The GCC Guidance for Presenting the SPC, PIL and Labeling ...

Appendix 4: Lactation statements1. {Active substance} is not excreted in breast milk. {Invented name} can be used duringlactation.2. {Active substance} is excreted in breast milk. However, at therapeutic doses of {Inventedname} no effects on the suckling child are anticipated. {Invented name} can be used duringbreast-feeding.3. {Active substance} is excreted in breast milk to such an extent that effects on the sucklingchild are likely if therapeutic doses of {Invented name} are administered to breast-feedingwomen.• Alternative recommendations (combinations of recommendations may be used):- {Invented name} should not be used during breast-feeding.- {Invented name} is contraindicated during breast-feeding (must also becontraindicated in 4.3).- Lactation should be discontinued during treatment with {Invented name}.- A decision must be made whether to discontinue breast-feeding or todiscontinue/abstain from {Invented name} therapy.• Additional recommendation (if applicable):- Due to the long retention time of {substance} in the body, breast-feeding must not beresumed until x (days, months) after {Invented name} therapy is completed.4. It is unknown whether {Active substance} is excreted in human breast milk. The excretion of{Active substance} in milk has not been studied in animals. A decision on whether tocontinue/discontinue breast-feeding or to continue/discontinue therapy with {Invented name}should be made taking into account the benefit of breast-feeding to the child and the benefitof {Invented name} therapy to the woman.Page 35 of 52