Basic Info
  • Factory Location: Wuhu Simcere Pharmaceutical Co. Ltd.

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

  • Monthly Production Capacity: 5, 000, 000

    Packaging Information: Box Carton

  • Sample Provided: no

    Payment Terms: L/C, T/T, D/P, Western Union, Paypal, Money Gram

    Fluorouracil Implants
     


    Generic name: Fluorouracil Implants
    Brand name: Sinofuan
    Composition:5-fluoro-2,4(1H,3H)-pyrimidinedione
    Chemical structure:
    Fluorouraci Implant


    Molecular formula: C4H3FN2O2
    Molecular weight:130.08
    Description:Sinofuan is a white or almost white cylindrical particle.
    Indications:Sinofuan may be effective in the management of carcinoma of the esophagus, breast, colon,
    rectum, stomach pancreas, bladder, head and neck, and cervix etc .
    Strength:0.1g
    Dosage and Administration:
    Recommended Dosage(1)Palliative therapy for aged patients: a single dose of 0.2g per square meter body
    surface should be implanted subcutaneously. The second course should be started after 10 days of the first
    course, if necessary, or in accordance with the physician's advice.(2)Combined chemotherapy: A single dose
    of 0.5g per square meter body surface should be implanted, and repeated dosage should be given every 3
    weeks for 2 to 4 times for the therapy, or in accordance with the physician's advice.(3)Superficial tumor or
    tumor body implantation: a single dosage of 0.2 to 0.5g per square meter body surface should be given once,
     or depending on medical advice.
    Hypodermal Administration: (1) The insertion area can be either in two sides of the upper arms, or bilateral
    hypogastrium of abdominal wall (see figures 1a and 1b). Neither acute or chronic skin illness nor nodular
    scars can be in the implantation area.
    Fluorouraci Implant
    (2) Anesthetize the insertion area by 0.5% of lidocaine and the infiltrated zones depends on the inserted area.
    (3) After the local anesthesia, insert the trocar slowly beneath the deep fasciae forward 3 to 5 cm, and then
    backward 1 cm, remove the obturator and load the first tube(dosage) with 20 mg of the Sinofuan particles
    inside and gently advance the obturator until it touches the end of the tube (see Figure 2). Hold the trocar
    steady and backward 1 cm, and insert the second dosage accordingly. The biggest dosage for one puncture
    should be less than 80 mg (4 tubes). 
    Fluorouraci Implant

    (4) Star the second the puncture to mimic the fanlike position of the implanted trocar with the same procedure
    as the above.
    Fluorouraci Implant
    (5) Each implantation area contains 5 to 6 punctures with a fanlike shape.The total dosage for the upper arms
    and hypogastrium should be less than 300 mg and 460 mg, respectively.
    (6) After the procedure is completed, press the punctures with 75% alcohol swabs for a few minutes, then
    cover the wound with sterile guaze.
    Adverse Effects:
    1. Anorexia and leucopenia have been reported during the therapy. Diarrhoea, nousea and
    vomiting, alopecia, stomatitis, and thrombocytopenia may be seen in some cases with increasing dosage as
    observed in fluorouracil injection.
    2.Local side-effects:
    (1) If the dose for each puncture is over 80 mg, redness and swell, solid nodule and
    slight pain in the implanted area may be encountered on the day 4 to day 8 of the insertion, but eventually
    disappeared automatically during the days of 8 to 15.
    (2) If the dose is over 150 mg in one puncture, severe pain and local ulceration may occur around the
    puncture area, which often found during the day 4 to day 10 since implantation, and disappeared after about
    20 to 60 days.
    (3) If Sinofuan given superficially into subcutis, the above side-effects may aggravate, and subcutaneous
    miliary scleroma may be touched aftertwo weeks, but softened later. Local pigmentation has been reported
    in some cases.
    Contraindications:Sinofuan is contraindicated in patients who are hypersensitive to fluorouracil, who are
    suffering from bone marrow depression, who are undergoing chickenpox or herpes zoster, and in patients
    who are pregnant.
    Precautions:
    1.Sinofuan is strictly used by those who are medical qualified only.
    2. Following cases should be used with caution.
    (1) Abnormal liver function.
    (2) The W.B.C. count falls below 3,500 per mm3, or the pallets fall bellow 50,000
    mm3.
    (3) Infections, hemorrhages including subcutanea and gastrointestinal tract, or fever higher than 38ºC.
    (4) Gastrointestinal tract obviously obstructed.
    (5) Patients with dehydration, or acid-base disturbance, or electrolyte disorder.
    3. Close monitoring for regular blood examinations are necessary during pre- and post-treatment.
    Lactating Women:Since fluorouracil has potentially caused incidence of mutagenicity, teratogenicity, and
    carcinogenicity, and may induce babies under lactation with toxic and adverse effects, Sinofuan is therefore
    strictly contraindicated in breast feeding women.
    Children:No studies on child patients have been reported for Sinofuan yet.
    Aged Patients:Induced dosage for the aged should be considered under certain circumstances, and close
    observations on the poly-organs by drug toxicity should be practiced.
    Drug Interactions:
    1. Allopurinol may alleviate the bone marrow depression caused by fluorouracil.
    2. Cemitidine may increase AUC (area under the curve) and the clearance of fluorouracil.
    3. There have been reports of fluorouracil anticancer effects and toxicity influenced by methotrexate,
    metronidazole and aldohydrofolic acid in combination.
    Pharmacology:
    Fluorouracil, an antineoplastic antimetabolite acts as false pyrimidine base, mainly reacts on
    the phase S (DNA synthesis) of the cell proliferative cycle, and has the destructive effect on the other phases
    of tumor cell cycles. After intracellular conversion to the active deoxynucleotide, it interferes with the synthesis
    of DNA by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate
    synthetase. Fluorouracil may also interfere with DNA or RNA syntheses by incorporation false pyrimidine
    bases into DNA or RNA.
    Pharmacokinetics:
    Following a single dose (0.5g/m2) of Sinofuan implantation subcutaneously to the cancer
    patients, the main pharmacokinetic parameters of fluorouracil were as the follows, tmax was 25.2 h, Cmax
    was 2.204μg/ml, t1/2β was 126.18 h. The level of above 0.1μg of the drug per ml in plasma was detected
    within 10 days since implantation. About twenty percent of fluorouracil is excreted unchanged in the urine,
    the remainder of the administered dose is metabolized primarily in the liver in major degradation products
    of carbon dioxide exhaled from the lungs.
    Storage:Protect from light, and keep air-tightly.
    Packs:Package material: stainless-steel capillary; Package size: 1 bottle/box.
    Validity:36 months

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