580 Bacterial infection BNF 78
For healthcare workers who are immunocompromised,
follow standard advice for testing and treatment (see
Chemoprophylaxis for latent tuberculosis
Chemoprophylaxis involves use of either isoniazid p. 587
(with pyridoxine hydrochloride p. 1080) alone for six months
(recommended if interactions with rifamycins are a concern)
or rifampicin p. 582 and isoniazid (with pyridoxine
hydrochloride) for three months (recommended when
Choice of regimen is dependent on clinical factors,
including age, risk of hepatotoxicity and possible drug
interactions. Testing for HIV, hepatitis B and hepatitis C
should be offered before starting antituberculosis treatment
as this may affect choice of therapy.
Patients with severe liver disease should be treated under
the care of a specialist team; careful monitoring of liver
function is necessary in patients with non-severe liver
disease, abnormal liver function, or who misuse alcohol or
See advice on immunisation against tuberculosis in BCG
Major causes of treatment failure are incorrect prescribing by
the physician and inadequate compliance by the patient.
Monthly tablet counts and urine examination (rifampicin
imparts an orange-red coloration) may be useful indicators
of compliance with treatment. Avoid both excessive and
inadequate dosage. Treatment should be supervised by a
A break in antituberculosis treatment of at least two weeks
(during the initial phase) or missing more than 20 % of
is key to ensuring treatment success without relapse, drug
resistance or further adverse events. If an adverse reaction
recurs upon re-introducing a particular drug, do not give
that drug in future regimens and consider extending the
Treatment interruptions due to drug-induced hepatotoxicity
Following treatment interruption due to drug-induced
hepatotoxicty, all potential causes of hepatotoxicity should
be investigated. Once hepatic function has recovered,
than ten days, initially with ethambutol hydrochloride p. 586
and either isoniazid (with pyridoxine hydrochloride) or
In patients with severe or highly infectious tuberculosis
who need to interrupt the standard regimen, consider
continuing treatment with at least two drugs with low risk of
hepatotoxicity, such as ethambutol hydrochloride and
streptomycin p. 520 (with or without a quinolone, such as
levofloxacin p. 559 or moxifloxacin p. 560), with ongoing
monitoring by a liver specialist.
Treatment interruptions due to cutaneous reactions
If a patient with severe or highly infectious tuberculosis has
a cutaneous reaction, consider continuing treatment with a
combination of at least two drugs with low risk for causing
cutaneous reactions, such as ethambutol hydrochloride and
streptomycin, with monitoring by a dermatologist.
Isoniazid is cheap and highly effective. Like rifampicin it
should always be included in any antituberculosis regimen
unless there is a specific contra-indication.
Rifampicin, a rifamycin, is a key component of any
antituberculosis regimen. Like isoniazid it should always be
included unless there is a specific contra-indication.
During the first two months (‘initial phase’) of rifampicin
administration transient disturbance of liver function with
elevated serum transaminases is common but generally does
not require interruption of treatment. Occasionally more
serious liver toxicity requires a change of treatment
particularly in those with pre-existing liver disease.
On intermittent treatment six toxicity syndromes have
been recognised—influenza-like, abdominal, and respiratory
symptoms, shock, renal failure, and thrombocytopenic
purpura—and can occur in 20–30% of patients.
Rifabutin p. 575, another rifamycin, is indicated for
prophylaxis against M. avium complex infections in patients
with a low CD4 count; it is also licensed for the treatment of
non-tuberculous mycobacterial disease and pulmonary
Pyrazinamide p. 588 is a bactericidal drug only active
against intracellular dividing forms of Mycobacterium
tuberculosis; it exerts its main effect only in the first two or
three months. It is particularly useful in tuberculous
meningitis because of good meningeal penetration. It is not
Ethambutol hydrochloride is included in a treatment
regimen if isoniazid resistance is suspected; it can be
omitted if the risk of resistance is low.
Streptomycin [unlicensed] is now rarely used in the UK
except for resistant organisms.
