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Medication Safety Issues
Sound-alike/look-alike issues:
Protonix® may be confused with Lotronex®, Lovenox®, protamine
Vials containing Protonix® I.V. for injection are not recommended for use with spiked I.V. system adaptors. Nurses and pharmacists have reported breakage of the glass vials during attempts to connect spiked I.V. system adaptors, which may potentially result in injury to healthcare professionals.
International issues:
Protonix® may be confused with Pretanix® which is a brand name for indapamide in Hungary
Pronunciation
(pan TOE pra zole)
U.S. Brand Names
Generic Available
Yes: Delayed release tablet
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Oral: Treatment and maintenance of healing of erosive esophagitis associated with GERD; reduction in relapse rates of daytime and nighttime heartburn symptoms in GERD; hypersecretory disorders associated with Zollinger-Ellison syndrome or other GI hypersecretory disorders
I.V.: Short-term treatment (7-10 days) of patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis; hypersecretory disorders associated with Zollinger-Ellison syndrome or other neoplastic disorders
Use: Unlabeled/Investigational
Peptic ulcer disease, active ulcer bleeding (parenteral formulation); adjunct treatment with antibiotics for Helicobacter pylori eradication; stress-ulcer prophylaxis in the critically-ill
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Use in pregnancy only if clearly needed.
Lactation
Enters breast milk/not recommended
Breast-Feeding Considerations
Not recommended due to carcinogenicity in animal studies.
Contraindications
Hypersensitivity to pantoprazole, substituted benzamidazoles (eg, esomeprazole, lansoprazole, omeprazole, rabeprazole), or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Atrophic gastritis: Long-term pantoprazole therapy (especially in patients who were H. pylori positive) has caused biopsy-proven atrophic gastritis.
• Carcinoma: No occurrences of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia, such as those seen in rodent studies, have been reported in humans.
• Vitamin B12 malabsorption: Prolonged treatment (typically >3 years) may lead to vitamin B12 malabsorption and subsequent deficiency.
Disease-related concerns:
• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.
Dosage form specific issues:
• Edetate sodium (EDTA): Intravenous preparation contains edetate sodium; use caution in patients who are at risk for zinc deficiency if other EDTA-containing solutions are coadministered.
Adverse Reactions
?1%:
Cardiovascular: Chest pain
Central nervous system: Headache (2% to 9%), insomnia (?1%), anxiety, dizziness, migraine
Dermatologic: Rash (?2%)
Endocrine & metabolic: Hyperglycemia (?1%), hyperlipidemia
Gastrointestinal: Diarrhea (2% to 6%), flatulence (2% to 4%), abdominal pain (1% to 4%), nausea (?2%), vomiting (?2%), eructation (?1%), constipation, dyspepsia, gastroenteritis, rectal disorder
Genitourinary: Urinary frequency, UTI
Hepatic: Liver function tests abnormal (?2%)
Local: Injection site reaction (includes thrombophlebitis and abscess)
Neuromuscular & skeletal: Arthralgia, back pain, hypertonia, neck pain, weakness
Respiratory: Bronchitis, cough, dyspnea, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection
Miscellaneous: Flu syndrome, infection, pain
