natgillin/translations-raw huggingface dataset:
Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradno sproščanje serije: skladno s 114. členom Direktive 2001/ 83/ ES s spremembami bo uradno sproščanje serije opravil državni laboratorij ali laboratorij, določen za ta namen.
Privigen 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Ig)
Human plasma protein.............100 mg IgG purity................................. ≥ 98% IgA.....................................≤ 0.025 mg
En ml vsebuje: humane plazemske beljakovine100 mg čistost IgG............................... ≥ 98% IgA..................................... ≤ 0, 025 mg
5 g/50 ml 10 g/100 ml 20 g/200 ml Will be placed in the upper right corner of the main face of the box to give total content and volume of the container
5 g/ 50 ml 10 g/ 100 ml 20 g/ 200 ml Oznaka za skupen volumen in volumen vsebnika bo v zgornjem desnem kotu prednje strani škatle.
L-proline, water for injections.
L- prolin, voda za injekcije.
Solution for infusion (10%)
Raztopina za infundiranje (10- odstotna)
CSL Behring GmbH D-35041 Marburg Germany
CSL Behring GmbH D- 35041 Marburg Nemčija
LOT
Serija
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
16 PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
Human plasma protein:
En ml vsebuje: humane plazemske beljakovine:
100 mg; IgG purity: ≥ 98%.
100 mg; čistost IgG: ≥ 98%.
5 g/50 ml 10 g/100 ml 20 g/200 ml Will be placed in the upper right corner of the label to give total content and volume of the container
5 g/ 50 ml 10 g/ 100 ml 20 g/ 200 ml Oznaka za skupen volumen in volumen vsebnika bo v zgornjem desnem kotu embalaže.
CSL Behring GmbH, D-35041 Marburg, Germany
CSL Behring GmbH, D- 35041 Marburg, Nemčija
Privigen 100 mg/ml (10%) solution for infusion Human normal immunoglobulin (IVIg)
Ig)
- If you have any further questions, ask your doctor or health care professional.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali zdravstvenim delavcem.
please tell your doctor or health care professional.
omenjen v tem navodilu, obvestite svojega zdravnika ali zdravstvenega delavca.
What Privigen is and what it is used for 2.
Kaj je zdravilo Privigen in za kaj ga uporabljamo 2.
Before you receive Privigen 3.
Kaj morate vedeti, preden boste uporabili zdravilo Privigen 3.
How to use Privigen 4.
Kako uporabljati zdravilo Privigen 4.
How to store Privigen 6.
Shranjevanje zdravila Privigen 6.
WHAT PRIVIGEN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PRIVIGEN IN ZA KAJ GA UPORABLJAMO
What Privigen is
Kaj je zdravilo Privigen
Privigen is a ready-to-use solution for infusion.
Privigen je raztopina za infundiranje, pripravljena za uporabo.
The solution contains special proteins, isolated from human blood plasma.
Raztopina vsebuje posebne beljakovine, izolirane iz človeške krvne plazme.
These proteins belong to the class of "immunoglobulins", also called antibodies.
Te beljakovine spadajo v razred » imunoglobulinov «, ki se imenujejo tudi protitelesa.
Antibodies are usually produced by our immune system and help the body to fight infections.
Telesu pomagajo pri boju proti okužbam.
Certain diseases can cause severe disturbance of the immune system.
Nekatere bolezni lahko povzročijo hude motnje imunskega sistema.
Because of this, you may not have enough of your own antibodies or you may need additional antibodies.
Zaradi tega morda ne boste imeli dovolj lastnih protiteles ali pa boste potrebovali dodatna protitelesa.
The antibodies which are given to you by Privigen can complement your own antibodies or substitute missing antibodies.
Protitelesa, ki jih dobite z zdravilom Privigen, lahko dopolnijo vaša lastna protitelesa ali nadomestijo manjkajoča protitelesa.
The antibodies in Privigen are isolated from human blood plasma.
Protitelesa v zdravilu Privigen so izolirana iz človeške krvne plazme.
Therefore they work exactly as if they were your own antibodies.
Zato delujejo tako kot vaša protitelesa.
Privigen can also reduce the symptoms in certain inflammatory disorders.
