ブドウ球菌ファージ溶解物
Staphylococcal Phage Lysate
Staphylococcal Phage Lysate (prepared by lysing cultures of Staphylococcus aureus Cowan serologic types I & III by a staphylococcal bacteriophage)
別名: Staphage Lysate · SPL Immune Stimulant
VetSheet 獣医チームが監修更新日 2026年4月5日エビデンスに基づく獣医学リファレンス
用量は獣医専門家向けの臨床参考資料です。必ず最新の医薬品情報および個別症例に基づいて確認してください。
動物種別用量
🌎 NA — North America🌍 EU — Europe
犬
| 適応 | 用量 | 経路 | 頻度 | 期間 | 地域 |
|---|---|---|---|---|---|
| Labeled indications (Highly allergic patients) | Skin test with 0.05-0.1 mL intradermally. Therapy: Initially, 0.2 mL SC, then incremental increases of 0.2 mL once a week to 1 mL (a total of 5 injections). Then continue at 1 mL SC weekly for approximately 10-12 weeks. | SC/ID | Weekly | 10-12 weeks | 🌎 NA |
| Labeled indications (Non-allergic patients) | 0.5 mL SC twice weekly for 10-12 weeks, then 0.5-1 mL every 1-2 weeks. | SC | Twice weekly then every 1-2 weeks | 10-12 weeks initial, then maintenance | 🌎 NA |
| Idiopathic, recurrent pyoderma | 0.5 mL SC twice weekly for 10-12 weeks, then tapered to effect. | SC | Twice weekly | 10-12 weeks then tapered | 🌎 NA |
| Chronic recurrent idiopathic pyoderma | Injections are administered twice weekly (0.5 mL) and slowly reduced to 0.5 mL every 2 weeks. | SC | Twice weekly then reduced | Ongoing | 🌎 NA |
- Labeled indications (Highly allergic patients): Concomitant antibiotic therapy is recommended for an initial 4-6 week period. Maximum dose should be decreased in small dogs and can be increased cautiously, if necessary, in large dogs to 1.5 mL.
- Labeled indications (Non-allergic patients): Concomitant antibiotic therapy is recommended for an initial 4-6 week period.
- Idiopathic, recurrent pyoderma: This agent is rarely needed, because in most cases, an underlying cause can be identified and treated.
- Chronic recurrent idiopathic pyoderma: Pyoderma needs to be under control as this product is not a substitute for antibiotics.
用量は獣医専門家向けの臨床参考資料です。必ず最新の医薬品情報および個別症例に基づいて確認してください。
概要
ブドウ球菌ファージ溶解物（SPL）は、主に獣医皮膚科で使用される注射用の生物学的製剤および免疫刺激剤です。特に犬の再発性・特発性ブドウ球菌性膿皮症の管理に適応があり、多くの場合、適切な抗菌薬治療と併用されます。
臨床のポイント： 薬剤耐性（MRSPなど）が増加している現在、SPLのような免疫調節剤は、全身性抗生物質の使用頻度と期間を減らすための有用な補助的アプローチを提供します。
本製品は、ブドウ球菌ファージを用いて黄色ブドウ球菌（Cowan血清型IおよびIII；ヒト株）の培養物を溶解することによって調製されます。調製された溶液には、黄色ブドウ球菌成分（プロテインA抽出物）、ファージ、および未濾過の牛心臓浸出液ブロスが含まれており、細菌学的無菌性を達成するために限外濾過されています。
作用機序
SPL functions as an immunomodulator that specifically enhances cell-mediated immunity (Th1 immune response).
- Cytokine Stimulation: It stimulates the production of key pro-inflammatory and immunoregulatory cytokines, including Tumor Necrosis Factor (TNF-α), Interleukin-6 (IL-6), and Interferon-gamma (IFN-γ).
- Mechanism: By upregulating IFN-γ and TNF-α, SPL enhances the phagocytic and bactericidal activities of macrophages and neutrophils → leading to improved clearance of intracellular and extracellular staphylococcal organisms from the skin.
- Protein A Role: The presence of staphylococcal Protein A acts as a potent B-cell superantigen and immunogen, further stimulating a robust host immune response against staphylococcal antigens.
安全性・警告
禁忌
- Prior systemic hypersensitivity reactions to SPL
- Documented hypersensitivity reactions to beef products (contains unfiltered beef heart infusion broth)
有害事象
- Post vaccine-type reactions (fever, malaise)
- Injection site reactions (redness, itching, swelling occurring 2-3 hours post-injection and persisting up to 3 days)
- Systemic hypersensitivity reactions (weakness, vomiting, diarrhea, severe itching, rapid breathing, fatigue/lassitude)
注意事項
Hypersensitivity Risk: Use with extreme caution (if at all) in patients with a history of systemic hypersensitivity to SPL or documented allergies to beef products, as the formulation contains unfiltered beef heart infusion broth.
- Administration: Avoid administering subsequent doses at the exact same injection site to minimize local reactions.
- Handling: The product contains no preservatives. It must be handled strictly aseptically. The manufacturer recommends using the entire contents of a vial once opened.
- Allergic Patients: In highly allergic patients, reduced desensitizing doses and prior intradermal skin testing may be indicated.
医薬品相互作用
May reduce the efficacy of SPL
監視
- Clinical efficacy (resolution of pyoderma)
- Local injection site reactions (redness, swelling, itching)
- Systemic hypersensitivity reactions (anaphylaxis, vomiting, weakness)
過剰投与
No specific information was located regarding acute toxicity. Other than an increased risk for local or systemic hypersensitivity reactions, significant morbidity appears unlikely. Should an anaphylactic-type reaction occur, treat supportively; the manufacturer recommends epinephrine and atropine as antidotes.
製品
製剤
- Injection: 1 mL ampules
- Injection: 10 mL multi-dose vials
動物用医薬品
- Staphage Lysate (SPL) in 1 mL ampules (box of 10)
- Staphage Lysate (SPL) in 10 mL multi-dose vials
規制ステータス
規制データなし: 🇺🇸 US · 🇪🇺 EU · 🇬🇧 UK · 🇭🇰 HK · 🇹🇼 TW · 🇯🇵 JP · 🇰🇷 KR · 🇦🇺 AU
保管・安定性
Store in the refrigerator (2-7°C); do not freeze. Unopened, properly stored vials and ampules have an average expiration date of one year past the shipment date. The product contains no preservative and must be handled aseptically. It is recommended to use the entire contents of the vial after opening. Do not use if contents are cloudy. Do not mix with other drugs or solutions prior to administration.
飼主向け情報
治療について：
- この薬は、犬自身の免疫システムが慢性または再発性の細菌性皮膚感染症（膿皮症）と戦うのを助けるように設計された「免疫刺激剤」です。
- 抗生物質ではありませんが、感染をコントロールするために最初は抗生物質と一緒に使用されることがよくあります。
投与と安全性：
-
重要： まれに重篤なアレルギー反応（アナフィラキシー）のリスクがあるため、緊急治療がすぐに受けられる動物病院で注射を行うことが理想的です。
注意すべき症状： 注射後に以下の症状に気づいた場合は、すぐに獣医師に連絡してください：
- 局所反応： 注射部位の赤み、かゆみ、腫れ（通常2〜3時間以内に発生し、最大3日間続くことがあります）。
- 全身反応： 虚弱、嘔吐、下痢、重度の全身のかゆみ、速い呼吸や呼吸困難、または突然の極度の疲労/無気力。
VetSheet医薬品リファレンスは獣医専門家の臨床意思決定支援を目的としており、専門的判断または製造業者の最新医薬品情報の代替にはなりません。