Drug-resistant tuberculosis should be treated by a specialist
physician with experience in such cases, and where
with or without any other resistance) requires treatment with
at least six antituberculosis drugs to which the
mycobacterium is likely to be sensitive. Testing for
resistance to second-line drugs is recommended and
treatment should be modified according to susceptibility.
The risk of resistance is minimised by ensuring therapy is
administered in the correct dose and combination for the
Second-line drugs available for infections caused by
resistant organisms, or when first-line drugs cause
unacceptable side-effects, include aminosalicylic acid p. 584,
amikacin p. 518, capreomycin p. 585, cycloserine p. 585,
newer macrolides (e.g. azithromycin p. 536 and
clarithromycin p. 538), moxifloxacin and protionamide
(prothionamide; no longer on UK market). Bedaquiline
p. 585 and delamanid p. 586 are licensed for the treatment of
multiple-drug resistant pulmonary tuberculosis. Bedaquiline
Single drug-resistant tuberculosis
For single drug-resistance the following treatment regimens
. First two months (initial phase): rifampicin, pyrazinamide
. Continue with (continuation phase): rifampicin and
ethambutol hydrochloride for seven months (up to ten
. First two months (initial phase): rifampicin, ethambutol
hydrochloride and isoniazid (with pyridoxine
. Continue with (continuation phase): rifampicin and
isoniazid (with pyridoxine hydrochloride) for seven
Resistance to ethambutol hydrochloride:
. First two months (initial phase): rifampicin, pyrazinamide
and isoniazid (with pyridoxine hydrochloride)
. Continue with (continuation phase): rifampicin and
isoniazid (with pyridoxine hydrochloride) for four months
Resistance to rifampicin below:
. Offer treatment with at least six antituberculosis drugs to
which the mycobacterium is likely to be sensitive.
Management of tuberculosis in children
Children are given isoniazid p. 587, rifampicin, pyrazinamide
p. 588, and ethambutol hydrochloride p. 586 for the first two
months followed by isoniazid and rifampicin during the next
four months. However, care is needed in young children
receiving ethambutol hydrochloride because of the difficulty
in testing eyesight and in obtaining reports of visual
ANTIMYCOBACTERIALS › RIFAMYCINS
Brucellosis in combination with other antibacterials |
Legionnaires disease in combination with other
antibacterials | Serious staphylococcal infections in
combination with other antibacterials
▶ BY MOUTH, OR BY INTRAVENOUS INFUSION
▶ Child 1–11 months: 5–10 mg/kg twice daily
▶ Child 1–17 years: 10 mg/kg twice daily (max. per dose
▶ Adult: 0.6–1.2 g daily in 2–4 divided doses
Endocarditis in combination with other drugs
▶ BY MOUTH, OR BY INTRAVENOUS INFUSION
▶ Adult: 0.6–1.2 g daily in 2–4 divided doses
Tuberculosis, in combination with other drugs
(intermittent supervised 6-month treatment) (under
▶ Child: 15 mg/kg 3 times a week (max. per dose 900 mg)
for 6 months (initial and continuation phases)
▶ Adult: 600–900 mg 3 times a week for 6 months (initial
Tuberculosis, in combination with other drugs (standard
unsupervised 6-month treatment)
▶ Child (body-weight up to 50 kg): 15 mg/kg once daily for
6 months (initial and continuation phases); maximum
▶ Child (body-weight 50 kg and above): 15 mg/kg once daily
for 6 months (initial and continuation phases);
▶ Adult (body-weight up to 50 kg): 450 mg once daily for
6 months (initial and continuation phases)
▶ Adult (body-weight 50 kg and above): 600 mg once daily
for 6 months (initial and continuation phases)
Prevention of tuberculosis in susceptible close contacts or
those who have become tuberculin positive, in
▶ Child 1 month–11 years (body-weight up to 50 kg):
15 mg/kg daily for 3 months; maximum 450 mg per day
▶ Child 1 month–11 years (body-weight 50 kg and above):
15 mg/kg daily for 3 months; maximum 600 mg per day
▶ Child 12–17 years (body-weight up to 50 kg): 450 mg daily
