TEICOPLANIN NORIDEM 400 mg POWDER AND SOLVENT FOR INJECTION AND INFUSION SOLUTION
Ask a doctor about a prescription for TEICOPLANIN NORIDEM 400 mg POWDER AND SOLVENT FOR INJECTION AND INFUSION SOLUTION
How to use TEICOPLANIN NORIDEM 400 mg POWDER AND SOLVENT FOR INJECTION AND INFUSION SOLUTION
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Teicoplanin Noridem 400 mg Powder and solvent for solution for injection and infusion EFG
Teicoplanin
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 further questions, ask your doctor, pharmacist, or nurse.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Teicoplanin Noridem and what is it used for
- What you need to know before you use Teicoplanin Noridem
- How to use Teicoplanin Noridem
- Possible side effects
- Storage of Teicoplanin Noridem
- Contents of the pack and other information
1. What is Teicoplanin Noridem and what is it used for
Teicoplanin Noridem is an antibiotic. It contains a medicine called “teicoplanin”.
It works by killing the bacteria that cause infections in your body.
Antibiotics are used to treat bacterial infections and will not work for viral infections such as flu or the common cold.
It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.
Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.
Teicoplanin Noridem is used in adults and children (including newborns) to treat infections in:
- the skin and under the skin - sometimes referred to as “soft tissues”
- bones and joints
- the lung
- the urinary tract
- the heart – sometimes referred to as “endocarditis”
- the abdominal wall - peritonitis
- the blood, when caused by any of the above conditions
Teicoplanin can be used to treat some infections caused by the bacteria Clostridioidesdifficilein the intestine. In this case, the solution should be taken by mouth.
2. What you need to know before you use Teicoplanin Noridem
Do not use Teicoplanin Noridem:
- if you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting Teicoplanin Noridem if:
- you are allergic to an antibiotic called “vancomycin”
- you have had a reddening of the upper 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 have regular tests to check if your kidneys and/or liver are working properly (see “Using Teicoplanin Noridem with other medicines”).
If any of the above applies to you (or if you are not sure), inform your doctor, pharmacist, or nurse before using Teicoplanin Noridem.
Tests
During treatment, you may have tests to check your blood, kidneys, liver, and/or hearing. This is more likely if:
- your treatment is going to last a long time
- you need to be treated with high loading doses (12 mg/kg twice a day)
- you have kidney problems
- you are taking or may take other medicines that may affect your nervous system, kidneys, and hearing.
In people who are being treated with Teicoplanin Noridem for a long period, bacteria that are not affected by the antibiotic may grow more than usual – your doctor will check this.
Using Teicoplanin Noridem with other medicines
Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines. This is because Teicoplanin Noridem may affect how other medicines work. Also, some medicines may affect how Teicoplanin Noridem works.
In particular, tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:
- Aminoglycosides, as they must not be mixed with Teicoplanin Noridem in the same injection. They may also cause hearing and/or kidney problems.
- amphotericin B – a medicine that treats fungal infections that may cause hearing and/or kidney problems
- ciclosporin – a medicine that affects the immune system that may cause hearing and/or kidney problems
- cisplatin – a medicine that treats malignant tumors that may cause hearing and/or kidney problems
- water pills (such as furosemide) also known as “diuretics” that may cause hearing and/or kidney problems.
If any of the above applies to you (or if you are not sure), inform your doctor, pharmacist, or nurse before using Teicoplanin Noridem.
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 using this medicine. They will decide whether you should be given this medicine while pregnant. There may be a potential risk of problems in the inner ear and kidneys.
Tell your doctor if you are breastfeeding before they give you this medicine. They will decide whether you can continue breastfeeding while being given Teicoplanin Noridem.
Animal reproduction studies have not shown evidence of fertility problems.
Driving and using machines
You may have headaches or feel dizzy while being treated with Teicoplanin Noridem. If this happens, do not drive or use tools or machines.
Teicoplanin Noridem contains sodium
This medicine contains less than 1 mmol (0.41 mmol/9.43 mg) of sodium (23 mg) per vial; this is essentially “sodium-free”.
3. How to use Teicoplanin Noridem
The recommended dose is:
Adults and children (12 years or older) without kidney problems
Infections of the skin and soft tissues, lung, and urinary tract
- 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 a day, by intravenous or intramuscular injection
Infections of the bones and joints, and heart
- 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 a day, by intravenous or intramuscular injection
Infection caused by the bacteriaClostridioidesdifficile
The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, it will normally be necessary to reduce your dose 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 of the maintenance dose will be administered 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 will be administered 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 alternate dialysis bags
- Week three: 20 mg/L in the dialysis bags used at night.
Neonates (from birth to 2 months of age)
- Initial dose (on day one): 16 mg per kilogram of body weight, as an intravenous infusion through a drip.
- Maintenance dose: 8 mg per kilogram of body weight, administered once a day, as an intravenous infusion through a drip.
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 Teicoplanin Noridem is administered
This medicine will normally be administered to you by a doctor or nurse.
- It will be administered by intravenous injection (into a vein) or intramuscular injection (into a muscle).
- It can also be administered by intravenous infusion through a drip.
In babies from birth to two months, it will only be administered by infusion.
To treat certain infections, the solution may be administered by mouth (orally).
If you take more Teicoplanin Noridem than you should
It is unlikely that your doctor or nurse will give you too much medicine. However, if you think you have been given too much Teicoplanin Noridem or if you are concerned, talk to your doctor or nurse immediately.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Teicoplanin Noridem
Your doctor or nurse will have instructions on when to administer Teicoplanin Noridem to you. It is unlikely that they will not administer the medicine as prescribed. However, if you are concerned, talk to your doctor or nurse.
