TIGECICLINE ACCORD 50 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you are given Tigecycline Accord

Do not use Tigecycline Accord

• If you are allergic to tigecycline or any of the other ingredients of this medicine (listed in section 6). If you are allergic to antibiotics of the tetracycline group (e.g. minocycline, doxycycline, etc.), you may be allergic to tigecycline.

Warnings and precautions

Tell your doctor or nurse immediately before taking Tigecycline Accord:

• If you have poor or slow wound healing.
• If you have diarrhea before taking Tigecycline Accord. If you experience diarrhea during or after treatment, tell your doctor immediately. Do not take any medicine for the treatment of diarrhea without consulting your doctor first.
• If you have or have had any adverse effects due to the use of antibiotics that belong to the tetracycline group (e.g. sensitivity of the skin to sunlight, tooth discoloration

in development, pancreatitis and alteration of certain laboratory tests intended to measure if your blood clots properly).

• If you have or have had liver disorders. Depending on the condition of your liver, your doctor may reduce the dose to avoid possible side effects.

• If you have bile duct obstruction (cholestasis).

• If you have a bleeding disorder or are being treated with anticoagulant medications, as this medicine may interfere with blood clotting.

During treatment with Tigecycline Accord:

• Tell your doctor immediately if you develop symptoms of an allergic reaction.
• Tell your doctor immediately if you develop severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas that can cause severe abdominal pain, nausea, and vomiting).
• In certain severe infections, your doctor may consider the need to use Tigecycline Accord in combination with other antibiotics.
• Your doctor will closely monitor you for the appearance of any other bacterial infection. If you contract another bacterial infection, your doctor may prescribe a different antibiotic, specific to the type of infection.
• Although antibiotics like Tigecycline Accord attack certain types of bacteria, other bacteria and fungi may continue to grow. This process is called overgrowth. Your doctor will closely monitor you to detect any possible infection and treat you if necessary.

Children

Tigecycline Accord should not be used in children under 8 years old due to the lack of safety and efficacy data in this age group and because it may induce permanent dental defects, such as tooth discoloration in developing teeth.

Other medicines and Tigecycline Accord

Tell your doctor if you are using, have recently used, or might use any other medicines.

Tigecycline Accord may prolong certain tests that measure if your blood clots properly. It is important that you inform your doctor if you are taking certain medications to avoid excess blood clotting (called anticoagulants). If so, your doctor will closely monitor you.

Tigecycline Accord may interfere with the contraceptive pill (birth control pill). Ask your doctor about the need to use an additional contraceptive method while receiving treatment with Tigecycline Accord.

Tigecycline Accord may increase the effect of medications used to suppress the immune system (such as tacrolimus or cyclosporine). It is essential that you inform your doctor if you are taking these medications so that you can be closely monitored.

Pregnancy and breastfeeding

Tigecycline Accord may harm the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.

It is not known if tigecycline passes into breast milk. Consult your doctor before starting breastfeeding.

Driving and using machines

Tigecycline Accord may cause side effects such as dizziness. This may reduce your ability to drive or use machines.

Tigecycline Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml of solution, which is essentially sodium-free

3. How to use Tigecycline Accord

Tigecycline Accord should be administered by a doctor or nurse.

The recommended dose in adults is an initial dose of 100 mg, followed by 50 mg every 12 hours. These doses are administered intravenously (directly into the bloodstream) over a period of 30 to 60 minutes.

The recommended dose in children from 8 to <12 years old is 1.2 mg kg administered intravenously every 12 hours, up to a maximum dose of 50 hours.< p>

The recommended dose for adolescents from 12 to <18 years old is 50 mg administered every 12 hours.< p>

The normal duration of treatment is 5 to 14 days. Your doctor will decide the appropriate duration of treatment for you.

If you receive more Tigecycline Accord than you should

If you think you may have received more doses of Tigecycline Accord than you should, tell your doctor or nurse immediately.

If you miss a dose of Tigecycline Accord

If you are concerned about missing a dose, tell your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this product can cause side effects, although not everybody gets them.

Pseudomembranous colitis may occur with most antibiotics, including Tigecycline Accord. Pseudomembranous colitis consists of severe, persistent, or bloody diarrhea associated with abdominal pain or fever, which can be a symptom of severe intestinal inflammation that can occur during or after treatment.

Very common side effects are (may affect more than 1 in 10 people):

• Nausea, vomiting, diarrhea.

Common side effects are (may affect up to 1 in 10 people):

• Abscesses (accumulation of pus), infections.
• Alterations in certain laboratory tests that indicate decreased ability to clot blood.
• Dizziness.
• Irritation of the vein where the medicine is injected, including pain, inflammation, swelling, and clot formation.
• Abdominal pain, dyspepsia (stomach pain and feeling of indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in the blood).
• Pruritus (itching), skin rash.
• Poor or slow wound healing.
• Headache.

