# Business Verification — Critical Numeric Tokens

## Executive conclusion

Codex checked **all 15 AstraZeneca package inserts** on **2026-07-30 04:49 JST** by comparing the source PDF glyph layer with the generated HTML content layer.

- **3/15 documents have a verified token match after the documented representation normalisations.**
- **12/15 documents contain at least one token difference that requires review.**
- Every difference is listed below by document; no difference is hidden inside an aggregate score.
- The visible tables and graphics are exact source-PDF crops and are covered separately by the pixel/object QC in `QC_REPORT.md`. This report tests the searchable and accessible HTML text layer.

**VERIFIED** means every occurrence of every in-scope token agrees after the explicitly reported source-representation reconciliations. **NEEDS REVIEW** is a conservative flag, not a failure: it can identify a confirmed semantic error, a missing searchable occurrence, or only a PDF glyph-spacing/count difference while the displayed source crop remains exact.

## Scope and method

The following token groups were checked:

1. dose and strength values with medicinal units or dosage-form counters;
2. administration schedules such as `1日2回`, `4週間隔`, and `Q8W`;
3. percentages;
4. Japanese pharmaceutical approval numbers; and
5. Japanese year-month and year-month-day dates.

The comparison is occurrence-sensitive. Unicode compatibility forms, full-width digits, `µg`/`μg`, and harmless spacing are normalised. PDF line-wrap recovery is limited to tokens that visibly cross a line boundary; standalone section numbers are excluded. Page-1 approval values are read from the PDF-derived masthead metadata guarded by the existing header-fidelity gate, and outlined product strengths are guarded by the exact source identity crop. No OCR or LLM was used.

## How business users should use this report

1. Find the product in **Package-insert status**.
2. **VERIFIED** means no critical-token action is required for this audit.
3. **NEEDS REVIEW** means at least one strict occurrence count differs. It does not automatically mean the visible HTML is wrong.
4. Use **Business review queue** to see whether the PDF has an unmatched token or HTML has an additional/differently reconstructed token.
5. Use **Regression-risk assessment** before authorising a correction. Only confirmed semantic errors are recommended for correction; conservative count differences are left unchanged.

**Column guide:** Package insert ID is the internal document identifier; Product / strength is the business-facing product name; Source PDF pages is the source length; Critical-token status is the result of this audit only; the two version fingerprints are shortened SHA-256 hashes that identify the exact PDF and HTML checked. The two hashes are not expected to match each other.

## Corpus summary

| Check category | Documents verified | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Printed in PDF, not matched in HTML | Additional or different in HTML |
|---|---:|---:|---:|---:|---:|---:|
| Dose / strength | 9/15 | 1155 | 1155 | 1148 | 7 | 7 |
| Administration schedule | 6/15 | 217 | 235 | 217 | 0 | 18 |
| Percentage | 12/15 | 1184 | 1176 | 1170 | 14 | 6 |
| Approval number | 15/15 | 26 | 26 | 26 | 0 | 0 |
| Date | 14/15 | 233 | 232 | 232 | 1 | 0 |

\* Matched includes reviewed PDF/HTML unit-representation equivalents (for example, a PDF base unit plus a positioned superscript denominator versus one semantic HTML token).

