of reconstituted solution.
Zdravilo Respreeza vsebuje približno 1,9 mg (< 1 mmol) natrija na ml rekonstituirane raztopine.
Make sure that you only pull away the blister package and not the Mix2Vial set (Figure 3).
Glejte, da odstranite le pretisni omot in ne tudi kompleta Mix2Vial.
The solution should be clear, colourless to slightly yellow, and free from visible particles.
Raztopina mora biti bistra, brezbarvna do rahlo rumenkasta in brez vidnih delcev.
What Respreeza is used for
Za kaj se zdravilo Respreeza uporablja
The recommended dose of 60 mg per kg of body weight will take approximately 15 minutes to infuse.
Infundiranje priporočenega odmerka 60 mg na kg telesne mase traja približno 15 minut.
• 1°solvent vial of 95 ml water for injections
• 1 viala z vehiklom s 95 ml vode za injekcije
Asthenia, infusion-site reactions (including infusion site hematoma)
Splošne težave in spremembe na mestu aplikacije astenija, reakcije na mestu infundiranja (vključno s hematomom na mestu infundiranja)
Attach the administration set to the administration container.
Pripomoček za infundiranje priključite na vsebnik za apliciranje.
• 1°solvent vial of 76 ml water for injections
• 1 viala z vehiklom s 76 ml vode za injekcije
This medicine contains 1.9mg sodium perml of reconstituted solution.
To zdravilo vsebuje približno 1,9mg natrija na ml rekonstituirane raztopine.
The reconstituted solution must be administered using an intravenous administration set (not supplied).
Rekonstituirano raztopino morate aplicirati z uporabo kompleta za intravensko infundiranje (ni priloženo).
Since alpha1-proteinase inhibitor is a normal component of human blood, recommended dose of this medicine is not expected to cause harm to the developing foetus.
Ker je zaviralec alfa1-proteinaze normalna sestavina človeške krvi, ni za pričakovati, da bi priporočeni odmerek tega zdravila škodoval razvoju zarodka.
Sodium dihydrogen phosphate monohydrate Mannitol
Prašek: natrijev klorid natrijev dihidrogenfosfat monohidrat manitol
Respreeza 1,000 mg powder and solvent for solution for infusion Respreeza 4,000 mg powder and solvent for solution for infusion Respreeza 5,000 mg powder and solvent for solution for infusion
Respreeza 1.000 mg prašek in vehikel za raztopino za infundiranje Respreeza 4.000 mg prašek in vehikel za raztopino za infundiranje Respreeza 5.000 mg prašek in vehikel za raztopino za infundiranje
Take the Mix2Vial set together with the blister package and vertically pierce the water for injections vial with the blue tip of the Mix2Vial set (Figure 2).
Vzemite komplet Mix2Vial skupaj s pretisnim omotom in z modro konico kompleta Mix2Vial navpično prebodite vialo z vodo za injekcije (slika 2).
Altered sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (paraesthesia), flushing, hives (urticaria), scaly rash and rash all over the body, physical weakness (asthenia), infusion-site reactions (such as burning, stinging, pain, swelling or redness at the infusion site (hematoma)).
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) spremenjen občutek na dotik, kot je pekoč občutek, mravljinčenje ali občutek otrplosti v dlaneh, rokah, nogah ali stopalih (parestezija), vročinski oblivi, koprivnica (urtikarija), luskast izpuščaj in izpuščaj po vsem telesu, fizična oslabelost (astenija), reakcije na mestu infundiranja (kot je ščemenje, zbadanje, bolečina, oteklost ali rdečina na mestu infundiranja (hematom)).
CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Nemčija
ELF levels of antigenic alpha1-proteinase inhibitor and alpha1-proteinase inhibitor: NE complexes increased from baseline.
Ravni antigenskega zaviralca alfa1-proteinaze in zaviralca alfa1-proteinaze v epitelijski tekočini: Povečanje kompleksov NE od izhodišča.
The administration of Respreeza increases and maintains serum levels and lung epithelial lining fluid (ELF) levels of alpha1-proteinase inhibitor leading to a slowdown of the progression of emphysema.
Dajanje zdravila Respreeza poveča in ohranja ravni zaviralca alfa1-proteinaze v serumu in epitelijski tekočini pljuč, kar upočasni napredovanje emfizema.
Inspect visually the reconstituted solution.
Rekonstituirano raztopino preglejte s prostim očesom.
• 1°single-use powder vial
• 1 viala s praškom za enkratno uporabo
• 1°transfer set 20/20 (Mix2Vial set) for reconstitution
•1kompletza prenos 20/20(komplet Mix2Vial) za rekonstitucijo
CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany
CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Nemčija
- If you get any side effects, talk to your doctor or healthcare professional.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali zdravstvenim delavcem.
