Tigecicline Tzf

Package Leaflet: Information for the User

Tigecycline TZF, 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 leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

Tigecycline TZF is an antibiotic belonging to the group of glycylcyclines, which works by inhibiting the growth of bacteria that cause infections.
Tigecycline TZF has been prescribed by your doctor for an adult patient or a child from 8 years of age to treat one of the following types of severe infections:

• complicated skin and soft tissue infections (tissues under the skin), except for diabetic foot infections,
• complicated intra-abdominal infections.

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

2. Important information before using Tigecycline TZF

When not to use Tigecycline TZF:

• if you are allergic to tigecycline or any of the other ingredients of this medicine (listed in section 6). Patients who have been found to be allergic to tetracycline antibiotics (e.g. minocycline, doxycycline, etc.) may also be allergic to tigecycline.

Warnings and precautions

Before starting treatment with Tigecycline TZF, discuss with your doctor or nurse if:

• you have poorly or slowly healing wounds.
• you had diarrhea before starting treatment with Tigecycline TZF. If diarrhea occurs during or after treatment, tell your doctor immediately. Do not take any anti-diarrheal medicines without consulting your doctor.
• you have ever had side effects after taking tetracycline antibiotics (e.g. sensitivity to sunlight, tooth discoloration during development,

pancreatitis and changes in some laboratory test results used to assess blood coagulation).

• you have or have had liver function disorders. Depending on the liver condition, your doctor may reduce the dose to avoid side effects.
• you have been diagnosed with bile duct obstruction (bile stasis).
• you have blood coagulation disorders or are being treated with anticoagulant medicines, as this medicine may affect blood coagulation.

During treatment with Tigecycline TZF:

• contact your doctor immediately if you experience symptoms of an allergic reaction.
• contact your doctor immediately if you experience 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).
• for some severe infections, your doctor may consider administering Tigecycline TZF together 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 suitable for that type of infection.
• although antibiotics like Tigecycline TZF combat certain types of bacteria, other bacteria and fungi can still multiply. This phenomenon is called "superinfection". Your doctor will closely monitor your condition to diagnose possible infections and treat them if necessary.

Children and adolescents

Tigecycline TZF should not be used in children under 8 years of age due to the lack of data on safety and efficacy in this age group and because it may cause permanent tooth damage, such as discoloration occurring during tooth development.

Tigecycline TZF 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 TZF may increase the value of some parameters used to assess blood coagulation. It is essential that you inform your doctor if you are taking anticoagulant medicines. In this case, your doctor will closely monitor your health.
Tigecycline TZF may affect the action of birth control pills. You should discuss with your doctor whether you need to use an additional method of contraception while taking Tigecycline TZF.
Tigecycline TZF may enhance the effect of medicines used to weaken the immune system (such as tacrolimus or cyclosporine). It is crucial that you tell your doctor if you are taking these medicines so that your condition can be closely monitored.

Pregnancy and breastfeeding

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

Driving and using machines

Tigecycline TZF may cause side effects such as dizziness, which can lead to impaired ability to drive vehicles or operate machines.

3. How to use Tigecycline TZF

Tigecycline TZF is administered by your 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.
The recommended dose for children from 8 to 12 years old 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 from 12 to 18 years old is 50 mg every 12 hours.
The treatment cycle usually lasts from 5 to 14 days, and the duration is determined by your doctor.

Using more than the recommended dose of Tigecycline TZF

If you are concerned that you have received too much Tigecycline TZF, tell your doctor or nurse immediately.

Missing a dose of Tigecycline TZF

If you are concerned that a dose of Tigecycline TZF has been missed, tell your doctor or nurse immediately.

4. Possible side effects

Like all medicines, Tigecycline TZF can cause side effects, although not everybody gets them.
During treatment with most antibiotics, including Tigecycline TZF, pseudomembranous colitis may occur. It is characterized by severe, persistent, or bloody diarrhea, abdominal pain, or fever, which may indicate severe intestinal inflammation that can occur during or after treatment.

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

• nausea, vomiting, diarrhea.

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

• abscess (collection of pus), infections,
• laboratory test results indicating decreased blood coagulation,
• dizziness,
• vein irritation after injection, including pain, inflammation, swelling, and blood clots,
• abdominal pain, indigestion (stomach pain), loss of appetite (decreased appetite),
• increased liver enzyme activity, hyperbilirubinemia (elevated levels of bile pigments in the blood),
• itching (pruritus), rash,
• poorly or slowly healing wounds,
• headache,
• increased amylase activity (an enzyme found in salivary and pancreatic glands),
• increased urea levels in the blood,
• pneumonia,
• low blood sugar levels,
• sepsis (severe infection of the body and blood) or septic shock (a severe condition resulting from sepsis, which can lead to impaired function of multiple organs and death),
• injection site reaction (pain, redness, inflammation),
• low protein levels in the blood.

