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Description of Tuberculin PPD RT 23
Description of Tuberculin PPD RT 23 SSI
1 NAME OF THE MEDICINAL PRODUCT
Tuberculin PPD RT 23 SSI
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2 T.U./0.1 mL: One single dose of 0.1 mL contains 0.04 micrograms of Tuberculin PPD RT 23.
10 T.U./0.1 mL: One single dose of 0.1 mL contains 0.2 micrograms of Tuberculin PPD RT 23.
3 PHARMACEUTICAL FORM
Solution for injection. Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Tuberculin PPD RT 23 is used for Mantoux tuberculin skin testing to help diagnose if a person has ever been infected with Mycobacterium tuberculosis. Some countries also recommend Mantoux tuberculin skin testing in conjunction with BCG vaccination, either to ensure that only tuberculinnegative individuals are vaccinated or as a post-vaccination test.
This medicinal product is for diagnostic use only.
4.2 Posology and method of administration
Dosage and strength: The dosage is always 0.1 mL regardless of the strength used. The route of administration is strictly intradermal injection. The strength 2 T.U./0.1 mL is recommended. If low tuberculin reactivity is expected 10 T.U./0.1 mL may be used.
Administration:
• 0.1 mL is administered with a 1 mL graduated syringe fitted with a short bevel needle (gauge 25 or 26).
• The injection should be given strictly intradermally in the middle third of the forearm. Administration near the wrist or the elbow joint may weaken the reaction.
• The skin is slightly stretched, and the needle is held almost parallel with the skin surface with bevel upwards. The tip of the needle is inserted into the superficial layer of the
dermis.
• The needle should be visible through the epidermis during insertion. The 0.1 mL is slowly injected and a small blanched papule of 8 – 10 mm in diameter appears. This papule will disappear after approximately ten minutes.
• If a papule does not appear the injection has been given too deep, and the skin test should be repeated on the other arm or on the same arm, separated at least 4 cm from the first injection site.
National recommendations regarding the application of the skin test may be taken into consideration.
Evaluating the reaction: A skin test reaction is seen as a flat, uneven, slightly raised induration surrounded by an area of redness. The induration should be evaluated 48-72 hours after the injection. Hereafter the induration will decrease.
Only the induration is assessed. The diameter of the induration is measured in millimetres transversely to the long axis of the forearm with a transparent, flexible plastic ruler. Recommendations for interpreting the Mantoux tuberculin skin test are shown in table 1. Alternative interpretations, depending on national recommendations, individual and epidemiological factors, may be applied.
Diameter of induration in milimetres Negative0-5 mm
Positive6-14 mm
Strongly positive15+ mm
Table 1: Normal interpretation of the skin test result
Interpretation: A positive reaction indicates an immune response due to one or more of the following reasons:
• Infection with Mycobacterium tuberculosis complex, including M. tuberculosis, M. bovis, M. africanum, M. microtii, or M. tuberculosis subsp. caprae.
• Infection with non-tuberculous mycobacteria.
• Previous BCG vaccination (BCG vaccinated persons normally become tuberculin positive after 4 – 8 weeks).
Reactions larger than 15 mm are unlikely to be due to previous BCG vaccination or exposure to environmental mycobacteria.
Waning of tuberculin sensitivity: In most individuals tuberculin sensitivity caused by infection with M. tuberculosis or related mycobacteria normally persists throughout life. However, in some individuals this sensitivity may decrease or disappear over time. In BCG vaccinated individuals the tuberculin sensitivity most often wanes within a few years.
Booster effect: If tuberculin is administered to individuals whose tuberculin sensitivity has waned, the reaction to the skin test will be weak or absent. Retesting with tuberculin weeks or months later may result in an accentuation of the response, i.e. a booster effect. Repeated tuberculin skin testing will not induce a positive reaction in individuals who have no previous cellular immunity against the antigens in tuberculin PPD.
Repeated tuberculin skin testing: If it is anticipated to repeat the tuberculin skin test e.g. in health care workers potentially exposed to tuberculosis infection, a two-step method is recommended. In this method, the individual who has a weak or an absent initial Mantoux tuberculin skin test should receive a second tuberculin skin test 2 - 4 weeks after the first test. Skin test conversion in such individuals is defined as a reaction to the second test of more than 10 mm and an increase of at least 6 mm compared to the first test. Individuals showing skin test conversion after the second test should be considered to be previously infected with Mycobacteria or may have been BCG vaccinated, whereas individuals with a negative reaction to the second test should be considered uninfected. It is important to emphasize that the predictive value of the skin test result and the expected risk of tuberculosis should be considered on an individual basis.
