natgillin/translations-raw huggingface dataset:
10 ml Type I glass vial with an isobutylene-isoprene (Teflon-laminated) rubber stopper and a flip-off cap.
10- ml steklena viala (iz stekla tipa I) z izobutilen- izoprenskim (teflonsko- laminiranim) gumijastim zamaškom in snemljivo zaporko.
The vial is wrapped with an UV-protective film.
Viala je prevlečena z UV- zaščitnim slojem.
Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall.
Aseptično je treba izvleči 5 mililitrov 9 mg/ ml (0, 9%) raztopine natrijevega klorida za infundiranje ali 50 mg/ ml (5%) raztopine glukoze za infundiranje (iz 100 ml steklenice/ vrečke) in jih ob notranji steni viale počasi injicirati v vsako vialo.
The refore, please discard unused reconstituted concentrate immediately.
Zato neporabljen koncentrat takoj zavrzite.
4.
13 4.
All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
Iz vsake viale je treba potegniti ves koncentrat in ga vbrizgati v infuzijsko steklenico/ vrečko, iz katere je bila originalno vzeta raztopina.
The diluted infusion solution should be
Razredčeno raztopino za infundiranje je treba uporabiti takoj.
The infusion bottle/ bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming.
NE SME pa se je stresati, ker sicer nastane pena.
The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.
Infuzijsko steklenico/ vrečko, ki vsebuje razredčeno raztopino za infundiranje, je treba za zaščito pred svetlobo vložiti v neprosojno vrečko, ki jo je mogoče zapreti.
Mycamine vial to be used (mg/vial)
Viala zdravila Mycamine, ki jo je treba uporabiti (mg/ vialo)
Volume of sodium chloride (0.9%) or glucose (5%) to be added per vial
Volumen natrijevega klorida (0, 9%) ali glukoze (5%), ki se ga doda na vialo
Standard infusion (added up to 100 ml) Final concentration
Standardna infuzija (dodano do 100 ml) Končna koncentracija
5 ml (20 mg/ml)
približno 5 ml (10 mg/ ml) približno 5 ml (20 mg/ ml) približno 10 ml približno 10 ml
1. 5 mg/ ml
0, 5 mg/ ml 1, 0 mg/ ml 1, 5 mg/ ml 2, 0 mg/ ml
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Each 100 mg vial contains 200 mg lactose.
Vsaka 100 mg viala vsebuje 200 mg laktoze.
Consideration should be given to official/national guidance on the appropriate use of antifungal agents.
Upoštevane morajo biti uradne/ nacionalne smernice za primerno uporabo sredstev proti glivicam.
15 The dose regimen of Mycamine depends on the body weight of the patient as given in the following tables:
15 Režim odmerjanja zdravila Mycamine je odvisen od telesne mase bolnika in je predstavljen v spodnjih tabelah:
100 mg/day* 150 mg/day 50 mg/day
100 mg/ dan * 150 mg/ dan 50 mg/ dan
2 mg/kg/day* 3 mg/kg/day 1 mg/kg/day
2 mg/ kg/ dan * 3 mg/ kg/ dan 1 mg/ kg/ dan
*If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients ≤ 40 kg.
* Če je odziv bolnika nezadosten, npr. ponavljajoči se pozitivni rezultati kulture ali če se klinično stanje ne izboljša, se lahko odmerek pri bolnikih s telesno maso > 40 kg poveča na 200 mg/ dan, pri bolnikih s telesno maso ≤ 40 kg pa na 4 mg/ kg/ dan.
100 mg/day* 50 mg/day
100 mg/ dan * 50 mg/ dan
2 mg/kg/day* 1 mg/kg/day
2 mg/ kg/ dan * 1 mg/ kg/ dan
*If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg.
* Če je odziv bolnika nezadosten, npr. ponavljajoči se pozitivni rezultati kulture ali če se klinično stanje ne izboljša, se lahko odmerek pri bolnikih s telesno maso > 40 kg poveča na 200 mg/ dan, pri bolnikih s telesno maso ≤ 40 kg pa na 4 mg/ kg/ dan.
