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SCHEDULING STATUS: Schedule 4 / Schedule 1
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
DYNA TEICOPLANIN 200 mg: Lyophilised sterile powder for injection
DYNA TEICOPLANIN 400 mg: Lyophilised sterile powder for injection
DYNA TEICOPLANIN SOLVENT: Water for injection
Please read this information carefully before receiving DYNA TEICOPLANIN
- Keep this information. You may need to read it again.
- If you have any further questions, please ask your doctor or your pharmacist.
- DYNA TEICOPLANIN has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
WHAT DYNA TEICOPLANIN CONTAINS:
Active ingredients: DYNA TEICOPLANIN contains 200 mg or 400 mg teicoplanin powder. DYNA TEICOPLANIN SOLVENT contains 3,2 ml water for injection.
Inactive ingredients: DYNA TEICOPLANIN also contains sodium chloride and water for injection.
WHAT DYNA TEICOPLANIN IS USED FOR:
DYNA TEICOPLANIN is an antibiotic prescribed by physicians to both children (older than 3 years) and adults to treat certain microbial infections. The dosage and duration of the treatment is unique to your infection.
DYNA TEICOPLANIN is indicated in the treatment infections of the blood, lungs, airways, heart, bone and joints, skin and soft tissues, urinary tract and bowel. DYNA TEICOPLANIN may also be used before some operations to prevent infection.
BEFORE YOU RECEIVE DYNA TEICOPLANIN
Do not receive DYNA TEICOPLANIN:
Inform your doctor:
- If you are hypersensitive (allergic) to DYNA TEICOPLANIN or any of the other ingredients of DYNA TEICOPLANIN or similar medicines such as vancomycin.
- If you pregnant or breastfeeding.
- If you have history of or have a kidney or liver disorder.
Special care to be taken with DYNA TEICOPLANIN:
- Tell your doctor if you are generally an allergic person.
- Your doctor will need to check you blood, kidneys and hearing at regular visits while you are on DYNA TEICOPLANIN treatment. Keep all your appointments.
Pregnancy and breastfeeding:
Do not receive DYNA TEICOPLANIN if you are pregnant, planning to become pregnant or breastfeeding. The safety of DYNA TEICOPLANIN in pregnancy and breastfeeding has not yet been established. Please consult your doctor for advice.
Using other medicines with DYNA TEICOPLANIN:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of DYNA TEICOPLANIN with these medicines may cause undesirable interactions. Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop. Please consult your doctor, pharmacist or other healthcare professional for advice.
DYNA TEICOPLANIN may enhance the effects of medicines that affect hearing or the liver. Please consult your doctor if you are taking any of these types of medicines.
HOW DYNA TEICOPLANIN IS USED
DYNA TEICOPLANIN is for intravenous (into a vein) and intramuscular (into the muscle) use. Your doctor will decide on the suitable dose based on the type of infection you have.
POSSIBLE SIDE EFFECTS
DYNA TEICOPLANIN may have side effects.
Not all side effects reported for DYNA TEICOPLANIN are included in this leaflet.
Should your general health worsen while receiving DYNA TEICOPLANIN, please consult your doctor, pharmacist or other healthcare professional for advice.
You may experience the following less frequent side effects:
Skin rash, skin allergy, itching, fever, shortness of breath, pain at the injection site, nausea and vomiting, loss of hearing, ringing in the ears, headaches or dizziness.
If any of these side effects persists or worsens please inform your physician as soon as possible.
STORING AND DISPOSING OF DYNA TEICOPLANIN
- Store at or below 25 °C. Protect from moisture.
- After reconstitution, the solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would not be longer than 24 hours stored at 2 °C – 8 °C, unless reconstitution/ dilution has taken place under controlled and validated aseptic conditions.
- KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
- Do not use DYNA TEICOPLANIN after the expiry date printed on the carton and vial.
- Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).
PRESENTATION OF DYNA TEICOPLANIN
DYNA TEICOPLANIN 200 mg: 20 ml clear, colourless, Type I glass vial with grey bromobuthyl rubber closure and a aluminium secure cap with a blue plastic removable cover.
DYNA TEICOPLANIN 400 mg: 20 ml clear, colourless, Type I glass vial with grey bromobuthyl rubber closure and a aluminium secure cap with a red plastic removable cover.
DYNA TEICOPLANIN SOLVENT: 5 ml clear, colourless, Type I glass ampoules.
One vial and one ampoule are presented in an outer carton, for single use only.
IDENTIFICATION OF DYNA TEICOPLANIN:
DYNA TEICOPLANIN 200 mg is a white-yellow lyophilised (freeze-dried) powder.
DYNA TEICOPLANIN 400 mg is a white-yellow lyophilised (freeze-dried) powder.
DYNA TEICOPLANIN SOLVENT is a clear, colourless, odourless liquid.
When DYNA TEICOPLANIN is reconstituted, it is a clear, yellowish solution.
DYNA TEICOPLANIN 200 mg: 43/20.1.1/0573
DYNA TEICOPLANIN 400 mg: 43/20.1.1/0575
DYNA TEICOPLANIN SOLVENT: 43/34/0574
NAME AND ADDRESS OF REGISTRATION HOLDER
Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Cape Town, South Africa
DATE OF PUBLICATION
10 October 2013