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    3fiseke 2021 Web

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    gloriachiemenambachu

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    3fiseke 2021 Web

    Uploaded by

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    4 views4 pages

    3fiseke 2021 Web

    Uploaded by

    gloriachiemenambachu

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    © All Rights Reserved
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    SEKROL®

    SEKROL® syrup SEKROL® syrup


    15 mg / 5ml 30 mg / 5ml
    Bottle of 100 ml Bottle of 150 ml

    SEKROL® INDICATIONS
    The symptomatic treatment of acute and / or chronic respiratory tract infections where
    mucus viscosity is increased, secretion is decreased and mucociliary clearance is impaired.

    (Secretolytic therapy in bronchopulmonor disease associated


    with abnormal mucus secretion)
    SEKROL® SEKROL®
    15 MG/5ML CHILDREN 30MG/5ML ADULTS
    AGE Quantity to administer
    < 2 years 2,5 ml (1/2 measure) twice daily
    2-5 First 2 or 3 days of treatment
    2,5-5 ml (1/2-1 measure) thrice daily 5 to 10 ml 3 times per day
    years
    5 - 12
    2,5-5 ml (1/2-1 measure) thrice daily Maintenance treatment 5ml two to three
    years
    times a day.
    10 -20 ml thrice daily for the first 2-3
    > 12 years days of therapy, 10 ml twice-thrice
    daily for the maintenance therapy.
    3FISEKE 2021

    DAFRA PHARMA INTERNATIONAL


    Headquarters
    Slachthuisstraat 30/7
    2300 Turnhout
    Belgium
    SEKROL ambroxol HCl
    ®

    E E P L Y AGAIN
    R E E L Y AND D r e s s f u l and
    EF ist
    BREATH ing becomes d
    h e n c ough m f ortable
    W u n c o
    D ADU LTS
    R E N A N
    CHILD

    n l y m u colytic
    The o o r c h ildren
    d f
    indicate age of 2
    he
    under t

    Setting the Standard


    www.dafrapharma.com
    SEKROL ®
    PROPERTY CLINICAL IMPLICATION
    Stimulates serous epithelial cells to secrete a watery
    SECRETOLYTIC
    mucus. The mucus is easier to cough up.
    Increases the frequency of the activity of the ciliary
    SECRETOMOTOR structures and mucus is evacuated in an active way
    (restarting the treadmill).
    To facilitate production of a substance that lines the
    PROMOTE THE PRODUCTION
    inner surface of the lungs and reduces the surface
    OF SURFACTANT
    tension of the liquid film.
    Indirect anti-inflammatory action in the tracheobronchial
    INCREASE GAMMAGLOBULINS mucosa by increasing a blood plasma protein belonging
    to the family of immunoglobulins (antibodies).
    ANTIOXIDANT ACTION Makes oxidation reduce which is increased during
    (anti-free radical properties) infection and which is harmful to lung tissue.
    LOCAL ANESTHETIC EFFECT Reduces irritations that are often present in a productive
    cough (emollient effect, sore throat).

    - S EKROL® is the best available product against productive


    cough and bronchopulmonar congestion (including sore
    throat)
    - S EKROL® allows children and adults to breathe freely and
    deeply again
    - SEKROL® is the only mucolytic - expectorant indicated for
    children under the age of 2
    - E
     xcellent Dafra Quality
    - Affordable price
    PRESCRIBING INFORMATION
    Pharmacological properties: Ambroxol is the N-desmethyl metabolite of bromhexine which
    is a mucolytic agent. It has properties that decreases the viscosity and the adhesiveness of the
    secretions in the respiratory tract. By this way, it facilitates the removal of secretions from the
    respiratory tract and therefore eases breathing.
    Ambroxol eases the mucociliary transport by stimulating the cilias and secretions via the
    stimulation of serous glands. Thus, the secretion that covers the respiratory mucosa which has
    an important role in the natural protection, can be restored. Also, ambroxol scavenges the free
    radicals (antioxidant effect) and decreases the oxidation which is increased in case of infection
    and harmful for the lung tissue.
    It is shown that ambroxol eases the bronchopulmonary penetration of antibiotics which are
    used in respiratory tract infections, such as ampicillin, amoxicillin and erythromycin. When
    administered orally, ambroxol is absorbed completely and has a bioavailability of 70-80%.
    Following oral administration, it reaches the peak plasma concentration in 2 hours. Mean peak
    plasma concentration after oral administration of 30mg ambroxol is 88.8ng/ml. Elimination half-
    life is approximately 10 hours. When plasma levels are evaluated during and after maintenance
    treatment, no accumulation is observed. Ambroxol binds to plasma proteins with a rate of 90%, and
    is metabolised to inactive forms that are excreted as water soluble conjugates like glucuronides.
    80% of ambroxol is excreted unchanged (5-6%) and as metabolites via the kidneys.

    Contraindications: Should not be used in patients with a known hypersensivity to ambroxol and/
    or bromhexine.

    Warnings/Precautions: SEKROL® should not be used concomitantly with codeine or other


    antitussive drugs, because the excretion of mucus and secretions may become harder. Ambroxol
    should be used with caution in patients with hepatic and renal failure.

    Use in pregnancy and lactation: However the animal studies do not indicate any teratogenicity, it
    is not confirmed by studies on pregnant women. Ambroxol is not recommended to be used during
    the first trimester of pregnancy.
    It is not known whether ambroxol is excreted in maternal milk. Therefore, caution should be
    exercised when ambroxol is administered to nursing mothers.

    Side effects/adverse effects: SEKROL® is generally well tolerated. Gastrointestinal disorders,


    diarrhea, vomiting, rash, pruritus, weakness, headache and rarely transient serum aminotransferase
    elevations have been reported.

    Drug interactions and other interactions: SEKROL® does not have any interaction between the
    drugs used in the treatment of chronic bronchitis such as cardiotonic glycosides, corticosteroids,
    bronchodilatators and diuretics.
    It does not change the serum levels of antibiotics like amoxicillin, erythromycin and cefuroxime.
    They can be used concomitantly.
    Atropine and drugs that have antimuscarinic effects such as amantadin, tricyclic antidepressants,
    haloperidol, antihistaminics and procainamid (except ipratropium) can reduce the ciliary motility
    and mucociliary clearance which causes accumulation of mucosal secretions.
    Antitussive drugs, in high dosages, can inhibit cough reflex. Thus the excretion of mucosal secretion
    which has increased in amount and mobilised by SEKROL®, may become harder.

    Overdosage: To date there are no reported cases of overdosage. There is no specific antidote for
    ambroxol. If an overdose occurs, it should be treated symptomatically (emesis should be induced
    and the stomach should be emptied through lavage) and supportive measures should be
    instituted as required.
    For the complete SMPC, please visit www.dafrapharma.com

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