Tigecycline Tecnigen 50 mg powder for solution for infusion EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tigecycline TecniGen 50 mg powder for solution for infusion EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

If you have any questions, consult your doctor or nurse.

• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Tigecycline TecniGen is and what it is used for
2. What you need to know before using Tigecycline TecniGen
3. How to take Tigecycline TecniGen
4. Possible adverse effects
5. How to store Tigecycline TecniGen
6. Contents of the pack and other information

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

Tigecycline is an antibiotic belonging to the glycylcycline group that works by inhibiting the growth of the bacteria causing the infection.

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

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

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

2. What you need to know before starting to take Tigecycline TecniGen

Do not use Tigecycline TecniGen

If you are allergic to tigecycline or to any of the other components of this medicine (listed in section 6).

If you are allergic to antibiotics belonging to the tetracycline group (e.g., minocycline, doxycycline, etc.), you may also be allergic to tigecycline.

Warnings and precautions

Consult your doctor or nurse before starting to use Tigecycline.

• If you have poor or delayed wound healing.
• If you have diarrhea before taking tigecycline. If you develop diarrhea during or after treatment, inform your doctor immediately. Do not take any medication for diarrhea without first consulting your doctor.
• If you have had or currently have any side effects from using antibiotics belonging to the tetracycline group (e.g., skin sensitivity to sunlight, staining of developing teeth, inflammation of the pancreas, or changes in certain laboratory tests used to monitor blood clotting).
• If you have or have previously had liver problems. Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects.
• If you have bile duct obstruction (cholestasis).
• If you have a bleeding disorder or are being treated with anticoagulant medicines, as this medicine may interfere with blood clotting.

During treatment with Tigecycline:

• Inform your doctor immediately if you develop symptoms of an allergic reaction.
• Inform your doctor immediately if you develop severe abdominal pain, nausea, or vomiting. These may 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 development of any additional bacterial infections. If you develop another bacterial infection, your doctor may prescribe a different antibiotic specific to the type of infection.
• Although antibiotics such as tigecycline target certain types of bacteria, other bacteria and fungi may continue to grow. This process is known as overgrowth. Your doctor will closely monitor you for any possible infections and treat you if necessary.

Children

Tigecycline 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 dental defects, such as staining of developing teeth.

Other medicines and Tigecycline TecniGen

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Tigecycline may prolong certain tests that measure whether your blood clots properly. It is important that you inform your doctor if you are taking certain medicines that affect blood clotting (called anticoagulants). If so, your doctor will monitor you closely.

Tigecycline may interfere with the oral contraceptive pill (birth control pill). Ask your doctor about the need to use an additional contraceptive method while receiving treatment with tigecycline.

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

Pregnancy and breastfeeding

Tigecycline may cause harm to 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 unknown whether tigecycline passes into breast milk. Consult your doctor before starting breastfeeding.

Driving and using machines

Tigecycline may cause side effects such as dizziness. This could reduce your ability to drive or operate machinery.

3. How to take Tigecycline TecniGen

Tigecycline must be administered by a doctor or nurse.

The recommended dose of tigecycline 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.

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 for adolescents aged 12 to <18 years is 50 mg administered every 12 hours.

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

If you receive more tigecycline than you should

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

If a dose of tigecycline is missed

If you are concerned that a dose has been missed, inform your doctor or nurse immediately.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone experiences them.

Pseudomembranous colitis may occur with most antibiotics, including tigecycline. Pseudomembranous colitis involves severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which may be a sign of serious intestinal inflammation, and can occur during or after treatment.

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

• Nausea, vomiting, diarrhoea.

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

• Abscesses (collections of pus), infections.
• Abnormalities in certain laboratory tests indicating reduced blood clotting ability.
• Dizziness.
• Irritation of the vein where the drug is injected, including pain, inflammation, swelling, and blood clot formation.
• Abdominal pain, dyspepsia (stomach discomfort and indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in the blood).
• Pruritus (itching), skin rash.
• Poor or delayed wound healing.
• Headache.
• Increased amylase levels (an enzyme found in the salivary glands and pancreas), increased blood urea nitrogen (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (a severe infection affecting the whole body and blood)/septic shock (a life-threatening medical condition resulting from sepsis that may lead to multiple organ failure and death).
• Local reaction at the injection site (pain, redness, swelling).
• Low levels of proteins in the blood.

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

• Acute pancreatitis (inflammation of the pancreas causing severe abdominal pain, nausea, and vomiting).
• Jaundice (yellowing of the skin), liver inflammation.
• Low platelet count in the blood (which may increase the tendency to bleed and bruise).

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

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

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Anaphylactic/anaphylactoid reactions (which may range from mild to severe, including sudden, generalized allergic reactions that may lead to life-threatening shock [e.g. difficulty breathing, decreased blood pressure, rapid pulse]).
• Liver failure.
• Skin rash, which may progress to blistering and severe skin peeling (Stevens-Johnson Syndrome).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tigecycline TecniGen

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the vial after "EXP". The expiry date refers to the last day of the month indicated.

Storage after preparation

Once the powder has been reconstituted and diluted and is ready for use, it should be administered immediately.

The solution of this medicine should be yellow to orange in colour after dissolution; if not, it must be discarded immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Tigecycline TecniGen

The active substance is tigecycline. Each vial contains 50 mg of tigecycline.

The other components are: trehalose, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH).

Appearance of the medicine and contents of the container

This medicine is supplied as a powder for solution for infusion in vials containing orange-coloured powder before dilution. These vials are marketed in packs of 10 vials. The powder must be mixed in the vial with a small amount of solvent. The vial should be gently shaken until the medicine is dissolved. The solution must then be withdrawn immediately from the vial and added to a 100 ml intravenous infusion bag or another suitable hospital infusion container.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid)
Spain

Manufacturer

Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias, Alto do Colaride,
2735-213 Cacém
Portugal

Local representative

Pharmavic Ibérica, S.L.

• Compositor Lehmberg Ruiz, 6. Office 7
  29007 Málaga. Spain.

Date of the most recent revision of this leaflet: November 2020

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

The following information is intended for healthcare professionals only:

Instructions for use and handling (see also section 3. of the leaflet “How to use Tigecycline TecniGen”):

The powder must be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) injection solution, 50 mg/ml (5%) dextrose injection solution, or Ringer Lactate injection solution to achieve a concentration of 10 mg/ml of tigecycline. The vial should be gently shaken until the active substance is completely dissolved. Immediately after reconstitution, 5 ml of the reconstituted solution should be withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable infusion container (e.g. glass bottle).

To obtain a 100 mg dose, two vials should be reconstituted and added to a 100 ml intravenous infusion bag or another suitable infusion container (e.g. glass bottle).

Note: The vial contains a 6% overfill. Thus, 5 ml of reconstituted solution is equivalent 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 for particulate matter and discoloration (e.g. green or black particles) prior to administration.

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

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

When administration is performed via a Y-site, the compatibility of tigecycline diluted in 0.9% sodium chloride for injection has been established with the following drugs or diluents: dobutamine, dopamine HCl, gentamicin, Ringer Lactate, metoclopramide, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, and tobramycin.

Tigecycline must not be mixed with other medicines for which compatibility data are not available.

Once reconstituted and diluted in an infusion bag or another suitable infusion container (e.g. glass bottle), tigecycline must be used immediately.

This medicine is intended for single-dose administration only; any unused solution must be discarded.