## Package-insert status

| Package insert ID | Product / strength | Source PDF pages | Critical-token status | Source PDF version fingerprint | HTML version fingerprint |
|---|---|---:|---|---|---|
| `etc_pi` | エトカマ錠75mg | 6 | **NEEDS REVIEW** | `b7dd5165342c` | `ce03339cd57f` |
| `tag40_pi` | タグリッソ錠40mg・80mg | 8 | VERIFIED | `f52169ef1a87` | `150f46f27e39` |
| `imf120_pi` | イミフィンジ点滴静注120mg・500mg | 10 | **NEEDS REVIEW** | `2a8a71cfdcb2` | `e469f76b193e` |
| `brz56_pi` | ビレーズトリエアロスフィア56吸入・120吸入 | 6 | **NEEDS REVIEW** | `d19bbdcb6460` | `c874a8e9271f` |
| `calc100_pi` | カルケンスカプセル100mg | 6 | **NEEDS REVIEW** | `ee394bec25d3` | `af9df30c95ee` |
| `calt100_pi` | カルケンス錠100mg | 8 | **NEEDS REVIEW** | `ec5776da3dd2` | `73b153b718c0` |
| `fsn10_pi` | ファセンラ皮下注30mgシリンジ・30mgペン・10mgシリンジ | 6 | **NEEDS REVIEW** | `edf2565025c9` | `9873277d55e7` |
| `fxg_pi` | フォシーガ錠5mg・10mg | 8 | **NEEDS REVIEW** | `a486eb5cb69a` | `ce4d2f710110` |
| `jd025_pi` | イジュド点滴静注25mg・300mg | 6 | VERIFIED | `da27ab9c5f5a` | `1b6eb5d0211c` |
| `lok05_pi` | ロケルマ懸濁用散分包5g・10g | 4 | **NEEDS REVIEW** | `b9f9f70bf59b` | `8cb70fe15df6` |
| `lyn100_pi` | リムパーザ錠100mg・150mg | 8 | **NEEDS REVIEW** | `a069219f6eb2` | `d688416e99aa` |
| `spn120p_pi` | サフネロー皮下注120mgオートインジェクター | 4 | **NEEDS REVIEW** | `5bbfcbb4bae7` | `f96005d71a0e` |
| `spn300_pi` | サフネロー点滴静注300mg | 4 | **NEEDS REVIEW** | `d67680af6814` | `91ca8ef383fa` |
| `tez210_pi` | テゼスパイア皮下注210mgシリンジ・210mgペン | 4 | **NEEDS REVIEW** | `0d4a8cbeec5e` | `a372f5a8ea25` |
| `trq160_pi` | トルカプ錠160mg・200mg | 6 | VERIFIED | `79b95a2710db` | `9251799ddfa4` |

## Business review queue

| Package insert ID | Check categories needing review | Printed in PDF but not matched in HTML | Additional or different in HTML |
|---|---|---|---|
| `etc_pi` | Administration schedule | — | Administration schedule: `1日1回`×1 |
| `imf120_pi` | Dose / strength, Percentage, Date | Dose / strength: `1,500mg`×2<br>Percentage: `95%`×12<br>Date: `2022年11月10日`×1 | Percentage: `5%`×4 |
| `brz56_pi` | Dose / strength | — | Dose / strength: `4.8μg`×3 |
| `calc100_pi` | Administration schedule | — | Administration schedule: `1日2回`×1 |
| `calt100_pi` | Administration schedule | — | Administration schedule: `1日1回`×1, `1日2回`×3 |
| `fsn10_pi` | Dose / strength | Dose / strength: `100mg`×1 | Dose / strength: `0mg`×1 |
| `fxg_pi` | Dose / strength, Administration schedule, Percentage | Percentage: `95%`×1 | Dose / strength: `0.2単位/kg`×1<br>Administration schedule: `1日1回`×3<br>Percentage: `5%`×1 |
| `lok05_pi` | Administration schedule | — | Administration schedule: `1日1回`×2 |
| `lyn100_pi` | Dose / strength, Administration schedule, Percentage | Dose / strength: `1120mg`×2<br>Percentage: `95%`×1 | Dose / strength: `20mg`×2<br>Administration schedule: `1日2回`×3<br>Percentage: `5%`×1 |
| `spn120p_pi` | Administration schedule | — | Administration schedule: `1週間ごと`×2 |
| `spn300_pi` | Administration schedule | — | Administration schedule: `4週間ごと`×1 |
| `tez210_pi` | Dose / strength, Administration schedule | Dose / strength: `1.91mL`×2 | Administration schedule: `4週間隔`×1 |

Context text in the detailed diff is an example occurrence of the token. When that token also has matched occurrences, the example is not necessarily the specific surplus occurrence.

