Consumer medicine information

Teicoplanin Sandoz

Teicoplanin

BRAND INFORMATION

Brand name

Teicoplanin Sandoz

Active ingredient

Teicoplanin

Schedule

What is in this leaflet

This leaflet answers some common questions about Teicoplanin Sandoz.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you being given this medicine against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Teicoplanin Sandoz is used for

Teicoplanin Sandoz is an antibiotic. It is used to kill bacteria responsible for infections of the bones, blood or joints. This antibiotic is generally used when the bacteria causing the infection are not satisfactorily eliminated by other antibiotics(eg: penicillin), or when may be patients are allergic to other antibiotics.

It contains the active ingredient teicoplanin.

Teicoplanin belongs to a group of medicines called glycopeptide antibiotics.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor's prescription.

There is no evidence that this medicine is addictive.

Before you are given Teicoplanin Sandoz

When you must not take it

Do not take this medicine name if you have an allergy to:

teicoplanin, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product description.

Some of the symptoms of an allergic reaction may include:

shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin

Do not have this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

kidney problems.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you have ever had a reaction to any other antibiotic, especially an antibiotic called vancomycin.

If you have not told your doctor about any of the above, tell him/her before you are given Teicoplanin Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Teicoplanin Sandoz may interfere with each other. These include:

aminoglycoside antibiotics, a group of medicines used to treat bacterial infections
amphotericin, a medicine used to treat fungal infections
cyclosporin, a medicine used to control the immune system
cisplatin, a medicine used to treat certain cancers
frusemide and ethacrynic acid, medicines that reduce the amount of fluid in the body.

These medicines may be affected by Teicoplanin Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How Teicoplanin Sandoz is given

How much to be given

On the first day of treatment, most adult patients generally receive two doses of this medicine 12 hours apart. During the following days, most patients receive one dose each day. Each dose is usually 400mg to 800mg or 6mg to12mg per kilogram of body weight, depending on the type of infection. Your doctor may have prescribed a different dose.

If you have kidney problems, the dose may be reduced or you may receive doses less often than other patients.

How it is given

Teicoplanin Sandoz should be prepared and given by a qualified person such as a doctor or a nurse. The vial of powder should be mixed carefully with the sterile water which is included in the pack, to form a clear solution.

The solution may be injected into a vein directly over about 5 minutes or it may be mixed with other sterile solutions and delivered into a vein from a ‘drip’ bottle or bag over about 30 minutes.

This medicine may also be injected directly into a muscle.

How long you will be given Teicoplanin Sandoz

If you have an infection in your blood, you will probably need to be given this medicine for 2 to 4 weeks.

If you have an infection in any bones or joints, you may be given this medicine for 3 to 6 weeks.

If you are given too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Teicoplanin Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are given Teicoplanin Sandoz

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are receiving Teicoplanin Sandoz.

Tell any other doctors, dentists, and pharmacists who treat you that you are receiving this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are receiving this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are given Teicoplanin Sandoz.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

fever
rashes or itching
nausea or vomiting
stiffness
diarrhoea.

These are the more common side effects of the medicine.

Tell your doctor as soon as possible if you notice any of the following:

redness and pain at the injection site
dizziness
headache
hearing loss
‘ringing’ in the ears
balance problems.

The above list includes serious side effects that may require medical attention.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

Some side effects such as temporary kidney or liver problems can only be found when your doctor does tests from time to time to check your progress.

After are given Teicoplanin Sandoz

Storage

It is unlikely that you will be asked to store this medication.

Teicoplanin Sandoz should be kept in its original container and in a cool dry place where the temperature stays below 25°C.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If you are no longer receiving this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Teicoplanin Sandoz 400mg injection – white to light yellow powder (vial); clear and colourless diluent (ampoule).

Available in packs containing one vial of powder for injection and one ampoule of diluent.

Ingredients

Active ingredient:

Teicoplanin Sandoz 400mg powder for injections – 400mg teicoplanin

Inactive ingredients:

sodium chloride.

Diluent:

sterile water for injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

Novartis New Zealand Ltd
PO Box 99102
Newmarket, Auckland 0754
New Zealand
Tel: 0800 354 335

This leaflet was revised in August 2018

Australian Register Number(s)
400mg injection AUST R 157812 (1 vial and 1 ampoule)

Published by MIMS October 2018

BRAND INFORMATION

Brand name

Teicoplanin Sandoz

Active ingredient

Teicoplanin

Schedule

1 Name of Medicine

Teicoplanin.

