Teicoplanin Altan

Leaflet accompanying the packaging: information for the user

Teicoplanin Altan, 400 mg, powder for solution for injection/infusion or oral solution

or oral solution
Teicoplanin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Teicoplanin Altan and what is it used for
• 2. Important information before using Teicoplanin Altan
• 3. How to use Teicoplanin Altan
• 4. Possible side effects
• 5. How to store Teicoplanin Altan
• 6. Contents of the packaging and other information

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

Teicoplanin Altan is an antibiotic. It contains the active substance teicoplanin. It works by killing bacteria that cause infection in the patient's body.
Teicoplanin Altan is used in adults and children (including newborns) to treat the following bacterial infections:

• skin and soft tissue - sometimes called "soft tissue"
• bones and joints
• lungs
• urinary tract
• heart - sometimes called endocarditis
• abdomen - peritonitis
• blood, if caused by any of the above conditions

Teicoplanin Altan can be used to treat some infections caused by Clostridium difficile- bacteria in the intestines. For this purpose, the solution is taken orally.

2. Important information before using Teicoplanin Altan

When not to use Teicoplanin Altan

• if the patient is allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Teicoplanin Altan, the patient should discuss with their doctor, pharmacist or nurse if:

• the patient is allergic to the antibiotic vancomycin
• the patient has experienced redness of the upper body (red man syndrome)
• the patient has a low platelet count (thrombocytopenia)
• the patient has kidney problems
• the patient is taking other medicines that may cause hearing or kidney problems. The patient may need to have regular tests to check if their kidneys and/or liver are working properly (see "Teicoplanin Altan and other medicines")

If any of the above conditions apply to the patient (or the patient is unsure), they should consult their doctor, pharmacist or nurse before taking Teicoplanin Altan.

Diagnostic tests

During treatment, the patient may have blood tests, kidney function tests, liver function tests and/or hearing tests. This is more likely if:

• treatment is long-term
• the patient is being treated with high loading doses (12 mg/kg twice a day)
• the patient has kidney problems
• the patient is taking or may take other medicines that can damage the nervous system, kidneys or hearing

In patients taking Teicoplanin Altan for a long time, there may be a greater than usual increase in bacteria that the antibiotic does not work against - the doctor will check this.

Teicoplanin Altan and other medicines

The patient should tell their doctor, pharmacist or nurse about all medicines they are taking, have recently taken or might take. This is because Teicoplanin Altan may affect the way other medicines work. Also, some medicines may affect the way Teicoplanin Altan works. In particular, the patient should inform their doctor, pharmacist or nurse if they are taking:

• aminoglycosides - because they must not be mixed with Teicoplanin Altan in the same injection. They may also cause hearing or kidney problems
• amphotericin B - a medicine used to treat fungal infections, which may cause hearing or kidney problems
• cyclosporin - a medicine that affects the immune system, which may cause hearing or kidney problems
• cisplatin - a medicine used to treat cancer, which may cause hearing or kidney problems
• colistin - a medicine used to treat bacterial infections, which may cause hearing problems
• diuretics (such as furosemide and ethacrynic acid) - also known as "water tablets", which may cause hearing or kidney problems

If any of the above points apply to the patient (or the patient is unsure), they should consult their doctor, pharmacist or nurse before taking Teicoplanin Altan.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, thinks they may be pregnant or plans to have a baby, they should consult their doctor, pharmacist or nurse before using this medicine. They will decide whether the medicine can be given during pregnancy. There is a risk of damage to the inner ear and kidney problems.
If the patient is breastfeeding, they should tell their doctor before taking this medicine. The doctor will decide whether the patient can breastfeed while taking Teicoplanin Altan.
Studies on the effects on fertility in animals have not shown any adverse effects of the medicine on fertility.

Driving and using machines

During treatment with Teicoplanin Altan, the patient may experience pain or dizziness.
If such side effects occur, the patient should not drive or operate any tools or machines.

Teicoplanin Altan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which means the medicine is essentially "sodium-free".

3. How to use Teicoplanin Altan

This medicine should always be used exactly as the doctor or pharmacist has told the patient. If the patient is unsure, they should ask their doctor or pharmacist.

Recommended dose

Adults and children (12 years and older) without kidney problems

Skin and soft tissue, lung and urinary tract infections

• Initial dose (for the first three to five doses): 400 mg (which is 6 mg per kilogram of body weight) given every 12 hours by injection into a vein or muscle.
• Maintenance dose: 400 mg (which is 6 mg per kilogram of body weight) given once a day by injection into a vein or muscle.

