Tigecycline Hikma 50 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tigecycline Hikma 50 mg powder for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

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

• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tigecycline Hikma is and what it is used for
2. What you need to know before taking Tigecycline Hikma
3. How to take Tigecycline Hikma
4. Possible adverse effects
5. How to store Tigecycline Hikma
6. Contents of the pack and other information

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

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

Your doctor has prescribed tigecycline because you or your child is at least 8 years old and has one of the following types of serious infections:

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

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

2. What you need to know before starting to take Tigecycline Hikma

Do not use Tigecycline Hikma

• 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 of the tetracycline group (e.g. minocycline, doxycycline, etc.), you may also be allergic to tigecycline.

Warnings and precautions

Consult your doctor or nurse before starting to use Tigecycline Hikma.

• If you have poor or slow wound healing.
• If you have diarrhoea before taking tigecycline. If you develop diarrhoea during or after treatment, inform your doctor immediately. Do not take any medicine for diarrhoea without first consulting your doctor.
• If you have or have previously had any side effects from using antibiotics belonging to the tetracycline group (e.g. skin sensitivity to sunlight, staining of developing teeth, inflammation of the pancreas, or changes in certain laboratory tests used to monitor 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 side 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 Hikma:

• 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 that may cause severe abdominal pain, nausea, and vomiting).
• In certain serious infections, your doctor may consider the need to use tigecycline in combination with other antibiotics.
• Your doctor will closely monitor you for the development of any additional bacterial infection. If you develop another bacterial infection, your doctor may prescribe a different antibiotic specific to the type of infection.
• Although antibiotics such as tigecycline attack 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 infection 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 staining of developing teeth.

Other medicines and Tigecycline Hikma

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 that you inform your doctor if you are taking certain medicines 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 about the need to use an additional contraceptive method while receiving treatment with tigecycline.

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

Pregnancy and breastfeeding

Tigecycline could cause harm to the foetus. 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 whether 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 operate machinery.

This medicine contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml of solution; therefore, it is essentially “sodium-free”.

3. How to use Tigecycline Hikma

Tigecycline must be administered by a doctor or nurse.

The recommended dose of tigecycline 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 Hikma than you should

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

If a dose of Tigecycline Hikma is 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 experiences 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 can 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 discomfort and indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in blood).
• Pruritus (itching), skin rash.
• Poor or delayed wound healing.
• Headache.
• Increased amylase levels (an enzyme found in the salivary glands and pancreas), increased blood urea nitrogen (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (a serious infection affecting the entire body and bloodstream)/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 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 blood (which may increase the tendency to bleed and bruise).

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

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

Frequency not known (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, which may progress 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 may also report them directly via 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 Hikma

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

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

Store below 25°C.

Storage after preparation

Chemical and physical in-use stability has been demonstrated for a period of 48 hours at 2-8°C once the product has been reconstituted with 0.9% sodium chloride or 5% dextrose.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.

The solution of this medicine should be yellow to orange in colour after reconstitution; if not, it must be discarded immediately.

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

6. Contents of the container and other information

Composition of Tigecycline Hikma

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

The other components are: arginine, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH).

Appearance of the medicinal product and contents of the container

This medicine is supplied as a powder or compacted powder for solution for infusion in vials containing orange to reddish-orange powder before dilution. These vials are marketed in hospitals in pack sizes of 10 vials or 1 vial. Only certain pack sizes may be available.

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. 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 and Manufacturer

Marketing Authorization Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, Nº 8, 8A and 8B

Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Italia S.p.A.

Viale Certosa 10, 27100 – Pavia (PV)

Italy

Or

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36

San Agustín de Guadalix, 28750, Madrid,

Spain

Or

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000,

Malta

Or

Galenicum Health, S.L.U

Sant Gabriel 50, Esplugues de Llobregat 08950 Barcelona, Spain

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

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

Date of latest review of this leaflet: August 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

The following information is intended exclusively for healthcare professionals:

Instructions for use and handling (see also section 3. of the leaflet “How to use Tigecycline Hikma”):

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 completely 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 changes in color (e.g. green or black particles) prior to administration.

Tigecycline must be administered intravenously through a dedicated line or via 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 either 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 medication 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 has been shown to be incompatible 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 confirmed 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 medicines for which compatibility data are not available.

Once reconstituted and diluted in an infusion bag or other suitable infusion container (e.g. glass bottle), tigecycline must be used immediately.

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