2 Qualitative and Quantitative Composition

Teicoplanin Sandoz 400 mg injection containing a white to pale yellow, sterile lyophilised powder, equivalent to 400 mg teicoplanin. It is freely soluble in water and on reconstitution gives a clear solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Teicoplanin Sandoz 400 mg injection is presented as a sterile, lyophilised white to light yellow powder for reconstitution with water for injections.

4 Clinical Particulars

4.1 Therapeutic Indications

Teicoplanin Sandoz is indicated for the treatment of the following serious infections due to Staphylococci or Streptococci, which cannot be treated satisfactorily with less toxic agents, including beta-lactam antibiotics: bone (osteomyelitis); joints (septic arthritis); blood (non-cardiac bacteraemia, septicaemia).

4.2 Dose and Method of Administration

Note.

Special instructions apply for reconstitution. See below.
The reconstituted Teicoplanin Sandoz injection should be administered intravenously or intramuscularly. Intravenous dosing may be by slow injection over 5 minutes or by infusion over 30 minutes.

Dosage.

Maintenance dosage is once daily; however, initially a loading dose regimen of three doses at 12 hourly intervals is recommended for rapid attainment of steady-state plasma levels.
The dose is to be adjusted on bodyweight whatever the weight of the patient.
An intramuscular injection of Teicoplanin Sandoz should not exceed 3 mL (400 mg) at a single site.
Teicoplanin Sandoz should not be administered by intraventricular route, due to risk of seizure.
Adults.

Septicaemia/ bacteraemia, acute or chronic osteomyelitis.

Treatment should be started with 6 to 12 mg/kg by the intravenous route every 12 hours for 3 doses, then the daily maintenance dose should be 6 mg/kg.

Septic arthritis.

Patients with septic arthritis should receive 12 mg/kg intravenously every 12 hours for 3 doses then a daily maintenance dose of 12 mg/kg.

Duration of treatment.

While the total duration of therapy is determined by the type and severity of infection and by the clinical response of the patient, the following periods are often appropriate. Uncomplicated bacteraemia: two to four weeks; septic arthritis or osteomyelitis: three to six weeks.

Method of administration.

Preparation of Teicoplanin Sandoz injection.

The powder should be reconstituted strictly in accordance with the instructions that follow. Errors in reconstitution may result in the formation of a stable foam and delivery of smaller doses.
Withdraw 3.0 mL from the accompanying water for injections ampoule and add it slowly down the side wall of the vial of Teicoplanin Sandoz. The vial should be rolled gently between the palms until the powder is completely dissolved, taking care to avoid foam formation. Do not shake. If the solution does become foamy, allow to stand for 15 minutes for the foam to subside. Withdraw the entire contents from the vial slowly into a syringe, trying to recover most of the solution by placing the needle in the central part of the stopper. The reconstituted solution contains teicoplanin 400 mg/3 mL.

Dilution of reconstituted solution.

The reconstituted solution may be injected directly, or alternatively diluted with any of the following diluents.
Sodium chloride solution 0.9% and Hartmann's solution: if necessary, diluted solutions may be stored between 2°C and 8°C for up to 24 hours. Solutions left for longer than 24 hours should be discarded.
Glucose 5% solution, sodium chloride 0.18% and glucose 4% solution: solutions containing these diluents can be stored between 2°C and 8°C and should be used within 24 hours; solutions kept longer than 24 hours should be discarded.
Ringer's solution: the diluted solution can be stored between 2°C and 8°C for up to 24 hours only.

Dosage adjustment.

Renal impairment. Reduction of dosage in patients with impaired renal function is not required until the fourth day of teicoplanin treatment. Trough plasma teicoplanin concentrations should be monitored periodically after the first week of therapy and the dosage adjusted to prevent trough concentrations exceeding 30 microgram/mL in patients with septic arthritis or 15 microgram/mL in other cases.
From the fourth day of treatment, dose adjustments should be made as follows.

Mild renal insufficiency.

If the creatinine clearance is between 40 and 60 mL/minute, the dose should be halved, either by administering the initial unit dose every two days, or by administering half of this dose once a day.

Severe renal insufficiency.

If the creatinine clearance is less than 40 mL/minute and in haemodialysed patients, the dose should be one-third of the normal dose. This is achieved either by administering the initial unit dose every third day, or by administering one-third of this dose once a day. Teicoplanin is not removed by dialysis.
Elderly. As for adults. If renal function is impaired, the instructions for impaired renal function should be followed.
While the total duration of therapy is determined by the type and severity of infection and by the clinical response of the patient, the following periods are often appropriate: uncomplicated bacteraemia 2-4 weeks; septic arthritis or osteomyelitis 3-6 weeks.

