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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Teicoplanin

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 side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Targocid is and what it is used for

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of down the drain or in household waste.

Targocid 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 lungs
• the urinary tract
• the heart – sometimes called "endocarditis"
• the abdominal wall – peritonitis
• the bloodstream, when caused by one of the conditions listed above.

Targocid can be used to treat certain infections caused by "Clostridium difficile", a bacterium in the intestine. In this case, the solution should be taken by mouth.

2. What you need to know before using Targocid

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

Consult your doctor, pharmacist, or nurse before being given Targocid if:

• you are allergic to an antibiotic called “vancomycin”
• you have experienced redness on 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 problems and/or kidney problems.

You may have regular tests to check whether your kidneys and/or liver are functioning properly (see “Use of Targocid 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 being given Targocid.

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 be given tests to monitor your blood, kidneys, liver, and/or hearing. This is more likely if:

• your treatment will last for a long period
• you need to receive 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 Targocid, bacteria not affected by the antibiotic may grow excessively—your doctor will monitor for this.

Use of Targocid with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because Targocid may affect how other medicines work. In addition, some medicines may affect how Targocid works.

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

• Aminoglycosides, as they must not be mixed with Targocid in the same injection. They may also cause hearing problems and/or kidney problems
• amphotericin B – an antifungal medicine that may cause hearing and/or kidney problems
• cyclosporine – an immunosuppressive medicine that may cause hearing and/or kidney problems
• cisplatin – a medicine used to treat malignant tumors that may cause hearing and/or kidney problems
• tablets for urination (such as furosemide), also known as “diuretics,” 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 being given Targocid.

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 being given this medicine. They will decide whether or not you should receive this medicine during pregnancy. There may be a potential risk of inner ear and kidney problems.

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

Animal reproduction studies have not shown evidence of fertility impairment.

Driving and using machines

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

Targocid contains sodium

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

3. How to use Targocid

Recommended dose

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): 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 daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

• Initial dose (for the first three to five 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 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 or 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

Initial dose: 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 Targocid is administered

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

• It will be given by intravenous or intramuscular injection.
• It may also be given by intravenous infusion (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 Targocid than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 915 620 420, stating the name of the medicine and the amount taken. You may need to go to a hospital. It is recommended to bring the medicine packaging and leaflet 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 the medicine will not be given as prescribed. However, if you are concerned, speak to your doctor or nurse.

If you stop using Targocid

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

Stop treatment with Targocid immediately 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)

• development of blisters on the skin, mouth, eyes, or genitals – these could be signs of a condition called "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; the rash spreads along with fever, increased liver enzyme levels in blood tests, increased number of a type of white blood cells (eosinophilia), and swollen lymph nodes.

Contact your doctor or nurse immediately if you experience any of the adverse effects listed above.

Contact your doctor or nurse immediately 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 – these 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 blood tests. The frequency or severity of kidney problems may increase if you receive higher doses.
• seizures.

Contact your doctor or nurse immediately 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 (to monitor kidney function)
• hearing loss, tinnitus (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 (abscess).

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 may 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 Targacid

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

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

This medicine does not require any special storage conditions.

Information on storage and the time within which Targocid must be used after reconstitution and preparation for administration is detailed in "Practical information for healthcare professionals on the preparation and handling of Targocid".

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Targocid

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

Appearance of the product and contents of the pack

Targocid is a powder and solvent for injectable solution and for infusion. The powder is a homogeneous, ivory-coloured, spongy mass. The solvent is a clear, colourless solution.

The powder is packed:

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

The solvent is packed in a colourless type I glass ampoule.

Pack sizes:

• 1 vial with powder with 1 solvent ampoule
• 5x1 vials with powder with 5x1 solvent ampoules
• 10x1 vials with powder with 10x1 solvent ampoules
• 25x1 vials with powder with 25x1 solvent ampoules

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

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 authorised in the European Economic Area member states under the following names:

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

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

Italy: TARGOSID

Portugal: Targosid

Date of the most recent review of this summary: October 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of 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 Targocid.

This medicine is for single use only.

Method of administration

The reconstituted solution may be injected directly or alternatively administered in diluted form.

The injection may be given either as a bolus over 3–5 minutes or by 30-minute infusion.

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 the entire contents of the provided solvent into the vial containing the powder.
• Gently rotate the vial between the hands until the powder is completely dissolved. If foaming occurs, allow the solution to stand for approximately 15 minutes.

The reconstituted solutions will contain 400 mg in 3.0 ml.

Only clear solutions should be used. The solution colour may vary from pale yellow to dark yellow.

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

Nominal content of teicoplanin per vial	400 mg
Volume of the vial with powder	22 ml
Extractable volume from the solvent ampoule for reconstitution	3.14 ml
Volume containing the nominal dose of teicoplanin (extracted using a 5 ml syringe and 23 G needle)	3.0 ml

Preparation of the diluted solution prior to infusion

Targocid may be administered in the following infusion solutions:

• Sodium chloride solution 9 mg/ml (0.9%)
• Ringer's solution
• Ringer-lactate solution
• 5% glucose injection
• 10% glucose 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.

Stability of the reconstituted solution

Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.

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

Stability of the diluted medicinal product

Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.

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

Disposal

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