natgillin/translations-raw huggingface dataset:
Amning Ciprofloxacin udskilles i brystmælk.
Ciprofloxacin is excreted in breast milk.
4. 8 Bivirkninger Der er rapporteret om bivirkninger hos 5- 14% af de patienter, der får ciprofloxacin.
Adverse reactions have been reported in 5-14% of patients receiving ciprofloxacin.
I dette afsnit er bivirkningerne defineret som følger:
24 In this section undesirable effects are defined as follows:
Meget almindelig Almindelig Ikke almindelig Sjælden
very common common uncommon rare very rare, including isolated reports
(> 1/ 10) (> 1/ 100, < 1/ 10) (> 1/ 1000, < 1/ 100) (> 1/ 10 000, < 1/ 1000)
(> 1/ 10) (> 1/ 100 ,< 1/10) (> 1/1000 ,< 1/100) (> 1/10 000, < 1/ 1000) (< 1/10 000)
Meget sjælden, inklusive enkeltstående rapporter
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infektioner og infestationer Ikke almindelig:
Infections and infestations:
Moniliasis
Uncommon: moniliasis
Lidelser i blod og lymfe Ikke almindelig:
Blood and the lymphatic system disorders:
22 Sjælden:
Uncommon: eosinophilia, leukopenia.
Leukopeni (granulocytopeni), anæmi, leukocytose, ændrede protrombinværdier, trombocytopeni, trombocytemi (trombocytose).
Rare: leukopenia (granulocytopenia), anaemia, leukocytosis, altered prothrombin values, thrombocytopenia, thrombocytemia (thrombocytosis).
Hæmolytisk anæmi, pancytopeni, agranulocytose.
Very rare: haemolytic anaemia, pancytopenia, agranulocytosis.
Lidelser i immunsystemet Sjælden:
Immune system disorders:
Ødem ((perifer, angio, facial), allergisk reaktion, lægemiddelinduceret feber, anafylaktoid (anafylaktisk) reaktion.
Rare: oedema (peripheral, angio, facial), allergic reaction, drug fever, anaphylactoid (anaphylactic) reaction.
Lungeødem ved chok (anafylaktisk; livstruende), kløende udslæt, symptomlignende serumsygdom.
Very rare: pulmonary oedema in case of shock (anaphylactic; life-threatening), itching rash, serum sickness-like symptoms.
Metaboliske og ernæringsmæssige lidelser Sjælden:
Metabolism and nutrition disorders:
Hyperglykæmi.
Rare: hyperglycaemia.
Psykiatriske lidelser Sjælden:
Psychiatric disorders:
Meget sjælden:
Rare: anxiety, nightmares, depression, hallucinations.
Psykotiske reaktioner.
Very rare: psychotic reactions.
Lidelser i det centrale og perifere nervesysteme Almindelig:
Nervous system disorders:
Sjælden:
Common: perverted sensation of taste, dizziness, headache, insomnia, agitation, confusion.
Tab af smagsevne (nedsat smagsevne), paræstesier (perifere paralgesi), tremor (rysten), krampeanfald, migræne.
Rare: taste loss (reduced taste), paraesthesia (peripheral paralgesia), tremor (shaking), convulsions, migraine.
Parosmi (nedsat lugtesans), anosmi (almindeligvis reversibel efter afbrydelse af behandling), generaliserede tonisk kloniske epilepsianfald, unormal (ustabil) gang, intrakranial hypertension.
Very rare: parosmia (impaired smell), anosmia (usually reversible after interruption), grand mal convulsion, abnormal (unstable) gait, intracranial hypertension.
Lidelser i øjne Sjælden:
Eye disorders:
Forstyrret syn, diplopi, kromatopsi.
Rare: disturbed vision, diplopia, chromatopsia.
Lidelser i øre Sjælden:
Ear and labyrinth disorders:
Tinnitus, forbigående høretab (især de høje frekvenser).
Rare: tinnitus, transient hearing loss (particularly high frequencies).
Lidelser i myo -, endo -, perikardium og klapper Sjælden:
Cardiac disorders:
Takykardi.
