Tigecycline Accord

Package Leaflet: Information for the User

Tigecycline Accord 50 mg powder for solution for infusion

tigecycline
Please read this leaflet carefully before using this medicine because it contains important information for you or for the child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What Tigecycline Accord is and what it is used for
2. What you must know before being given Tigecycline Accord
3. How Tigecycline Accord is given
4. Possible side 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 that works by inhibiting the growth of bacteria causing infections.
Your doctor has prescribed Tigecycline Accord because you or your child (aged at least 8 years) have one of the following serious infections:

• complicated skin (skin) and soft tissue (tissues beneath the skin) infections, excluding diabetic foot infections
• complicated intra-abdominal infection.

Tigecycline Accord is used only when your doctor considers other antibiotics to be inappropriate.

2. What you need to know before receiving Tigecycline Accord

Do not use Tigecycline Accord

• If you are allergic to tigecycline, the active substance in Tigecycline Accord. If you are allergic to tetracycline antibiotics (e.g. minocycline, doxycycline, etc.), you may also be allergic to tigecycline.

Warnings and precautions
Talk to your doctor or nurse before using Tigecycline Accord:

• if you have slow or poor wound healing;
• if you have diarrhoea before starting treatment with Tigecycline Accord. If you develop diarrhoea during or after treatment, inform your doctor immediately. Do not take medicines for diarrhoea without first consulting your doctor;
• if you have or have previously had any adverse reactions to tetracycline antibiotics (e.g. skin sensitivity to sunlight, tooth staining in developing teeth, inflammation of the pancreas, or changes in certain laboratory test results assessing blood clotting function);
• if you have or have previously had liver problems. Depending on the condition of your liver, your doctor may reduce your dose to avoid adverse effects;
• if you have biliary obstruction (cholestasis);
• if you have a blood clotting disorder or are taking anticoagulant medicines, as this medicine may interfere with blood clotting.

During treatment with Tigecycline Accord:

• inform your doctor immediately if you develop symptoms of an allergic reaction;
• inform your doctor immediately if you experience severe abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis (inflamed pancreas, which may cause severe abdominal pain, nausea, and vomiting);
• for certain serious infections, your doctor may decide to use Tigecycline Accord in combination with other antibiotics;
• your doctor will closely monitor you for the development of any additional bacterial infections. If necessary, your doctor may prescribe a different antibiotic specific to the type of infection present;
• although antibiotics such as Tigecycline Accord fight certain bacteria, other bacteria and fungi may continue to grow; this phenomenon is known as overgrowth. Your doctor will closely monitor you for any possible infections and, if necessary, will treat you accordingly.

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 tooth defects such as staining of developing teeth.

Other medicines and Tigecycline Accord
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Tigecycline Accord may alter certain tests measuring your blood's clotting ability. It is important that you inform your doctor if you are taking medicines to prevent excessive blood clotting (called anticoagulants). In such cases, your doctor will monitor you closely.
Tigecycline Accord may interfere with the oral contraceptive pill (birth control pill). Consult your doctor regarding the need for an additional contraceptive method during treatment with Tigecycline Accord.

Pregnancy and breastfeeding
Tigecycline Accord may cause harm to the foetus. If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning a pregnancy, consult your doctor before taking this medicine.
It is not known whether tigecycline is excreted in human breast milk. Consult your doctor before breastfeeding.

Driving and using machines
Tigecycline Accord may cause adverse effects such as dizziness. This may affect your ability to drive or operate machinery.

Tigecycline Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is essentially "sodium-free".

3. How Tigecycline Accord is administered

Tigecycline Accord will be administered to you by a doctor or a nurse.
The recommended dose in adults is initially 100 mg, followed by 50 mg every 12 hours.
This dose is given intravenously (into a vein) over a period of 30 to 60 minutes.
The recommended dose in 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 in adolescents aged 12 to <18 years is 50 mg administered every 12 hours.
A course of treatment usually lasts from 5 to 14 days. Your doctor will decide the duration of treatment.
If you are given more Tigecycline Accord than you should have
If you are concerned that you have been given too much Tigecycline Accord, contact your doctor or nurse immediately.
If you miss a dose of Tigecycline Accord
If you are concerned that you have missed a dose, contact your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pseudomembranous colitis may occur with most antibiotics, including Tigecycline Accord.
It consists of severe, persistent or bloody diarrhoea, associated with abdominal pain or fever, which may be signs of a serious inflammation of the intestine that can occur during or after treatment.

