Primary Disease Name: Depression
Primary Drug Name: Zoloft
Chemical Drug Name: sertraline hci
What is Zoloft?
ZOLOFT is an antidepressant that is the newest member of the family
of medications known as selective serotonin reuptake inhibitors
(SSRIs). As a result, ZOLOFT is able to provide effective and well-tolerated
therapy to treat depression, panic disorder, obsessive-compulsive
disorder (also called OCD) and posttraumatic stress disorder (also
called PTSD) in adults.
Major Depressive Disorder—ZOLOFT® (sertraline hydrochloride)
is indicated for the treatment of major depressive disorder.
The efficacy of ZOLOFT in the treatment of a major depressive episode
was established in six to eight week controlled trials of outpatients
whose diagnoses corresponded most closely to the DSM-III category
of major depressive disorder.
A major depressive episode implies a prominent and relatively persistent
depressed or dysphoric mood that usually interferes with daily functioning
(nearly every day for at least 2 weeks); it should include at least
4 of the following 8 symptoms: change in appetite, change in sleep,
psychomotor agitation or retardation, loss of interest in usual
activities or decrease in sexual drive, increased fatigue, feelings
of guilt or worthlessness, slowed thinking or impaired concentration,
and a suicide attempt or suicidal ideation.
The antidepressant action of ZOLOFT in hospitalized depressed patients
has not been adequately studied.
The efficacy of ZOLOFT in maintaining an antidepressant response
for up to 44 weeks following 8 weeks of open-label acute treatment
(52 weeks total) was demonstrated in a placebo-controlled trial.
The usefulness of the drug in patients receiving ZOLOFT for extended
periods should be reevaluated periodically.
Obsessive-Compulsive Disorder—ZOLOFT is indicated for the
treatment of obsessions and compulsions in patients with obsessive-compulsive
disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions
or compulsions cause marked distress, are time-consuming, or significantly
interfere with social or occupational functioning.
The efficacy of ZOLOFT was established in 12-week trials with obsessive-compulsive
outpatients having diagnoses of obsessive-compulsive disorder as
defined according to DSM-III or DSM-III-R criteria.
Obsessive-compulsive disorder is characterized by recurrent and
persistent ideas, thoughts, impulses, or images (obsessions) that
are ego-dystonic and/or repetitive, purposeful, and intentional
behaviors (compulsions) that are recognized by the person as excessive
or unreasonable.
The efficacy of ZOLOFT in maintaining a response, in patients with
OCD who responded during a 52-week treatment phase while taking
ZOLOFT and were then observed for relapse during a period of up
to 28 weeks, was demonstrated in a placebo-controlled. Nevertheless,
the physician who elects to use ZOLOFT for extended periods should
periodically re-evaluate the long-term usefulness of the drug for
the individual patient (see DOSAGE AND ADMINISTRATION).
Panic Disorder—ZOLOFT is indicated for the treatment of panic
disorder, with or without agoraphobia, as defined in DSM-IV. Panic
disorder is characterized by the occurrence of unexpected panic
attacks and associated concern about having additional attacks,
worry about the implications or consequences of the attacks, and/or
a significant change in behavior related to the attacks.
The efficacy of ZOLOFT was established in three 10-12 week trials
in panic disorder patients whose diagnoses corresponded to the DSM-III-R
category of panic disorder.
Panic disorder (DSM-IV) is characterized by recurrent unexpected
panic attacks, i.e., a discrete period of intense fear or discomfort
in which four (or more) of the following symptoms develop abruptly
and reach a peak within 10 minutes: (1) palpitations, pounding heart,
or accelerated heart rate; (2) sweating; (3) trembling or shaking;
(4) sensations of shortness of breath or smothering; (5) feeling
of choking; (6) chest pain or discomfort; (7) nausea or abdominal
distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9)
derealization (feelings of unreality) or depersonalization (being
detached from oneself); (10) fear of losing control; (11) fear of
dying; (12) paresthesias (numbness or tingling sensations); (13)
chills or hot flushes.
