natgillin/translations-raw huggingface dataset:
232 Indikationer
400 mg twice daily 400 mg twice daily to 400 mg three times a day
Behandlingen skal begynde så hurtigt som muligt efter mistanke om eller bekræftet eksponering.
Children and adolescents
mg to gange dagligt
400 mg twice daily 226
Børn og unge
Indication
233 Nedsat nyre - og leverfunktion
Renal and hepatic impairment
Ciprofloxacin skal anvendes til intravenøs infusion.
227 Ciprofloxacin should be administered by intravenous infusion.
Streptokokinfektioner (herunder Streptococcus pneumonia) Ciprofloxacin må ikke anvendes til behandling af streptokokinfektioner på grund af utilstrækkelig effekt..
Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
234 Intra- abdominale infektioner Der er begrænsede data om virkningen af ciprofloxacin til behandling af postoperative intra - abdominale infektioner.
Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Sikkerhedsdata fra et randomiseret, dobbeltblindt studie om brug af ciprofloxacin til børn (ciprofloxacin: n=335, gennemsnitsalder = 6, 3 år; referencegruppe: n = 349, gennemsnitsalder = 6, 2 år, aldersområde:
Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years)
1 til 17 år) viste en hyppighed af formodet lægemiddelrelateret artropati (bedømt ud fra ledrelaterede kliniske symptomer) efter dag 42 på hhv.
228 revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%.
235 Det muskuloskeletale system Ciprofloxacin bør generelt ikke bruges til patienter, som har haft senesygdomme relateret til behandling med quinoloner.
Musculoskeletal System Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment.
4. 8).
Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including
Hjertesygdomme Da ciprofloxacin er forbundet med tilfælde af QT- forlængelse (se pkt.
229 pain, burning, tingling, numbness, and/or weakness in order to prevent the development of an irreversible condition (see section 4.8).
236 Glucose- 6- phosphat dehydrogenase- mangel Hos patienter med glucose- 6- phosphat dehydrogenase- mangel er der indberetninger om hæmolytiske reaktioner ved behandling med ciprofloxacin.
Glucose-6-phosphate dehydrogenase deficiency Haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency.
2 vedrørende natriumindholdet).
230 NaCl Load In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.), the additional sodium load should be taken into account (for sodium chloride content, see section 2).
237 Methotrexat
Methotrexate
238 Amning Ciprofloxacin udskilles i modermælk.
Lactation Ciprofloxacin is excreted in breast milk.
1/ 10
232
240
234
241 Børn Hyppigheden af ovennævnte artropati refererer til data, som stammer fra studier hos voksne.
The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
Som et fluorquinolon- antibiotikum udøver Ciprofloxacin sin baktericide virkning ved at hæmme både type II topo- isomerase (DNA- gyrase) og top- isomerase IV, som er nødvendig for bakteriel DNA - replikation, transskription, genopretning og rekombination.
235 As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
242 Antibakterielt spektrum:
Spectrum of antibacterial activity:
4. 4 vedrørende Streptokokarter).
Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4) COMMONLY SUSCEPTIBLE SPECIES
ALMINDELIGE FØLSOMME ARTER Aerobe grampositive mikroorganismer Bacillus anthracis (1) Aerobe gramnegative mikroorganismer Aeromonas spp.
236 Aerobic Gram-positive micro-organisms Bacillus anthracis (1) Aerobic Gram-negative micro-organisms Aeromonas spp.
Yersinia pestis Anaerobe mikroorganismer Mobiluncus Andre mikroorganismer Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) ARTER, HVOR ERHVERVET RESISTENS KAN VÆRE ET PROBLEM Aerobe grampositive mikroorganismer Enterococcus faecalis ($) Staphylococcus spp. * (2) Aerobe gramnegative mikroorganismer Acinetobacter baumannii+ Burkholderia cepacia+ * Campylobacter spp. + * Citrobacter freundii * Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Klebsiella pneumoniae * Morganella morganii * Neisseria gonorrhoeae * Proteus mirabilis * Proteus vulgaris * Providencia spp.
