Tigecycline viatris

Tigecycline Viatris, 50 mg, powder for solution for infusion
Tigecycline
Please read this leaflet carefully before receiving the medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if needed.
• If you have any questions or doubts, please consult your doctor or nurse.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Leaflet contents:

1. What Tigecycline Viatris is and what it is used for
2. Important information before using Tigecycline Viatris
3. How Tigecycline Viatris is administered
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 bacteria causing infections.
This medicine has been prescribed by the doctor for an adult patient or a child over 8 years of age to treat one of the following serious infections:

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

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

2. Important information before using Tigecycline Viatris

When not to use Tigecycline Viatris

• If the patient is allergic to tigecycline or to any of the other ingredients of this medicine (listed in section 6). Patients who have shown hypersensitivity to tetracycline antibiotics (e.g. minocycline, doxycycline, etc.) may also be allergic to tigecycline.

Warnings and precautions
Inform your doctor or nurse before receiving Tigecycline Viatris:

• If the patient’s wounds are healing poorly or slowly.

• If the patient has had diarrhoea before starting the treatment. If diarrhoea develops during or after treatment, inform the doctor immediately. Do not take anti-diarrhoeal medicines without first consulting a doctor.

• If the patient has ever experienced any adverse reactions related to tetracycline antibiotics (e.g. photosensitivity, tooth discoloration during tooth development, pancreatitis, or changes in certain laboratory test results used to monitor blood coagulation).

• If the patient has ever had liver disease. Depending on liver function, the doctor may reduce the dose to avoid possible adverse effects.

• If the patient has biliary obstruction (cholestasis).

• If the patient has blood clotting disorders or is being treated with anticoagulant medicines, as this medicine may interfere with the blood clotting process.

During treatment with Tigecycline Viatris:

• Inform the doctor immediately if symptoms of allergy appear.
• Inform the doctor immediately if the patient develops severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas may cause severe abdominal pain, nausea, and vomiting).
• For certain serious infections, the doctor may consider administering Tigecycline Viatris together with other antibiotics.
• The doctor will closely monitor the patient for the development of other bacterial infections. If another bacterial infection occurs, the doctor may prescribe a different antibiotic appropriate for that type of infection.
• Although antibiotics such as Tigecycline Viatris kill certain bacteria, other types of bacteria and fungi may continue to grow. This phenomenon is known as superinfection. The doctor will closely observe the patient for possible infections and treat them if necessary.

Children
Tigecycline Viatris must not be used in children under 8 years of age due to lack of safety and efficacy data in this age group and because it may cause permanent tooth damage, such as tooth discoloration during tooth development.

Tigecycline Viatris and other medicines
Inform your doctor about all medicines currently used, previously used, or planned to be used.
Tigecycline Viatris may prolong the duration of certain tests monitoring blood coagulation. It is important that the patient informs the doctor if taking medicines to prevent excessive blood clotting (called anticoagulants). In such cases, the doctor will closely monitor the patient’s health status.
Tigecycline may interfere with the effectiveness of oral contraceptives ("the pill"). The patient should discuss with the doctor whether an additional method of contraception is necessary during treatment with tigecycline.
Tigecycline may enhance the effects of medicines used to suppress the immune system (such as tacrolimus or cyclosporine). It is important that the patient informs the doctor about taking these medicines so that the patient’s condition can be closely monitored.

Pregnancy and breastfeeding
Tigecycline Viatris may harm the unborn baby. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
It is not known whether Tigecycline Viatris passes into breast milk. Consult your doctor before breastfeeding.

Driving and operating machinery
Tigecycline Viatris may cause side effects such as dizziness. These may impair the ability to drive or operate machinery.

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

3. How is the medicine Tigecycline Viatris administered

The medicine Tigecycline Viatris is administered by a doctor or nurse.
The recommended initial dose in adults is 100 mg, followed by 50 mg every 12 hours.
The medicine is administered intravenously (directly into the bloodstream) over 30 to 60 minutes.
The recommended dose for children aged 8 to 12 years is 1.2 mg/kg administered intravenously every 12 hours, with 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 treatment course usually lasts from 5 to 14 days, and the duration is determined by the doctor.
Administration of a higher than recommended dose of Tigecycline Viatris
If the patient is concerned that they have received too high a dose of Tigecycline Viatris, they should immediately inform the doctor or nurse.
Missed dose of Tigecycline Viatris
If the patient is concerned that a dose of Tigecycline Viatris has been missed, they should immediately inform the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although they do not occur in everyone.
During treatment with most antibiotics, including Tigecycline Viatris, pseudomembranous colitis may occur.
This condition is characterised by severe, persistent or bloody diarrhoea, abdominal pain or fever, which may indicate serious intestinal inflammation that can occur during or after treatment.

