ZOMACTON- somatropin kit

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL)

Beschikbaar vanaf:

Ferring Pharmaceuticals Inc.

INN (Algemene Internationale Benaming):

SOMATROPIN

Samenstelling:

SOMATROPIN 5 mg

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

ZOMACTON is indicated for the treatment of pediatric patients with: - growth failure due to inadequate secretion of endogenous growth hormone (GH), - short stature associated with Turner syndrome, - idiopathic short stature (ISS), height standard deviation score (HSDS) ≤-2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range, - short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, - short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. ZOMACTON is indicated for the replacement of endogenous GH in adults with GH deficiency. ZOMACTON is contraindicated in patients with: - Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions (5.1)] . - Pediatric patients with Prader-Willi s

Product samenvatting:

ZOMACTON for injection is a white, lyophilized powder available as: Before Reconstitution Refrigerate ZOMACTON vials at 36° to 46°F (2° to 8°C). Avoid freezing the accompanying diluent. After Reconstitution ZOMACTON 5 mg is stable for 14 days when reconstituted with bacteriostatic 0.9% sodium chloride and refrigerated at 36° to 46°F (2° to 8°C). Do not freeze. ZOMACTON 10 mg is stable for 28 days when reconstituted with bacteriostatic water and refrigerated at 36° to 46°F (2° to 8°C). Do not freeze.

Autorisatie-status:

Biologic Licensing Application

Productkenmerken

ZOMACTON- SOMATROPIN
FERRING PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOMACTON SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOMACTON.
ZOMACTON (SOMATROPIN) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Indications and Usage (1)
1/2018
Dosage and Administration (2)
1/2018
Contraindications (4)
1/2018
Warnings and Precautions (5)
1/2018
INDICATIONS AND USAGE
ZOMACTON is a recombinant human growth hormone indicated for:
_Pediatric:_ Treatment of pediatric patients with growth failure due
to inadequate secretion of
endogenous growth hormone (GH), short stature associated with Turner
syndrome, idiopathic short
stature (ISS), short stature or growth failure in short stature
homeobox-containing gene (SHOX)
deficiency, and short stature born small for gestational age (SGA)
with no catch-up growth by 2 years to
4 years. (1.1)
_Adult:_ Replacement of endogenous GH in adults with GH deficiency
(1.2)
DOSAGE AND ADMINISTRATION
Administer by subcutaneous injection to the back of upper arm,
abdomen, buttock, or thigh with regular
rotation of injection sites (2.1)
_Pediatric dosage:_ Divide the calculated weekly dosage into equal
doses given either 3, 6, or 7 days per
week (2.2)
_GH deficiency:_ 0.18 mg/kg/week to 0.3 mg/kg/week (2.2)
_Turner syndrome:_ Up to 0.375 mg/kg/week (2.2)
_ISS:_ Up to 0.37 mg/kg/week (2.2)
_SHOX deficiency:_ 0.35 mg/kg/week (2.2)
_SGA:_ Up to 0.47 mg/kg/week (2.2)
_Adult dosage:_ Either of the following two dosing regimens may be
used:
_Non-weight based dosing_: Initiate with a dose of approximately 0.2
mg/day (range, 0.15 mg/day to
0.3 mg/day) and increase the dose every 1 to 2 months by increments of
approximately 0.1 mg/day
to 0.2 mg/day, according to individual patient requirements (2.3)
_Weight-based dosing (Not recommended for obese patients)_: Initiate
at 0.006 mg/kg daily and
increase the dose according to individual patient requirements to a
maxi