Rare: tachycardia.
(Trombo) flebit Sjælden:
Uncommon:
Synkope (besvimelse), vasodilation (varmepåvirkning).
Rare: syncope (fainting), vasodilation (heat stress).
Vaskulitis (punktformede blodudtrækninger, hæmoragisk bulløs, papula, skorpedannelse).
Very rare: vasculitis (petechiae, hemorrhagic bullae, papules, crust formation).
Respiratoriske lidelser, lidelser i thorax og mediastinum Sjælden:
Respiratory, thoracic and mediastinal disorders:
Dyspnø, laryngal ødem.
25 Rare: dyspnoea, laryngeal oedema.
Gastrointestinale lidelser Almindelig:
Gastrointestinal disorders:
Ikke almindelig:
Common: nausea, diarrhoea.
Sjælden:
Uncommon: vomiting, dyspepsia, flatulence, anorexia, abdominal pain.
Pseudomembranøs colitis, moniliasis (oral).
Rare: pseudomembranous colitis, moniliasis (oral).
Moniliasis (gastro- intestinal), pancreatitis.
Very rare: moniliasis (gastro-intestinal), pancreatitis.
Lever - og galdevejslidelser Sjælden:
Hepato-biliary disorders:
Gulsot, chlolestatisk ikterus.
Rare: icterus, cholestatic icterus.
Hepatitis, levercelle nekrose, (resulterer yderst sjældent i livstruende leverfunktionssvigt).
Very rare: hepatitis, liver cell necrosis (very rarely resulting in life-threatening liver function failure).
Dermatologiske lidelser
Skin and subcutaneous tissue disorders:
23 Almindelig:
Common: rash.
Pruritis, papillomakulært udslæt, nældefeber.
Uncommon: pruritis, papillo-macular rash, urticaria.
Fotosensibilitet.
Rare: photosensibility.
Erythema nodosum, erythema multiforme (mindre), Stevens- Johnson syndrom, epidermal nekrolyse (Lyells syndrom).
Very rare: erythema nodosum, erythema multiforme (minor), Stevens-Johnson syndrome, epidermal necrolysis (Lyell Syndrome).
Muskuloskeletale -, bindevævs - og knoglelidelser Ikke almindelig:
Musculoskeletal, conective tissue and bone disorders:
Sjælden:
Uncommon: arthralgia (joint pain).
Myalgi (muskelsmerter), ledlidelser (hævede led).
Rare: myalgia (muscular pain), joint disorder (swollen joints).
Tendinitis (især af Achillessenen), delvis eller hel seneruptur (især af Achillessenen), forværring af symptomerne ved myasteni.
Very rare: tendinitis (in particular of the Achilles tendon), partial or total tendon ruptures (in particular of the Achilles tendon), aggravation of the symptoms of myasthenia.
Lidelser i nyrer og urinveje Sjælden:
Renal and urinary disorders:
Akut nyresvigt, nedsat nyrefunktion, vaginal moniliasis, hæmaturi, krystalluri, interstitial nephritis.
Rare: acute renal failure, impaired renal function, vaginal moniliasis, haematuria, crystalluria, interstitial nephritis.
Generelle symptomer og forstyrrelser ved applikationssted Ikke almindelig:
General disorders and administration site conditions:
Asteni (generel følelse af svaghed, udmattelse), reaktioner på indstiksstedet.
Uncommon: asthenia (general sensation of weakness, fatigue), injection site reactions.
Sveden.
Rare: transpiration.
Laboratorietest Ikke almindelig:
Investigations:
Meget sjælden:
Uncommon: increase of blood creatinine levels, increased blood urea; abnormal liver function test results (increased SGOT and SGPT), bilirubinemia and increased alkaline phosphatase.
Forøgelse af amylase/ lipase niveauer.
Very rare: increment of amylase/ lipase levels.
Ved hæmo - eller peritonealdialyse elimineres kun en ringe del af ciprofloxacin (mindre end 10%).
At haemodialysis or peritoneal dialysis only a modest amount of ciprofloxacin (less than 10%) is eliminated.