Gender/Race No dose adjustment is necessary based on gender or race (see section 5.2).
Spol/ rasa Prilagoditev odmerka zaradi spola ali rase ni potrebna (glejte poglavje 5. 2).
16 4.3 Contraindications
16 Po pripravi raztopine in redčenju je treba raztopino dati v obliki intravenske infuzije v približno eni uri.
Hypersensitivity to the active substance or to any of the excipients.
Hitrejše infundiranje lahko povzroči pogostejše reakcije, v katerih ima glavno vlogo histamin.
4.4 Special warnings and precautions for use
Za navodila za pripravo zdravila glejte poglavje 6. 6.
The development of foci of altered hepatocytes (FAH) and hepatocellular tumours after a treatment period of 3 months or longer were observed in rats.
4. 3 Kontraindikacije
To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended.
Za zmanjšanje tveganja adaptivne regeneracije in morebiten posledičen nastanek jetrnih tumorjev na najmanjšo možno mero, je v primeru značilnega in trajnega povišanja ALT/ AST priporočljiva predčasna prekinitev terapije.
Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties.
Zdravljenje z mikafunginom mora biti osnovano na temeljiti oceni razmerja med tveganjem in koristjo, še posebej pri bolnikih s hudimi motnjami v delovanju jeter, ali kronično boleznijo jeter, za katero je bilo ugotovljeno, da predstavlja preneoplastično stanje, kot je napredovala jetrna fibroza, ciroza, virusni hepatitis, neonatalna jetrna bolezen ali prirojeni encimski defekt, ali bolnikih deležnih sočasnega zdravljenja s hepatotoksičnimi in/ ali genotoksičnimi lastnostmi.
Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction between micafungin and mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole and amphotericin B.
17 Pri zdravih preiskovancih so izvedli študije medsebojnega delovanja, da bi ocenili možnost medsebojnega delovanja med mikafunginom in mofetilmikofenolatom, ciklosporinom, takrolimusom, prednizolonom, sirolimusom, nifedipinom, flukonazolom, ritonavirjem, rifampicinom, itrakonazolom, vorikonazolom in amfotericinom B.
17 Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
18%).
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother.
Odločitev o nadaljevanju/ prekinitvi dojenja ali nadaljevanju/ prekinitvi zdravljenja z zdravilom Mycamine mora temeljiti na oceni koristi dojenja za otroka in koristi zdravljenja z zdravilom Mycamine za mater.
The se patients had a wide variety of complex underlying conditions such as haematological malignancies and HIV-infection or were transplant recipients and/or treated in intensive care.
Ti bolniki so imeli široko paleto sočasno prisotnih kompleksnih bolezni, kot so maligne krvne bolezni in okužbe s HIV, so bili prejemniki presadkov in/ ali so se zdravili na oddelku intenzivne nege.
