"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Special warnings and precautions for use
Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) or anaphylactoid reactions may occur. Familiarity with the practice and technique of resuscitation and treatment of anaphylaxis is essential. Appropriate medicinal products and instruments should be readily available.
Care should be exercised in patients with severe cardiac disease and in patients with injuries of the blood brain barrier and severe cerebral disease.
The fact that long term parenteral nutrition with manganese supplementation can cause manganese accumulation in the basal ganglia should be considered when administering TESLASCAN (mangafodipir) to patients on such treatment.
This medicinal product contains 5.5 mmol (126 mg) sodium per normal dose of 35 ml. To be taken into consideration by patients on a controlled sodium diet.
Pregnancy and lactation
The safety of TESLASCAN (mangafodipir) in human pregnancy has not been established. TESLASCAN (mangafodipir) must not be used during pregnancy (see the CONTRAINDICATIONS section).
Prior to administration of TESLASCAN (mangafodipir) to women of child bearing potential, pregnancy should be excluded.
Pre-clinical studies in rats have established teratogenic effects when TESLASCAN (mangafodipir) was given repeatedly during major organogenesis. TESLASCAN (mangafodipir) causes foetotoxicity and embryotoxicity in rabbits. TESLASCAN (mangafodipir) is not teratogenic in rabbits. TESLASCAN (mangafodipir) has no effect on male or female fertility in rats.
The degree of excretion into human breast milk is not known. Breast-feeding should be discontinued from the time of administration and should not be recommenced until 14 days after administration of TESLASCAN (mangafodipir) .
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/3/2009
Additional Teslascan Information
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