4.3 Contraindications
Tuberculin PPD RT 23 SSI should not be administered to:
• Patients known to be hypersensitive (Type I) to the active substance or any of the excipients. This can cause vesiculation and skin necrosis in the centre of a widespread tuberculin reaction. The necrosis will generally disappear after a few days.
• Patients who previously have experienced a severe local reaction to Tuberculin products.
4.4 Special warnings and precautions for use
Although anaphylaxis is rare, facilities for its management should always be available during Mantoux tuberculin skin test.
Avoid subcutaneous or intramuscular injection of Tuberculin PPD RT 23 SSI. If this occurs, a papule will not develop and the Mantoux tuberculin skin test should be repeated on the other arm or if the same arm is used the injection site should be separated at least 4 cm from the first injection site.
4.5 Interaction with other medicinal products and other forms of interaction
A variety of host-related factors such as age, nutrition, renal failure, diabetes, immunosuppression by medicinal products (e.g. corticosteroids) or disease, e.g. cancer, HIV infection and sarcoidosis, can cause false negative tuberculin reactions. Viral infections (particularly measles, mumps, mononucleosis, varicella and influenza) can lower the
tuberculin reactivity for a few months. After vaccinations with vaccines containing live virus (e.g. vaccines against measles, mumps and rubella) a reduced reactivity may be observed. This decreased reactivity may result in false negative reactions. Therefore, if Mantoux tuberculin skin testing cannot be done at the same time as measles, mumps and rubella immunisation, the test should be postponed for 4 – 6 weeks. Tuberculin PPD RT 23 SSI can be safely administered simultaneously with all live and inactivated vaccines. Many patients co-infected with HIV and M. tuberculosis have anergy for tuberculin with or without anergy to other skin test antigens. In patients with severe tuberculosis (e.g. miliary tuberculosis) tuberculin reactivity may be suppressed. Previous BCG vaccination or recent infection with environmental non-tuberculous mycobacteria can result in cross-sensitization and a false-positive reaction to a Mantoux tuberculin skin test.
4.6 Pregnancy and lactation
Animal reproduction studies have not been performed with Tuberculin PPD RT 23 SSI. Mantoux tuberculin skin test with Tuberculin PPD RT 23 SSI is considered safe during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Tuberculin PPD RT 23 SSI should not affect the ability to drive and use machines.
4.8 Undesirable effects
The most common side-effects after administration of Tuberculin PPD RT 23 SSI are pain, itching and irritation at the injection site.
Blood and lymphatic system disorders Uncommon (> 1/1,000 to <1/100) Enlargement of regional lymph nodesSkin and subcutaneous tissue disorders Rare (>1/10,000 to <1/1,000) Vesiculation
Skin necrosisUrticaria
General disorders and administration site conditionsCommon (> 1/100 to 1/10) Pain at the injection site
Itching at the injection siteIrritation at the injection site
Uncommon (> 1/1,000 to <1/100) FeverImmune system disordersVery rare (<1/10,000) Hypersensitivity, including anaphylactic
reactionsNervous system disordersUncommon (>1/1,000 to <1/100) Headache
4.9 Overdose
Undesirable effects in relation to overdosage are not expected.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group, ATC code: V04CF01
6 Pharmaceutical particulars
6.1 List of excipients
Disodium phosphate dehydrate Potassium dihydrogen phosphate Sodium chloride Potassium hydroxychinoline sulphate Water for injections Polysorbate 80
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products.
6.3 Special precautions for storage
Store in a refrigerator (2ºC – 8ºC).
Store in the original package in order to protect from light.
6.4 Nature and contents of container
Type I glass vials, Ph. Eur. Stoppers of chlorobutyl rubber, Ph. Eur. The stoppers do not contain latex. Vials containing 1.5 mL or 5 mL in pack sizes of 1 or 10.
6.5 Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements. Tuberculin PPD RT 23 SSI does not contain any live material.
Description
Tuberculin PPD RT 23 (2TU) is a purified protein derivative, prepared from a culture of seven selected strains of Mycobacterium tuberculosis. It is a clear liquid, uncoloured to light
yellowish. One dose (0.1 mL) contains 2 Tuberculin Units, that equal to 0.04 μg of Tuberculin PPD RT 23.