Wipe the rubber stopper of the Respreeza vial with antiseptic solution and allow it to dry.
Gumijasti zamašek viale zdravila Respreeza obrišite z antiseptično raztopino in počakajte, da se posuši.
Invert the water for injections vial with the Mix2Vial set attached and vertically pierce the Respreeza vial with the clear tip of the Mix2Vial set (Figure 4).
Obrnite vialo z vodo za injekcije, na katero je pritrjen komplet Mix2Vial, in navpično prebodite vialo z zdravilom Respreeza s prozorno konico kompleta Mix2Vial (slika 4).
• 1°solvent vial of 20 ml water for injections
• 1 viala z vehiklom z 20 ml vode za injekcije
Remove the plastic flip-top cap from the Respreeza vial.
Odstranite plastično zunanjo zaščitno zaporko z viale zdravila Respreeza.
The recommended dose of 60 mg / kg bw will take approximately 15 minutes to infuse.
Infundiranje priporočenega odmerka 60 mg/kg telesne mase traja približno 15 minut.
Follow the steps provided below for the preparation and reconstitution of Respreeza:
Za pripravo in rekonstitucijo zdravila Respreeza sledite spodnjim navodilom:
Since alpha1-proteinase inhibitor is an endogenous human protein, it is considered unlikely that Respreeza will cause harm to the foetus when given at recommended doses.
Ker je zaviralec alfa1-proteinaze endogena človeška beljakovina, ni verjetno, da bi zdravilo Respreeza škodovalo plodu, če se daje v priporočenih odmerkih.
One-hundred forty subjects (76 Respreeza-treated subjects and 64 subjects treated with placebo in the RAPID Study) continued into the RAPID extension study and were treated with a weekly 60 mg / kg bw intravenous dose of Respreeza for up to 24 months.
V podaljšek študije je bilo vključenih 140 preiskovancev (76 preiskovancev, ki so se v študiji RAPID zdravili z zdravilom Respreeza, in 64 preiskovancev, ki so prejemali placebo).
Powder for solution for infusion
prašek za raztopino za infundiranje
Posology The recommended dose of Respreeza is 60 mg / kg body weight (bw) administered once weekly.
Odmerjanje Priporočeni odmerek zdravila Respreeza je 60 mg/kg telesne mase, dan enkrat na teden.
Respreeza contains sodium
Zdravilo Respreeza vsebuje natrij
Powder and solvent for solution for infusion
prašek in vehikel za raztopino za infundiranje
• how to identify side effects, including signs of allergic reactions, and measures to be taken in case such effects occur (see also section 2 and section 4) Your doctor or your healthcare professional will regularly review your / your caregiver's infusion technique to ensure continued appropriate handling.
• kako identificirati neželene učinke, vključno z znaki alergijskih reakcij in ukrepi, ki jih je treba izvesti, če se pojavijo (glejte tudi poglavje 2 in poglavje 4).
Human alpha1-proteinase inhibitor 5,000 mg
humani zaviralec alfa1-proteinaze 5.000 mg
Human alpha1-proteinase inhibitor 4,000 mg
humani zaviralec alfa1-proteinaze 4.000 mg
Dizziness may occur after the administration of this medicine.
Po apliciranju tega zdravila se lahko pojavi omotica.
Human alpha1-proteinase inhibitor 1,000 mg
humani zaviralec alfa1-proteinaze 1.000 mg
Respreeza 5,000 mg powder and solvent for solution for infusion One vial contains approximately 5,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.
Respreeza 5.000 mg prašek in vehikel za raztopino za infundiranje Ena viala vsebuje približno 5.000 mg humanega zaviralca alfa1-proteinaze*, kot je določeno glede na zmogljivost nevtralizacije humane nevtrofilne elastaze.
A double-blind, randomized, active-controlled, crossover pharmacokinetic study was conducted in 13 males and 5 females with alpha1-proteinase inhibitor deficiency, ranging in age from 36 to 66 years.
S 13 moškimi in 5 ženskami s pomanjkanjem zaviralca alfa1-proteinaze, starih od 36 do 66 let, so izvedli dvojno slepo, randomizirano, z učinkovino nadzorovano navzkrižno farmakokinetično študijo.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca biološke učinkovine
Since human alpha1-proteinase inhibitor is an endogenous human protein, no adverse effects on fertility are expected when given at recommended doses.
Ker je humani zaviralec alfa1proteinaze endogena človeška beljakovina, ni verjetno, da bi v priporočenih odmerkih povzročili neželene učinke na plodnost.
