Targocid

Leaflet attached to the packaging: information for the user

Targocid, 200 mg, powder and solvent for solution for injection/infusion or oral solution

for infusion or oral solution

Targocid, 400 mg, powder and solvent for solution for injection/infusion or oral solution

teicoplanin
{logo sanofi}

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Targocid and what is it used for

Targocid is an antibiotic. It contains the active substance teicoplanin. It has a bactericidal effect on bacteria that cause infection in the patient's body.
Targocid is used in adults and children (including newborns) to treat bacterial infections:

• of the skin and subcutaneous tissue - sometimes called soft tissue infections,
• of the joints and bones,
• of the lungs,
• of the urinary tract,
• of the heart - sometimes called endocarditis,
• of the abdomen - peritonitis,
• of the blood, if caused by any of the above conditions.

Targocid can be used to treat some infections caused by Clostridium difficile- bacteria in the intestines. Then the solution is taken orally.

2. Important information before using Targocid

When not to use Targocid

Warnings and precautions

Before starting treatment with Targocid, the patient should discuss with their doctor, pharmacist, or nurse if:

• the patient is allergic to the antibiotic vancomycin,
• the patient has experienced redness of the upper body (red man syndrome),
• the patient has a decreased platelet count (thrombocytopenia),
• the patient has kidney problems,
• the patient is taking other medicines that may cause hearing or kidney problems. The patient may have regular tests to check if their kidneys and/or liver are working properly (see "Targocid and other medicines"). If any of the above conditions apply to the patient (or the patient is unsure), they should consult their doctor, pharmacist, or nurse before taking Targocid.

There have been reports of severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) after using teicoplanin. If the patient experiences a severe rash or other skin reactions, as described in section 4, they should stop taking Targocid and seek medical attention immediately.

Diagnostic tests

During treatment, the patient may have blood tests, kidney function tests, liver function tests, and/or hearing tests. This is more likely if:

• treatment will last for a long time,
• the patient will be treated with high loading doses (12 mg/kg twice a day),
• the patient has kidney problems,
• the patient is taking or may take other medicines that can damage the nervous system, kidneys, or hearing.

In patients taking Targocid for a long time, there may be an increased growth of bacteria that are not affected by the antibiotic. The doctor will monitor this.

Targocid and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is because Targocid may affect the action of other medicines. Also, some medicines may affect the action of Targocid.
In particular, the patient should tell their doctor, pharmacist, or nurse if they are taking:

• aminoglycosides - because they should not be mixed with Targocid in the same injection. They can also cause hearing or kidney problems.
• amphotericin B - a medicine used to treat fungal infections, which can cause hearing or kidney problems.
• cyclosporin - a medicine that affects the immune system, which can cause hearing or kidney problems.
• cisplatin - a medicine used to treat cancer, which can cause hearing or kidney problems.
• diuretics (such as furosemide) - also known as "water pills", which can cause hearing or kidney problems.

If any of the above points apply to the patient (or the patient is unsure), they should consult their doctor, pharmacist, or nurse before taking Targocid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor, pharmacist, or nurse before using this medicine. They will decide whether the medicine can be given to the patient during pregnancy. There is a risk of damage to the inner ear and kidney problems.
If the patient is breastfeeding, they should tell their doctor before taking this medicine. The doctor will decide whether the patient can breastfeed while taking Targocid.
Studies on the effects on fertility in animals have not shown any evidence of fertility problems.

Driving and using machines

During treatment with Targocid, the patient may experience pain or dizziness. If the patient experiences these adverse reactions, they should not drive or operate any tools or machines.

Targocid contains sodium

1 vial of the medicine contains less than 1 mmol of sodium (23 mg), which means that the medicine is considered "sodium-free".

3. How to use Targocid

Recommended dose

Adults and children (12 years and older) without kidney problems

Infections of the skin and soft tissues, lungs, and urinary tract

• 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.

Infections of the bones and joints, 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 a day by intravenous or intramuscular injection.

Infection caused by 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 the patient has kidney problems, the dose should usually be reduced after the fourth day of treatment:

• In patients with mild or moderate kidney problems, the maintenance dose will be administered every two days or half of the maintenance dose will be administered once a day.
• In patients with severe kidney problems or those undergoing hemodialysis, the maintenance dose will be administered every three days or one-third of the maintenance dose will be administered once a day.

Peritonitis in patients undergoing peritoneal dialysis

The initial dose is 6 mg per kilogram of body weight, administered as a single intravenous injection, and then:

• First week: 20 mg/l in each dialysis bag
• Second week: 20 mg/l in every other dialysis bag
• Third week: 20 mg/l in the dialysis bag left overnight.

Infants (from birth to 2 months)

• Initial dose (on the first day): 16 mg per kilogram of body weight, administered as an intravenous infusion.
• Maintenance dose: 8 mg per kilogram of body weight, administered once a day as an 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 is usually administered by a doctor or nurse.

• The medicine will be administered by intravenous injection (intravenous administration) or into a muscle (intramuscularly).
• It can also be administered as an intravenous infusion. In infants from birth to 2 months, only intravenous infusion should be used. In the treatment of some infections, the solution can be taken orally (oral administration).

Using a higher dose of Targocid than recommended

It is unlikely that the doctor or nurse will administer too much of the medicine. However, if the patient thinks they have received too much Targocid or if they are agitated, they should immediately consult their doctor or nurse.

Missing a dose of Targocid

The doctor or nurse will have instructions on how to administer Targocid to the patient. It is unlikely that they will administer the medicine incorrectly. However, if the patient has concerns, they should consult their doctor or nurse.