Antibakterielt quinolonderivat (ATC kode:
Quinolone antibacterials (ATC code:
J 01 MA 02)
J01MA02)
Virkningmekanisme:
Mode of action:
Ciprifloxacin er in vitro effektiv mod et stort antal gramnegative aerobe bakterier inklusiv P. aeruginosa.
26 Ciprofloxacin is effective in vitro against a large number of Gram-negative aerobic bacteria including P. aeruginosa.
Ciprofloxacin har en hurtig baktericid virkning både i vækst - og hvilefasen.
Ciprofloxacin has a rapid bactericidal effect, both in the growth phase and in the rest phase.
Enzymet DNA- gyrase spiller en afgørende rolle i denne proces.
The enzyme DNA-gyrase plays a crucial role in this process.
Ciprofloxacin hæmmer DNA- gyrase med det resultat at DNA syntesen hæmmes.
Ciprofloxacin inhibits DNA-gyrase, resulting in inhibition of DNA synthesis.
Overførbar plasmid medieret quinolonresistens forbundet med qnr er blevet påvist i quinolon resistente kliniske stammer af E. coli og Klebsiella spp.
Transferable plasmid-mediated quinolone resistance associated with qnr has been detected in quinolone-resistant clinical strains of E. coli and Klebsiella spp.
24 Der er observeret krydsresistens indenfor quinolonklassen.
Within the class of quinolones cross-resistance has been observed.
Udvikling af resistens mod ciprofloxacin og andre fluoroquinoloner er observeret ved stafylokokker, især methicillin- resistente S. aureus, P. aeruginosa, E. coli og E. faecalis (se følsomhedstabellen).
Development of resistance to ciprofloxacin and other fluoroquinolones has been observed in staphylococci, especially methicillin- resistant S. aureus, P. aeruginosa, E. coli and E. faecalis (see the sensitivity table).
Størst risiko viser især patienter i langtidsbehandling (f. eks. med cystisk fibrose, osteomyelitis) eller patienter, som er yderst følsomme for infektioner (f. eks. ved valgt profylakse til en bestemt gruppe neutropeniske patienter, kunstig ventilering).
Especially patients undergoing long-term treatment (e. g. in cystic fibrosis, osteomyelitis), or patients who are extremely susceptible to infections (e. g. in selective prophylaxis in certain groups of neutropenic patients, artificial ventilation) show the highest risk.
Den procentvise andel resistente stammer kan være genstand for stor lokal variation, hvorfor regelmæssig resistensbestemmelse anbefales.
Regular determination of resistance is therefore recommended.
Gænseværdier:
Breakpoints:
I følge EUCAST er der for ciprofloxacin defineret følgende grænseværdier for aerobe bakterier:
According to EUCAST the following breakpoints for aerobic bacteria have been defined for ciprofloxacin:
- Enterobakterier: ≤0. 5 µg/ ml for følsomme, > 1 µg/ ml for resistente;
- Enterobacteriaceae: ≤ 0.5 µg/ ml for susceptible, > 1 µg/ ml for resistant;
- Pseudomonas spp. ≤0. 5 µg/ ml for følsomme, > 1 µg/ ml for resistente;
- Pseudomonas spp. ≤ 0.5 µg/ ml for susceptible, > 1 µg/ ml for resistant;
- Acinetobacter spp. ≤1 µg/ ml for følsomme, > 1 µg/ ml for resistente;
- Acinetobacter spp. ≤ 1 µg/ ml for susceptible, > 1 µg/ ml for resistant;
- S. pneumonia ≤0. 125 µg/ ml for følsomme, > 2 µg/ ml for resistente;
- S. pneumonia ≤ 0.125 µg/ ml for susceptible, > 2 µg/ ml for resistant;
- Staphylococcus spp. ≤1 µg/ ml for følsomme > 1 µg/ ml for resistente;
- Staphylococcus spp. ≤ 1 µg/ ml for susceptible, > 1 µg/ ml for resistant;
- H. influenza and M. catarrhalis ≤0. 5 µg/ ml for følsomme, > 0. 5 µg/ ml for resistente;
- H. influenza and M. catarrhalis ≤ 0.5 µg/ ml for susceptible, > 0.5 µg/ ml for resistant;
- Neisseria gonorrhoeae: ≤0. 03 µg/ ml for følsomme, > 0. 06 µg/ ml for resistente;
- Neisseria gonorrhoeae: ≤ 0.03 µg/ ml for susceptible, > 0.06 µg/ ml for resistant;
- N. meningitides: ≤0. 03 µg/ ml for følsomme, > 0. 06 µg/ ml for resistente;
- N. meningitides: ≤ 0.03 µg/ ml for susceptible, > 0.06 µg/ ml for resistant;
Ikke artsrelaterede grænseværdier er ≤0. 5 µg/ ml for følsomme, and > 1 µg/ ml for resistente organismer.
