Special precautions for disposal and other handling
The lyophilised 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. The vial should be gently swirled until the medicinal product is dissolved. Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e.g., glass bottle).
For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag or other suitable infusion container (e.g., glass bottle). Note: The vial contains a 6 % overage. Thus, 5 ml of reconstituted solution is equivalent to 50 mg of the active substance. The reconstituted solution should be yellow to orange in colour; if not, the solution should be discarded. Parenteral products should be inspected visually for particulate matter and discolouration (e.g., green or black) prior to administration.
Tygacil may be administered intravenously through a dedicated line or through a Y-site. If the same intravenous line is used for sequential infusion of several active substances, the line should be flushed before and after infusion of Tygacil with either sodium chloride 9 mg/ml (0.9 %) solution for injection or dextrose 50 mg/ml (5 %) solution for injection. Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line (see section 6.2)
This medicinal product is for single use only; any unused solution should be discarded.
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.
When administered through a Y-site, compatibility of Tygacil 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.
7. MARKETING AUTHORISATION HOLDER
Wyeth Europa Ltd.
Huntercombe Lane South
Taplow, Maidenhead
Berkshire, SL6 0PH
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/06/336/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24 April 2006.
Date of last renewal: 06 May 2011
10. DATE OF REVISION OF THE TEXT
27 October 2011
Detailed information on this medicinal product is available on the website of the European Medicines Agency |
