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Active ingredient:
Ceftriaxone sodium 269.9 mg (Present as 0.298g ceftriaxone Na*3.5H2O. Eq 0.269g of ceftriaxone Na anhyd or 0.25g ceftriaxone anhy)
Available from:
Douglas Pharmaceuticals Limited
INN (International Name):
Ceftriaxone sodium 269.9 mg (Present as 0.298g ceftriaxone Na*3.5H2O. Eq 0.269g of ceftriaxone Na anhyd or 0.25g ceftriaxone anh
250 mg
Pharmaceutical form:
Powder for injection
Active: Ceftriaxone sodium 269.9 mg (Present as 0.298g ceftriaxone Na*3.5H2O. Eq 0.269g of ceftriaxone Na anhyd or 0.25g ceftriaxone anhy)
Units in package:
Vial, glass, single dose, 1 dose unit
Prescription type:
Manufactured by:
Orchid Chemicals and Pharmaceuticals Limited
Product summary:
Package - Contents - Shelf Life: Vial, glass, single dose, - 1 dose units - 36 months from date of manufacture stored at or below 25°C 6 hours reconstituted stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
Authorization date:


Ceftriaxone sodium equivalent to ceftriaxone 500 mg, 1 g and 2 g powder for



Ceftriaxone-AFT is a white to pale yellow powder packed in vials which contain the

equivalent of 500 mg, 1 g or 2 g ceftriaxone.



Ceftriaxone is a long acting, broad-spectrum cephalosporin antibiotic for parenteral use. The

bactericidal activity of ceftriaxone results from inhibition of cell wall synthesis. Ceftriaxone









microorganisms. Ceftriaxone is highly stable to most beta-lactamases, both penicillinases

and cephalosporinases, of Gram-positive and Gram-negative bacteria.

Ceftriaxone is usually active against the following microorganisms in vitro and in clinical

infections (see Indications):

Gram-positive aerobes:

Staphylococcus aureus (methicillin-sensitive)

Staphylococci coagulase-negative

Streptococcus pyogenes (

-hemolytic, group A)

Streptococcus agalactiae (

-hemolytic, group B)


-hemolytic (non-group A or B)

Streptococcus viridans

Streptococcus pneumoniae















monocytogenes are resistant.

Gram-negative aerobes:

Acinetobacter lwoffi

Acinetobacter anitratus (mostly A. baumanii)*

Aeromonas hydrophila

Alcaligenes faecalis

Alcaligenes odorans

Alcaligenes-like bacteria

Borrelia burgdorferi

Capnocytophaga spp.

Citrobacter diversus (including C. amalonaticus)

Citrobacter freundii*

Escherichia coli

Enterobacter aerogenes*

Enterobacter cloacae*

Enterobacter spp. (other)

Haemophilus ducreyi

Haemophilus influenzae

Haemophilus parainfluenzae

Hafnia alvei

Klebsiella oxytoca

Klebsiella pneumoniae**

Moraxella catarrhalis (formerBranhamella catarrhalis)

Moraxella osloensis

Moraxella spp. (other)

Morganella morganii

Neisseria gonorrhoeae

Neisseria meningitidis

Pasteurella multocida

Plesiomonas shigelloides

Proteus penneri*

Proteus mirabilis

Proteus vulgaris

Pseudomonas fluorescens*

Psudomonas spp. (other)*

Providentia rettgeri

Providentia spp. (other)

Salmonella typhi

Salmonella spp. (non-typhoid)

Serratia marcescens

Serratia spp. (other)

Shigella spp.

Vibrio spp.

Yersinia enterocolitica

Yersinia spp. (other)

*Some isolates of these species are resistant to ceftriaxone, mainly due to the production of

the chromosomally encoded


**Some isolates of these species are resistant due to production of extended spectrum

plasmid mediated



Many strains of the above microorganisms that are multiple resistant to other antibiotics, e.g.

amino – and ureido-penicillins, older cephalosporins and aminoglycosides, are susceptible to

ceftriaxone. Treponema pallidum is sensitive in vitro and in animal experiments. Clinical

investigations indicate that primary and secondary syphilis respond well to ceftriaxone

therapy. With a few exceptions clinical P. aeruginosa isolates are resistant to ceftriaxone.

Anaerobic organisms:

Bacteroides spp. (bile-sensitive)*

Clostridium spp. (excluding the C. difficle)

Fusobacterium nucleatum

Fusobacterium spp. (other)

Gaffkia anaerobica (former Peptococcus)

Peptostreptococcus spp.

*Some isolates of these species are resistant to ceftriaxone due to



Many strains of

-lactamase-producing Bacteroides spp. (notably B. fragilis) are resistant.

Clostridium difficile is resistant.

Susceptibility to ceftriaxone can be determined by the disk diffusion test or by the agar or

broth dilution test using standardised techniques for susceptibility testing such as those

recommended by the National Committee for Clinical Laboratory Standards (NCCLS). The

NCCLS issued interpretative breakpoints for ceftriaxone are:


Moderately Susceptible


Dilution test

Inhibitory concentrations in mg/L











diameter in mm




Microorganisms should be tested with the ceftriaxone disk since it has been shown by in

vitro tests to be active against certain strains resistant to cephalosporin class disks.









susceptibility interpretative guidelines such as those issued by DIN, ICS and others may be



Ceftriaxone is a long acting, broad-spectrum cephalosporin antibiotic for parenteral use.

Ceftriaxone inhibits the bacterial cell wall synthesis leading to lysis of bacteria.






parameters, except the elimination half-life, are dose dependent if based on total drug

concentrations. An overall mean and the range of means from studies have been presented

for the primary pharmacokinetic parameters of ceftriaxone administered in the dose range

150 mg - 3 g.


The maximum plasma concentration after a single IM dose of 1 g is about 81 mg/L and is

reached in 2-3 hours after administration. The area under the plasma concentration-time

curve after IM administration is equivalent to that after IV administration of an equivalent

dose, indicating 100% bioavailability of intramuscularly administered ceftriaxone.


The volume of distribution of ceftriaxone is 7-12 L. Ceftriaxone has shown excellent tissue

and body fluid penetration after a dose of 1-2 g; concentrations well above the minimal

inhibitory concentrations of most pathogens responsible for infection are detectable for more

than 24 hours in over 60 tissues or body fluids including lung, heart, biliary tract/liver, tonsil,

middle ear and nasal mucosa, bone; and cerebrospinal, pleural, prostatic and synovial fluids.

On intravenous administration, ceftriaxone diffuses rapidly into the interstitial fluid, where

bactericidal concentrations against susceptible organisms are maintained for 24 hours.

Protein Binding:

Ceftriaxone is reversibly bound to albumin, and the binding decreases with the increase in

the concentration, e.g. from 95% binding at plasma concentrations of <100 mg/L to 85%

binding at 300 mg/L. Owing to the lower albumin content, the proportion of free ceftriaxone

in interstitial fluid is correspondingly higher than in plasma.


Ceftriaxone is not metabolized systemically; only the intestinal flora transforms the agent into

inactive metabolites.

Penetration into particular tissues:








Ceftriaxone concentration are >1.4 mg/L in the CSF 24 hours after IV injection of Ceftriaxone

in doses of 50 -100 mg per kg (neonates and infants, respectively). Peak concentration in

CSF is reached about 4 hours after IV injection and gives an average value of 18 mg/L. The

average extent of diffusion into the cerebrospinal fluid during bacterial meningitis is 17% of

the plasma concentration and 4% in patients with aseptic meningitis. In adult meningitis

patients, administration of 50 mg per kg leads within 2 - 24 hours to CSF concentrations

several times higher than the minimum inhibitory concentrations required for the most

common causative organisms of meningitis.










The total plasma clearance is 10 - 22 mL/min. Renal clearance is 5-12 mL/min. 50-60% of

ceftriaxone is excreted unchanged in the urine, while 40-50% is excreted unchanged in the

bile. The elimination half-life in adults is about eight hours.

Pharmacokinetics in special clinical situations:

In neonates, urinary recovery accounts for about 70% of the dose. In infants aged less than

eight days and in elderly persons aged over 75 years, the average elimination half life is

usually 2 to 3 times that in the young adult group. In patients with renal or hepatic







elimination half-life is only slightly increased. If kidney function alone is impaired, biliary

elimination of ceftriaxone is increased; if liver function alone is impaired, renal elimination is


Preclinical safety data:

Repeated dose administrations in animals revealed the known and reversible side effect of

parenterally administered 3

-generation cephalosporins at high doses (e.g. alteration of

laboratory parameters, enteric disturbances and a certain degree of nephrotoxocity). A

specific side effect of ceftriaxone is the formation of biliary calculi in the gallbladder of dogs,

and to a minor extent in monkeys. Ceftriaxone had no effect on reproductive parameters,

and was found to have neither mutagenic nor antigenic activity.


Infections caused by pathogens sensitive to Ceftriaxone e.g.:



abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts);

infections of the bones, joints, soft tissue, skin and of wounds;

infections in patients with impaired defence mechanisms;

renal and urinary tract infections;

respiratory tract infections, particularly pneumonia, and ear, nose and throat infections;

genital infections, including gonorrhoea.

Perioperative prophylaxis of infections.

Dosage and administration

Do NOT use diluents containing calcium, e.g. Ringer’s solution or Hartmann’s solution, to

reconstitute ceftriaxone. Particulate formation can result.







infusions such as parenteral nutrition, should not be mixed or co-administered to any patient

irrespective of age, even via different infusion lines at different sites.

Calcium-containing solutions or products must not be administered with 48 hours of last

administration of ceftriaxone.

Adults and Children over twelve years:

The usual dosage is 1-2 g of ceftriaxone administered once daily (every 24 hours). In

severe cases or in infections caused by moderately sensitive organisms, the dosage may be

raised to 4 g, administered once daily.

Elderly patients:

The dosages recommended for adults require no modification in the case of geriatric


Neonates, Infants and Children up to twelve years:

The following dosage schedules are recommended for once daily administration:

Neonates (up to 14 days): A daily dose of 20-50 mg/kg bodyweight, not to exceed 50 mg/kg,

on account of the immaturity of the infant’s enzyme systems. It is not necessary to

differentiate between premature and infants born at term.

Infants and children (15 days to twelve years): A daily dose of 20-80 mg/kg.


For children with bodyweights of 50 kg or more, the usual adult dosage should be used.

Intravenous doses of 50 mg or more per kg should be give by infusion over at least 30


Duration of therapy:

The duration of therapy varies according to the course of the disease. As with antibiotic

therapy in general, administration of ceftriaxone should be continued for a minimum of 48 to

72 hours after the patient has become afebrile or evidence of bacterial eradication has been


Combination therapy:

Synergy between ceftriaxone and aminoglycosides has been demonstrated with many

Gram-negative bacteria under experimental conditions. Although enhanced activity of such

combinations is not always predictable, it should be considered in severe, life-threatening

infections due to microorganisms such as Pseudomonas aeruginosa. Because of physical

incompatibility the two medicines must be administered separately at the recommended


Special dosage instructions:


In bacterial meningitis in infants and children, treatment begins with doses of 100 mg/kg (not

to exceed 4 g) once daily. As soon as the causative organism has been identified and its

sensitivity determined, the dosage can be reduced accordingly. Effective results have been

found with the following duration of therapy:

Neisseria meningitidis

4 days

Haemophilus influenzae

6 days

Streptococcus pneumoniae

7 days


For the treatment of gonorrhoea (penicillinase-producing and nonpenicillinase-producing

strains), a single IM dose of 250 mg ceftriaxone is recommended.

Perioperative prophylaxis:

To prevent postoperative infections in contaminated or potentially contaminated surgery, the

recommended approach – depending on the risk of infection – is a single dose of 1 – 2 g

ceftriaxone administered 30-90 minutes prior to surgery. In colorectal surgery, concurrent









ornidazole, has proven effective.

Impaired renal and hepatic function:

In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone

provided hepatic function is intact. Only in cases of preterminal renal failure (creatinine

clearance <10 mL/min) should the ceftriaxone dosage not exceed 2 g daily. In patients with

liver damage, there is no need for the dosage to be reduced provided renal function is intact.

In cases of concomitant severe renal and hepatic dysfunction, the plasma concentrations of

ceftriaxone should be determined at regular intervals and if necessary the dose adjusted.

In patients undergoing dialysis no additional supplementary dosing is required following the









dosage adjustments are necessary, since the elimination rate in these patients may be


Directions for use:

As a general rule, the solution should be used immediately after preparation.

Reconstituted solutions retain their physical and chemical stability for six hours at room

temperature or 24 hours under refrigeration (2-8 °C).

The solutions range in colour from pale yellow to amber, depending on the concentration

and the length of storage. This characteristic of the active ingredient is of no significance for

the efficacy or tolerance of the drug.

Intramuscular injection:

For IM injection, Ceftriaxone-AFT 1 g is dissolved in 3.5 mL of 1% lidocaine hydrochloride

solution and injected well within the body of a relatively large muscle. It is recommended

that not more than 1 g to be injected at one site.

The lidocaine solution must never be administered intravenously.

Intravenous injection:

For IV injection, Ceftriaxone-AFT 500 mg is dissolved in 5 mL, or Ceftriaxone-AFT 1 g in 10

mL, of sterile water for injections. The intravenous administration should be given over two

to four minutes.

Intravenous infusion:

The infusion should last at least 30 minutes.

For IV infusion, 2 g ceftriaxone are dissolved in 40 mL of one of the following calcium-free

infusion solutions: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose

5%, dextrose 10%, dextran 6% in dextrose 5%, hydroxyethyl starch 6-10% infusions, sterile

water for injections. Ceftriaxone solutions should not be mixed with or piggybacked into

solutions containing other antimicrobial drugs or into diluent solutions other than those listed

above, owing to possible incompatibility.


Ceftriaxone is contraindicated in patients who have had previous experience of a major

allergy or anaphylaxis to cephalosporin or penicillin.

Ceftriaxone is contraindicated in hyperbilirubinemic neonates, especially prematures. In vitro

studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin

and bilirubin encephalopathy can possibly develop in these patients.

Ceftriaxone must not be co-administered with calcium-containing IV solutions, including

continuous calcium-containing infusions such as parental nutrition, in neonates because of

the risk of precipitation of ceftriaxone-calcium salt. Cases of fatal reactions with ceftriaxone-

calcium precipitates in lung and kidneys in neonate have been described. In some cases the

infusion lines and the times of administration of ceftriaxone and calcium-containing solutions


Warnings and precautions

Hypersensitivity reactions may occur in susceptible individuals.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough

patient history is taken. Anaphylactic shock requires immediate countermeasures.

Hepatitis and hepatocellular injury:

Cases of hepatitis and hepatocellular injury with or without jaundice have been observed

during ceftriaxone therapy and may occur early in the treatment period and independently of

cholelithiasis. Patients should be advised to report immediately any symptoms suggestive of

liver injury.

Antibiotic Associated Pseudomembranous Colitis:

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics

including ceftriaxone. A toxin produced by Clostridium difficile appears to be the primary

cause. The severity of the colitis may range from mild to life threatening. It is important to

consider this diagnosis in patients who develop diarrhoea or colitis in association with

antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild

case usually respond to drug discontinuation alone. However, in moderate to severe cases

appropriate therapy with a suitable oral antibacterial agent effective against C. difficile should

be considered. Fluids, electrolytes and protein replacement should be provided when


Drugs which delay peristalsis eg opiates and diphenoxylate with atropine (Lomotil) may

prolong and/or worsen the condition and should not be used.

Other causes of colitis should be considered.

Therefore, it is important to consider this diagnosis in patients who present with diarrhoea

subsequent to the administration of antibacterial agents.

Superinfections with non-susceptible microorganisms may occur as with other antibacterial


Immune Mediated Haemolytic Anaemia









cephalosporin class antibacterials. Severe cases of haemolytic anaemia, including fatalities,

have been reported during treatment in both adults and children. If a patient develops

anaemia while on ceftriaxone, the diagnosis of a cephalosporin associated anaemia should

be considered and ceftriaxone discontinued until the aetiology is determined.

Alterations in Clotting Time:

Alterations in prothrombin times have occurred rarely in patients treated with ceftriaxone.

Patients with impaired vitamin K synthesis or low vitamin K stores (eg chronic hepatic

disease and malnutrition) may require monitoring of prothrombin time during ceftriaxone








prothrombin time is prolonged before or during therapy.

During prolonged treatment the blood profile should be checked at regular intervals.


Ceftriaxone should be given with caution to patients who have experienced symptoms of

allergy associated with a cephalosporin or penicillin.

Pseudomembranous colitis and delaying peristalsis-Pseudomembranous colitis has been

reported with virtually all broad-spectrum antibiotics. It is important to consider this diagnosis

in patients who develop diarrhoea in association with the use of ceftriaxone. Drugs which

delay peristalsis may prolong and/or worsen the condition and should not be used.

Prothrombin time-Prolonged prothrombin time may occur in patients receiving protracted

antimicrobial therapy.

Ability to drive or operate machinery-During treatment with ceftriaxone undesirable effects

may occur (e.g. dizziness), which may influence the ability to drive and use machines.

Patients should be cautious when driving or operating machinery.

Shadows which have been mistaken for gallstones have been detected on sonograms of the

gallbladder, usually following doses higher than the standard recommended dose. These

shadows are, however, precipitates of calcium ceftriaxone which disappear on completion or

discontinuation of ceftriaxone therapy. Rarely have these findings been associated with

symptoms. In asymptomatic cases discontinuation of treatment is not recommended as the

condition is reversible after completion of the treatment. In symptomatic cases, conservative

non-surgical management is recommended. Discontinuation of ceftriaxone treatment in

symptomatic cases should be at the discretion of the clinician.

Pancreatitis possibly of biliary obstruction aetiology have been rarely reported in patients

treated with ceftriaxone. Most patients presented with risk factors for biliary stasis and biliary

sludge e.g. preceding major therapy, severe illness and total parenteral nutrition. A trigger or

co-factor role of ceftriaxone-related biliary precipitation cannot be discounted.









established for the dosages described in the Dosage and Administration section. In vitro

studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin





should be


when considering

ceftriaxone for

hyperbilirubinaemic neonates, especially prematures. Ceftriaxone should not be used in

neonates (especially prematures) at risk of developing bilirubin encephalopathy.

Interactions with Calcium-Containing Products

There are no reports to date of intravascular or pulmonary precipitations in patients, other

than neonates, treated with ceftriaxone and calcium-containing IV solutions. However, the

theoretical possibility exists for an interaction between ceftriaxone and calcium-containing IV

solutions in patients other than neonates. Therefore, ceftriaxone and calcium-containing

solutions, including continuous calcium-containing infusions such as parenteral nutrition,

should not be mixed or co-administered to any patient irrespective of age, even via different

infusion lines at different sites.

As a further theoretical consideration and based on 5 half-lives of ceftriaxone, calcium-

containing IV solutions and ceftriaxone should not be administered within 48 hours of each

other, in any patient.

No data are available on the potential interaction between ceftriaxone and oral calcium-

containing products or interaction between intramuscular ceftriaxone and calcium-containing

products (IV or Oral).

Pregnancy and Lactation:

Category B1









established. Reproductive toxicity studies have been performed in mice and rats at doses

up to 20 times the human dose of 2 g/d (586 mg/kg/d in rats), and have not shown evidence

of embryotoxocity, foetotoxicity, teratogenicity or adverse effects on male or female fertility,

birth or peri- and postnatal development. In primates, no embryotoxicity or teratogenicity

was demonstrated at a dose approximately 3 times the human dose (84 mg/kg/d in


As ceftriaxone is secreted in the breast milk at low concentrations, caution is advised in

nursing mothers.

Effects on ability to drive and use machines:

During the treatment with cefazolin, undesirable effects may occur (e.g. dizziness),

which my influence the ability to drive and use machine. Patients should be cautions

when driving or operating machinery.

Adverse effects

Ceftriaxone is generally well tolerated. During the use of ceftriaxone, the following side

effects, which were reversible either spontaneously or after withdrawal of the medicine, have

been observed:

Systemic side effects:

















leukopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia.

Skin reactions

(about 1%):




pruritus, urticaria,


erythema multiforme.

Other, rare side effects: Headache and dizziness, increase in liver enzymes, jaundice and

hepatitis, symptomatic precipitation of the calcium salt of ceftriaxone in the gallbladder,

oliguria, increase in serum creatinine, mycosis of the genital tract, shivering and anaphylactic

or anaphylactoid reactions and secondary infection.

Psudomembranous enterocolitis and coagulation disorders have been reported as very rare

side effects. Pancreatitis and Steven Johnson Syndrome have also been reported as very

rare side effects.

Very rare cases of renal precipitation have been reported, mostly in children aged 3 years or

older, who have been treated with high doses (> 80 mg/kg/day) or total doses of greater than

10 g and presenting other risk factors e.g. fliud restrictions, confinement to bed etc). This

may be symptomatic or asymptomatic, may lead to renal insufficiency and is reversible with

discontinuation of ceftiraxone.

Fatal reactions with calcium-ceftriaxone precipitates in lungs and kidney in neonates and

premature infants have been described. In some cases the infusion lines and times of

administration of ceftriaxone and calcium containing solutions differed. Ceftriaxone must not

been mixed or administered simultaneously with calcium containing solutions or products

even via different infusion lines.

Local side effects:

Phlebitis at the site of injection and cutaneous vasculitis may occur. These may be

minimized by slow (two to four minutes) injection of the substance.

Intramuscular injection without lidocaine solution is painful.


No impairment of renal function has so far been observed after concurrent administration of

large doses of ceftriaxone and potent diuretics (e.g. frusemide).

There is no evidence that ceftriaxone increases renal toxicity of aminoglycosides.

No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol

subsequent to the administration of ceftriaxone. Ceftriaxone does not contain an N-









problems of certain other cephalosporins.

The elimination of ceftriaxone is not altered by probenecid.

In an in vitro study antagonistic effects have been observed with the combination of

chloramphenicol and ceftriaxone.

In patients treated with ceftriaxone the Coombs’ test may rarely become false-positive.

Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.

Nonenzymatic methods for the glucose determination in urine may give false-positive

results. For this reason, urine-glucose determination during therapy with ceftriaxone should

be done enzymatically.


In the case of overdosage, drug concentration would not be reduced by haemodialysis or

peritoneal dialysis.

There is no specific antidote. Treatment of overdosage should be symptomatic.

Pharmaceutical precautions


Ceftriaxone should not be added to solutions containing calcium such as Hartmann’s

solution and Ringer’s solution.

Based on literature reports ceftriaxone is incompatible with amsacrine, vancomycin and

fluconazole and aminoglycosides.

Cetrixaone-AFT powder for injection should be stored below 25 °C.

Instructions for use/handling:

Ceftriaxone powder must be reconstituted prior to use

Reconstituted solutions retain their physical and chemical stability for six hours at room

temperature (or 24 hours at 2-8 °C).

For IM injection, Ceftriaxone-AFT 1 g is dissolved in 3.5 mL of 1% lidocaine hydrochloride


For IV injection, Ceftriaxone-AFT 500 mg is dissolved in 5 mL, or Ceftriaxone-AFT 1 g in 10

mL, of sterile water for injections.

For IV infusion, 2 g ceftriaxone are dissolved in 40 mL of one of the following calcium-free

infusion solutions: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose

5%, dextrose 10%, dextran 6% in dextrose 5%, hydroxyethyl starch 6-10% infusions, sterile

water for injections.

Medicine classification

Prescription Medicine.

Package quantities

Ceftriaxone-AFT 500 mg, 1 g and 2 g are available in:

Single vial packs

Packs of 5 vials

Packs of 10 vials.

Further information

Ceftriaxone-AFT contains approximately 83mg (3.6m Eq) of sodium per gram of ceftriaxone.

Name and address

AFT Pharmaceuticals,

Po Box 33-203,



E:mail: customer.service@aftpharm.com

Date of preparation

March 2016

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