Tigecicline Fresenius Kabi

Package Leaflet: Information for the User

Tigecycline Fresenius Kabi, 50 mg, Powder for Solution for Infusion

Tigecycline

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

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

Table of Contents of the Package Leaflet

• 1. What is Tigecycline Fresenius Kabi and what is it used for
• 2. Important information before using Tigecycline Fresenius Kabi
• 3. How to use Tigecycline Fresenius Kabi
• 4. Possible side effects
• 5. How to store Tigecycline Fresenius Kabi
• 6. Contents of the pack and other information

1. What is Tigecycline Fresenius Kabi and what is it used for

Tigecycline Fresenius Kabi is an antibiotic belonging to the group of glycylcyclines, which works by inhibiting the growth of bacteria that cause infections.
Your doctor has prescribed Tigecycline Fresenius Kabi to an adult or child aged 8 years or older to treat one of the following severe infections:

• complicated skin and soft tissue infections (tissue under the skin), excluding diabetic foot infections;
• complicated intra-abdominal infections.

Tigecycline Fresenius Kabi is used only when your doctor considers that other antibiotics are not suitable.

2. Important information before using Tigecycline Fresenius Kabi

When not to use Tigecycline Fresenius Kabi

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

Warnings and precautions

Before starting treatment with Tigecycline Fresenius Kabi, discuss with your doctor or nurse:

• If you have poor or slow wound healing.
• If you had diarrhea before starting treatment with Tigecycline Fresenius Kabi. If diarrhea occurs during or after treatment, inform your doctor immediately. Do not take any anti-diarrheal medicines without consulting your doctor.

If you are concerned about any side effects, inform your doctor or nurse.

• If you have ever had adverse reactions to tetracycline antibiotics (e.g. sensitivity to sunlight, tooth discoloration during tooth development, pancreatitis, and changes in some laboratory test results used to evaluate blood clotting).
• If you currently have or have had liver disease. Depending on your liver condition, your doctor may reduce the dose to avoid side effects.
• If you have bile duct obstruction (bile stasis).
• If you have bleeding disorders or are taking anticoagulant medicines, as this medicine may affect blood clotting.

During treatment with Tigecycline Fresenius Kabi

• Immediately contact your doctor if you experience symptoms of an allergic reaction.
• Immediately contact your doctor if you experience severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas, which can cause severe abdominal pain, nausea, and vomiting).
• In some severe infections, your doctor may consider administering Tigecycline Fresenius Kabi with other antibiotics.
• Your doctor will closely monitor you for the development of other bacterial infections. If another bacterial infection occurs, your doctor may prescribe another antibiotic specific to that type of infection.
• Although Tigecycline Fresenius Kabi fights certain types of bacteria, other types of bacteria and fungi may continue to multiply. This phenomenon is called superinfection. Your doctor will monitor your condition to diagnose and treat any potential infection.

Children

Tigecycline Fresenius Kabi should 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 discoloration, such as discoloration that occurs during tooth development.

Tigecycline Fresenius Kabi and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tigecycline Fresenius Kabi may increase the values of certain parameters used to evaluate blood clotting. It is essential to inform your doctor if you are taking anticoagulant medicines. In this case, your doctor will closely monitor your health.
Tigecycline Fresenius Kabi may affect the action of oral contraceptives (birth control pills). Female patients should discuss with their doctor whether they need to use an additional method of contraception while taking Tigecycline Fresenius Kabi.
Tigecycline Fresenius Kabi may increase the action of immunosuppressive medicines (such as tacrolimus or cyclosporine). It is essential to inform your doctor if you are taking these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using Tigecycline Fresenius Kabi.
Tigecycline Fresenius Kabi may be harmful to the fetus.
It is not known whether Tigecycline Fresenius Kabi passes into human milk. Before breastfeeding, consult your doctor.

Driving and using machines

Tigecycline Fresenius Kabi may cause side effects such as dizziness, which may affect your ability to drive or operate machines.

Tigecycline Fresenius Kabi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, which means it is essentially "sodium-free".

3. How to use Tigecycline Fresenius Kabi

Tigecycline Fresenius Kabi is administered by a doctor or nurse.
The recommended initial dose for adults is 100 mg, followed by 50 mg every 12 hours. The medicine is administered intravenously (directly into the bloodstream) over a period of 30 to 60 minutes.

Use in children and adolescents

The recommended dose for children aged 8 to 12 years is 1.2 mg/kg body weight, 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 every 12 hours.
Treatment usually lasts from 5 to 14 days. The duration of treatment will be decided by your doctor.

Using more than the recommended dose of Tigecycline Fresenius Kabi

If you are concerned that you have received too much Tigecycline Fresenius Kabi, inform your doctor or nurse immediately.

Missing a dose of Tigecycline Fresenius Kabi

If you are concerned that a dose of Tigecycline Fresenius Kabi has been missed, inform your doctor or nurse immediately.
If you have any questions about using the medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Tigecycline Fresenius Kabi can cause side effects, although not everybody gets them.
During treatment with most antibiotics, including Tigecycline Fresenius Kabi, pseudomembranous colitis may occur. This is characterized by severe, persistent, or bloody diarrhea, abdominal pain, or fever, which may be a sign of a severe intestinal infection that can occur during or after treatment.
Very common(may affect more than 1 in 10 people):

• nausea, vomiting, diarrhea.