Zdravilo Privigen lahko zmanjša tudi simptome nekaterih vnetnih motenj.
In these cases Privigen is regulating the malfunctioning immune system.
V teh primerih zdravilo Privigen uravnava nepravilno delujoč imunski sistem.
However, these effects are not fully understood.
Vendar pa teh učinkov ne razumemo popolnoma.
What Privigen is used for
Za kaj se zdravilo Privigen uporablja
Privigen is used in three different situations:
Zdravilo Privigen se uporablja v treh različnih primerih:
A) Treatment of patients with too few antibodies (replacement therapy).
Zdravljenje bolnikov s premalo protitelesi (nadomestno zdravljenje).
There are three groups:
A)
Patients with an inborn lack of antibodies (primary immunodeficiency syndromes (PID)) such as: ● congenital agammaglobulinaemia or hypogammaglobulinaemia, ● common variable immunodeficiency, ● severe combined immunodeficiency, ● Wiskott Aldrich syndrome.
bolniki s prirojenim pomanjkanjem protiteles (primerni imunodeficitni sindromi – PID), kot so: ● kongenitalna agamaglobulinemija ali hipogamaglobulinemija, ● navadna spremenljiva imunodeficienca, ● huda kombinirana imunodeficienca, ● Wiskott- Aldrichov sindrom;
Patients with certain kinds of blood cancer which lead to a lack of antibody production and recurrent infections such as: ● myeloma, ● chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia.
bolniki z nekaterimi vrstami krvnega raka, ki povzročijo odsotnost tvorbe protiteles in ponavljajoče se okužbe, kot so: ● mielom, ● kronična limfocitna levkemija s hudo sekundarno hipogamaglobulinemijo; 20
Children who suffer from inborn AIDS (Acquired Immunodeficiency Syndrome) and recurrent infections.
otroci s prirojenim aidsom (pridobljeno imunsko pomanjkljivostjo) in ponavljajočimi se okužbami.
B) Treatment of patients with certain inflammatory disorders (immunomodulation).
B) Zdravljenje bolnikov z nekaterimi vnetnimi motnjami (imunomodulacijo).
Patients who do not have enough blood platelets (immune thrombocytopenic purpura (ITP)) and ● who are at high risk of bleeding, ● will have a surgery in the near future.
bolniki s premajhnim številom trombocitov (idiopatično trombocitopenično purpuro – ITP) in ● velikim tveganjem krvavitve, ● ki bodo imeli v bližnji prihodnosti kirurški poseg;
Patients with Guillain-Barré syndrome.
bolniki z Guillain- Barréjevim sindromom.
This is an acute disease of primarily young children characterised by an inflammation of the blood vessels throughout the body.
To je akutna bolezen, ki se večinoma pojavi pri majhnih otrocih, za katero je značilno vnetje krvnih žil po celem telesu.
C) Treatment or prevention of infections after a bone marrow transplantation (allogeneic bone marrow transplantation).
C) Zdravljenje ali preprečevanje okužb po presaditvi krvnega mozga (transplantaciji alogenskega krvnega mozga).
BEFORE YOU RECEIVE PRIVIGEN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PRIVIGEN
Please read this section carefully.
Prosimo, da pozorno preberete to poglavje.
The information given should be taken in to consideration by you and your doctor before you receive Privigen.
Preden prejmete zdravilo Privigen, morate vi in vaš zdravnik upoštevati te informacije.
Privigen must not be used
Ne uporabljate zdravila Privigen
► If you are allergic (hypersensitive)
► Če ste alergični na (preobčutljivi za):
to human immunoglobulins, to any other ingredient of Privigen (for a complete list of ingredients see section 6 of this leaflet).
humane imunoglobuline; katero koli sestavino zdravila Privigen (za celoten seznam pomožnih snovi glejte 6. poglavje teh navodil).
Please tell your doctor or health care professional prior to treatment about any medicine or food which you have not well tolerated earlier.
Pred zdravljenjem zdravniku ali zdravstvenemu delavcu povejte za katero koli zdravilo ali hrano, ki je niste dobro prenašali.
have antibodies against immunoglobulins of the type IgA in your blood.