System Organ
18 Organski sistem
Common
Pogosti ≥ 1/ 100 do < 1/ 10
Uncommon
Občasni ≥ 1/ 1. 000 do < 1/ 100
Rare
Redki ≥ 1/ 10. 000 do < 1/ 1. 000
Not known
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
Class
Bolezni krvi in
≥ 1/100 to < 1/10
levkopenija, nevtropenija,
≥ 1/1,000 to < 1/100
pancitopenija,
≥
hemolitična
1/10,000 to < 1/1,000
limfatičnega
(frequency cannot be
anemija
estimated from available data)
trombocitopenija,
18 System Organ
anemija,
Common
sistema
Uncommon
eozinofilija,
Rare
hemoliza
Not known
(glejte poglavje 4. 4)
Class
Presnovne in
≥ 1/100 to < 1/10
hipokaliemija,
≥ 1/1,000 to < 1/100
hiponatriemija,
≥
prehranske
1/10,000 to < 1/1,000
hipomagneziemija,
(frequency cannot be
hiperkaliemija,
estimated from available data) Blood and lymphatic system disorders
motnje Psihiatrične motnje
leukopenia, neutropenia, anaemia
hipokalciemija
pancytopenia, thrombocytopenia, eosinophilia, hypoalbuminaemia
hipofosfatemija, anoreksija nespečnost, anksioznost, konfuznost
haemolytic anaemia, haemolysis (see section 4.4)
Bolezni živčevja Srčne bolezni
Immune system disorders
glavobol
anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity
zaspanost, tremor, omotičnost, paragevzija tahikardija, palpitacije, bradikardija
Endocrine disorders
Žilne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
hyperhidrosis
flebitis
hypokalaemia, hypomagnesaemia, hypocalcaemia
hipotenzija, hipertenzija, zardevanje (vročinski obliv) dispneja
hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia
šok
phlebitis
hepatocelularne
dyspnoea
okvare,
19 System Organ
kreatinina v krvi, povečana vrednost sečnine v krvi, poslabšanje ledvičnega 19
Common
(glejte poglavje 4. 4), akutna ledvična odpoved Neznana
≥ 1/100 to < 1/10
(pogostnosti ni
1/10,000 to < 1/1,000
≥ 1/ 1. 000 do < 1/ 100 popuščanja
(frequency cannot be
≥ 1/ 10. 000 do < 1/ 1. 000
renal impairment (see section 4.4), acute renal failure
mogoče oceniti iz razpoložljivih podatkov)
injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
tromboza na mestu injiciranja, vnetje na mestu infundiranja, bolečina na mestu injiciranja, periferni edem povečana koncentracija laktat- dehidrogenaze v krvi
20 Renal and urinary disorders common
20 Bolezni sečil akutna ledvična odpoved, povečana vrednost sečnine v krvi pogosti
Commonly susceptible species [MIC ranges in Europe, mg/l] Candida albicans [0.007 - 0.25]
Pogosto občutljivi sevi [razpon MIC v Evropi, mg/ l] Candida albicans [0, 007– 0, 25] Candida glabrata [0, 007– 0, 12] Candida tropicalis [0, 007– 0, 12]
21 Candida glabrata [0.007 - 0.12] Candida tropicalis [0.007 - 0.12] Candida krusei [0.015 - 0.12] Candida kefyr [0.03 - 0.06] Candida parapsilosis [0.12 - 2] Candida guilliermondii [0.5] Candida lusitaniae [0.12 - 0.25] Candida spp.
21 Candida krusei [0, 015– 0, 12] Candida kefyr [0, 03– 0, 06] Candida parapsilosis [0, 12– 2] Candida guilliermondii [0, 5] Candida lusitaniae [0, 12– 0, 25] Candida spp.
Amphotericin B
Amfotericin B v obliki liposomov
[95% CI]
% razlike [95% interval zaupanja]
Adult Patients
Odrasli bolniki
Neutropenia at baseline
% razlike [95% interval zaupanja]
24
31 24 (77, 4) 6 (66, 7)
18 (75.0)
10 7 (70, 0)
15
Stari 2 do 15 let
12 (80.0)
22 14 (63, 6)
0.7 [-5.3, 6.7] ‡
19 14 (73, 7)
No neutropenia at baseline
Candida albicans
178
102
163 (91.6) 175
89 (90, 8)
158 (90.3)
133 (88, 1)
Paediatric Patients
123 (87, 9) 49 (96, 1)
Overall Treatment Success
C. parapsilosis
35 (72.9)
35 (79, 5)
2 to 15 years old
C. glabrata
19
19 (82, 6)
14 (73.7)
14 (82, 4)
Adults and Children Combined, Overall Treatment Success by Candida Species
C. krusei
Candida albicans Non-albicans species ¶: all C. tropicalis C. parapsilosis C. glabrata C. krusei
9
102 151 59 48 23 9
8 (88, 9)
91 (89.2) 133 (88.1) 54 (91.5) 41 (85.4) 19 (82.6) 8 (88.9)
7
98 140 51 44 17 7
6 (85, 7)
Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg.