▶ Child 12–17 years (body-weight 50 kg and above): 600 mg
▶ Adult (body-weight up to 50 kg): 450 mg daily for
▶ Adult (body-weight 50 kg and above): 600 mg daily for
Prevention of tuberculosis in susceptible close contacts or
those who have become tuberculin positive, who are
▶ Child 1 month–11 years (body-weight up to 50 kg):
15 mg/kg daily for 6 months; maximum 450 mg per day
▶ Child 1 month–11 years (body-weight 50 kg and above):
15 mg/kg daily for 6 months; maximum 600 mg per day
▶ Child 12–17 years (body-weight up to 50 kg): 450 mg daily
▶ Child 12–17 years (body-weight 50 kg and above): 600 mg
Prevention of tuberculosis in susceptible close contacts or
those who have become tuberculin positive, who are
isoniazid-resistant and under 35 years
▶ Adult 18–34 years (body-weight up to 50 kg): 450 mg daily
▶ Adult 18–34 years (body-weight 50 kg and above): 600 mg
Prevention of secondary case of Haemophilus influenzae
▶ Child 1–2 months: 10 mg/kg once daily for 4 days
▶ Child 3 months–11 years: 20 mg/kg once daily (max. per
▶ Child 12–17 years: 600 mg once daily for 4 days
▶ Adult: 600 mg once daily for 4 days
Prevention of secondary case of meningococcal meningitis
▶ Child 1–11 months: 5 mg/kg every 12 hours for 2 days
▶ Child 1–11 years: 10 mg/kg every 12 hours (max. per dose
▶ Child 12–17 years: 600 mg every 12 hours for 2 days
▶ Adult: 600 mg every 12 hours for 2 days
Multibacillary leprosy in combination with dapsone and
clofazimine (3-drug regimen)| Paucibacillary leprosy in
combination with dapsone (2-drug regimen)
▶ Adult (body-weight up to 35 kg): 450 mg once a month,
▶ Adult (body-weight 35 kg and above): 600 mg once a
month, supervised administration
l CONTRA-INDICATIONS Acute porphyrias p. 1058 . jaundice
l CAUTIONS Discolours soft contact lenses
l INTERACTIONS → Appendix 1: rifampicin
▶ Common or very common Nausea .thrombocytopenia . vomiting
▶ Uncommon Diarrhoea . leucopenia
▶ Frequency not known Abdominal discomfort. acute kidney
injury . adrenal insufficiency . agranulocytosis . appetite
582 Bacterial infection BNF 78
SIDE-EFFECTS, FURTHER INFORMATION Side-effects that
respiratory symptoms (including shortness of breath),
collapse and shock, haemolytic anaemia,
thrombocytopenic purpura, and acute renal failure.
Discontinue if serious side-effects develop.
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated in
patients with rifamycin hypersensitivity.
l CONCEPTION AND CONTRACEPTION
Important Effectiveness of hormonal contraceptives is
reduced and alternative family planning advice should be
l PREGNANCY Manufacturers advise very high doses
teratogenic in animal studies in first trimester; risk of
neonatal bleeding may be increased in third trimester.
l BREAST FEEDING Amount too small to be harmful.
l HEPATIC IMPAIRMENT Manufacturer advises caution—
monitor liver function weekly for two weeks, then every
two weeks for the next six weeks.
Dose adjustments Manufacturer advises maximum 8 mg/kg
▶ In children Use with caution if doses above 10 mg/kg daily.
▶ In adults Use with caution if dose above 600 mg daily.
▶ Renal function should be checked before treatment.
▶ Hepatic function should be checked before treatment. If
there is no evidence of liver disease (and pre-treatment
liver function is normal), further checks are only necessary
if the patient develops fever, malaise, vomiting, jaundice
or unexplained deterioration during treatment. However,
liver function should be monitored on prolonged therapy.
▶ Blood counts should be monitored in patients on
▶ In adults Those with alcohol dependence should have
frequent checks of hepatic function, particularly in the
first 2 months. Blood counts should also be monitored in
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use in adults For intravenous infusion
(Rifadin ®), give intermittently in Glucose 5% or Sodium
chloride 0.9%; reconstitute with solvent provided then
dilute with 500 mL infusion fluid; give over 2–3 hours.