Anaerobic micro-organisms Mobiluncus Other micro-organisms Chlamydia trachomatis ($) 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.
244 Enteroccus faecium Listeria monocytogenes Aerobe gramnegative mikroorganismer Stenotrophomonas maltophilia Anaerobe mikroorganismer Undtagen ovennævnte Andre mikroorganismer Mycoplasma genitalium Ureaplasma urealitycum * Der er dokumenteret klinisk effekt for følsomme isolater ved godkendte indikationer + Resistensgrad ≥ 50% i et eller flere EU- lande ($):
237 INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces Enteroccus faecium Listeria monocytogenes Aerobic Gram-negative micro-organisms Stenotrophomonas maltophilia Anaerobic micro-organisms Excepted as listed above Other micro-organisms Mycoplasma genitalium Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥ 50% in one or more EU countries ($):
Ciprofloxacin når høje koncentrationer i mange væv som f. eks. lungevæv (epitelvæske, alveolære makrofager, biopsivæv), bihuler og inflammerede læsioner (cantharides blistervæske) og urogenitalsystemet (urin, prostata, endometrium), hvor totalkoncentrationerne kan overstige plasmakoncentrationerne.
238 reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.
245 Metabolisme
Metabolism
Artikulær tolerance:
239 Articular tolerability:
246 hunde forårsagede ciprofloxacin alvorlige forandringer i leddene ved terapeutiske doser efter 2 ugers behandling, som stadig blev observeret efter 5 måneder.
In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.
[Udfyldes nationalt}
240 [To be completed nationally]
247 10.
10.
248 1.
241 1.
4. 4 og 5. 1.
Ciprofloxacin Bayer 400 mg/200 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
249 • Infektioner i hud og bløddele forårsaget af gramnegative bakterier
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Infektioner i knogler og led
242 • Infections of the bones and joints
250 Voksne
Adults
(iht. sværhedsgrad og
243 Indications
251 Indikationer
400 mg twice daily to 400 mg three times a day
over for infektioner hos patienter med neutropeni Ciprofloxacin skal gives sammen med andre antibakterielle stoffer i henhold til officielle retningslinjer.
244 Indications
dagligt op til 400 mg tre gange dagligt
Daily dose in mg
hele neutropeniperioden
Total duration of treatment (including switch to oral therapy as soon as possible)
252 Nedsat nyre - og leverfunktion
Renal and hepatic impairment
124- 168
124
253 Intra- abdominale infektioner Der er begrænsede data om virkningen af ciprofloxacin til behandling af postoperative intra - abdominale infektioner.
Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Rejsediaré Ved valget af ciprofloxacin skal der tages hensyn til resistensen over for ciprofloxacin hos relevante patogener i de lande, der besøges.
246 Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
254 Det muskuloskeletale system Ciprofloxacin bør generelt ikke bruges til patienter, som har haft senesygdomme relateret til behandling med quinoloner.
Musculoskeletal System Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment.
Allerede 48 timer efter start af behandlingen med ciprofloxacin kan der forekomme tendinitis og seneruptur (specielt af akillessenen), af og til bilateralt.
247 Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
255 Glucose- 6- phosphat dehydrogenase- mangel Hos patienter med glucose- 6- phosphat dehydrogenase- mangel er der indberetninger om hæmolytiske reaktioner ved behandling med ciprofloxacin.
Glucose-6-phosphate dehydrogenase deficiency Haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency.
Cytokrom P450 Ciprofloxacin hæmmer CYP1A2 og kan derfor medføre øgede serumkoncentrationer af lægemidler, som gives samtidigt, og som metaboliseres af dette enzym (f. eks. teofyllin, clozapin, ropinirol og tizanidin).
248 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).
256 Methotrexat
Methotrexate
Andre xanthinderivativer
249 Other xanthine derivatives
257 Amning Ciprofloxacin udskilles i modermælk.
Lactation Ciprofloxacin is excreted in breast milk.