Non-species related breakpoints are ≤ 0.5 µg/ ml for susceptible, and > 1 µg/ ml for resistant organisms.
Normalt følsomme Gram- positive arter Bacillus anthracis Gram- negative aerobe arter Citrobacter spp.
Commonly susceptible species Gram-positive species Bacillus anthracis Gram-negative aerobe species Citrobacter spp.
25 Staphylococcus aureus (methicillin følsom) Streptococcus spp.
Species for which acquired resistance may be a problem Gram-positive aerobes Coagulase-negative Staphylococcus Enterococcous faecalis MRSA* Staphylococcus aureus Staphylococcus aureus (methicillin susceptible) Streptococcus spp.
Streptococcus agalactiae Streptococcus pneumoniae S. pneumoniae PEN- R Streptococcus pyogenes Gram- negative aerober Acinetobacter spp.
Streptococcus agalactiae Streptococcus pneumoniae S. pneumoniae PEN-R Streptococcus pyogenes Gram-negative aerobes Acinetobacter spp.
Amp- C producerende Escherichia coli E. coli ESBL producine Klebsiella pneumonia Klebsiella oxytoca Klebsiella pneumoniae ESBL producerende Neisseria gonorrhoeae Pseudomonas aeruginosa
Amp-C producing Escherichia coli E. coli ESBL producing Klebsiella pneumoniae Klebsiella oxytoca Klebsiella pneumoniae ESBL producing Neisseria gonorrhoeae Pseudomonas aeruginosa
Enterococcus faecium Staphylococcus epidermidis Staphylococcus haemolyticus Gram- negative aerober E. coli multi- resistente Providencia spp.
Enterococcus faecium Staphylococcus epidermidis Staphylococcus haemolyticus Gram-negative aerobes E. coli multi-resistant Providencia spp.
Stenotrophomonas maltophilia Andre patogener Ureaplasma urealyticum Anaerober Bacteroides fragilis
Stenotrophomonas maltophilia Other pathogens Ureaplasma urealyticum Anaerobes Bacteroides fragilis
Forkortelser:
28 Abbreviations:
Extended Spectrum Beta- lactamases (bredspektrede Beta- laktamase antibiotika) MRSA:
Extended Spectrum Beta-lactamases MRSA:
En undersøgelse med rhesusaber, der blev eksponeret for inhaleret anthrax, viste at 8/ 9 af dyrene overlevede forsøget, når disse var behandlet med ciprofloxacin 2 gange dagligt i en periode på 30 dage fra 1. dag efter exponeringen.
A study on Rhesus-monkeys that were exposed to anthrax by inhalation revealed that 8/ 9 animals survived the experiment when these animals were treated from 1 day after anthrax exposure with ciprofloxacin twice daily for a period of 30 days.
MIC90 af Bacillus anthrax stammen, der blev påført i denne undersøgelse, var 0, 08 µg/ ml.
The MIC of the Bacillus anthrax strain that was applied in this study was 0.08 µg/ ml.
Da MIC90 for ciprofloxacin for 70 andre Bacillus anthraxstammer varierer mellem 0, 03- 0, 06 µg/ ml, er det sandsynligt at ciprofloxacin også vil være virksomt mod andre stammer end den der er anvendt i undersøgelsen.
