Teicoplanin Sala 400 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Teicoplanina SALA 400 mg

Powder for solution for injection and infusion EFG

Read all of this leaflet carefully before you start 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 or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Teicoplanina SALA is and what it is used for

2. What you need to know before using Teicoplanina SALA

3. How to use Teicoplanina SALA

4. Possible side effects

5. How to store Teicoplanina SALA

6. Contents of the pack and other information

1. What Teicoplanin Sala is and what it is used for

Teicoplanin is an antibiotic. 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 dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines by flushing them down the sink or into household waste.

Teicoplanin is used in adults and children (including newborns) to treat infections in:

• the skin and tissues 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 any of the conditions listed above.

Teicoplanin may be used to treat certain intestinal infections caused by the bacterium Clostridium difficile. In this case, the solution must be taken orally.

2. What you need to know before using Teicoplanin Sala

Do not use Teicoplanin Sala

• 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 or nurse before you are given teicoplanin if:

• you are allergic to an antibiotic called "vancomycin"
• you have 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 blood, kidneys and/or liver are working properly (see "Other medicines and Teicoplanin Sala").

If any of the conditions listed above apply to you (or if you are unsure), inform your doctor or nurse before receiving teicoplanin.

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 teicoplanin and contact your doctor or seek immediate medical attention.

Tests

During treatment, you may have 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 be treated with 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 teicoplanin, bacteria not affected by the antibiotic may grow excessively—your doctor will monitor this.

Other medicines and Teicoplanin Sala

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might need to use any other medicines. This is because teicoplanin may affect how other medicines work. In addition, some medicines may affect how teicoplanin works.

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

• aminoglycosides, as they must not be mixed with teicoplanin in the same injection. They 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
• diuretics such as furosemide (medicines that help you urinate) 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 or nurse before receiving teicoplanin.

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 receiving this medicine. They will decide whether or not you should be given this medicine during pregnancy. There may be a potential risk of problems in the inner ear and kidneys of the unborn baby.

Inform your doctor if you are breastfeeding before receiving this medicine.

Your doctor will decide whether or not you can continue breastfeeding while receiving teicoplanin.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines

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

Teicoplanin Sala 400 mg contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per vial and is therefore considered essentially "sodium-free".

3. How to use Teicoplanin Sala

Recommended dose:

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

Skin and soft tissue infections, lung and urinary tract infections

• Initial dose (for the first three doses): 400 mg (equivalent to 6 mg per kilogram of body weight), administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 400 mg (equivalent to 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): 800 mg (equivalent to 12 mg per kilogram of body weight), administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 800 mg (equivalent to 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 undergoing 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 Teicoplanin Sala is administered

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

• It is given by intravenous (IV) or intramuscular (IM) injection.
• It may also be given as an intravenous infusion by drip.

Intravenous infusion should only be used in infants from birth up to two months of age.

For the treatment of certain infections, the solution may be administered orally.

If you use more Teicoplanin Sala than you should

It is unlikely that a doctor or nurse would administer too much medicine. However, if you think you have received too much Teicoplanin, or if you feel unwell, speak immediately with your doctor or nurse.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 5620420, stating the medicine and the amount ingested.

If you forget to use Teicoplanin Sala

Your doctor or nurse will follow specific instructions on when to administer teicoplanin. It is unlikely that the medicine will not be administered as prescribed. However, if you are concerned, speak with your doctor or nurse.

If you stop using Teicoplanin Sala

Do not stop this treatment without first talking to your doctor or nurse.

If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

You must immediately stop treatment with teicoplanin and contact your doctor or nurse if you experience any of the following serious adverse effects – urgent medical treatment may be required:

Uncommon (may affect up to 1 in 100 people)

• life-threatening sudden 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)

• appearance of blisters on the skin, mouth, eyes, or genitals – these could be signs of "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• "drug reaction with eosinophilia and systemic symptoms (DRESS)". DRESS initially appears as flu-like symptoms and a rash on the face, which spreads with fever, increased liver enzyme levels in blood tests, increased number of a type of white blood cells (eosinophilia), and swollen lymph nodes.
• 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)".

Immediately inform your doctor or nurse if you experience any of the above-mentioned adverse effects.

Contact a doctor or nurse if you notice any of the following serious adverse effects – you may require urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• swelling 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 laboratory tests
• the frequency or severity of kidney problems may increase if higher doses are administered
• seizures

Immediately inform your doctor or nurse if you experience any of the above-mentioned adverse effects.

Other adverse effects

Talk to your doctor 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 creatinine levels (to monitor kidney function)
• Hearing loss, ringing in the ears (tinnitus), 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 (abscesses)

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 effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Teicoplanina Sala

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 label of the vial after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Information regarding storage and the time for using Teicoplanina Sala once it has been reconstituted and is ready for use is detailed in "Practical information for healthcare professionals on the preparation and handling of Teicoplanina Sala 400 mg".

6. Contents of the container and other information

Composition of Teicoplanina Sala 400 mg

The active substance is Teicoplanin. Each vial contains 400 mg of teicoplanin. The other component is sodium chloride.

Appearance of the product and contents of the container

Teicoplanina Sala 400 mg is a powder for solution for injection and infusion. The powder is white or slightly beige.

The powder is contained in a colorless glass vial of type II, closed with a rubber stopper and an aluminum seal with a plastic flip-off cap.

Pack sizes:

• Unit pack: 1 vial
• Clinical pack: 5 vials.

Marketing Authorization Holder and Manufacturer:

Laboratorio REIG JOFRÉ, S.A.
Gran Capitán, 10
08970 Sant Joan Despí – Barcelona
Spain

Date of the most recent review of this summary: January 2024

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:

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

This medicinal product 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 up 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 3 ml of water for injections into the vial containing the powder.
• Gently rotate the vial between the hands until the powder is completely dissolved. If foam appears, allow the solution to stand for approximately 15 minutes.

The reconstituted solutions will contain 400 mg in 3.0 ml.

Only clear, slightly yellowish solutions should be used.

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

Nominal content of teicoplanin per vial	400 mg
Vial volume	10 ml
Volume containing the nominal dose of teicoplanin (drawn up using a 5 ml syringe and 23 G needle)	3.0 ml

Preparation of the diluted solution prior to infusion:

Teicoplanin Sala 400 mg can be administered in the following infusion solutions:

• Sodium chloride solution 9 mg/ml (0.9%)
• Ringer's solution
• Ringer-lactate solution
• 5% dextrose injection
• 10% dextrose 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 period 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 duration and conditions of in-use storage are the responsibility of the user and normally should not exceed 24 hours at 2 to 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

Stability period 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 duration and conditions of in-use storage are the responsibility of the user and normally should not 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.