4.3 Contraindications

Teicoplanin Sandoz is contraindicated in patients with known hypersensitivity to teicoplanin or any excipients associated with this product.

4.4 Special Warnings and Precautions for Use

Hypersensitivity reactions and anaphylaxis.

Serious, life-threatening hypersensitivity reactions, sometimes fatal, have been reported with teicoplanin (e.g. anaphylactic shock). If an allergic reaction to teicoplanin occurs, treatment should be discontinued immediately and appropriate emergency measures should be initiated.

Hypersensitivity to vancomycin.

Teicoplanin should be administered with caution in patients known to be hypersensitive to vancomycin since cross hypersensitivity reactions, including fatal anaphylactic shock, may occur. However, a history of the 'Red Man Syndrome', that can occur with vancomycin, is not a contraindication to teicoplanin.

Infusion related reactions.

"Red man syndrome" (a complex of symptoms including pruritus, urticaria, erythema, angioneurotic oedema, tachycardia, hypotension, dyspnoea), has been rarely observed (even at the first dose). Stopping or slowing the infusion may result in cessation of these reactions. Infusion related reactions can be limited if the daily dose is not given via bolus injection but infused over a 30 minute period.

Severe cutaneous adverse reactions (SCARS).

Life-threatening and fatal cutaneous reactions including Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of teicoplanin. Acute generalised exanthematous pustulosis (AGEP) has also been reported. Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. If symptoms or signs of SJS or TEN, DRESS or AGEP (e.g. progressive skin rash often with blisters or mucosal lesion or pustular rash, or any other sign of skin hypersensitivity) are present, teicoplanin treatment should be discontinued immediately.

Nephrotoxicity.

Nephrotoxicity and renal failure have been reported in patients treated with teicoplanin (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients with renal insufficiency, or with risk factors for development of nephrotoxicity, patients receiving the high loading dose regimen of teicoplanin, and/or patients receiving teicoplanin in conjunction with or sequentially with other medicinal products with known nephrotoxic potential (e.g. aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and ethacrynic acid) should be carefully monitored.

Thrombocytopenia.

Thrombocytopenia has been reported with teicoplanin. Periodic haematological examinations are recommended during treatment, including complete cell blood count.

Ototoxicity.

Hearing impairment has been reported with use of teicoplanin (see Section 4.8 Adverse Effects (Undesirable Effects)). Periodic auditory function tests are advised especially in cases of prolonged treatment, patients with renal insufficiency and/or patients receiving teicoplanin in conjunction with or sequentially with other medicinal products with known nephrotoxic and/or neurotoxic/ototoxic potential (e.g. aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and ethacrynic acid). These patients should be carefully monitored and the benefit of teicoplanin evaluated if hearing deteriorates.

Hepatic toxicity.

Hepatic toxicities have been reported with use of teicoplanin (see Section 4.8 Adverse Effects (Undesirable Effects)). Periodic liver function tests are recommended for prolonged treatment.

Haematologic toxicity.

Haematologic toxicities have been reported with the use of teicoplanin (see Section 4.8 Adverse Effects (Undesirable Effects)). Periodic haematological studies are advised during prolonged treatment.

Loading dose regimen.

Safety data show increased rates of nephrotoxicity when high teicoplanin loading doses such as 12 mg/kg body weight twice a day are administered (see Section 4.8 Adverse Effects (Undesirable Effects)). For patients given high loading dose regimens, blood creatinine values should be closely monitored for nephrotoxicity in addition to haematological examinations.

Intraventricular use.

Teicoplanin should not be administered by intraventricular route, due to the risk of seizure.

Superinfection.

The use of teicoplanin may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If new infections due to bacteria or fungi appear during treatment, appropriate measures should be taken.

Spectrum of antibacterial activity.

Teicoplanin has a limited spectrum of antibacterial activity (Gram positive). It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.
The rational use of teicoplanin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient. On this basis it is expected that in most instances teicoplanin will be used to treat severe infections in patients for whom standard antibacterial activity is considered to be unsuitable.

Intrathecal use.

The safety and efficacy of teicoplanin by the intrathecal route has not been studied.

Use in hepatic impairment.

No data available.

Use in renal impairment.

See Section 4.2 Dose and Method of Administration, Renal impairment; Section 4.4 Special Warnings and Precautions for Use, Loading dose regimen, Ototoxicity, Nephrotoxicity.

