Label: Information for the User

Teicoplanin SALA 200 mg

Powder for injectable solution and for EFG infusion

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label.See section 4.

6. Contents of the container and additional information

Teicoplanina is an antibiotic. It works by killing the bacteria that cause infections in your body.

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

• the skin and underlying tissues – sometimes referred to as "soft tissues"
• bones and joints
• the lungs
• the urinary tract
• the heart – sometimes referred to as "endocarditis"
• the abdominal wall – peritonitis
• the blood, when caused by one of the conditions listed above.

Teicoplanina may be used to treat some infections caused by the bacteriaClostridium difficilein the intestines. In this case, the solution should be taken orally.

No use Teicoplanin Injection

• if you are allergic to teicoplanin or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or nurse before receiving teicoplanin if:

• you are allergic to an antibiotic called “vancomycin”
• you have a redness on the upper part of your body (red man syndrome)
• you have a decreased platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medications that may cause hearing and/or kidney problems.

You may be required to undergo regular tests to check if your blood, kidneys, and/or liver are functioning correctly (see “Other Medications and Teicoplanin Injection”).

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

Severe 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 generalized acute pustular psoriasis (PEGA). 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 be required to undergo tests to check your blood, kidneys, liver, and/or hearing. This is more likely if:

• your treatment is expected to last a long period of time
• you need to be treated with high-dose loading doses (12 mg/kg twice a day)
• you have kidney problems
• you are taking or may take other medications that may affect your nervous system, kidneys, and/or hearing.

In people who are being treated with teicoplanin for a long period, bacteria that are not affected by the antibiotic may grow more than usual – your doctor will review this.

Other Medications and Teicoplanin Injection

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication. This is because teicoplanin may affect the functioning of other medications.

Additionally, some medications may affect the functioning of teicoplanin.

Particularly, inform your doctor if you are taking any of the following medications:

• aminoglycosides, as they should not be mixed with teicoplanin in the same injection. They may also cause hearing and/or kidney problems
• amphotericin B – a medication that treats fungal infections that may cause hearing and/or kidney problems
• ciclosporin – a medication that affects the immune system that may cause hearing and/or kidney problems
• cisplatin – a medication that treats malignant tumors that may cause hearing and/or kidney problems
• diuretics such as furosemide (medications that help you urinate) that may cause hearing and/or kidney problems.

If any of the above conditions 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 intend to become pregnant, consult your doctor, pharmacist, or nurse before receiving this medication. They will decide whether you should receive this medication while pregnant. There may be a potential risk of problems in the inner ear and kidneys of the fetus.

Inform your doctor if you are breastfeeding before receiving this medication. Your doctor will decide whether you can continue breastfeeding while receiving teicoplanin.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and Operating Machinery

You may experience headaches or feel dizzy while receiving this medication. If this happens, do not drive or use tools or machinery.

Teicoplanin Injection contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per vial, making it essentially “sodium-free”.

The recommended dose is:

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

Skin and soft tissue, 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 a day, by intravenous or intramuscular injection.

Bone and joint, and heart infections

• Initial dose (for three to five first 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 a day, by intravenous or intramuscular injection.

Infection caused by the bacteriaClostridium 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 you have kidney problems, your dose will usually be reduced after the fourth day of treatment:

• For people with mild to moderate kidney problems, the maintenance dose will be administered every two days, or half the maintenance dose once a day.
• For people with severe kidney problems and on hemodialysis, the maintenance dose will be administered every three days, or one-third of the maintenance dose once a day.

Treatment of peritonitis in patients on peritoneal dialysis

The initial dose is 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 dialysis bags alternately.
• Week three: 20 mg/l in dialysis bags used at night.

Newborns (from birth to 2 months of age)

• Initial dose (on day one): 16 mg per kilogram of body weight, as a continuous intravenous infusion.
• Maintenance dose: 8 mg per kilogram of body weight, administered once a day, as a continuous 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 Teicoplanina Sala

This medication will usually be administered by a doctor or nurse.

• It will be administered by intravenous or intramuscular injection.
• It can also be administered by continuous intravenous infusion.

Continuous intravenous infusion administration should only be used in newborns, from birth to 2 months of age.

For certain infections, the solution may be administered orally.

If you use more Teicoplanina Sala than you should

It is unlikely that the doctor or nurse will administer too much medication. However, if you think you have received too much teicoplanin or are worried, speak immediately with your doctor or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 5620420, indicating the medication and the amount ingested.

If you forgot to use Teicoplanina Sala 200 mg

Your doctor or nurse will have instructions on when to administer teicoplanin. It is unlikely that they will not administer the medication as prescribed. However, if you are concerned, speak with your doctor or nurse.

