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SYNAREL®(nafarelin acetate)

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SYNAREL® Quick Finder

INDICATIONS AND USAGE FOR CENTRAL PRECOCIOUS PUBERTY

(For Endometriosis, See

INDICATIONS AND USAGE FOR ENDOMETRIOSIS

(For Central Precocious Puberty, See...

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DOSAGE AND ADMINISTRATION

For the treatment of central precocious puberty (CPP), the recommended daily dose of SYNAREL is 1600 µg. The dose can be increased to 1800 µg daily if adequate suppression cannot be achieved at 1600...

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CONTRAINDICATIONS

1. Hypersensitivity to GnRH, GnRH agonist analogs or any of the excipients in SYNAREL;

2. Undiagnosed abnormal vaginal bleeding;

3. Use in pregnancy or in women who may become pregnant while...

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WARNINGS

The diagnosis of central precocious puberty (CPP) must be established before treatment is initiated. Regular monitoring of CPP patients is needed to assess both patient response as well as...

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ADVERSE REACTIONS

In clinical trials of 155 pediatric patients, 2.6% reported symptoms suggestive of drug sensitivity, such as shortness of breath, chest pain, urticaria, rash, and pruritus.

In these 155 patients...

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OVERDOSAGE

In experimental animals, a single subcutaneous administration of up to 60 times the recommended human dose (on a µg/kg basis, not adjusted for bioavailability) had no adverse effects. At present, there is no...

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DESCRIPTION

SYNAREL (nafarelin acetate) Nasal Solution is intended for administration as a spray to the nasal mucosa. Nafarelin acetate, the active component of SYNAREL Nasal Solution, is a decapeptide with the chemical name...

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CLINICAL PHARMACOLOGY

Nafarelin acetate is a potent agonistic analog of gonadotropin-releasing hormone (GnRH). At the onset of administration, nafarelin stimulates the release of the pituitary gonadotropins, LH and FSH,...

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HOW SUPPLIED

Each 0.5 ounce bottle (NDC 0025-0166-08) contains 8 mL SYNAREL (nafarelin acetate) Nasal Solution 2 mg/mL (as nafarelin base), and is supplied with a metered spray pump that delivers 200 µg of nafarelin per spray...

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MEDICATION GUIDE
SYNAREL
(sin-na-rell...
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CENTRAL PRECOCIOUS PUBERTY (FOR ENDOMETRIOSIS, SEE

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