Tigecycline Mylan Pharma

Package leaflet: Information for the user

Tigecycline Mylan Pharma 50 mg powder for solution for infusion

Equivalent medicine
Please read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Tigeciclina Mylan Pharma is and what it is used for

Tigecycline is an antibiotic belonging to the glycylcycline group that works by inhibiting the growth of bacteria causing infections.
Your doctor has prescribed Tigeciclina Mylan Pharma because you or your child, aged at least 8 years, have one of the following serious types of infection:

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

Tigeciclina Mylan Pharma is used only when your doctor considers other antibiotics to be inappropriate.

2. What you need to know before using Tigecycline Mylan Pharma

Do not use Tigecycline Mylan Pharma

• 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 class (e.g. minocycline, doxycycline, etc.), you may also be allergic to tigecycline.

Warnings and precautions
Talk to your doctor or nurse before using Tigecycline Mylan Pharma:

• if you have delayed or impaired wound healing;
• if you are suffering from diarrhoea before starting treatment with Tigecycline Mylan Pharma. If you develop diarrhoea during or after treatment, inform your doctor immediately. Do not take medicines for diarrhoea without first consulting your doctor;
• if you currently have or have previously had any adverse effects related to tetracycline-class antibiotics (e.g. photosensitivity, tooth discoloration in developing teeth, pancreatitis, or changes in certain laboratory tests assessing your blood coagulation);
• if you have or have previously had liver problems. Depending on the condition of your liver, your doctor may reduce the dose to prevent possible adverse effects;
• if you have biliary obstruction (cholestasis);
• if you have a coagulation disorder or are taking anticoagulant medicines, as this medicine may interfere with blood clotting.

During treatment with Tigecycline Mylan Pharma:

• 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 may be symptoms of acute pancreatitis (inflammation of the pancreas, which may cause severe abdominal pain, nausea, and vomiting).
• For certain serious infections, your doctor may decide to use Tigecycline Mylan Pharma in combination with other antibiotics.
• Your doctor will closely monitor you for the development of any additional bacterial infections. If necessary, you may be prescribed a different antibiotic specific to the type of infection present.
• Although antibiotics such as Tigecycline Mylan Pharma fight certain bacteria, other bacteria and fungi may continue to grow. This phenomenon is known as overgrowth. Your doctor will closely monitor you for any possible infections and, if needed, initiate appropriate treatment.

Children and adolescents
Tigecycline Mylan Pharma 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 defects such as discoloration of developing teeth.

Other medicines and Tigecycline Mylan Pharma
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
Tigecycline may alter certain tests measuring your blood coagulation. It is
important that you inform your doctor if you are taking medicines to prevent excessive
blood clotting (called anticoagulants). In such cases, your doctor will monitor you closely.
Tigecycline may interfere with oral contraceptives (birth control pills). Discuss with your
doctor the need for an additional contraceptive method during treatment with
tigecycline.
Tigecycline Mylan Pharma may increase the effect of medicines used to suppress the
immune system (such as tacrolimus or cyclosporine). It is important that you inform your doctor if you are taking these medicines so that you can be closely monitored.

Pregnancy and breastfeeding
Tigecycline may cause fetal harm. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before using Tigecycline Mylan Pharma.
It is not known whether tigecycline is excreted in human breast milk. Consult your doctor before breastfeeding.

Driving and using machines
Tigecycline may cause adverse effects such as dizziness. This could impair your ability to drive or operate machinery.

Tigecycline Mylan Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to use Tigecycline Mylan Pharma

Tigecycline Mylan Pharma will be administered to you by a doctor or a nurse.
The recommended dose is initially 100 mg, followed by a dose of 50 mg every 12 hours. This
dose is given by intravenous infusion (directly into your 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
every 12 hours by intravenous infusion, up to a maximum dose of 50 mg every 12 hours.
The recommended dose in adolescents aged 12 to <18 years is 50 mg administered
every 12 hours.
A treatment course usually lasts between 5 and 14 days. Your doctor will decide the
duration of treatment.
If you use more Tigecycline Mylan Pharma than you should
If you think you have been given too much Tigecycline Mylan Pharma, contact your doctor
or nurse immediately.
If you forget a dose of Tigecycline Mylan Pharma
If you think you have missed a dose, contact 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. It is characterised by severe, persistent diarrhoea or diarrhoea with blood, associated with abdominal pain or fever, which may be signs of a serious inflammation of the intestine. This may occur during or after treatment.

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

• Nausea, vomiting, diarrhoea.

