PANHEMATIN Powder for reconstitution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Panhematin Hemin for Injection.
Description
PANHEMATIN (hemin for injection) is an enzyme inhibitor derived from processed red blood cells. This product is prepared from large pools of human red blood cells which may contain the causative agents ...
Indications and clinical use
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, after initial carbohydrate ...
Contraindications
PANHEMATIN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete ...
Warnings and precautions
General There are insufficient data available for a long term use of PANHEMATIN for prevention. Risk of Phlebitis A large arm vein or a central venous catheter should be utilized for the administration ...
Adverse reactions
8.1 Adverse Reaction Overview The most common adverse reactions (occurring in >1% of patients) are: headache, pyrexia, infusion site reactions, and phlebitis. 8.2 Clinical Trial Adverse Reactions Because ...
Drug interactions
9.1 Overview PANHEMATIN therapy is intended to limit the rate of porphyria/heme biosynthesis possibly by inhibiting the enzyme δ-aminolevulinic acid synthase 1 (ALAS1) (see Action and Clinical Pharmacology). ...
Dosage and administration
3.1 Dosing Considerations PANHEMATIN should only be used by or in consultation with physicians experienced in the management of porphyrias. Before PANHEMATIN therapy is begun, the presence of acute porphyria ...
Overdosage
Reversible renal shutdown has been observed in a case where an excessive hematin dose (12.2 mg/kg) was administered in a single infusion (see Warnings and Precautions). Treatment of this case consisted ...
Action and clinical pharmacology
10.1 Mechanism of Action Heme acts to limit the hepatic and/or marrow synthesis of porphyrin. This action is likely due to the inhibition of δ-aminolevulinic acid synthase, the enzyme which limits the ...
Storage and stability
Store lyophilized powder at 20-25°C (68-77°F).
Dosage forms, composition and packaging
<b>Table 2. Dosage Forms, Strengths, Composition and Packaging:</b> <b>Route of Administration</b> <b>Dosage Form/Strength/Composition</b> <b>Non-medicinal Ingredients</b> Intravenous (IV) Infusion ...
Pharmaceutical information
Drug Substance Proper name: Hemin Chemical name: chloro [7,12-diethenyl-3,8,13,17-tetramethyl-21H,23H-porphine-2,18- dipropanoato(2-)-N<sup>21</sup>,N<sup>22</sup>,N<sup>23</sup>,N<sup>24</sup>] iron ...
Clinical trials
The effectiveness of PANHEMATIN for the amelioration of recurrent attacks of acute intermittent porphyria (AIP) was evaluated in five open-label studies, one compassionate-use study, case reports, and ...
Toxicology
Non-clinical toxicology PANHEMATIN was not mutagenic in bacteria systems in vitro and was not clastogenic in mammalian systems in vitro and in vivo. No data are available on potential for carcinogenicity ...
Marketing authorization holder
Recordati Rare Diseases Canada Inc., Toronto, Ontario, Canada, M4N 3N1 Distributed by: Recordati Rare Diseases Canada Inc., Oakville, ON, Canada, L6M 2W2
Submission control number
212276
Date of approval
July 13, 2018
References
Watson CJ, Pierach CA, Bossenmaier I, Cardinal R. Use of hematin in the acute attack of the inducible hepatic porphyrias. Adv Intern Med. 1978;23:265-286. Pierach CA, Bossenmaier I, Cardinal R, Weimer ...
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