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HIGHLIGHTS OF PRESCRIBING INFORMATION
------------------------ WARNINGS AND PRECAUTIONS ---------------------
These highlights do not include all the information needed to use
DICLEGIS safely and effectively. See full prescribing information for

 Activities requiring mental alertness: Avoid engaging in activities DICLEGIS.
requiring complete mental alertness, such as driving or operating heavy machinery, while using DICLEGIS until cleared to do so by a healthcare DICLEGIS (doxylamine succinate and pyridoxine hydrochloride)
delayed-release tablets, for oral use.
Initial U.S. Approval: 1976

 Central nervous system (CNS) depressants: Concurrent use with alcohol or other CNS depressants is not recommended (5.1) ---------------------------- INDICATIONS AND USAGE --------------------------
 Anticholinergic actions: Use with caution in patients with asthma, DICLEGIS is a fixed dose combination drug product of doxylamine succinate, increased intraocular pressure, narrow angle glaucoma, stenosing peptic an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. (1) ------------------------------- ADVERSE REACTIONS ----------------------------
----------------------- DOSAGE AND ADMINISTRATION ----------------------
The most common adverse reaction with DICLEGIS (≥5 percent and Take two tablets daily at bedtime. If symptoms are not adequately controlled, exceeding the rate in placebo) is somnolence. (6) the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime) as described To report SUSPECTED ADVERSE REACTIONS, contact Duchesnay
in the full prescribing information. (2) Inc. at 1-855-722-7734 or medicalinfo@duchesnayusa.com or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
---------------------- DOSAGE FORMS AND STRENGTHS -------------------
------------------------------- DRUG INTERACTIONS ----------------------------
Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. (3)  Severe drowsiness can occur when used in combination with alcohol or -------------------------------CONTRAINDICATIONS-----------------------------
------------------------USE IN SPECIFIC POPULATIONS----------------------
 Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive Pregnancy Category A. DICLEGIS is intended for use in pregnant women.  Monoamine oxidase (MAO) inhibitors (4, 7) See 17 for PATIENT COUNSELING INFORMATION and FDA-
approved patient labeling.

Revised: 04/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
INDICATIONS AND USAGE
10 OVERDOSAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
11 DESCRIPTION
CONTRAINDICATIONS
12 CLINICAL PHARMACOLOGY
WARNINGS AND PRECAUTIONS
5.1 Activities Requiring Mental Alertness 13 NONCLINICAL TOXICOLOGY
ADVERSE REACTIONS
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
DRUG INTERACTIONS
17 PATIENT COUNSELING INFORMATION
USE IN SPECIFIC POPULATIONS
*Sections or subsections omitted from the full prescribing information are not

FULL PRESCRIBING INFORMATION
1 INDICATIONS


DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to
conservative management.
Limitations of Use

DICLEGIS has not been studied in women with hyperemesis gravidarum.

2

DOSAGE AND ADMINISTRATION

2.1 Dosage Information
Initially, take two DICLEGIS delayed-release tablets orally at bedtime (Day 1). If this dose adequately controls
symptoms the next day, continue taking two tablets daily at bedtime. However, if symptoms persist into the
afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on
Day 3 (one tablet in the morning and two tablets at bedtime). If these three tablets adequately control symptoms
on Day 4, continue taking three tablets daily. Otherwise take four tablets starting on Day 4 (one tablet in the
morning, one tablet mid-afternoon and two tablets at bedtime).
The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at
bedtime) daily.
Take on an empty stomach with a glass of water [see Clinical Pharmacology (12.3)]. Swallow tablets whole. Do
not crush, chew, or split DICLEGIS tablets.
Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for
DICLEGIS as her pregnancy progresses.
3
DOSAGE FORMS AND STRENGTHS

DICLEGIS delayed-release tablets are white, round, film coated tablets containing 10 mg doxylamine succinate
and 10 mg pyridoxine hydrochloride. The tablets are imprinted with the pink image of a pregnant woman on
one side.
4 CONTRAINDICATIONS
DICLEGIS is contraindicated in women with any of the following conditions:
 Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation  Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of DICLEGIS [see Drug Interactions (7.1)]. WARNINGS AND PRECAUTIONS

5.1 Activities Requiring Mental Alertness
DICLEGIS may cause somnolence due to the anticholinergic properties of doxylamine succinate, an
antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving
or operating heavy machinery, while using DICLEGIS until cleared to do so by their healthcare provider.
DICLEGIS use is not recommended if a woman is concurrently using central nervous system (CNS)
depressants including alcohol. The combination may result in severe drowsiness leading to falls or accidents
[see Drug Interactions (7.1)].