The efficacy of ZOLOFT in maintaining a response, in patients with
panic disorder who responded during a 52-week treatment phase while
taking ZOLOFT and were then observed for relapse during a period
of up to 28 weeks, was demonstrated in a placebo-controlled. Nevertheless,
the physician who elects to use ZOLOFT for extended periods should
periodically re-evaluate the long-term usefulness of the drug for
the individual patient (see DOSAGE AND ADMINISTRATION).
Posttraumatic Stress Disorder (PTSD)—ZOLOFT (sertraline hydrochloride)
is indicated for the treatment of posttraumatic stress disorder.
The efficacy of ZOLOFT in the treatment of PTSD was established
in two 12-week placebo-controlled trials of outpatients whose diagnosis
met criteria for the DSM-III-R category of PTSD.
PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic
event that involved actual or threatened death or serious injury,
or threat to the physical integrity of self or others, and a response
which involves intense fear, helplessness, or horror. Symptoms that
occur as a result of exposure to the traumatic event include reexperiencing
of the event in the form of intrusive thoughts, flashbacks or dreams,
and intense psychological distress and physiological reactivity
on exposure to cues to the event; avoidance of situations reminiscent
of the traumatic event, inability to recall details of the event,
and/or numbing of general responsiveness manifested as diminished
interest in significant activities, estrangement from others, restricted
range of affect, or sense of foreshortened future; and symptoms
of autonomic arousal including hypervigilance, exaggerated startle
response, sleep disturbance, impaired concentration, and irritability
or outbursts of anger. A PTSD diagnosis requires that the symptoms
are present for at least a month and that they cause clinically
significant distress or impairment in social, occupational, or other
important areas of functioning.
The efficacy of ZOLOFT in maintaining a response in patients with
PTSD for up to 28 weeks following 24 weeks of open-label treatment
was demonstrated in a placebo-controlled trial. Nevertheless, the
physician who elects to use ZOLOFT for extended periods should periodically
re-evaluate the long-term usefulness of the drug for the individual
patient (see DOSAGE AND ADMINISTRATION).
Premenstrual Dysphoric Disorder (PMDD)—ZOLOFT is indicated
for the treatment of premenstrual dysphoric disorder (PMDD).
The efficacy of ZOLOFT in the treatment of PMDD was established
in 2 placebo-controlled trials of female outpatients treated for
3 menstrual cycles who met criteria for the DSM-III-R/IV category
of PMDD.
The essential features of PMDD include markedly depressed mood,
anxiety or tension, affective lability, and persistent anger or
irritability. Other features include decreased interest in activities,
difficulty concentrating, lack of energy, change in appetite or
sleep, and feeling out of control. Physical symptoms associated
with PMDD include breast tenderness, headache, joint and muscle
pain, bloating and weight gain. These symptoms occur regularly during
the luteal phase and remit within a few days following onset of
menses; the disturbance markedly interferes with work or school
or with usual social activities and relationships with others. In
making the diagnosis, care should be taken to rule out other cyclical
mood disorders that may be exacerbated by treatment with an antidepressant.
The effectiveness of ZOLOFT in long-term use, that is, for more
than 3 menstrual cycles, has not been systematically evaluated in
controlled trials. Therefore, the physician who elects to use ZOLOFT
for extended periods should periodically re-evaluate the long-term
usefulness of the drug for the individual patient (see DOSAGE AND
ADMINISTRATION).
Social Anxiety Disorder—ZOLOFT (sertraline hydrochloride)
is indicated for the treatment of social anxiety disorder, also
known as social phobia.
The efficacy of ZOLOFT in the treatment of social anxiety disorder
was established in two placebo-controlled trials of outpatients
with a diagnosis of social anxiety disorder as defined by DSM-IV
criteria (see Clinical Trials under CLINICAL PHARMACOLOGY).
Social anxiety disorder, as defined by DSM-IV, is characterized
by marked and persistent fear of social or performance situations
involving exposure to unfamiliar people or possible scrutiny by
others and by fears of acting in a humiliating or embarrassing way.