Use in the elderly.

See Section 4.2 Dose and Method of Administration, Elderly.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Due to the potential for increased adverse effects, teicoplanin should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs, such as aminoglycosides, colistin, amphotericin B (amphotericin), ciclosporin, cisplatin, furosemide (frusemide) and ethacrynic acid.
Teicoplanin and aminoglycosides solutions are incompatible when mixed directly and therefore should not be mixed before injection.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Animal reproduction studies have not shown evidence of impairment of fertility.
(Category B3)
Reproductive studies in rats and rabbits with subcutaneous doses up to 200 mg/kg/day and 15 mg/kg/day, respectively, did not reveal teratogenic effects. Teicoplanin was associated with an increase in the number of stillborn pups when rats were treated with subcutaneous doses ≥ 100 mg/kg/day. Pup weight was reduced at all doses tested (subcutaneous doses ≥ 10 mg/kg/day).
Teicoplanin should not be used during confirmed or presumed pregnancy unless the potential benefits outweigh possible risks.
It is not known if teicoplanin is excreted in breast milk during lactation. Teicoplanin should not be used during lactation unless the potential benefits outweigh possible risks.

4.7 Effects on Ability to Drive and Use Machines

Teicoplanin has minor influence on the ability to drive and use machines.
Teicoplanin can cause dizziness and headache. The ability to drive or use machines may be affected. Patients experiencing these undesirable effects should not drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

In an open clinical trial involving patients with bone or joint infections, teicoplanin was associated with adverse reactions in 32% of the patients. However, treatment was discontinued because of adverse reactions in 17% of patients only. A clear cause-effect relationship was not established in these patients. The most frequent adverse reactions were fever, rashes, nausea, vomiting, rigors, pruritus and diarrhoea.
The following adverse effects have been reported.

Local reactions.

Pain, pyrexia, phlebitis, redness, abscess, thrombophlebitis.

Hypersensitivity.

Skin rash, erythema, pruritus, rigor, fever, bronchospasm, anaphylaxis, urticaria, angioedema, DRESS syndrome (drug reaction with eosinophilia and systemic symptoms), toxic epidermal necrolysis, erythema multiforme including Stevens-Johnson syndrome and rare reports of exfoliative dermatitis. Acute generalised exanthematous pustulosis (see Section 4.4 Special Warnings and Precautions for Use, Severe cutaneous adverse reactions (SCARS)). Anaphylactic shock has also been reported.

Hepatic.

Increased transaminases and/or alkaline phosphatase.

Haematological.

Eosinophilia, thrombocytopenia, leucopenia, neutropenia, rare cases of reversible agranulocytosis, and pancytopenia.

Renal and urinary disorders.

Rise in serum creatinine, blood urea, acute renal failure. Based on literature reports, the estimated rate of nephrotoxicity in patients receiving low loading dose regimen of average 6 mg/kg twice a day, followed by a maintenance dose of average 6 mg/kg once daily, is around 2%. In an observational post-authorisation safety study which enrolled 300 patients with a mean age of 63 years (treated for bone and joint infection, endocarditis or other severe infections) who received the high loading dose regimen of 12 mg/kg twice a day (receiving 5 loading doses as a median) followed by a maintenance dose of 12 mg/kg once daily, the observed rate of confirmed nephrotoxicity was 11.0% (95% CI = [7.4%; 15.5%]) over the first 10 days. The cumulative rate of nephrotoxicity from the start of treatment up to 60 days after the last dose was 20.6% (95% CI = [16.0%; 25.8%]). In patients receiving more than 5 high loading doses of 12 mg/kg twice a day, followed by a maintenance dose of 12 mg/kg once daily, the observed cumulative rate of nephrotoxicity from the start of treatment up to 60 days after the last administration was 27% (95% CI = [20.7%; 35.3%]).

Gastrointestinal.

Nausea or vomiting, diarrhoea.

Nervous system.

Dizziness, headache, seizures with intraventricular use.

Auditory.

Hearing loss, tinnitus, vertigo, other vestibular disorders.

Infections and infestations.

Superinfection (overgrowth of non-susceptible organisms).

Infusion related events.