▶ With intravenous use in children Displacement value may be
significant, consult local reconstitution guidelines;
reconstitute with solvent provided. May be further diluted
with Glucose 5% or Sodium chloride 0.9% to a final
concentration of 1.2 mg/mL. Infuse over 2–3 hours.
l PRESCRIBING AND DISPENSING INFORMATION If treatment
interruption occurs, re-introduce with low dosage and
Flavours of syrup may include raspberry.
▶ With oral use in children In general, doses should be rounded
up to facilitate administration of suitable volumes of liquid
or an appropriate strength of tablet. Doses may also need
to be recalculated to allow for weight gain in younger
Soft contact lenses Patients or their carers should be advised
that rifampicin discolours soft contact lenses.
Hepatic disorders Patients or their carers should be told how
to recognise signs of liver disorder, and advised to
discontinue treatment and seek immediate medical
attention if symptoms such as persistent nausea,
vomiting, malaise or jaundice develop.
Medicines for Children leaflet: Rifampicin for meningococcal
prophylaxis www.medicinesforchildren.org.uk/rifampicinmeningococcal-prophylaxis
Medicines for Children leaflet: Rifampicin for the treatment of
tuberculosis www.medicinesforchildren.org.uk/rifampicintreatment-tuberculosis
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
CAUTIONARY AND ADVISORY LABELS 8, 14, 23
EXCIPIENTS: May contain Sucrose
Rifampicin 20 mg per 1 ml Rifadin 100mg/5ml syrup | 120 ml P £4.27 DT = £4.27
CAUTIONARY AND ADVISORY LABELS 8, 14, 23
▶ Rifampicin (Non-proprietary)
Rifampicin 150 mg Rifampicin 150mg capsules | 100 capsule P £50.49 DT = £50.49
Rifampicin 300 mg Rifampicin 300mg capsules | 100 capsule P £123.89 DT = £123.89
Rifampicin 150 mg Rifadin 150mg capsules | 100 capsule P £18.32 DT = £50.49
Rifampicin 300 mg Rifadin 300mg capsules | 100 capsule P £36.63 DT = £123.89
Rifampicin 300 mg Rimactane 300mg capsules | 60 capsule P £21.98
Powder and solvent for solution for infusion
ELECTROLYTES: May contain Sodium
Rifampicin 600 mg Rifadin 600mg powder and solvent for solution
for infusion vials | 1 vial P £9.20
Rifampicin with ethambutol, isoniazid
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, rifampicin p. 582, ethambutol hydrochloride
p. 586, isoniazid p. 587, pyrazinamide p. 588.
Initial treatment of tuberculosis
▶ Adult (body-weight 30–39 kg): 2 tablets daily for
▶ Adult (body-weight 40–54 kg): 3 tablets daily for
▶ Adult (body-weight 55–69 kg): 4 tablets daily for
▶ Adult (body-weight 70 kg and above): 5 tablets daily for
DOSE EQUIVALENCE AND CONVERSION
▶ Tablet quantities refer to the number of Voractiv ®
Tablets which should be taken. Each Voractiv ® Tablet
contains ethambutol hydrochloride 275 mg, isoniazid
75 mg, pyrazinamide 400 mg and rifampicin 150 mg.
Peripheral neuropathy The risk of peripheral neuropathy
may be increased by high doses of isoniazid; pyridoxine
should, therefore, be considered for those receiving
l INTERACTIONS → Appendix 1: ethambutol . isoniazid . pyrazinamide .rifampicin
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 8, 14, 22
▶ Voractiv (Genus Pharmaceuticals Ltd)
Isoniazid 75 mg, Rifampicin 150 mg, Ethambutol hydrochloride
275 mg, Pyrazinamide 400 mg Voractiv tablets | 60 tablet P £39.50
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, rifampicin p. 582, isoniazid p. 587.
Treatment of tuberculosis (continuation phase)
▶ Adult (body-weight up to 50 kg): 450/300 mg daily for
4 months (continuation phase after 2-month initial
phase), use Rifinah ® 150/100 Tablets, preferably taken
▶ Adult (body-weight 50 kg and above): 600/300 mg daily
for 4 months (continuation phase after 2-month initial
phase), use Rifinah ® 300/150 Tablets, preferably taken
DOSE EQUIVALENCE AND CONVERSION
▶ Rifinah ® Tablets contain rifampicin and isoniazid; the
proportions are expressed in the form x/y where x and y
are the strengths in milligrams of rifampicin and
▶ Each Rifinah ® 150/100 Tablet contains rifampicin
▶ Each Rifinah ® 300/150 Tablet contains rifampicin
l INTERACTIONS → Appendix 1: isoniazid .rifampicin
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 8, 14, 23
Isoniazid 100 mg, Rifampicin 150 mg Rifinah 150mg/100mg
tablets | 84 tablet P £19.09 DT = £19.09
Isoniazid 150 mg, Rifampicin 300 mg Rifinah 300mg/150mg
tablets | 56 tablet P £25.22 DT = £25.22
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, rifampicin p. 582, isoniazid p. 587,
Initial unsupervised treatment of tuberculosis (in
▶ Adult (body-weight up to 40 kg): 3 tablets daily for
2 months (initial phase), use Rifater ® Tablets,
preferably taken before breakfast.
▶ Adult (body-weight 40–49 kg): 4 tablets daily for
2 months (initial phase), use Rifater ® Tablets,
preferably taken before breakfast.
▶ Adult (body-weight 50–64 kg): 5 tablets daily for
2 months (initial phase), use Rifater ® Tablets,
preferably taken before breakfast.
▶ Adult (body-weight 65 kg and above): 6 tablets daily for
2 months (initial phase), use Rifater ® Tablets,
preferably taken before breakfast.
DOSE EQUIVALENCE AND CONVERSION
▶ Tablet quantities refer to the number of Rifater ®
Tablets which should be taken. Each Rifater ® Tablet
contains isoniazid 50 mg, pyrazinamide 300 mg and
l INTERACTIONS → Appendix 1: isoniazid . pyrazinamide . rifampicin
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 8, 14, 22
Isoniazid 50 mg, Rifampicin 120 mg, Pyrazinamide
300 mg Rifater tablets | 100 tablet P £26.34
Aminosalicylic acid 28-May-2018
Multiple-drug resistant tuberculosis, in combination with
▶ Adult: 4 g every 8 hours for a usual treatment duration
of 24 months; maximum 12 g per day
▶ Adult: (consult product literature)
l INTERACTIONS → Appendix 1: aminosalicylic acid
▶ Common or very common Diarrhoea . gastrointestinal
discomfort. nausea . skin reactions . vestibular syndrome . vomiting
metallic .tendon pain .thrombocytopenia . visual
▶ Frequency not known Hypersensitivity
l PREGNANCY Manufacturer advises avoid unless
essential—toxicity in animal studies (highest risk during
l BREAST FEEDING Present in milk—manufacturer advises
l HEPATIC IMPAIRMENT Manufacturer advises use with
l RENAL IMPAIRMENT Use with caution in mild to moderate
impairment. Avoid in severe impairment due to
accumulation of inactive metabolites.
▶ Monitor for hypersensitivity reaction during the first
3 months of treatment—for desensitisation dosing
regimen consult product literature.