Bone and joint infections and heart infections

• Initial dose (for the first three doses): 800 mg (which is 12 mg per kilogram of body weight) given every 12 hours by injection into a vein.
• Maintenance dose: 800 mg (which is 12 mg per kilogram of body weight) given once a day by injection into a vein or muscle.

Infection caused by Clostridium 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 the patient has kidney problems, the dose is usually reduced after the fourth day of treatment:

• In patients with mild and moderate kidney problems - the maintenance dose will be given every two days or half the maintenance dose will be given once a day.
• In patients with severe kidney problems or those undergoing hemodialysis - the maintenance dose will be given every three days or one-third of the maintenance dose will be given once a day.

Peritonitis in patients undergoing peritoneal dialysis

The initial dose is 6 mg per kilogram of body weight, given as a single injection into a vein, and then:

• first week: 20 mg/l in each dialysis bag
• second week: 20 mg/l in every other dialysis bag
• third week: 20 mg/l in the dialysis bag left overnight.

Newborns and infants (from birth to 2 months)

• Initial dose (on the first day): 16 mg per kilogram of body weight in an intravenous infusion.

in a drip.

• Maintenance dose: 8 mg per kilogram of body weight given once a day in an intravenous infusion in a drip.

Children (from 2 months to 12 years)

• Initial dose (for the first three doses): 10 mg per kilogram of body weight, given every 12 hours, by injection into a vein.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, given once a day by injection into a vein.

How Teicoplanin Altan is given

This medicine is usually given by a doctor or nurse.

• The medicine will be given by injection into a vein (intravenously) or into a muscle (intramuscularly).
• It can also be given in an intravenous infusion in a drip.

In newborns and infants from birth to 2 months, only infusion should be used. In the treatment of some infections, the solution may be taken orally (by mouth).

Using more than the recommended dose of Teicoplanin Altan

It is unlikely that the doctor or nurse will give too much medicine. However, if the patient thinks they have been given too much Teicoplanin Altan or if the patient is agitated, they should immediately consult their doctor or nurse.

Missing a dose of Teicoplanin Altan

The doctor or nurse will receive instructions on how to give the patient Teicoplanin Altan.
It is unlikely that the patient will be given the medicine contrary to the recommendations. However, if the patient has concerns, they should consult their doctor or nurse.

Stopping treatment with Teicoplanin Altan

The patient should not stop taking the medicine without first consulting their doctor, pharmacist or nurse.
If the patient has any further questions about the use of this medicine, they should ask their doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

If the patient experiences any of the following severe side effects, they should stop treatment and immediately consult their doctor or nurse - they may need urgent medical attention.

Uncommon(may affect up to 1 in 100 people):

• life-threatening allergic reaction - symptoms may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills
• abnormal increase in a type of white blood cell (eosinophilia)

Rare(may affect up to 1 in 1,000 people)

• redness of the upper body.

Frequency not known(frequency cannot be estimated from the available data)

• blisters on the skin, mouth, eyes or genitals - these may be symptoms of a condition called "toxic epidermal necrolysis (Lyell's syndrome)" or "Stevens-Johnson syndrome" or drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS appears as flu-like symptoms and a rash on the face, and then as a widespread rash with a high temperature, increased liver enzyme activity observed in blood tests and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.
  Decrease in the number of a type of white blood cell (neutropenia).
  Inflammation of the vein with blood clot formation (thrombophlebitis)

  If the patient experiences any of the above side effects, they should immediately inform their doctor or nurse.

  If the patient notices any of the following severe side effects, they should immediately inform their doctor or nurse, as they may need urgent medical attention.

  Uncommon(may affect up to 1 in 100 people):

  • swelling and blood clots in the vein
  • difficulty breathing or wheezing (bronchospasm)
  • more infections than usual - these may be symptoms of a decrease in the number of blood cells

  Frequency not known(frequency cannot be estimated from the available data)

  • lack of white blood cells - symptoms may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
  • kidney problems or changes in kidney function - seen in tests. If the patient is given higher doses, there may be an increased frequency or severity of kidney problems.
  • seizures
  • low levels of all types of blood cells

  If the patient experiences any of the above side effects, they should immediately inform their doctor or nurse.

  Other side effects

  The patient should consult their doctor, pharmacist or nurse if they experience any of the following side effects:

  Common(may affect up to 1 in 10 people)

  • rash, redness, itching
  • pain
  • fever.

  Uncommon(may affect up to 1 in 100 people):

  • decrease in platelet count
  • increased liver enzymes in the blood
  • increased creatinine levels in the blood (monitoring kidney function)
  • hearing loss, ringing in the ears or feeling that the patient or objects around them are moving
  • nausea or vomiting, diarrhea
  • dizziness or headache

  Rare(may affect up to 1 in 1,000 people)

  • infection (abscess).