Uncommon side effects (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 cause increased bleeding tendency and the formation of bruises or hematomas).

Rare side effects (may affect up to 1 in 1000 people):

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

Side effects with unknown frequency (frequency cannot be estimated from 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, sudden drop in blood pressure, rapid heartbeat]),
• liver failure,
• skin rash that can lead to blistering and peeling of the skin with significant severity (Stevens-Johnson syndrome).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell 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 TZF

Keep the medicine out of sight and reach of children.
There are no special precautions for storing the medicinal product.
Do not use this medicine after the expiry date stated on the carton and label of the vial after: (EXP). The expiry date refers to the last day of the month.

Storage after preparation of the solution

It has been shown that the prepared solution is chemically and physically stable for 1 hour at 25°C.
For microbiological reasons, the medicine should be used immediately after preparation.
If the medicine is not administered immediately, the user is responsible for the storage time and conditions.
After preparation, the Tigecycline TZF solution should be clear and orange in 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 TZF contains

• The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
• The other ingredients are: arginine, hydrochloric acid (to adjust pH).

What Tigecycline TZF looks like and contents of the pack

Tigecycline TZF is available as an orange powder for solution for infusion in a vial. The vials are supplied to the hospital in packs of 10.
The powder should be mixed in the vial with a small amount of solution. The vial should be gently swirled until the medicine is dissolved. Then, 5 ml of the prepared solution should be immediately withdrawn from the vial and added to 100 ml of an intravenous infusion bag or another suitable container (e.g. a glass bottle).
To prepare a 100 mg dose, solutions should be prepared in two vials and added to 100 ml of an intravenous infusion bag or another suitable container (e.g. a glass bottle).
Note: the vial contains a 6% excess of the substance, so 5 ml of the prepared solution corresponds to 50 mg of the active substance. The solution after preparation should be orange in color; otherwise, it should be discarded. Before using products for parenteral administration, check for visible particles or color changes.

Marketing authorization holder

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw

Manufacturer

• 1. Laboratorios NORMON S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos Madrid Spain
• 2. Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna ul. A. Fleminga 2 03-176 Warsaw

For more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
tel. +48 22 811-18-14
Date of last revision of the leaflet:August 2023
Information intended for healthcare professionals only:

Instructions for preparing the medicine for use (see also section 3 "How to use Tigecycline TZF")

Instructions for preparing the medicine for use

To obtain a tigecycline solution with a concentration of 10 mg/ml, the lyophilized powder should be dissolved in 5.3 ml of 0.9% (9 mg/ml) sodium chloride injection solution, 5% (50 mg/ml) glucose injection solution, or Ringer's solution with lactate for injection. The vial should be gently swirled in a circular motion until the active substance is dissolved. Then, 5 ml of the prepared solution should be immediately withdrawn from the vial and added to 100 ml of an intravenous infusion bag or another suitable container (e.g. a glass bottle).
To prepare a 100 mg dose, solutions should be prepared in two vials and added to 100 ml of an intravenous infusion bag or another suitable container (e.g. a glass bottle).
Note: the vial contains a 6% excess of the substance, so 5 ml of the prepared solution corresponds to 50 mg of the active substance. The solution after preparation should be orange in color; otherwise, it should be discarded. Before using products for parenteral administration, check for visible particles or color changes.
Tigecycline should be administered intravenously through a separate infusion line or through a Y-connector.
If several active substances are administered sequentially through the same intravenous infusion line, the line should be flushed with 0.9% (9 mg/ml) sodium chloride injection solution or 5% (50 mg/ml) glucose injection solution before and after tigecycline administration. Only solutions for infusion that are compatible with tigecycline and other medicines should be administered through the same line.
Compatible infusion solutions: 0.9% (9 mg/ml) sodium chloride injection solution, 5% (50 mg/ml) glucose injection solution, and Ringer's solution with lactate for injection.
Tigecycline TZF should not be mixed with other medicinal products for which compatibility data are not available.
The tigecycline solution should be used immediately after preparation and dilution in an intravenous infusion bag or another container for infusion solution (e.g. a glass bottle).
For single use only - any unused solution should be discarded.