Lactose monohydrate

Hydrochloric acid, sodium hydroxide (for pH adjustment)

6.2 Incompatibilities
 The following active substances should not be administered simultaneously through the same Y-site as Tygacil: Amphotericin B, amphotericin B lipid complex, diazepam esomeprazole, omeprazole and intravenous solutions that could result in an increase of pH above 7.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
 2 years.
Once reconstituted and diluted in the bag or other suitable infusion container (e.g. glass bottle), tigecycline should be used immediately.

6.4 Special precautions for storage
 Store below 25°C.
For storage conditions of the reconstituted product see section 6.3.
6.5 Nature and contents of container
 5 ml Type 1 clear glass vials fitted with grey butyl rubber stoppers and snap-off aluminium crimp seals. Tygacil is distributed in a ten vial tray pack.
6.6 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 Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e.g., glass bottle).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 L