Exposure to the feared social situation almost always provokes anxiety
and feared social or performance situations are avoided or else
are endured with intense anxiety or distress. In addition, patients
recognize that the fear is excessive or unreasonable and the avoidance
and anticipatory anxiety of the feared situation is associated with
functional impairment or marked distress.
The efficacy of ZOLOFT in maintaining a response in patients with
social anxiety disorder for up to 24 weeks following 20 weeks of
ZOLOFT treatment was demonstrated in a placebo-controlled trial.
Physicians who prescribe ZOLOFT for extended periods should periodically
re-evaluate the long-term usefulness of the drug for the individual
patient
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Zoloft Side Effects
Commonly Observed Adverse Events and Zoloft Side Effects
Like all medicines, ZOLOFT side effects may be caused in some people.
In clinical studies, few people had to stop taking ZOLOFT because
of side effects. The most common Zoloft Side Effects are :
- dry mouth
- upset stomach
- decreased appetite
- feeling unusually tired or sleepy
- trouble sleeping
- sexual problems in men and women
- diarrhea/loose stools
- tremor
- feeling agitated
- indigestion
- increased sweating
Children who take ZOLOFT may also have other Zoloft side effects
such as excessive movement or twitching, fever, not "feeling
well," trouble concentrating, not thinking normally, nosebleeds,
weight loss, easy bruising, manic or excited behavior, or rapid
mood swings.
Until you learn how you are going to respond to ZOLOFT, be careful
doing activities when you need to be alert, such as driving a car
or operating machinery. Drinking alcohol is not advised while you
are being treated with ZOLOFT.
ZOLOFT may cause other less common side effects besides those listed
here.
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Zoloft Mechanism of Action
Everyone has a normal substance in the brain called serotonin.
It is thought that not having enough serotonin may contribute to
depression, panic disorder, OCD and PTSD. How ZOLOFT works for all
of these conditions is not known. What is known is that ZOLOFT may
help correct the chemical imbalance of serotonin in the brain. This
helps relieve your symptoms. It may take several weeks for your
symptoms to get better.
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Zoloft Canada - Is Zoloft from Canada Safe?
Canadian Interenet Pharmacies with the CIPA
seal are a part of the Canadian International Pharmacy Association
Canada and only ship drugs that are of the highest quality, and
as safe as in the United States.
CIPA Certified Canadian Pharmacies dispense only Health Canada approved
prescription drugs such as Zoloft from Canada.
Health Canada is the equivalent to the US FDA and has standards
that match those of the FDA.
Prescription drugs from a Cipa Certified Canadian pharmacies are
just as good as those purchased in the United States and the generic
drugs, commonly purchased from online Canadian pharmacies, are of
the highest standard in the world. When purchasing your prescriptions
from an online Canadian Pharmacy you will notice that generic versions
of many popular brand names drugs are readily available.
Zoloft from Canada and other Prescription drugs from Canada
points to note:
- All Drugs are approved by Health Canada
- Health Canada is Canada's equivilent to the FDA
- Canadian Generics are of the highest quality in the world
- Prescrition medications from Canada really are of the highest
quality in the world
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Zoloft Clinical Pharmacology
Everyone has a normal substance in the brain called serotonin.
It is thought that not having enough serotonin may contribute to
depression, panic disorder, OCD and PTSD. How ZOLOFT works for all
of these conditions is not known. What is known is that ZOLOFT may
help correct the chemical imbalance of serotonin in the brain. This
helps relieve your symptoms. It may take several weeks for your
symptoms to get better.
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How to Take Zoloft
Take ZOLOFT once a day in the morning or evening. You can take
ZOLOFT with or without food. Try to take ZOLOFT at the same time
every day.
Do not take an extra dose if you are having a bad day. ZOLOFT does
not work right away. Do not stop taking ZOLOFT without talking to
your doctor first.
Do not run out of ZOLOFT. Make sure you have your refill for ZOLOFT
at home before you need it. Continue to take ZOLOFT even when you
feel better for as long as your doctor says.
It may take several weeks before you start to feel better. Do not
get discouraged. Keep taking ZOLOFT every day for as long as your
doctor tells you to take it.
