Label: information for the user

Tigeciclina Viatris 50 mg powder for solution for infusion EFG

Read this label carefully before this medicine is administered to you, as it contains important information for you or your child.

-Keep this label, as you may need to read it again.

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

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

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

2. What you need to know before starting to use Tigeciclina Viatris

3. How to use Tigeciclina Viatris

4. Possible adverse effects

5. Storage of Tigeciclina Viatris

6. Contents of the package and additional information

Tigeciclina is an antibiotic belonging to the group of glycyclins, which acts by blocking the growth of the bacteria that causes the infection.

Your doctor has prescribed tigeciclina because you or your child, at least 8 years old, suffers from one of the following severe types of infections:

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

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

Do not use Tigeciclina Viatris

• If you are allergic to tigeciclina or any of the other components of this medication (listed in section 6). If you are allergic to antibiotics in the tetracycline group (for example minocycline, doxycycline, etc.), you may be allergic to tigeciclina.

Warnings and precautions

Consult your doctor or nurse before starting to receive Tigeciclina Viatris:

• If you have poor or slow wound healing.
• If you have diarrhea before using tigeciclina. If you develop diarrhea during treatment or after treatment, inform your doctor immediately. Do not take any medication for diarrhea without consulting your doctor first.
• If you have or have had any adverse effects due to the use of antibiotics in the tetracycline group (for example sensitivity of the skin to sunlight, discoloration of developing teeth, inflammation of the pancreas, and alteration of certain laboratory tests to measure if your blood clots properly).

• If you have or have had liver disorders. Depending on your liver condition, 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 being treated with anticoagulant medications, as this medication may interfere with blood clotting.

During treatment with Tigeciclina Viatris

• Inform your doctor immediately if you develop symptoms of an allergic reaction.
• Inform your doctor immediately if you develop intense abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas, which may cause intense abdominal pain, nausea, and vomiting).
• In certain severe infections, your doctor may consider the need to use tigeciclina in combination with other antibiotics.
• Your doctor will closely monitor you for the appearance of any other bacterial infections. If you contract another bacterial infection, your doctor may prescribe a different antibiotic specific to the type of infection you have.
• Although antibiotics like tigeciclina 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

Tigeciclina 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 induce permanent dental defects, such as discoloration of developing teeth.

Other medications and Tigeciclina Viatris

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Tigeciclina may prolong certain tests that measure if your blood clots properly. It is essential to inform your doctor if you are taking certain medications to avoid excessive blood clotting (called anticoagulants). In this case, your doctor will closely monitor you.

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

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

Pregnancy and breastfeeding

Tigeciclina 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 tigeciclina.

The passage of tigeciclina into breast milk is unknown. Consult your doctor before starting breastfeeding.

Driving and operating machinery

Tigeciclina may cause adverse effects such as dizziness. This may reduce your ability to drive or operate machinery.

Tigeciclina Viatris contains sodium

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

Tigeciclina Viatris should 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>

The recommended dose for adolescents aged 12 to <18>

The normal duration of treatment is 5 to 14 days. It will be your doctor who decides the appropriate duration of treatment for you.

If you receive more Tigeciclina Viatris than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to administer a dose of Tigeciclina

If you are concerned that you have not received a dose, inform your doctor or nurse immediately.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Pseudomembranous colitis may appear with most antibiotics, including tigecycline. Pseudomembranous colitis consists of severe, persistent, or bloody diarrhea associated with abdominal pain or fever, which may be a symptom of severe intestinal inflammation, which may appear 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 (accumulation of pus), infections.
• Alterations in certain laboratory tests indicating a decrease in the ability to coagulate blood.
• Dizziness.
• Irritation of the vein in which the drug is injected, including pain, inflammation, swelling, and clot formation.
• Abdominal pain, dyspepsia (stomach pain and sensation of indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in the blood).
• Pruritus (itching), skin rash.
• Slow or delayed wound healing.
• Headache.
• Increased amylase, which is an enzyme present in salivary glands and the pancreas, increased urea nitrogen in the blood (NUS).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (severe infection affecting the entire body and blood)/septic shock (serious medical condition resulting from sepsis and which may lead to failure of multiple organs and death).
• Local reaction at the injection site (pain, redness, inflammation).
• Low blood protein levels.

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

• Acute pancreatitis (inflammation of the pancreas that produces severe abdominal pain, nausea, and vomiting).
• Icterus (yellowing of the skin), liver inflammation.
• Low platelet counts in the blood (which may lead to an increase in bleeding tendency and the appearance of petechiae/hematomas).

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

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

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

• Anaphylactic/anaphylactoid reactions (which may range from mild to severe, including a sudden and generalized allergic reaction that may lead to life-threatening shock [e.g., difficulty breathing, decreased blood pressure, rapid pulse]).
• Hepatic failure.
• Skin rash, which may lead to the formation of blisters and severe skin peeling (Stevens-Johnson syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 25°C.

Do not use this medication after the expiration date that appears on the vial and carton after CAD or EXP. The expiration date is the last day of the month indicated.

Storage after preparation

The physical-chemical stability in use has been demonstrated for tigeciclina, 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 after the immediate transfer of the reconstituted solution to the bag.

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

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

The Tigeciclina Viatris solution must have a color between yellow and orange after dissolution, if not, it must be discarded immediately.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Tigecycline Viatris Composition

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

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

Appearance of the product and contents of the package

Tigecycline Viatris is supplied in the form of a cake or powder for solution for infusion in vials, which contain orange-colored powder before being diluted.

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 must be shaken gently until the medication dissolves. Subsequently, the solution must be removed immediately from the vial and added to a 100 ml intravenous infusion bag or other suitable hospital infusion container.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Person

Pharmadox Healthcare, Ltd

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

or

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet:May 2022.

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/).

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The following information is intended only for healthcare professionals:

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 9 mg/ml (0.9%) sodium chloride injection solution, 50 mg/ml (5%) dextrose injection solution, or 0.9% sodium chloride injection solution with Ringer Lactate to achieve a concentration of 10 mg/ml of tigecycline. The vial must be shaken gently until the active ingredient dissolves. Subsequently, 5 ml of the reconstituted solution must be removed immediately from the vial and added to a 100 ml intravenous infusion bag or other suitable infusion container (e.g. glass bottle).

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

Nota: The vial contains an excess of 6% of the dose. Thus, 5 ml of the reconstituted solution are equivalent to 50 mg of the active ingredient. The reconstituted solution must be yellow to orange in color; if not, the solution must be discarded. Parenteral products must be visually inspected to verify the presence of particles in suspension or changes in the color of the particles (e.g. green or black) before administration.

Tigecycline Viatris must be administered intravenously through a dedicated line or through a Y-line. If the same intravenous line is used for sequential infusion of other active ingredients, the line must be cleaned 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 made with a solution compatible with tigecycline and any other medication through this common line.

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

When administration is performed through a Y-line, the compatibility of tigecycline, diluted in 0.9% sodium chloride injection solution, has been verified with the following medications or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Ringer Lactate, 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 there is no compatibility data.

The physical-chemical stability in use has been demonstrated for Tigecycline Viatris, once the powder has been reconstituted and diluted in 0.9% sodium chloride injection solution or 50 mg/ml (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 the immediate transfer of the reconstituted solution to the infusion bag.

From a microbiological point of view, the product must be used immediately.

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

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