natgillin/translations-raw huggingface dataset:
Enterobacteria Pseudomonas Acinetobacter Staphylococcus spp.1
Enterobacteria Pseudomonas Acinetobacter Staphylococcus spp. 1 Haemophilus influenzae in Moraxella catarrhalis Neisseria gonorrhoeae Neisseria meningitidis Mejne vrednosti za nespecifične vrste *
S ≤ 0.5 mg/ L S ≤ 0.5 mg/ L S ≤ 1 mg/ L S ≤ 1 mg/ L
S < 0, 5 mg/ l S < 0, 5 mg/ l S < 1 mg/ l S < 1 mg/ l S < 0, 5 mg/ l S < 0, 03 mg/ l S < 0, 03 mg/ l S < 0, 5 mg/ l
R > 1 mg/ L R > 1 mg/ L R > 1 mg/ L R > 1 mg/ L
R > 1 mg/ l R > 1 mg/ l R > 1 mg/ l R > 1 mg/ l R > 0, 5 mg/ l R > 0, 06 mg/ l R > 0, 06 mg/ l R > 1 mg/ l
124 COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
125 SPLOŠNO OBČULJIVE VRSTE aerobni, po Gramu pozitivni mikroorganizmi Bacillus anthracis( 1) aerobni, po Gramu negativni mikroorganizmi Aeromonas spp.
Citrobacter koseri Francisella tularensis Haemophilus ducreyi Haemophilus influenzae * Legionella spp.
Citrobacter koseri Francisellatularensis Haemophilus ducreyi Haemophilus influenzae * Legionella spp.
Yersinia pestis Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms Enterococcus faecalis($) Staphylococcus spp. *(2) Aerobic Gram-negative micro-organisms Acinetobacter baumannii+ Burkholderia cepacia+* Campylobacter spp. +* Citrobacter freundii* Enterobacter aerogenes Enterobacter cloacae * Escherichia coli* Klebsiella oxytoca Klebsiella pneumoniae* Morganella morganii* Neisseria gonorrhoeae* Proteus mirabilis* Proteus vulgaris* Providencia spp.
Yersinia pestis anaerobni mikroorganizmi Mobinculus drugi mikroorganizmi Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) VRSTE, PRI KATERIH JE PRIDOBLJENA ODPORNOST LAHKO DVOMLJIVA aerobni, po Gramu pozitivni mikroorganizmi Enterococcus faecalis ($) Staphylococcus spp. * (2) aerobni, po Gramu negativni mikroorganizmi Acinetobacter baumannii+ Burkholderia cepacia + * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
Pprotein binding of ciprofloxacin is low (20-30%).
Ciprofloksacin se slabo veže na plazemske beljakovine (20 - 30%) in je v plazmi prisoten pretežno v neionizirani obliki.
Metabolism
127 Presnova
126 Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4).
To so desetilenciprofloksacin (M1), sulfociprofloksacin (M2), oksociprofloksacin (M3) in formilciprofloksacin (M4).
Articular tolerability:
128 Vplivi zdravila na sklepe:
[To be completed nationally.]
[Izpolni država članica] 129 10.
128 1.
130 1.
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/ mL granules and solvent for oral suspension [See Annex I - To be completed nationally]
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 50 mg/ ml zrnca in vehikel za peroralno suspenzijo [Glejte Dodatek I – Izpolni država članica]
Granules and solvent for oral suspension [To be completed nationally]
zrnca in vehikel za peroralno suspenzijo [Izpolni država članica]
The Ciprofloxacin Bayer 50 mg/ mL oral suspension is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Zdravilo Ciprofloksacin Bayer 50 mg/ ml zrnca in vehikel za peroralno suspenzijo se uporablja za zdravljenje naslednjih okužb (glejte poglavji 4. 4 in 5. 1)..