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

• nausea, vomiting, diarrhoea

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

• abscess (collection of pus), infections
• laboratory test results indicating reduced blood clotting
• dizziness
• vein irritation after injection, including pain, inflammation, swelling and thrombosis
• abdominal pain, dyspepsia (stomach pain and indigestion), anorexia (loss of appetite)
• increased liver enzyme activity, hyperbilirubinaemia (increased concentration of bile pigments in the blood)
• itching (pruritus), rash
• slow or poor wound healing
• headache
• increased amylase activity (an enzyme found in salivary glands and pancreas), increased blood urea nitrogen
• pneumonia
• low blood sugar levels
• sepsis (a serious infection affecting the body and bloodstream) or septic shock (a severe condition that may lead to multiple organ failure and death due to sepsis)
• injection site reaction (pain, redness, inflammation)
• low blood protein levels

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

• acute pancreatitis (inflammatory condition of the pancreas leading to abdominal pain, nausea and vomiting)
• jaundice (yellowing of the skin), hepatitis
• low platelet count (which may lead to increased bleeding, bruising or haematomas)

Rare adverse reactions (may affect up to 1 in 1000 people):

• low fibrinogen levels in blood (a protein involved in blood clotting)

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

• anaphylactic/anaphylactoid reactions (ranging from mild to severe, including sudden, generalized allergic reactions which may lead to life-threatening shock [e.g. breathing difficulties, drop in blood pressure, rapid heartbeat])
• liver failure
• rash which may lead to severe blistering and skin peeling (Stevens-Johnson syndrome)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store 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 label and the carton after EXP. The expiry date refers to the last day of the specified month.
Storage after preparation
Tigecycline Viatris has been shown to be chemically and physically stable when mixed with 0.9% sodium chloride injection solution or 5% glucose solution. The solution may be stored in a refrigerator at 2°C to 8°C for up to 48 hours, provided the prepared solution is transferred immediately to an intravenous infusion bag.
From a microbiological point of view, the medicine should be used immediately after preparation.
If the medicine is not used immediately, the user is responsible for the storage duration and conditions.
After preparation, the Tigecycline Viatris solution should be yellow to orange in colour; if not, it should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tigecycline Viatris contains
The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
Other components are L-arginine, hydrochloric acid and sodium hydroxide (used to adjust pH to 4.5–5.0).
What Tigecycline Viatris looks like and contents of the pack
Tigecycline Viatris is supplied in a vial as a lyophilized cake or powder for solution for infusion. Before reconstitution, it is an orange or orange-red solid. Vials are supplied to hospitals in packaging containing either 1 vial or 10 vials of the medicinal product. Not all pack sizes may be marketed.
The powder must be mixed in the vial with a small volume of diluent. The vial should be gently rotated until the drug is completely dissolved. The prepared solution should then be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable container for infusion fluid used in hospitals.
Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Importer:
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain
SAG Manufacturing S.L.U.
Crta. N-I, Km 36, San Agustin de Guadalix
28750 Madrid
Spain
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Höhe
Benzstrasse 1, 61352 Bad Homburg v. d. Höhe
Germany
Hikma Italia S.p.A.
Viale Certosa, 10
27100, Pavia (PV)
Italy
The following information is intended exclusively for healthcare professionals:
Instructions for preparation of the medicinal product for administration (see also section 3 of the leaflet “How is Tigecycline Viatris administered?”)
To obtain a tigecycline solution at a concentration of 10 mg/ml, the powder should be reconstituted with 5.3 ml of 0.9% (9 mg/ml) sodium chloride injection solution or 5% (50 mg/ml) glucose injection solution. The vial should be gently rotated until the active substance is completely dissolved. Then, 5 ml of the resulting solution should be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable container for infusion fluid available in hospitals (e.g. a glass bottle).
To prepare a 100 mg dose, the powder from two vials should be reconstituted and added to a 100 ml intravenous infusion bag or another suitable container for infusion fluid available in hospitals (e.g. a glass bottle).
Note: Each vial contains a 6% overage of the medicinal product. Therefore, 5 ml of the reconstituted solution corresponds to 50 mg of active substance. The resulting solution should be yellow to orange in colour; if not, it should be discarded. Parenteral products should be inspected visually for particulate matter and discoloration (e.g. green or black) prior to administration.
Tigecycline Viatris should be administered intravenously through a separate infusion line or via a Y-connector. If multiple active substances are administered sequentially through the same intravenous infusion line, the line should be flushed before and after the tigecycline infusion with 0.9% (9 mg/ml) sodium chloride injection solution or 5% (50 mg/ml) glucose injection solution. Only solutions compatible with tigecycline and other medicinal products should be administered through a common infusion line.
Compatible infusion solutions: 0.9% (9 mg/ml) sodium chloride injection solution and 5% (50 mg/ml) glucose injection solution. The product has been shown to be incompatible with Ringer's lactate solution.
Compatibility has been demonstrated for Tigecycline Viatris solution administered via a Y-connector after dilution in 0.9% sodium chloride injection solution with the following medicinal products or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, haloperidol, lidocaine hydrochloride, metoclopramide, morphine, norepinephrine, piperacillin with tazobactam (with EDTA), potassium chloride, propofol, ranitidine hydrochloride, theophylline, tobramycin.
Tigecycline should not be mixed with other medicinal products for which compatibility data are not available.
Tigecycline has been shown to be chemically and physically stable when mixed with 0.9% sodium chloride injection solution or 5% glucose solution. The product may be stored refrigerated at 2°C to 8°C for up to 48 hours after the reconstituted solution is immediately transferred to an intravenous infusion bag.
From a microbiological standpoint, the product should be used immediately after preparation. If not used immediately, the user is responsible for the storage time and conditions.
For single use only – any unused solution should be discarded.