Targocid

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Targocid
200 mg, powder and solvent for solution for injection/infusion or oral solution
Teicoplanin
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What Targocid is and what it is used for
2. What you need to know before you use 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 the active substance teicoplanin. This works by killing bacteria causing infection in the patient's body.
Targocid is used in adults and children (including newborns) to treat bacterial infections of:

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

Targocid may be used to treat certain infections caused by Clostridium difficile

• bacteria in the intestines. In this case, the medicine solution is taken orally.

2. Important information before using Targocid

When not to use Targocid

• if the patient is allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Targocid, discuss this with your doctor, pharmacist, or
nurse if:

• the patient is allergic to an antibiotic called vancomycin,
• the patient has experienced redness of the upper part of the body (red man syndrome),
• the patient has reduced platelet count (thrombocytopenia),
• the patient has impaired kidney function,
• the patient is taking other medicines that may cause hearing problems and/or kidney problems. The patient may undergo regular tests to monitor whether the kidneys and/or liver are functioning properly (see "Targocid with other medicines"). If any of the above conditions apply to the patient (or if the patient is unsure), contact a doctor, pharmacist, or nurse before taking Targocid.

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) have been reported following the use of teicoplanin. If the patient develops a severe rash or other skin reactions described in section 4, treatment with Targocid should be discontinued immediately and the patient should contact a doctor or seek medical help without delay.

Diagnostic tests
During treatment, the patient may undergo 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 daily),
• the patient has impaired kidney function,
• the patient is taking or may take other medicines that can damage the nervous system, kidneys, or hearing.

In patients receiving Targocid for prolonged periods, there may be an increased risk of overgrowth of bacteria not susceptible to the antibiotic. This will be monitored by the treating physician.

Targocid with other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking, has recently taken, or plans to take. This is because Targocid may affect the action of other medicines, and some medicines may affect the action of Targocid.

In particular, inform your doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

• aminoglycosides – because they must not be mixed with Targocid in the same injection. They may also cause hearing problems and/or kidney problems.
• amphotericin B – a medicine used to treat fungal infections, which may cause hearing problems and/or kidney problems.
• cyclosporine – an immunosuppressive medicine, which may cause hearing problems and/or kidney problems.
• cisplatin – a medicine used in the treatment of malignant tumors, which may cause hearing problems and/or kidney problems.
• diuretics (such as furosemide) – also known as "water tablets", which may cause hearing problems and/or kidney problems.

If any of the above points apply to the patient (or if the patient is unsure), contact a doctor, pharmacist, or nurse before taking Targocid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor, pharmacist, or nurse before using this medicine. They will decide whether this medicine can be administered during pregnancy. There is a risk of damage to the inner ear and kidney dysfunction.

If the patient is breastfeeding, she should inform her doctor before taking this medicine. The doctor will decide whether she may continue breastfeeding while taking Targocid.

Animal studies on fertility showed no evidence of impaired fertility.

Driving and using machines

During treatment with Targocid, the patient may experience headache or dizziness. If such adverse effects occur, the patient should not drive or operate any tools or machinery.

Targocid contains sodium

One vial of this medicine contains less than 1 mmol of sodium (23 mg), meaning the medicine is considered "sodium-free".

3. How to use Targocid

The medicine is available in the following strengths: 200 mg and 400 mg.
Recommended dose
Adults and children (aged 12 years and older) with normal kidney function
Skin and soft tissue infections, lung infections, 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 impaired kidney function
If the patient has impaired kidney function, the dose usually needs to be reduced after the fourth day of treatment:

• In patients with mild to moderate kidney impairment – the maintenance dose should be administered every two days, or half the maintenance dose should be given once daily.
• In patients with severe kidney impairment or undergoing hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose should be given once daily.

Peritonitis in patients undergoing peritoneal dialysis
The initial dose is 6 mg per kilogram of body weight, given as a single intravenous injection, followed by:

• Week 1: 20 mg/liter in each dialysis bag
• Week 2: 20 mg/liter in every other dialysis bag
• Week 3: 20 mg/liter in the dialysis bag left in overnight.

Infants (from birth to 2 months of age)

• 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 daily as an intravenous infusion.

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 is usually administered by a doctor or nurse.

• The medicine will be given by intravenous (IV) or intramuscular (IM) injection.
• It may also be given as an intravenous infusion. In infants from birth to 2 months of age, only infusion administration should be used. For the treatment of certain infections, the solution may be taken orally (oral administration).

Use of a higher than recommended dose of Targocid
It is unlikely that a doctor or nurse will administer too high a dose of the medicine. However, if you think you have received too high a dose of Targocid, or if you feel agitated, contact your doctor or nurse immediately.
Missed dose of Targocid
Your doctor or nurse will have instructions on how to administer Targocid. It is unlikely they will give you the medicine incorrectly. However, if you have any concerns, speak to your doctor or nurse.
Stopping Targocid treatment
Do not stop taking this medicine without first consulting your doctor, pharmacist, or nurse.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following serious adverse reactions occur, treatment must be discontinued and the doctor or nurse contacted immediately – the patient may require urgent medical attention.
Uncommon (may occur in up to 1 in 100 patients):

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

Rare (may occur in up to 1 in 1,000 patients):

• redness of the upper body.

