Teicoplanin Accord 400 mg powder for solution for injection and for infusion EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Teicoplanin Accord 400 mg powder for solution for injection and infusion EFG

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. Section 4, towards the end, includes information on how to report these adverse reactions.

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

Contents of this leaflet

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

1. What Teicoplanina Accord is and what it is used for

Teicoplanina Accord is an antibiotic. It contains a medicine called "teicoplanin". It works by killing the bacteria that cause infections in your body.

Teicoplanin is used in adults and children (including newborns) to treat infections in:

• The skin and beneath the skin – sometimes referred to as “soft tissues”
• Bones and joints
• The lung
• The urinary tract
• The heart – sometimes referred to as “endocarditis”
• The abdominal wall – peritonitis
• The blood, when caused by any of the conditions listed above

Teicoplanin may be used to treat certain infections caused by the bacterium "Clostridium difficile" in the intestine. In this case, the solution should be taken orally.

2. What you need to know before starting Teicoplanina Accord

Do not use this medicine:

• If you are allergic to teicoplanin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Teicoplanina Accord if:

• You are allergic to an antibiotic called “vancomycin”
• You have previously experienced redness of the upper part of your body (red man syndrome)
• You have a low platelet count (thrombocytopenia)
• You have kidney problems
• You are taking other medicines that may cause hearing and/or kidney problems.

You may have regular tests to check whether your kidneys and/or liver are functioning properly (see “Use of Teicoplanina Accord with other medicines”).

If any of the conditions listed above apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before you are given this medicine.

Serious skin reactions have been reported with the use of teicoplanin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you develop a severe rash or other skin symptoms as described in section 4, stop taking Targocid and contact your doctor or seek immediate medical attention.

Tests

During treatment, you may have tests to monitor your blood, kidneys, liver, and/or hearing. This is more likely if:

• Your treatment will last for a long period
• You require high loading doses (12 mg/kg twice daily)
• You have kidney problems
• You are taking or may take other medicines that could affect your nervous system, kidneys, or hearing.

In people receiving long-term treatment with Teicoplanina Accord, bacteria not affected by the antibiotic may grow excessively—your doctor will monitor for this.

Use of Teicoplanina Accord with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might need to use any other medicines. This is because Teicoplanina Accord may affect how other medicines work. In addition, some medicines may affect how Teicoplanina Accord works.

In particular, inform your doctor if you are taking any of the following medicines:

• Aminoglycosides, as they must not be mixed with Teicoplanina Accord in the same injection. They may also cause hearing and/or kidney problems
• Amphotericin B – a medicine used to treat fungal infections that may cause hearing and/or kidney problems
• Cyclosporine – a medicine that affects the immune system and may cause hearing and/or kidney problems
• Cisplatin – a medicine used to treat malignant tumors that may cause hearing and/or kidney problems
• Diuretics (tablets for passing water), such as furosemide, which may cause hearing and/or kidney problems.

If any of the conditions listed above apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before you are given this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before you are given this medicine. They will decide whether or not you should receive this medicine during pregnancy. There may be a potential risk of problems affecting the inner ear and kidneys.

Inform your doctor if you are breastfeeding before you are given this medicine. They will decide whether or not you can continue breastfeeding while receiving Teicoplanina Accord.

Animal reproduction studies have not shown evidence of impaired fertility.

Driving and using machines

You may experience headaches or feel dizzy while being treated with Teicoplanina Accord. If this happens, do not drive or operate tools or machinery.

Teicoplanina Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial, which is essentially “sodium-free”.

3. How to take Teicoplanin Accord

The recommended dose is

Adults and children (12 years of age or older) with normal kidney function

Skin and soft tissue, lung, and urinary tract infections

• Initial dose (for the first three doses): 400 mg (equivalent to 6 mg per kilogram of body weight), administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 400 mg (equivalent to 6 mg per kilogram of body weight), administered once daily by intravenous or intramuscular injection.

Bone and joint, and heart infections

• Initial dose (for the first three to five doses): 800 mg (equivalent to 12 mg per kilogram of body weight), administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 800 mg (equivalent to 12 mg per kilogram of body weight), administered once daily by intravenous or intramuscular injection.

Infection caused by the bacterium “Clostridium difficile”

The recommended dose is 100 to 200 mg orally, twice daily for 7 to 14 days.

Adults and elderly patients with kidney problems

If you have kidney problems, your dose will usually need to be reduced after the fourth day of treatment:

• For patients with mild to moderate kidney problems – the maintenance dose should be administered every two days, or half the maintenance dose should be given once daily.
• For patients with severe kidney problems and those on hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose should be given once daily.

Treatment of peritonitis in patients undergoing peritoneal dialysis

The initial dose is 6 mg per kilogram of body weight, as a single intravenous injection, followed by:

• Week one: 20 mg/L in each dialysis bag.
• Week two: 20 mg/L in alternate dialysis bags.
• Week three: 20 mg/L in the dialysis bags used overnight.

Infants (from birth up to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, administered as an intravenous infusion by drip.
• Maintenance dose: 8 mg per kilogram of body weight, administered once daily as an intravenous infusion by drip.

Children (from 2 months to 12 years of age)

• Initial dose (for the first three doses): 10 mg per kilogram of body weight, administered every 12 hours by intravenous injection.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, administered once daily by intravenous injection.

How Teicoplanin Accord is administered

This medicine will normally be administered by a doctor or nurse.

