Teicoplanina noridem 40… – инструкция – Испания

Инструкция по применению Teicoplanina noridem 400 mg polvo y disolvente para solucion inyectable y para perfusion efg

Introduction

PATIENT INFORMATION LEAFLET

Teicoplanina Noridem 400 mg Powder and solvent for injection and for infusion EFG

Teicoplanina

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

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

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

2. What you need to know before you start using Teicoplanina Noridem

3. How to use Teicoplanina Noridem

4. Possible side effects

5. Storage of Teicoplanina Noridem

6. Contents of the pack and additional information

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

Teicoplanina Noridem is an antibiotic. It contains a medication called “teicoplanin”.

It works by eliminating the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Teicoplanina 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 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

Teicoplanin may be used to treat some infections caused by the bacteriaClostridioidesdifficilein the intestine. In this case, the solution should be taken orally.

2. What you need to know before starting to use Teicoplanin Noridem

Do not use Teicoplanina Noridem:

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, pharmacist, or nurse before starting to use Teicoplanina Noridem if:

you are allergic to an antibiotic called “vancomycin”
you have hada 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. Regular tests may be performed to check if your kidneys and/or liver are functioning correctly (see “Using Teicoplanina Noridem with other medications”).

If any of the above cases apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before using Teicoplanina Noridem.

Tests

During treatment, you may be tested to check your blood, kidneys, liver, and/or ear. This is more likely if:

your treatment is going to last a long period of 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 medications that may affect your nervous system, kidneys, and/or ear.

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

Using Teicoplanina Noridem with other medications

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

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

Aminoglycosides, as they should not be mixed with Teicoplanina Noridem in the same injection. They may also cause hearing and/or kidney problems.
Anidulafungin – an antifungal medication that may cause hearing and/or kidney problems
Ciclosporin – an immunosuppressive medication that may cause hearing and/or kidney problems
Cisplatin – a medication used to treat malignant tumors that may cause hearing and/or kidney problems
Diuretics (such as furosemide) that may cause hearing and/or kidney problems.

If any of the above cases apply to you (or if you are unsure), inform your doctor, pharmacist, or nurse before using Teicoplanina 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 medication. They will decide whether you should or should not be given this medication while pregnant. There may be a potential risk of inner ear and kidney problems.

Inform your doctor if you are breastfeeding before they administer this medication to you. They will decide whether you can or cannot continue breastfeeding while being treated with Teicoplanina Noridem.

Animal reproduction studies have not shown evidence of fertility problems.

Driving and operating machinery

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

Teicoplanina Noridem contains sodium

This medication 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

Skin and soft tissue, lung, and urinary tract infections

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

Bone and joint, and heart infections

Initial dose (for three to five first 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 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 the 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 alternating dialysis bags
Week three: 20 mg/L in dialysis bags used at night.

Newborns (from birth to 2 months old)

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 old)

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 Noridem

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

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

In newborns from birth to 2 months, it will only be administered by continuous infusion.

For certain infections, the solution may be administered orally.

If you take more Teicoplanina Noridem 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 Teicoplanina Noridem or if you 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Teicoplanina Noridem

Your doctor or nurse will have instructions on when to administer Teicoplanina Noridem. 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 Noridem

Do not stop this treatment without having spoken first with your doctor, pharmacist, or nurse.

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

4. Possible Adverse Effects

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

Severe side effects

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

Rare(may affect up to 1 in 100 people)

Life-threatening allergic reaction – symptoms 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

Unknown frequency(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" ordrug reaction with eosinophilia and systemic symptoms (DRESS).DRESS initially appears as flu-like symptoms and a rash on the face, followed by a prolonged rash with high temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

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

Inform your doctor or nurse immediately if you experience any of the following severe side effects – you may need urgent medical treatment:

Rare(may affect up to 1 in 100 people)

Swelling and clotting in a vein
Difficulty breathing and wheezing (bronchoconstriction)
If you experience more infections than usual – may be signs of a decrease in your white blood cell count

Unknown frequency(cannot be estimated from available data)

Lack of white blood cells in the blood – symptoms may include: fever, intense chills, sore throat, or ulcers in the mouth (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

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

Other side effects

Talk to your doctor, pharmacist, 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)

Decrease in platelet count
Increased levels of liver enzymes in the blood
Increased levels of creatinine in the blood (to monitor kidney function)

Loss of hearing, ringing in the ears, or the 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)

Unknown frequency(cannot be estimated from available data)

Problems at the injection site – such as skin redness, pain, or inflammation

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughthe 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.