Composition
Each dos(1 mL) contains:
Tuberculin PPD RT 23 from :
Mycobacterium tuberculosis 0,4 mcg
Disodium phosphate dihydrate 7,6 mcg
Potassium dihydrogen phosphate 1,45 mcg
Sodium chloride 4,8 mcg
Potassium hydroxyquinoline sulphate 100 mcg
Polysorbate 80 50 mcg
Water for injection 1 mL
Indication
For Mantoux Test to help diagnose of tuberculosis.
Administration
The test is made by intradermal injection of exactly 0.1 mL of the tuberculin solution. It is essential that the injection be given in the upper layer of the skin, since a possible positive reaction will be difficult to interpret if the tuberculin too deep. Site of injection is preferred in the middle third of the forearm, or in flexor.
Reading and Evaluation
The diamater of indurations is measured 48 to 72 hours after injection.
Storage
PPD RT 23 must be stored at temperatures between +2°C and +8°C. Protected from light. Do not freeze. Expiry date 3 years. Once a vial of PPD RT 23 tuberculin has been opened, its contents should be used within 24 hours. The remaining must be discarded.
Presentation
Vial 1,5 mL Vial of 1.5 mL
Note
On to the injection site, avoid to :
scratch or rub take antiseptic, soap, or other substances cover by bandage
Mantoux Test Readingnegative Positive Strongly Positive0-5 mm 6-14 mm 15 + mm
DESKRIPSITuberkulin Purified Protein Derivative (PPD) RT 23 adalah cairan bening yang me- ngandung PPD dari galur terpilih bakteri Mycobacterium tuberculosis. Tuberkulin PPD RT 23 diproduksi dengan kekuatan 2 tuberculin unit (T.U, dimana 1 T.U = 0,02 mcg (microgram) Tuberkulin PPD RT 23).
1 mL larutan Tuberkulin mengandung 50 mcg penstabil, polysorbate 80 (Tween 80) dan 100 mcg pengawet, potassium hy- droxyquinoline sulphate (Khinosol) dalam buffer fosfat.
KOMPOSISI1 mL Tuberkulin PPD 2 TU mengandung:Tuberkulin PPD RT 23 dari
Mycobacterium tuberculosis 0,4 mcg Disodium phosphate dihydrate 7,6 mg
Potassium dihydrogen phosphate 1,45 mg Sodium chloride 4,8 mg Potassium hydroxyquinoline sulphate 100 mcg Polysorbate 80 50 mcg\ Water for injection 1 mL
INDIKASIUntuk tujuan diagnostik. Uji Mantoux de- ngan Tuberculin PPD RT 23 merupakan alat pengujian dalam menentukan apakah sese- orang pernah terinfeksi oleh Mycobacterium tuberculosis.
KONTRAINDIKASIJika diketahui menyebabkan reaksi yang hipersensitif setelah dilakukan pengujian terhadap kulit dengan produk Sensitin PPD atau Tuberculin PPD, hindari penggunaan lebih lanjut.
PERINGATAN & PERHATIAN
Pasien yang memiliki latar belakang pernah mengalami vesikulasi dan nekrosis dengan berbagai metode uji tuberkulin, tes tuberkulin harus dihindarkan.
Reaktifitas terhadap tes dapat menu- run pada pasien yang mengkonsumsi kortikosteroid atau obat-obatan yang bersifat imunosupresif atau orang yang baru diimunisasi dengan vaksin virus hidup seperti MMR, Polio.
KEHAMILAN & MENYUSUITuberkulin PPD RT 23 dapat diberikan kepada wanita hamil jika benar-benar diperlukan.
INTERAKSI
Vaksinasi dengan vaksin virus hidup (sebagai contoh vaksin MMR terhadap campak, mumps, dan rubella) atau in- feksi virus, seperti campak, HIV atau influenza dapat menurunkan reaksi tuberkulin untuk sementara waktu. Penyakit lainnya, termasuk kanker dan sarcoidosis, dapat menurunkan sensi- tivitas terhadap tuberkulin. Seseorang yang kekurangan gizi dan sedang melakukan perawatan imunosupresif dapat menunjukkan reaksi yang ren- dah terhadap Tuberculin PPD RT 23 dibanding dengan yang diperkirakan.
Seseorang dengan tuberkulosis aktif dapat menunjukkan reaksi kurang dari 6 mm jika sistem kekebalan menga-lami penurunan yang drastis akibat infeksi tuberkulosis.
Seseorang dapat menunjukkan hasil uji Mantoux positif walaupun tidak / tidak pernah terinfeksi Tuberculosis. Hal ini dapat disebabkan oleh vaksi- nasi BCG sebelumnya ataupun infeksi awal mycobacterium non-tubercu- lous dari lingkungan yang tidak me- nyebabkan suatu penyakit tertentu.
DOSIS & METODE PENYUNTIKAN
Pengujian pada kulit harus dilakukan menggunakan metode Mantoux. Saat digunakan untuk tujuan diagnostik medis, sangat disarankan untuk meng- gunakan 0,1 mL Tuberkulin PPD RT 23 2 TU. Tuberkulin PPD RT 23 1 TU dapat digunakan bila diinginkan reaksi yang kuat.
Dosis yang digunakan adalah 0,1 mL cairan PPD RT 23. Penyuntikan harus dilakukan secara intrakutan di tengah sepertiga lengan, karena reaksi yang lemah di dekat pergelangan atau siku.
Untuk penyuntikan sebaiknya meng- gunakan jarum suntik 1 mL dengan kemiringan pendek 25 – 26 gauge (0,5 x 10 mm). Ambil 0,1 mL cairan tuberkulin dengan dilebihkan sedikit. Keluarkan kelebihan dan gelembung udara dari alat suntik, hingga ter- sisa tepat 0,1 mL cairan tuberkulin. Regangkan kulit sedikit, dan bagian jarum yang miring menghadap ke atas dimasukkan ke dalam lapisan dangkal dari kulit, kemudian suntikan perlahan seluruh dosis 0,1 mL.
Sangat penting untuk menyuntikan di bagian paling atas dari lapisan kulit, karena reaksi lanjutan akan sulit untuk ditafsirkan jika cairan Tuberkulin PPD disuntikan terlalu dalam. Penyuntikan yang tepat akan menghasilkan pem- bentukan gelembung kecil atau papul berdiameter 8 – 10 mm, yang akan terlihat sampai kira-kira 10 menit. Jika tidak ada gelembung yang terbentuk, kemungkinan cairan disuntikan terlalu dalam, dan tes harus diulangi pada sisi yang lain, atau pada sisi yang sama de- ngan jarak 4 cm atau lebih.
EVALUASI & INTERPRETASI UJI MANTOUX
Dalam 48 – 72 jam setelah penyuntikan, terjadi indurasi, dan kemerahan,yang dapat diamati sebagai reaksi positif. Ukur hanya indurasi yang terbentuk kurang lebih 3 hari setelah penggu- naan Tuberkulin PPD RT 23. Reaksi kulit dapat dirasakan berupa indurasi yang datar, sedikit pengerasan yang menonjol, yang harus diukur menggu- nakan penggaris plastik bening yang fleksibel.
Reaksi positif dari Tuberkulin PPD RT 23 berupa penebalan atau pengerasan dengan diameter lebih dari 6 mm.
Di negara – negara yang melakukan vaksinasi BCG, dapat memilih nilai batas yang lebih tinggi sebagai indikasi reaksi positif.
Dalam situasi tertentu, orang yang mengalami imunosupresif dapat dipertimbangkan mengalami reaksi positif terhadap tuberkulin, meskipun diameter indurasi yang terjadi kurang dari 6 mm.
EFEK SAMPINGSegera setelah penyuntikan, rasa sakit, irita- si atau rasa tidak nyaman walaupun jarang timbul di daerah suntikan, akan mereda dalam waktu singkat.Pada orang yang sa- ngat sensitif terhadap tuberkulin, vesikula atau kebekuan dapat muncul pada lokasi suntikan. Pernah dilaporkan adanya de- mam ringan atau pembengkakan kelenjar getah bening.
PENYIMPANAN
Cairan Tuberkulin PPD RT 23 harus disimpan pada suhu antara +2°C s/d +8°C, serta terlindungi dari cahaya.
Tanggal kadaluarsa yang tercantum pada label tidak boleh terlampaui. Setelah dibuka untuk dosis pertama, vial harus disimpan pada suhu antara +2°C s/d +8°C.
Isi yang masih tersisa harus digunakan dalam jangka waktu 24 jam.
KEMASANDus : 5 Vial @ 1,5 mL (15 dosis)Catatan :Pada daerah penyuntikan tidak boleh :
Digaruk ataupun digosok. Diberikan antiseptik, sabun, atau zat-zat tertentu. Ditutup dengan plester.
Diproduksi oleh Statens Serum InsitutDiimpor dan dikemas oleh PT Bio Farma (Persero).
