Teicoplanin Seacross

Patient Information Leaflet

Teicoplanina Seacross 200 mg Powder for injectable/infusion solution or oral solution, 400 mg Powder for injectable/infusion solution or oral solution

teicoplanin
Please read all of this leaflet carefully before taking 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, pharmacist, or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Teicoplanina Seacross is and what it is used for
2. What you need to know before being given Teicoplanina Seacross
3. How to use Teicoplanina Seacross
4. Possible side effects
5. How to store Teicoplanina Seacross
6. Contents of the pack and other information

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

Teicoplanina Seacross is an antibiotic that contains the active substance “teicoplanin”. It works by killing the bacteria responsible for infections in the body.
Teicoplanina Seacross is used in adults and children (including newborns) to treat bacterial infections of:

• skin and underlying tissues (sometimes called “soft tissues”)
• bones and joints
• lungs
• urinary tract
• heart (endocarditis)
• abdominal area (peritonitis)
• blood, when caused by one of the above-mentioned conditions.

Teicoplanina Seacross may be used to treat certain intestinal infections caused by Clostridioides difficile bacteria. For this purpose, the solution is taken orally.

2. What you need to know before you are given Teicoplanina Seacross

Do not use Teicoplanina Seacross 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, pharmacist, or nurse before you are given Teicoplanina Seacross if:

• you are allergic to an antibiotic called “vancomycin”
• you have experienced redness of the upper part of the body (red man syndrome)
• you have a low platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medicines that could cause hearing and/or kidney problems. You may need regular tests to check whether your kidneys and/or liver are functioning properly (see “Other medicines and Teicoplanina Seacross”).

If any of the above applies to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before you are given Teicoplanina Seacross.
Serious 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 Teicoplanina Seacross and contact your doctor or seek immediate medical advice.

Tests
During treatment, you may need to undergo tests to monitor your blood, kidneys, liver, and/or hearing. This is more likely if:

• your treatment will last a long time
• you need to be treated with high loading doses (12 mg/kg twice daily)
• you have kidney problems
• you are taking or may take other medicines that can affect the nervous system, kidneys, or hearing.

In patients receiving long-term teicoplanin treatment, bacteria not affected by the antibiotic may grow more than usual – your doctor will carry out checks to monitor for this possibility.

Other medicines and Teicoplanina Seacross
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because teicoplanin may affect how other medicines work. Likewise, some medicines may affect how teicoplanin works.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• aminoglycosides, which must not be mixed with teicoplanin in the same injection. These 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 that affects the immune system and may cause hearing and/or kidney problems
• cisplatin – a medicine used to treat malignant tumours that may cause hearing and/or kidney problems
• diuretic tablets (such as furosemide) that may cause hearing and/or kidney problems.

If any of the above applies to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before you are given Teicoplanina Seacross.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor, pharmacist, or nurse for advice before you are given this medicine. They will decide whether you should be given this medicine during pregnancy. There may be a potential risk of inner ear and kidney problems.
Tell your doctor if you are breastfeeding before you are given this medicine. Your doctor will decide whether you can continue breastfeeding while being treated with Teicoplanina Seacross.
Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines
While being treated with Teicoplanina Seacross, you may experience headache or dizziness. If this occurs, do not drive or operate machinery.

Teicoplanina Seacross contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.

3. How to use Teicoplanina Seacross

Recommended dose
Adults and children (12 years of age and older) with normal kidney function
Skin and soft tissue infections, lung infections, and urinary tract infections

• Initial dose (for the first 3 doses): 6 mg per kg of body weight administered every 12 hours by intravenous or intramuscular injection
• Maintenance dose: 6 mg per kg of body weight administered once daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

• Initial dose (for the first 3–5 doses): 12 mg per kg of body weight administered every 12 hours by intravenous injection
• Maintenance dose: 12 mg per kg of body weight administered once daily by intravenous or intramuscular injection.

To treat infections caused by Clostridioides difficile bacteria
The recommended dose is 100–200 mg orally twice daily for 7–14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, your dose will generally be reduced after the fourth day of treatment:

• For patients with mild to moderate kidney impairment: the maintenance dose should be administered every 2 days, or half the maintenance dose should be given daily.
• For patients with severe kidney impairment or undergoing hemodialysis: the maintenance dose should be administered every 3 days, or one-third of the maintenance dose should be given daily.

Peritonitis in patients undergoing peritoneal dialysis
The initial dose is 6 mg per kg of body weight, administered 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 nighttime bag.

Neonates (from birth to 2 months of age)

• Initial dose (first day): 16 mg per kg of body weight administered by intravenous infusion
• Maintenance dose: 8 mg per kg of body weight administered once daily by intravenous infusion.

Children (from 2 months to 12 years of age)

• Initial dose (first three doses): 10 mg per kg of body weight administered every 12 hours by intravenous injection
• Maintenance dose: 6–10 mg per kg of body weight administered once daily by intravenous injection.