4. 8 Bivirkninger
250 4.8 Undesirable effects
258
Nervous System Disorders
Almindelig
Par- and Dysaesthesia Hypoaesthesia Tremor Seizures (see section 4.4) Vertigo
Ikke almindelig
Migraine Disturbed coordination Gait disturbance Olfactory nerve disorders Intracranial hypertension
Sjælden
Peripheral neuropathy (see section 4.4)
Meget
251
Ukendt
System Organ Class
beregnes fra de foreliggende data) Nervesystemet
(cannot be estimated from available data)
Gastrointesti - nale sygdomme
Gastrointestinal Disorders
Petekkier Erythema multiforme Erythema nodosum Stevens - Johnson - syndrom (potentielt livstruende) Toksisk epidermal
Petechiae Erythema multiforme Erythema nodosum Stevens- Johnson syndrome (potentially life- threatening) Toxic epidermal necrolysis (potentially life- threatening)
Organklasse
252 System Organ Class
beregnes fra de foreliggende data) nekrolyse (potentielt livstruende) Knogler, led, muskler og bindevæv
Musculoskeletal, Connective Tissue and Bone Disorders
Børn Hyppigheden af ovennævnte artropati refererer til data, som stammer fra studier hos voksne.
The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
260 4. 9 Overdosering
4.9 Overdose
Det er indberettet, at en overdosis på 12 g har medført lette toksiske symptomer.
253 An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
261 EUCAST- rekommendationer
EUCAST Recommendations
Enterobacteria Pseudomonas Acinetobacter Staphylococcus spp. 1
Enterobacteria
Yersinia pestis Anaerobe mikroorganismer Mobiluncus Andre mikroorganismer Chlamydia trachomatis ($) Chlamydia pneumoniae ($) Mycoplasma hominis ($) Mycoplasma pneumoniae ($) ARTER, HVOR ERHVERVET RESISTENS KAN VÆRE ET PROBLEM Aerobe grampositive mikroorganismer Enterococcus faecalis ($) Staphylococcus spp. * (2) Aerobe gramnegative mikroorganismer 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.
255 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.
En sammenligning af de farmakokinetiske parametre efter intravenøs administration hhv. to gange dagligt og tre gange dagligt viste ingen tegn på akkumulering af ciprofloxacin og dets metabolitter.
256 Comparison of the pharmacokinetic parameters for a twice a day and three times a day intravenous dose regimen indicated no evidence of drug accumulation for ciprofloxacin and its metabolites.
264 Metabolisme
Metabolism
I et studie med børn var Cmax og AUC ikke aldersafhængige (over 1 år).
257 In a study in children Cmax and AUC were not age-dependent (above one year of age).
265 hunde forårsagede ciprofloxacin alvorlige forandringer i leddene ved terapeutiske doser efter 2 ugers behandling, som stadig blev observeret efter 5 måneder.
In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.
For at lette brugen, skal gummiproppen på infusionshætteglasset penetreres i den centrale ring.
258 For ease of use the infusion vial stopper should be penetrated in the central ring.
266 10.
10.
267 ETIKETTERING
259 LABELLING
268 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
260 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
[Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
ANVENDELSESMÅDE OG INDGIFTSVEJ
METHOD AND ROUTE(S) OF ADMINISTRATION
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 261 11.
{Navn og adresse} < {Tlf} > < {Fax} > < {Email} >
{Name and Address} < {tel} > < {fax} > < {e-mail} >
270 MINDSTEKRAV TIL MÆRKNING DER SKAL ANFØRES PÅ BLISTERKORT ELLER BLISTERSTRIPS
262 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 100 mg filmovertrukne tabletter [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
271 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
263 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 250 mg filmovertrukne tabletter.
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 264 11.
273 MINDSTEKRAV TIL MÆRKNING DER SKAL ANFØRES PÅ BLISTERKORT ELLER BLISTERSTRIPS
265 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 250 mg filmovertrukne tabletter [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
274 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
266 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
[Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 267 11.
276 MINDSTEKRAV TIL MÆRKNING DER SKAL ANFØRES PÅ BLISTERKORT ELLER BLISTERSTRIPS
268 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 500 mg filmovertrukne tabletter [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
277 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
269 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
[Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 750 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 270 11.