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

• blisters on the skin, mouth, eyes or genital organs – these may be symptoms of a disease called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"

• red, scaly widespread rash with subcutaneous nodules [including in skin folds, chest, abdomen (including stomach), back and arms] and blisters, accompanied by fever – these may be symptoms of so-called "acute generalized exanthematous pustulosis (AGEP)".

• "drug reaction with eosinophilia and systemic symptoms (DRESS)". Initially, DRESS presents as flu-like symptoms and facial rash, followed by widespread rash with high fever, increased liver enzyme activity observed in blood tests, increased number of a certain type of white blood cells (eosinophilia), and enlarged lymph nodes.
  If any of the above adverse symptoms occur, the doctor or nurse must be informed immediately.
  If the patient experiences any of the following serious adverse reactions, the doctor or nurse must be informed immediately, as the patient may require urgent medical attention.
  Uncommon (may occur in up to 1 in 100 patients):

• swelling and blood clots in a vein

• difficulty breathing or wheezing (bronchospasm)

• more infections than usual – these may be symptoms of reduced white blood cell count.

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

• absence of white blood cells – symptoms may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• kidney function disorders or changes in kidney function – visible in tests. When higher doses are administered to the patient, the frequency or severity of kidney function disorders may increase
• seizures. If any of the above adverse symptoms occur, the doctor or nurse must be informed immediately.

Other adverse reactions
Consult a doctor, pharmacist, or nurse if any of the following symptoms occur:
Common (may occur in up to 1 in 10 patients)

• rash, redness, itching
• pain
• fever.

Uncommon (may occur in up to 1 in 100 patients):

• decreased platelet count
• increased liver enzyme activity in blood
• increased blood creatinine levels (monitoring kidney function)
• hearing loss, ringing in the ears or sensation that the patient or surrounding objects are moving
• nausea or vomiting, diarrhoea
• dizziness or headache.

Rare (may occur in up to 1 in 1,000 patients)

• infection (abscess).

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

• injection site reactions – such as skin redness, pain or swelling.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Targocid medicine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Information on storage conditions of Targocid after reconstitution of the powder and the time for its use are described in the section "Practical information for healthcare professionals on preparation and handling of Targocid".

6. Contents of the package and other information

What Targocid contains

• The active substance is teicoplanin. Each vial contains 200 mg of teicoplanin.
• The other ingredients are: sodium chloride and sodium hydroxide (for pH adjustment) in the powder, and water for injections in the solvent.

What Targocid looks like and contents of the pack
Targocid is a powder for solution for injection / infusion or for oral solution, supplied with solvent. The powder is a porous, homogeneous, ivory-coloured mass. The solvent is a clear, colourless solution.
The powder is packed in vials made of colourless type I glass with a nominal capacity of 10 ml, closed with a bromobutyl rubber stopper and an aluminium yellow cap with a plastic flip-off seal;
The solvent is packed in ampoules made of colourless type I glass.
Pack size: 1 vial of powder and 1 ampoule of solvent.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, the country of export:
sanofi-aventis, s.r.o.
Evropská 846/176a
160 00 Prague 6
Czech Republic
Manufacturer:
Sanofi S.p.A.
Anagni, Italy
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in the Czech Republic, the country of export: 15/216/93-A/C
Parallel import authorisation number: 148/17
This medicinal product is authorised for marketing in 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

The following information is intended for healthcare professionals only:
Practical instructions for healthcare professionals on the preparation and handling of Targocid
This medicinal product is for single use only.
Route of administration
The solution obtained after dissolving the powder may be administered directly or further diluted.
The solution may be given as an injection lasting from 3 to 5 minutes or as a 30-minute infusion.
In infants from birth to 2 months of age, infusion should be used only.
The solution obtained after dissolving the powder may also be administered orally.
Preparation of the solution by dissolving the powder

• Slowly inject the entire contents of the supplied solvent into the vial containing the powder.
• Then gently rotate the vial in the hands until the powder is completely dissolved. If foaming occurs, allow the solution to stand for about 15 minutes. The resulting solution will contain 200 mg in 3.0 ml. Only clear solutions should be used. The solution may vary in colour from yellowish to dark yellow. The final solution is isotonic with serum and has a pH of 7.2–7.8.

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

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

Shelf life of the solution after reconstitution
Chemical and physical stability of the solution prepared as recommended has been demonstrated
for 24 hours at a temperature of 2 to 8°C.
From a microbiological point of view, the medicinal product should be used immediately. If not used
immediately, the user is responsible for the storage conditions and duration prior to use, which should
generally not exceed 24 hours at a temperature of 2 to 8°C, provided the solution was prepared
under controlled and validated aseptic conditions.

Shelf life of the diluted solution
Chemical and physical stability of the solution prepared as recommended has been demonstrated
for 24 hours at a temperature of 2 to 8°C.
From a microbiological point of view, the medicinal product should be used immediately. If not used
immediately, the user is responsible for the storage conditions and duration prior to use, which should
generally not exceed 24 hours at a temperature of 2 to 8°C, provided reconstitution of the powder and
dilution of the solution were carried out under controlled and validated aseptic conditions.

Disposal
Any unused portions of the medicinal product or waste materials should be disposed of in accordance
with local regulations.