<1%, postmarketing, and/or case reports: Abnormal dreams, acne, albuminuria, alkaline phosphatase increased, allergic reaction, alopecia, anaphylaxis, anemia, angioedema, angina pectoris, anorexia, aphthous stomatitis, appetite increased, arrhythmia, asthma exacerbation, atrial fibrillation/flutter, atrophic gastritis, balanitis, biliary pain, blurred vision, bone pain, breast pain, bursitis, cataract, CHF, chills, cholecystitis, cholelithiasis, CPK increased, colitis, confusion, contact dermatitis, creatinine increased, cystitis, deafness, decreased reflexes, dehydration, depression, diabetes mellitus, diaphoresis, diplopia, duodenitis, dysarthria, dysmenorrhea, dysphagia, dysuria, ecchymosis, ECG abnormality, eczema, eosinophilia, epididymitis, epistaxis, erythema multiforme, esophagitis, extraocular palsy, facial edema, fever, fungal dermatitis, gastrointestinal carcinoma, gastrointestinal hemorrhage, gastrointestinal moniliasis, generalized edema, GGT increased, gingivitis, glaucoma, glossitis, glycosuria, goiter, gout, halitosis, hallucinations, heat stroke, hematemesis, hematuria, hemorrhage, hepatic failure, hepatitis, hernia, herpes simplex, herpes zoster, hiccup, hyperbilirubinemia, hyperesthesia, hyper-/hypotension, hyperkinesia, hyperuricemia, hypokinesia, impaired urination, impotence, interstitial nephritis, jaundice, kidney calculus, kidney pain, laryngitis, leg cramps, leukocytosis, leukopenia, libido decreased, lichenoid dermatitis, maculopapular rash, malaise, melena, mouth ulceration, myalgia, myocardial infarction, myocardial ischemia, neoplasm, nervousness, neuralgia, neuritis, nocturia, optic neuropathy (including anterior ischemic), otitis externa, palpitation, pancreatitis, pancytopenia, paresthesia, periodontal abscess, periodontitis, photosensitivity, pneumonia, pruritus, pyelonephritis, rectal hemorrhage, retinal vascular disorder, rhabdomyolysis, salivation increased, scrotal edema, seizure, skin ulcer, somnolence, Stevens-Johnson syndrome, stomach ulcer, stomatitis, syncope, tachycardia, taste perversion, tenosynovitis, thrombocytopenia, thrombosis, tinnitus, tongue discoloration, toxic epidermal necrolysis, tremor, urethral pain, urethritis, urticaria, vaginitis, vasodilation, vertigo, vision abnormal, weight changes, xerostomia
Metabolism/Transport Effects
Substrate of CYP2C19 (major), 2C9 (minor), 2D6 (minor), 3A4 (minor); Inhibits 2C9 (weak); Induces CYP1A2 (weak), 3A4 (weak)
Drug Interactions
Antifungal Agents (Azole Derivatives, Systemic): Proton Pump Inhibitors may decrease the absorption of Antifungal Agents (Azole Derivatives, Systemic). Exceptions: Miconazole. Risk D: Consider therapy modification
Atazanavir: Proton Pump Inhibitors may decrease the absorption of Atazanavir. Risk D: Consider therapy modification
Clopidogrel: Proton Pump Inhibitors may diminish the therapeutic effect of Clopidogrel. This appears to be due to reduced formation of the active clopidogrel metabolite. Risk C: Monitor therapy
CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates. Risk C: Monitor therapy
Dabigatran Etexilate: Proton Pump Inhibitors may decrease the serum concentration of Dabigatran Etexilate. Risk C: Monitor therapy
Dasatinib: Proton Pump Inhibitors may decrease the absorption of Dasatinib. Risk D: Consider therapy modification
Indinavir: Proton Pump Inhibitors may decrease the absorption of Indinavir. Risk C: Monitor therapy
Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Iron Dextran Complex; Iron Sucrose. Risk C: Monitor therapy
Methotrexate: Proton Pump Inhibitors may decrease the excretion of Methotrexate. Antirheumatic doses of methotrexate probably hold minimal risk. Risk C: Monitor therapy
Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy
Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor therapy
Topotecan: BCRP/ABCG2 Inhibitors may increase the serum concentration of Topotecan. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may cause gastric mucosal irritation).
Herb/Nutraceutical: Prolonged treatment (typically >3 years) may lead to vitamin B12 malabsorption and subsequent deficiency.
Storage
Oral: Store tablet and oral suspension at controlled room temperature of 20°C to 25°C (68°F to 77°F).