23 Farmakokinetika je v območjih dnevnih odmerkov od 12, 5 mg do 200 mg in od 3 mg/ kg do 8 mg/ kg linearna.
Distribution Following intravenous administration concentrations of micafungin show a biexponential decline.
Porazdelitev Po intravenski aplikaciji padajo koncentracije mikafungina bieksponentno.
23 In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
V sistemskem krvnem obtoku se mikafungin v veliki meri veže na plazemske beljakovine (> 99%), predvsem na albumin.
The development of foci of altered hepatocytes (FAH) and hepatocellular tumours in rats was dependent on both dose and duration of micafungin treatment.
24 Razvoj žarišč spremenjenih hepatocitov (FAH) in hepatocelični tumorji pri podganah sta bila odvisna od odmerka in trajanja zdravljenja z mikafunginom.
No standard carcinogenicity studies have been conducted but the development of FAH was assessed in female rats after up to 20 and 18 months after cessation of a 3 and 6 month treatment, respectively.
18 mesecev po prekinitvi 3 oz.
In both studies
6 mesečnega zdravljenja.
24 increased incidences/numbers of hepatocellular tumours were observed after the 18 and 20 month treatment free period in the high dose group of 32 mg/kg/day as well as in a lower dose group (although not statistically significant).
V obeh študijah je bila opažena povečana incidenca/ število hepatoceličnih tumorjev, ki so jih opazili po 18 in 20 mesečnih obdobjih brez zdravljenja v skupini z velikim odmerkom (32 mg/ kg/ dan) kot tudi v skupini z manjšim odmerkom (čeprav ni bila statistično pomembna).
Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)
laktoza monohidrat brezvodna citronska kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH)
25 6.2 Incompatibilities
6. 2 Inkompatibilnosti
Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall.
Aseptično je treba izvleči 5 mililitrov 9 mg/ ml (0, 9%) raztopine natrijevega klorida za infundiranje ali 50 mg/ ml (5%) raztopine glukoze za infundiranje (iz 100 ml steklenice/ vrečke)
26 4.
5.
The infusion bottle/bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming.
NE SME pa se je stresati, ker sicer nastane pena.
10 ml
približno 5 ml (10 mg/ ml) približno 5 ml (20 mg/ ml) približno 10 ml približno 10 ml
5 ml
0, 5 mg/ ml 1, 0 mg/ ml 1, 5 mg/ ml 2, 0 mg/ ml
27 ANNEX III
27 DODATEK III
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 PODATKI NA ZUNANJI OVOJNINI ŠKATLA
50 mg micafungin (as sodium).
50 mg mikafungina (v obliki natrijeve soli).
For intravenous infusion after reconstitution and dilution.
Za intravensko infundiranje po pripravi koncentrata in razredčenju.
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Mycamine 50 mg powder for solution for infusion Micafungin Intravenous use.
Mycamine 50 mg prašek za raztopino za infundiranje Mikafungin Intravenska uporaba.
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 PODATKI NA ZUNANJI OVOJNINI ŠKATLA
100 mg micafungin (as sodium).
100 mg mikafungina (v obliki natrijeve soli).
Mycamine 100 mg powder for solution for infusion Micafungin Intravenous use.
Mycamine 100 mg prašek za raztopino za infundiranje Mikafungin Intravenska uporaba.
What Mycamine is and what it is used for 2.
Kaj je zdravilo Mycamine in za kaj ga uporabljamo 2.
Before you use Mycamine 3.
Kaj morate vedeti, preden boste uporabili zdravilo Mycamine 3.
How to use Mycamine 4.
Kako uporabljati zdravilo Mycamine 4.
How to store Mycamine 6.
Shranjevanje zdravila Mycamine 6.
WHAT MYCAMINE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO MYCAMINE IN ZA KAJ GA UPORABLJAMO
It interferes with the production of a part of the fungal cell wall.
Zdravilo Mycamine učinkovito zdravi sistemske okužbe (okužba, ki je zajela večji del organizma), tako da ovira nastajanje dela celične stene glivic.
An intact cell wall is necessary for the fungus to continue living and growing.