• It will be given by intravenous (IV) or intramuscular (IM) injection.
• It may also be given by intravenous infusion by drip.

Intravenous infusion should only be used in infants from birth up to 2 months of age.

For the treatment of certain infections, the solution may be administered orally.

If you use more Teicoplanin Accord than you should

It is unlikely that a doctor or nurse will administer too much medicine. However, if you think you have received too much Teicoplanin Accord, or if you feel unwell, speak immediately with your doctor or nurse.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested. It may be necessary to go to a hospital. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Teicoplanin Accord

Your doctor or nurse will have instructions on when to administer Teicoplanin Accord. It is unlikely that the medicine will not be given as prescribed. However, if you are concerned, speak with your doctor or nurse.

If you stop using Teicoplanin Accord

Do not stop this treatment without first talking to your doctor, pharmacist, or nurse.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Immediately stop treatment with Teicoplanin Accord and contact a doctor or nurse if you notice any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• Sudden, life-threatening allergic reaction – signs may include: difficulty breathing or wheezing, swelling, skin rash, itching, fever, chills

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

• Redness of the upper part of the body

Frequency not known (cannot be estimated from available data)

• Appearance of blisters on the skin, mouth, eyes, or genitals – could be signs of "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• Widespread red, scaly rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms) and blisters accompanied by fever – these may be symptoms of a condition called "acute generalized exanthematous pustulosis (AGEP)"
• "Drug reaction with eosinophilia and systemic symptoms" (DRESS). DRESS initially appears as flu-like symptoms and a rash on the face, which then spreads with fever, increased liver enzyme levels in blood tests, increased number of a type of white blood cells (eosinophilia), and enlarged lymph nodes.

Immediately inform your doctor or nurse if you experience any of the serious adverse effects listed above.

Immediately inform your doctor or nurse if you experience any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• Inflammation and blood clot in a vein
• Difficulty breathing and wheezing (bronchospasm)
• If you get more infections than usual – could be signs of a decrease in your blood cell count

Frequency not known (cannot be estimated from available data)

• Lack of white blood cells in the blood – signs may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
• Kidney problems or changes in kidney function – shown in laboratory tests
• The frequency or severity of kidney problems may increase if you receive higher doses
• Seizures

Immediately inform your doctor or nurse if you experience any of the adverse effects listed above.

Other adverse effects

Talk to your doctor, pharmacist, or nurse if you experience any of the following adverse effects:

Common (may affect up to 1 in 10 people)

• Skin rash, erythema, itching
• Pain
• Fever

Uncommon (may affect up to 1 in 100 people)

• Decrease in platelet count
• Increased blood levels of liver enzymes
• Increased blood levels of creatinine (used to monitor kidney function)
• Hearing loss, ringing in the ears, or sensation that you or objects around you are moving
• Nausea or vomiting, diarrhea
• Dizziness or headache

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

• Infection (abscesses)

Frequency not known (cannot be estimated from available data)

• Problems at the injection site – such as redness, pain, or swelling
• Low levels of all types of blood cells

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teicoplanina Accord

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

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

Do not store above 30°C. Store in the original packaging.

Information regarding storage and the time for using Teicoplanina Accord once reconstituted and ready for use is detailed in “Practical information for healthcare professionals on the preparation and handling of Teicoplanina Accord”.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, 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 Teicoplanina Accord

• The active substance is teicoplanin. Each vial contains 400 mg of teicoplanin.
• The other component is sodium chloride.

Appearance of the product and contents of the container

Teicoplanina Accord is a powder for injectable solution and for infusion. The powder is a sterile, lyophilized, endotoxin-free powder, white or slightly beige in color.

The powder is contained in a 10 ml type II colourless glass vial with a useful volume of 10 ml, closed with a chlorobutyl rubber stopper and a flip-off cap.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona, Spain

Manufacturer

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10 - Sant Joan Despí

08970 Barcelona, Spain

Date of the most recent review of this summary: July 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Practical information for healthcare professionals on the preparation and handling of Teicoplanina Accord.

This medicine is for single use only.

Method of administration

The reconstituted solution may be administered either by direct injection or alternatively diluted.

The injection may be given either as a bolus over 3–5 minutes or by infusion over 30 minutes. In infants from birth to two months of age, administration must be by infusion only.

The reconstituted solution may also be administered orally.

Preparation of the reconstituted solution:

• Slowly inject 3 ml of water for injection into the vial containing the powder.

• Gently rotate the vial between the hands until the powder is completely dissolved. If foam appears, allow the solution to stand for approximately 15 minutes.

The reconstituted solutions will contain 400 mg in 3.0 ml.

Only clear, slightly yellow solutions should be used.

The final solution is isotonic with plasma and has a pH of 7.2–7.8.

Preparation of the diluted solution prior to infusion:

This medicinal product may be administered in the following infusion solutions:

• Sodium chloride 9 mg/ml (0.9%) solution.
• Ringer's solution.
• Ringer-lactate solution.
• 5% dextrose injection.
• 10% dextrose injection.
• Solution containing 0.18% sodium chloride and 4% glucose.
• Solution containing 0.45% sodium chloride and 5% glucose.
• Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Proposed shelf life

Proposed shelf life (after first opening of the container, reconstitution, and dilution): 24 hours at 5±3°C.

Disposal

Disposal of unused medicinal product and waste materials must be carried out in accordance with local regulations.