5.2 Concomitant Medical Conditions
DICLEGIS has anticholinergic properties and, therefore, should be used with caution in women with: asthma,
increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and
urinary bladder-neck obstruction.
6 ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere in the labeling:
 Somnolence [see Warnings and Precautions (5.1)]
 Falls or other accidents resulting from the effect of the combined use of DICLEGIS with CNS depressants including alcohol [see Warnings and Precautions (5.1)]
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in clinical practice.
The safety and efficacy of DICLEGIS were compared to placebo in a double-blind, randomized, multi-center
trial in 261 women with nausea and vomiting of pregnancy. The mean gestational age at enrollment was 9.3
weeks, range 7 to 14 weeks gestation [see Clinical Studies (14)]. Adverse reactions for DICLEGIS that
occurred at an incidence ≥5 percent and exceeded the incidence for placebo are summarized in Table 1.
Table 1: Number (Percent) of Subjects with ≥ 5 Percent Adverse Reactions in a 15-Day Placebo-
Controlled Study of DICLEGIS (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent
and at a Higher Incidence with DIGLEGIS than Placebo are Shown)


6.2 Postmarketing Experience

The following adverse events, listed alphabetically, have been identified during post-approval use of the
combination of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure.

Cardiac disorders: dyspnea, palpitation, tachycardia
Ear and labyrinth disorders: vertigo
Eye disorders: vision blurred, visual disturbances
Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, diarrhea
General disorders and administration site conditions: chest discomfort, fatigue, irritability, malaise
Immune system disorders: hypersensitivity
Nervous system disorders: dizziness, headache, migraines, paresthesia, psychomotor hyperactivity
Psychiatric disorders: anxiety, disorientation, insomnia, nightmares
Renal and urinary disorders: dysuria, urinary retention
Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, rash, rash maculo-papular

7 DRUG

INTERACTIONS

7.1 Drug Interactions
Use of DICLEGIS is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which
prolong and intensify the anticholinergic (drying) effects of antihistamines. Concurrent use of alcohol and other
CNS depressants (such as hypnotic sedatives and tranquilizers) with DICLEGIS is not recommended.
7.2 Drug-Food Interactions
A food-effect study demonstrated that the delay in the onset of action of DICLEGIS may be further delayed,
and a reduction in absorption may occur when tablets are taken with food [see Dosage and Administration (2),
Clinical Pharmacology (12.3)]
. Therefore, DICLEGIS should be taken on an empty stomach with a glass of
water [see Dosage and Administration (2)].
8
USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category A

DICLEGIS is intended for use in pregnant women.
The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many
epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. A
meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991 reported no increased
risk for malformations from first trimester exposures to doxylamine succinate and pyridoxine hydrochloride,
with or without dicyclomine hydrochloride. A second meta-analysis of 12 cohort and 5 case-control studies
published between 1963 and 1985 reported no statistically significant relationships between fetal abnormalities
and the first trimester use of the combination doxylamine succinate and pyridoxine hydrochloride with or
without dicyclomine hydrochloride.