  Frequency not known(frequency cannot be estimated from the available data)

  • problems at the injection site - such as redness of the skin, pain or swelling.

  Reporting side effects

  If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse.
  Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
  Al. Jerozolimskie 181C
  02-222 Warsaw
  Phone: +48 22 49 21 301
  Fax: +48 22 49 21 309
  Website: https://smz.ezdrowie.gov.pl
  Side effects can also be reported to the marketing authorization holder or its representative in Poland.
  By reporting side effects, more information can be gathered on the safety of the medicine.

  5. How to store Teicoplanin Altan

  The medicine should be stored out of sight and reach of children.
  Do not use this medicine after the expiry date stated on the carton and vial label after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
  There are no special precautions for storage.
  Information on storage conditions and shelf life of teicoplanin after reconstitution of the powder and preparation for use is described in the section "Practical information for healthcare professionals to prepare and handle teicoplanin".
  Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

  6. Contents of the packaging and other information

  What Teicoplanin Altan contains

  • The active substance of the medicine is teicoplanin. Each vial contains 400 mg of teicoplanin.
  • The other ingredients are: sodium chloride, sodium hydroxide (to adjust pH) and hydrochloric acid (to adjust pH).

  What Teicoplanin Altan looks like and contents of the pack

  Teicoplanin Altan is a powder for solution for injection/infusion or oral solution.
  The powder is white to slightly yellow.
  The reconstituted solution is a yellowish to light brown solution.
  The powder is packed in type I glass vials with a usable volume of 10 ml for 400 mg, closed with a type I bromobutyl rubber stopper and a green aluminum seal and a plastic "flip-off" cap.
  Pack sizes:

  • 1 vial of powder

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Altan Pharma Limited
  The Lennox Building, 50 South Richmond street
  Dublin 2, D02FK02
  Ireland

  Manufacturer

  Altan Pharmaceuticals S.A.
  Pol. Industrial de Bernedo S/N
  01118 Bernedo, Álava
  Spain
  Altan Pharmaceuticals S.A.
  Avda. de la Constitución 198-199
  Polígono Industrial Monte Boyal
  45950 Casarrubios del Monte, Toledo
  Spain

  This medicinal product is authorized in the Member States of the European Economic Area under the following names:

  Poland: Teicoplanin Altan, 400 mg, powder for solution for injection/infusion or oral solution
  Austria: Teicoplanin Altan 400 mg Pulver zur Herstellung einer Injektions-/Infusionslösung oder einer Lösung zum Einnehmen
  France: Teicoplanine Altan 400 mg poudre pour solution injectable/pour perfusion ou solution buvable

  Date of approval of the leaflet: 11/2023

  Other sources of information

  Information intended only for healthcare professionals:

  Practical information for healthcare professionals to prepare and handle teicoplanin

  This medicinal product is intended for single use only.
  Method of administration
  The reconstituted solution can be injected directly or further diluted if necessary.
  The solution can be given by injection over 3 to 5 minutes or in a 30-minute infusion.
  In infants from birth to 2 months, only infusion should be used. The reconstituted solution can also be given orally.
  Preparation of the solution

  • Slowly inject 3 ml of water for injections into the vial with the powder.
  • Gently rotate the vial in the hands until the powder is completely dissolved. If the solution becomes frothy, it should be left to stand for about 15 minutes. Only clear and yellowish solutions should be used.

  The reconstituted solutions will contain 400 mg in 3.0 ml.
  Only clear and yellowish solutions should be used.
  The final solution is isotonic with blood serum and has a pH of 6.3-7.7.

  Nominal teicoplanin content in the vial	400 mg
  Volume of the vial with powder	10 ml
  Volume containing the nominal dose of teicoplanin (withdrawn with a 5 ml syringe and a 23 G needle)	3.0 ml

  Dilution of the solution before infusion
  Teicoplanin Altan can be administered in the following infusion solutions:

  • 9 mg/ml (0.9%) sodium chloride solution
  • Ringer's solution
  • Ringer's solution with lactate
  • 5% glucose solution for injection
  • 10% glucose solution for injection
  • 0.18% sodium chloride and 4% glucose solution
  • 0.45% sodium chloride and 5% glucose solution
  • Peritoneal dialysis solution containing 1.36%.

  Shelf life of the solution after reconstitution of the powder and dilution
  The chemical and physical stability of the solution prepared as recommended has been demonstrated for 24 hours at a temperature of 2 to 8°C.
  From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and time before use, which normally should not exceed 24 hours at 2 to 8°C, unless the reconstitution and dilution process is carried out under controlled and validated aseptic conditions.
  Disposal

  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.