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

• nausea, vomiting, diarrhoea.

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

• abscess (collection of pus), infections;
• laboratory tests showing reduced blood clotting ability;
• dizziness;
• vein irritation following injection, including pain, inflammation, swelling and clotting;
• abdominal pain, dyspepsia (stomach discomfort and indigestion), anorexia (loss of appetite);
• increased liver enzymes, hyperbilirubinemia (excess bile pigments in the blood);
• itching, skin rash;
• slow or poor wound healing;
• headache;
• increased amylase, an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN);
• pneumonia;
• low blood sugar levels;
• sepsis (serious infection in the body and blood)/septic shock (a serious medical condition that may lead to multi-organ failure and death as a result of sepsis);
• injection site reactions (pain, redness, inflammation);
• low levels of protein in the blood.

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

• acute pancreatitis (inflammation of the pancreas which may present with severe abdominal pain, nausea and vomiting);
• jaundice (yellowing of the skin), inflammation of the liver;
• low levels of platelets in the blood (which may lead to increased tendency to bleed and bruising/haematoma).

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

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

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

• anaphylactic/anaphylactoid reaction (which may range from mild to severe, including sudden and generalized allergic reaction that may lead to potentially life-threatening shock [e.g. difficulty breathing, rapid drop in blood pressure, rapid pulse]);
• liver failure;
• skin rash, which may lead to severe blistering and peeling of the skin (Stevens-Johnson syndrome).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tigecycline Accord

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of that month.

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

Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at a temperature of 20–25 °C, and for 48 hours at a temperature of 2–8 °C. From a microbiological standpoint, this product should be used immediately. If not administered immediately, the storage times and conditions prior to use are the responsibility of the user and must not exceed the times specified above regarding chemical and physical in-use stability.

The solution of Tigecycline Accord after dissolution should be yellow to orange in colour; if not, the solution must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tigecycline Accord contains
The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
The other ingredients are maltose monohydrate, hydrochloric acid, and sodium hydroxide.

Description of the appearance of Tigecycline Accord and contents of the pack
Tigecycline Accord is supplied as a powder for solution for infusion in a vial and, before dilution, appears as an orange powder or tablet. These vials are distributed to hospitals in packs of one vial or ten vials. Not all pack sizes may be marketed.

The powder must be mixed in the vial with a small amount of solution. The vial should then be gently shaken until the drug is completely dissolved. The solution should then be immediately withdrawn from the vial and added to a 100 mL intravenous infusion bag or another suitable container for infusion in a hospital setting.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer:
Or
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

More detailed information on this medicinal product is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu .

The following information is intended exclusively for healthcare professionals:

Instructions for use and handling (see also in this summary of product characteristics 3. How Tigecycline Accord is administered)

The powder must be reconstituted with 5.3 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion, or dextrose 50 mg/mL (5%) solution for infusion, or Ringer's lactate solution for infusion to obtain a concentration of 10 mg/mL of tigecycline. The vial should be gently shaken until the active substance is completely dissolved. Subsequently, 5 mL of the reconstituted solution must be immediately withdrawn from the vial and added to a 100 mL intravenous infusion bag or to another suitable infusion container (e.g., a glass bottle).

For a 100 mg dose, reconstitute using two vials in a 100 mL intravenous infusion bag or in another suitable infusion container (e.g., a glass bottle).

Note: The vial contains a 6% overage. Therefore, 5 mL of reconstituted solution corresponds to 50 mg of active substance. The reconstituted solution should be yellow to orange in colour; if not, the solution must be discarded. Parenteral products should be inspected visually before administration for particulate matter and for any change in colour (e.g., green or black).

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

Compatible intravenous solutions include: sodium chloride 9 mg/mL (0.9%) solution for infusion, dextrose 50 mg/mL (5%) solution for infusion, and Ringer's lactate solution for infusion.

When administered via a Y-site connector, compatibility of tigecycline diluted in 0.9% sodium chloride solution for infusion has been demonstrated with the following drugs or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, haloperidol, Ringer's lactate, lidocaine hydrochloride, metoclopramide, morphine, noradrenaline, piperacillin/tazobactam (EDTA-containing formulation), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.

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

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

Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at a temperature of 20–25 °C and for 48 hours at a temperature of 2–8 °C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed the times specified above regarding chemical and physical in-use stability.

For single use only; any unused solution must be discarded.