Targosid

Package Leaflet: Information for the User

TARGOSID 200 mg powder and solvent for injectable/infusion solution or oral solution, 400 mg powder and solvent for injectable/infusion solution or oral solution

teicoplanin
Please read 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 questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Targosid is and what it is used for

Targosid is an antibiotic that contains the active substance "teicoplanin". It works by killing the bacteria responsible for infections in the body.
Targosid is used in adults and children (including newborns) to treat bacterial infections of:
skin and underlying tissues (sometimes referred to as "soft tissues")
bones and joints
lungs
urinary tract
heart (endocarditis)
abdominal area (peritonitis)
bloodstream, when caused by any of the above-mentioned conditions.
Targosid may be used to treat certain intestinal infections caused by Clostridium difficile bacteria. For this use, the solution is taken orally.

2. What you need to know before being given Targosid

Do not use Targosid 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 being given Targosid if:

• you are allergic to an antibiotic called "vancomycin"
• you have experienced redness of the upper part of the 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 need regular tests to check whether your kidneys and/or liver are functioning properly (see "Other medicines and Targosid"). If any of the above applies to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before being given Targosid.

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 skin rash or other skin symptoms as described in section 4, stop taking Targosid and contact your doctor or seek immediate medical advice.

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

• the treatment will last a long time
• you require high loading doses (12 mg/kg twice daily)
• you have kidney problems
• you are taking or may take other medicines that can affect the nervous system, kidneys, or hearing.

In patients receiving Targosid for prolonged periods, bacteria not affected by the antibiotic may grow more than usual – your doctor will carry out checks to monitor for this possibility.

Other medicines and Targosid
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Targosid may affect how other medicines work. Likewise, some medicines may affect how Targosid works.

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

• aminoglycosides, which must not be mixed with Targosid in the same injection. These 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
• diuretic tablets (such as furosemide) that may cause hearing and/or kidney problems.

If any of the above applies to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before being given Targosid.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor, pharmacist, or nurse for advice before being given this medicine. They will decide whether you should be given 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. Your doctor will decide whether you can continue breastfeeding while receiving Targosid.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines
While being treated with Targosid, you may experience headache or dizziness. If this occurs, do not drive or operate machinery.

Targosid contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially "sodium-free".

3. How to use Targosid

Recommended dose
Adults and children (12 years of age and older) with normal kidney function
Skin and soft tissue, lung, and urinary tract infections

• Initial dose (for the first 3 doses): 6 mg per kg of body weight administered every 12 hours by intravenous or intramuscular injection
• Maintenance dose: 6 mg per kg of body weight administered once daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

• Initial dose (for the first 3–5 doses): 12 mg per kg of body weight administered every 12 hours by intravenous injection
• Maintenance dose: 12 mg per kg of body weight administered once daily by intravenous or intramuscular injection.

To treat infections caused by Clostridium difficile bacteria
The recommended dose is 100–200 mg orally twice daily for 7–14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, your dose will generally be reduced after the fourth day of treatment:

• For patients with mild to moderate kidney impairment: the maintenance dose should be given every 2 days, or half the maintenance dose should be given daily.
• For patients with severe kidney impairment or on hemodialysis: the maintenance dose should be given every 3 days, or one-third of the maintenance dose should be given daily.

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

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

Neonates (from birth to 2 months of age)

• Initial dose (first day): 16 mg per kg of body weight, administered by intravenous infusion
• Maintenance dose: 8 mg per kg of body weight, administered once daily by intravenous infusion.

Children (from 2 months to 12 years of age)

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

How Targosid is administered
This medicine is usually administered by a doctor or nurse.

• It is given by intravenous (IV) or intramuscular (IM) injection
• It may also be given by intravenous infusion. In neonates from birth to 2 months of age, it must be administered only by infusion. For certain infections, the solution may be taken orally (oral use).

If you receive more Targosid than you should
It is unlikely that a doctor or nurse will give you too much medicine. However, if you think you have been given too much Targosid, or if you feel agitated, inform your doctor or nurse immediately.
If you miss a dose of Targosid
Your doctor or nurse will follow specific instructions on when to administer Targosid. It is unlikely that the medicine will not be given as prescribed. However, if you are concerned, inform your doctor or nurse.
If you stop Targosid treatment
Do not stop taking this medicine without first discussing it with your doctor, pharmacist, or nurse.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Stop treatment and contact your doctor or nurse immediately if you notice any of the
following serious side effects – you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)

• sudden allergic reaction which may be life-threatening – signs may include: difficulty breathing or wheezing, sweating, rash, itching, fever, chills

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

• hot flushes in the upper part of the body

Not known (frequency cannot be estimated from the available data)

• skin, mouth, eye or genital lesions – these may 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 generalised exanthematous pustulosis (AGEP)"
• “drug reaction with eosinophilia and systemic symptoms (DRESS)”. This reaction initially presents with flu-like symptoms and facial rash, followed by widespread rash and high temperature, increased liver enzyme levels seen in blood tests, increase in white blood cells (eosinophilia), and swollen lymph nodes.

Contact your doctor or nurse immediately if you notice any of the side effects listed above.
Contact your doctor or nurse immediately if you notice any of the following serious side effects – you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)

• swelling and blood clot in a vein
• difficulty breathing or wheezing (bronchospasm)
• increased risk of infections – this could be a sign of reduced number of blood cells

Not known (frequency cannot be estimated from the available data)

• lack of white blood cells – signs 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 – shown by blood tests. The frequency or severity of kidney problems may increase if higher doses are given.
• seizures

Contact your doctor or nurse immediately if you notice any of the side effects listed above.
Other side effects
Tell your doctor, pharmacist or nurse if you notice 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 number of platelets
• increased liver enzyme levels in the blood
• increased creatinine levels in the blood (to monitor kidney function)
• hearing loss, ringing in the ears or sensation that you or objects around you are moving
• feeling unwell or nausea, diarrhoea
• dizziness or headache

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

• infection (abscess)

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Targosid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
vial after Scad/EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Information on storage and the duration of use of Targosid after reconstitution and when ready for use are described in the “Practical information for healthcare professionals on the preparation and handling of Targosid”.

6. Package contents and other information

What Targosid contains

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

Description of the appearance of Targosid and contents of the pack
Targosid is a powder and solvent for solution for injection/infusion or oral solution. The powder is
a homogeneous, ivory-coloured, sponge-like mass. The solvent is a clear, colourless liquid.
The powder is packaged:

• in colourless type I glass vials with a useful volume of 10 mL for 200 mg, closed with a bromobutyl rubber stopper, a yellow aluminium seal, and a plastic tear-off cap
• in colourless type I glass vials with a useful volume of 22 mL for 400 mg, closed with a bromobutyl rubber stopper, a green aluminium seal, and a plastic tear-off cap. The solvent is packaged in a colourless type I glass ampoule.

Packs:

• 1 vial of powder with 1 ampoule of solvent. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi S.r.l. – Viale L. Bodio, 37/B – Milano
Manufacturer
Sanofi S.r.l. - Via Valcanello, 4 - 03012 Anagni (FR)
This medicinal product is authorised in the European Economic Area countries 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 exclusively for physicians or healthcare professionals:
Practical information for healthcare personnel on the preparation and handling of Targosid.
This medicinal product is for single use only.
Method of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection can be administered as a bolus over 3-5 minutes or as a 30-minute infusion.
In neonates and infants from birth up to 2 months of age, administration must be only by infusion.
The reconstituted solution may also be administered orally (oral use).
Preparation of the reconstituted solution
Slowly inject the entire contents of the solvent ampoule 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 contain 200 mg of teicoplanin in 3.0 mL and 400 mg in 3.0 mL.
Only clear solutions should be used. The colour of the solution may vary from pale 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 prior to infusion
Targosid can be administered in the following infusion solutions:

• sodium chloride 9 mg/mL (0.9%) solution
• Ringer's solution
• Ringer lactate solution
• 5% dextrose solution
• 10% dextrose solution
• 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
The chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature between 2 and 8°C.

From a microbiological standpoint, the product should be used immediately. If this is not the case, the user is responsible for the storage period and conditions of the product, which should normally not exceed 24 hours at a temperature between 2 and 8°C, unless reconstitution is carried out under controlled and validated aseptic conditions.

Stability of the diluted medicinal product
The chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature between 2 and 8°C.

From a microbiological standpoint, the product should be used immediately. If this does not occur, the user is responsible for the storage period and conditions of the product, which should normally not exceed 24 hours at a temperature between 2 and 8°C, unless reconstitution/dilution is carried out under controlled and validated aseptic conditions.

Disposal
Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with current local regulations.