FrancophonIA/ELRC3.0 huggingface dataset:
English: Bone discolouring was observed in rats which was not reversible after two weeks of dosing.
Danish: Hos rotter blev der efter to ugers dosering observeret knoglemisfarvning, som ikke var reversibel.
English: • Jaundice (yellow coloration of the skin), inflammation of the liver
Danish: • Gulsot (gulfarvning af huden), betændelse i leveren
English: In repeated dose toxicity studies in rats and dogs, lymphoid depletion/atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets, in association with bone marrow hypocellularity, and adverse renal and gastrointestinal effects have been seen with tigecycline at exposures of 8 and 10 times the human daily dose based on AUC in rats and dogs, respectively.
Danish: I gentagne dosis-toksicitetsstudier med tigecyclin på rotter og hunde sås lymfoid depletion/atrofi af lymfekirtler, milt og thymus, nedsat antal erytrocytter, retikulocytter, leucocytter og trombocytter i forbindelse med knoglemarvshypocellularitet og uønskede nyre- og gastrointestinale virkninger ved eksponeringer med tigecyclin på 8 og 10 gange højere end den daglige humandosis, baseret på AUC hos henholdsvis rotter og hunde.
English: This medicinal product is for single use only; any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: • Injection site reaction (pain, redness, inflammation)
Danish: • Reaktioner på injektionsstedet (smerte, rødme, irritation)
English: Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line.
Danish: Injektionen skal foretages med en infusionsopløsning, som er forenelig med tigecyclin og alle andre lægemidler via denne fælles slange (se pkt.
English: C-tigecycline, unchanged tigecycline was the primary
Danish: Hos raske frivillige mænd var uændret tigecyclin det primære
English: mg/L and R  2 mg/L
Danish: (^)mg/l og Resistent > 2 mg/l
English: General disorders and administration site conditions impaired healing, injection site reaction, headache injection site inflammation, injection site pain, injection site oedema, injection site phlebitis
Danish: Almene sygdomme og reaktioner på administrationsstedet dårlig sårheling, reaktion ved injektionsstedet, hovedpine inflammation ved injektionsstedet, smerte ved injektionsstedet, ødem ved injektionsstedet, flebitis ved injektionsstedet
English: No loading dose was administered in these studies.
Danish: Der blev ikke givet mætningsdosis i disse forsøg.
English: Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.
Danish: Patienter, som er overfølsomme over for antibiotika i tetracyklinklassen, kan være overfølsomme over for tigecyclin.
English: Hepatobiliary disorders elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinaemia jaundice, liver injury, mostly cholestatic hepatic failure
Danish: Lever og galdeveje forhøjet aspartataminotransferase (ASAT) i serum, og forhøjet alaninaminotransferase (ALAT) i serum, hyperbilirubinæmi gulsot, leverskader, ofte kolestatisk leversvigt
English: Overgrowth of non-susceptible organisms, including fungi (see section 4.4).
Danish: Overvækst af ikke-følsomme mikroorganismer, herunder svampe (se pkt.
English: C-tigecycline indicates that 59 % of the dose is eliminated by biliary/faecal excretion, and 33 % is excreted in urine.
Danish: 59 % af dosis elimineres via galden og fæces, og 33 % udskilles via urin.
English: Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics.
Danish: Antibiotika i glycylcyklinklassen har samme struktur som antibiotika i tetracyklinklassen.
English: Tygacil should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).
Danish: Tygacil bør kun bruges i situationer, hvor andre antibiotika ikke er egnede (se pkt.
English: When administered through a Y-site, compatibility of tigecycline diluted in sodium chloride 0.9 % for injection is demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer's, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.
Danish: Ved administration via et Y-site er tigecyclin fortyndet med 0,9% natriumchlorid-injektionvæske forligelig med følgende lægemidler eller fortyndingsvæsker: amikacin, dobutamin, dopaminhydrochlorid, gentamicin, haloperidol, Ringerlactat, lidocainhydrochlorid, metoclopramid, morphin, noradrenalin, piperacillin/tazobactam (EDTA-formulering), kaliumchlorid, propofol, ranitidinhydrochlorid, theophyllin og tobramycin.
English: Species for which acquired resistance may be a problem Gram-negative Aerobes
Danish: Arter hvor erhvervet resistens kan være et problem Gramnegative aerobe bakterier Acinetobacter baumannii
English: Pseudomembranous colitis which may range in severity from mild to life threatening (see section 4.4).
Danish: Pseudomembranøs colitis, som kan variere fra let til livstruende (se pkt.