## Regression-risk assessment

Do not change a document merely to turn **NEEDS REVIEW** into **VERIFIED**. The safe rule is: preserve all visible source crops; correct only a confirmed wrong or missing semantic value; scope the change to the named table/figure/document; and add a token-specific QC assertion before rebuilding all 15 package inserts.

| Package insert ID | Current business risk | Regression risk if changed | Recommended decision | Assessment |
|---|---|---|---|---|
| `etc_pi` | LOW | MEDIUM | **LEAVE AS IS** | The one additional `1日1回` occurs in source-derived text. No incorrect dose instruction was confirmed; removing a repeated instruction or caption could delete valid content. |
| `imf120_pi` | MEDIUM | MEDIUM if asset-scoped; HIGH if parser-wide | **TARGETED CORRECTION** | The visible crops are exact, but the searchable layer omits dose, confidence-interval and date occurrences, while `tbl-8-1` splits `95%` into `5%`. Correct only the named semantic tables/figure descriptions and add occurrence-level tests. |
| `brz56_pi` | LOW | MEDIUM | **LEAVE AS IS** | The three-count `4.8μg` difference is consistent with PDF glyph splitting; no wrong visible strength was confirmed. De-duplicating could remove legitimate repeated formulation or study text. |
| `calc100_pi` | LOW | MEDIUM | **LEAVE AS IS** | The additional `1日2回` is source-derived and clinically consistent. A generic de-duplication rule could remove a valid dose instruction, table value or study description. |
| `calt100_pi` | LOW | HIGH | **LEAVE AS IS** | The repeated schedules occur across legitimate dose-adjustment tables and clinical text. Removing occurrences to satisfy the counter could erase clinically distinct instructions. |
| `fsn10_pi` | HIGH for search/structured use; LOW for visible crop | LOW if limited to `tbl-3-0`; HIGH if parser-wide | **CORRECT** | A confirmed semantic-cell error changes `100mg` to `0mg`. Keep the pixel-exact table crop unchanged and correct only the accessible cell for `tbl-3-0`, with a token-specific QC assertion. |
| `fxg_pi` | MEDIUM | LOW–MEDIUM if limited to `tbl-6-1` | **TARGETED CORRECTION** | `tbl-6-1` contains a confirmed `95%` to `5%` semantic split. Correct that cell only. Leave schedule and `0.2単位/kg` count differences unchanged because they are consistent with source spacing/segmentation rather than a wrong instruction. |
| `lok05_pi` | LOW | HIGH | **LEAVE AS IS** | All additional `1日1回` occurrences are source-derived and appear in distinct dosing or study contexts. Removing them risks losing valid instructions. |
| `lyn100_pi` | HIGH for search/structured use; LOW for visible crops | LOW–MEDIUM if limited to `tbl-7-0` and `tbl-6-2` | **CORRECT** | Confirmed semantic-table errors change two `1120mg` occurrences to `20mg` in `tbl-7-0` and split `95%` to `5%` in `tbl-6-2`. Correct those cells only; leave schedule counts unchanged. |
| `spn120p_pi` | LOW | HIGH | **LEAVE AS IS** | All three `1週間ごと` statements are source-derived and serve different dosing/study contexts. The PDF glyph layer under-counts the phrase because of spacing; deletion would remove valid text. |
| `spn300_pi` | LOW | HIGH | **LEAVE AS IS** | The three `4週間ごと` statements are source-derived; the strict counter misses the page-1 occurrence. Removing one would risk deleting the approved dosing instruction. |
| `tez210_pi` | MEDIUM for search/accessibility; LOW for visible content | LOW–MEDIUM if formulation-table scoped | **TARGETED CORRECTION** | Two page-1 `1.91mL` formulation occurrences are visible in source content but absent from searchable HTML. Add them only to the corresponding semantic formulation data. Leave the `4週間隔` count unchanged because both HTML statements are source-derived. |

**Decision summary:** correct `fsn10_pi` and `lyn100_pi`; apply asset-scoped semantic corrections to `imf120_pi`, `fxg_pi`, and `tez210_pi` only if searchable/accessibility parity is required; leave `etc_pi`, `brz56_pi`, `calc100_pi`, `calt100_pi`, `lok05_pi`, `spn120p_pi`, and `spn300_pi` unchanged.