► Če imate v krvi protitelesa proti imunoglobulinom vrste IgA.
This is very rare and may occur if you do not have enough immunoglobulins of the type IgA in your blood.
To je zelo redko in se lahko pojavi, če nimate dovolj imunoglobulinov vrste A v krvi.
Please tell your doctor or health care professional prior to treatment if you have an immunoglobulin type IgA deficiency. ► If you have too much of the amino acid proline in your blood (hyperprolinaemia).
Pred zdravljenjem zdravniku ali zdravstvenemu delavcu povejte za pomanjkanje imunoglobulina vrste IgA. ► Če imate v krvi preveč aminokisline prolina (hiperprolinemijo).
Please tell your doctor or health care professional prior to treatment if you have too much proline in your blood.
Pred zdravljenjem zdravniku ali zdravstvenemu delavcu povejte, da imate v krvi preveč prolina.
Take special care with Privigen
Bodite posebno pozorni pri uporabi zdravila Privigen
► The risk of having certain side effects may be increased in the following circumstances:
► Tveganje nekaterih neželenih učinkov se lahko poveča pri naslednjih okoliščinah:
● ● ● ● ●
● ● ● ● ● ● ● ● ● ● ● ●
you are overweight, you are elderly, you have diabetes, you have been bedridden for a longer time, you have or have already had problems with your blood vessels (vascular diseases or blockage of a vessel),
debelost; starost; sladkorna bolezen; dolgotrajna priklenjenost na posteljo; če imate ali ste že imeli težave s krvnimi žilami (žilne bolezni ali zaporo žile); če imate ali ste že imeli ledvične težave; visok krvni tlak; premajhen krvni volumen (hipovolemija); bolezen, ki povzroča zgostitev krvi; povečana nagnjenost k strjevanju krvi (trombofilija); stanje, ki povzroča nizko raven protiteles v krvi (hipogamaglobulinemija ali agamaglobulinemija); ledvična bolezen;
21
jemanje zdravil, ki lahko poškodujejo ledvice (nefrotoksična zdravila); 21
you suffer from a condition that causes low antibody levels in your blood (hypogammaglobulinaemia or agammaglobulinaemia),
prvo prejemanje zdravila Privigen ali prejemanje zdravila Privigen po dolgi prekinitvi zdravljenja (na primer po več mesecih).
Please tell your doctor or health care professional prior to treatment if at least one of these circumstances applies to you.
Pred zdravljenjem obvestite zdravnika ali zdravstvenega delavca, če je pri vas prisotna vsaj ena od teh okoliščin.
Your doctor will then choose the right intravenous immunoglobulin for you and will take special precautions.
Zdravnik se bo odločil za ustrezen intravenski imunoglobulin in bo upošteval posebne previdnostne ukrepe.
► You may be allergic (hypersensitive) to immunoglobulins (antibodies) without knowing it.
► Na (za) imunoglobuline (protitelesa) ste lahko alergični (preobčutljivi), pa tega ne veste.
This may occur even if you have previously received human immunoglobulins and had tolerated them well.
To se lahko zgodi celo, če ste že prejemali humane imunoglobuline in jih dobro prenašali.
It may happen particularly if you do not have enough immunoglobulins of the type IgA in your blood.
To se lahko zgodi predvsem, če v krvi nimate dovolj imunoglobulinov vrste IgA.
In these rare cases allergic reactions such as a sudden fall in blood pressure or shock may occur.
V teh redkih primerih se lahko pojavijo alergijske reakcije, kot je nenadno znižanje krvnega tlaka ali šok.
If you notice such reactions during the infusion of Privigen, please tell your doctor immediately.
Če med infundiranjem zdravila Privigen opazite take reakcije, o tem takoj obvestite zdravnika.
He will decide whether to slow down the infusion rate or whether to abort the infusion completely.
Odločil se bo za upočasnitev infundiranja ali njegovo popolno prekinitev.
For your personal safety the treatment with Privigen will take place under the supervision of your doctor or health care professional.
Zaradi vaše osebne varnosti bo zdravljenje z zdravilom Privigen potekalo pod nadzorom zdravnika ali zdravstvenega delavca.
