Label: information for the user

Targocid 400 mg powder and solvent for injectable solution and for infusion

Teicoplanin

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Contentsofthelabel:

1. What Targocid is and for what it is used
2. What you need to know before starting to use Targocid
3. How to use Targocid
4. Possible adverse effects
5. Storage of Targocid
6. Contents of the package and additional information

Targocid is an antibiotic. It contains a medication called “teicoplanin”. It works by killing the bacteria that cause infections in your body.

Targocid is used in adults and children (including newborns) totreatinfections in:

• the skin and under the skin - sometimes referred to as “soft tissues”
• bones and joints
• the lungs
• the urinary tract
• the heart - sometimes referred to as “endocarditis”
• the abdominal wall - peritonitis
• the blood, when caused by one of the conditions listed above.

Targocid can be used to treat some infections caused by “Clostridium difficile”, a bacteria in the intestine. In this case, the solution should be taken orally.

Do not usethis medicationif:

• You are allergic to teicoplanin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before Targocid is administered to you if:

• You are allergic to an antibiotic called “vancomycin”
• You have had a redness on the upper part of your body (red man syndrome)
• You have a decreased platelet count (thrombocytopenia)
• You have kidney problems
• You are taking other medications that can cause hearing and/or kidney problems.

Regular tests may be performed to check if your kidneys and/or liver are functioning correctly (see “Targocid use with other medications”).

If any of the above cases apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before Targocid is administered to you.

Severe 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 generalized acute pustular psoriasis (PEGA). 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 be tested to check your blood, kidneys, liver, and/or hearing. This is more likely if:

• Your treatment will last a long period of time
• You need to be treated with high loading doses (12 mg/kg twice a day)
• You have kidney problems
• You are taking or may take other medications that can affect your nervous system, kidneys, and hearing.

In people being treated with Targocid for a long period, bacteria that are not affected by the antibiotic may grow more than usual – your doctor will check this.

Targocid use with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.This is because Targocid may affect the functioning of other medications. Additionally, some medications may affect the functioning of Targocid.

Particularly, inform your doctor if you are taking any of the following medications:

• Aminoglycosides, as they should not be mixed with Targocid in the same injection. They may also cause hearing and/or kidney problems
• Amphotericin B – an antifungal medication that may cause hearing and/or kidney problems
• Ciclosporin – an immunosuppressive medication that may cause hearing and/or kidney problems
• Cisplatin – a medication used to treat malignant tumors that may cause hearing and/or kidney problems
• Diuretics (such as furosemide) that may cause hearing and/or kidney problems.

If any of the above cases apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before Targocid is administered to you.

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 this medication is administered to you. They will decide if you should or should not receive this medication while pregnant. There may be a potential risk of inner ear and kidney problems.

Inform your doctor if you are breastfeeding before this medication is administered to you. They will decide if you can or cannot continue breastfeeding while receiving Targocid.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and operating machinery

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

Targocid contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per vial; it is essentially “sodium-free”.

The recommended dose is

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

Skin and soft tissue, lung, and urinary tract infections

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

Bone and joint, and heart infections

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

Infection caused by the bacteria “Clostridium difficile”

The recommended dose is 100 to 200 mg orally, twice a day 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 people with mild to moderate kidney problems - the maintenance dose will be administered every two days, or the half of the maintenance dose will be administered once a day.
• For people with severe kidney problems and on hemodialysis - the maintenance dose will be administered every three days, or one-third of the maintenance dose will be administered once a day.

Treatment of peritonitis in patients on 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 dialysis bags alternately.
• Week three: 20 mg/l in dialysis bags used at night.

Infants (from birth to 2 months of age)

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

Children(from 2 months to 12 years)

• 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 a day, by intravenous injection.

How to administer Targocid

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

• It will be administered by intravenous (IV) or intramuscular (IM) injection.
• It can also be administered by continuous intravenous infusion.

Continuous intravenous infusion should only be administered in infants, from birth to 2 months of age.

For certain infections, the solution may be administered orally.

If you use more Targocid than you should

It is unlikely that the doctor or nurse will administer too much medicine. However, if you think you have received too much Targocid or if you are worried, speak immediately with your doctor or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken. You may need to go to the hospital. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to use Targocid

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

If you interrupt the treatment with Targocid

Do not stop this treatment without having spoken first with your doctor, pharmacist, or nurse.

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

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

Severe side effects

Stop taking Targocid immediately and contact a doctor or nurse if you notice any of the following severe side effects – you may need urgent medical treatment:

Rare(may affect up to 1 in 100 people)

• life-threatening allergic reaction – symptoms may include: difficulty breathing or wheezing, inflammation, skin rash, itching, fever, chills.

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

• flushing of the upper body.

Frequency not known(cannot be estimated from available data)

• appearance of blisters on the skin, mouth, eyes, or genitals – they may be signs of the so-called

“toxic epidermal necrolysis” or “Stevens-Johnson syndrome”

• generalized red and 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 something called "acute generalized pustular psoriasis (AGPP)".
• “drug reaction with eosinophilia and systemic symptoms (DRESS)”. DRESS initially appears as flu-like symptoms and a rash on the face, the rash spreads with fever, elevated liver enzyme levels in blood tests, increased eosinophil count, and lymph node enlargement.

Inform your doctor or nurse immediately if you experience any of the above-mentioned side effects.

Inform your doctor or nurse immediately if you experience any of the following severe side effects – you may need urgent medical treatment:

Rare(may affect up to 1 in 100 people)

• inflammation and clot in a vein
• difficulty breathing and wheezing (bronchospasm)
• if you experience more infections than usual – they may be signs of a decrease in your white blood cell count.

Frequency not known(cannot be estimated from available data)

• lack of white blood cells in the blood – symptoms may include: fever, intense chills, sore throat, or mouth ulcers (agranulocytosis)
• kidney problems or changes in kidney function – shown in tests.The frequency or severity of kidney problems may increase if you receive higher doses.
• seizures.

Inform your doctor or nurse immediately if you experience any of the above-mentioned side effects.

Other side effects

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

Common(may affect up to 1 in 10 people)

• skin rash, erythema, itching
• pain
• fever.

Rare(may affect up to 1 in 100 people)

• decrease in platelet count
• increase in blood levels of liver enzymes
• increase in blood levels of creatinine (to monitor your kidney function)
• loss of hearing, ringing in the ears, or the sensation that you or things around you are moving
• nausea or vomiting, diarrhea
• dizziness or headache.

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

• infection (abscess).

Frequency not known(cannot be estimated from available data)

• problems at the injection site – such as skin redness, pain, or inflammation
• low levels of all types of blood cells.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and the vial label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Information about the conservation and the time to use Targocid once it is reconstituted and ready for use is detailed in “Practical information for healthcare professionals for the preparation and handling of Targocid”.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you do not need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Targocid

• The active ingredient is teicoplanin. Each vial contains 400 mg of teicoplanin.
• The other components are sodium chloride and sodium hydroxide in the powder and water for injection in the solvent.

Appearance of the product and contents of the package

Targocid is a powder and solvent for injectable solution and for infusion. The powder is ahomogeneous, ivory-colored sponge-like mass. The solvent is a transparent and colorless solution.

The powder is packaged:

• in a colorless type I glass vial of 22ml useful volume for 400 mg closed with a bromobutyl rubber stopper and a green plastic flip-off cap and aluminum seal.

The solvent is packaged in a colorless type I glass ampule.

Presentations:

-1 vial with powder with1ampule of solvent

-5x1 vials with powder with 5x1 ampules of solvent

-10x1 vials with powder with 10x1 ampules of solvent

-25x1 vials with powder with 25x1 ampules of solvent

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Responsible manufacturer:

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR)

Italy

or

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main,

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Czech Republic, Croatia, Germany, Hungary, Ireland, Luxembourg, Malta, Poland, Slovak Republic, Slovenia: Targocid

Bulgaria, France, Greece, Netherlands, Romania, Spain: TARGOCID

Italy: TARGOSID

Portugal : Targosid

Date of the last review of this leaflet: October 2022

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

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

This medicinal product is for single use only.

Method of administration

The reconstituted solution can be injected directly or alternatively in a diluted form.

The injection will be administered either as a bolus over 3-5 minutes or by infusion over 30 minutes.

In babies from birth to two months, only administration by infusion will be given.

The reconstituted solution can also be administered orally.

Preparation of the reconstituted solution

• Inject the solvent slowly into the vial containing the powder.
• Shake the vial gently until the powder is completely dissolved. If the solution becomes foamy, it should be left to stand for 15 minutes.

The reconstituted solutions will contain 400mg in 3.0ml.

Only transparent solutions should be used. The color of the solution may vary from yellow to dark yellow.

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

Preparation of the diluted solution before infusion

Targocid can be administered in thefollowing solutions for infusion:

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

Shelf life of the reconstituted solution

Chemical and physical stability has been demonstrated for 24 hours between 2 and8°C.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user and should not normally exceed 24 hours between 2 and8°C, unless reconstitution was performed in controlled and validated aseptic conditions.

Shelf life of the diluted medicinal product

Chemical and physical stability has been demonstrated for 24 hours between 2 and8°C.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user and should not normally exceed 24 hours between 2 and8°C, unless reconstitution/dilution was performed in controlled and validated aseptic conditions.

Elimination

The elimination of unused medicinal product and waste materials will be carried out in accordance with local regulations.