Teicoplanin Sala 200 mg powder for injection and for infusion EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Teicoplanina SALA 200 mg
Powder for injectable solution and for 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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of this leaflet
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What Teicoplanina Sala is and what it is used for
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What you need to know before using Teicoplanina Sala
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How to use Teicoplanina Sala
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Possible side effects
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How to store Teicoplanina Sala
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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 the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.
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 down the drain or in the household waste.
Teicoplanin is used in adults and children (including newborns) to treat infections in:
- the skin and beneath the skin – sometimes referred to as "soft tissues"
- bones and joints
- the lung
- the urinary tract
- the heart – sometimes called "endocarditis"
- the abdominal wall – peritonitis
- the blood, when caused by one of the conditions listed above.
Teicoplanin may be used to treat certain infections caused by the bacterium Clostridium difficile in the intestine. In this case, the solution should 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 functioning properly (see "Other medicines and Teicoplanin Sala").
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 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 require 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 taking, have recently taken, or might need to take 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 affecting the immune system that 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) 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 plan to become pregnant, consult your doctor, pharmacist, or nurse before receiving this medicine. They will decide whether or not this medicine should be given during pregnancy. There may be a potential risk of problems in the fetus's inner ear and kidneys.
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 impairment.
Driving and using machines
You may experience headaches or feel dizzy while being treated with this medicine. If this occurs, do not drive or operate tools or machinery.
Teicoplanin Sala 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
The recommended dose is:
Adults and children (12 years of age 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 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 impairment, the maintenance dose should be administered every two days, or half the maintenance dose should be given once daily.
- For 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.
Treatment of peritonitis in patients undergoing peritoneal dialysis
The initial dose is 6 mg per kilogram of body weight as a single intravenous infusion, 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 will be given by intravenous or intramuscular injection.
- It may also be administered 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 your doctor or nurse will 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, indicating the medication and the amount ingested.
If you forget to use Teicoplanin Sala 200 mg
Your doctor or nurse will have instructions on when to administer teicoplanin. It is unlikely that the medication will be omitted 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 the use of 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
Treatment with teicoplanin must be stopped immediately and you should contact your doctor or nurse if you notice any of the following serious adverse effects – urgent medical treatment may be required:
Uncommon (may affect up to 1 in 100 people)
- sudden, life-threatening allergic reaction – signs 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 part of the body
Frequency not known (cannot be estimated from available data)
- appearance of blisters on the skin, mouth, eyes or genitals – these may be signs of a condition called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
- or "drug reaction with eosinophilia and systemic symptoms (DRESS)". DRESS initially presents with flu-like symptoms and a rash on the face; the rash spreads accompanied by fever, increased liver enzyme levels in blood tests, increased number of a type of white blood cells (eosinophilia), and enlarged 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 your 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)
- inflammation 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 you receive higher doses.
- 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)
- decreased 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 things 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 of the skin
- low levels of all types of blood cells.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 on the label of the vial after EXP. The expiry date refers to the last day of the month indicated.
Store below 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 200 mg".
6. Contents of the pack and other information
Composition of Teicoplanina Sala 200 mg
The active substance is Teicoplanin. Each vial contains 200 mg of teicoplanin. The other component is sodium chloride.
Appearance of the product and contents of the pack
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 colorless type II glass vial closed with a rubber stopper and a plastic flip-off cap with an aluminum seal.
Pack sizes:
- Unit pack: 1 vial
- Hospital 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 revision of this summary: January 2024
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
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 may be administered either directly by injection or alternatively in diluted form.
The injection may be given either as an intravenous bolus over 3–5 minutes or by infusion over 30 minutes.
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 foaming occurs, allow the solution to stand for approximately 15 minutes.
The reconstituted solutions will contain 200 mg in 3.0 ml.
Only clear, yellowish solutions should be used.
The solution is isotonic with plasma and has a pH of 7.2 – 7.8.
Nominal teicoplanin content per vial | 200 mg |
Vial volume | 10 ml |
Volume containing the nominal dose of teicoplanin (extracted using a 5 ml syringe and 23 G needle) | 3.0 ml |
Preparation of the diluted solution prior to infusion:
Teicoplanin 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
- 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
Shelf life 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 storage times and conditions during use 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.
Shelf life 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 storage times and conditions during use 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.