Cataflam Sử dụng ở phụ nữ có thai & cho con bú


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Novartis Pharma
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Use In Pregnancy & Lactation
Women of child-bearing potential: There are no data to suggest any recommendations for women of child-bearing potential.
Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and or cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1% up to approximately 1.5%.
The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has shown to result in increased pre-and post-implantation loss and embryo-foetal lethality.
In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during organogenetic period. If Cataflam is used by a woman attempting to conceive, or during the 1st trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); Renal dysfunction, which may progress to renal failure with oligo-hydroamniosis.
The mother and the neonate, at the end of the pregnancy, to: Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; Inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, Cataflam is contraindicated during the third trimester of pregnancy.
Breast-feeding: Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Cataflam should not be administered during breast-feeding in order to avoid undesirable effects in the infant.
Fertility: As with other NSAIDs, the use of Cataflam may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Cataflam should be considered.
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