Examples of such circumstances are: ● you are receiving Privigen at a high infusion rate or ● you are receiving Privigen for the first time or after a long break in treatment (e.g. several months).
Taki primeri so: ● zdravilo Privigen prejemate pri veliki hitrosti infundiranja ali ● zdravilo Privigen prejemate prvič ali pa zdravilo Privigen prejemate po dolgi prekinitvi zdravljenja (na primer po več mesecih).
In these cases you will be closely observed during the whole infusion and for at least 1 hour thereafter.
V teh primerih vas bodo skrbno opazovali med celotnim infundiranjem in vsaj še eno uro po njem.
Information on the starting material of Privigen Privigen is made from human blood plasma (this is the liquid part of the blood).
Informacije o vhodnih snoveh za zdravilo Privigen Zdravilo Privigen je narejeno iz človeške krvne plazme (tekočega dela krvi).
These include ● careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and ● the testing of each donation and pools of plasma for signs of virus/infections.
Mednje spadajo: ● skrbna izbira darovalcev krvi in plazme, da se zagotovi izključitev tveganj za prenos okužb, in ● preiskovanje vsake darovane in zbrane plazme za znake virusa/ okužb.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Proizvajalci teh zdravil vključijo tudi korake pri obdelavi krvi ali plazme, ki lahko deaktivirajo ali odstranijo viruse.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A and B19 viruses.
Ukrepi so učinkoviti proti virusom z ovojnico, kot so virus imunske pomanjkljivosti (HIV), virusa hepatitisa B in C, ter za viruse brez ovojnice – virus hepatitisa A in viruse B19.
Immunoglobulins like Privigen have not been associated with hepatitis A or B19 infections.
Imunoglobulini, kot je zdravilo Privigen, niso bili povezani z okužbami s hepatitisom A ali virusom B19.
This is possibly because antibodies against these infections are also present in immunoglobulins.
To je verjetno zato, ker so protitelesa proti tem okužbam prisotna tudi v imunoglobulinih.
► It is strongly recommended that every time you receive a dose of Privigen the name and batch number of the product are recorded in order to maintain a record of the batches used.
Ta protitelesa lahko pomagajo preprečiti okužbe z virusom hepatitisa A in B19. ► Močno se priporoča, da se vsakič, ko prejmete odmerek zdravila Privigen, zapišete ime in serijo zdravila, da bi vzdrževali evidenco uporabljenih serij.
Taking Privigen with other medicines
Jemanje drugih zdravil
Please tell your doctor or health care professional prior to treatment
Pred zdravljenjem obvestite svojega zdravnika ali zdravstvenega delavca,
if you are currently taking any other medicines or if you have recently taken any other medicines.
če jemljete katero koli zdravilo ali če ste pred kratkim jemali katero koli zdravilo,
This also includes non-prescription medicines.
tudi če ste ga dobili brez recepta.
22 Vaccinations After receiving Privigen, the efficacy of certain vaccinations may be impaired.
Cepljenje Po zdravljenju z zdravilom Privigen je lahko učinkovitost nekaterih cepiv zmanjšana.
In the case of measles vaccinations the impairment may persist for up to one year.
Pri ošpicah lahko zmanjšana učinkovitost cepiva traja do enega leta.
Therefore your vaccinating doctor should check the efficacy of the measles vaccination.
Zato mora zdravnik, ki vas bo cepil, preveriti učinkovitost cepiva proti ošpicam.
Please tell your vaccinating doctor prior to a vaccination about your treatment with Privigen.
Pred cepljenjem zdravnika, ki vas bo cepil, obvestite o zdravljenju z zdravilom Privigen.
Blood tests After receiving Privigen, the results of certain blood tests (serological tests) may be impaired for a certain time.
Krvne preiskave 22 Po prejemu zdravila Privigen so lahko rezultati nekaterih krvnih (seroloških) preiskav nekaj časa poslabšani.
Please tell your doctor about your treatment with Privigen prior to any blood test.
Pred katero koli krvno preiskavo zdravnika obvestite o jemanju zdravila Privigen.
Please tell your doctor or health care professional if you are pregnant or breast-feeding.
Če ste noseči ali dojite, o tem obvestite zdravnika ali zdravstvenega delavca.
