1. NAME OF THE MEDICINAL PRODUCT

Teicoplanin for Injection 200mg Taj Pharma
Teicoplanin for Injection 400mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION 

    a) Each vial contains:
    Teicoplanin………………………….200mg equivalent to not less than 200,000 IUb) Each vial contains:
    Teicoplanin………………………….400mg equivalent to not less than 400,000 IU

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Powder for solution for injection/infusion or oral solution

Powder for solution for injection/infusion or oral solution: spongy ivory coloured homogeneous mass

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Teicoplanin for Injection 200mg / 400mg Taj Pharma is indicated in adults and in children from birth for the parenteral treatment of the following infections (see sections 4.2, 4.4 and 5.1):

  • complicated skin and soft tissue infections,
  • bone and joint infections,
  • hospital acquired pneumonia,
  • community acquired pneumonia,
  • complicated urinary tract infections,
  • infective endocarditis,
  • peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD),
  • bacteraemia that occurs in association with any of the indications listed above.

Teicoplanin for Injection 200mg / 400mg Taj Pharma is also indicated as an alternative oral treatment for Clostridium difficile infection-associated diarrhoea and colitis.

Where appropriate, teicoplanin should be administered in combination with other antibacterial agents.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function.

Measurement of serum concentrations

Teicoplanin trough serum concentrations should be monitored at steady state after completion of the loading dose regimen in order to ensure that a minimum trough serum concentration has been reached:

  • For most Gram-positive infections, teicoplanin trough levels of at least 10 mg/L when measured by High Performance Liquid Chromatography (HPLC), or at least 15 mg/L when measured by Fluorescence Polarization Immunoassay (FPIA) method.
  • For endocarditis and other severe infections, teicoplanin trough levels of 15-30 mg/L when measured by HPLC, or 30-40 mg/L when measured by FPIA method.

During maintenance treatment, teicoplanin trough serum concentrations monitoring may be performed at least once a week to ensure that these concentrations are stable.

Adults and elderly patients with normal renal function

IndicationsLoading doseMaintenance dose
Loading dose regimenTargeted trough concentrations at day 3 to 5Maintenance doseTargeted trough concentrations during maintenance
– Complicated skin and soft tissue infections

– Pneumonia

– Complicated urinary tract infections

6 mg/kg body weight every 12 hours for 3 intravenous or intramuscular administrations>15 mg/L16 mg/kg body weight intravenous or intramuscular once a day>15 mg/L1 once a week
– Bone and joint infections12 mg/kg body weight every 12 hours for 3 to 5 intravenous administrations>20 mg/L112 mg/kg body weight intravenous or intramuscular once a day>20 mg/L1
– Infective endocarditis12 mg/kg body weight every 12 hours for 3 to 5 intravenous administrations30-40 mg/L112 mg/kg body weight intravenous or intramuscular once a day>30 mg/L1

Measured by FPIA

The dose is to be adjusted on bodyweight whatever the weight of the patient.

Duration of treatment

The duration of treatment should be decided based on the clinical response. For infective endocarditis a minimum of 21 days is usually considered appropriate. Treatment should not exceed 4 months.

Combination therapy

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.

Clostridium difficile infection-associated diarrhoea and colitis

The recommended dose is 100-200 mg administered orally twice a day for 7 to 14 days.

Elderly population

No dose adjustment is required, unless there is renal impairment (see below).

Adults and elderly patients with impaired renal function

Dose adjustment is not required until the fourth day of treatment, at which time dosing should be adjusted to maintain a serum trough concentration of at least 10 mg/L when measured by HPLC, or at least 15 mg/L when measured by FPIA method.

After the fourth day of treatment:

  • In mild and moderate renal insufficiency (creatinine clearance 30-80 mL/min): maintenance dose should be halved, either by administering the dose every two days or by administering half of this dose once a day.
  • In severe renal insufficiency (creatinine clearance less than 30 mL/min) and in haemodialysed patients: dose should be one-third the usual dose, 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 haemodialysis.

Patients in continuous ambulatory peritoneal dialysis (CAPD)

After a single intravenous loading dose of 6 mg/kg bodyweight, 20 mg/L is administered in the bag of the dialysis solution in the first week, 20 mg/L in different bags the second week and then 20 mg/L in the overnight bag in the third week.

Paediatric population

The dose recommendations are the same in adults and children above 12 years of age.

Neonates and infants up to the age of 2 months:

Loading dose

One single dose of 16 mg/kg body weight, administered intravenously by infusion on the first day.

Maintenance dose

One single dose of 8 mg/kg body weight administered intravenously by infusion once a day.

Children (2 months to 12 years):

Loading dose

One single dose of 10 mg/kg body weight administered intravenously every 12 hours, repeated 3 times.

Maintenance dose

One single dose of 6-10 mg/kg body weight administered intravenously once a day.

Method of administration

Teicoplanin should be administered by the intravenous or intramuscular route. The intravenous injection may be administered either as a bolus over 3 to 5 minutes or as a 30-minute infusion.

Only the infusion method should be used in neonates.

For Clostridium difficile infection-associated diarrhoea and colitis, the oral route is to be used.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to teicoplanin or to any of the excipients listed in section 6.

4.4 Special warnings and precautions for use

Hypersensitivity reactions

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.

Teicoplanin must be administered with caution in patients with known hypersensitivity to vancomycin, as crossed hypersensitivity reactions, including fatal anaphylactic shock, may occur.

However, a prior history of “red man syndrome” with vancomycin is not a contraindication to the use of teicoplanin.

Infusion related reactions

In rare cases (even at the first dose), red man syndrome (a complex of symptoms including pruritus, urticaria, erythema, angioneurotic oedema, tachycardia, hypotension, dyspnoea) has been observed.

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 bullous reactions

Life-threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with the use of teicoplanin. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present teicoplanin treatment should be discontinued immediately.

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.

Loading dose regimen

Since data on safety are limited, patients should be carefully monitored for adverse reactions when teicoplanin doses of 12mg/kg body weight twice a day are administered. Under this regimen blood creatinine values should be monitored in addition to the recommended periodic haematological examination.

Teicoplanin should not be administered by intraventricular use.

Thrombocytopenia

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

Nephrotoxicity

Renal failure has been reported in patients treated with teicoplanin (see section 4.8). Patients with renal insufficiency, and/or in those receiving teicoplanin in conjunction with or sequentially with other medicinal products with known nephrotoxic potential (aminoglycosides, colistin, amphotericin B, ciclosporin, and cisplatin) should be carefully monitored, and should include auditory tests.

Since teicoplanin is mainly excreted by the kidney, the dose of teicoplanin must be adapted in patients with renal impairment (see section 4.2).

Ototoxicity

As with other glycopeptides, ototoxicity (deafness and tinnitus) has been reported in patients treated with teicoplanin (see section 4.8). Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with teicoplanin should be carefully evaluated and monitored, especially in case of prolonged treatment and in patients with renal insufficiency. Patients receiving teicoplanin in conjunction with or sequentially with other medicinal products with known neurotoxic/ototoxic potential (aminoglycosides, ciclosporin, cisplatin, furosemide and ethacrynic acid) should be carefully monitored and the benefit of teicoplanin evaluated if hearing deteriorates.

Special precautions must be taken when administering teicoplanin in patients who require concomitant treatment with ototoxic and/or nephrotoxic medicinal products for which it is recommended that regular haematology, liver and kidney function tests are carried out.

Superinfection

As with other antibiotics, the use of teicoplanin, especially if prolonged, may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

4.5 Interaction with other medicinal products and other forms of interaction

No specific interaction studies have been performed.

Teicoplanin and aminoglycoside solutions are incompatible and must not be mixed for injection; however, they are compatible in dialysis fluid and may be freely used in the treatment of CAPD-related peritonitis. Teicoplanin should be used with care in conjunction with or sequentially with other medicinal products with known nephrotoxic or ototoxic potential. These include aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide, and ethacrynic acid (see section 4.4). However, there is no evidence of synergistic toxicity in combinations with teicoplanin.

In clinical studies, teicoplanin has been administered to many patients already receiving various medications including other antibiotics, antihypertensives, anaesthetic agents, cardiac medicinal products and antidiabetic agents without evidence of adverse interaction.

Paediatric population

Interaction studies have only been performed in adults.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are a limited amount of data from the use of teicoplanin in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3): in rats there was an increased incidence of stillbirths and neonatal mortality. The potential risk for humans is unknown.

Therefore, teicoplanin should not be used during pregnancy unless clearly necessary. A potential risk of inner ear and renal damage to the foetus cannot be excluded (see section 4.4).

Breast-feeding

It is unknown whether teicoplanin is excreted in human milk. There is no information on the excretion of teicoplanin in animal milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with teicoplanin should be made taking into account the benefit of breast-feeding to the child and the benefit of teicoplanin therapy to the mother.

Fertility

Animal reproduction studies have not shown evidence of impairment of fertility.

4.7 Effects on ability to drive and use machines

Teicoplanin for Injection 200mg / 400mg Taj Pharma 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 Undesirable effects

Tabulated list of adverse reactions

In the table below all the adverse reactions, which occurred at an incidence greater than placebo and more than one patient are listed using the following convention:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse reactions should be monitored when teicoplanin doses of 12 mg/kg body weight twice a day are administered (see section 4.4).

System organ classCommon

(≥1/100 to <1/10 )

Uncommon

(≥1/1,000 to <1/100)

Rare

(≥1/10,000 to <1/1,000)

Very rare

(<1/10,000)

Not known (cannot be estimated from available data)
Infections and infestationsAbscessSuperinfection (overgrowth of non-susceptible organisms)
Blood and the lymphatic system disordersLeucopenia, thrombocytopenia, eosinophiliaAgranulocytosis, neutropenia
Immune system disordersAnaphylactic reaction (anaphylaxis) (see section 4.4)Drug reaction with eosinophilia and systemic symptoms (DRESS), anaphylactic shock (see section 4.4)
Nervous system disordersDizziness, headacheSeizures
Ear and Labyrinth disordersDeafness, hearing loss (see section 4.4), tinnitus, vestibular disorder
Vascular disordersPhlebitisThrombophlebitis
Respiratory, thoracic and mediastinal disordersBronchospasm
Gastro-intestinal disordersDiarrhoea, vomiting, nausea
Skin and subcutaneous tissue disordersRash, erythema, pruritusRed man syndrome (e.g. Flushing of the upper part of the body) (see section 4.4).Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioedema, dermatitis exfoliative, urticaria (see section 4.4)
Renal and Urinary disordersBlood creatinine increasedRenal failure (including renal failure acute)
General disorders and administration site conditionsPain, pyrexiaInjection site abscess, chills (rigors)
InvestigationsTransaminases increased (transient abnormality of transaminases), blood alkaline phosphatase increased (transient abnormality of alkaline phosphatase), blood creatinine increased (transient rise of serum creatinine)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Symptoms

Cases of accidental administration of excessive doses to paediatric patients have been reported. In one case agitation occurred in a 29-day-old newborn who had been administered 400 mg intravenously (95 mg/kg).

Management

Treatment of teicoplanin overdose should be symptomatic.

Teicoplanin is not removed by haemodialysis and only slowly by peritoneal dialysis.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Glycopeptide Antibacterials

Mechanism of action

Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site different from that affected by beta-lactams. Peptidoglycan synthesis is blocked by specific binding to D-alanyl-D-alanine residues.

Mechanism of resistance

Resistance to teicoplanin can be based on the following mechanisms:

  • Modified target structure: this form of resistance has occurred particularly in Enterococcus faecium. The modification is based on exchange of the terminal D-alanine-D-alanine function of the amino-acid chain in a murein precursor with D-Ala-D-lactate, thus reducing the affinity to vancomycin. The responsible enzymes are a newly synthesised D-lactate dehydrogenase or ligase.
  • The reduced sensitivity or resistance of staphylococci to teicoplanin is based on the overproduction of murein precursors to which teicoplanin is bound.

Cross-resistance between teicoplanin and the glycoprotein vancomycin may occur. A number of vancomycin-resistant enterococci are sensitive to teicoplanin (Van-B phenotype).

Susceptibility testing breakpoints

The MICs breakpoints according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST), version 7.1, March 10, 2017 are displayed in the following table:

MicroorganismSusceptibleResistant
Staphylococcus aureus a, b≤2 mg/L>2 mg/L
Coagulase-negative staphylococci a, b≤4 mg/L>4 mg/L
Enterococcus spp.≤2 mg/L>2 mg/L
Streptococcus groupsA, B, C, G b≤2 mg/L>2 mg/L
Streptococcus pneumoniae b≤2 mg/L>2 mg/L
Viridans group streptococci b≤2 mg/L>2 mg/L
Gram-positive anaerobes except Clostridium difficile

PK/PD (Non-species related) breakpoints c

IE

IE

IE

IE

Glycopeptide MICs are method dependent and should be determined by broth microdilution (reference ISO 20776). S. aureus with vancomycin MIC values of 2 mg/L are on the border of the wild type MIC distribution and there may be an impaired clinical response. The resistance breakpoint for S. aureus has been reduced to 2 mg/L to avoid reporting of GISA isolates intermediate as serious infections with GISA isolates are not treatable with increased doses of vancomycin or teicoplanin.

Non-susceptible isolates are rare or not yet reported. The identification and antimicrobial susceptibility test result on any such isolate must be confirmed and the isolate sent to a reference laboratory.

“IE” indicates that there is insufficient evidence that the organism or group is a good target for therapy with the agent. A MIC with a comment but without an accompanying S, I or R categorisation may be reported.

Pharmacokinetic/Pharmacodynamic relationship

Teicoplanin antimicrobial activity depends essentially on the duration of time during which the substance level is higher than the minimum inhibitory concentration (MIC) of the pathogen.

Susceptibility

The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some of types of infections is questionable.

Commonly susceptible species

Aerobic Gram-positive bacteria

Corynebacterium jeikeium a

Enterococcus faecalis

Staphylococcus aureus (including methicillin-resistant strains)

Streptococcus agalactiae

Streptococcus dysgalactiae subsp. equisimilis a

(Group C & G streptococci)

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococci in the viridans group a b

Anaerobic Gram-positive bacteria

Clostridium difficile a

Peptostreptococcus spp.a

Species for which acquired resistance may be a problem

Aerobic Gram-positive bacteria

Enterococcus faecium

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Inherently resistant bacteria

All Gram-negative bacteria

Other bacteria

Chlamydia spp.

Chlamydophila spp.

Legionella pneumophila

Mycoplasma spp.

No current data were available when the tables were published. The primary literature, standard volumes and treatment recommendations assume sensitivity

Collective term for a heterogeneous group of streptococcus species. Resistance rate can vary depending on the actual streptococcus species

5.2 Pharmacokinetic properties

Absorption

Teicoplanin is administered by parenteral route (intravenously or intramuscularly). After intramuscular administration, the bioavailability of teicoplanin (as compared to intravenous administration) is almost complete (90%). After six daily intramuscular administrations of 200 mg the mean (SD) maximum teicoplanin concentration (Cmax) amounts to 12.1 (0.9) mg/L and occurs at 2 hours after administration.

After a loading dose of 6 mg/kg administered intravenously every 12 hours for 3 to 5 administrations, Cmax values range from 60 to 70 mg/L and Ctrough are usually above 10 mg/L. After an intravenous loading dose of 12 mg/kg administered every 12 hours for 3 administrations, mean values of Cmax and Ctrough are estimated to be around 100 mg/L and 20 mg/L, respectively.

After a maintenance dose of 6 mg/kg administered once daily Cmax and Ctrough values are approximately 70 mg/L and 15 mg/L, respectively. After a maintenance dose of 12 mg/kg once daily Ctrough values range from 18 to 30 mg/L.

When administered by oral route teicoplanin is not absorbed from the gastrointestinal tract. When administered by oral route at 250 or 500 mg single dose to healthy subjects, teicoplanin is not detected in serum or urine but only recovered in feces (about 45% of the administered dose) as unchanged medicinal product.

Distribution

The binding to human serum proteins ranges from 87.6 to 90.8% without any variation in function of the teicoplanin concentrations. Teicoplanin is mainly bound to human serum albumin. Teicoplanin is not distributed in red cells.

The volume of distribution at steady-state (Vss) varies from 0.7 to 1.4 L/kg. The highest values of Vss are observed in the recent studies where the sampling period was superior to 8 days.

Teicoplanin distributed mainly in lung, myocardium and bone tissues with tissue/serum ratios superior to 1. In blister fluids, synovial fluid and peritoneal fluid the tissue/serum ratios ranged from 0.5 to 1. Elimination of teicoplanin from peritoneal fluid occurs at the same rate as from serum. In pleural fluid and subcutaneous fat tissue the tissue/serum ratios are comprised between 0.2 and 0.5. Teicoplanin does not readily penetrate into the cerebrospinal fluid (CSF).

Biotransformation

Unchanged form of teicoplanin is the main compound identified in plasma and urine, indicating minimal metabolism. Two metabolites are formed probably by hydroxylation and represents 2 to 3% of the administered dose.

Elimination

Unchanged teicoplanin is mainly excreted by urinary route (80% within 16 days) while 2.7% of the administered dose is recovered in feces (via bile excretion) within 8 days following administration.

Elimination half-life of teicoplanin varies from 100 to 170 hours in the most recent studies where blood sampling duration is about 8 to 35 days.

Teicoplanin has a low total clearance in the range of 10 to 14 mL/h/kg and a renal clearance in the range of 8 to 12 mL/h/kg indicating that teicoplanin is mainly excreted by renal mechanisms.

Linearity

Teicoplanin exhibited linear pharmacokinetics at dose range of 2 to 25 mg/kg.

Special populations

  • Renal impairment:

As teicoplanin is eliminated by renal route, teicoplanin elimination decreases according to the degree of renal impairment. The total and renal clearances of teicoplanin depends on the creatinine clearance.

  • Elderly patients:

In the elderly population the teicoplanin pharmacokinetics is not modified unless in case of renal impairment.

  • Paediatric population

A higher total clearance (15.8 mL/h/kg for neonates, 14.8 mL/h/kg for a mean age 8 years) and a shorter elimination half-life (40 hours neonates; 58 hours for 8 years) are observed compared to adult patients.

5.3 Preclinical safety data

Following repeated parenteral administration to the rat and dog, effects on the kidney were observed and were shown to be dose-dependent and reversible. Studies to investigate the potential to cause ototoxicity in the guinea-pig indicate that a mild impairment of cochlear and vestibular function is possible, in the absence of morphological damage.

Subcutaneous administration of teicoplanin at up to 40 mg/kg/day did not affect male and female fertility in the rat. In embryofetal development studies, no malformations were observed following subcutaneous administration of up to 200 mg/kg/day in the rat and intramuscular administration up to 15 mg/kg/day in the rabbit. However, in the rat, there was an increased incidence of stillbirths at doses of 100 mg/kg/day and above and neonatal mortality at 200 mg/kg/day. This effect was not reported at 50 mg/kg/day. A peri and postnatal study in rats showed no effects on the fertility of the F1 generation or on the survival and development of the F2 generation following subcutaneous administration of up to 40 mg/kg/day.

Teicoplanin did not show any potential to cause antigenicity (in mice, guinea-pigs or rabbits), genotoxicity or local irritancy.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride, Sodium hydroxide (for pH adjustment)

6.2 Incompatibilities

Teicoplanin and aminoglycoside are incompatible when mixed directly and must not be mixed before injection.

If teicoplanin is administered in combination therapy with other antibiotics, the preparation must be administered separately.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

Shelf life of powder as packaged for sale:

3 years

Shelf life of reconstituted solution:

Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Shelf life of diluted medicinal product:

Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

Powder as packaged for sale:

This medicinal product does not require any special storage condition.

For storage conditions of the reconstituted/diluted medicinal product, see section 6.3.

6.5 Nature and contents of container

Primary packaging:

The freeze-dried medicinal product is packaged in:

Type I, colourless glass vial of useful volume of 10 mL for 200 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium yellow overseal.

Pack sizes:

– 1 powder vial

– 5×1 powder vials

– 10×1 powder vials

– 25×1 powder vials

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

This medicinal product is for single use only.

Preparation of reconstituted solution:

The solution is reconstituted by adding 3.14 mL of water for injection to the 200 mg and 400 mg powder vial. The water is slowly added to the vial which should be rotated until all the powder is dissolved to avoid foaming. If foam is developed, allow the solution to stand for approximately 15 minutes so that the foam disappears. Only clear and yellowish solutions should be used.

Nominal teicoplanin content of vial200 mg400 mg
Volume of powder vial10 mL22 mL
Volume containing nominal teicoplanin dose (extracted by 5 mL syringe and 23 G needle)3.0 mL3.0 mL

The reconstituted solution may be injected directly or alternatively further diluted, or orally administered.

Preparation of the diluted solution before infusion:

Teicoplanin for Injection 200mg / 400mg Taj Pharma can be administered in the following infusion solutions:

– sodium chloride 9 mg/mL (0.9%) solution

– Ringer solution

– Ringer-lactate solution

– 5% dextrose injection

– 10% dextrose injection

– 0.18% sodium chloride and 4% glucose solution

– 0.45% sodium chloride and 5% glucose solution

– Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

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

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

PACKAGE LEAFLET: INFORMATION FOR THE USER

TEICOPLANIN FOR INJECTION
200MG / 400MG
TAJ PHARMA

Teicoplanin

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side affects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

  1. What Teicoplanin for Injection 200mg / 400mg Taj Pharma is and what it is used for
  2. What you need to know before you are given Teicoplanin for Injection 200mg / 400mg Taj Pharma
  3. How to use Teicoplanin for Injection 200mg / 400mg Taj Pharma
  4. Possible side effects
  5. How to store Teicoplanin for Injection 200mg / 400mg Taj Pharma
  6. Contents of the pack and other information1. WHAT TEICOPLANIN FOR INJECTION 200MG / 400MG TAJ PHARMA IS AND WHAT IT IS USED FOR

Teicoplanin for Injection 200mg / 400mg Taj Pharma is an antibiotic. It contains a medicine called ‘teicoplanin’. It works by killing the bacteria that cause infections in your body.

Teicoplanin for Injection 200mg / 400mg Taj Pharma is used in adults and children (including newborn babies) to treat bacterial infections of:

  • the skin and underneath the skin – sometimes called ‘soft tissue’
  • the bones and joints
  • the lung
  • the urinary tract
  • the heart – sometimes called ‘endocarditis’
  • the abdominal wall – peritonitis
  • the blood, when caused by any of the conditions listed above

Teicoplanin for Injection 200mg / 400mg Taj Pharma can be used to treat some infections caused by ‘Clostridium difficile’ bacteria in the gut. For this, the solution is taken by mouth.

  1. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TEICOPLANIN FOR INJECTION 200MG / 400MG TAJ PHARMA

Do not use Teicoplanin for Injection 200mg / 400mg Taj Pharma 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 you are given Teicoplanin for Injection 200mg / 400mg Taj Pharma if:

  • you are allergic to an antibiotic called ‘vancomycin’
  • you have had a flushing of your upper part of your body (red man syndrome)
  • you have a decrease in platelet count (thrombocytopenia)
  • you have kidney problems
  • you are taking other medicines which may cause hearing problems and/or kidney problems. You may have regular tests to check if your kidneys and/or liver are working properly (see ‘Other medicines and Teicoplanin for Injection 200mg / 400mg Taj Pharma’).

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Teicoplanin for Injection 200mg / 400mg Taj Pharma.

Tests

During treatment you may have tests to check your blood, your kidneys and/or your hearing. This is more likely if:

  • your treatment will last for a long time
  • you have a kidney problem
  • you are taking or may take other medicines that may affect your nervous system, kidneys or hearing.

In people who are given Teicoplanin for Injection 200mg / 400mg Taj Pharma for a long time, bacteria that are not affected by the antibiotic may grow more than normal – your doctor will check for this.

Other medicines and Teicoplanin for Injection 200mg / 400mg Taj Pharma

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This is because Teicoplanin for Injection 200mg / 400mg Taj Pharma can affect the way some other medicines work. Also, some medicines can affect the way Teicoplanin for Injection 200mg / 400mg Taj Pharma works. In particular, tell your doctor, pharmacist or nurse if you are taking the following medicines:

  • Aminoglycosides as they must not be mixed together with Teicoplanin for Injection 200mg / 400mg Taj Pharma in the same injection. They may also cause hearing problems and/or kidney problems.
  • amphotericin B – a medicine that treats fungal infections which may cause hearing problems and/or kidney problems
  • ciclosporin – a medicine that affects the immune system which may cause hearing problems and/or kidney problems
  • cisplatin – a medicine that treats malignant tumors which may cause hearing problems and/or kidney problems
  • water tablets (such as furosemide) – also called ‘diuretics’ which may cause hearing problems and/or kidney problems.

If any of the above apply to you, (or you are not sure), talk to your doctor, pharmacist or nurse before being given Teicoplanin for Injection 200mg / 400mg Taj Pharma.

Pregnancy, breast-feeding and fertility

If you are pregnant, think that you might be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before being given this medicine. They will decide whether or not you are given this medicine while you are pregnant. There may be a potential risk of inner ear and kidney problems.

Tell your doctor if you are breast-feeding, before being given this medicine. He/she will decide whether or not you can keep breast-feeding, while you are given Teicoplanin for Injection 200mg / 400mg Taj Pharma.

Studies in animal reproduction have not shown evidence of fertility problems.

Driving and using machines

You may have headaches or feel dizzy while being treated with Teicoplanin for Injection 200mg / 400mg Taj Pharma. If this happens, do not drive or use any tools or machines.

Teicoplanin for Injection 200mg / 400mg Taj Pharma contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial and is essentially ‘sodium-free’.

  1. HOW TO USE TEICOPLANIN FOR INJECTION 200MG / 400MG TAJ PHARMA

The recommended dose is

Adults and children (12 years and over) with no kidney problems

Skin and soft tissue, lung and urinary tract infections

  • Starting dose (for the first three doses): 6 mg for every kilogram of body weight, given every 12 hours, by injection into a vein or muscle
  • Maintenance dose: 6 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle

Bone and joint infections, and heart infections

  • Starting dose (for the first three to five doses): 12 mg for every kilogram of body weight, given every 12 hours, by injection into a vein
  • Maintenance dose: 12 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle

Infection caused by ‘Clostridium difficile’ bacteria

The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days.

Adults and elderly patients with kidney problems

If you have kidney problems, your dose will usually need to be lowered after the fourth day of treatment:

  • For people with mild and moderate kidney problems – the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day.
  • For people with severe kidney problems or on haemodialysis – the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day.

Peritonitis for patients on peritoneal dialysis

The starting dose is 6 mg for every kilogram of body weight, as a single injection into a vein, followed by:

  • Week one: 20 mg/L in each dialysis bag
  • Week two: 20 mg/L in every other dialysis bag
  • Week three: 20 mg/L in the overnight dialysis bag.

Babies (from birth to the age of 2 months)

  • Starting dose (on the first day): 16 mg for every kilogram of body weight, as an infusion through a drip into a vein.
  • Maintenance dose: 8 mg for every kilogram of body weight, given once a day, as an infusion through a drip into a vein.

Children (from 2 months to 12 years)

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

How Teicoplanin for Injection 200mg / 400mg Taj Pharma is given

The medicine will normally be given to you by a doctor or nurse.

  • It will be given by injection into a vein (intravenous use) or muscle (intramuscular use).
  • It can also be given as a infusion through a drip into a vein.

Only the infusion should be given in babies from birth to the age of 2 months.

To treat certain infections, the solution may be taken by mouth (oral use).

If you have more Teicoplanin for Injection 200mg / 400mg Taj Pharma than you should

It is unlikely that your doctor or nurse will give you too much medicine. However, if you think you have been given too much Teicoplanin for Injection 200mg / 400mg Taj Pharma or if you are agitated, talk to your doctor or nurse straight away.

If you forget to have Teicoplanin for Injection 200mg / 400mg Taj Pharma

Your doctor or nurse will have instructions about when to give you Teicoplanin for Injection 200mg / 400mg Taj Pharma. It is unlikely that they will not give you the medicine as prescribed. However, if you are worried, talk to your doctor or nurse.

If you stop having Teicoplanin for Injection 200mg / 400mg Taj Pharma

Do not stop having this medicine without first talking to your doctor, pharmacist or nurse.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

  1. POSSIBLE SIDE EFFECTS

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

Serious side effects

Stop your treatment and tell your doctor or nurse straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

  • sudden life-threatening allergic reaction – the signs may include: difficulty in breathing or wheezing, swelling, rash, itching, fever, chills

Rare (may affect up to 1 in 1000 people)

  • flushing of the upper body

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

  • blistering of the skin, mouth, eyes or genitals – these may be signs of something called ‘toxic epidermal necrolysis’ or ‘Stevens-Johnson syndrome’ or ‘drug reaction with eosinophilia and systemic symptoms (DRESS)’. DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

Tell your doctor or nurse straight away, if you notice any of the side effects above.

Tell your doctor or nurse straight away, if you notice 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 in breathing or wheezing (bronchospasm)
  • getting more infections than usual – these could be signs of a decrease in your blood cell count

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

  • lack of white blood cells – the signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
  • kidney problems or changes in the way your kidneys work – shown in tests
  • epileptic fits

Tell your doctor or nurse straight away, if you notice any of the side effects above.

Other side effects

Talk to your doctor, pharmacist or nurse if you get any of these:

Common (may affect up to 1 in 10 people)

  • Rash, erythema, pruritus
  • Pain
  • Fever

Uncommon (may affect up to 1 in 100 people)

  • decrease in platelet count.
  • raised blood levels of liver enzymes
  • raised in blood levels of creatinine (to monitor your kidney)
  • hearing loss, ringing in the ears or a feeling that you, or things around you are moving
  • feeling or being sick (vomiting), diarrhoea
  • feeling dizzy 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 where the injection was given – such as reddening of the skin, pain or swelling

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. HOW TO STORE TEICOPLANIN FOR INJECTION 200MG / 400MG TAJ PHARMA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label of the vial after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Information about storage and the time to use Teicoplanin for Injection 200mg / 400mg Taj Pharma, after it has been reconstituted and is ready to use, are described in the ‘Practical information for healthcare professionals on preparation and handling of Teicoplanin for Injection 200mg / 400mg Taj Pharma’.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Teicoplanin for Injection 200mg / 400mg Taj Pharma contains

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

What Teicoplanin for Injection 200mg / 400mg Taj Pharma looks like and contents of the pack

Teicoplanin for Injection 200mg / 400mg Taj Pharma is a powder for solution for injection/infusion or oral solution.

The powder is spongy, ivory and coloured homogeneous mass.

The powder is packaged:

  • in a Type I, colourless glass vial of useful volume of 10 mL for 200 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium yellow overseal.
  • in a Type I, colourless glass vial of useful volume of 22 mL for 400 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium green overseal.

Pack size:

  • 1 powder vial
  • 5×1 powder vials
  • 10×1 powder vials
  • 25×1 powder vials

Not all pack sizes may be marketed.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com