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Zoloft Dose / Supply
Zoloft is available in three doses. Zoloft comes as a 10mg tablet,
20mg tablet, & 30mg tablet. It is also available in a Controlled
Release delivery system form – Zoloft CR in 12.5mg, 25mg tablets
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Types of Depression
Depressive disorders come in different forms. There are several
different diagnoses for depression, mostly determined by the intensity
of the symptoms, the duration of the symptoms, and the specific
cause of the symptoms, if that is known.
Psychology Information Online provides information on the following
depressive disorders. Follow the title link for more information
about each type of depression:
1. Major Depression - This is the most serious
type of depression, in terms of number of symptoms and severity
of symptoms, but there are significant individual differences in
the symptoms and severity. You do not need to feel suicidal to have
a major depression, and you do not need to have a history of hospitalizations
either, although both of these factors are present in some people
with major depression. There is no official diagnosis of "moderate
depression."
2. Dysthymic Disorder - This refers to a low to
moderate level of depression that persists for at least two years,
and often longer. While the symptoms are not as severe as a major
depression, they are more enduring and resistant to treatment. Some
people with dysthymia develop a major depression at some time during
the course of their depression.
3. Unspecified Depression - This category is used
to help researchers who are studying other specific types of depression,
and do not want their data confounded with marginal diagnoses. It
includes people with a serious depression, but not quite severe
enough to have a diagnosis of a major depression. It also includes
people with chronic, moderate depression, which has not been present
long enough for a diagnosis of a Dysthymic disorder. (You get the
idea!)
4. Adjustment Disorder, with Depression - This
category describes depression that occurs in response to a major
life stressor or crisis.
5. Bipolar Depression - This type includes both
high and low mood swings, as well as a variety of other significant
symptoms not present in other depressions.
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Zoloft Dosage and Administration
Dosage for Adults
Depression and Obsessive-Compulsive Disorder: Sertraline HCl treatment
should be administered at a dose of 50 mg once daily.
Panic Disorder: Sertraline HCl treatment should be initiated with
a dose of 25 mg once daily. After one week, the dose should be increased
to 50 mg once daily.
While a relationship between dose and effect has not been established
for depression, OCD, or panic disorder, patients were dosed in a
range of 50-200 mg/day in the clinical trials demonstrating the
effectiveness of sertraline HCl for these indications. Consequently,
a dose of 50 mg, administered once daily, is recommended as the
initial dose. Patients not responding to a 50 mg dose may benefit
from dose increases up to a maximum of 200 mg/day. Given the 24
hour elimination half-life of sertraline HCl, dose changes should
not occur at intervals of less than 1 week.
Sertraline HCl should be administered once daily, either in the
morning or evening.
Obsessive-Compulsive Disorder: Sertraline HCl treatment
should be initiated with a dose of 25 mg once daily in children
(ages 6-12) and at a dose of 50 mg once daily in adolescents (ages
13-17).
While a relationship between dose and effect has not been established
for OCD, patients were dosed in a range of 25-200 mg/day in the
clinical trials demonstrating the effectiveness of sertraline HCl
for pediatric patients (6-17 years) with OCD. Patients not responding
to an initial dose of 25 or 50 mg/day may benefit from dose increases
up to a maximum of 200 mg/day. For children with OCD, their generally
lower body weights compared to adults should be taken into consideration
in advancing the dose, in order to avoid excessive dosing. Given
the 24 hour elimination half-life of sertraline HCl, dose changes
should not occur at intervals of less than 1 week.
Sertraline HCl should be administered once daily, either in the
morning or evening.
Dosage for Hepatically Impaired Patients
The use of sertraline in patients with liver disease should be approached
with caution. The effects of sertraline in patients with moderate
and severe hepatic impairment have not been studied. If sertraline
is administered to patients with liver impairment, a lower or less
frequent dose should be used.