• Increased amylase, which is an enzyme present in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (severe infection that affects the whole body and blood)/septic shock (serious medical condition resulting from sepsis that can lead to multiple organ failure and death).
• Local reaction at the injection site (pain, redness, inflammation).
• Low protein levels in the blood.

Uncommon side effects are (may affect up to 1 in 100 people):

• Acute pancreatitis (inflammation of the pancreas that produces severe abdominal pain, nausea, and vomiting).
• Jaundice (yellowing of the skin), liver inflammation.
• Low platelet count in the blood (which can lead to increased tendency to bleed and bruise).

Rare side effects are (may affect up to 1 in 1,000 people):

• Low fibrinogen levels in the blood (a protein involved in blood clotting).

Side effects with unknown frequency are (frequency cannot be estimated from available data):

• Anaphylactic/anaphylactoid reactions (which can range from mild to severe, including a sudden and generalized allergic reaction that can lead to life-threatening shock [e.g. difficulty breathing, decreased blood pressure, rapid heartbeat]).
• Liver failure.
• Skin rash, which can lead to severe skin peeling (Stevens-Johnson syndrome).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tigecycline Accord

Keep this medicine out of the sight and reach of children.

Store below 30°C. Do not use this medicine after the expiry date stated on the vial. The expiry date is the last day of the month indicated.

Storage after preparation

Reconstituted solution: The chemical and physical stability up to use has been demonstrated for 6 hours at 20-25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not exceed the times indicated above for chemical and physical stability up to use.

Diluted solution: The chemical and physical stability up to use has been demonstrated for 24 hours at 20-25°C and 49 hours at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not exceed the times indicated above for chemical and physical stability up to use.

The solution of Tigecycline Accord should have a color between yellow and orange after dissolution; if not, it should be discarded immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tigecycline Accord

The active substance is tigecycline. Each vial contains 50 mg of tigecycline.

The other ingredients are maltose monohydrate, hydrochloric acid, and sodium hydroxide.

Appearance of Tigecycline Accord and contents of the pack

Tigecycline Accord is supplied as a powder for solution for infusion in vials containing orange-colored powder or compact powder before dilution. Tigecycline Accord is marketed in a pack of one vial or ten vials.

Not all pack sizes may be marketed.

The powder should be mixed in the vial with a small amount of solution. The vial should be gently shaken until the medicine is dissolved. Then, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or other suitable hospital infusion container.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Accord Healthcare S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona, Spain

Manufacturers:

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice

Poland

Or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

Spain

Date of last revision of this leaflet{MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Instructions for use and handling(see also section 3.of the leaflet "How to use Tigecycline Accord"):

The powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) injection solution, dextrose 50 mg/ml (5%) injection solution, or Ringer's Lactate solution to achieve a concentration of 10 mg/ml of tigecycline. The vial should be gently shaken until the active substance is dissolved. Then, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or other suitable hospital infusion container (e.g. glass bottle).

To obtain a dose of 100 mg, two vials should be reconstituted in a 100 ml intravenous infusion bag or other suitable hospital infusion container (e.g. glass bottle).

Note: The vial contains an excess dose of 6%. Thus, 5 ml of reconstituted solution is equivalent to 50 mg of active substance. The reconstituted solution should be yellow to orange in color; if not, the solution should be discarded. Parenteral products should be visually inspected for particulate matter or changes in particle color (e.g. green or black) before administration.

Tigecycline should be administered intravenously through a dedicated line or via a Y-line. If the same intravenous line is used for the sequential infusion of other active substances, the line should be flushed before and after the infusion of tigecycline with a sodium chloride 9 mg/ml (0.9%) injection solution or a dextrose 50 mg/ml (5%) injection solution. The infusion should be performed with a solution compatible with tigecycline and any other medicine administered through this common line.

Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9%) injection solution, dextrose 50 mg/ml (5%) injection solution, and Ringer's Lactate solution.

When administration is performed through a Y-line, the compatibility of tigecycline, diluted in sodium chloride for injection at 0.9%, has been verified with the following drugs or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Ringer's Lactate, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.

Tigecycline Accord should not be mixed with other medicines for which compatibility data are not available.

Reconstituted solution: The chemical and physical stability up to use has been demonstrated for 6 hours at 20-25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not exceed the times indicated above for chemical and physical stability up to use.

Diluted solution: The chemical and physical stability up to use has been demonstrated for 24 hours at 20-25°C and 49 hours at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not exceed the times indicated above for chemical and physical stability up to use.

This medicine should only be used for the administration of a single dose; any unused solution should be discarded.