TIGECICLINE NORIDEM 50 mg POWDER FOR SOLUTION FOR INFUSION

Contents of the pack

1. What is Tigecycline Noridem and what is it used for
2. What you need to know before you are given Tigecycline Noridem
3. How to use Tigecycline Noridem
4. Possible side effects
5. Storage of 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 of the glycylcycline group that works by blocking the growth of the bacteria that causes the infection.

Your doctor has prescribed this medicine because you or your child is at least 8 years old and has one of the following types of severe infections:

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

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

2. What you need to know before you are given Tigecycline Noridem

Do not use Tigecycline Noridem

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

Warnings and precautions

Talk to your doctor or nurse before taking tigecycline:

• If you have poor or slow wound healing.
• If you have diarrhea before taking this medicine. If you experience diarrhea during or after treatment, inform your doctor immediately. Do not take any medicine for diarrhea without consulting your doctor first.
• If you have or have had any side effects due to the use of antibiotics belonging to the tetracycline group (such as sensitivity of the skin to sunlight, staining of developing teeth, pancreatitis, and alteration of certain laboratory tests to measure if your blood clots properly).
• If you have or have had liver disorders. Depending on the condition of your liver, your doctor may reduce the dose to avoid possible side effects.
• If you have bile duct obstruction (cholestasis).
• If you have a bleeding disorder or are being treated with anticoagulant medications, as tigecycline may interfere with blood clotting.

During treatment with Tigecycline Noridem:

• Tell your doctor immediately if you develop symptoms of an allergic reaction.
• Tell your doctor immediately if you develop severe abdominal pain, nausea, and vomiting. These can be symptoms of acute pancreatitis (inflammation of the pancreas that can cause severe abdominal pain, nausea, and vomiting).
• In certain severe infections, your doctor may consider the need to use tigecycline in combination with other antibiotics.
• Your doctor will closely monitor you for the appearance of any other bacterial infection. If you contract another bacterial infection, your doctor may prescribe a different antibiotic, specific to the type of infection.
• Although antibiotics like tigecycline attack certain types of bacteria, other bacteria and fungi may continue to grow. This process is called overgrowth. Your doctor will closely monitor you to detect any possible infection and treat you if necessary.

Children

This medicine 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 dental defects, such as staining of developing teeth.

Other medicines and Tigecycline Noridem

Tell your doctor if you are using, have recently used, or might use any other medicines.

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

Tigecycline may increase the effect of medicines used to suppress the immune system (such as tacrolimus or cyclosporin). It is essential that you inform your doctor if you are taking these medicines so that you can be closely monitored.

Pregnancy and breastfeeding

Tigecycline may harm the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using tigecycline.

It is not known if tigecycline passes into breast milk. Consult your doctor before starting breastfeeding.

Driving and using machines

Tigecycline may cause side effects such as dizziness. This may reduce your ability to drive or use machines.

Tigecycline Noridem contains sodium

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

3. How to take Tigecycline Noridem

This medicine must be administered by a doctor or nurse.

The recommended dose of Tigecycline Noridem in adults is an initial dose of 100 mg, followed by 50 mg every 12 hours. These doses are administered intravenously (directly into the bloodstream) over a period of 30 to 60 minutes.

Use in children and adolescents

• The recommended dose in children from 8 to <12 years of age is 1.2 mg kg administered intravenously every 12 hours, up to a maximum dose 50 hours.< li>
• The recommended dose for adolescents from 12 to <18 years of age is 50 mg administered every 12 hours.< li>

The normal treatment duration is 5 to 14 days. Your doctor will decide the appropriate treatment duration for you.

If you are given more Tigecycline Noridem than you should

If you think you may have received more doses of tigecycline than you should, inform your doctor or nurse immediately.

If you miss a dose of Tigecycline Noridem

If you are concerned about missing a dose, inform your doctor or nurse immediately.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this product can cause side effects, although not everybody gets them.