Maintenance/Continuation/Extended Treatment
Depression: It is generally agreed that acute episodes
of depression require several months or longer of sustained pharmacologic
therapy. Whether the dose of antidepressant needed to induce remission
is identical to the dose needed to maintain and/or sustain euthymia
is unknown. Systematic evaluation of sertraline HCl has shown that
its antidepressant efficacy is maintained for periods of up to 44
weeks following 8 weeks of open-label acute treatment (52 weeks
total) at a dose of 50-200 mg/day (mean dose of 70 mg/day) (see
CLINICAL STUDIES).
Obsessive-Compulsive Disorder and Panic Disorder:
Although the efficacy of sertraline HCl beyond 10-12 weeks of dosing
for OCD and panic disorder has not been documented in controlled
trials, both are chronic conditions, and it is reasonable to consider
continuation of a responding patient for either indication. Dosage
adjustments may be needed to maintain the patient on the lowest
effective dosage, and patients should be periodically reassessed
to determine the need for continued treatment
Switching Patients to or from a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of a MAOI
and initiation of therapy with sertraline HCl. In addition, at least
14 days should be allowed after stopping sertraline HCl before starting
a MAOI.
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Zoloft Storage
Keep this medication in the container it came in, tightly closed,
and out of reach of children. Store it at room temperature and away
from excess heat and moisture (not in the bathroom). Throw away
any medication that is outdated or no longer needed. Talk to your
pharmacist about the proper disposal of your medication.
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Zoloft Warnings
Potential for Interaction with Monoamine Oxidase Inhibitors
In patients receiving serotonin reuptake inhibitor drugs in combination
with a monoamine oxidase inhibitor (MAOI), there have been reports
of serious, sometimes fatal, reactions including hyperthermia, rigidity,
myoclonus, autonomic instability with possible rapid fluctuations
of vital signs, and mental status changes that include extreme agitation
progressing to delirium and coma. These reactions have also been
reported in patients who have recently discontinued SSRI treatment
and have been started on a MAOI. Some cases presented with features
resembling neuroleptic malignant syndrome.
Furthermore, limited
animal data on the effects of combined use of SSRIs and MAOIs suggest
that these drugs may act synergistically to elevate blood pressure
and evoke behavioral excitation. Therefore, it is recommended that
Zoloft should not be used in combination with a MAOI, or within
14 days of discontinuing treatment with a MAOI. Similarly, at least
14 days should be allowed after stopping Zoloft before starting
a MAOI.
Serotonin syndrome has been reported in two patients who were concomitantly
receiving linezolid an antibiotic which is a reversible non-selective
MAOI.
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Zoloft Precautions
General
Activation of Mania/Hypomania: During premarketing testing, hypomania
or mania occurred in approximately 0.4% of sertraline HCl treated
patients.
Weight Loss: Significant weight loss may be an
undesirable result of treatment with sertraline for some patients,
but on average, patients in controlled trials had minimal, 1 to
2 pound weight loss, versus smaller changes on placebo. Only rarely
have sertraline patients been discontinued for weight loss.
Seizure: Sertraline HCl has not been evaluated
in patients with a seizure disorder. These patients were excluded
from clinical studies during the product's premarket testing. No
seizures were observed among approximately 3000 patients treated
with sertraline HCl in the development program for depression. However,
4 patients out of approximately 1800 (220 < 18 years of age)
exposed during the development program for obsessive-compulsive
disorder experienced seizures, representing a crude incidence of
0.2%. Three of these patients were adolescents, two with a seizure
disorder and one with a family history of seizure disorder, none
of whom were receiving anticonvulsant medication. Accordingly, sertraline
HCl should be introduced with care in patients with a seizure disorder.
Suicide: The possibility of a suicide attempt is
inherent in depression and may persist until significant remission
occurs. Close supervision of high risk patients should accompany
initial drug therapy. Prescriptions for sertraline HCl should be
written for the smallest quantity of tablets consistent with good
patient management, in order to reduce the risk of overdose.
Because of the well-established comorbidity between both OCD and
depression and panic disorder and depression, the same precautions
observed when treating patients with depression should be observed
when treating patients with OCD or panic disorder.