I.V.: Prior to reconstitution, store at controlled room temperature of 20°C to 25°C (68°F to 77°F). Protect from light. When reconstituted, solution is stable up to 96 hours at room temperature (Johnson, 2005). The preparation should be stored at 3°C to 5°C (37°F to 41°F) if it is stored beyond 48 hours to minimize discoloration. If further diluting in 100 mL of D5W, LR, or NS, dilute within 6 hours of reconstitution. Diluted solution is stable at room temperature for up to 24 hours from the time of initial reconstitution; protection from light is not required.
Reconstitution
Reconstitute with 10 mL NS (final concentration 4 mg/mL). Reconstituted solution may be given intravenously (over 2 minutes) or may be added to 100 mL D5W, NS, or LR (for 15-minute infusion).
Compatibility
Stable in D5W, LR, NS.
Y-site administration: Incompatible: Midazolam, zinc.
Mechanism of Action
Suppresses gastric acid secretion by inhibiting the parietal cell H+/K+ ATP pump
Pharmacodynamics/Kinetics
Absorption: Rapid, well absorbed
Distribution: Vd: 11-24 L
Protein binding: 98%, primarily to albumin
Metabolism: Extensively hepatic; CYP2C19 (demethylation), CYP3A4; no evidence that metabolites have pharmacologic activity
Bioavailability: 77%
Half-life elimination: 1 hour; increased to 3.5-10 hours with CYP2C19 deficiency
Time to peak: Oral: 2.5 hours
Excretion: Urine (71%); feces (18%)
Dosage
Oral:
Children ?5 years (unlabeled use): GERD, erosive esophagitis associated with GERD: 20-40 mg once daily
Adults:
Erosive esophagitis associated with GERD:
Treatment: 40 mg once daily for up to 8 weeks; an additional 8 weeks may be used in patients who have not healed after an 8-week course
Maintenance of healing: 40 mg once daily
Note: Lower doses (20 mg once daily) have been used successfully in mild GERD treatment and maintenance of healing
Hypersecretory disorders (including Zollinger-Ellison): Initial: 40 mg twice daily; adjust dose based on patient needs; doses up to 240 mg/day have been administered
Helicobacter pylori eradication (unlabeled use): Doses up to 40 mg twice daily have been used as part of combination therapy
I.V.:
Erosive esophagitis associated with GERD: 40 mg once daily for 7-10 days
Hypersecretory disorders: 80 mg twice daily; adjust dose based on acid output measurements; 160-240 mg/day in divided doses has been used for a limited period (up to 7 days)
Prevention of rebleeding in peptic ulcer bleed (unlabeled use): 80 mg, followed by 8 mg/hour infusion for 72 hours. Note: A daily infusion of 40 mg does not raise gastric pH sufficiently to enhance coagulation in active GI bleeds.
Elderly: Dosage adjustment not required
Dosage adjustment in renal impairment: Not required; pantoprazole is not removed by hemodialysis
Dosage adjustment in hepatic impairment: Not required
Administration: Oral
Tablet: Should be swallowed whole, do not crush or chew. Best if taken before breakfast.
Delayed-release oral suspension: Should only be administered in apple juice or applesauce and taken ~30 minutes before a meal. Do not administer with any other liquid (eg, water) or foods.
Oral administration in applesauce: Sprinkle intact granules on 1 tablespoon of applesauce and swallow within 10 minutes of preparation.
Oral administration in apple juice: Empty intact granules into 5 mL of apple juice (~1 teaspoonful), stir for 5 seconds, and swallow immediately after preparation. Rinse container once or twice with apple juice and swallow immediately.
Nasogastric tube administration: Separate the plunger from the barrel of a 60 mL catheter tip syringe and connect to a ?16 French nasogastric tube. Holding the syringe attached to the tubing as high as possible, empty the contents of the packet into barrel of the syringe, add 10 mL of apple juice and gently tap/shake the barrel of the syringe to help empty the syringe. Add an additional 10 mL of apple juice and gently tap/shake the barrel to help rinse. Repeat rinse with at least 2 -10 mL aliquots of apple juice. No granules should remain in the syringe.
Administration: I.V.
Flush I.V. line before and after administration. In-line filter not required.
2-minute infusion: The volume of reconstituted solution (4 mg/mL) to be injected may be administered intravenously over at least 2 minutes.
15-minute infusion: Infuse over 15 minutes at a rate not to exceed 7 mL/minute (3 mg/minute).
Monitoring Parameters
Hypersecretory disorders: Acid output measurements, target level <10 mEq/hour (<5 mEq/hour if prior gastric acid-reducing surgery)
Test Interactions
False-positive urine screening tests for tetrahydrocannabinol (THC) have been noted in patients receiving proton pump inhibitors, including pantoprazole.
Dietary Considerations
Oral: May be taken with or without food; best if taken before breakfast.
I.V.: Due to EDTA in preparation, zinc supplementation may be needed in patients prone to zinc deficiency.
Patient Education
Take as directed; do not alter dosage without consulting prescriber. Take at similar time each day. Swallow tablet whole (do not crush or chew). Avoid alcohol. You may experience dizziness, headache, or anxiety (use caution when driving or engaging in dangerous activities until response to medication is known); vomiting or loss of appetite (small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or diarrhea (boiled milk, yogurt, or buttermilk may help). Report persistent abdominal discomfort; chest pain or palpitations; acute headache; unresolved diarrhea; excessive fatigue; increased muscle, joint, or body pain; shortness of breath or wheezing; cold or flu symptoms; changes in urinary pattern; or other persistent adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Breast-feeding is not recommended.
Geriatric Considerations
Dosage adjustment not required.
Anesthesia and Critical Care Concerns/Other Considerations
Acute ulcer: Postendoscopy therapy: Intravenous omeprazole has been studied in prevention of rebleeding in ulcer patients who are at high risk for rebleeding (endoscopic findings of active bleeding or nonbleeding visible vessel) after successful hemostasis (Lin, 1998; Lau, 2000).
Lin and his group treated 100 ulcer patients (actively bleeding ulcers or ulcers with nonbleeding visible vessels) endoscopically and then randomized them to cimetidine (300 mg bolus followed by 50 mg/hour infusion) or omeprazole (40 mg bolus, ~7 mg/hour infusion) for 72 hours. Patients were discharged on the oral form of the drug arm they were assigned to. The omeprazole group maintained an intragastric pH >6 for about 84% of the infusion duration, while the cimetidine group maintained their pH >6 only about 50% of the time. Rebleeding occurred significantly more often in the cimetidine group.
Lau and his colleagues treated patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels with an epinephrine infusion followed by thermocoagulation. They were then randomized to omeprazole (80 mg bolus followed by a continuous infusion of 8 mg/hour for 72 hours) or placebo. All patients were discharged on oral omeprazole (20 mg/day) for 8 weeks and received H. pylori treatment if indicated. The primary goal was to evaluate the rate of rebleeding during the first 30 days after endoscopy. Two hundred and forty patients were enrolled with randomization of 120 into each group. Bleeding recurred in significantly more patients receiving placebo than omeprazole infusion. The authors concluded that after endoscopic therapy, omeprazole reduces the risk of rebleeding in patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels.
Acute ulcer: Pre-endoscopy therapy: Lau and associates (2007) evaluated the effects of preemptive infusion of omeprazole before endoscopy in upper gastrointestinal bleeding. Consecutive patients (638) were stabilized and then randomly assigned to intravenous omeprazole (80 mg bolus followed by a continuous infusion of 8 mg/hour) or placebo infusion before endoscopy the next morning. The primary endpoint was the need for endoscopic therapy (eg, epinephrine, thermocoagulation). Seven patients were excluded from the analysis. The need for endoscopic treatment was significantly lower in the omeprazole group (60/314 patients; 19%) than in the placebo group (90/317; 28%). The active treatment group had a significantly shorter hospital stay. Duration of infusion before endoscopy was similar in both groups (~8-21 hours).