The use of Privigen in pregnant or breast-feeding women has not been studied separately.
Uporabe zdravila Privigen pri nosečnicah in doječih materah niso preučevali ločeno.
Nevertheless, medicines containing antibodies have been used in pregnant or breast-feeding women.
Kljub temu pa so se zdravila, ki vsebujejo protitelesa, uporabljala pri nosečnicah in doječih materah.
The long-time experience showed that no harmful effects on the course of the pregnancy or the newborn are to be expected.
Dolgotrajne izkušnje so pokazale, da ni pričakovati škodljivih učinkov na potek nosečnosti ali novorojenčka.
If you receive Privigen while you are breast-feeding the antibodies in th is medicine will also be found in the breast milk.
Če prejmete zdravilo Privigen, ko dojite, bodo protitelesa tega zdravila tudi v materinem mleku.
Thus also your baby can receive the protecting antibodies.
Zato lahko tudi vaš dojenček prejme zaščitna protitelesa.
No effects of Privigen on the ability to drive and use machines are expected.
Pri zdravilu Privigen ni pričakovati nobenega vpliva na sposobnost vožnje in upravljanja strojev.
HOW TO USE PRIVIGEN
KAKO UPORABLJATI ZDRAVILO PRIVIGEN
► Privigen is usually administered by your doctor or health care professional. ► Privigen is intended solely for the infusion into a vein (intravenous infusion). ► Your doctor decides how much Privigen you will receive.
► Zdravilo Privigen navadno infundira zdravnik ali zdravstveni delavec. ► Zdravilo Privigen je namenjeno samo infundiranju v veno (intravensko infundiranje). ► O količini zdravila Privigen, ki jo boste prejeli, odloči zdravnik.
The amount depends on your illness, your present condition and your body weight. ► At the beginning of the infusion you will receive Privigen at a slow infusion rate.
Količina je odvisna od bolezni, trenutnega stanja in telesne mase. ► Na začetku infundiranja boste zdravilo Privigen prejeli z majhno hitrostjo.
If you tolerate this well your doctor can gradually increase the infusion rate.
Če ga boste dobro prenašali, bo zdravnik postopoma povečal hitrost infundiranja.
If you receive more Privigen than you should
Če ste uporabili večji odmerek zdravila Privigen, kot bi smeli:
Privigen is usually administered under medical supervision only.
Zdravilo Privigen se navadno daje samo pod zdravniškim nadzorom.
Overdose is therefore very unlikely to occur.
Zato ni verjetno, da bo prišlo do prevelikega odmerjanja.
This may happen particularly if you are a patient at risk, for example if you are elderly or if you suffer from a kidney disease.
To se lahko zgodi predvsem, če ste bolnik s tveganjem, na primer, če ste starejša oseba ali imate ledvično bolezen.
Like all medicines, Privigen can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Privigen neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
► You may be allergic (hypersensitive) to immunoglobulins (antibodies) and allergic reactions such as a sudden fall in blood pressure or shock may occur.
► Morda ste alergični na (preobčutljivi za) imunoglobuline (protitelesa), pri čemer se pojavijo alergijske reakcije, kot je nenadno znižanje krvnega tlaka ali šok.
23 Please see also section 2 of this leaflet about the risk of allergic reactions.
Glejte tudi 2. poglavje teh navodil o tveganju za alergijske reakcije.
► Possible side effects may be reduced or even avoided by infusing Privigen at a slow infusion rate.
► Morebitni neželeni učinki se lahko zmanjšajo ali se jim lahko celo izognete z infundiranjem zdravila Privigen pri majhni hitrosti.
The general experience with immunoglobulin preparations showed that the following side effects may occur: ● headache, ● chills, ● fever, ● vomiting, ● mild hypersensitivity reactions (allergic reactions), ● nausea, ● pain in the joints (arthralgia), ● low blood pressure, ● moderate low back pain.
Splošne izkušnje s pripravki imunoglobulina so pokazale, da se lahko pojavijo naslednji neželeni učinki: ● glavobol, ● mrzlica, ● zvišana telesna temperatura, ● bruhanje, 23 ● blage preobčutljivostne reakcije (alergijske reakcije), ● slabost, ● bolečina v sklepih (artralgija), ● nizek krvni tlak, ● zmerna bolečina v križu.