Glivice za življenje in rast potrebujejo nepoškodovano celično steno.
Mycamine causes defects in the fungal cell wall, making the fungus unable to live and grow.
Zdravilo Mycamine celično steno glivic okvari in jim tako onemogoči življenje in rast.
• To treat adults, adolescents and children who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body). • To treat adults and adolescents ≥ 16 years of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is appropriate. • To treat adults, adolescents and children who are at risk of developing a Candida fungal infection that may penetrate the body.
• Za zdravljenje odraslih, mladostnikov in otrok z resno glivično okužbo, imenovano invazivna kandidoza (okužba, ki je zajela večji del organizma). • Za zdravljenje odraslih in mladostnikov, ki so stari 16 let ali več, z glivično okužbo v požiralniku, kadar je primerno intravensko zdravljenje. • Za zdravljenje odraslih, mladostnikov in otrok s tveganjem za razvoj sistemske glivične okužbe s Candido.
BEFORE YOU USE MYCAMINE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO MYCAMINE
Do not use Mycamine
Ne uporabljajte zdravila Mycamine
- if you are allergic (hypersensitive) to micafungin or any of the other ingredients of Mycamine.
- če ste alergični na (preobčutljivi za) mikafungin ali katerokoli sestavino zdravila Mycamine.
Take special care with Mycamine In rats, long-term treatment with micafungin led to liver damage and subsequent liver tumours.
Bodite posebno pozorni pri uporabi zdravila Mycamine Pri podganah je dolgotrajno zdravljenje z mikafunginom povzročilo poškodbe jeter in posledične jetrne tumorje.
- if you have haemolytic anaemia (anaemia due to breakdown of red blood cells) or haemolysis
- če imate hemolitično anemijo (anemijo zaradi razpadanja eritrocitov) ali hemolizo (razpadanje
(breakdown of red blood cells).
eritrocitov).
If this
- če imate težave z ledvicami (na primer ledvično odpoved in nenormalne rezultate preiskav
happens, your doctor may decide to monitor your kidney function more closely.
Če se to zgodi, se bo zdravnik morda odločil, da bo podrobneje spremljal delovanje ledvic.
Using Mycamine with food and drink As Mycamine is given intravenously (into a vein), no restrictions on food or drink are required.
Uporaba zdravila Mycamine skupaj s hrano in pijačo Za zdravilo Mycamine ni omejitev glede hrane in pijače, ker se uporablja intravensko (daje v veno).
Driving and using machines There is no information on the effect of Mycamine on the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni podatkov, da bi zdravilo Mycamine vplivalo na sposobnost upravljanja vozil ali strojev.
Important information about some of the ingredients of Mycamine If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Pomembne informacije o nekaterih sestavinah zdravila Mycamine Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
HOW TO USE MYCAMINE
KAKO UPORABLJATI ZDRAVILO MYCAMINE
Mycamine must be prepared and given to you by a doctor or another health care professional.
Zdravilo Mycamine mora pripraviti in vam ga dati zdravnik ali drug zdravstveni delavec.
Use in adults, adolescents ≥ 16 years of age and elderly
Uporaba pri odraslih, mladostnikih ≥ 16 let in starejših
- The usual dose to treat an invasive Candida infection is 100 mg per day for patients weighing
- Običajni odmerek za zdravljenje invazivne okužbe s Candida je 100 mg na dan za bolnike s
40 kg or more and 2 mg/kg per day for patients weighing 40 kg or less.
telesno maso 40 kg ali več in 2 mg/ kg za bolnike s telesno maso 40 kg ali manj.
- The dose to treat a Candida infection of the oesophagus is 150 mg for patients weighing more
- Odmerek za zdravljenja okužbe požiralnika s Candida je 150 mg za bolnike s telesno maso nad
than 40 kg and 3 mg/kg per day for patients weighing 40 kg or less.
40 kg in 3 mg/ kg za bolnike s telesno maso 40 kg ali manj.
