Tigecycline Viatris 50 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tigecycline Viatris 50 mg powder for solution for infusion EFG

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tigecycline Viatris is and what it is used for
2. What you need to know before being given Tigecycline Viatris
3. How Tigecycline Viatris is given
4. Possible side effects
5. How to store Tigecycline Viatris
6. Contents of the pack and other information

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

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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 infection:

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

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

2. What you need to know before using Tigecycline Viatris

Do not use Tigecycline Viatris

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

Warnings and precautions

Talk to your doctor or nurse before starting treatment with Tigecycline Viatris:

• If you have poor or delayed wound healing.

• If you have diarrhea before using 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 adverse effects from using antibiotics belonging to the tetracycline group (for example, skin sensitivity to sunlight, discoloration of developing teeth, inflammation of the pancreas, or changes in certain laboratory tests measuring 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 possible adverse effects.

• If you have bile duct obstruction (cholestasis).

• If you have a bleeding disorder or are taking anticoagulant medicines, as this medicine may interfere with blood clotting.

During treatment with Tigecycline Viatris

• Inform your doctor immediately if you develop symptoms of an allergic reaction.
• Inform your doctor immediately 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).
• For certain serious infections, your doctor may consider using 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 appropriate for the specific type of infection.
• Although antibiotics such as tigecycline kill 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 discoloration of developing teeth.

Other medicines and Tigecycline Viatris

Tell 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 to inform your doctor if you are taking certain medications to prevent excessive 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 whether you need to use an additional contraceptive method while being treated with tigecycline.

Tigecycline may increase the effect of medicines used to suppress the immune system (such as tacrolimus or cyclosporine). It is important to inform 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 adverse effects such as dizziness. This could reduce your ability to drive or operate machinery.

Tigecycline Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; therefore, it is essentially “sodium-free”.

3. How to use Tigecycline Viatris

Tigecycline Viatris must be administered by a doctor or nurse.

The recommended dose 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 Viatris than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If a dose of Tigecycline was 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 cause adverse effects, although not everyone will experience 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 may 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 (collection of pus), infections.
• Abnormalities in certain laboratory tests indicating reduced blood clotting ability.
• Dizziness.
• Vein irritation at the injection site, including pain, inflammation, swelling, and blood clot formation.
• Abdominal pain, dyspepsia (stomach pain 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 present in the salivary glands and pancreas), increased blood urea nitrogen (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (serious 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 injection site (pain, redness, swelling).
• Low levels of protein 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 lead to increased bleeding tendency and bruising).

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 of unknown frequency (frequency cannot be estimated from available data):

• Anaphylactic/anaphylactoid reactions (ranging 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, potentially progressing 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 nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Viatris

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

Store below 25°C.

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

Storage after preparation

The physico-chemical stability in use has been demonstrated for tigecycline once the powder has been reconstituted and diluted in 0.9% sodium chloride or 5% dextrose injectable solution and is ready for use. The product may be stored refrigerated between 2°C and 8°C for up to 48 hours following immediate transfer of the reconstituted solution into the bag.

From a microbiological standpoint, the product should be used immediately.

If the solution is not used immediately, the storage time and conditions during use are the responsibility of the user.

Tigecycline Viatris solution should be yellow to orange in colour after dissolution; if not, it must be discarded immediately.

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

6. Contents of the container and other information

Composition of Tigecycline Viatris

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

The other components are L-arginine, hydrochloric acid, and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the container

Tigecycline Viatris is supplied as a cake or powder for solution for infusion in vials, containing orange-colored powder or compacted powder before dilution.

Tigecycline Viatris is distributed to hospitals in packs of one or ten vials. Not all pack sizes may be marketed.

The powder must be mixed in the vial with a small amount of solution. The vial should be gently shaken until the medication is dissolved. The solution must then be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or another appropriate hospital infusion container.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 - Esplugues de Llobregat, Barcelona
Spain

or

SAG Manufacturing S.L.U
Ctra. N-I, Km 36
28750, San Agustín de Guadalix, Madrid
Spain

or

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Höhe, Benzstrasse 1
Bad Homburg v. d. Hohe
61352, Hessen
Germany

or

Hikma Italia S.p.A.
Viale Certosa, 10
27100, Pavia
Italy

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent review of this leaflet: May 2022

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://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 Viatris”):

The powder must be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) injection solution or dextrose 50 mg/ml (5%) injection solution to obtain a concentration of 10 mg/ml of tigecycline. The vial should be gently shaken until the active substance is 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 appropriate 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 appropriate infusion container (e.g., glass bottle).

Note: The vial contains a 6% overfill. Thus, 5 ml of reconstituted solution are equivalent to 50 mg of active substance. The reconstituted solution should be yellow to orange in color; if not, the solution must be discarded. Parenteral products should be visually inspected for the presence of particulate matter or discoloration (e.g., green or black particles) prior to administration.

Tigecycline Viatris must be administered intravenously via a dedicated line or 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 9 mg/ml (0.9%) sodium chloride injection solution or 50 mg/ml (5%) dextrose injection solution. The injection 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 and dextrose 50 mg/ml (5%) injection solution. The product is not compatible with Lactated Ringer's solution.

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

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

Chemical and physical in-use stability has been demonstrated for Tigecycline Viatris once the powder has been reconstituted and diluted in 0.9% sodium chloride or 5% dextrose injection solution and is ready for use. The product may be stored refrigerated between 2°C and 8°C for up to 48 hours after immediate transfer of the reconstituted solution to the infusion bag.

From a microbiological standpoint, the product should be used immediately.

If the solution is not used immediately, the storage conditions and duration of in-use storage are the responsibility of the user.

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