400 mg powder and liquid for injection/infusion, solution
teicoplanin
What Teicoplanin Sandoz is and what it is used for
Teicoplanin Sandoz is an antibiotic . It contains a medicine called “teicoplanin”. It works by killing the bacteria that cause infection in your body.
Teicoplanin is used in adults and children (including newborn babies) to treat bacterial infections in:
- the skin and under the skin – sometimes referred to as “soft tissue”
- bone tissue and joints
- the lungs
- the urinary tract
- the heart – sometimes referred to as “endocarditis”
- abdominal wall – peritonitis
- the blood, caused by any of the conditions listed above
Teicoplanin Sandoz can be used to treat certain infections caused by ” Clostridium difficile ” bacteria in the intestines. For this, the solution is taken by mouth.
What you need to know before you use Teicoplanin Sandoz
Do not use Teicoplanin Sandoz
- if you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Teicoplanin Sandoz if:
- you are allergic to an antibiotic called “vancomycin”
- you have redness on the upper part of the body (red man syndrome)
- you have a reduced number of blood platelets ( thrombocytopenia )
- you suffer from kidney problems
- you are taking other medicines that can cause hearing problems and/or kidney problems. You may have regular tests to check that the blood, kidneys, and/or liver are working properly (see “Other medicines and Teicoplanin Sandoz”).
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before you are given Teicoplanin Sandoz.
Samples
During treatment, you may be given samples to check your kidneys, liver, and/or hearing. This is more likely if:
- your treatment should be for a longer period
- you must be treated with high loading doses (12 mg/kg twice daily)
- you suffer from kidney problems
- you are taking or may take other medicines that can affect the nervous system, kidneys, or hearing.
In patients treated with Teicoplanin Sandoz for a long time, bacteria that are not affected by this antibiotic may grow more than normal – your doctor will check this.
Other medicines and Teicoplanin Sandoz
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. This is because Teicoplanin Sandoz can affect how certain other medicines work. In addition, some medicines can affect how Teicoplanin Sandoz works.
In particular, tell your doctor, pharmacist, or nurse if you are taking the following medicines:
- Aminoglycosides because they must not be mixed with Teicoplanin Sandoz in the same injection. They can also cause hearing problems and/or kidney problems.
- amphotericin B – a medicine to treat fungal infections that can cause hearing problems and/or kidney problems
- ciclosporin – a medicine that affects the immune system, which can cause hearing problems and/or kidney problems
- cisplatin – a medicine for the treatment of malignant tumors, which can cause hearing problems and/or kidney problems
- diuretics (e.g. furosemide ) – also called “diuretics”, which can cause hearing problems and/or kidney problems.
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before you are given Teicoplanin Sandoz.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist, or nurse for advice before using this medicine. They will decide whether you should be given this medicine while you are pregnant. There may be a potential risk of inner ear and kidney problems
If you are breastfeeding, consult a doctor before using this medicine. They will decide whether or not you can continue to breastfeed while you are being treated with Teicoplanin Sandoz.
Animal reproduction studies have shown no evidence of fertility problems.
Driving ability and use of machinery
You may suffer from headaches or dizziness during treatment with Teicoplanin Sandoz. If this happens, do not drive or use tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Teicoplanin Sandoz contains sodium
This medicine contains 1 mmol (or 24 mg) of sodium per dose. This should be taken into account by patients prescribed a low-salt diet.
How to use Teicoplanin Sandoz
The recommended dose is
Adults and children (12 years and older) without kidney problems
Infections in the skin and soft tissue, lungs, and urinary tract
- Starting dose (for the first three doses): 6 mg for each kilogram of body weight given every 12 hours by injection into a vein or muscle.
- Maintenance dose: 6 mg for each kilogram of body weight given once daily by injection into a vein or muscle.
Infections in bone tissue and joints, as well as heart infections
- Starting dose (for the first three to five doses ): 12 mg for each kilogram of body weight given every 12 hours by injection into a vein or muscle.
- Maintenance dose: 12 mg for each kilogram of body weight given once daily by injection into a vein or muscle.
Infection caused by ” Clostridium difficile ” bacteria
The recommended dose is 100 to 200 mg by mouth twice daily for 7 to 14 days.
Adults and elderly patients with kidney problems
If you suffer from kidney problems, your dose usually needs to be reduced after the fourth day of treatment:
- For patients with mild and moderate kidney problems – the maintenance dose is given every other day or half the maintenance dose is given once daily.
- For patients with severe kidney problems or who are treated with hemodialysis – the maintenance dose is given every three days or one-third of the maintenance dose is given once daily.
Peritonitis in patients treated with peritoneal dialysis
The starting dose is 6 mg for each kilogram of body weight as a single injection into a vein, followed by:
- Week one: 20 mg/l for each dialysis bag
- Week two: 20 mg/l every other dialysis bag
- Week three: 20 mg/l in the nocturnal dialysis bag.
Infants (from birth to 2 months of age)
- Starting dose (on the first day): 16 mg for each kilogram of body weight as an infusion via a drip into a vein.
