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Special Alerts

Oseltamivir (Tamiflu®): Labeling Updated Due to Change in Oral Suspension Concentration

July 2011

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals about labeling changes being made to oseltamivir (Tamiflu®) oral suspension to reduce the likelihood of medication errors. The changes to the product label include:

- A reduction in the concentration from 12 mg/mL to 6 mg/mL; this new concentration will reduce the froth generated when shaken therefore providing a more accurate measurement.

- A change in the measurements on the oral dosing device from milligrams (mg) to milliliters (mL).

- A change in the dosing table for oseltamivir (Tamiflu®) to include a column for the volume (mL) based on the new currently available 6 mg/mL concentration.

- Revised compounding instructions for pharmacies to prepare a 6 mg/mL oral suspension from oseltamivir (Tamiflu®) capsules in the event of a shortage of the commercially available suspension.

The manufacturer, Genentech, has instituted a voluntary Take Back Program to remove the 12 mg/mL concentration from the marketplace and program participation is encouraged; however, the FDA wants to alert healthcare professionals that both concentrations may remain on the market and until the current stock of oseltamivir (Tamiflu®) 12 mg/mL oral suspension expires, patients could potentially receive either concentration. To reduce potential errors, the FDA is encouraging prescribers to take additional safety measures when prescribing, such as writing both the strength (6 mg/mL) and volume (mL) in addition to the dose in milligrams (mg) on all prescriptions for oseltamivir (Tamiflu®) oral suspension.

Additional information may be found at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm262432.htm

Pronunciation

(oh sel TAM i vir)

Generic Available (U.S.)

No

Brand Names: U.S.

• Tamiflu®

Brand Names: Canada

• Tamiflu®

Pharmacologic Category

• Antiviral Agent
• Neuraminidase Inhibitor

Use: Labeled Indications

Treatment of uncomplicated acute illness due to influenza (A or B) infection in children ≥1 year of age and adults who have been symptomatic for no more than 2 days; prophylaxis against influenza (A or B) infection in children ≥1 year of age and adults

The Advisory Committee on Immunization Practices (ACIP) recommends that treatment be considered for the following:

• Persons with severe, complicated or progressive illness

• Hospitalized persons

• Persons at higher risk for influenza complications:

- Children <2 years of age (highest risk in children <6 months of age)

- Adults ≥65 years of age

- Persons with chronic disorders of the pulmonary (including asthma) or cardiovascular systems (except hypertension)

- Persons with chronic metabolic diseases (including diabetes mellitus), hepatic disease, renal dysfunction, hematologic disorders (including sickle cell disease), or immunosuppression (including immunosuppression caused by medications or HIV)

-Persons with neurologic/neuromuscular conditions (including conditions such as spinal cord injuries, seizure disorders, cerebral palsy, stroke, mental retardation, moderate to severe developmental delay, or muscular dystrophy) which may compromise respiratory function, the handling of respiratory secretions, or that can increase the risk of aspiration

- Pregnant or postpartum women (≤2 weeks after delivery)

-Persons <19 years of age on long-term aspirin therapy

- American Indians and Alaskan Natives

- Persons who are morbidly obese (BMI ≥40)

- Residents of nursing homes or other chronic care facilities

• Use may also be considered for previously healthy, nonhigh-risk outpatients with confirmed or suspected influenza based on clinical judgment when treatment can be started within 48 hours of illness onset.

The ACIP recommends that prophylaxis be considered for the following:

• Postexposure prophylaxis may be considered for family or close contacts of suspected or confirmed cases, who are at higher risk of influenza complications, and who have not been vaccinated against the circulating strain at the time of the exposure.

• Postexposure prophylaxis may be considered for unvaccinated healthcare workers who had occupational exposure without protective equipment.

• Pre-exposure prophylaxis should only be used for persons at very high risk of influenza complications who cannot be otherwise protected at times of high risk for exposure.

• Prophylaxis should also be administered to all eligible residents of institutions that house patients at high risk when needed to control outbreaks.

The ACIP recommends that treatment and prophylaxis be given to children <1 year of age when indicated.

Pregnancy Risk Factor

C

Pregnancy Considerations

In animal reproduction studies, a dose-dependent increase in the rates of minor skeleton abnormalities was found in exposed offspring. The rate of each abnormality remained within the background rate of occurrence in the species studied. In an in vitro study, placental transfer of oseltamivir phosphate and its active metabolite oseltamivir carboxylate was found to be incomplete, resulting in minimal accumulation in the fetus. An increased risk of adverse neonatal outcomes has generally not been observed following maternal use of oseltamivir during pregnancy. Untreated influenza infection is associated with an increased risk of adverse events to the fetus and an increased risk of complications or death to the mother. Oseltamivir and zanamivir are currently recommended for the treatment or prophylaxis of influenza in pregnant women and women up to 2 weeks postpartum. Oseltamivir and zanamivir are currently recommended as an adjunct to vaccination and should not be used as a substitute for vaccination in pregnant women (consult current CDC guidelines).

Lactation

Enters breast milk/not recommended

Breast-Feeding Considerations

Small amounts of oseltamivir and oseltamivir carboxylate have been detected in breast milk. Breast-feeding is not recommended by the manufacturer. According to the CDC, breast-feeding while taking oseltamivir can be continued. The CDC recommends that women infected with the influenza virus follow general precautions (eg, frequent hand washing) to decrease viral transmission to the child. Mothers with influenza-like illnesses at delivery should consider avoiding close contact with the infant until they have received 48 hours of antiviral medication, fever has resolved, and cough and secretions can be controlled. These measures may help decrease (but not eliminate) the risk of transmitting influenza to the newborn. During this time, breast milk can be expressed and bottle-fed to the infant by another person who is well. Protective measures, such as wearing a face mask, changing into a clean gown or clothing, and strict hand hygiene should be continued by the mother for ≥7 days after the onset of symptoms or until symptom-free for 24 hours. Infant care should be performed by a noninfected person when possible (consult current CDC guidelines). Influenza may cause serious illness in postpartum women and prompt evaluation for febrile respiratory illnesses is recommended.

Contraindications

Hypersensitivity to oseltamivir or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity: Rare but severe hypersensitivity reactions (anaphylaxis, severe dermatologic reactions) have been associated with use.

• Neuropsychiatric events: Rare occurrences of neuropsychiatric events (including confusion, delirium, hallucinations, and/or self-injury) have been reported primarily in pediatric patients from postmarketing surveillance; direct causation is difficult to establish (influenza infection may also be associated with behavioral and neurologic changes). Monitor closely for signs of any unusual behavior.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with chronic cardiac disease; efficacy has not been established.

• Hepatic impairment: Use with caution in patients with severe hepatic impairment; safety and efficacy have not been established.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment is required for creatinine clearance <30 mL/minute.

• Respiratory disease: Use with caution in patients with respiratory disease; efficacy has not been established.

Special populations:

• Immunocompromised patients: Use with caution in immunocompromised patients; safety and efficacy for treatment or prophylaxis in immunocompromised patients have not been established.

Other warnings/precautions:

• Appropriate use: Oseltamivir is not a substitute for the influenza virus vaccine. It has not been shown to prevent primary or concomitant bacterial infections that may occur with influenza virus. Antiviral treatment should begin within 48 hours of symptom onset. However, the CDC recommends that treatment may still be beneficial and should be started in hospitalized patients with severe, complicated or progressive illness if >48 hours. Nonhospitalized persons who are not at high risk for developing severe or complicated illness and who have a mild disease are not likely to benefit if treatment is started >48 hours after symptom onset. Nonhospitalized persons who are already beginning to recover do not need treatment.