In rare and isolated cases, the following side effects have also been reported with immunoglobulin preparations: ● temporary non-infectious meningitis (reversible aseptic meningitis), ● transient skin reactions, ● increase in blood creatinine level, ● acute renal failure, ● sudden fall in blood pressure, ● severe hypersensitivity reactions (anaphylactic shock), even when you have shown no hypersensitivity on previous infusions, ● formation of blood clots which may be carried off in the blood circulation (thromboembolic reactions) and which may result e.g. in:
V redkih in posameznih primerih so pri pripravkih imunoglobulina poročali tudi o naslednjih neželenih učinkih: ● začasni neinfekciozni meningitis (reverzibilni aseptični meningitis); ● prehodne kožne reakcije; ● zvišana raven kreatinina v krvi; ● akutna ledvična odpoved; ● nenadno znižanje krvnega tlaka; ● hude preobčutljivostne reakcije (anafilaktični šok), celo kadar preobčutljivosti ni bilo pri predhodnih infundiranjih; ● tvorba krvnih strdkov, ki lahko potujejo po krvnem obtoku (trombembolične reakcije) in lahko povzročijo:
myocardial infarction, stroke, lung vein blockage (pulmonary embolism), deep vein thrombosis,
miokardni infarkt, možgansko kap, zaporo pljučne vene (pljučno embolijo), globoko vensko trombozo;
● transient decrease of red blood cells (reversible haemolytic anaemia/haemolysis).
● prehodno zmanjšanje števila eritrocitov (reverzibilna hemolitična anemija/ hemoliza).
Such side effects may occur even when you have previously received human immunoglobulins (antibodies) and had tolerated them well.
Ti neželeni učinki se lahko pojavijo celo, če ste že prejemali humane imunoglobuline (protitelesa) in jih dobro prenašali.
Please tell your doctor or health care professional
Obvestite zdravnika ali zdravstvenega delavca;
if any of the side effects gets serious or if you notice any side effects not listed in this leaflet.
če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželen učinek, ki ni omenjen v tem navodilu.
HOW TO STORE PRIVIGEN
SHRANJEVANJE ZDRAVILA PRIVIGEN
► Keep out of the reach and sight of children.
► Zdravilo shranjujte nedosegljivo otrokom!
Do not use Privigen after the expiry date which is stated on the outer carton and the vial label after EXP.
Zdravila Privigen ne smete uporabljati po izteku roka uporabnosti, ki je naveden na zunanji škatli in viali poleg oznake EXP.
► Do not store above 25 °C. ► Do not freeze. ► Keep the vial in the outer carton in order to protect from light.
Zdravilo shranjujte pri temperaturi do 25 °C. ► ► Ne zamrzujte. ► Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Do not use Privigen if you notice that the solution is cloudy or has particles.
Ne uporabljajte zdravila Privigen, če opazite, da je raztopina motna ali vsebuje delce.
What Privigen contains
Kaj vsebuje zdravilo Privigen
● The active substance is human normal immunoglobulin (antibodies of the type IgG).
● Zdravilna učinkovina je humani polispecifični imunoglobulin (protitelesa vrste IgG).
Privigen contains 100 mg/ml (10%) human protein of which at least 98% is IgG. ● The other ingredients are the amino acid L-proline and water for injections.
Zdravilo Privigen vsebuje 100 mg/ ml (10%) človeške beljakovine, od katere je vsaj 98% IgG. ● Pomožne snovi so aminokislina L- prolin in voda za injekcije.
Pack size of 1 vial (5 g/50 ml, 10 g/100 ml or 20 g/200 ml).
Velikost pakiranja 1 viala (5 g/ 50 ml, 10 g/ 100 ml ali 20 g/ 200 ml).
Vagajeva ulica 4 SI-1000 Ljubljana Tel: +386 1 25 71 496
Vagajeva ulica 4 SI- 1000 Ljubljana Tel.: +386 1 25 71 496
This leaflet was last approved in 04/2008.
Navodilo je bilo odobreno 04/ 2008.