▶ Monitor liver function—discontinue immediately if signs
or symptoms of hepatic toxicity (including rash, fever and
gastrointestinal disturbance).
l DIRECTIONS FOR ADMINISTRATION Disperse granules in
orange or tomato juice and take immediately (granules will
not dissolve, ensure all granules are swallowed). Granules
can be sprinkled on apple sauce or yoghurt for
584 Bacterial infection BNF 78
l PATIENT AND CARER ADVICE Patients should be advised
that the skeletons of the granules may be seen in the
stools. Counselling advised on administration.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 9, 25
▶ Granupas (Lucane Pharma Ltd)
Aminosalicylic acid 1 gram per 1 gram Granupas gastro-resistant
granules 4g sachets sugar-free | 30 sachet P £331.00
Multiple-drug resistant pulmonary tuberculosis, in
▶ Adult: Initially 400 mg once daily for 2 weeks, then
200 mg 3 times a week for 22 weeks, intervals of at least
48 hours between each dose, continue appropriate
combination therapy after bedaquiline
l CONTRA-INDICATIONS QTc interval more than
500 milliseconds (derived using Fridericia’s formula). ventricular arrhythmia
l CAUTIONS Hypothyroidism . QTc interval (derived using
Fridericia’s formula) 450–500 milliseconds—discontinue if
QTc interval more than 500 milliseconds .risk factors for
QT interval prolongation (e.g. electrolyte disturbances,
heart failure with reduced left ventricular ejection fraction,
history of symptomatic arrhythmias (avoid if ventricular
arrhythmia present), bradycardia, congenital long QT
l INTERACTIONS → Appendix 1: bedaquiline
SIDE-EFFECTS, FURTHER INFORMATION If syncope occurs,
l PREGNANCY Manufacturer advises avoid unless potential
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment; avoid in severe impairment—no
l RENAL IMPAIRMENT Manufacturer advises caution if eGFR
less than 30 mL/minute/1.73 m2
▶ Determine serum potassium, calcium, and magnesium
before starting treatment (correct if abnormal)—
remeasure if QT prolongation occurs during treatment.
▶ Obtain ECG before starting treatment, and then at least
monthly during treatment or more frequently if
concomitant use with other drugs known to prolong the
▶ Monitor liver function before starting treatment and then
at least monthly during treatment—discontinue treatment
if severe abnormalities in liver function tests.
Missed doses If a dose is missed during the first two weeks
of treatment, the missed dose should not be taken and the
next dose should be taken at the usual time; if a dose is
missed during weeks 3–24 of treatment, the missed dose
should be taken as soon as possible and then the usual
Driving and skilled tasks Dizziness may affect performance
of skilled tasks (e.g. driving)
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 4, 8, 21
▶ Sirturo (Janssen-Cilag Ltd) A
Bedaquiline (as Bedaquiline fumarate) 100 mg Sirturo 100mg
tablets | 188 tablet P £18,700.00
Tuberculosis resistant to first-line drugs, in combination
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: 1 g daily (max. per dose 20 mg/kg) for
2–4 months, then reduced to 1 g 2–3 times a week
l CAUTIONS Auditory impairment
l INTERACTIONS → Appendix 1: capreomycin
l SIDE-EFFECTS Eosinophilia .febrile disorders . hearing
l PREGNANCY Manufacturer advises use only if potential
benefit outweighs risk—teratogenic in animal studies.
l BREAST FEEDING Manufacturer advises caution—no
l RENAL IMPAIRMENT Nephrotoxic; ototoxic.
Dose adjustments Reduce dose—consult product literature.
l MONITORING REQUIREMENTS Monitor renal, hepatic,
auditory, and vestibular function and electrolytes.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for injection
▶ Capreomycin (Non-proprietary)
Capreomycin (as Capreomycin sulfate) 1 gram Capreomycin 1g
powder for solution for injection vials | 1 vial P £31.47
Tuberculosis resistant to first-line drugs, in combination
▶ Adult: Initially 250 mg every 12 hours for 2 weeks, then
increased if necessary up to 500 mg every 12 hours,
dose to be increased according to blood concentration
▶ Cycloserine penetrates the CNS.
l CONTRA-INDICATIONS Alcohol dependence . depression . epilepsy . psychotic states . severe anxiety
l INTERACTIONS → Appendix 1: cycloserine
SIDE-EFFECTS, FURTHER INFORMATION CNS toxicity
Discontinue or reduce dose if symptoms of CNS toxicity
Rashes or allergic dermatitis Discontinue or reduce
dose if rashes or allergic dermatitis develop.
l PREGNANCY Manufacturer advises use only if potential
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