50 mg\u00a0powder for\u00a0infusion, solution
tigecycline<\/p>\n\n\n\n
Tigecycline Accord is an\u00a0antibiotic\u00a0in the glycylcycline group that works by stopping the growth of bacteria that cause\u00a0infection.<\/p>\n\n\n\n
Your doctor has prescribed Tigecycline Accord because you or your child over 8 years of age has one of the following serious\u00a0infections.<\/p>\n\n\n\n
Tigecycline Accord is only used when your doctor considers other antibiotics unsuitable. Talk to your doctor or nurse before receiving Tigecycline Accord:<\/strong><\/p>\n\n\n\n During treatment with Tigecycline Accord:<\/strong><\/p>\n\n\n\n Tigecycline Accord should not be used in children under 8 years of age as there is a lack of data on safety and efficacy in this age group and as it may cause permanent defects on the teeth, such as discoloration of developing teeth.<\/a><\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Tigecycline Accord may prolong certain tests that measure how well your blood clots.\u00a0You must tell your doctor if you are taking medicines to avoid excess blood clotting (so-called\u00a0anticoagulants\u00a0).\u00a0If so, your doctor will monitor you closely.<\/p>\n\n\n\n Tigecycline Accord can affect the effectiveness of\u00a0birth control pills.\u00a0Talk to your doctor about the need for additional contraception while using Tigecycline Accord.<\/p>\n\n\n\n Tigecycline Accord may increase the effect of medicines used to\u00a0suppress\u00a0the immune system (such as tacrolimus and cyclosporine<\/a>).\u00a0You must tell your doctor if you are taking these medicines so that you can be monitored closely.<\/p>\n\n\n\n Tigecycline Accord may be harmful to the fetus.\u00a0If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.<\/p>\n\n\n\n It is not known whether tigecycline passes into breast milk. Consult a doctor before breastfeeding your baby.<\/a><\/p>\n\n\n\n Tigecycline Accord can cause side effects such as dizziness. This may impair the ability to drive and operate machinery.<\/a><\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg)\u00a0of sodium\u00a0per\u00a0vial, i.e. it is almost “sodium-free”.<\/p>\n\n\n\n Tigecycline Accord will be administered to you by a doctor or nurse.<\/p>\n\n\n\n The recommended\u00a0dose\u00a0for adults is 100 mg as an initial dose followed by 50 mg every 12 hours.\u00a0This\u00a0dose\u00a0is given\u00a0intravenously\u00a0(directly into the blood) over 30 to 60 minutes.<\/p>\n\n\n\n The recommended dose for children aged 8 to <12 years is 1.2 mg\/kg given every 12 hours intravenously up to a maximum dose of 50 mg every 12 hours.<\/p>\n\n\n\n The recommended dose for adolescents aged 12 to <18 years is 50 mg given every 12 hours.<\/p>\n\n\n\n Usually, the treatment lasts for 5 to 14 days.\u00a0Your doctor will decide how long you will be treated.<\/p>\n\n\n\n If you are concerned that you may have received too much Tigecycline Accord, talk to your doctor or nurse immediately.<\/a><\/p>\n\n\n\n If you are concerned that you may have missed a\u00a0dose, talk to your doctor or nurse straight away.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Pseudomembranous\u00a0colitis\u00a0can occur during treatment with most\u00a0antibiotics, including Tigecycline Accord.\u00a0It presents as severe, persistent, or bloody diarrhea associated with abdominal pain or fever.\u00a0This may be a sign of serious intestinal inflammation, which may occur during or after your treatment.<\/p>\n\n\n\n Very common side effects are (may affect more than 1 in 10 users):<\/p>\n\n\n\n Common side effects are (may affect up to 1 in 10 users):<\/p>\n\n\n\n Uncommon side effects are (may affect up to 1 in 100 users):<\/p>\n\n\n\n Rare side effects are (may affect up to 1 in 1,000 users):<\/p>\n\n\n\n Has been reported (occurring in an unknown number of users):<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n No special storage instructions. Use before the expiry date stated on the bottle. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Storage after preparation<\/strong><\/p>\n\n\n\n Prepared solution: Chemical and physical stability has been demonstrated for 6 hours at 20\u201125 \u00b0C.\u00a0From a\u00a0microbiological\u00a0point of view, the product must be used immediately.\u00a0If not used immediately, in-use storage times and conditions before use is the responsibility of the user and should not exceed the times stated above for chemical and physical stability.<\/p>\n\n\n\n Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 20-25 \u00b0C and 48 hours at 2-8 \u00b0C.\u00a0From a\u00a0microbiological\u00a0point of view, the product must be used immediately.\u00a0If not used immediately, in-use storage times and conditions before use is the responsibility of the user and should not exceed the times stated above for chemical and physical stability.<\/p>\n\n\n\n Tigecycline Accord solution should be yellow to orange after the dissolution of the powder;\u00a0otherwise, the solution should be discarded.<\/p>\n\n\n\n Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n Tigecycline Accord is supplied as a powder for infusion in a vial and looks like an orange powder or cake before dilution. These vials are distributed to hospitals in a package of one vial or ten vials. Not all pack sizes may be marketed.<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before you receive Tigecycline Accord<\/h2>\n\n\n\n
Do not use Tigecycline Accord<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Children<\/h2>\n\n\n\n
Other medicines and Tigecycline Accord<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Tigecycline Accord contains sodium<\/h2>\n\n\n\n
How Tigecycline Accord is given<\/h2>\n\n\n\n
If you have been given too much Tigecycline Accord<\/h2>\n\n\n\n
If you have forgotten a dose of Tigecycline Accord<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Tigecycline Accord<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n