DESMOPRESSIN ACETATE injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

Dostupné z:

UBI Pharma Inc.

Spôsob podávania:

SUBCUTANEOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Desmopressin Acetate Injection USP is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Limitations of Use: Desmopressin Acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. Desmopressin Acetate Injection USP is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to: - Maintain hemostasis during surgical procedures and postoperatively - Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. Desmopressin Acetate Injection USP is indicated for patients with mild to moderate von Willebrand’s disease (Type I) with factor VIII levels greater than 5% to: - Maintain hemostasis during surgical procedures and postoperatively - Reduce bleeding wi

Prehľad produktov:

Desmopressin Acetate Injection USP is available as a sterile solution supplied as 4 mcg/mL in cartons of ten 1 mL single-dose, type 1 glass vials with rubber stopper and a flip off seal (NDC 72843-461-10) and 40 mcg/10 mL (4 mcg/mL) in 10 mL multiple-dose vials, type 1 glass vial with rubber stopper and a flip off seal, (NDC 72843-440-01), each containing 4 mcg Desmopressin Acetate per mL. Store refrigerated 2° to 8°C (36° to 46°F).

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE INJECTION
UBI PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESMOPRESSIN ACETATE
INJECTION USP SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DESMOPRESSIN ACETATE INJECTION
USP.
DESMOPRESSIN ACETATE INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1978
WARNING: HYPONATREMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Desmopressin Acetate can cause hyponatremia, which may be
life-threatening if severe. ( 5.1)
Desmopressin Acetate is contraindicated in patients at increased risk
of severe hyponatremia,
such as patients with excessive fluid intake, illnesses that can cause
fluid or electrolyte
imbalances, and in those using loop diuretics or systemic or inhaled
glucocorticoids. ( 4, 5.1)
Ensure serum sodium concentration is normal before starting or
resuming Desmopressin Acetate.
Measure serum sodium within 1 week and approximately 1 month after
starting therapy and
periodically during treatment. More frequently monitor serum sodium in
patients 65 years of age
and older and in patients at increased risk of hyponatremia. ( 2.1,
5.1)
If hyponatremia occurs, interrupt or discontinue Desmopressin Acetate.
( 5.1)
INDICATIONS AND USAGE
Desmopressin Acetate Injection USP is a vasopressin analog used for:
Central Diabetes Insipidus - as antidiuretic replacement therapy in
the management of central (cranial)
diabetes insipidus and for the management of the temporary polyuria
and polydipsia following head
trauma or surgery in the pituitary region. ( 1.1)
Hemophilia A- for patients with factor VIII coagulant activity levels
greater than 5% to maintain
hemostasis during surgical procedures and postoperatively or reduce
bleeding with episodes of
spontaneous or traumatic injuries such as hemarthroses, intramuscular
hematomas, or mucosal
bleeding. ( 1.2)
von Willebrand’s disease (Type I) - for patients with mild to
moderate disease with factor VIII level