- exacerbations of chronic obstructive pulmonary disease
– – –
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
eksacerbacije kronične obstruktivne pljučne bolezni okužbe dihal pri cistični fibrozi ali bronhiektazijah pljučnica
• Infections of the skin and soft tissue caused by Gram-negative bacteria
131 • okužbe kože in mehkih tkiv, ki jih povzročajo po Gramu negativne bakterije
129 • Malignant external otitis
• maligno vnetje zunanjega ušesa
Daily dose in mL (Number of 5-mL
dnevni odmerki (ml) (število 5- ml merilnih žličk)
measuring spoonfuls)
skupno trajanje zdravljenja (lahko vključuje tudi začetno parenteralno zdravljenje s ciprofloksacinom)
(potentially
okužbe spodnjih dihal
500 mg twice
500 mg do 750 mg
10 mL twice daily to
10 – 15 ml
daily to 750 mg
dvakrat na dan
15 mL twice daily
dvakrat na dan (dve do tri 5- ml merilne
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
žličke dvakrat na dan)
Indications
132 indikacije
(potentially
okužbe zgornjih dihal
including initial parenteral treatment with ciprofloxacin) Infections of
akutno poslabšanje kroničnega sinusitisa
500 mg twice
500 mg do 750 mg dvakrat na dan
10 mL twice daily to
10 – 15 ml dvakrat na dan (dve do tri 5- ml merilne žličke dvakrat na dan)
exacerbation of
kronično gnojno vnetje srednjega ušesa
daily to 750 mg
500 mg do 750 mg dvakrat na dan
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
10 – 15 ml dvakrat na dan (dve do tri 5- ml merilne žličke dvakrat na dan)
15 mL twice daily
maligno vnetje zunanjega ušesa
750 mg twice
750 mg
15 mL twice daily
dvakrat na 15 ml dan
28 days up to 3
dvakrat na 28 dni do 3 mesecev dan (tri 5- ml merilne
(three 5-mL measuring spoonfuls twice daily)
žličke dvakrat na dan) okužbe sečil
(one 5-mL measuring
nezapleten cistitis
spoonful twice daily up to two 5-mL measuring spoonfuls twice daily) In pre-menopausal women, 500 mg single dose may be used corresponding to 10 mL single dose = two 5-mL measuring spoonfuls as a single dose
250 mg do 500 mg 5 – 10 ml dvakrat 3 dni dvakrat na dan na dan (ena do dve 5- ml merilni žlički dvakrat na dan) Pri ženskah v premenopavzi se lahko uporabi 500 mg enkrat na dan (ustreza 10 ml enkrat na dan = dve 5- ml merilni žlički enkrat na dan)
cystitis, Uncomplicated pyelonephritis
zapleten cistitis, nezapleten pielonefritis
(two 5-mL measuring spoonfuls twice daily)
500 mg dvakrat na 10 ml dvakrat na 7 dni dan dan (dve 5- ml merilni žlički dvakrat na dan)
10 mL twice daily to
zapleten pielonefritis
at least 10 days, it
500 mg do 750 mg 10 – 15 ml najmanj 10 dni, v dvakrat na dan dvakrat na dan posebnih primerih je (dve do tri lahko podaljšano za 5- ml merilne več kot 21 dni (npr. žličke dvakrat na absces) dan)
daily to 750 mg
prostatitis
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
500 mg do 750 mg 10 – 15 ml 2 do 4 tednov dvakrat na dan dvakrat na dan (akutni) do (dve do tri 4 do 6 tednov 5- ml merilne (kronični) žličke dvakrat na dan)
Prostatitis
133 indikacije
500 mg twice
dnevni odmerki (mg)
(acute) to 4 to 6
dnevni odmerki (ml) (število 5- ml merilnih žličk)
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
skupno trajanje zdravljenja (lahko vključuje tudi začetno parenteralno zdravljenje s ciprofloksacinom)
131 Indications
okužbe spolovil
Daily dose in mL (Number of 5-mL
gonokokni uretritis in cervicitis
500 mg as a
500 mg enkrat na dan
10 mL as a single dose
10 ml enkrat na dan (dve 5- ml merilni žlički enkrat na dan)
1 day (single
1 dan (enkraten odmerek)
corresponding to two 5- mL measuring spoonfuls as a single dose
epididimo - orhitis in medenična vnetna bolezen
pelvic inflammatory diseases
okužbe prebavil in intraabdominalne okužbe
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