English: Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours for 5 to 14 days.
Danish: Unge i alderen 12 til <18 år: 50 mg tigecyclin hver 12. time i 5 til 14 dage.
English: • Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
Danish: • Stigning i amylase, som er et enzym, der findes i spytkirtlerne og bugspytkirtlen, forhøjet urinkvælstof i blodet
English: Immune system disorders anaphylaxis/ anaphylactoid reactions
Danish: Immunsystemet anafylaktiske/ anafylaktoide reaktioner
English: Tigecycline may be associated with permanent tooth discolouration if used during tooth development (see section 4.4).
Danish: Tigecyclin kan være forbundet med permanent misfarvning af tænderne, hvis det anvendes under tandudviklingen (se pkt.
English: Pseudomonas aeruginosa *denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Danish: Pseudomonas aeruginosa * Betegner arter mod hvilke det anses, at aktitivitet er tilfredsstillende påvist i kliniske studier † Se afsnit 5.1, Grænseværdier, ovenfor
English: Tigecycline may have adverse reactions similar to tetracycline class antibiotics.
Danish: Tigecyclin kan have bivirkninger, som ligner dem, der forekommer i forbindelse med antibiotika i tetracyklinklassen.
English: Tetracycline class antibiotics
Danish: Antibiotika i tetracyklinklassen
English: Results of studies in rats with tigecycline have shown bone discolouration.
Danish: Resultater fra rotteforsøg med tigecyclin har påvist knoglemisfarvning.
English: Tygacil should not be used in children under 8 years of age due to the lack of safety and efficacy data in this age group and because tigecycline may be associated with permanent teeth discolouration (see sections 4.2 and 4.8).
Danish: Tygacil bør ikke bruges til børn under 8 år på grund af mangel på data om sikkerhed og virkning i denne aldersgruppe, og fordi tigecyclin kan være forbundet med permanent misfarvning af tænderne (se pkt.
English: The target AUC0-12h in adults after the recommended dose of 100 mg loading and 50 mg every 12 hours, was approximately 2500 ng•h/mL.
Danish: Mål-AUC0-12h hos voksne efter den anbefalede dosis på 100 mg mætningsdosis og 50 mg hver 12. time var ca. 2.500 ng•t/ml.
English: Co-administration of P-gp inhibitors (e.g., ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of tigecycline.
Danish: Samtidig administration af P-pg-hæmmere (f.eks. ketoconazol eller ciclosporin) eller P-gp-induktorer (f.eks. rifampicin) kunne påvirke farmakokinetikken af tigecyclin.
English: S  0.5 mg/L and R  0.5 mg/L Streptococcus spp.
Danish: Følsom  0,5 mg/l og Resistent > 0,5 mg/l Streptococcus spp.
English: If you are concerned that you may have been given too much Tygacil, talk to your doctor or nurse immediately.
Danish: Hvis De tror, at De har fået for meget Tygacil, skal De straks kontakte lægen eller sygeplejersken.
English: The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
Danish: Den anbefalede dosis for voksne er en initialdosis på 100 mg efterfulgt af 50 mg hver 12. time i 5 til 14 dage.
English: There is limited evidence of the clinical efficacy of tigecycline against enterococci.
Danish: Der er begrænset evidens for klinisk effekt af tigecyclin over for enterokokker.
English: Tygacil is distributed in a ten vial tray pack.
Danish: Tygacil leveres i en bakke med ti hætteglas.
English: • Abdominal pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite)
Danish: • Mavemerter, dyspepsi (mavegener og fordøjelsesbesvær), appetitløshed
English: Gastrointestinal disorders nausea, vomiting, diarrhoea abdominal pain, dyspepsia, anorexia acute pancreatitis (see section 4.4)
Danish: Mavetarmkanalen kvalme, opkastning, diarré abdominalsmerter, dyspepsi, anoreksi akut pankreatitis (se pkt.
English: Tygacil should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 5.1).
Danish: Tygacil må ikke anvendes til børn under 8 år på grund af misfarvning af tænderne (se pkt.
English: After reconstitution, 1 ml contains 10 mg of tigecycline.
Danish: Efter opløsning indeholder 1 ml 10 mg tigecyclin.
English: Co-administration of P-gp inhibitors (e.g., ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of tigecycline (see section 5.2).
Danish: Samtidig administration af P-pg-hæmmere (f.eks. ketoconazol eller ciclosporin) eller P-gp-induktorer (f.eks. rifampicin) kunne påvirke farmakokinetikken af tigecyclin (se pkt.