## Document-by-document verification

### エトカマ錠75mg (`etc_pi`)

- Source: `Package Insert/ETC_PI.pdf` (6 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 38 | 38 | 38 | VERIFIED |
| Administration schedule | 13 | 14 | 13 | **NEEDS REVIEW** |
| Percentage | 25 | 25 | 25 | VERIFIED |
| Approval number | 1 | 1 | 1 | VERIFIED |
| Date | 14 | 14 | 14 | VERIFIED |

**Per-document diff**

- **Administration schedule**
  - PDF only: None
  - HTML only: `1日1回` ×1 — HTML context: “CDK4/6阻害剤との併用において、通常、成人にはカミゼストラントとして75mgを1日1回経口投与する。”

**Reviewed representation notes (not defects)**

- `75mg` ×1: outlined product identity validated by source crop

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.29g`, `100mg` ×2, `100μg/kg`, `10mg`, `10mg/kg`, `14錠`, `150mg`, `1mg` ×2, `1錠`, `2.5mg`, `200mg` ×2, `20mg` ×3, `300mg`, `75mg` ×19, `7錠`
- **Administration schedule:** `1日1回` ×11, `1日2回` ×2
- **Percentage:** `1%` ×2, `10%` ×2, `11.0%`, `11.2%`, `11.6%`, `13.6%`, `15.5%`, `16.1%`, `16.8%`, `17.4%`, `19.4%`, `20.0%`, `20.1%`, `27.1%`, `29.0%`, `4.8%`, `43%`, `65.1%`, `75.3%`, `93.5%`, `95%` ×2, `99.99%`
- **Approval number:** `30800AMX00146`
- **Date:** `2024年11月28日`, `2026年6月` ×5, `2026年6月19日` ×8

</details>

### タグリッソ錠40mg・80mg (`tag40_pi`)

- Source: `Package Insert/TAG40_PI.pdf` (8 pages)
- Critical-token status: **VERIFIED**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 65 | 65 | 65 | VERIFIED |
| Administration schedule | 8 | 8 | 8 | VERIFIED |
| Percentage | 176 | 176 | 176 | VERIFIED |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 26 | 26 | 26 | VERIFIED |

**Per-document diff**

- No differences. Every in-scope token occurrence matches.

**Reviewed representation notes (not defects)**

- `30mL` (PDF) ↔ `30mL/min` (HTML) ×1: positioned unit denominator

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.26g`, `0.52g`, `100μg`, `120mg` ×2, `14錠` ×3, `1錠` ×2, `200mg`, `20mg` ×2, `240mg`, `28錠`, `30mL`, `40mg` ×7, `47.7mg`, `500mg/m2` ×2, `5mg・min`, `600mg/日`, `75mg/m2`, `80mg` ×30, `80mg/日` ×4, `90mL/min`, `95.4mg`
- **Administration schedule:** `1日1回` ×7, `1日2回`
- **Percentage:** `0.3%`, `1%` ×5, `1.9%`, `10%` ×5, `10.0%`, `10.4%`, `10.5%`, `10.6%`, `103%`, `107%`, `108%`, `11%`, `12.3%`, `13%`, `13.0%`, `13.6%`, `14.2%`, `14.7%`, `15%` ×2, `15.7%`, `17.8%`, `19%`, `19.0%`, `2%`, `2.7%`, `20%`, `20.3%` ×2, `21.0%`, `21.1%`, `21.5%`, `22.5%`, `22.6%`, `23%` ×2, `23.6%`, `24%`, `24.6%`, `25%`, `25.8%`, `26.1%`, `26.2%`, `264%`, `27%` ×2, `28.3%`, `3.3%`, `3.5%`, `30.4%`, `30.6%`, `30.8%` ×2, `31%`, `31.2%`, `32.6%`, `33.3%`, `34.1%` ×2, `34.2%`, `34.8%`, `35%` ×3, `37%` ×2, `38.7%`, `4.3%`, `4.6%`, `40.1%`, `40.8%`, `41.3%`, `42%`, `45.7%` ×2, `46%` ×2, `47%`, `48%`, `48.8%`, `49%`, `49.5%`, `50%`, `50.0%`, `51%`, `53.8%`, `54.5%`, `56%`, `56.9%`, `57%`, `57.4%`, `59.6%`, `6%` ×3, `6.3%`, `6.6%`, `60.9%`, `61%`, `61.7%`, `63%`, `67.4%`, `67.8%`, `68%`, `69.2%`, `7.3%`, `7.4%`, `70%` ×2, `72%` ×2, `73%`, `76%` ×3, `78%`, `79%`, `8%`, `8.1%`, `8.5%`, `80.4%`, `81%`, `84.6%`, `85%` ×2, `87.3%`, `87.6%`, `89%`, `9%`, `9.2%`, `90%` ×19, `90.7%`, `91.3%`, `91.4%`, `94%`, `95%` ×11, `95.1%`, `97.8%`, `97.9%`, `98.5%`
- **Approval number:** `22800AMX00385`, `22800AMX00386`
- **Date:** `2016年3月28日` ×8, `2016年4月15日`, `2016年5月`, `2016年9月`, `2017年6月12日`, `2020年1月17日` ×3, `2021年2月1日` ×4, `2023年4月3日` ×3, `2024年1月5日` ×2, `2025年5月`, `2026年1月`

</details>

### イミフィンジ点滴静注120mg・500mg (`imf120_pi`)

- Source: `Package Insert/IMF120_PI.pdf` (10 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 155 | 153 | 153 | **NEEDS REVIEW** |
| Administration schedule | 18 | 18 | 18 | VERIFIED |
| Percentage | 207 | 199 | 195 | **NEEDS REVIEW** |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 22 | 21 | 21 | **NEEDS REVIEW** |

**Per-document diff**

- **Dose / strength**
  - PDF only: `1,500mg` ×2 (PDF pages 3, 4, 5, 6, 7, 8)
  - HTML only: None
- **Percentage**
  - PDF only: `95%` ×12 (PDF pages 5, 6, 7, 8, 9)
  - HTML only: `5%` ×4 — HTML context: “必要量をバイアルから抜き取り、生理食塩液又は5%ブドウ糖注射液の点滴バッグに注入し、最終濃度を1~15mg/mLとする。点滴バッグをゆっくり反転させて混和すること。希釈液を凍結又は振盪させないこと。”
- **Date**
  - PDF only: `2022年11月10日` ×1 (PDF page 6)
  - HTML only: None

**Reviewed representation notes (not defects)**

- `50mg` (PDF) ↔ `50mg/m2` (HTML) ×1: positioned unit denominator

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.5mg`, `1,000mg/m2` ×6, `1,120mg` ×2, `1,250mg/m2` ×2, `1,500mg` ×28, `100mg/m2` ×5, `1040mg`, `10mL` ×3, `10mg/kg` ×3, `1120mg`, `120mg` ×5, `1500mg` ×16, `15mg/mL`, `175mg/m2`, `1バイアル` ×6, `2,600mg/m2`, `2.4mL` ×3, `200mg/m2` ×2, `20mg`, `20mg/kg` ×12, `250mg`, `25mg/m2`, `2600mg/m2`, `27mg`, `2mg`, `300mg` ×3, `30kg` ×15, `35mg/m2`, `4.8mg`, `40mL/min`, `500mg` ×5, `500mg/m2` ×4, `50mg`, `50mg/m2`, `5mg・min` ×2, `6.5mg`, `60mL/min` ×2, `6mg・min` ×2, `70mg/m2`, `75mg` ×3, `75mg/m2` ×4, `80mg/m2` ×2, `85mg/m2`
- **Administration schedule:** `1日1回`, `1日2回` ×2, `Q3W` ×5, `Q4W` ×10
- **Percentage:** `0.1%` ×10, `0.2%` ×2, `0.3%` ×2, `0.4%` ×2, `0.8%` ×2, `1%` ×2, `1.2%`, `1.3%`, `1.6%` ×2, `10%` ×4, `10.1%`, `10.3%` ×4, `10.7%` ×2, `10.8%`, `101.6%`, `11.1%` ×2, `11.3%`, `11.9%`, `116.2%`, `12.1%` ×2, `12.2%` ×2, `12.4%`, `12.6%` ×2, `13.0%`, `13.1%`, `13.7%`, `14.4%` ×2, `14.9%`, `15.1%`, `15.3%` ×2, `16.0%`, `16.5%`, `16.8%`, `17.0%` ×3, `17.2%`, `17.5%`, `18.5%` ×2, `19.2%`, `2.0%`, `20.0%` ×2, `20.2%` ×2, `20.6%`, `20.7%` ×2, `20.8%`, `21.5%`, `22.3%`, `22.4%`, `22.9%` ×2, `23.8%`, `24.5%`, `25.1%` ×2, `25.7%` ×2, `25.8%`, `25.9%`, `26.1%`, `26.5%`, `26.6%`, `26.9%` ×2, `28.2%`, `28.8%`, `280.1%`, `30.0%` ×2, `30.46%`, `30.5%` ×2, `31.3%`, `31.7%`, `32.2%` ×2, `32.7%`, `33.6%`, `34.9%`, `35.4%`, `36.0%`, `38.5%`, `38.6%`, `38.7%` ×2, `4.9%`, `40.8%`, `40.9%`, `41.5%`, `41.9%`, `43.6%`, `47.2%`, `47.9%`, `48.2%`, `49.7%`, `49.70%`, `5%`, `5.9%`, `50%`, `50.2%`, `50.7%`, `50.8%`, `53.6%`, `54.6%`, `61.8%`, `62.2%`, `62.3%`, `64.41%`, `67.4%`, `7.6%`, `72.4%`, `86.7%`, `88.9%`, `9.7%`, `94.3%`, `95%` ×47, `95.67%`, `95.877%`, `96.5%`, `96.8%`, `97.3%`, `97.4%`, `98.1%`, `98.7%`, `99.0101%`, `99.2%`, `99.4%` ×2, `99.6%`
- **Approval number:** `23000AMX00485`, `23000AMX00486`
- **Date:** `2017年2月13日`, `2018年3月22日`, `2018年8月`, `2019年3月11日`, `2021年3月12日`, `2021年8月11日`, `2021年8月27日`, `2022年11月10日` ×2, `2023年4月12日` ×4, `2024年12月20日` ×3, `2024年1月15日` ×2, `2024年4月29日`, `2024年5月10日`, `2026年1月`, `2026年6月`

