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The Main Pharmaceutical Inspectorate ordered the withdrawal from pharmacies throughout Poland of a series of the drug facilitating the onset of labor. It’s about 25 mcg Angusta tablets. The decision is immediately enforceable. What specific series was withdrawn from sale and why?
- GIF is recalling the drug Angusta (Misoprostolum), 25 mcg tablets, 8 tablets
- The number of the withdrawn series is B26789, expiry date: 30.09.2023/XNUMX/XNUMX.
- Check the current list of recalled drugs
- More information can be found on the Onet homepage
Series of the drug for induction of Angusta childbirth withdrawn from sale
The decision (No. 15) to withdraw Angusta 25 mcg 8 tablets was made by the Main Pharmaceutical Inspectorate on June 28. As we read in the release, the GIF received information about the B26442 series of Angusta 5 mcg tablets intended for the Italian market. Unknown contamination has been detected in it.
As a preventive measure, the marketing authorization holder, Norgine BV, based in the Netherlands, proposed to withdraw the drug Angusta 25 mcg tablets, 8 tablets, batch number B26789, intended for the Polish market. The expiry date of the withdrawn series is September 30.09.2023, XNUMX.
GIF emphasizes that «at present, the cause of the out-of-specification result for an unknown contamination and the impact of non-compliance on the quality of the medicinal product and its safety is unknown, it cannot be ruled out that the further marketing of the product in question may pose a threat to the health of the patient ».
Due to the above-mentioned risk of a quality defect, GIF decided to withdraw the above-mentioned series of Angusta from the national market.
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What is the drug Angusta
Angusta is used to help start the birth process. The active substance is misoprostol. As we read in the leaflet, misoprostol belongs to a group of drugs called prostaglandins. These compounds have a double effect during childbirth. One is to relax the cervix so that the baby can be born more easily through the vagina. The second is to induce contractions that will help push the baby out of the womb.
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Before taking Angusta, the woman should talk to her midwife, doctor or nurse. The drug should be administered only by trained obstetricians in a hospital setting that allows constant monitoring of the condition of the fetus and uterine function. Before using it, the doctor carefully assesses the condition of the cervix.
Angusta may overstimulate the uterus.
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