- Maintenance dose: 8 mg for each kilogram of body weight given once daily, as an infusion via a drip into a vein.
Children (from 2 months to 12 years)
- Starting dose (for the first three doses ): 10 mg for each kilogram of body weight given every 12 hours as an injection into a vein.
- Maintenance dose: 6 to 10 mg for each kilogram of body weight, given once daily as an injection into a vein.
How Teicoplanin Sandoz is given
The medicine is usually given to you by a doctor or nurse.
- It is given as an injection into a vein ( intravenous use) or muscle ( intramuscular use).
- It can also be given as an infusion via a drip into a vein.
Only infusion may be given to infants from birth to 2 months of age.
For the treatment of certain infections, the solution can be taken by mouth (oral use).
If you have used too much Teicoplanin Sandoz
Your doctor or nurse is unlikely to give you too much medicine.
However, if you think you may have been given too much Teicoplanin Sandoz or if you are not sure, talk to a doctor or nurse immediately.
If you forget to use Teicoplanin Sandoz
The doctor or nurse will give you instructions about when to give you Teicoplanin Sandoz.
It is unlikely that they will not give you the medicine as prescribed.
Consult a doctor or nurse if you are worried.
If you stop using Teicoplanin Sandoz
Do not stop using this medicine without first talking to your doctor, pharmacist, or nurse.
If you have any further questions about this medicine, ask your doctor or pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop treatment and talk to a doctor or nurse immediately if you get any of the following serious side effects – you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 users)
- sudden life-threatening allergic reaction – signs may include difficulty breathing or wheezing, swelling, rash, itching, fever, and chills.
Rare (may affect up to 1 in 1,000 users)
- redness on the upper body
- Blisters on the skin, mouth, eyes, or genitals have been reported (occurring in an unknown number of users) – this may be a sign of something called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or “drug reaction with eosinophilia and systemic symptoms ( DRESS)”. DRESS presents initially with flu-like symptoms with a rash on the face and then by more widespread rashes, fever, elevated levels of liver enzymes seen in blood tests, and elevated levels of a type of white blood cell ( eosinophils ) and enlarged lymph nodes.
Talk to a doctor or nurse immediately if you get any of the side effects mentioned above.
Talk to a doctor or nurse immediately if you get any of the following serious side effects – you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 users)
- swelling and blood clots in a vein
- difficulty breathing or wheezing ( bronchospasm )
- more infections than usual – this may be a sign of a decrease in the number of blood cells
Has been reported (occurring in an unknown number of users)
- lack of white blood cells – signs may include: fever, severe chills, sore throat, or mouth ulcers ( agranulocytosis )
- kidney problems or changes in kidney function – seen in samples. The frequency or severity of kidney problems may increase if you receive a higher dose of er.
- epileptic seizures.
Talk to a doctor or nurse immediately if you get any of the side effects mentioned above.
Other side effects
Talk to your doctor, pharmacist, or nurse if you experience any of these:
Common (may affect up to 1 in 10 users)
- rash, redness, itching
- pain
- fever.
Uncommon (may affect up to 1 in 100 users)
- decreased number of platelets
- increased levels of liver enzymes in the blood
- increased levels of creatinine in the blood (measured to check kidney function)
- hearing loss, ringing in the ears, or a feeling that you, or things around you, are moving
- nausea or vomiting, diarrhea
- dizziness or headache.
Rare (may affect up to 1 in 1,000 users)
- infection (abscess).
Has been reported (occurring in an unknown number of users)
- discomfort at the injection site – e.g. skin redness, pain, or swelling.
How to store Teicoplanin Sandoz
Keep this medicine out of sight and reach of children.
Use before the expiry date which is stated on the carton and vials after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C.
Information on storage and treatment time for Teicoplanin Sandoz after preparation and when it is ready to be used is described in “Practical information for healthcare professionals on the preparation and handling of Teicoplanin Sandoz”.
Do not store it in a syringe.
Contents of the packaging and other information
Contents declaration
- The active substance is teicoplanin. One vial contains 400 mg of teicoplanin corresponding to 400,000 IU. After preparation, the solution contains 400 mg of teicoplanin in 3.0 ml.
- Other ingredients are powder: sodium chloride and, if necessary, sodium hydroxide to adjust the pH (see the end of section 2 for more information regarding sodium )diluent: water for injections.
Appearance and package sizes of the medicine
Teicoplanin Sandoz is a powder and diluent for injection/infusion, solution. The powder is a white to light yellow powder. The diluent is a clear liquid without particles.
The powder is packaged:
- in a colorless type, I glass vial of the useful volume of 22 ml for 400 mg is sealed with a bromobutyl rubber stopper and blue plastic pull-off closure on an aluminum top.
The diluent is packaged in a colorless type I glass ampoule containing 3 ml for 400 mg.
Package sizes:
- 1 vial of powder with 1 ampoule of diluent
- 5×1 vials of powder with 5×1 ampoules of diluent.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia