Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)
CooperSurgical, Inc.
COPPER
COPPER 313.4 mg
INTRAUTERINE
PRESCRIPTION DRUG
Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. The use of Paragard is contraindicated when one or more of the following conditions exist: - Pregnancy or suspicion of pregnancy [see Warnings and Precautions ( 5.1 , 5.2 ) and Use in Specific Populations ( 8.1 )] - Abnormalities of the uterus resulting in distortion of the uterine cavity - Acute pelvic inflammatory disease (PID) [see Warnings and Precautions ( 5.4 )] - Postpartum endometritis or postabortal endometritis in the past 3 months [see Warnings and Precautions ( 5.4 )] - Known or suspected uterine or cervical malignancy - Uterine bleeding of unknown etiology - Untreated acute cervicitis or vaginitis or other lower genital tract infection - Conditions associated with increased susceptibility to pelvic infections [see Warnings and Precautions ( 5.4 )] - Wilson’s disease [see Warnings and Precautions ( 5.9 )] - A previously placed IUD or IUS that has not been removed - Hypersensitivity to any co
Paragard (intrauterine copper contraceptive) is available in cartons of 1 (one) sterile unit (NDC 59365-5128-1). Each Paragard is white, T-shaped, and measures 32 mm horizontally and 36 mm vertically, with approximately 176 mg of copper wire wrapped around the vertical arm and an approximately 68.7 mg copper wire collar placed on each side of the horizontal arms, and with a monofilament polyethylene thread tied through the tip of the vertical arm [see Dosage and Administration ( 2.3 )]. The T-frame is made of polyethylene with barium sulfate. Each Paragard is packaged together with an insertion tube with blue flange and solid white rod in a Tyvek® polyethylene pouch. Store at controlled room temperature: 59° to 86°F (15° to 30°C).
New Drug Application
PARAGARD T 380A- COPPER INTRAUTERINE DEVICE COOPERSURGICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PARAGARD® SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PARAGARD. PARAGARD® (INTRAUTERINE COPPER CONTRACEPTIVE) INITIAL U.S. APPROVAL: 1984 INDICATIONS AND USAGE Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. (1) DOSAGE AND ADMINISTRATION Insert a single Paragard at the fundus of the uterine cavity. Remove Paragard no later than 10 years from the date of insertion. (2.1) Insert and remove Paragard only if you are a healthcare provider trained on these procedures. (2.1) See the Full Prescribing Information for recommended timing of insertion preparation instructions, insertion procedures, postplacement management, and instructions on removing Paragard (2.2, 2.3, 2.4, 2.5, 2.6) Following the insertion, examine the patient after her first menses to confirm Paragard is still in place. (2.5) DOSAGE FORMS AND STRENGTHS One sterile, T-frame IUS containing copper consisting of a T-shaped polyethylene frame with a total exposed copper surface area of 380 ± 23 mm², (approximately 176 mg of wire wrapped around the vertical stem and an approximately 68.7 mg collar placed on each side of the horizontal arm) packaged together with an insertion tube with blue flange and solid white rod. (3, 16) CONTRAINDICATIONS Pregnancy or suspicion of pregnancy (4) Abnormalities of the uterus resulting in distortion of the uterine cavity (4) Acute pelvic inflammatory disease (PID) (4) Postpartum endometritis or postabortal endometritis in past 3 months (4) Known or suspected uterine or cervical malignancy (4) Uterine bleeding of unknown etiology (4) Untreated acute cervicitis or vaginitis or other lower genital tract infection (4) Conditions associated with increased susceptibility to pelvic infections (4) Wilson’s disease (4) A previously Đọc toàn bộ tài liệu