Tigecicline Noridem

Package Leaflet: Information for the User

Tigecycline Noridem, 50 mg, Powder for Solution for Infusion

Tigecycline

Read the package leaflet carefully before using the medicine, as it contains important information for adult and child patients.

• 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, tell your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

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

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

Tigecycline Noridem is used only when your doctor considers other antibiotics to be unsuitable.

2. Important information before using Tigecycline Noridem

When not to use Tigecycline Noridem

• If you are allergic to tigecycline or any of the other ingredients of this medicine (listed in section 6).
• Patient with known allergy to tetracycline antibiotics (such as minocycline, doxycycline, etc.) may also be allergic to tigecycline.

Warnings and precautions

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

• If you have poor or slow wound healing.
• If you have had diarrhea before starting treatment with this medicine. If diarrhea occurs during or after treatment, tell your doctor immediately. Do not take any anti-diarrheal medicines without consulting your doctor.
• If you have ever had side effects after taking tetracycline antibiotics (such as sensitivity to sunlight, tooth discoloration during development, pancreatitis, and changes in some laboratory test results

conducted to assess blood coagulation).

• If you currently have or have had liver disease. Depending on the liver condition, your doctor may reduce the dose to avoid side effects.
• If you have bile duct obstruction (bile stasis).
• If you have blood coagulation disorders or are being treated with anticoagulant medicines, as Tigecycline Noridem may affect blood coagulation.

During treatment with Tigecycline Noridem:

• 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 Noridem 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 specific to that type of infection.
• Although Tigecycline Noridem fights some 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 possible infection.

Children
This medicine should not be used in children under 8 years of age due to lack of data on safety and efficacy in this age group and because it may cause permanent tooth discoloration, such as discoloration that occurs during tooth development.

Tigecycline Noridem 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 Noridem may increase the values of some parameters measured to assess blood coagulation. It is essential to inform your doctor if you are taking anticoagulant medicines. In this case, your doctor will closely monitor your health.
Tigecycline Noridem may enhance the effects of medicines used to weaken the immune system (such as tacrolimus or cyclosporin). It is essential to tell your doctor if you are taking these medicines so that your condition can be closely monitored.

Pregnancy and breastfeeding

Tigecycline Noridem 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 Tigecycline Noridem.
It is not known whether Tigecycline Noridem passes into human milk. Before breastfeeding, consult your doctor.

Driving and using machines

Tigecycline Noridem may cause side effects such as dizziness, which may impair your ability to drive or operate machines.

Tigecycline Noridem contains sodium

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

3. How to use Tigecycline Noridem

This medicine is administered by a doctor or nurse.
The recommended initial dose in 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 in 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 in 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 Noridem

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

Missing a dose of Tigecycline Noridem

If you are concerned that you have missed a dose of Tigecycline Noridem, tell your doctor or nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Tigecycline Noridem can cause side effects, although not everybody gets them.
During treatment with most antibiotics, including tigecycline, pseudomembranous colitis (swelling or inflammation of the colon) may occur. It is characterized by severe, persistent, or bloody diarrhea, abdominal pain, or fever, which may be a sign of severe intestinal inflammation 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 coagulation,
• dizziness,
• vein irritation after injection, which can cause pain, inflammation, swelling, and blood clots,
• abdominal pain, indigestion (stomach pain), loss of appetite (loss of appetite), increased liver enzyme activity, hyperbilirubinemia (excessive amount of bile pigment in the blood),
• itching (itching), rash,
• poor or slow wound healing,
• headache,
• increased amylase activity (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 (severe condition resulting from sepsis, which can lead to dysfunction of multiple organs 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 or bleeding).

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

• low fibrinogen levels in the blood.

