Tuberculin PPD 100,000 units in 1 ml for Heaf Testing continues to be available.

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1 abcdefghijklm Health Department St Andrew s House Regent Road Edinburgh EH1 3DG To: Immunisation Co-ordinators Scottish Specialists in Pharmaceutical Public Health Association of Scottish Trust Chief Pharmacists cc Medical Directors for cascade to Chest Physicians, Chest Clinics, Paediatricians Telephone: Fax: e.mail: Dr.elizabeth.stewart@scotland.gsi.gov.uk Date: 25 March 2003 Dear Colleague SUPPLIES OF TUBERCULIN PPD FOR MANTOUX TESTING Current stocks of Tuberculin PPD for Mantoux Testing from Evans Vaccines Ltd (the sole supplier of UK licensed product) date expired at the end of January Evans Vaccines have informed us that new stocks will not be available until the beginning of April Tuberculin PPD 100,000 units in 1 ml for Heaf Testing continues to be available. The Health Departments have a limited supply of Tuberculin PPD manufactured by Statens Serum Institut (SSI) in Denmark for such instances. Tuberculin PPD from SSI is available as an unlicensed medicine in the UK (although it has a licence for use in other European countries and has passed tests at the National Institute for Biological Standards and Control (NIBSC) as if it were a licensed product). Tuberculin PPD 2TU and 10TU SSI will shortly be available from childhood vaccine holding centres in boxes of 10 x 1.5ml vials. As the supply is limited issue will be restricted to a maximum of 1 box of each presentation per order. If transportation is required for individual vials to neighbouring hospitals, this should be in accordance with the recommended temperature storage conditions of +2 C to +8 C. Please note also that the product information supplied with the Tuberculin PPD from SSI is in four languages. Please note the following key differences between the products from SSI and Evans Vaccines: The SSI presentations are labelled with the strength expressed as the number of units in 0.1ml of their PPD solutions. The licensed preparations manufactured by Evans Vaccines used routinely in the UK state the strength in units in 1ml. Users must read the label and package insert. BMA IC.doc 1.

2 Two preparations are available from SSI: 2 TU per 0.1ml dose (20 units in 1ml), and 10 TU per 0.1ml dose (100 units in 1ml - the strength of Evans product recommended for routine Mantoux testing). a unit of PPD from SSI may not be equivalent to a unit of PPD from Evans. Dosage recommendations for routine testing and subsequent re-testing are different. SSI recommends lower doses. SSI recommends a preliminary test using a dose of 2TU (using the preparation containing 2 units in 0.1ml) before proceeding to the routine Mantoux test using the preparation containing 10 units in 0.1ml. Advice in Immunisation against Infectious Disease 1996 (The Green Book) is still relevant for the SSI product but it needs to be interpreted in the light of the SSI directions. Orders should be placed with childhood vaccine holding centres using the following product codes: SSI2SCO for the 2 TU presentation SSI10SCO for the 10 TU presentation but if you require further information please contact: Dr Elizabeth Stewart (Medical issues) Tel: Mrs Norma Darroch (Pharmacy issues) Tel: Mrs Siobhan Souness (Vaccine Supply issues) Tel: Yours sincerely DR ELIZABETH STEWART Senior Medical Officer BMA IC.doc 2.

3 Appendix 1 Differences Between the Summary of Product Characteristics of the Tuberculin PPD Solutions available from Evans Vaccines and SSI This table provides a summary of the difference between the licensed Tuberculin PPD dilutions manufactured by Evans Vaccines (formerly Medeva) and the solutions available from Statens Serum Institute(SSI). Presentations Characteristics Evans SSI Recommendations/ Presentation 1ml ampoules in a pack of 5 ampoules 1.5ml vials in a pack of 10 vials The SSI vials have a chlorobutyl rubber Label Strength NB. Please refer to the Dosage and Administration Section. 1 unit of PPD from SSI may not be equivalent to 1 unit of PPD from Evans Not available 100 units per ml 1000 units per ml 2 units in 0.1ml 10 units in 0.1ml Not available (package insert mentions the use of 100 unit/0.1ml according to an individual physicians assessment). stopper Caution advised due to the difference in the labelling format using units per ml (Evans) compared to units in 0.1ml. (SSI). The use of decimal points in labelling can cause misinterpretation of the strength. BMA IC.doc 3.

4 Presentations (continued). Dosage and Administration. Instructions Evans SSI Recommendations/ Route of Administration Intradermal Intracutaneous * Routes of administration are identical both mean Method of administration Routine Dose Package leaflet recommends the use of a syringe fitted with a short bevel gauge 25 or 26 needle. A separate syringe and needle must be used for each subject to prevent cross-infection. Skin preparation and test site defined. Routine dose of (0.1ml) of 100 units per ml PPD (equivalent to 10 units). Package leaflet recommends the use of a 1ml syringe with a short hypodermic needle 26 gauge be used. No advice on skin preparation given and slight difference in the test site definition. SPC and Package Leaflet recommend an initial diagnostic test of 2 units in 0.1ml within the skin. Please refer to the guidance on skin preparation and test site definition given in Immunisation against Infectious Disease 1996 (Green Book) section page 231. Users are strongly recommended to follow the dosage instructions as indicated in the SSI package insert. BMA IC.doc 4.

5 Paediatric Dosage and Administration. Instructions Evans SSI Recommendations/ Paediatric use No specific dosage recommendations but the SPC recommends testing all infants over the age of 3 months prior to BCG vaccination. The Green Book recommends the use of 10 units for routine Mantoux Testing (see Green Book section page 230) Recommended that children exposed to tuberculosis must be tested using 2 units of tuberculin before any BCG vaccination. Users are strongly recommended to follow the dosage instructions as indicated in the SSI package insert. Mantoux Test Results. Instructions Evans SSI Recommendations/ Test results Results should be read after 72 hours, but usually a valid reading can be obtained up to 96 hours. A positive reaction is characterised by an area of 5 mm or greater of palpable induration. The result is read two or three days (48-72 hours) after the injection. The infiltration must have a diameter of at least 6 mm to be interpreted as positive. Test results should be read after 72 hours please refer to the Green Book section page 231. Post Mantoux test BCG Vaccination Tuberculin positive subjects should not be given BCG vaccine. No statement given. Tuberculin positive subjects should not be given BCG vaccine please refer to the Green Book section pages BMA IC.doc 5.

6 Pharmaceutical Particulars. Characteristics Evans SSI Recommendations/ Excipients Excipients listed in the Summary of Product Characteristics (SPC) Minor difference in most excipients when compared with the Evans presentation. Product contains an additional excipient Potassium hydroxychinoline sulphate B.P. Control solution for Mantoux Test available from Evans is not a suitable control for the SSI solutions. Shelf life 12 months 18 to 24 months Instructions of use/handling Storage Disposal Use the contents of the ampoule as soon as possible and within 1 hour of opening provided adequate aseptic precautions are taken. Between 2 o C and 8 o C.Do not freeze. Disposal should be by incineration at a temperature not less than 1100 o C at a registered waste disposal contractor. The contents of the vial should not be used more than 24 hours after the first dose has been removed. Between 2 o C and 8 o C No instructions given. Follow the SSI Package Leaflet/SPC instructions. It is recommended that the SSI vials are marked with the date and time of opening. DH recommends that the product is not frozen. Disposal of all Tuberculin solutions from either manufacturer should be by incineration at a temperature not less than 1100 o C at a registered waste disposal contractor. BMA IC.doc 6.