Stress ulcer prophylaxis: The 2008 Surviving Sepsis Campaign guidelines recommend that stress ulcer prophylaxis using an H2 blocker (Grade 1A) or proton pump inhibitor (Grade 1B) be given to patients with severe sepsis to prevent upper GI bleed. Benefit of prevention of upper GI bleed must be weighed against potential effect of increased stomach pH on development of ventilator-associated pneumonia.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause anxiety or dizziness; may rarely produce confusion, depression, dysarthria, hallucinations, nervousness, or somnolence
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Assess other medications for effectiveness and interactions (cytochrome P450 enzyme substrate), especially those drugs where absorption is determined by an acidic gastric pH. Monitor therapeutic effectiveness and adverse effects at beginning of therapy and regularly with long-term use. Assess knowledge/teach patient appropriate use, possible side effects/interventions, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [CAN] = Canadian brand name
Note: Strength expressed as base
Granules for suspension, delayed release, enteric coated, as sodium, oral:
Protonix®: 40 mg/packet (30s)
Injection, powder for reconstitution, as sodium:
Protonix®: 40 mg [contains edetate sodium 1 mg]
Tablet, delayed release, as sodium: 20 mg, 40 mg
Protonix®: 20 mg, 40 mg
Tablet, enteric coated, as magnesium:
Pantoloc® M [CAN]: 40 mg [not available in the U.S.]
Pricing: U.S. (www.drugstore.com)
Tablet, EC (Pantoprazole Sodium)
20 mg (30): $109.99
40 mg (90): $324.98
Tablet, EC (Protonix)
20 mg (30): $127.89
40 mg (30): $125.99
Extemporaneously Prepared
A 2 mg/mL pantoprazole oral liquid can be prepared with twenty pantoprazole 40 mg tablets, 340 mL sterile water, and 33.6 g of sodium bicarbonate powder. Remove the Protonix® imprint from each of the tablets on a paper towel dampened with ethanol (improves the look of product). Let tablets air dry. Grind the tablets into a coarse powder, transfer to a 600 mL beaker and add 340 mL of sterile water for irrigation and place beaker on a magnetic stirrer. Add 16.8 g of sodium bicarbonate powder and stir for about 20 minutes until the tablet remnants have disintegrated. While stirring, add another 16.8 g of sodium bicarbonate powder and stir for about 5 minutes until powder has dissolved. Add enough sterile water for irrigation to bring the final volume to 400 mL. Mix well. Transfer to amber-colored bottle. Stable for 62 days under refrigeration. Shake well before use.
Dentinger PJ, Swenson CF, and Anaizi NH, “Stability of Pantoprazole in an Extemporaneously Compounded Oral Liquid,” Am J Health Syst Pharm, 2002, 59:953-6.
References
Bardhan KD, Dillon J, Axon AT, et al, “Triple Therapy for Helicobacter pylori Eradication: A Comparison of Pantoprazole Once Versus Twice Daily,” Aliment Pharmacol Ther, 2000, 14(1):59-67.
Brunner G, Luna P, Hartmann M, et al, “Optimizing the Intragastric pH as a Supportive Therapy in Upper GI Bleeding,” Yale J Biol Med, 1996, 69(3):225-31.
Cockayne SE, Glet RJ, Gawkrodger DJ, et al, “Severe Erythrodermic Reactions to the Proton Pump Inhibitors Omeprazole and Lansoprazole,” Br J Dermatol,1999, 141(1):173-5.
Dellinger RP, Levy MM, Carlet JM, et al, “Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2008,” Intensive Care Med, 2008, 34(1): 17-60. Available at http://www.survivingsepsis.org/system/files/images/2008_20International_20SSC_20Guidelines_1_.pdf
Escourrou J, Deprez P, Saggioro A, et al, “Maintenance Therapy With Pantoprazole 20 mg Prevents Relapse of Reflux Oesophagitis,” Aliment Pharmacol Ther, 1999, 13(11):1481-91.