If you stop treatment with Teicoplanin Noridem
Do not stop this treatment without first talking to your doctor, pharmacist, or nurse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop treatment immediately and contact a doctor or nurse 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 life-threatening allergic reaction – the signs may include: difficulty breathing or wheezing, swelling, skin rash, itching, fever, chills
Rare(may affect up to 1 in 1,000 people)
- reddening of the upper body
Frequency not known(cannot be estimated from the available data)
appearance of blisters on the skin, mouth, eyes, or genitals – could be signs of “toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS appears initially as flu-like symptoms and a rash on the face, then a prolonged rash with a high temperature, elevated liver enzymes seen in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Tell your doctor or nurse immediately if you experience any of the above side effects.
Tell your doctor or nurse immediately if you experience any of the following serious side effects – you may need urgent medical treatment:
Uncommon(may affect up to 1 in 100 people)
- inflammation and clot in a vein
- difficulty breathing and wheezing (bronchospasm)
- if you get more infections than usual – could be signs of a decrease in your blood cell count
Frequency not known(cannot be estimated from the available data)
- lack of white blood cells in the blood – the 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 in tests. The frequency or severity of kidney problems may increase if you receive higher doses.
- seizures
Tell your doctor or nurse immediately if you experience any of the above side effects.
Other side effects
Talk to your doctor, pharmacist, or nurse if you get any of the following side effects:
Common(may affect up to 1 in 10 people)
- skin rash, redness, itching
- pain
- fever
Uncommon(may affect up to 1 in 100 people)
- decrease in platelet count
- increase in blood levels of liver enzymes
- increase in blood levels of creatinine (to check your kidney)
- hearing loss, ringing in the ears, or the feeling that you or your surroundings are spinning
- 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 the available data)
- problems at the injection site – such as skin redness, pain, or inflammation
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System for human use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Teicoplanin Noridem
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date is the last day of the month shown.
For powder and solvent:
Store below 25°C. Keep the container in the outer packaging to protect it from light.
For single use only.
Discard any unused solution.
Information about the storage and use of Teicoplanin Noridem once reconstituted and ready to use is detailed in “Practical information for healthcare professionals on the preparation and handling of Teicoplanin Noridem”.
6. Container Contents and Additional Information
Composition of Teicoplanina Noridem
- The active ingredient is teicoplanin. Each vial contains 400 mg of teicoplanin.
Each mL of reconstituted solution contains 133.4 mg of teicoplanin.
- The other components are sodium chloride and sodium hydroxide in the powder, and water for injectable preparations in the solvent.
Appearance of the Product and Container Contents
Teicoplanina Noridem is a powder and solvent for injectable solution and for infusion or for oral solution.
The powder is a white to off-white powder. The solvent is a clear and colorless solution.
The powder is packaged:
- in a 22 mL clear glass type I vial for 400 mg, closed with a rubber stopper (Ph.Eur., type I) and sealed with aluminum flip-off caps.
Presentation:
1 vial of 400 mg + 1 ampoule of 3 mL of solvent
10 vials of 400 mg + 10 ampoules of 3 mL of solvent
Only some package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.
Manufacturer:DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Attica, Greece.
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
United Kingdom | Teicoplanin 400 mg Powder and Solvent for Solution for injection/infusion or oral solution |
Austria | Teicoplanin Noridem 400 mg Powder and Solvent for Solution for injection/infusion or oral solution |
Germany | Teicoplanin Noridem 400 mg Powder and Solvent for Solution for injection/infusion or oral solution |
Greece | Teicoplanin Noridem 400 mg Powder and Solvent for Solution for injection/infusion or oral solution |
Spain | Teicoplanina Noridem 400 mg Powder and Solvent for injectable solution and for perfusion EFG |
Ireland | Teicoplanin 400 mg Powder and Solvent for Solution for injection/infusion or oral solution |
Date of Last Revision of this Leaflet: 10/2022.
This information is intended only for healthcare professionals:
Practical Information for Healthcare Professionals on the Preparation and Handling of Teicoplanina Noridem. This medicinal product is for single use. Discard any unused solution. Reconstitution/dilution must be carried out under aseptic conditions. Before administration, the solution must be visually inspected for particles and color change. The solution should only be used if it is clear and free of particles. Method of Administration Teicoplanin must be administered by intravenous or intramuscular route. Intravenous injection can be administered as a bolus over 3-5 minutes or by infusion over 30 minutes. In newborn babies, it should only be administered by infusion. For diarrhea and colitis associated with Clostridioides difficileinfection, the oral route should be used. Preparation of the Reconstituted Solution: The solution is reconstituted by adding the entire contents of the supplied solvent to the vial of 200 mg and 400 mg powder. Water is added slowly to the vial, which should be rotated until all the powder is dissolved to avoid foam formation. If foam develops, allow the solution to stand for approximately 15 minutes for the foam to disappear. Only clear and yellowish solutions should be used. The reconstituted solutions will contain 400 mg of teicoplanin in 3.0 mL The final solution is isotonic with plasma and has a pH of 7.2-7.8.
The reconstituted solution can be injected directly or alternatively in a diluted form, or it can be administered orally. Preparation of the Diluted Solution before Infusion Teicoplanina Noridem can be administered in the following infusion solutions:
Validity Period of the Reconstituted Solution: Chemical and physical stability in use of the reconstituted solution with water for injectable preparations has been demonstrated for 24 hours between 2°C and 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless the reconstitution has been carried out under controlled and validated aseptic conditions. Validity Period of the Diluted Medicinal Product Chemical and physical stability in use of the reconstituted solution prepared as recommended has been demonstrated for 24 hours between 2 and 8°C. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2 and 8°C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions. Disposal Disposal of the unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations. |