279 MINDSTEKRAV TIL MÆRKNING DER SKAL ANFØRES PÅ BLISTERKORT ELLER BLISTERSTRIPS
271 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 750 mg filmovertrukne tabletter [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 750 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
280 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
272 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 250 mg oral suspension i enkeltdosisposer [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin
Ryst posen før brug med et let tryk på siden af posen.
Oral use Shake before use applying slight pressure to the wall.
281 10.
273 10.
282 MINDSTEKRAV TIL MÆRKNING DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
274 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
ENKELTDOSISPOSE 250 MG
SINGLE DOSE SACHETS 250 MG
LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ€
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 250 mg oral suspension i enkeltdosisposer [Se bilag I – Udfyldes nationalt] Ciprofloxacin Oral anvendelse
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin Oral use
283 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
275 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 500 mg oral suspension i enkeltdosisposer [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin
284 10.
276 10.
285 MINDSTEKRAV TIL MÆRKNING DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
277 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
ENKELTDOSISPOSE 500 MG
SINGLE DOSE SACHETS 500 MG
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 500 mg oral suspension i enkeltdosisposer [Se bilag I – Udfyldes nationalt] Ciprofloxacin Oral anvendelse
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin Oral use
286 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
278 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
YDRE KARTON 50 mg/ ml ORAL SUSPENSION (som indeholder flasken/ flaskerne med granulat og flasken/ flaskerne med solvens
OUTER CARTON 50 mg/mL ORAL SUSPENSION (containing the bottle(s) for the granules and the bottle(s) for the solvent)
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 50 mg/ ml granulat og solvens til oral suspension.
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Rystes godt før brugen.
Oral use Only after reconstitution Shake well before use.
[Udfyldes nationalt]
279 [To be completed nationally]
288 MÆRKNING DER SKAL ANFØRES PÅ DEN INDRE PAKNING
280 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
GLASFLASKE 50 mg/ ml
GLASS BOTTLE 50 mg/mL
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 50 mg/ ml granulat og solvens til oral suspension [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL granules for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Læs indlægssedlen inden brug.
Oral use Only after reconstitution Read the package leaflet before use.
289 10.
281 10.
290 MÆRKNING DER SKAL ANFØRES PÅ DEN INDRE PAKNING
282 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
HDPE- FLASKE 50 mg/ ml
HDPE BOTTLE 50 mg/mL
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 50 mg/ ml granulat og solvens til oral suspension [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
10.
283 10.
291 11.
11.
292 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
284 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
YDRE KARTON 100 mg/ ml ORAL SUSPENSION (som indeholder flasken/ flaskerne med granulat og flasken/ flaskerne med solvens)
OUTER CARTON 100 mg/mL ORAL SUSPENSION (containing the bottle(s) for the granules and the bottle(s) for the solvent)
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 100 mg/ ml granulat og solvens til oral suspension.
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
293 [Udfyldes nationalt]
285 [To be completed nationally]
294 MÆRKNING DER SKAL ANFØRES PÅ DEN INDRE PAKNING
286 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
GLASFLASKE 100 mg/ ml
GLASS BOTTLE 100 mg/mL
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 100 mg/ ml granulat og solvens til oral suspension [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Til oral anvendelse Kun efter rekonstitution.
Oral use Only after reconstitution.
295 10.
287 10.
296 MÆRKNING DER SKAL ANFØRES PÅ DEN INDRE PAKNING
288 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
HDPE- FLASKE 100 mg/ ml
HDPE BOTTLE 100 mg/mL
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 100 mg/ ml granulat og solvens til oral suspension [Se bilag I – Udfyldes nationalt] Ciprofloxacin
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
10.
289 10.
297 11.
11.
298 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
290 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
YDRE KARTON (indeholder beskyttelsesposer med poser med hver med 100 ml infusionsvæske, opløsning)
OUTER CARTON (containing wraps with bags of 100 mL solution for infusion)
Ciprofloxacin Bayer og tilhørende navne (se bilag I) 200 mg/ 100 ml infusionsvæske, opløsning
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin