引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| European Union: Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines (English only) |
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European Medicines Agency (EMA) announces that the Committee for Veterinary Medicinal Products (CVMP) recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines. The recommendations address inconsistencies in the product information of veterinary medicines containing NMP, which are marketed in many European Union (EU) Member States.
The CVMP recommended that veterinary medicines that expose the user to amounts of NMP above a certain threshold should not be given to animals by pregnant women or by women who may be pregnant. Furthermore, women who are able to have children should exercise caution when using these medicines. This includes wearing personal protective equipment such as gloves, particularly for pour-on and spot-on products, shampoos, sprays and concentrates for oral solutions.
The Committee also recommended that in the absence of studies demonstrating the safe use of veterinary medicines containing NMP in the target animal species during pregnancy, lactation or lay, NMP-containing veterinary medicines should only be given to animals that are pregnant, lactating, in lay or intended for breeding after assessment of the benefits and risks by the treating veterinarian. To assist veterinarians in their decision-making, the product information must specify the precise quantity of NMP contained in these veterinary medicines.
NMP is an excipient used in some veterinary medicines that is classified as a teratogen (a substance that can cause birth defects following exposure during pregnancy) in laboratory animals. There is therefore the possibility that NMP could cause birth defects in children of women who handle or come into contact with NMP-containing medicines during their pregnancy, and in the offspring of animals given these medicines.
More than 1,100 veterinary medicines containing the excipient NMP are available in the EU under various trade names and in different formulations, for use mainly in companion animals and large farm animals. These medicines are available as injections, solutions for infusion, spot-on and pour-on products, shampoos, sheep dips, sprays and concentrates for oral solutions for use in the drinking water of animals or solutions for fish treatment.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/reducing-risks-human-animal-health-exposure-n-methyl-pyrrolidone-veterinary-medicines
In Hong Kong, there is one registered pharmaceutical product for veterinary use containing NMP as excipient, namely, Fido’s Fre-itch Rinse Concentrate (Vet) (HK-61356). This product is registered by Evergreen Pet Supplies Ltd. It is an over-the-counter medicine. So far, the Department of Health has not received any case of adverse drug reaction related to NMP. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Monday, Apr 17, 2023
Issued at HKT 18:00
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