- The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing
- Običajni odmerek za preprečevanje invazivnih okužb s Candida je 50 mg na dan za bolnike s
more than 40 kg and 1 mg/kg per day for patients weighing 40 kg or less.
telesno maso nad 40 kg in 1 mg/ kg na dan za bolnike s telesno maso 40 kg ali manj.
Use in children (including newborns) and adolescents < 16 years of age
Uporaba pri otrocih (vključno z novorojenčki) in mladostnikih < 16 let
40 kg or more and 2 mg/kg per day for patients weighing 40 kg or less.
telesno maso nad 40 kg in 2 mg/ kg za bolnike s telesno maso 40 kg ali manj.
If you receive more Mycamine than you should Your doctor monitors your response and condition to determine what dose of Mycamine is needed.
Če ste dobili večji odmerek zdravila Mycamine, kot bi smeli Zdravnik spremlja vaš odziv in vašo bolezen ter glede na to določi, kolikšen odmerek zdravila Mycamine potrebujete.
However, if you are concerned that you may have been given too much Mycamine, speak to your doctor or another health care professional immediately.
A če vas skrbi, da ste dobili preveč zdravila Mycamine, se takoj posvetujte z zdravnikom ali drugim zdravstvenim delavcem.
If you miss a dose of Mycamine Your doctor monitors your response and condition to determine what Mycamine treatment is needed.
Če ste izpustili odmerek zdravila Mycamine Zdravnik spremlja vaš odziv in vašo bolezen in glede na to določi, kakšno zdravljenje z zdravilom Mycamine je potrebno.
However, if you are concerned that you may have missed a dose, speak to your doctor or another health care professional immediately.
A če vas skrbi, da ste izpustili odmerek, se takoj posvetujte z zdravnikom ali drugim zdravstvenim delavcem.
38 Effects when treatment with Mycamine is stopped There are no known withdrawal symptoms.
38 Učinki, ko prenehate zdravljenje z zdravilom Mycamine Ni znanih odtegnitvenih simptomov.
Like all medicines, Mycamine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Mycamine neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The safety of Mycamine has been assessed in clinical trials.
Varnost zdravila Mycamine so ocenili v kliničnih preskušanjih.
Patients in these trials were critically ill, had a wide variety of other medical conditions, and required many other medicines.
Bolniki v teh preskušanjih so bili kritično bolni, imeli so različna druga zdravstvena stanja in so potrebovali mnogo drugih zdravil.
Mycamine may cause the following side effects:
Zdravilo Mycamine lahko povzroči naslednje neželene učinke:
Common (affects 1 to 10 users in 100)
Pogosti (prizadanejo 1 do 10 uporabnikov od 100)
- abnormal blood tests (decreased white blood cells [leucopenia; neutropenia]); decreased red blood
- nenormalne krvne preiskave (zmanjšano število belih krvničk [levkopenija, nevtropenija]),
cells (anaemia)
zmanjšano število rdečih krvničk (anemija)
- decreased potassium in the blood (hypokalaemia); decreased magnesium in the blood
- zmanjšana količina kalija v krvi (hipokaliemija), zmanjšana količina magnezija v krvi
(hypomagnesaemia); decreased calcium in the blood (hypocalcaemia)
(hipomagneziemija), zmanjšana količina kalcija v krvi (hipokalciemija)
- inflammation of the vein wall (at injection-site)
- vnetje venske stene (na mestu injiciranja)
- nausea (feeling sick); vomiting (being sick); diarrhoea; abdominal pain
- slabost, bruhanje, driska, bolečina v trebuhu
- abnormal liver function tests (increased alkaline phosphatase; increased aspartate
- nenormalne preiskave jetrnega delovanja (povečana vrednost alkalne fosfataze, povečana vrednost
aminotransferase, increased alanine aminotransferase)
aspartat- aminotransferaze, povečana vrednost alanin- aminotransferaze)
- increased bile pigment in the blood (hyperbilirubinaemia)
- povečana vrednost žolčnega pigmenta v krvi (hiperbilirubinemija)
- fever
- povečana telesna temperatura
- rigors (shivering)
- tresenje