Adverse Reactions

>10%: Gastrointestinal: Vomiting (2% to 15%)

1% to 10%:

Gastrointestinal: Nausea (4% to 10%), abdominal pain (2% to 5%), diarrhea (1% to 3%)

Ocular: Conjunctivitis (1%)

Respiratory: Epistaxis (1%)

<1%: Anemia, angina, fracture, peritonsillar abscess, pneumonia, pseudomembranous colitis, pyrexia

Postmarketing and/or case reports: Allergy, anaphylactic/anaphylactoid reaction, arrhythmia, confusion, dermatitis, diabetes aggravation, eczema, erythema multiforme, gastrointestinal bleeding, hemorrhagic colitis, hepatitis, hypothermia, liver function tests abnormal, neuropsychiatric events (abnormal behavior, agitation, anxiety, consciousness altered, confusion, delirium, delusion, hallucinations, nightmares, self-injury), rash, seizure, Stevens-Johnson syndrome, swelling of face or tongue, toxic epidermal necrolysis, urticaria

Metabolism/Transport Effects

None known.

Drug Interactions

Influenza Virus Vaccine (Live/Attenuated): Antiviral Agents (Influenza A and B) may diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Management: Avoid anti-influenza antivirals during the period beginning 48 hours prior to and ending 2 weeks after vaccine administration. Persons receiving these agents within 2 weeks of the live intranasal spray vaccine should receive a repeat vaccine dose. Risk D: Consider therapy modification

Probenecid: May increase serum concentrations of the active metabolite(s) of Oseltamivir. Management: Consider a change in therapy when using oseltamivir together with probenecid; reduced oseltamivir dose may be necessary. Increase monitoring for adverse events, such as thrombocytopenia. Risk D: Consider therapy modification

Storage

Capsules: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Oral suspension: Store powder for suspension at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Once reconstituted, store suspension under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. Use within 10 days of preparation if stored at room temperature or within 17 days of preparation if stored under refrigeration.

Reconstitution

Oral suspension:

New concentration (6 mg/mL): Reconstitute with 55 mL of water to a final concentration of 6 mg/mL (to make 60 mL total suspension).

Discontinued concentration (12 mg/mL): Reconstitute with 23 mL of water to a final concentration of 12 mg/mL (to make 25 mL total suspension).

Mechanism of Action

Oseltamivir, a prodrug, is hydrolyzed to the active form, oseltamivir carboxylate (OC). OC inhibits influenza virus neuraminidase, an enzyme known to cleave the budding viral progeny from its cellular envelope attachment point (neuraminic acid) just prior to release.

Pharmacodynamics/Kinetics

Absorption: Well absorbed

Distribution: V_d: 23-26 L (oseltamivir carboxylate)

Protein binding, plasma: Oseltamivir carboxylate: 3%; Oseltamivir: 42%

Metabolism: Hepatic (90%) to oseltamivir carboxylate; neither the parent drug nor active metabolite has any effect on the cytochrome P450 system

Bioavailability: 75% as oseltamivir carboxylate

Half-life elimination: Oseltamivir: 1-3 hours; Oseltamivir carboxylate: 6-10 hours

Excretion: Urine (>90% as oseltamivir carboxylate); feces

Dosage

Oral:

Influenza prophylaxis: Initiate prophylaxis within 48 hours of contact with an infected individual

Manufacturer's recommendation:

Children: 1-12 years:

≤15 kg: 30 mg once daily

>15 kg to ≤23 kg: 45 mg once daily

>23 kg to ≤40 kg: 60 mg once daily

>40 kg: 75 mg once daily

Adolescents ≥13 years and Adults: 75 mg once daily

Alternate recommendations:

Children 3-11 months (unlabeled dosing; AAP, 2010): Note: Dosing based on age (use only if weight not available)

3-5 months: 20 mg once daily

6-11 months: 25 mg once daily

Children <12 months (unlabeled dosing, CDC 2011): Note: Prophylaxis is not recommended for infants <3 months of age unless clinically critical; weight-based dosing recommendations are not intended for premature neonates: 3 mg/kg/dose once daily

Children 3-23 months (unlabeled dosing, IDSA/PIDS, 2011):

3-8 months: 3 mg/kg/dose once daily (do not exceed maximum dose of weight-based dosing)

9-23 months: 3.5 mg/kg/dose once daily (do not exceed maximum dose of weight-based dosing)

Prophylaxis duration:

Individual/household exposure: 10 days

Community/institutional outbreak:

Manufacturer recommendation: May be used for up to 6 weeks

Alternate recommendations: Continue for ≥2 weeks and until ~10 days after identification of illness onset in the last patient (CDC, 2011) or until influenza activity in community subsides or immunity obtained from immunization (IDSA/PIDS, 2011). During community outbreaks, duration of protection lasts for length of dosing period; safety and efficacy have been demonstrated for use up to 6 weeks in immunocompetent patients and safety has been demonstrated for use up to 12 weeks in patients who are immunocompromised.

Influenza treatment: Initiate treatment within 48 hours of onset of symptoms; duration of treatment: 5 days unless severely ill and hospitalized. Note: Hospitalized patients may require longer (eg, ≥10 days) treatment courses. Some experts also recommend empirically doubling the treatment dose. Doubling the dose in adult outpatients was not associated with increased adverse events. As no double-dose studies have been published in children, use caution. Initiate as early as possible in any hospitalized patient with suspected/confirmed influenza (CDC, 2011); may be administered via naso- or orogastric tube in mechanically-ventilated patients (Taylor, 2008).

Manufacturer's recommendation: Note: The following dosing is also supported by some clinicians (IDSA/PIDS, 2011):

Children: 1-12 years:

≤15 kg: 30 mg twice daily

>15 kg to ≤23 kg: 45 mg twice daily

>23 kg to ≤40 kg: 60 mg twice daily

>40 kg: 75 mg twice daily

Adolescents ≥13 years and Adults: 75 mg twice daily

Alternate recommendations:

Children <12 months (unlabeled dosing, CDC 2011): Note: Weight-based dosing recommendations are not intended for premature neonates: 3 mg/kg/dose twice daily.

Children <12 months (unlabeled dosing; AAP, 2010): Note: Dosing based on age (use only if weight not available):

<3 months: 12 mg twice daily

3-5 months: 20 mg twice daily

6-11 months: 25 mg twice daily

Children <24 months (unlabeled dosing; IDSA/PIDS, 2011): Note: Do not exceed maximum dose of weight-based dosing.

Infants, premature: 1 mg/kg/dose twice daily

0-8 months: 3 mg/kg/dose twice daily

9-23 months: 3.5 mg/kg/dose twice daily

Dosage adjustment in renal impairment:

Treatment: Adults:

U.S. labeling: Cl_cr 10-30 mL/minute: 75 mg once daily for 5 days

Canadian labeling:

Cl_cr >30-60 mL/minute: 30 mg twice daily for 5 days

Cl_cr 10-30 mL/minute: 30 mg once daily for 5 days

High-dose treatment (unlabeled [eg, severely-ill hospitalized patients with 2009 H1N1 influenza]): Currently no data are available; consider 150 mg once daily

Prophylaxis: Adults:

U.S. labeling: Cl_cr 10-30 mL/minute: 75 mg every other day or 30 mg once daily

Canadian labeling:

Cl_cr >30-60 mL/minute: 30 mg once daily for 10-14 days

Cl_cr 10-30 mL/minute: 30 mg every other day for 10-14 days

CAPD: Adults:

Unlabeled dose: 30 mg once weekly (Robson, 2006)

Canadian labeling (not in U.S. labeling):

Treatment: 30 mg prior to start of dialysis

Prophylaxis: 30 mg prior to start of dialysis, then 30 mg every 7 days for 10-14 days

Hemodialysis:

Children >1 year (unlabeled dose; Schreuder, 2010):

≤15 kg: 7.5 mg after each hemodialysis session

>15 kg to ≤23 kg: 10 mg after each hemodialysis session

>23 kg to ≤40 kg: 15 mg after each hemodialysis session

>40 kg: 30 mg after each hemodialysis session

Adults:

Unlabeled dose: 30 mg after every other session (Robson, 2006)

Canadian labeling (not in U.S. labeling):

Treatment: 30 mg prior to dialysis; if symptomatic between dialysis sessions, then administer 30 mg after each dialysis session over period of 5 days

Prophylaxis: 30 mg prior to dialysis, then 30 mg after every other dialysis session for period of 10-14 days

Dosage adjustment in hepatic impairment:

Mild-to-moderate impairment: No adjustment necessary

Severe impairment: Pharmacokinetics and safety have not been evaluated

Administration: Oral

May be administered without regard to meals; take with food to improve tolerance. Capsules may be opened and mixed with sweetened liquid (eg, chocolate syrup).

Administration: Other

Mechanically-ventilated critically-ill patients: May administer via naso- or orogastric (NG/OG) tube. For a 150 mg dose, dissolve powder from two 75 mg capsules in 20 mL of sterile water and inject down the NG/OG tube; follow with a 10 mL sterile water flush (Taylor, 2008).

Monitoring Parameters

Signs or symptoms of unusual behavior, including attempts at self-injury, confusion, and/or delirium

Critically-ill patients: Repeat rRT-PCR or viral culture may help to determine on-going viral replication

Dietary Considerations

Take without regard to meals; take with food to improve tolerance.

Patient Education

This is not a substitute for the flu shot. Must be taken within 2 days of contact with an infected individual or onset of flu symptoms (eg, fever, cough, headache, fatigue, muscular weakness, and sore throat). You may experience dizziness, nausea, vomiting, loose stools, headache, or feeling tired and weak. Report hallucinations, unusual behavior, or inability to think clearly.

Geriatric Considerations

Preferred influenza antiviral because of its ease of use compared to zanamivir and resistance associated with amantadine and rimantadine.

Additional Information

In clinical studies of the influenza virus, 1.3% of post-treatment isolates in adults and adolescents and 8.6% of isolates in children had decreased neuraminidase susceptibility in vitro to oseltamivir carboxylate.

The absence of symptoms does not rule out viral influenza infection and clinical judgment should guide the decision for therapy. Treatment should not be delayed while waiting for the results of diagnostic tests. Treatment should be considered for high-risk patients with symptoms despite a negative rapid influenza test when the illness cannot be contributed to another cause. Use of oseltamivir is not a substitute for vaccination (when available); susceptibility to influenza infection returns once therapy is discontinued.

Anesthesia and Critical Care Concerns/Other Considerations

2009 H1N1 Influenza: Clinical characteristics of 272 hospitalized patients who tested positive for the 2009 H1N1 influenza virus have been described (Jain, 2009). Of these patients, 67 (25%) were admitted to the ICU with 45 (67%) having an underlying medical condition (asthma/COPD: 28%; immunosuppression: 18%; pregnancy: 9%). Forty-two patients required mechanical ventilation, 24 had acute respiratory distress syndrome (ARDS), and 21 developed sepsis. There was no description of specific antiviral therapy for patients admitted to the ICU; however, of the total group, 188 received oseltamivir, 19 zanamivir, 13 amantadine/oseltamivir, and 14 rimantadine/oseltamivir. Of the ICU patients who received antiviral drugs (56/65, 86%; data not available in 2 patients), the median time to initiation was 6 days (range, 0 to 24 days); only 23% received antiviral drugs within 48 hours after onset of illness. Of the patients who expired (19/272, 7%), all were admitted to the ICU and required mechanical ventilation. These patients were less likely to have been vaccinated for seasonal influenza during the 2008-9 season and had a longer time between onset of illness and antiviral therapy initiation compared to non-ICU patients. In a multivariable analysis, the only variable associated with a positive outcome was initiation of antiviral therapy within 2 days after onset of illness. Also see http://www.cdc.gov/h1n1flu/EUA/peramivir_recommendations.htm

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 insomnia

Mental Health: Effects on Psychiatric Treatment

None reported

Nursing: Physical Assessment/Monitoring

Recommendations for antiviral susceptibility and effectiveness may change. Validate with the CDC recommendations for use prior to prescribing.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, oral, as phosphate:

Tamiflu®: 30 mg, 45 mg, 75 mg

Powder for suspension, oral:

Tamiflu®: 6 mg/mL (60 mL); 12 mg/mL (25 mL [DSC]) [contains sodium benzoate; tutti frutti flavor]

Pricing: U.S. (www.drugstore.com)

Capsules (Tamiflu)

30 mg (10): $110.08

45 mg (10): $110.08

75 mg (10): $110.99

Suspension (reconstituted) (Tamiflu)

12 mg/mL (25): $53.54

Extemporaneously Prepared

If the commercially prepared oral suspension is not available, the manufacturer provides the following compounding information to prepare a 6 mg/mL suspension in emergency situations.

1. Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle.

2. Carefully separate the capsule body and cap and pour the contents of the required number of 75 mg capsules into the PET or glass bottle.

3. Gently swirl the suspension to ensure adequate wetting of the powder for at least 2 minutes.

4. Slowly add the specified amount of vehicle to the bottle.

5. Close the bottle using a child-resistant cap and shake well for 30 seconds to completely dissolve the active drug.

6. Label “Shake Well Before Use.”

Stable for 35 days refrigerated or 5 days at room temperature. Shake gently prior to use. Do not dispense with dosing device provided with commercially-available product.

References

American Academy of Pediatrics, Committee on Infectious Diseases, “Policy, Statement -- Recommendations for Prevention and Control of influenza in Children, 2010-2011,” Pediatrics, 2010, 126(4):816-26.

Bradley JS, Byington CL, Shah SS, et al. “The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age: Clinical Practice Guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America”, Clin Infect Dis, 2011, 53(7):e25-76.

Centers for Disease Control and Prevention, “Intensive-Care Patients With Severe Novel Influenza A (H1N1) Virus Infection - Michigan, June 2009,” MMWR Morb Mortal Wkly Rep, 2009, 58(27):749-52. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5827a4.htm

Centers for Disease Control and Prevention (CDC), "Influenza Division, National Center for Immunization and Respiratory Diseases. Antiviral Agents for the Treatment and Chemoprophylaxis of Influenza --- Recommendations of the Advisory Committee on Immunization Practices (ACIP)," MMWR Surveill Summ, 2011, 60(1):1-28.

Harper SA, Bradley JS, Englund JA, et al, “Seasonal Influenza in Adults and Children--Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management: Clinical Practice Guidelines of the Infectious Diseases Society of America,” Clin Infect Dis, 2009, 48(8):1003-32.

He G, Massarella J, and Ward P, “Clinical Pharmacokinetics of the Prodrug Oseltamivir and Its Active Metabolite Ro 64-0802,” Clin Pharmacokinet, 1999, 37(6):471-84.

Jain S, Kamimoto L, Bramley AM, et al, “Hospitalized Patients With 2009 H1N1 Influenza in the United States, April-June 2009,” N Engl J Med, 2009, 361(20):1935-44.

Okumura A, Kubota T, and Kato T, “Oseltamivir and Delirious Behavior in Children With Influenza,” Pediatr Infect Dis J, 2006, 25(6):572.

Robson R, Buttimore A, Lynn K, et al, “The Pharmacokinetics and Tolerability of Oseltamivir Suspension in Patients on Haemodialysis and Continuous Ambulatory Peritoneal Dialysis,” Nephrol Dial Transplant, 2006, 21(9):2556-62.

Schreuder MF, van der Flier M, Knops NB, et al, “Oseltamivir Dosing in Children Undergoing Hemodialysis,” Clin Infect Dis, 2010, 50(10):1427-8.

Taylor WRJ, Thinh BN, Anh GT, et al, “Oseltamivir is Adequately Absorbed Following Nasogastric Administration to Adult Patients With Severe H5N1 Influenza,” PLoS One, 2008, 3(10):e3410.

Wentges-van Holthe N, van Eijkeren M, and van der Laan JW, “Oseltamivir and Breastfeeding,” Int J Infect Dis, 2008, 12(4):451.

International Brand Names

• Ao Er Fei (CL)
• Omiflu (MY)
• Tamiflu (AR, AT, AU, BE, BG, BR, CH, CL, CN, CO, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, HK, HN, HU, IE, IL, IT, JP, KP, MT, MX, NL, NO, NZ, PE, PH, PK, PL, PT, PY, RU, SE, SG, SK, TH, TR, UY)

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Last full review/revision January 2012