5. Conservation of Teicoplanin Noridem

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.

For powder and solvent:

Store below 25°C. Store the container in the outer packaging to protect it from light.

For single use only.

Discard any unused solution.

The information about conservation and the time to use Teicoplanin Noridem once it is reconstituted and ready for use is detailed in “Practical information for healthcare professionals on the preparation and handling of Teicoplanin Noridem”.

6. Contents of the packaging and additional information

Composition of Teicoplanin 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 injection in the solvent.

Appearance of the product and contents of the package

Teicoplanin Noridem is a powder and solvent for injectable and infusible solution or oral solution.

The powder is a white to off-white powder. The solvent is a transparent and colorless solution.

The powder is packaged:

in a colorless type I glass vial, with a useful volume of 22 mL for 400 mg, closed with a rubber stopper (Ph.Eur., type I) and sealed with aluminum flip-off capsules.

Presentations:

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 commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.

Responsible 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 with the following names::

United Kingdom	Teicoplanin 400 mg Powder and Solvent for Solution for injection/infusion or oral solution
Austria	Teicoplanin Noridem 400 mg Pulver und Lösungsmittel zur Herstellung einer Injektion-/Infusionslösung oder einer Lösung zum Einnehmen
Germany	Teicoplanin Noridem 400 mg Pulver und Lösungsmittel zur Herstellung einer Injektions-/Infusionslösung oder einer Lösung zum Einnehmen
Greece	Teicoplanin Noridem 400 mg Κ?νις και διαλ?της για παρασκευ? ενεσ?μου διαλ?ματος ? διαλ?ματος προς ?γχυση
Spain	Teicoplanina Noridem 400 mg Polvo y disolvente para solución inyectable y para perfusión EFG
Ireland	Teicoplanin 400 mg Powder and Solvent for Solution for injection/infusion or oral solution

Last review date of this leaflet: 10/2022.

This information is intended solely for healthcare professionals:

Practical information for healthcare professionals on the preparation and handling of Teicoplanin Noridem.

This medicinal product is for single use only.Dispose of any unused solution.

The reconstitution/dilution must be performed in aseptic conditions. Before administration, the solution must be visually inspected for particles and color change. Only the solution should be used if it is transparent and free of particles.

Administration form

Teicoplanin must be administered intravenously or intramuscularly.The intravenous injection can be administeredas a bolus over 3-5 minutes or by infusion over 30 minutes.

In newborn babies, only administration by infusion will be used.

For diarrhea and colitis associated with Clostridioides difficile infection, oral administration should be used.

Preparation of the reconstituted solution:

The solution is reconstituted by adding all the contents of the solvent supplied to the 200 mg and 400 mg powder vial. Water is added slowly to the vial, which must be rotated until all the powder is dissolved to prevent foam formation. If foam develops, allow the solution to stand for approximately 15 minutes for the foam to dissipate. Only transparent and yellowish solutions should be used.

The reconstituted solutions will contain400 mg of teicoplanin in 3.0 mL

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

Nominal teicoplanin content per vial		400 mg
Vial volume with powder		22 mL
Volume containing the nominal dose of teicoplanin (extracted using a 5 mL syringe and 23 G needle)		3.0 mL

The reconstituted solution can be injected directly or alternatively diluted, or administered orally.

Preparation of the diluted solution before infusion

Teicoplanin Noridem can be administered in the following infusion solutions:

0.9 %Sodium chloride solution (9 mg/mL) for infusion
Ringer's solution
Ringer-lactate solution

5 %Dextrose solution (50 mg/mL) for infusion

0.18 %Sodium chloride solution (1.8 mg/mL) and4 %dextrose (40 mg/mL) for infusion
Dialysis peritoneal solution containing 13.6 mg/mL (1.36 %) of glucose
Dialysis peritoneal solution containing 38.6 mg/mL (3.86 %) of glucose

Validity period of the reconstituted solution:

Chemical and physical stability has been demonstrated in use 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 storage times and conditions in use are the responsibility of the user and should not normally exceed 24 hours between 2°C and 8°C, unless reconstitution has been performed in 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 storage times and conditions in use are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C, unless reconstitution/dilution has been performed in controlled and validated aseptic conditions.

Elimination

The disposal of unused medicinal product and all materials that have been in contact with it will be carried out in accordance with local regulations.