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

• Abscess (collection of pus), infections.
• Laboratory tests showing reduced blood clotting ability.
• Dizziness.
• Vein irritation due to injection, including pain, inflammation, swelling and clotting.
• Abdominal pain, dyspepsia (stomach pain and indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinaemia (excess bile pigments in the blood).
• Itching (pruritus), rash.
• Incomplete or slow wound healing.
• Headache.
• Increased amylase, an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
• Pneumonia.
• Hypoglycaemia.
• Sepsis (serious infection in the body and blood) / septic shock (a serious medical condition that may lead to multi-organ failure and death as a result of sepsis).
• Reactions at the injection site (pain, redness, inflammation).
• Low levels of protein in the blood.

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

• Acute pancreatitis (inflammation of the pancreas, which may present with severe abdominal pain, nausea and vomiting).
• Jaundice (yellowing of the skin), inflammation of the liver.
• Low levels of platelets in the blood (which may lead to increased tendency to bleeding and bruising/haematoma).

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

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

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

• Anaphylaxis/anaphylactoid reactions (which may range from mild to severe, including sudden and widespread allergic reaction that may lead to potentially fatal shock [e.g. difficulty breathing, rapid drop in blood pressure, rapid pulse]).
• Liver failure.
• Skin rash, which may present with severe blisters and skin peeling (Stevens-Johnson syndrome).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tigecycline Mylan Pharma

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 the packaging after EXP. The expiry date refers to the last day of that month.
Storage after preparation
Chemical and physical in-use stability has been demonstrated for Tigecycline Mylan Pharma mixed with 0.9% sodium chloride for injection or 5% dextrose. The product may be stored refrigerated at a temperature between 2°C and 8°C for up to 48 hours, followed by immediate transfer of the reconstituted solution into the intravenous infusion bag.
From a microbiological standpoint, the product should be used immediately.
If not used immediately, the storage times and conditions during use are the responsibility of the user.
The reconstituted solution of Tigecycline Mylan Pharma should be yellow to orange in colour; if not, the solution must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Tigecycline Mylan Pharma Contains
The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
The other components are L-arginine, hydrochloric acid, and sodium hydroide (for pH adjustment).

Description of the Appearance of Tigecycline Mylan Pharma and Package Contents
Tigecycline Mylan Pharma is supplied as a tablet or powder for solution for infusion in a vial and, before dilution, appears as an orange or red-orange compact powder. These vials are distributed to hospitals in packs of 10 vials or single 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 product is completely dissolved. Then, the solution must be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable infusion container available in the hospital.

Marketing Authorization Holder:
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano

Manufacturer:
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat 08950 Barcelona
Spain
or
SAG Manufacturing S.L.U
Ctra. N-I, Km 36
San Agustín de Guadalix, 28750, Madrid,
Spain
or
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany
or
Hikma Italia S.p.A.
Viale Certosa, 10
27100, Pavia
Italy

The following information is intended exclusively for physicians or healthcare professionals:

Instructions for Use and Handling (see also section 3. How to use Tigecycline Mylan Pharma, in this leaflet)
The powder must be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection to obtain a tigecycline concentration of 10 mg/ml.
The vial should be gently shaken until the product is completely dissolved. Then, 5 ml of the reconstituted solution must be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable infusion container (e.g., a glass bottle).
For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous infusion bag or another suitable infusion container (e.g., a glass bottle).
Note: The vial contains a 6% overage of product. Therefore, 5 ml of the reconstituted solution is equivalent to 50 mg of the active substance.
The reconstituted solution should be yellow to orange in color; if not, the solution must be discarded. Parenteral products should be inspected visually before administration for the presence of particulate matter and discoloration (e.g., green or black).

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

Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9%) solution for injection and dextrose 50 mg/ml (5%) solution for injection. The product has been shown to be incompatible with Ringer's Lactate solution.

When administered via a Y-site connector, compatibility of diluted tigecycline in sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated with the following drugs or diluents: amikacin, dobutamine, hydrochloride dopamine, gentamicin, haloperidol, hydrochloride lidocaine, metoclopramide, morphine, noradrenaline, piperacillin/tazobactam (EDTA-containing formulation), potassium chloride, propofol, hydrochloride ranitidine, theophylline, and tobramycin.

Tigecycline must not be mixed with any medicinal products for which compatibility data are not available.

Chemical and physical in-use stability has been demonstrated for Tigecycline Mylan Pharma mixed with 0.9% sodium chloride solution for injection or 5% dextrose solution. The product may be stored refrigerated at 2°C to 8°C for up to 48 hours, followed by immediate transfer of the reconstituted solution into the intravenous infusion bag.

From a microbiological standpoint, the product should be used immediately.
If not used immediately, the storage times and conditions in use are the responsibility of the user.

For single use only; any unused solution must be discarded.