Animal Data
The effects of doxylamine succinate and pyridoxine hydrochloride on embryofetal development have been
studied in rats and monkeys.
Once daily treatment of pregnant rats with doxylamine succinate and pyridoxine hydrochloride during
organogenesis (gestational day (GD) 6-15) resulted in increased fetal resorptions, decreased fetal body weight
and increased skeletal variations with reduced ossification at doses 60 to 100 times the highest clinical dose
based on body surface area.
Pregnant cynomolgus monkeys were treated once daily with doxylamine succinate and pyridoxine
hydrochloride during organogenesis (GD 22-50). At birth, there were no observed malformations, and no
evidence of embryo, fetal or maternal toxicity at doses up to 3.2 times the highest proposed clinical dose based
on body surface area. In a similarly designed study in pregnant cynomolgus and rhesus monkeys and baboons,
ventricular septal defects (VSDs) were observed in the preterm (GD 100) fetuses. Doses used in this study were
0.5-20 times higher than the clinical dose based on body surface area, with no relationship between dose and
incidence of VSD. There were no VSDs in infant monkeys at term. No VSDs were observed at GD 100 in
cynomolgus monkeys administered the combination of doxylamine succinate and pyridoxine hydrochloride for
4-day periods between 22 and 41 days of gestation.
8.3 Nursing Mothers
Women should not breastfeed while using DICLEGIS.
The molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected.
Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine
succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable
to the sedative effects of DICLEGIS resulting in worsening of their apnea or respiratory conditions.
Pyridoxine hydrochloride is excreted into breast milk. There have been no reports of adverse events in infants
presumably exposed to pyridoxine hydrochloride through breast milk.
8.4 Pediatric Use
The safety and effectiveness of DICLEGIS in children under 18 years of age have not been established.

Fatalities have been reported from doxylamine overdose in children. The overdose cases have been
characterized by coma, grand mal seizures and cardiorespiratory arrest. Children appear to be at a high risk for
cardiorespiratory arrest. A toxic dose for children of more than 1.8 mg/kg has been reported. A 3 year old child
died 18 hours after ingesting 1,000 mg doxylamine succinate. However, there is no correlation between the
amount of doxylamine ingested, the doxylamine plasma level and clinical symptomatology.



10 OVERDOSAGE

10.1 Signs and Symptoms of Overdose

DICLEGIS is a delayed-release formulation, therefore, signs and symptoms of intoxication may not be apparent
immediately.
Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo,
mental confusion and tachycardia.
At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal
failure and death.
10.2 Management of Overdose

If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and
symptomatic treatment. For additional information about overdose treatment, call a poison control center
(1-800-222-1222).

11 DESCRIPTION

DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-
coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine
hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman.
Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon
dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl
alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102,
PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, talc, titanium dioxide.
Doxylamine Succinate
Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is
ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is
C17H22N2O • C4H6O4 and the molecular mass is 388.46. The structural formula is:
Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene.
Pyridoxine Hydrochloride
Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-
pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 • HCl and the
molecular mass is 205.64. The structural formula is:
Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water,
slightly soluble in alcohol and insoluble in ether.
12 CLINICAL
PHARMACOLOGY

12.1 Mechanism of Action
The mechanism of action of DICLEGIS is unknown.
12.3 Pharmacokinetics

The pharmacokinetics of DICLEGIS has been characterized in healthy non-pregnant adult women.
Pharmacokinetic results for doxylamine and pyridoxine, including its vitamin B6 metabolites, pyridoxal,
pyridoxal 5’-phosphate, pyridoxamine and pyridoxamine 5’-phosphate, are summarized in Tables 2 to 5.
Absorption
A single-dose (two tablets) and multiple-dose (four tablets daily), open-label study was conducted to assess the
safety and pharmacokinetic profile of DICLEGIS administered in healthy non-pregnant adult women. Single-
doses (two tablets at bedtime) were administered on Days 1 and 2. Multiple-doses (one tablet in the morning,
one tablet in the afternoon and two tablets at bedtime) were administered on Days 3-18.
Blood samples for pharmacokinetic analysis were collected pre-and post-dose on Days 2 and 18 as well as pre-
dose prior to bedtime dose only (trough) on Days 9, 10, 11, 16, 17, and 18.
Doxylamine and pyridoxine are absorbed in the gastrointestinal tract, mainly in the jejunum.
The Cmax of doxylamine and pyridoxine are achieved within 7.5 and 5.5 hours, respectively (see Table 2).