Because the MIC90 for ciprofloxacin of 70 other Bacillus anthrax strains varied between 0.03-0.06 µg/ ml, it seems likely that ciprofloxacin would also be effective in other strains than the one that was applied in this study.
Lægerne anbefales at følge nationale og/ eller internationale konsensusdokumenter for så vidt angår behandling af antrax.
Physicians are recommended to follow current national and/ or international consensus documents regarding the treatment of anthrax.
Den maksimale plasmakoncentration nås 0, 5 - 2 timer efter oral indtag af 50 - 1000 mg og varierer fra 0, 3 – 5, 9 mg/ l.
The peak plasma concentration is reached 0.5 - 2 hours after taking 50 - 1000 mg p. o. and varies from 0.3 - 5.9 mg/ l.
Biotilgælgeligheden efter oral indgift af ciprofloxacin er mellem 70 og 85%.
The bioavailability of ciprofloxacin after oral administration is between 70% and 85%.
Biotilgængeligheden bliver lavere ved samtidig indgift af antacida med indhold af aluminium og/ eller magnesiumhydroxid samt calcium - og jernsalte.
The bioavailability is lower if antacids that contain aluminium and/ or magnesium hydroxide, and calcium and iron salts are used concomitantly.
I steady state tilstand er det umiddelbare fordelingsvolumen af ciprofloxacin mellem 1, 7 og 2, 7 l/ kg.
In steady-state conditions the apparent distribution volume of ciprofloxacin is situated between 1,7 and 2,7 l/ kg.
Dette relativt høje fordelingsvolumen indikerer en effektiv vævs - og væskepenetrering, hvilket gælder galde, nyre, galdeblære og levervæv.
This applies to gall, kidney, gall bladder and liver tissue.
Ciprofloxacin koncentrationen i spyt er tæt på 50 - 70% af serumkoncentrationen.
The ciprofloxacin concentration in the sputum consists of 50-70% of the serum concentration.
Ciprofloxacin har en proteinbinding mellen 16 og 28% og er uafhængig af koncentration og pH (bestemt ved hjælp af ultrafiltration).
The plasma protein binding of ciprofloxacin is situated between 16% and 28% and is not dependent on the concentration and pH (determined by means of ultrafiltration).
En del er omdannet til desethylene -, sulpho -, oxo - and formylciprofloxacin.
Part of it is converted into desethylene-, sulpho-, oxo- and formylciprofloxacin.
Elimination:
29 Elimination:
Efter oral indgift udskilles ca.
After oral administration ciprofloxacin is excreted unchanged for approx.
70% ciprofloxacin uomdannet og efter i. v indgift 77%.
77%.
Efter oral indgift udskilles 45% uomdannet i urinen og 25% i fæces.
After oral administration 45% is excreted unchanged in the urine and 25% is excreted in the faeces.
Tilsvarende efter i. v indgift er 62% og 15%.
After i. v. administration 62% is excreted unchanged in the urine and 15% is excreted in the faeces.
Efter oral indgift udskilles 19% og efter i. v 12% af ciprofloxacin i urin og fæces i form af metabolitter.
After oral administration 19% and after i. v. administration 12% of ciprofloxacin is excreted in the urine and faeces in the form of metabolites.
Et stort antal metabolitter efter oral indgift tyder på en vis grad af first- pass metabolisme, hovedsagelig under dannelse af sulphociprofloxacin.
A larger number of metabolites after oral administration indicates some degree of first-pass metabolism, mainly forming sulphociprofloxacin.
Eliminationshalveringstiden af ciprofloxacin efter enkelt - eller flerdosis oral indgift er mellem 3, 4 og 6, 9 timer.
The elimination half-life of ciprofloxacin after single or multiple oral dosage is between 3,4 and 6,9 hours.
Efter enkelt – og flerdosis i. v indgift er eliminationshalveringstiden mellem 3 og 4, 6 timer.
After single and multiple i. v. dosage the elimination half-life is between 3 – 4,6 hours.
Hos patienter med alvorlig nedsat nyrefunktion (kreatininclearance < 30 ml/ min) kan eliminationshalveringtiden blive forlænget med en faktor 2.
In patients with severely impaired renal function (creatinine clearance < 30 ml/ min) the elimination half-life may be prolonged by a factor of 2.
Oral indgift af 20 mg/ kg to gange dagligt til børn med cystisk fibrose giver en eksponering, der er sammenlignelig med oral indgift af 750 mg to gange dagligt til voksne.
Oral administration of 20 mg/ kg twice daily to children with cystic fibrosis gives an exposure that is comparable to that in adults following an oral dose of 750 mg twice daily.
27 Som for andre gyrase hæmmere kan ciprofloxacin foranledige ledskader i vækstfasen hos unge dyr.
Like with other gyrase inhibitors, ciprofloxacin may induce joint damage during the growth phase of juvenile animals.
Vand til injektionsvæsker.
Sodium chloride Sulphuric acid Sodium hydroxide for pH adjustment Water for injections
Ciprofloxacin Kabi må ikke blandes med opløsninger, der ikke er stabile ved pH ca.
Ciprofloxacin Kabi cannot be mixed with solutions that are not stable at a pH of approximately 4.
6. 3 Opbevaringstid
30 6.3 Shelf life
Ud fra et mikrobiologisk synspunkt skal produktet anvendes umiddelbart.
18 months From a microbiological point of view, the product should be used immediately.
Ciprofloxacin Kabi 100 mg/ 50 ml infusionsvæske, opløsning: pakningsstørrelser:
[Ciprofloxacin Kabi 100 mg/ 50 ml solution for infusion: pack sizes:
1, 5, 10, 20, 30 eller 40 poser.
1, 5, 10, 20, 30 or 40 bags.
Ciprofloxacin Kabi 200 mg/ 100 ml infusionsvæske, opløsning: pakningsstørrelser:
Ciprofloxacin Kabi 200 mg/ 100 ml solution for infusion: pack sizes:
1, 5, 10, 20, 30 or 40 poser.
1, 5, 10, 20, 30 or 40 bags.
Ciprofloxacin Kabi 400 mg/ 200 ml infusion, opløsning: pakningsstørrelser:
Ciprofloxacin Kabi 400 mg/ 200 ml solution for infusion: pack sizes:
1, 5, 10, 20, 30 or 40 poser.
1, 5, 10, 20, 30 or 40 bags.]
28 Fremstil ikke tilblandinger i glasflasker.
Do not prepare admixtures in glass bottles.
Ciprofloxacin Kabi er forligelig med isotonisk natriumklorid opløsninger, Ringer’ s opløsninger, Ringer Lactat opløsning, 50 mg/ ml (5%), Glucose opløsninger 50 mg/ ml (5%) og 100 mg/ ml (10%) samt Glucose opløsninger 50 mg/ ml (5%) med 2, 25 mg/ ml (0, 225%) eller 4, 5 mg/ ml (0, 45%) natriumklorid.
Ciprofloxacin Kabi is compatible with isotonic sodium chloride solution, Ringer’ s solution, Ringer’ s lactate solution, 50 mg/ ml (5%) or 100 mg/ ml (10%) glucose solution and 50 mg/ ml (5%) glucose s olution with 2.25 mg/ ml (0.225%) or 4.5 mg/ ml (0.45%) sodium chloride solution.
Forligeligheden med disse opløsninger har været testet i et fortyndingsområde på 1+1 og 1+4, svarende til ciprofloxacin koncentrationer på fra 0, 4 til 0, 1 mg/ ml.
Compatibility with these solutions has been proven in the dilution range of 1+1 and 1+4, corresponding to ciprofloxacin concentrations of 0.4 to 1 mg/ ml.
Pkt.
Unless compatibility is proven, the solution for infusion should always be administered separately (see also section 6.2).
[Se Annex I – udfyldes nationalt]
[See Annex I – To be completed nationally]
29 ETIKETTERING
32 LABELLING
30 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
33 PARTICULARS TO APPEAR ON THE OUTER PACKING
Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 100 mg/ 50 ml, infusionsvæske, opløsning [Se Annex I – Udfyldes nationalt]
Ciprofloxacin Kabi and associated names (See Annex I) 100 mg/ 50 ml solution for infusion [See Annex I – To be completed nationally]
Hver ml infusionsvæske indeholder 2 mg ciprofloxacin (som hydrogensulphat)
Each ml of solution for infusion contains 2 mg ciprofloxacin (as hydrogen sulphate)
Hver pose med 50 ml indeholder 100 mg ciprofloxacin
Each bag with 50 ml contains 100 mg ciprofloxacin.