</details>

### ビレーズトリエアロスフィア56吸入・120吸入 (`brz56_pi`)

- Source: `Package Insert/BRZ56_PI.pdf` (6 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 86 | 89 | 86 | **NEEDS REVIEW** |
| Administration schedule | 13 | 13 | 13 | VERIFIED |
| Percentage | 56 | 56 | 56 | VERIFIED |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 23 | 23 | 23 | VERIFIED |

**Per-document diff**

- **Dose / strength**
  - PDF only: None
  - HTML only: `4.8μg` ×3 — HTML context: “1回噴霧量(送達量):ブデソニド160μgグリコピロニウム臭化物9.0μg(グリコピロニウムとして7.2μg)ホルモテロールフマル酸塩水和物5.0μg(ホルモテロールフマル酸塩として4.8μg)”

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.66μg/kg`, `1000μg`, `10mg/kg`, `115.2μg`, `120吸入` ×4, `14.4μg` ×2, `160μg` ×9, `1mg/kg`, `200mg` ×2, `2吸入` ×12, `30mL`, `320μg` ×2, `38.4μg`, `3mg`, `4.5μg` ×4, `4.8μg` ×28, `5.0μg`, `50mL`, `56吸入` ×4, `7.2μg` ×5, `9.0μg`, `9.6μg` ×3
- **Administration schedule:** `1日2回` ×13
- **Percentage:** `0.0%`, `0.2%`, `0.3%` ×4, `0.5%` ×4, `0.6%` ×7, `0.8%` ×2, `0.9%` ×3, `1%` ×3, `1.0%` ×2, `1.1%`, `1.3%` ×4, `1.4%`, `1.6%` ×2, `12.6%`, `14.6%`, `15.3%`, `17.5%`, `24%`, `3.0%`, `34%`, `38%`, `4.1%`, `5%`, `50%`, `57%`, `62%`, `80%`, `85%`, `90%` ×2, `95%` ×4
- **Approval number:** `30100AMX00002`, `30100AMX00003`
- **Date:** `2009年10月16日` ×4, `2019年6月`, `2019年6月18日` ×14, `2019年9月`, `2022年3月`, `2022年6月`, `2024年1月`

</details>

### カルケンスカプセル100mg (`calc100_pi`)

- Source: `Package Insert/CALC100_PI.pdf` (6 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 57 | 57 | 57 | VERIFIED |
| Administration schedule | 16 | 17 | 16 | **NEEDS REVIEW** |
| Percentage | 69 | 69 | 69 | VERIFIED |
| Approval number | 1 | 1 | 1 | VERIFIED |
| Date | 16 | 16 | 16 | VERIFIED |

**Per-document diff**

- **Administration schedule**
  - PDF only: None
  - HTML only: `1日2回` ×1 — HTML context: “通常、成人にはアカラブルチニブとして1回100mgを1日2回経口投与する。なお、患者の状態により適宜減量する。”