English: In female rats, there were no compound-related effects on ovaries or oestrus cycles at exposures up to 4.7 times the human daily dose based on AUC.
Danish: Hos hunrotter var der ingen substansrelateret virkning på ovarier eller løbetid ved en eksponering, der var 4,7 gange højere end den daglige dosis til mennesker baseret på AUC.
English: If the same intravenous line is used for sequential infusion of several active substances, the line should be flushed before and after infusion of tigecycline with either sodium chloride 9 mg/ml (0.9 %) solution for injection or dextrose 50 mg/ml (5 %) solution for injection.
Danish: Hvis den samme intravenøse slange bruges til sekventiel infusion af en række aktive stoffer, skal slangen skylles før og efter infusion af tigecyclin med en injektionsopløsning bestående af enten 9 mg/ml (0,9 %) natriumchlorid eller 50 mg/ml (5 %) glukose.
English: No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion eller hos patienter, som er i hæmodialyse (se pkt.
English: * (see sections 4.3 and
Danish: 4.4 og
English: Tigecycline may be associated with permanent tooth discolouration in humans if used during tooth development (see section 4.8).
Danish: Tigecyclin kan være forbundet med permanent misfarvning af tænder hos mennesker, hvis det anvendes under tandudviklingen (se pkt.
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Danish: Indehaveren af markedsføringstilladelsen Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: Based on an in vitro study tigecycline is a P-gp substrate.
Danish: Baseret på et in vitro studie er tigecyclin et P-glykoprotein-(P-gp-) substrat.
English: Race There were no differences in the clearance of tigecycline based on race.
Danish: Etnisk baggrund Der var ingen forskelle i tigecyclins clearance i forhold til etnisk baggrund.
English: S  0.25 mg/L and R  0.5 mg/L Enterobacteriaceae S  1
Danish: Følsom  0,25 mg/l og Resistent > 0,5 mg/l Enterobacteriaceae Følsom  1
English: Vascular disorders phlebitis thrombophlebitis
Danish: Vaskulære sygdomme flebitis tromboflebitis
English: The results in a large study in patients with diabetic foot infection, showed that tigecycline was less effective than comparator, therefore, tigecycline is not recommended for use in these patients (see section 4.1).
Danish: Resultaterne af et stort forsøg hos patienter med diabetisk fodinfektion har vist, at tigecyclin var mindre effektivt end det stof, det blev sammenlignet med.
English: The recommended dose in adolescents aged 12 to <18 years is 50 mg given every 12 hours.
Danish: Den anbefalede dosis til unge i alderen 12 til <18 år er 50 mg hver 12. time.
English: The powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, dextrose 50 mg/ml (5 %) solution for injection, or Lactated Ringer's solution for injection to achieve a concentration of 10 mg/ml of tigecycline.
Danish: Pulveret skal opløses i 5,3 ml 9 mg/ml (0,9 %) natriumchlorid-injektionsvæske, 50 mg/ml (5 %) glucose-injektionsvæske eller Ringer-lactat-injektionsvæske for at få en koncentration på 10 mg/ml tigecyclin.
English: The first study enrolled children aged 8-16 years (n=24) who received single doses of tigecycline (0.5, 1, or 2 mg/kg, up to a maximum dose of 50 mg, 100 mg, and 150 mg, respectively) administered intravenously over 30 minutes.
Danish: Det første studie inkluderede børn i alderen 8-16 år (n=24), som fik en enkelt dosis tigecyclin (0,5, 1 eller 2 mg/kg, op til en maksimumdosis på henholdsvis 50 mg, 100 mg og 150 mg), indgivet intravenøst i løbet af 30 minutter.
English: Such reactions may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.8).
Danish: Det kan være bivirkninger som lysfølsomhed, pseudotumor cerebri, pankreatitis og antianabolsk handling, som medfører øget BUN, azotæmi, acidose og hyperfosfatæmi (se pkt.
English: Lactose monohydrate Hydrochloric acid
Danish: Lactosemonohydrat Saltsyre
English: The recommended dose in children aged 8 to <12 years is 1.2 mg/kg given every 12 hours intravenously to a maximum dose of 50 mg every 12 hours.
Danish: Den anbefalede dosis til børn i alderen 8 til <12 år er 1,2 mg/kg, som gives intravenøst hver 12. time op til en maksimumdosis på 50 mg hver 12. time.
English: A patient developing impaired healing should be monitored for the detection of superinfection (see section 4.8).
Danish: Patienter med dårlig sårheling bør derfor monitoreres for superinfektion (se pkt.
English: Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):
Danish: Tygacil er indiceret til behandling af følgende infektioner hos voksne og hos børn i alderen fra otte år og opefter (se pkt.
English: Tetracycline class adverse reactions may include photosensitivity, pseudotumour cerebri, pancreatitis, and antianabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.4).
Danish: Bivirkninger i tetracyklinklassen kan omfatte lysfølsomhed, pseudotumor cerebri, pankreatitis og antianabolsk virkning, som kan føre til forhøjet BUN, azotæmi, acidose og hyperfosfatæmi (se pkt.
English: Thereafter, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag or other suitable infusion container in the hospital.
Danish: Derefter skal opløsningen straks trækkes op af hætteglasset og overføres til en 100 ml infusionspose eller anden passende infusionsbeholder på hospitalet.
English: Once reconstituted and diluted in the bag or other suitable infusion container (e.g. glass bottle) tigecycline should be used immediately.
Danish: Når tigecyclin er opløst og fortyndet i posen eller en anden passende infusionsbeholder (f.eks. glasflaske), bør det anvendes straks.
English: • Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4);
Danish: • Komplicerede hud- og bløddelsinfektioner (cSSTI) med undtagelse af diabetiske fodinfektioner
English: It is not known if Tygacil passes into breast milk in humans.
Danish: Det vides ikke, om Tygacil udskilles i modermælk.
English: Gram-positive Aerobes
Danish: Gramnegative aerober
English: Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9 %) solution for injection, dextrose 50 mg/ml (5 %) solution for injection, and Lactated Ringer's solution for injection.
Danish: Forligelige intravenøse opløsninger omfatter: 9 mg/ml (0,9 %) natriumchlorid-injektionsvæske, 50 mg/ml (5 %) glucose-injektionsvæske og Ringer-lactat-injektionsvæske.
English: Tygacil 50 mg powder for infusion Tigecycline
Danish: Tygacil 50 mg pulver til infusionsvæske, opløsning Tigecyclin
English: This consists of severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation, which may occur during or after your treatment.
Danish: Det kan være tegn på en alvorlig tarmbetændelse, som kan forekomme under eller efter behandlingen.
English: The second study was performed in children aged 8 to 11 years who received multiple doses of tigecycline (0.75, 1, or 1.25 mg/kg up to a maximum dose of 50 mg) every 12 hours administered intravenously over 30 minutes.
Danish: Det andet studie blev gennemført med børn i alderen 8-11 år, som fik flere doser tigecyclin (0,75, 1 eller 1,25 mg/kg op til en maksimal dosis på 50 mg) hver 12. time, indgivet intravenøst i løbet af 30 minutter.
English: Children aged 8 to <12 years: 1.2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days.
Danish: Børn i alderen 8 til <12 år: 1,2 mg/kg tigecyclin intravenøst hver 12. time op til en maksimumdosis på 50 mg hver 12. time i 5 til 14 dage.
English: Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients.
Danish: Hos pædiatriske patienter skal tigecyclin helst administreres som en infusion over 60 minutter.
English: Each 5 ml Tygacil vial contains 50 mg of tigecycline.
Danish: Hvert 5 ml Tygacil-hætteglas indeholder 50 mg tigecyclin.
English: • Complicated infection in the abdomen
Danish: • Komplicerede maveinfektioner
English: The total clearance of tigecycline is 24 L/h after intravenous infusion.
Danish: Tigecyclins samlede clearance er 24 l/t.
English: Powder for solution for infusion 10 vials
Danish: Pulver til infusionsvæske, opløsning 10 hætteglas
English: No significant effect of a single intravenous dose of tigecycline 50 mg or 200 mg on QTc interval was detected in a randomized, placebo- and active-controlled four-arm crossover thorough QTc study of 46 healthy subjects.
Danish: I et randomiseret placebo- og aktivt-kontrolleret, fire-armet, grundigt overkrydsnings-QTc-studie med 46 raske personer blev der ikke fundet nogen signifikant virkning på QTc-intervallet efter en intravenøs enkeltdosis på 50 mg eller 200 mg tigecyclin.
English: What Tygacil contains The active substance is tigecycline.
Danish: Aktivt stof: tigecyclin.
English: Biliary excretion accounts for approximately 50 % of the total tigecycline excretion.
Danish: Af tigecyclins samlede ekskretion udskilles ca. 50 % via galden.
English: Each vial contains 50 mg tigecycline.
Danish: Hvert hætteglas indeholder 50 mg tigecyclin.