driska, ki jo povzročajo bakterije, tudi iz vrste Shigella spp., ne pa Shigella dysenteriae tipa 1 in empirično zdravljenje hude potovalne driske
500 mg twice
500 mg dvakrat na dan
10 mL twice daily
10 ml dvakrat na dan (dve 5- ml merilni žlički dvakrat na dan)
caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea
driska, ki jo povzroča Shigella dysenteriae tipa 1
500
500 mg dvakrat na dan
10 mL twice daily (two 5-mL measuring spoonfuls twice daily)
10 ml dvakrat na dan (dve 5- ml merilni žlički dvakrat na dan)
Typhoid fever
tifusna vročica
Intra-abdominal
intraabdominal
5 to 14 days
5 do 14 dni
Gram-negative bacteria
ne okužbe, ki jih povzročajo po Gramu
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
dvakrat na dan (dve do tri 5- ml merilne
132 Indications
negative bakterije
Daily dose in mg
žličke
measuring spoonfuls)
dvakrat na dan)
(potentially
okužbe kože in mehkih tkiv
500 mg twice
500 mg do
tissue
indikacije
daily to 750 mg
dnevni odmerki (mg)
15-mL twice daily
dnevni odmerki (ml) (število 5- ml merilnih žličk)
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
dvakrat na dan (dve do tri 5- ml merilne žličke dvakrat na dan)
(two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily)
zdravljenje okužb ali preprečevanje okužb pri bolnikih z nevtropenijo; ciprofloksacin je treba dati hkrati z ustreznim antibakterijskim zdravilom( i) v skladu z veljavnimi smernicami
the entire period of neutropenia
zdravljenje je treba nadaljevati ves čas nevtropenije
Prophylaxis of invasive
preprečevanje invazivnih okužb, ki jih povzroča Neisseria meningitidis
corresponding to two 5- mL measuring spoonfuls as a single dose
inhalacijski vranični prisad (zaščita in zdravljenje po izpostavitvi povzročitelju) pri osebah, ki se lahko zdravijo peroralno, če je to klinično primerno; zdravljenje je treba začeti takoj po domnevni ali potrjeni izpostavitvi povzročitelju.
60 days from the
60 dni od potrjene izpostavljenosti Bacillus anthracis
prophylaxis and curative
Otroci in mladostniki
daily
indikacije
(two 5-mL measuring
dnevni odmerki (mg in ml)
Drug administration should begin as soon as possible after suspected or confirmed exposure.
skupno trajanje zdravljenja (lahko vključuje tudi začetno parenteralno zdravljenje s ciprofloksacinom)
Total duration of
cistična fibroza
20 mg/ kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.4 mL/ kg body weight twice daily with a maximum of 15-mL per dose
20 mg/ kg telesne mase dvakrat na dan; največ 750 mg na odmerek kar odgovarja 0, 4 ml/ kg telesne mase dvakrat na dan; največ 15 ml na odmerek
Daily dose in mg and in mL
zapletene okužbe sečil in pielonefritis
10 mg/ kg body weight twice daily to 20 mg/ kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.2 mL/ kg body weight twice daily to 0.4 mL/ kg body weight twice daily with a maximum of 15-mL per dose
10 mg/ kg do 20 mg/ kg telesne mase dvakrat na dan; največ 750 mg na odmerek kar odgovarja 0, 2 ml/ kg telesne mase dvakrat na dan do 0, 4 ml/ kg telesne mase dvakrat na dan;
Inhalation anthrax
največ 15 ml na odmerek inhalacijski vranični prisad (zaščita in zdravljenje po izpostavitvi povzročitelju) pri osebah, ki se lahko zdravijo peroralno, če je to klinično primerno; zdravljenje je treba začeti takoj po domnevni ali potrjeni izpostavitvi povzročitelju
10 mg/ kg body weight twice daily to 15 mg/ kg body
10 mg/ kg do 15 mg/ kg telesne mase dvakrat na dan; največ 500 mg na odmerek kar odgovarja 0, 2 ml/ kg telesne mase dvakrat na dan do 0, 3 ml/ kg telesne mase dvakrat na dan; največ 10 ml na odmerek
250-500 mg every 24 h (after dialysis)
250 – 500 mgvsakih 24 h (po dializi)
134 Method of administration
Način uporabe
Oral suspension can be taken independent of mealtimes.
Peroralno suspenzijo se zaužije neodvisno od obrokov hrane.
In severe cases or if the patient is unable to take oral suspension (e. g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
136 V hudih primerih ali če bolnik ne more jemati peroralne suspenzije (npr. bolniki na enteralni prehrani), je priporočena uporaba intravenskih oblik ciprofloksacina, dokler ni možna uporaba peroralnih oblik ciprofloksacina.
Appearance of the reconstituted product:
Izgled rekonstituiranega zdravila
Occasionally the suspension may contain yellow-orange droplets and globular particles.
Včasih lahko suspenzija vsebuje rumeno- oranžne kapljice in kroglaste delce.
½ measuring spoonful (approx 2.5-mL suspension) provides approx.
2, 5 ml suspenzije) ustreza pribl.
125 mg ciprofloxacin.
125 mg ciprofloksacina.
1 measuring spoonful (approx 5.0 mL suspension) provides approx.
5 ml suspenzije) ustreza pribl.
250 mg ciprofloxacin.
250 mg ciprofloksacina.
135 Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Okužbe kosti in sklepov Ciprofloksacin je treba uporabljati v kombinaciji z drugimi antibakterijskimi zdravili, odvisno od mikrobioloških izvidov.
Children and adolescents The use of ciprofloxacin in children and adolescents should follow available official guidance.
Otroci in mladostniki 137 Pomembno je, da se pri uporabi ciprofloksacinapri otrocih in mladostnikih upoštevajo veljavne smernice.
136 At any sign of tendinitis (e. g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued.
Če se pojavijo znaki tendinitisa (npr. boleča oteklina, vnetje), je treba prekiniti zdravljenje s ciprofloksacinom.
Central Nervous System Quinolones are known to trigger seizures or lower the seizure threshold.
Osrednje živčevje 138 Znano je, da kinoloni povzročajo krče in znižujejo prag zanje.
137 Cytochrome P450 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, ropinirole, tizanidine).
Citokrom P450 Ciprofloksacin zavira encimski sistem CYP1A2, kar lahko povzroči zvišanje serumskih koncentracij sočasno danih zdravil, ki se presnavljajo s pomočjo tega encima (npr. teofilin, klozapin, ropinirol, tizanidin).
Interaction with tests The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.
139 Pri bolnikih, ki jemljejo ciprofloksacin so lahko in vitro bakteriološki testi učinkovitosti ciprofloksacina proti Mycobacterium tuberculosis lažno negativni.
Sucrose Load As the oral suspension contains sucrose, it should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.
Sucrose Load As the oral suspension contains sucrose, it should not be used in patients with fructose intolerance, glucose- galactose malabsorption or sucrose- isomaltase deficiency.
As Ciprofloxacin Bayer 50 mg/ mL suspension contains 1.4 g sucrose per 5-mL measuring spoonful, this has to be taken into consideration in terms of daily intake.
As Ciprofloxacin Bayer 50 mg/ mL suspension contains 1. 4 g sucrose per 5- mL measuring spoonful, this has to be taken into consideration in terms of daily intake.
138 Methotrexate
Metotreksat
This can lead to theophylline-induced side effects that may rarely be life threatening or fatal.
Med
During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary (see section 4.4).
140 sočasno uporabo teh dveh zdravil, je treba spremljati serumsko koncentracijo teofilina in če je potrebno njegov odmerek zmanjšati (glejte poglavje 4. 4).
139 drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3).
Pri mladih in prenatalnih živalih, ki so bile izpostavljene kinolonom, so opažali učinke na nerazvitem hrustancu, zato se možnosti poškodb sklepnega hrustanca pri nerazvitih organizmih/ fetusih ne da zanesljivo izključiti (glejte poglavje 5. 3).
4.8 Undesirable effects
141 4. 8 Neželeni učinki
Leukopenia Anaemia Neutropenia Leukocytosis Thrombocytopenia Thrombocytaemia
(smrtno nevarna) depresija kostnega mozga (smrtno nevarna)
Haemolytic anaemia Agranulocytosis Pancytopenia (life- threatening) Bone marrow depression (life- threatening)
šok (smrtno nevaren) (glejte poglavje 4. 4) reakcija, podobna serumski bolezni
Immune System Disorders
Presnovne in prehranske motnje
Allergic reaction Allergic oedema / angiooedema
hiperaktivnos t / agitacija
Anaphylactic reaction Anaphylactic shock (life- threatening) (see section 4.4) Serum sickness- like reaction
anksiozna reakcija nočne more depresija halucinacije
Metabolism and Nutrition Disorders
(glejte poglavje 4. 4)
Anorexia
glavobol
Hyperglycaemia
parestezija in
140 System Organ
nevropatija
Common
motnje
Uncommon
(glejte
Rare
142
Very Rare
Organski
Frequency
Občasni
Psychiatric Disorders
spanja motnje okusa
Psychomotor hyperactivity / agitation
tremor krči (glejte poglavje 4. 4) vrtoglavica
Confusion and disorientation Anxiety reaction Abnormal dreams Depression Hallucinations
motnje ravnotežja motnje vohanja zvišan intrakranialni tlak
Psychotic reactions (see section 4.4)
poglavje 4. 4)
Headache Dizziness Sleep disorders Taste disorders
motnje vida zvonjenje v ušesih oglušitev/ motnje sluha
Eye Disorders Ear and Labyrinth Disorders
pankreatitis
Visual disturbances Tinnitus Hearing loss / Hearing impaired
bolečine v trebuhu dispepsija flatulenca
Visual colour distortions
jetrna okvara
Cardiac Disorders
jetrna nekroza
Tachycardia
holestatski
Ventricular arrhythmia, QT prolongation, torsades de pointes *
(zelo redko
Vascular Disorders
žolčnika in
Vasodilatation Hypotension Syncope
žolčevodov
Vasculitis
transaminaz
Respiratory, Thoracic and Mediastinal Disorders
zvišanje vrednosti bilirubina
Dyspnoea (including asthmatic condition)
nevarno jetrno odpoved)
Gastrointestinal Disorders
fotosenzitivne
Nausea Diarrhoea
reakcije (glejte
Vomiting Gastrointestinal and abdominal pains Dyspepsia Flatulence
Erythema
Pancreatitis
podkožja
Hepatobiliary Disorders
koprivnica
Increase in transaminases Increased bilirubin
poglavje 4. 4)
Hepatic impairment Cholestatic icterus Hepatitis
multiforme minor Erythema nodosum Stevens -
Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)
143
141 System Organ
Organski
(cannot be estimated from available data)
Johnsonov sindrom (lahko smrtno nevaren) toksična epidermalna nekroliza (lahko smrtno nevarna)
Skin and Subcutaneous Tissue Disorders
razpoložljivih podatkov)
Rash Pruritus Urticaria
tendinitis
Photosensitivity reactions (see section 4.4)
mišičnega tonusa
4.9 Overdose 142 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
144 Prekomerni odmerek 12 g je povzročil blage simptome toksičnosti.
PK/ PD relationship:
145 Razmerje farmokokinetike/ farmoakodinamike
S ≤ 0.5 mg/ L S ≤ 0.5 mg/ L S ≤ 1 mg/ L
1
R > 1 mg/ L R > 1 mg/ L R > 1 mg/ L
R > 1 mg/ l R > 1 mg/ l R > 1 mg/ l
Staphylococcus spp.1
Staphylococcus spp.
S ≤ 1 mg/ L
S < 1 mg/ l
Neisseria gonorrhoeae Neisseria meningitidis Non-species-related breakpoints *
Haemophilus influenzae in Moraxella catarrhalis Neisseria gonorrhoeae Neisseria meningitidis Mejne vrednosti za nespecifične vrste *
1 Staphylococcus spp. – breakpoints for ciprofloxacin relate to high dose therapy. * Non-species-related breakpoints have been determined mainly on the basis of PK/ PD data and are independent of MIC distributions of specific species.
1 Staphylococcus spp. – mejne vrednosti za ciprofloksacin povezane z zdravljenjem z visokimi odmerki. * Mejne vrednosti za nespecifične vrste so določili na podlagi farmakokinetičnih in farmakodinamičnih podatkov in so neodvisne od distribucije MIK- a za specifične vrste.
Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4)
146 Specifične vrste bakterij razvrščenih glede na občutljivost za ciprofloksacin (za streptokoke glejte poglavje 4. 4).
COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
SPLOŠNO OBČULJIVE VRSTE aerobni, po Gramu pozitivni mikroorganizmi Bacillus anthracis( 1) aerobni, po Gramu negativni mikroorganizmi Aeromonas spp.
Yersinia pestis Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms Enterococcus faecalis ($) Staphylococcus spp. *(2)
Pseudomonas aeruginosa * Pseudomonas fluorescens Serratia marcescens *
Pseudomonas aeruginosa* Pseudomonas fluorescens Serratia marcescens* Anaerobic micro-organisms Peptostreptococcus spp.
147 anaerobni mikroorganizmi Peptostreptococcus spp.
145 Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.
Najvišja serumska koncentracija je dosežena eno do dve uri po zaužitju zdravila.
The pharmacokinetics of ciprofloxacin oral suspension 50 mg/ mL and 100 mg/ mL are similar to those of tablets.
Farmakokinetika ciprofloksacina v peroralni suspenziji 50 mg/ ml in 100 mg/ ml je enaka kot farmakokinetika ciprofloksacina v tabletah.
Ciprofloxacin is present in plasma largely in a non- ionized form and has a large steady state distribution volume of 2-3 L/ kg body weight.
Ravnotežni volumen porazdelitve je velik, 2 – 3 l/ kg telesne mase.
Metabolism
148 Presnova
146 In 10 children with severe sepsis Cmax was 6.1 mg/ L (range 4.6-8.3 mg/ L) after a 1-hour intravenous infusion of 10 mg/ kg in children aged less than 1 year compared to 7.2 mg/ L (range 4.7-11.8 mg/ L) for children between 1 and 5 years of age.
Pri desetih otrocih s hudo sepso, mlajših od enega leta, je bila po 60- minutnem intravenskem infundiranju odmerka 10 mg/ kg, Cmax 6, 1 mg/ l (med 4, 6 in 8, 3 mg/ l); pri otrocih v starosti od 1 do 5 let je bila Cmax 7, 2 mg/ l (med 4, 7 in 11, 8 mg/ l).
The AUC values were 17.4 mg*h/ L (range 11.8-32.0 mg*h/ L) and 16.5 mg*h/ L (range 11.0-23.8 mg*h/ L) in the respective age groups.
Vrednosti AUC so bile 17, 4 mg* h/ l (med 11, 8 in 32, 0 mg * / l) oz.
These values are within the range reported for adults at therapeutic doses.
16, 5 mg * / l (med 11, 0 in 23, 8 mg * / l) glede na starostno skupino.
Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean half-life in children is approx.
Te vrednosti so v mejah vrednosti o katerih so poročali pri uporabi terapevtskih odmerkov pri odraslih.
Data on photomutagenicity/ photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments.
149 fototumorogeni učinek ciprofloksacina in vitro in v poskusih na živalih.
The small bottle contains the active substance and the large bottle contains the solvent.
Majha steklenička vsebuje zdravilno učinkovino, plastenka vsebuje suspenzijo.
147 Press down according to instructions on the cap while turning to the left.
Zaporko pritisnite navzdol glede na navodilo na zaporki in jo hkrati zavrtite v levo.
Taking the Ready-to-Use Suspension
Jemanje pripravljene suspenzije
The graduated measuring spoon with the markings 1/ 2 is equivalent to 2.6 mL containing 2.5-mL of final suspension and 1/ 1 is equivalent to 5.2 mL containing 5.0 mL of final suspension.
150 Graduirana merilna žlička z oznako ½ ustreza 2, 6 ml in vsebuje 2, 5 ml pripravljene suspenzije in z oznako 1 ustreza 5, 2 ml in vsebuje 5, 0 ml pripravljene suspenzije.
The graduated measuring spoon must be used for measuring the required prescribed amount of Ciprofloxacin oral suspension 50 mg/ mL.
Graduirano merilno žličko je treba uporabiti za odmerjanje zahtevane predpisane količine 5% peroralne suspenzije ciprofloksacina.
148 1.
151 1.
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/ mL granules and solvent for oral suspension [See Annex I - To be completed nationally]
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg/ ml zrnca in vehikel za peroralno suspenzijo [Glejte Dodatek I – Izpolni država članica]