TIGECICLINE VIATRIS 50 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you use Tigecycline Viatris

Do not use Tigecycline Viatris

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

Warnings and precautions

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

• If you have poor or slow wound healing.
• If you have diarrhea before using tigecycline. If you experience diarrhea during or after treatment, inform your doctor immediately. Do not take any medicine for diarrhea treatment without consulting your doctor first.
• If you have or have had any adverse effects due to the use of antibiotics belonging to the tetracycline group (e.g., skin sensitivity to sunlight, tooth discoloration in development, pancreatitis, and alteration of certain laboratory tests intended to measure if your blood coagulates properly).

• If you have or have had liver disorders. Depending on the state 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 being treated with anticoagulant medications, as this medicine may interfere with blood coagulation.

During treatment with Tigecycline Viatris

• Inform your doctor immediately if you develop symptoms of an allergic reaction.
• Inform your doctor immediately if you develop severe abdominal pain, nausea, and vomiting. These can be symptoms of acute pancreatitis (inflammation of the pancreas, which 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

Tigecycline should not be used in children under 8 years old due to the lack of safety and efficacy data in this age group and because it may induce permanent dental defects, such as tooth discoloration in developing teeth.

Other medicines and Tigecycline Viatris

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 coagulates properly. It is essential that you inform your doctor if you are taking certain medications to avoid excess blood coagulation (called anticoagulants). In this case, your doctor will closely monitor you.

Tigecycline may interfere with the 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 medications used to suppress the immune system (such as tacrolimus or cyclosporine). It is essential that you inform your doctor if you are taking these medications 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 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 could reduce your ability to drive or use machines.

Tigecycline Viatris contains sodium

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

3. How to use Tigecycline Viatris

Tigecycline 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 from 8 to <12 years old is 1.2 mg kg administered intravenously every 12 hours, up to a maximum dose of 50 hours.< p>

The recommended dose for adolescents from 12 to <18 years old is 50 mg administered every 12 hours.< p>

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

If you receive more Tigecycline Viatris than you should

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

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

If you miss a dose of Tigecycline Viatris

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

4. Possible side effects

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

Pseudomembranous colitis may 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 (accumulation of pus), infections.
• Alterations in certain laboratory tests that indicate decreased ability to coagulate 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 urea nitrogen in the blood (NUS).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (severe infection that affects the whole body and blood)/septic shock (serious medical 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 produces 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 appearance of bruises/hematomas).

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

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

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

• Anaphylactic/anaphylactoid reactions (which can range from mild to severe, including a sudden and generalized allergic reaction that can lead to life-threatening shock [e.g., difficulty breathing, decreased blood pressure, rapid pulse]).
• 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 it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (https://www.aemps.gob.es/). By reporting side 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. The expiry date is the last day of the month indicated.

Storage after preparation

The physical-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 can be stored refrigerated between 2°C and 8°C for up to 48 hours after immediate transfer of the reconstituted solution to the bag.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack 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 adjustments).

Appearance and packaging of the product

Tigecycline Viatris is supplied as a powder for solution for infusion in vials, which contain orange-colored powder or compact 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 medicine is dissolved. Then, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable hospital infusion container.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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 medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:May 2022.

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (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 should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) injectable solution or with dextrose 50 mg/ml (5%) injectable solution to achieve a concentration of 10 mg/ml of tigecycline. The vial should be gently shaken until the active substance 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 another suitable hospital infusion container (e.g., glass bottle).

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

Note: The vial contains a 6% excess dose. Thus, 5 ml of reconstituted solution is equivalent to 50 mg of active substance. The reconstituted solution should be yellow to orange in color; if it is not, the solution should be discarded. Parenteral products should be visually inspected for particulate matter or changes in particle color (e.g., green or black) before administration.

Tigecycline Viatris 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 substances, the line should be flushed before and after the infusion of tigecycline with a sodium chloride 9 mg/ml (0.9%) solution for injection or a dextrose 50 mg/ml (5%) solution for injection. The injection should be made with a perfusion solution compatible with tigecycline and any other medication through this common line.

Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9%) injectable solution and dextrose 50 mg/ml (5%) injectable solution. The product is not compatible with Ringer's Lactate solution.

When administration is performed through a Y-line, the compatibility of tigecycline, diluted in sodium chloride for injection at 0.9%, has been verified 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 should not be mixed with other medications for which compatibility data are not available.

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 or 5% dextrose injectable solution and is ready for use. The product can be stored refrigerated between 2°C and 8°C for up to 48 hours after immediate transfer of the reconstituted solution to the bag.

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

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

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