Infusion related events, such as erythema or flushing of the upper body or red man syndrome (a complex of symptoms including pruritus, urticaria, erythema, angioneurotic oedema, tachycardia, hypotension, dyspnoea), have been rarely reported. These events occurred without a history of previous teicoplanin exposure and did not recur on re-exposure when the infusion rate was slowed and/or the concentration was decreased. These events were not specific to any concentration or rate of infusion.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

In an observational post-authorisation safety study, patients receiving more than 5 high loading doses of 12 mg/kg twice a day, followed by a maintenance dose of 12 mg/kg once daily, had an observed cumulative rate of nephrotoxicity from the start of treatment up to 60 days after the last administration of 27% (95% CI = [20.7%; 35.3%]).
Cases of excessive doses administered in error to paediatric patients have been reported. In one report, agitation occurred in a 29 day-old newborn given 400 mg I.V. (95 mg/kg). In the other cases, there were no symptoms or laboratory abnormalities associated with teicoplanin.

Treatment.

In case of overdose, treatment should be supportive and symptomatic. Teicoplanin is not removed by haemodialysis or peritoneal dialysis.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Teicoplanin is a factorial mixture of glycopeptides, comprised of at least 80% of the teicoplanin A₂ group, not more than 20% of the teicoplanin A₃ group, and not more than 5% of other components.
Teicoplanin is a glycopeptide antibiotic produced by Actinoplanes teichomyceticus.

Mechanism of action.

Microbiology.

Teicoplanin is bactericidal or bacteriostatic on growing populations of susceptible Gram positive organisms, depending on the sensitivity of the organism and antibiotic concentration.
Teicoplanin inhibits the growth of susceptible organisms by interfering with cell wall biosynthesis at a different site from that affected by beta-lactams. Teicoplanin is therefore effective against Staphylococci (including those resistant to methicillin and other beta-lactam antibiotics) and Streptococci.
Some cross resistance is observed between teicoplanin and the glycopeptide vancomycin. Teicoplanin has shown no cross resistance to beta-lactam antibiotics, macrolides, aminoglycosides, tetracycline, rifampicin or chloramphenicol.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following intramuscular injection bioavailability is 100%; average peak plasma levels of 7.1 microgram/mL are achieved in 3 to 4 hours following a dose of 3 mg/kg.

Distribution.

In humans, the plasma level profile after intravenous administration indicates a biphasic distribution (with a rapid distribution phase having a half-life of about 0.3 hours, followed by a more prolonged distribution phase having a half-life of 3 hours). At the end of the distribution phase, plasma levels and the subsequent time concentration curves, are identical following intramuscular or intravenous administration of a 3 mg/kg dose.
The apparent volume of distribution at steady state is similar to total body water, i.e. 0.6 L/kg.
Approximately 90 to 95% of teicoplanin is bound to plasma proteins. Teicoplanin penetrates into blister exudates and bone where it achieves peak concentrations comparable to those in serum after intramuscular injection. Peak levels in joint fluid are approximately 60% of peak serum concentrations. Teicoplanin penetrates very poorly into cerebrospinal fluid (CSF) and red blood cells.

Metabolism.

Metabolic transformation is minor (about 3%).

Excretion.

The elimination half-life is 70 to 100 hours. About 80% of administered drug is excreted in the urine over a 16 day collection period.

5.3 Preclinical Safety Data

Genotoxicity.

Teicoplanin was negative in assays evaluating the potential to cause gene mutations, but assays to evaluate the potential to cause chromosome damage have not been performed.

Carcinogenicity.

Long-term studies in animals to evaluate the carcinogenic potential of teicoplanin have not been performed.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each vial of Teicoplanin Sandoz powder for injection also contains 24 mg sodium chloride.

6.2 Incompatibilities

Solutions of Teicoplanin Sandoz and aminoglycosides are incompatible when mixed directly and therefore should not be mixed before injection.

6.3 Shelf Life

To reduce microbiological hazard, use as soon as practicable after reconstitution/dilution. If storage is necessary, hold at 2°C - 8°C for not more than 24 hours.
As a matter of good pharmaceutical practice, solutions for intravenous infusion should be used immediately after admixing.

6.4 Special Precautions for Storage

When storing the reconstituted solution, do not store it in a syringe.
Store below 25°C.

6.5 Nature and Contents of Container

25 mL clear glass vial with rubber stopper and flip-off aluminium crimp. Each pack also contains an accompanying diluent containing 3.2 mL sterile water for injections in a glass ampoule. Available in a single pack containing one vial of teicoplanin powder for injection and one ampoule of water for injections diluent.

6.6 Special Precautions for Disposal

Teicoplanin Sandoz injection is for single use in one patient only. Discard any residue.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

The chemical structure of teicoplanin is:

CAS number.

61036-62-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

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