Hibitane™ Obstetric Cream - Abbreviated Prescribing Information

Abbreviated Prescribing Information for Hibitane™ Obstetric Cream

Presentation: Hibitane™ Obstetric Cream is a cream containing Chlorhexidine Gluconate 1% w/w. Indication: An antimicrobial preparation for use as an antiseptic and lubricant in obstetric and gynaecological practice. Dosage and Administration: Apply liberally to the skin around the vulva and perineum of the patient, and to the gloved hands of the midwife or doctor. Contraindications: Contraindicated for patients who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare. Warnings and Precautions: For topical application only. Keep out of the eyes and ears and avoid contact with the brain and meninges. Local stinging and/or chemical burns have been reported following off-label use of gauze packs soaked in Hibitane™ Obstetric Cream and left intra-vaginally for prolonged periods. Undesirable Effects: Irritative skin reactions can occasionally occur. Generalised allergic reactions to chlorhexidine including anaphylaxis have been reported but are extremely rare. Package Quantities: 50ml and 250ml bottle. Pharmaceutical Precautions: Store below 30ºC. Basic NHS Price: £4.80 (1 x 50ml) and £19.23 (1 X 250ml). Legal Category: GSL. Marketing Authorisation Number: PL 19876/0009. Marketing Authorisation Holder: Derma UK Ltd, Toffee Factory, Ouseburn, Newcastle upon Tyne, NE1 2DF, UK. “Hibitane” and “Derma UK” are registered Trade Marks. Date of Revision of Text: March 2021

Please refer to the full SPC text before prescribing this product. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Derma UK on +44 (0) 191 375 9020.