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

• abscess (collection of pus), infections;
• laboratory test results indicating decreased blood clotting;
• dizziness;
• vein irritation after injection, which can cause pain, inflammation, swelling, and blood clots;
• abdominal pain, indigestion (stomach pain), loss of appetite;
• increased liver enzyme activity, hyperbilirubinemia (excessive bilirubin in the blood);
• itching (pruritus), rash;
• poor or slow wound healing;
• headache;
• increased amylase activity (an enzyme found in salivary and pancreatic glands), increased blood urea nitrogen levels;
• pneumonia;
• low blood sugar levels;
• sepsis (severe infection of the body and blood) or septic shock (a severe condition that can lead to organ failure and death);
• injection site reaction (pain, redness, inflammation);
• low protein levels in the blood.

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

• acute pancreatitis (inflammation of the pancreas, which can cause severe abdominal pain, nausea, and vomiting);
• jaundice (yellowing of the skin), hepatitis;
• low platelet count (which can lead to increased bleeding tendency and bruising).

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

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

Frequency not known(frequency cannot be estimated from the available data):

• anaphylactic or pseudoanaphylactic reactions (ranging from mild to severe, including sudden, generalized allergic reaction that can lead to life-threatening shock [e.g. difficulty breathing, low blood pressure, rapid heartbeat]);
• liver failure;
• skin rash that can lead to widespread blisters and peeling of the skin (Stevens-Johnson syndrome).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tigecycline Fresenius Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of the month.
Vial before opening:do not store above 30°C.

Storage after preparation of the solution

Tigecycline Fresenius Kabi, after reconstitution and dilution, should be used immediately, but if necessary, it can be stored for up to 48 hours at 2°C to 8°C (if reconstituted and diluted in 0.9% sodium chloride solution or 5% glucose solution) and up to 24 hours at room temperature (up to 25°C) (if reconstituted and diluted in 0.9% sodium chloride solution).
The solution of Tigecycline Fresenius Kabi, after dilution, should have a yellow to orange color; otherwise, it should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tigecycline Fresenius Kabi contains

• The active substance is tigecycline.
• The other ingredients are maltose monohydrate, concentrated hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

What Tigecycline Fresenius Kabi looks like and contents of the pack

Tigecycline Fresenius Kabi is supplied as a powder for solution for infusion in a vial, which, before dilution, has the appearance of an orange powder or disk. The vials are supplied to hospitals in packs of 10. The powder in the vial should be mixed with a small amount of solvent. The vial should be gently swirled until the medicine is dissolved. The solution should then be immediately withdrawn from the vial and added to a 100 ml infusion bag or other suitable container (e.g. glass bottle) for intravenous use.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer/Importer

Laboratori FUNDACIO DAU
C/ De la letra C, 12-14, Polígono Industrial de la Zona Franca
08040 Barcelona
Spain
For more detailed information, please contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the package leaflet:23.03.2022
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Information intended for healthcare professionals only:

Instructions for use and handling of the medicine (see also section 3. How to use Tigecycline Fresenius Kabi in this package leaflet)

To obtain a tigecycline solution with a concentration of 10 mg/ml, the powder should be reconstituted in 5.3 ml of 0.9% (9 mg/ml) sodium chloride solution for injection, 5% (50 mg/ml) glucose solution for injection, or Ringer's solution with lactate for injection. The vial should be gently swirled in a circular motion until the product is dissolved. Then, 5 ml of the prepared solution should be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or other suitable container (e.g. glass bottle).
To prepare a 100 mg dose, solutions should be prepared in two vials and added to a 100 ml intravenous infusion bag or other suitable container (e.g. glass bottle).
Note:the vial contains a 6% overfill of the active substance, so 5 ml of the prepared solution corresponds to 50 mg of the active substance. The solution, after preparation, should have a yellow to orange color; otherwise, it should be discarded.
Before using products for parenteral administration, check for visible particles and changes in the color of the solution (e.g. to green or black).
Tigecycline should be administered intravenously through a dedicated infusion line or through a Y-connector.
If the same intravenous line is used to administer other substances, the line should be flushed with 0.9% sodium chloride solution for injection or 5% glucose solution for injection before and after administering tigecycline.
Only solutions for intravenous administration that are compatible with tigecycline should be administered through the same line.
Compatible solutions for intravenous administration are: 0.9% sodium chloride solution for injection, 5% glucose solution for injection, and Ringer's solution with lactate for injection.
It has been demonstrated that tigecycline solution, when administered through a Y-connector after dilution in 0.9% sodium chloride solution for injection, is compatible with the following medicinal products or solvents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, haloperidol, Ringer's solution with lactate, lidocaine hydrochloride, metoclopramide, morphine, noradrenaline, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.
Tigecycline Fresenius Kabi should not be mixed with other medicinal products for which compatibility data are not available.
Reconstitution and dilution in 0.9% sodium chloride solution:the chemical and physical stability of the reconstituted and diluted medicine has been demonstrated for 48 hours at 2°C to 8°C and for 24 hours at room temperature (up to 25°C).
Reconstitution and dilution in 5% glucose solution:the chemical and physical stability of the reconstituted and diluted medicine has been demonstrated for 48 hours at 2°C to 8°C.
From a microbiological point of view, the reconstituted and diluted solution should be used immediately. If not used immediately, the user is responsible for the storage conditions prior to use and the solution should not be stored for more than 24 hours at 2°C to 8°C (in a refrigerator), unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
For single use only, any unused solution should be discarded.