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

• anaphylactic or anaphylactoid reactions, which are severe allergic reactions that can be life-threatening. They can range from mild to severe, including sudden, generalized allergic reaction, which can lead to life-threatening shock [such as difficulty breathing, low blood pressure, rapid heartbeat),
• liver failure,
• skin rash, which can lead to the formation of extensive blisters and skin peeling (Stevens-Johnson syndrome),

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring, Medicinal Products, Medical Devices, and Biocidal Products Registration Office,
Al. Jerozolimskie 181C
02 222 Warsaw,
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tigecycline Noridem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after: (EXP). The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Storage after preparation of the solution

After reconstitution:
The solution should be prepared from the powder and used immediately.
After dilution:
Chemical and physical stability has been demonstrated after reconstitution and immediate dilution in a bag or other container for infusion solution (e.g., a glass bottle) for:

• 6 hours at 23-27°C in both artificial light and protected from light after dilution in 9 mg/ml (0.9%) sodium chloride injection solution, 50 mg/ml (5%) glucose injection solution, or Ringer's lactate injection solution at a concentration of 0.476 mg/ml and 0.909 mg/ml of Tigecycline Noridem.
• 48 hours at 2-8°C in protected from light conditions and for an additional 1 hour

at 23-27°C in artificial light after dilution in 9 mg/ml (0.9%) sodium chloride injection solution, 50 mg/ml (5%) glucose injection solution, or Ringer's lactate injection solution at a concentration of 0.476 mg/ml and 0.909 mg/ml of Tigecycline Noridem.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and storage time before use, which is usually not more than 24 hours at 2-8°C, unless the dilution has taken place in controlled and validated aseptic conditions.
The Tigecycline Noridem solution after dilution should be clear and 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tigecycline Noridem contains

• The active substance is tigecycline. Each vial contains 50 mg of tigecycline. After reconstitution, 1 ml of solution contains 10 mg of tigecycline.
• The other ingredients are: lactose monohydrate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH).

What Tigecycline Noridem looks like and contents of the pack

Tigecycline Noridem is supplied as a powder for solution for infusion in a 6 ml vial of clear glass type I with a gray bromobutyl rubber stopper type I, with an aluminum seal and a yellow polypropylene plastic flip-off cap type, and before dilution, it appears as an orange powder.
This medicine is supplied in packs containing 1 vial or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

Noridem Enterprises Limited, Evagorou & Makariou,
Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus
T: +30 210 8161802, F: +30 2108161587.

Manufacturer

DEMO S.A. PHARMACEUTICAL INDUSTRY,
21st km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece,

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet:

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Information intended for healthcare professionals only: Instructions for preparation of the medicine for administration (see also section 3. How to use Tigecycline Noridem in this package leaflet).

To obtain a tigecycline solution with a concentration of 10 mg/ml, the 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 lactate injection solution. The vial should be gently shaken 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 infusion bag or other suitable container (e.g., a glass bottle).
To prepare a 100 mg dose, the powder from two vials should be dissolved and added to 100 ml of an infusion bag or other suitable container (e.g., a 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 and be free from visible signs of contamination; otherwise, it should be discarded. Before administering products for parenteral use, check for visible particles or changes in the solution color (e.g., to green or black).
The ready-to-use infusion solution should be administered intravenously through a separate infusion line or through a Y-connector. If the same infusion line is used to administer several active substances in sequence, the line should be flushed with 0.9% (9 mg/ml) sodium chloride injection solution or 5% (50 mg/ml) glucose injection solution before starting the tigecycline infusion and after its completion. Only infusion solutions that are compatible with tigecycline and other medicinal products should be administered through the same infusion line.
Compatible infusion solutions: 0.9% (9 mg/ml) sodium chloride injection solution, 5% (50 mg/ml) glucose injection solution, and Ringer's lactate injection solution.
Compatibility of the tigecycline solution has been demonstrated when administered through a Y-connector after dilution in 9 mg/ml (0.9%) sodium chloride injection solution with the following medicinal products or solvents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, Ringer's lactate, lidocaine hydrochloride, metoclopramide, noradrenaline, piperacillin/tazobactam, potassium chloride, propofol, theophylline, and tobramycin.
Tigecycline Noridem should not be mixed with other medicinal products for which compatibility data are not available.
For single use only - unused solution should be discarded.