English: The recommended dose in adults is 100 mg given initially, followed by 50 mg every 12 hours.
Danish: Den anbefalede startdosis til voksne er 100 mg og derefter 50 mg hver 12. time.
English: For IV use only
Danish: Kun til engangsbrug.
English: other than S. pneumoniae S  0.25 mg/L and R  0.5 mg/L Enterococcus spp.
Danish: ud over S. Pneumoniae Følsom  0,25 mg/l og Resistent > 0,5 mg/l.
English: Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients (see section 4.4).
Danish: Hos pædiatriske patienter skal tigecyclin helst administreres som en infusion over 60 minutter (se pkt.
English: • Laboratory measurements of decreased ability to form blood clots
Danish: • Nedsat evne til at få blodet til at størkne (ses ved blodprøver)
English: * (see section 4.4)
Danish: 4.3 og 4.4)
English: Tygacil 50 mg powder for solution for infusion
Danish: Tygacil 50 mg pulver til infusionsvæske.
English: Adverse reactions reported with tigecycline, including clinical trials and post-marketing experience, are tabulated below.
Danish: Nedenstående tabel angiver bivirkninger indberettet på tigecyclin fra både kliniske undersøgelser og efter markedsføring:
English: • Dizziness
Danish: • Leversvigt
English: Tigecycline was not teratogenic in the rat or rabbit.
Danish: Hos rotter og kaniner var tigecyclin ikke teratogent.
English: Tygacil may interfere with the contraceptive pill (birth control pill).
Danish: Tygacil påvirker muligvis effekten af p-piller.
English: If you receive more Tygacil than you should
Danish: Hvis De har brugt for meget Tygacil
English: If you miss a dose of Tygacil If you are concerned that you may have missed a dose, talk to your doctor or nurse immediately.
Danish: Hvis De tror, at De har glemt at få en dosis, skal De straks kontakte lægen eller sygeplejersken.
English: How Tygacil is given
Danish: Tygacil indeholder
English: • Acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)
Danish: • Akut bugspytkirtelbetændelse (betændt bugspytkirtel som kan forårsage svære mavesmerter,
English: Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e.g. glass bottle).
Danish: Derefter skal 5 ml opløsning straks trækkes ud af hætteglasset og sættes til en intravenøs infusionspose på 100 ml eller en anden passende infusionsbeholder (f.eks. glasflaske).
English: Tetracycline class effects
Danish: Bivirkninger ved tetracyklinklassen
English: Peptostreptococcus spp.†
Danish: Anaerobe bakterier Clostridium perfringens† Peptostreptococcus spp.† Prevotella spp.
English: Tygacil may prolong certain tests that measure how well your blood is clotting.
Danish: Tygacil kan påvirke blodets størkningsevne.
English: • Vein irritations from the injection, including pain, inflammation, swelling and clotting
Danish: • Irritation i blodårerne pga. injektionen, inkl.
English: For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag or other suitable infusion container (e.g., glass bottle).
Danish: Ved en dosis på 100 mg skal der opløses to hætteglas i en intravenøs pose med 100 ml eller en anden passende infusionsbeholder (f.eks. glasflaske).
English: generalised allergic reaction that may lead to a life-threatening shock [e.g. difficulty in breathing, drop of blood pressure, fast pulse]).
Danish: Disse reaktioner kan variere fra milde til alvorlige og kan omfatte en pludseligt opstået overfølsomhedsreaktion i hele kroppen, hvilket kan føre til livstruende shock (dvs. besvær med vejrtrækningen,
English: • Abscess (collection of pus), infections
Danish: • Bylder, infektioner
English: What Tygacil is and what it is used for What you need to know before you receive Tygacil How Tygacil is given
Danish: Det skal De vide, før De begynder at bruge Tygacil Sådan skal De bruge Tygacil Bivirkninger
English: For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag for infusion or other suitable infusion container (e.g. glass bottle).
Danish: Til en dosis på 100 mg skal indholdet af to hætteglas opløses i en 100 ml infusionspose eller en anden passende infusionsbeholder (f.eks. glasflaske).
English: The reconstituted solution should be yellow to orange in colour; if not, the solution should be discarded.
Danish: Opløsningen skal være gul til orange.
English: Anaphylaxis/anaphylactoid reactions, potentially life-threatening, have been reported with tigecycline (see sections 4.3 and 4.8).
Danish: Der har været indberetninger om anafylaktiske/anafylaktoide reaktioner, potentielt livstruende, ved tigecyclin.