Johnson CE, “Stability of Pantoprazole in 0.9% Sodium Chloride Injection in Polypropylene Syringes,” Am J Health Syst Pharm, 2005, 62(22):2410-2.
Jung R and MacLaren R, “Proton-Pump Inhibitors for Stress Ulcer Prophylaxis in Critically Ill Patients,” Ann Pharmacother, 2002, 36(12):1929-37.
Lau JY, Sung JJ, Lee KK, et al, “Effect of Intravenous Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers,” N Engl J Med, 2000, 343(5):310-6.
Lau JY, Leung WK, Wu JC, et al, “Omeprazole Before Endoscopy in Patients With Gastrointestinal Bleeding,” N Engl J Med, 2007, 356(16):1631-40.
Lau JY, Sung JJ, Lee KK, et al, “Effect of Intravenous Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers,” N Engl J Med, 2000, 343(5):310-6.
Lew EA, Pisegna JR, Starr JA, et al, “Intravenous Pantoprazole Rapidly Controls Gastric Acid Hypersecretion in Patients With Zollinger-Ellison Syndrome,” Gastroenterology, 2000, 118(4):696-704.
Lin HJ, Lo WC, Lee FY, et al, “A Prospective Randomized Comparative Trial Showing That Omeprazole Prevents Rebleeding in Patients With Bleeding Peptic Ulcer After Successful Endoscopic Therapy,” Arch Intern Med, 1998, 158(1):54-8.
Madrazo-de la Garza A, Dibildox M, Vargas A, et al, “Efficacy and Safety of Oral Pantoprazole 20 mg Given Once Daily for Reflux Esophagitis in Children,” J Pediatr Gastroenterol Nutr, 2003, 36(2):261-5.
Morgan D, “Intravenous Proton-Pump Inhibitors in the Critical Care Setting,” Crit Care Med, 2002, 30(6 Suppl):369-72.
Natsch S, Vinks MH, Voogt AK, et al, “Anaphylactic Reactions to Proton-Pump Inhibitors,” Ann Pharmacother, 2000, 34(4):474-6.
Perri F, Festa V, Clemente R, et al, “Randomized Study of Two “Rescue” Therapies for Helicobacter pylori-infected Patients After Failure of Standard Triple Therapies,” Am J Gastroenterol, 2001, 96(1):58-62.
Poole P, “Pantoprazole,” Am J Health-Syst Pharm, 2001, 58:999-1008.
Tolia V, Bishop PR, Tsou VM, et al, “Multicenter, Randomized, Double-Blind Study Comparing 10, 20 and 40 mg Pantoprazole in Children (5-11 Years) With Symptomatic Gastroesophageal Reflux Disease,” J Pediatr Gastroenterol Nutr, 2006, 42(4):384-91.
Tsou VM, Baker R, Book L, et al, “Multicenter, Randomized, Double-Blind Study Comparing 20 and 40 mg of Pantoprazole for Symptom Relief in Adolescents (12 to 16 Years of Age) With Gastroesophageal Refulx Disease (GERD),” Clin Pediatr, 2006, 45(8):741-9.
Vcev A, Stimac D, Ivandic A, et al, “Pantoprazole, Amoxycillin, and Either Azithromycin or Clarithromycin for Eradication of Helicobacter pylori in Duodenal Ulcer,” Aliment Pharmacol Ther, 2000, 14(1):69-72.
Wolfe MM and Sachs G, “Acid Suppression: Optimizing Therapy for Gastroduodenal Ulcer Healing, Gastroesophageal Reflux Disease, and Stress-Related Erosive Syndrome,” Gastroenterology, 2000,118(2 Suppl 1):9-31.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
Content last modified August 2008
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