Tigecycline Accord 50 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tigecycline Accord 50 mg powder for solution for infusion EFG

tigecycline

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Tigecycline Accord is and what it is used for
2. What you need to know before being given Tigecycline Accord
3. How to use Tigecycline Accord
4. Possible adverse effects
5. How to store Tigecycline Accord
6. Contents of the pack and other information

1. What Tigecycline Accord is and what it is used for

Tigecycline Accord is an antibiotic belonging to the glycylcycline group, which works by inhibiting the growth of the bacteria causing the infection.

Your doctor has prescribed Tigecycline Accord because you or your child is at least 8 years old and has one of the following types of serious infections:

• Complicated skin and soft tissue infections (the tissue beneath the skin), excluding diabetic foot infections.

• Complicated intra-abdominal infections.

Tigecycline Accord is only used when the doctor considers that alternative antibiotics are not suitable.

2. What you need to know before using Tigecycline Accord

Do not use Tigecycline Accord

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

Warnings and precautions

Immediately inform your doctor or nurse before taking Tigecycline Accord:

• If you have poor or slow wound healing.

• If you already have diarrhea before starting Tigecycline Accord. If you develop diarrhea during or after treatment, inform your doctor immediately. Do not take any medication for diarrhea without first consulting your doctor.

• If you have had or currently have any adverse effects from using antibiotics belonging to the tetracycline group (e.g., skin sensitivity to sunlight, staining of developing teeth, pancreatitis, or changes in certain laboratory tests measuring blood clotting).

• If you have or have previously had liver problems. Depending on your liver function, your doctor may reduce the dose to avoid potential side effects.

• If you have bile duct obstruction (cholestasis).

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

During treatment with Tigecycline Accord:

• Immediately inform your doctor if you develop symptoms of an allergic reaction.
• Immediately inform your doctor if you develop severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas that may cause severe abdominal pain, nausea, and vomiting).
• In certain severe infections, your doctor may consider using Tigecycline Accord in combination with other antibiotics.
• Your doctor will closely monitor you for the development of any additional bacterial infections. If you develop another bacterial infection, your doctor may prescribe a different antibiotic specific to the type of infection.
• Although antibiotics such as Tigecycline Accord target certain types of bacteria, other bacteria and fungi may continue to grow. This process is known as overgrowth. Your doctor will closely monitor you for any possible infections and treat you if necessary.

Children

Tigecycline Accord must 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 it may cause permanent dental defects, such as staining of developing teeth.

Other medicines and Tigecycline Accord

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

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

Tigecycline Accord may interfere with oral contraceptives (birth control pills). 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 medicines used to suppress the immune system (such as tacrolimus or cyclosporine). It is important that you inform your doctor if you are taking these medicines so that you can be closely monitored.

Pregnancy and breastfeeding

Tigecycline Accord may cause harm to 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 unknown whether 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 could reduce your ability to drive or operate machinery.

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 must 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 given intravenously (directly into the bloodstream) over a period of 30 to 60 minutes.

The recommended dose for children aged 8 to <12 years is 1.2 mg/kg administered intravenously every 12 hours, up to a maximum dose of 50 mg every 12 hours.

The recommended dose for adolescents aged 12 to <18 years is 50 mg administered every 12 hours.

The usual 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 Tigecycline Accord than you should have, inform your doctor or nurse immediately.

If a dose of Tigecycline Accord has been missed

If you are concerned that a dose has been missed, inform your doctor or nurse immediately.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everyone experiences them.

Pseudomembranous colitis may occur with most antibiotics, including Tigecycline Accord. Pseudomembranous colitis is characterized by severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which may be a sign of serious intestinal inflammation. This may occur during or after treatment.

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

• Nausea, vomiting, diarrhoea.

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

• Abscesses (pus accumulation), infections.
• Abnormalities in certain laboratory tests indicating reduced blood clotting ability.
• Dizziness.
• Irritation of the vein where the drug is injected, including pain, inflammation, swelling and clot formation.
• Abdominal pain, dyspepsia (stomach pain and indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in blood).
• Pruritus (itching), skin rash.
• Poor or delayed wound healing.
• Headache.
• Increased amylase (an enzyme present in salivary glands and pancreas), increased blood urea nitrogen (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (a serious infection affecting the whole body and blood)/septic shock (a life-threatening medical condition resulting from sepsis that may lead to multiple organ failure and death).
• Local reaction at injection site (pain, redness, swelling).
• Low blood protein levels.

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

• Acute pancreatitis (inflammation of the pancreas causing severe abdominal pain, nausea and vomiting).
• Jaundice (yellowing of the skin), liver inflammation.
• Low platelet levels in blood (which may lead to increased tendency to bleed and bruising).

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

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 refers to the last day of the month indicated.

Storage after preparation

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 6 hours at 20–25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and must not exceed the time limits indicated above for chemical and physical in-use stability.

Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 20–25°C and 49 hours at 2–8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and must not exceed the time limits indicated above for chemical and physical in-use stability.

Tigecycline Accord solution should be yellow to orange in colour after reconstitution; if not, it must be discarded immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Tigecycline Accord

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

The other components 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 compacted powder before dilution. Tigecycline Accord is available in packs containing one vial or ten vials.

Only certain pack sizes may be marketed.

The powder must be mixed in the vial with a small amount of solution. The vial should be gently shaken until the medicine dissolves. The solution must then be withdrawn immediately from the vial and added to a 100 ml intravenous infusion bag or another suitable hospital infusion container.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est, 6th floor,

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 the most recent 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 must be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, 5 % dextrose (50 mg/ml) solution for injection, or Ringer Lactate solution for injection to achieve a concentration of 10 mg/ml of tigecycline. The vial should be gently shaken until the active substance dissolves. Immediately after reconstitution, 5 ml of the reconstituted solution should be withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable infusion container (e.g. glass bottle).

To obtain a 100 mg dose, two vials should be reconstituted and added to a 100 ml intravenous infusion bag or another suitable infusion container (e.g. glass bottle).

Note: The vial contains a 6 % overfill. 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 must be discarded. Parenteral products should be inspected visually for particulate matter and discoloration (e.g. green or black particles) prior to administration.

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

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

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

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

Reconstituted solution: Chemical and physical stability has been demonstrated for up to 6 hours at 20–25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the user's responsibility and must not exceed the times indicated above for chemical and physical stability.

Diluted solution: Chemical and physical stability has been demonstrated for up to 24 hours at 20–25°C and 49 hours at 2–8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the user's responsibility and must not exceed the times indicated above for chemical and physical stability.

This medicine is intended for single-dose administration only; any unused solution must be discarded.