If you interrupt the treatment with Teicoplanina Sala

Do not stop this treatment without first speaking with your doctor or nurse.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

Stop treatment with teicoplanin immediately and contact a doctor or nurse if you notice any of the following severe side effects – you may need urgent medical treatment:

Rare(may affect up to 1 in 100 people)

• Life-threatening allergic reaction – signs may include: difficulty breathing or wheezing, inflammation, skin 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 available data)

• Appearance of blisters on the skin, mouth, eyes, or genitals – may be signs of "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• or "drug reaction with eosinophilia and systemic symptoms (DRESS)". DRESS initially presents as flu-like symptoms and a rash on the face, the rash spreads with fever, elevated liver enzymes in blood tests, eosinophilia, and lymph node enlargement.
• Generalized red and scaly rash with skin protuberances (including skin folds, chest, abdomen (including stomach), back, and arms) and blisters accompanied by fever – may be symptoms of "acute generalized pustular psoriasis (PEGA)".

Inform your doctor or nurse immediately if you experience any of the above-mentioned side effects.

Contact a doctor or nurse if you notice any of the following severe side effects – you may need urgent medical treatment:

Rare(may affect up to 1 in 100 people)

• Thrombophlebitis and clot in a vein
• Difficulty breathing and wheezing (bronchospasm)
• If you experience more infections than normal – may be signs of a decrease in your white blood cell count.

Frequency not known(cannot be estimated from available data)

• Aganulocytosis – signs may include: fever, intense chills, sore throat, or mouth ulcers
• Renal problems or changes in kidney function – shown in tests.
• The frequencyor severity of renal problems may increase if you receive higher doses.
• Seizures

Inform your doctor or nurse immediately if you experience any of the above-mentioned side effects.

Other side effects

Talk to your doctor or nurse if you experience any of the following side effects:

Common(may affect up to 1 in 10 people)

• Skin rash, erythema, itching
• Pain
• Fever

Rare(may affect up to 1 in 100 people)

• Decreased platelet count
• Elevated liver enzymes in the blood
• Elevated creatinine levels in the blood (to monitor your kidney function)
• Loss of hearing, tinnitus, or the sensation that you or things around you are moving
• Nausea or vomiting, diarrhea
• Dizziness or headache

Rare(may affect 1 in 1,000 people)

• Infection (abscesses)

Frequency not known(cannot be estimated from available data)

• Problems at the injection site – such as skin redness, pain, or inflammation
• Low levels of all types of blood cells.

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and vial label after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Information about storage and the time to use Teicoplanina after it has been reconstituted and is ready for use is detailed in “Practical Information for Healthcare Professionals for the Preparation and Handling of Teicoplanina 200 mg”.

Composition of Teicoplanina Sala 200 mg

The active ingredient is Teicoplanina. Each vial contains 200 mg of teicoplanina. The other component is sodium chloride.

Appearance of the product and contents of the package

Teicoplanina Sala 200 mg is a powder for injectable solution and for infusion. The powder is white or slightly beige.

The powder is packaged in a type II clear glass vial closed with a rubber stopper and a plastic flip-off cap and aluminum seal.

Presentations:

• Unit package: 1 vial
• Clinical package: 5 vials

Marketing authorization holder and responsible manufacturer:

Laboratorio REIG JOFRÉ, S.A.

Gran Capitán, 10

08970 Sant Joan Despí –Barcelona

Spain

Last review date of this leaflet:January 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

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Practical information for healthcare professionals on the preparation and handling of Teicoplanina Sala 200 mg.

This medicine is for single use only.

Method of administration

The reconstituted solution can be injected directly or alternatively in a diluted form.

The injection will be administered either as a bolus over 3-5 minutes or by infusion over 30 minutes.

In babies from birth to two months, it will only be administered by infusion.

The reconstituted solution can also be administered orally.

Preparation of the reconstituted solution:

• Slowly inject 3 ml of injectable preparation water into the vial of powder.
• Gently shake the vial in your hands until the powder is completely dissolved. If the solution becomes foamy, it should be left to rest for 15 minutes.

The reconstituted solutions will contain 200 mg in 3.0 ml.

Only transparent and yellowish solutions should be used.

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

Preparation of the diluted solution before infusion:

Teicoplanina Sala 200 mg can be administered in the following infusion solutions:

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

Validity period of the reconstituted solution:

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

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the times and conditions of use are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C, unless reconstitution was performed in controlled and validated aseptic conditions.

Validity period of the diluted medicine

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

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the times and conditions of use are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C, unless reconstitution/dilution was performed in controlled and validated aseptic conditions.

Elimination

The elimination of unused medicine and waste materials will be carried out in accordance with local regulations.