Natriumchlorid, svovlsyre, natriumhydroxid, vand til injektionsvæsker
Sodium chloride, sulphuric acid, sodium hydroxide, water for injections
Indeholder natrium.
Contains sodium compounds.
Se indlægssedler for yderligere information
See leaflet for further information.
Infusionsvæske, opløsning 1, 5, 10, 20, 30, 40 x 50 ml
Solution for infusion 1, 5, 10, 20, 30, 40 x 50 ml
31 Må ikke opbevares i køleskab eller fryser
Do not refrigerate or freeze.
Opbevares i overposen indtil brugen for at beskytte mod lys.
Keep infusion bag in the overpouch until ready to use in order to protect from light.
[Se Annex I – Udfyldes nationalt]
[See Annex I – To be completed nationally]
Batchnummer
Batch (number)
32 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
35 PARTICULARS TO APPEAR ON THE OUTER PACKING
Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 200 mg/ 100 ml, infusionsvæske, opløsning [Se Annex I – Udfyldes nationalt]
Ciprofloxacin Kabi and associated names (See Annex I) 200 mg/ 100 ml solution for infusion [See Annex I – To be completed nationally]
Hver pose med 100 ml indeholder 200 mg ciprofloxacin
Each bag with 100 ml contains 200 mg ciprofloxacin.
Infusionsvæske, opløsning 1, 5, 10, 20, 30, 40 x 100 ml
Solution for infusion 1, 5, 10, 20, 30, 40 x 100 ml
33 Må ikke opbevares i køleskab eller fryser
Do not refrigerate or freeze.
34 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
37 PARTICULARS TO APPEAR ON THE OUTER PACKING
Ciprofloxacin Kabi navn og tilhørende navne (Se bilag I) 400 mg/ 200 ml, infusionsvæske, opløsning [Se Annex I – Udfyldes nationalt]
Ciprofloxacin Kabi and associated names (See Annex I) 400 mg/ 200 ml solution for infusion [See Annex I – To be completed nationally]
Hver pose med 200 ml indeholder 400 mg ciprofloxacin
Each bag with 200 ml contains 400 mg ciprofloxacin.
Infusionsvæske, opløsning 1, 5, 10, 20, 30, 40 x 200 ml
Solution for infusion 1, 5, 10, 20, 30, 40 x 200 ml
35 9.
38 9.
Må ikke opbevares i køleskab eller fryser
Do not refrigerate or freeze.
36 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
39 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKING
Hver pose med 50 ml indeholder 100 mg ciprofloxacin.
Each bag with 50 ml contains 100 mg ciprofloxacin.
Natriukchlorid, svovlsyre, natriumhydroxid, vand til injektionsvæsker
Sodium chloride, sulphuric acid, sodium hydroxide, water for injections
Infusionsvæske, opløsning 50 ml
Solution for infusion 50 ml
Til intravenous anvendelse.
For intravenous use.
Må ikke opbevares i køleskab eller fryser.
Do not refrigerate or freeze.
Opbevar infusionsposen i overposen indtil brug for at beskytte mod lys.
Keep infusion bag in the overpouch until ready to use in order to protect from light.
38 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
41 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKING
Hver pose med 100 ml indeholder 200 mg ciprofloxacin.
Each bag with 100 ml contains 200 mg ciprofloxacin.
40 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
43 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKING
Hver pose med 200 ml indeholder 400 mg ciprofloxacin.
Each bag with 200 ml contains 400 mg ciprofloxacin.
Infusionsvæske, opløsning 200 ml
Solution for infusion 200 ml
Opbevar infusionsposen I overposen indtil brug for at beskytte mod lys.
Keep infusion bag in the overpouch until ready to use in order to protect from light.