PANHEMATIN - hemin injection, powder, lyophilized, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Hemin (UNII: 743LRP9S7N) (Hemin - UNII:743LRP9S7N)

Mevcut itibaren:

RECORDATI RARE DISEASES, INC.

INN (International Adı):

Hemin

Kompozisyon:

Hemin 7 mg in 1 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

PANHEMATIN (hemin for injection) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women. Manifestations such as pain, hypertension, tachycardia, abnormal mental status and mild to progressive neurologic signs may be controlled in selected patients with this disorder. Similar findings have been reported in other patients with acute intermittent porphyria, porphyria variegata and hereditary coproporphyria. PANHEMATIN is not indicated in porphyria cutanea tarda. PANHEMATIN is contraindicated in patients with known hypersensitivity to this drug.

Ürün özeti:

PANHEMATIN is supplied as a sterile, lyophilized black powder in single dose dispensing vials (NDC 55292-701-54) in a carton (NDC 55292-701-55). When mixed as directed with Sterile Water for Injection, USP, each 43 mL provides the equivalent of approximately 301 mg hematin (7 mg/mL). Store lyophilized powder at 20-25°C (68-77°F). See USP controlled room temperature. Caution: The packaging (vial stopper) of this product contains natural rubber latex which may cause allergic reactions.

Yetkilendirme durumu:

Biologic Licensing Application

Ürün özellikleri

PANHEMATIN - HEMIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
RECORDATI RARE DISEASES, INC.
----------
PANHEMATIN
HEMIN FOR INJECTION
RX ONLY
FOR INTRAVENOUS INFUSION ONLY.
PANHEMATIN (hemin for injection) should only be used by physicians
experienced in the
management of porphyrias in hospitals where the recommended clinical
and laboratory diagnostic
and monitoring techniques are available.
PANHEMATIN therapy should be considered after an appropriate period of
alternate therapy
(i.e., 400 g glucose/day for 1 to 2 days). (See "WARNINGS",
"PRECAUTIONS" and "DOSAGE
AND ADMINISTRATION" sections.)
DESCRIPTION
PANHEMATIN (hemin for injection) is an enzyme inhibitor derived from
processed red blood cells.
Hemin for injection was known previously as hematin. The term hematin
has been used to describe the
chemical reaction product of hemin and sodium carbonate solution.
Hemin is an iron containing
metalloporphyrin. Chemically hemin is represented as chloro
[7,12-diethenyl-3,8,13,17-tetramethyl-
21H,23H-porphine-2,18-dipropanoato(2-)-N ,N ,N ,N ] iron. The
structural formula for hemin is:
PANHEMATIN is a sterile, lyophilized powder suitable for intravenous
administration after
reconstitution. Each dispensing vial of PANHEMATIN contains the
equivalent of 313 mg hemin,
215 mg sodium carbonate and 300 mg of sorbitol. The pH may have been
adjusted with hydrochloric
acid; the product contains no preservatives. When mixed as directed
with Sterile Water for Injection,
USP, each 43 mL provides the equivalent of approximately 301 mg
hematin (7 mg/mL).
CLINICAL PHARMACOLOGY
Heme acts to limit the hepatic and/or marrow synthesis of porphyrin.
This action is likely due to the
inhibition of δ-aminolevulinic acid synthetase, the enzyme which
limits the rate of the porphyrin/heme
biosynthetic pathway. The exact mechanism by which hematin produces
symptomatic improvement in
patients with acute episodes of the hepatic porphyrias has not been
elucidated.[1,9]
Following intravenous administration of hematin in non-jaundiced human
patient