Weak Uricosuric Effect: Sertraline HCl is associated
with a mean decrease in serum uric acid of approximately 7%. The
clinical significance of this weak uricosuric effect is unknown,
and there have been no reports of acute renal failure with sertraline
HCl.
Use in Patients with Concomitant Illness: Clinical
experience with sertraline HCl in patients with certain concomitant
systemic illness is limited. Caution is advisable in using sertraline
HCl in patients with diseases or conditions that could affect metabolism
or hemodynamic responses.
Sertraline HCl has not been evaluated or used to any appreciable
extent in patients with a recent history of myocardial infarction
or unstable heart disease. Patients with these diagnoses were excluded
from clinical studies during the product's premarket testing. However,
the electrocardiograms of 774 patients who received sertraline HCl
in double-blind trials were evaluated and the data indicate that
sertraline HCl is not associated with the development of significant
ECG abnormalities.
Sertraline HCl is extensively metabolized by the liver. In patients
with chronic mild liver impairment, sertraline clearance was reduced,
resulting in increased AUC, Cmax, and elimination half-life. The
effects of sertraline in patients with moderate and severe hepatic
impairment have not been studied. The use of sertraline in patients
with liver disease must be approached with caution. If sertraline
is administered to patients with liver impairment, a lower or less
frequent dose should be used.
Since sertraline HCl is extensively metabolized, excretion of unchanged
drug in urine is a minor route of elimination. A clinical study
comparing sertraline pharmacokinetics in healthy volunteers to that
in patients with renal impairment ranging from mild to severe (requiring
dialysis) indicated that the pharmacokinetics and protein binding
are unaffected by renal disease. Based on the pharmacokinetics results,
there is no need for dosage adjustment in patients with renal impairment.
Interference with Cognitive and Motor Performance: In controlled
studies, sertraline HCl did not cause sedation and did not interfere
with psychomotor performance.
Hyponatremia: Several cases of hyponatremia have
been reported and appeared to be reversible when sertraline HCl
was discontinued. Some cases were possibly due to the syndrome of
inappropriate antidiuretic hormone secretion. The majority of these
occurrences have been in elderly individuals, some in patients taking
diuretics, or who were otherwise volume depleted.
Platelet Function: There have been rare reports
of altered platelet function and/or abnormal results from laboratory
studies in patients taking sertraline HCl. While there have been
reports of abnormal bleeding or purpura in several patients taking
sertraline HCl, it is unclear whether sertraline HCl had a causative
role.
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Zoloft Information for Patients
Physicians are advised to discuss the following issues with patients
for whom they prescribe sertraline HCl:
Patients should be told that although sertraline HCl has not been
shown to impair the ability of normal subjects to perform tasks
requiring complex motor and mental skills in laboratory experiments,
drugs that act upon the central nervous system may affect some individuals
adversely.
Patients should be told that although sertraline HCl has not been
shown in experiments with normal subjects to increase the mental
and motor skill impairments caused by alcohol, the concomitant use
of sertraline HCl and alcohol in depressed patients is not advised.
Patients should be told that while no adverse interaction of sertraline
HCl with over-the-counter (OTC) drug products is known to occur,
the potential for interaction exists. Thus, the use of any OTC product
should be initiated cautiously according to the directions of use
given for the OTC product.
Patients should be advised to notify their physician if they become
pregnant or intend to become pregnant during therapy.
Patients should be advised to notify their physician if they are
breast feeding an infant.
Sertraline HCl oral concentrate is contraindicated with disulfuram
(Antabuse) due to the alcohol content of the concentrate.
Sertraline HCl contains 12% alcohol. Sertraline HCl oral concentrate
must be diluted before use. Just before taking, use the dropper
provided to remove the required amount of sertraline HCl oral concentrate
and mix with 4 o (½ cup) of water, gingerale, lemon/lime
soda, lemonade or orange juice ONLY. Do not mix sertraline HCl oral
concentrate with anything other than the liquids listed. The dose
should be taken immediately after mixing. Do not mix in advance.
At times, a slight haze may appear after mixing; this is normal.
Note that caution should be exercised for persons with latex sensitivity,
as the dropper dispenser contains dry natural rubber.
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