PARAGARD T 380A- copper intrauterine device

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)

Prieinama:

CooperSurgical, Inc.

INN (Tarptautinis Pavadinimas):

COPPER

Sudėtis:

COPPER 313.4 mg

Vartojimo būdas:

INTRAUTERINE

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

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).

Autorizacija statusas:

New Drug Application

Prekės savybės

PARAGARD T 380A- COPPER INTRAUTERINE DEVICE
COOPERSURGICAL, INC.
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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