How Teicoplanina Seacross is administered
This medicine is usually administered by a doctor or nurse:

• It is given by intravenous (IV) or intramuscular (IM) injection
• It may also be given by intravenous infusion.

In neonates from birth up to 2 months of age, the medicine must be administered only by infusion.
For the treatment of certain infections, the solution may be taken orally (oral use).
If you receive more Teicoplanina Seacross than you should
It is unlikely that a doctor or nurse will give you too much medicine. However, if you think you have been given too much Teicoplanina Seacross or if you feel unwell, inform your doctor or nurse immediately.
If you miss a dose of Teicoplanina Seacross
Your doctor or nurse will have specific instructions on when to administer Teicoplanina Seacross. It is unlikely that the medicine will not be given as prescribed. However, if you are concerned, inform your doctor or nurse.
If you stop Teicoplanina Seacross treatment
Do not stop taking this medicine without first discussing it with your doctor, pharmacist, or nurse.
If you have any doubts about how to use this medicine, consult 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 and contact 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)

• sudden allergic reaction that may be life-threatening – signs may include: difficulty breathing or wheezing, sweating, rash, itching, fever, chills

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

• hot flushes in the upper part of the body

Not known (frequency cannot be estimated from the available data)

• blistering of the skin, mouth, eyes or genitals – these may be signs of a condition called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome”
• 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)”
• “drug reaction with eosinophilia and systemic symptoms (DRESS)”. This reaction initially presents with flu-like symptoms and a rash on the face, followed by widespread rash and high temperature, increased liver enzyme levels seen in blood tests, an increase in white blood cells (eosinophilia), and swollen lymph nodes. Contact your doctor or nurse immediately if you notice any of the side effects listed above.

Contact 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)

• swelling and clotting in a vein
• difficulty breathing or wheezing (bronchospasm)
• increased occurrence of infections – this could be a sign of reduced blood cell count

Not known (frequency cannot be estimated from the available data)

• lack of white blood cells – 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 by blood tests. The frequency or severity of kidney problems may increase if higher doses are administered.
• seizures

Contact your doctor or nurse immediately if you experience any of the side effects listed above.
Other side effects
Tell your doctor, pharmacist, or nurse if you notice 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)

• decreased platelet count
• increased liver enzyme levels in the blood
• increased creatinine levels in the blood (to monitor kidney function)
• hearing loss, ringing in the ears or sensation that you or things around you are moving
• feeling unwell or nausea, diarrhoea
• dizziness or headache

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

• infection (abscess)

Not known (frequency cannot be estimated from the available data)

• problems at the injection site – such as redness, pain or swelling

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teicoplanina Seacross

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial after Scad/EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Information on storage and the duration of use of Teicoplanina Seacross after reconstitution and once it is ready for administration are described in the "Practical information for healthcare personnel on the preparation and handling of Teicoplanina Seacross".

6. Package contents and other information

What Teicoplanina Seacross contains

• The active substance is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
• The other ingredients are sodium chloride and sodium hydroxide.

Description of the appearance of Teicoplanina Seacross and package contents
Teicoplanina Seacross is a powder for injectable/infusion solution or oral solution.
The powder is a lyophilized mass, dissolved from almost white to pale yellow, packaged:

• in a 10 mL clear type I glass vial with a useful volume of 10 mL containing 200 mg, sealed with a chlorobutyl rubber stopper and an aluminum flip-off seal.
• in a 20 mL clear type I glass vial with a useful volume of 20 mL containing 400 mg, sealed with a chlorobutyl rubber stopper and an aluminum flip-off seal.
  Packaging:
  • 1 vial

Marketing Authorization Holder and Manufacturer
Seacross Pharma (Europe) Limited
POD 13, The Old Station House
15A Main Street, Blackrock
Dublin, A94 T8P8
Ireland
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare personnel on the preparation and handling of
Teicoplanin Seacross.
This medicinal product is for single use only.
Method of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection may be administered as a 3-5 minute bolus or as a 30-minute infusion.
In children from birth up to 2 months of age, administration must be performed only via infusion.
The reconstituted solution may also be administered orally (oral use).
Preparation of the reconstituted solution
Reconstitute the solution by adding 3.0 mL of water for injections to the 200 mg and 400 mg vial of powder.
Water should be added slowly to the vial, which must then be rotated until all the powder is dissolved, in order to avoid foam formation.
If foam develops, allow the solution to stand for approximately 15 minutes until the foam disappears.
Only clear solutions should be used. The color of the solution may vary from yellowish to dark yellow.
The final solution is isotonic with plasma and has a pH of 7.2–7.8.

Preparation of diluted solution prior to infusion
Teicoplanina Seacross may be administered in the following infusion solutions:

• sodium chloride solution 9 mg/mL (0.9%)
• Ringer's solution
• Ringer's lactate solution
• 5% dextrose solution
• 10% dextrose solution
• 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.

Stability of the reconstituted solution
The chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 30 hours at temperatures between 2 and 8°C or 25°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

Stability of the diluted medicinal product
The chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 30 hours at temperatures between 2 and 8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

Disposal
Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with current local regulations.