Respreeza 4,000 mg powder and solvent for solution for infusion One vial contains approximately 4,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.
Respreeza 4.000 mg prašek in vehikel za raztopino za infundiranje Ena viala vsebuje približno 4.000 mg humanega zaviralca alfa1-proteinaze*, kot je določeno glede na zmogljivost nevtralizacije humane nevtrofilne elastaze.
• Inspect the reconstituted solution for particulate matter and discoloration prior to administration.
• Pred dajanjem preverite rekonstituirano raztopino, da ne vsebuje delcev ali, da ni obarvana.
Respreeza 1,000 mg powder and solvent for solution for infusion One vial contains approximately 1,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.
Respreeza 1.000 mg prašek in vehikel za raztopino za infundiranje Ena viala vsebuje približno 1.000 mg humanega zaviralca alfa1-proteinaze*, kot je določeno glede na zmogljivost nevtralizacije humane nevtrofilne elastaze.
After reconstitution with 95 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.
Po rekonstituciji s 95 ml vehikla vsebuje raztopina približno 50 mg/ml humanega zaviralca alfa1-proteinaze.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived proteinase inhibitors.
Pri bolnikih, ki redno/večkrat prejemajo zaviralce proteinaze, pridobljene iz človeške plazme, je treba razmisliti o ustreznem cepljenju (proti hepatitisu A in B).
After reconstitution with 76 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.
Po rekonstituciji s 76 ml vehikla vsebuje raztopina približno 50 mg/ml humanega zaviralca alfa1-proteinaze.
Respreeza 1,000 mg powder and solvent for solution for infusion 3 years
Respreeza 1.000 mg prašek in vehikel za raztopino za infundiranje 3 leta
Respreeza 5,000 mg powder and solvent for solution for infusion 2 years
Respreeza 5.000 mg prašek in vehikel za raztopino za infundiranje 2 leti
Uncommon (≥1/1,000 to
Pogostnost neželenih učinkov pogosti (≥1/100 do občasni (≥1/1.000 do zelo redki neznana
Eye disorders
Očesne bolezni otekle oči
After reconstitution with 20 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.
Po rekonstituciji z 20 ml vehikla vsebuje raztopina približno 50 mg/ml humanega zaviralca alfa1-proteinaze.
The MAH shall complete, within the stated timeframe, the below measures: Description
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
Follow steps below to remove entire Mix2Vial set from Respreeza vial:
Za odstranitev celotnega kompleta Mix2Vial iz viale z zdravilom Respreeza sledite spodnjim navodilom:
Respreeza 4,000 mg powder and solvent for solution for infusion 2 years
Respreeza 4.000 mg prašek in vehikel za raztopino za infundiranje 2 leti
Transmissible agents
Prenosljive snovi
What Respreeza contains
Kaj vsebuje navodilo
Respreeza 4,000 mg powder and solvent for solution for infusion Respreeza 4,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Respreeza 4.000 mg prašek in vehikel za raztopino za infundiranje Zdravilo Respreeza 4.000 mg prašek v stekleni viali (tip I), zaprti z gumijastim (bromobutilnim ali klorobutilnim) zamaškom in aluminijasto folijo in plastično dvižno zaporko.
What Respreeza is
Kaj je zdravilo Respreeza
Respreeza 1,000 mg powder and solvent for solution for infusion Respreeza 1,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Respreeza 1.000 mg prašek in vehikel za raztopino za infundiranje Zdravilo Respreeza 1.000 mg prašek v stekleni viali (tip I), zaprti z gumijastim (bromobutilnim ali klorobutilnim) zamaškom in aluminijasto folijo in plastično dvižno zaporko.
Respreeza 5,000 mg powder and solvent for solution for infusion Respreeza 5,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
Respreeza 5.000 mg prašek in vehikel za raztopino za infundiranje Zdravilo Respreeza 5.000 mg prašek v stekleni viali (tip I), zaprti z gumijastim (bromobutilnim ali klorobutilnim) zamaškom in aluminijasto folijo in plastično dvižno zaporko.
95 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
95 ml vode za injekcije v stekleni viali (tip I), zaprti z gumijastim (klorobutilnim) zamaškom in aluminijasto folijo in plastično dvižno zaporko.
Consequences of an overdose are unknown.
Če ste uporabili večji odmerek zdravila Respreeza, kot bi smeli Posledice prevelikega odmerjanja niso znane.
76 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
76 ml vode za injekcije v stekleni viali (tip I), zaprti z gumijastim (klorobutilnim) zamaškom in aluminijasto folijo in plastično dvižno zaporko.