Table 2 – Single-Dose and Multiple-Dose Pharmacokinetics of DICLEGIS in Healthy Non-Pregnant

Adult Women
Single Dose
Multiple Dose
AUC0-inf
AUC0-inf
(ng•h/mL)
(ng•h/mL)
Doxylamine
Pyridoxine
Pyridoxal
Pyridoxal
5`Phosphate
Pyridoxamine 2.7
Pyridoxamine 5.2 ±
5'-phosphate

Multiple-dose administration of DICLEGIS results in increased concentrations of doxylamine as well as
increases in doxylamine Cmax and AUC0-last of absorption. The time to reach the maximum concentration is not
affected by multiple doses. The mean accumulation index is more than 1.0 suggesting that doxylamine
accumulates following multiple dosing (see Table 3).
Although no accumulation was observed for pyridoxine, the mean accumulation index for each metabolite
(pyridoxal, pyridoxal 5’-phosphate, and pyridoxamine 5’-phosphate) is more than 1.0 following multiple-dose
administration of DICLEGIS. The time to reach the maximum concentration is not affected by multiple doses
(see Table 2).
Table 3 – Pharmacokinetics of Doxylamine and Pyridoxine Following Single Dose and Multiple Dose
Administration of DICLEGIS to Healthy Non-Pregnant Adult Women

AUC0-last
AUC0-inf
(ng•h/mL)
(ng•h/mL)
Doxylamine Single
Multiple
Pyridoxine Single
Multiple
Food Effect The administration of food delays the absorption of both doxylamine and pyridoxine. This delay is associated with a lower peak concentration of doxylamine, but the extent of absorption is not affected (see Table 4). The effect of food on the peak concentration and the extent of absorption of the pyridoxine component is more complex because the pyridoxal, pyridoxamine, pyridoxal 5’-phosphate and pyridoxamine 5’-phosphate metabolites also contribute to the biological activity. Food significantly reduces the bioavailability of pyridoxine, lowering its Cmax and AUC by approximately 50% compared to fasting conditions. Similarly, food significantly reduces pyridoxal AUC and reduces its Cmax by 50% compared to fasting conditions. In contrast,
food slightly increases pyridoxal 5’-phosphate Cmax and extent of absorption. As for pyridoxamine and
pyridoxamine 5’-phosphate, the rate and extent of absorption seem to decrease under fed conditions.
Table 4 – Pharmacokinetics of Doxylamine and Pyridoxine Following Administration of DICLEGIS
Under Fed and Fasted Conditions in Healthy Non-Pregnant Adult Women

AUC0-inf
(ng•h/mL)
(ng•h/mL)
Doxylamine Fasted
Pyridoxine Fasted
a N=37; b N=18; c N=31
Distribution
Pyridoxine is highly protein bound, primarily to albumin. Its main active metabolite, pyridoxal 5’-phosphate
(PLP) accounts for at least 60% of circulating vitamin B6 concentrations.
Metabolism
Doxylamine is biotransformed in the liver by N-dealkylation to its principle metabolites N-desmethyl-
doxylamine and N, N-didesmethyldoxylamine.
Pyridoxine is a prodrug primarily metabolized in the liver.
Excretion
The principle metabolites of doxylamine, N-desmethyl-doxylamine and N, N-didesmethyldoxylamine, are
excreted by the kidney.
The terminal elimination half-life of doxylamine and pyridoxine are 12.5 hours and 0.5 hours, respectively (see
Table 5).
Table 5 – Terminal Elimination Half-Life (T1/2el) for DICLEGIS Administered as a Single Dose of Two
Tablets under Fasting Conditions in Healthy Non-Pregnant Adult Women

Use in Specific Populations
Race: No pharmacokinetic studies have been conducted related to race.
Hepatic Impairment: No pharmacokinetic studies have been conducted in hepatic impaired patients.
Renal Impairment: No pharmacokinetic studies have been conducted in renal impaired patients.
13 NONCLINICAL
TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility

Carcinogenicity
Two-year carcinogenicity studies in rats and mice have been conducted with doxylamine succinate.
Doxylamine succinate is not likely to have human carcinogenic potential. The carcinogenic potential of
pyridoxine hydrochloride has not been evaluated.
14 CLINICAL
A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of DICLEGIS in the treatment of nausea and vomiting of pregnancy. Adult women 18 years of age or older and 7 to 14 weeks gestation (median 9 weeks of gestation) with nausea and vomiting of pregnancy were randomized to 14 days of DICLEGIS or placebo. Two tablets of DICLEGIS were administered at bedtime on Day 1. If symptoms of nausea and vomiting persisted into the afternoon hours of Day 2, the woman was directed to take her usual dose of two tablets at bedtime that night and, beginning on Day 3, to take one tablet in the morning and two tablets at bedtime. Based upon assessment of remaining symptoms at her clinic visit on Day 4 (± 1 day), the woman may have been directed to take an additional tablet mid-afternoon. A maximum of four tablets (one in the morning, one in the mid-afternoon and two at bedtime) were taken daily. Over the treatment period, 19% of DICLEGIS-treated patients remained on 2 tablets daily, 21% received 3 tablets daily, and 60% received 4 tablets daily. The primary efficacy endpoint was the change from baseline at Day 15 in the Pregnancy Unique-Quantification of Emesis (PUQE) score. The PUQE score incorporates the number of daily vomiting episodes, number of daily heaves, and length of daily nausea in hours, for an overall score of symptoms rated from 3 (no symptoms) to 15 (most severe). At baseline, the mean PUQE score was 9.0 in the DICLEGIS arm and 8.8 in the placebo arm. There was a 0.7 (95% confidence interval 0.2 to 1.2 with p-value 0.006) mean decrease (improvement in nausea and vomiting symptoms) from baseline in PUQE score at Day 15 with DICLEGIS compared to placebo (see Table 6).
Table 6 – Change from Baseline in the Primary Endpoint, Pregnancy Unique-Quantification of Emesis
(PUQE) Score at Day 15. (Intent-to-Treat Population with Last-Observation Carried Forward)

PUQE Score*
Doxylamine Succinate +
Treatment Difference
Pyridoxine Hydrochloride
[95% Confidence Interval]
Baseline
Change from baseline at Day 15
*The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score incorporated the number of daily vomiting episodes,
number of daily heaves, and length of daily nausea in hours, for an overall score of symptoms rated from 3 (no symptoms) to 15 (most
severe). Baseline was defined as the PUQE score completed at the enrollment visit.
16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How supplied

DICLEGIS delayed-release tablets are supplied in a high-density polyethylene bottle with a polypropylene
child-resistant cap and a silica gel desiccant canister. Each white, round, film-coated, delayed-release tablet
contains 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and is imprinted on one side with
the pink image of a pregnant woman. DICLEGIS tablets are provided as follows:
NDC 55494-100-10 Bottles of 100.
16.2 Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP
Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Do not remove desiccant
canister from bottle.
17 PATIENT
COUNSELING
INFORMATION

See FDA-approved patient labeling (Patient Information)
17.1 Somnolence and Severe Drowsiness

Inform women to avoid engaging in activities requiring complete mental alertness, such as driving or operating
heavy machinery, while using DICLEGIS until cleared to do so.
Inform women of the importance of not taking DICLEGIS with alcohol or sedating medications, including other
antihistamines (present in some cough and cold medications), opiates and sleep aids because somnolence could
worsen leading to falls or other accidents.

DICLEGIS® is a registered trademark of Duchesnay Inc.
U.S. Patent Nos. 6,340,695 & 7,560,122.
Distributed by:
Duchesnay USA, Inc.
Bryn Mawr, PA, 19010
Tel: 1-855-722-7734

Fax: 1-888-588-8508
www.duchesnayusa.com
2013, Duchesnay Inc. All rights reserved.

Source: http://www.diclegis.com/pdf/Diclegis_Full_Prescribing_Information.pdf

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A “precauÇÃo padrÃo” como forma de prevenÇÃo de infecÇÃo cruzada

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