Pseudomembranous colitis (swelling or inflammation of the colon) can occur with most antibiotics, including tigecycline. Pseudomembranous colitis consists of severe, persistent, or bloody diarrhea associated with abdominal pain or fever, which can be a symptom of 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):

• Abscesses (collection of pus), infections.
• Alterations in certain laboratory tests that indicate decreased ability to clot blood.
• Dizziness.
• Irritation of the vein where the medicine is injected, including pain, inflammation, swelling, and clot formation.
• Abdominal pain, dyspepsia (stomach pain and feeling of indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in the blood).
• Pruritus (itching), skin rash.
• Poor or slow wound healing.
• Headache.
• Increased amylase, which is an enzyme present in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (severe infection that affects the whole body and blood)/septic shock (life-threatening condition resulting from sepsis that can lead to multiple organ failure and death).
• Local reaction at the injection site (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 that causes severe abdominal pain, nausea, and vomiting).
• Jaundice (yellowing of the skin), liver inflammation.
• Low platelet count in the blood (which can lead to increased tendency to bleed and bruising).

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

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

Side effects with frequency not known (frequency cannot be estimated from available data):

• Anaphylactic/anaphylactoid reactions (which are severe, potentially life-threatening allergic reactions; can range from mild to severe, including a sudden, generalized allergic reaction that can lead to life-threatening shock [such as difficulty breathing, decreased blood pressure, rapid heartbeat]).
• Liver failure.
• Skin rash, which can lead to severe skin peeling (Stevens-Johnson syndrome).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website, www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

Store below 30°C.

Storage after preparation

After reconstitution:

Once the powder has been reconstituted, it must be used immediately.

After dilution:

Physical and chemical stability has been demonstrated during use after reconstitution and immediate dilution in the bag or other suitable infusion container (e.g., glass bottle):

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

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2°C-8°C, unless the dilution has been made in controlled and validated aseptic conditions.

The Tigecycline Noridem solution should have a yellow to orange color after dissolution; if not, it should be discarded immediately.

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

Composition of Tigecycline Noridem

• 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, concentrated hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

Appearance of Tigecycline Noridem and pack contents

Tigecycline Noridem is supplied as a powder for solution for infusion in 6 ml clear glass type I vials with gray bromobutyl rubber stoppers, aluminum seals, and removable yellow polypropylene caps that contain orange powder before dilution.

This medicine is marketed in packs of 1 and 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Noridem Enterprises Ltd.

Evagorou & Makariou

Mitsi Building 3, Office 115

1065 Nicosia, Cyprus

Manufacturer

DEMO S.A. PHARMACEUTICAL INDUSTRY

21st Km National Road Athens-Lamia.

14568 Greece

Phone: +30 210 8161802, Fax: +30 2108161587.

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

Date of last revision of this leaflet: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/

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The following information is intended exclusively for healthcare professionals:

Instructions for use and handling (see also section 3.of the prospectus "How to take Tigecycline Noridem"):

The powder must be reconstituted with 5.3 ml of injectable sodium chloride solution at 9 mg/ml (0.9%), with injectable dextrose solution at 50 mg/ml (5%), or with injectable Ringer's Lactate solution to achieve a concentration of 10 mg/ml of tigecycline. The vial should be gently shaken until the active ingredient is dissolved. Then, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or other suitable infusion container (e.g., glass vial).

To obtain a dose of 100 mg, two vials should be reconstituted in a 100 ml intravenous infusion bag or other suitable infusion container (e.g., glass vial).

Note: The vial contains a 6% excess dose. Thus, 5 ml of reconstituted solution is equivalent to 50 mg of active ingredient. The reconstituted solution should be yellow to orange in color and free of visible signs of contamination; if not, the solution should be discarded. Parenteral products should be visually inspected for the presence of suspended particles or changes in particle coloration (e.g., green or black) before administration.

The ready-to-use infusion solution should be administered intravenously through a dedicated line or via a Y-line. If the same intravenous line is used for the sequential infusion of other active ingredients, the line should be flushed before and after the infusion of tigecycline with a sodium chloride solution at 9 mg/ml (0.9%) for injection or with a dextrose solution at 50 mg/ml (5%) for injection. The injection should be made with an infusion solution compatible with tigecycline and any other medication through this common line.

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

When administration is performed through a Y-line, the compatibility of tigecycline, diluted in injectable sodium chloride at 9 mg/ml (0.9%), has been verified with the following drugs or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, Ringer's Lactate, lidocaine hydrochloride, metoclopramide, norepinephrine, piperacillin/tazobactam, potassium chloride, propofol, theophylline, and tobramycin.

Tigecycline Noridem should not be mixed with other medications for which compatibility data are not available.

This medication should only be used for the administration of a single dose; any unused solution should be discarded.