Respreeza 5,000 mg powder and solvent for solution for infusion:
Respreeza 5.000 mg prašek in vehikel za raztopino za infundiranje:
Respreeza 1,000 mg powder and solvent for solution for infusion:
Respreeza 1.000 mg prašek in vehikel za raztopino za infundiranje:
Solvent for Respreeza
Vehikel za zdravilo Respreeza
Respreeza 4,000 mg powder and solvent for solution for infusion:
Respreeza 4.000 mg prašek in vehikel za raztopino za infundiranje:
20 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.
20 ml vode za injekcije v stekleni viali (tip I), zaprti z gumijastim (klorobutilnim) zamaškom in aluminijasto folijo in plastično dvižno zaporko.
Reporting of side effects If you get any side effects, talk to your doctor or healthcare professional.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali zdravstvenim delavcem.
1 solvent vial of 95 ml water for injections 1 transfer set 20/20 (Mix2Vial set) for reconstitution
1 viala s praškom za enkratno uporabo 1 viala z vehiklom z 95 ml vode za injekcije 1 komplet za prenos 20/20 (komplet Mix2Vial) za rekonstitucijo
A healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency will supervise the first infusions.
Prvo infundiranje bo nadziral zdravstveni delavec z izkušnjami v zdravljenju pomanjkanja zaviralca alfa1-proteinaze.
1 solvent vial of 76 ml water for injections 1 transfer set 20/20 (Mix2Vial set) for reconstitution
1 viala s praškom za enkratno uporabo 1 viala z vehiklom z 76 ml vode za injekcije 1 komplet za prenos 20/20 (komplet Mix2Vial) za rekonstitucijo
1 solvent vial of 20 ml water for injections 1 transfer set 20/20 (Mix2Vial set) for reconstitution
1 viala s praškom za enkratno uporabo 1 viala z vehiklom z 20 ml vode za injekcije 1 komplet za prenos 20/20 (komplet Mix2Vial) za rekonstitucijo
Patients with renal or hepatic impairment
Žilne bolezni vročinski oblivi
Talk to your doctor or healthcare professional before using Respreeza.
Pred začetkom uporabe zdravila Respreeza se posvetujtez zdravnikom ali zdravstvenim delavcem.
Respreeza 5,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor
Respreeza 5.000 mg prašek za raztopino za infundiranje humani zaviralec alfa1-proteinaze
Respreeza 1,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor
Respreeza 1.000 mg prašek za raztopino za infundiranje humani zaviralec alfa1-proteinaze
Respreeza 4,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor
Respreeza 4.000 mg prašek za raztopino za infundiranje humani zaviralec alfa1-proteinaze
Respreeza 5,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor
Respreeza 5.000 mg prašek in vehikel za raztopino za infundiranje humani zaviralec alfa1-proteinaze
Respreeza 4,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor
Respreeza 4.000 mg prašek in vehikel za raztopino za infundiranje humani zaviralec alfa1-proteinaze
One solvent vial of 95°ml water for injections One transfer set 20/20 (Mix2Vial set) for reconstitution
Respreeza 5.000 mg prašek in vehikel za raztopino za infundiranje: ena viala s praškom za enkratno uporabo ena viala z vehiklom z 95 ml vode za injekcije en komplet za prenos 20/20 (komplet Mix2vial) za rekonstitucijo
Respreeza 1,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor
Respreeza 1.000 mg prašek in vehikel za raztopino za infundiranje humani zaviralec alfa1-proteinaze
This summary was last updated in July 2010.
Povzetek je bil nazadnje posodobljen 07-2010.
Pigs and horses should not be slaughtered for 5 days.
Prašičev in konjev se ne sme klati 5 dni.
Accidental self-injection may cause pain.
Nenamerno samoinjiciranje lahko povzroči bolečino.
They usually occur during the first week of treatment and tend to be temporary.
Najpogosteje se pojavijo v prvem tednu zdravljenja in so večinoma prehodni.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) MELOXIDYL EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) MELOXIDYL Povzetek EPAR za javnost
The European Commission granted a marketing authorisation valid throughout the European Union for Meloxidyl to Ceva Santé Animal on 15 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Meloxidyl, veljavno po vsej Evropski uniji, odobrila družbi Ceva Santé Animal dne 15. januarja 2007.
Other information about Meloxidyl:
Druge informacije o zdravilu Meloxidyl:
After the last administration of Meloxidyl cattle should not be slaughtered for 15 days and the milk not used for 5 days.
Govedo, ki je prejelo zdravilo Meloxidyl, se ne sme klati 15 dni, mleko goveda pa se ne sme uporabljati 5 dni po zadnjem odmerku.