Stopping treatment with Targocid

The patient should not stop taking Targocid without first consulting their doctor, pharmacist, or nurse.
If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Targocid can cause side effects, although not everybody gets them.

Severe side effects

If the patient experiences any of the following severe side effects, they should stop treatment and immediately consult their doctor or nurse – the patient may need urgent medical attention.

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

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

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

• redness of the upper body.

Frequency not known(cannot be estimated from the available data)

• blisters on the skin, mouth, eyes, or genitals - these may be symptoms of a condition called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• red, scaly, widespread rash with bumps under the skin [including in skin folds, chest, abdomen (including stomach), back, and arms] and blisters, accompanied by fever - these may be symptoms of "acute generalized exanthematous pustulosis (AGEP)"
• "drug reaction with eosinophilia and systemic symptoms (DRESS)". Initially, DRESS occurs as flu-like symptoms and a rash on the face, then as a widespread rash with high fever, increased liver enzyme activity observed in blood tests, and an increase in the number of a certain type of white blood cell (eosinophilia) and swollen lymph nodes.

If the patient experiences any of the above side effects, they should immediately inform their doctor or nurse.

If the patient notices any of the following severe side effects, they should immediately inform their doctor or nurse, as they may need urgent medical attention.

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

• swelling and blood clots in a vein
• difficulty breathing or wheezing (bronchospasm)
• more infections than usual - these may be symptoms of a decrease in the number of white blood cells.

Frequency not known(cannot be estimated from the available data)

• lack of white blood cells - symptoms may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
• low levels of all types of blood cells
• kidney problems or changes in kidney function - visible in tests. If the patient is given higher doses, there may be an increased frequency or severity of kidney problems
• seizures. If the patient experiences any of the above side effects, they should immediately inform their doctor or nurse.

Other side effects

The patient should consult their doctor, pharmacist, or nurse if they experience any of the following side effects:
Common(may affect up to 1 in 10 people)

• rash, redness, itching
• pain
• fever.

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

• decreased platelet count
• increased liver enzyme activity in the blood
• increased creatinine levels in the blood (monitoring kidney function)
• hearing loss, ringing in the ears, or a feeling that the patient or objects around them 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 the available data)

• problems at the injection site - such as redness of the skin, pain, or swelling.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Targocid

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial label after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Information on the storage conditions for Targocid after dissolving the powder and the shelf life of the solution is described in the section "Practical information for healthcare professionals to prepare and handle Targocid".

6. Contents of the packaging and other information

What Targocid contains

• The active substance of the medicine is teicoplanin. Each vial contains 100 mg, 200 mg, or 400 mg of teicoplanin.
• The other ingredients are sodium chloride and sodium hydroxide in the powder, and water for injections in the solvent.

What Targocid looks like and what the pack contains

Targocid is a powder for solution for injection/infusion or oral solution with a solvent. The powder is a porous, homogeneous mass of ivory color. The solvent is a clear and colorless solution.
The powder is packed:

• in vials of colorless glass type I with a usable volume of 8 ml for 100 mg, closed with a bromobutyl rubber stopper and a red aluminum cap with a plastic flip-off cap;
• in vials of colorless glass type I with a usable volume of 10 ml for 200 mg, closed with a bromobutyl rubber stopper and a yellow aluminum cap with a plastic flip-off cap;
• in vials of colorless glass type I with a usable volume of 22 ml for 400 mg, closed with a bromobutyl rubber stopper and a green aluminum cap with a plastic flip-off cap. The solvent is packed in an ampoule of colorless glass type I.

Pack sizes:

• 1 vial with powder and 1 ampoule with solvent
• 5x1 vial with powder and 5x1 ampoule with solvent
• 10x1 vial with powder and 10x1 ampoule with solvent
• 25x1 vial with powder and 25x1 ampoule with solvent Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France

Manufacturer

Sanofi S.r.l.
Via Valcanello, 4
03012 Anagni (Frosinone)
Italy
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Germany

This medicine 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, Slovakia, Slovenia: Targocid
Bulgaria, France, Greece, Netherlands, Romania, Spain: TARGOCID
Italy: TARGOSID
Portugal: Targosid

Date of last revision of the leaflet:

The following information is intended for healthcare professionals only:

Practical information for healthcare professionals to prepare and handle Targocid

This medicinal product is intended for single use.
Method of administration
The solution obtained after dissolving the powder can be injected directly or further diluted.
The solution can be administered by injection lasting from 3 to 5 minutes or by 30-minute infusion.
In infants from birth to 2 months, only infusion should be used. The solution obtained after dissolving the powder can also be administered orally.
Preparation of the solution by dissolving the powder

• The entire contents of the attached solvent should be slowly injected into the vial with the powder.
• Then the vial should be gently rotated in the hands until the powder is completely dissolved. If the solution becomes foamy, it should be left to stand for about 15 minutes. The resulting solutions will contain 100 mg of teicoplanin in 1.5 ml, 200 mg in 3.0 ml, and 400 mg in 3.0 ml. Only clear solutions should be used. The solution may have a color from yellow to dark yellow. The final solution is isotonic with plasma and has a pH of 7.2-7.8.

Dilution of the solution before infusion
Targocid can be administered in the following infusion solutions:

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

Shelf life of the solution after dissolving the powder
The chemical and physical stability of the solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the user is responsible for the storage conditions and time before use, and this usually should not exceed 24 hours at a temperature of 2 to 8°C, if the solution was prepared in controlled and validated aseptic conditions.
Shelf life of the diluted solution
The chemical and physical stability of the solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the user is responsible for the storage conditions and time before use, and this usually should not exceed 24 hours at a temperature of 2 to 8°C, if the powder was dissolved and the solution was diluted in controlled and validated aseptic conditions.
Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.