**Reviewed representation notes (not defects)**

- `100mg` ×1: outlined product identity validated by source crop
- `500mg` (PDF) ↔ `500mg/m2` (HTML) ×1: positioned unit denominator

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.5mg/kg`, `1,000mg` ×4, `100mg` ×31, `14カプセル`, `150mg`, `1g`, `1カプセル`, `200mg`, `316mg`, `375mg/m2` ×2, `40mg`, `500mg`, `500mg/m2`, `50mg` ×2, `600mg` ×2, `69mL/min`, `70mg/m2`, `75mg`, `7カプセル`, `900mg` ×2
- **Administration schedule:** `1日1回` ×4, `1日2回` ×12
- **Percentage:** `0.2%` ×4, `0.4%` ×2, `1%`, `1.2%`, `1.5%`, `10%` ×2, `10.1%` ×3, `100%` ×2, `12.0%`, `12.4%`, `14.3%`, `14.9%`, `15.2%`, `17.5%` ×2, `19.6%`, `20.0%`, `21.9%`, `22.2%`, `22.5%` ×2, `24.0%`, `25.3%`, `3.2%`, `30.0%`, `34.7%`, `44.4%`, `5%` ×2, `5.1%`, `5.5%`, `5.6%` ×3, `5.8%` ×3, `6.2%`, `6.7%` ×2, `65.6%`, `65.9%`, `7.1%`, `7.7%`, `74.7%`, `80%`, `83.5%`, `88.9%` ×2, `9.1%`, `9.5%` ×2, `9.6%`, `90.0%`, `95%` ×4, `97.5%`, `98.6%`, `98.8%`
- **Approval number:** `30300AMX00032`
- **Date:** `2019年1月15日`, `2019年2月8日`, `2021年1月` ×2, `2021年1月22日` ×8, `2021年4月`, `2022年12月23日`, `2025年8月`, `2026年6月`

</details>

### カルケンス錠100mg (`calt100_pi`)

- Source: `Package Insert/CALT100_PI.pdf` (8 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 87 | 87 | 87 | VERIFIED |
| Administration schedule | 32 | 36 | 32 | **NEEDS REVIEW** |
| Percentage | 99 | 99 | 99 | VERIFIED |
| Approval number | 1 | 1 | 1 | VERIFIED |
| Date | 15 | 15 | 15 | VERIFIED |

**Per-document diff**

- **Administration schedule**
  - PDF only: None
  - HTML only: `1日1回` ×1 — HTML context: “1回100mgを1日1回”; `1日2回` ×3 — HTML context: “通常、成人にはアカラブルチニブとして1回100mgを1日2回経口投与する。なお、患者の状態により適宜減量する。”

**Reviewed representation notes (not defects)**

- `100mg` ×1: outlined product identity validated by source crop
- `500mg` (PDF) ↔ `500mg/m2` (HTML) ×1: positioned unit denominator

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.5mg/kg`, `1,000mg` ×6, `100mg` ×48, `129mg`, `14錠`, `150mg`, `1錠`, `200mg` ×2, `20mg` ×2, `375mg/m2` ×4, `400mg` ×2, `414mg`, `500mg`, `500mg/m2`, `50mL/min`, `50mg` ×3, `600mg` ×2, `69mL/min` ×2, `70mL/min`, `70mg/m2`, `7錠`, `900mg` ×3, `90mg/m2`
- **Administration schedule:** `1日1回` ×10, `1日2回` ×22
- **Percentage:** `0.1%` ×2, `0.2%` ×3, `0.4%`, `1%`, `1.0%`, `1.2%`, `1.8%`, `10%` ×2, `10.1%` ×3, `100%` ×2, `11.3%`, `12.0%`, `12.4%`, `13.7%`, `14.3%`, `14.9%`, `15.2%`, `18.5%`, `19.6%`, `20.0%`, `20.3%`, `20.9%`, `21.9%` ×2, `22.2%`, `22.5%` ×2, `22.6%`, `23.1%`, `23.4%`, `24.0%`, `25.3%` ×2, `25.8%`, `26.2%`, `3.9%`, `30.0%`, `30.8%`, `30.9%`, `34.7%`, `36.0%`, `38.7%`, `44.4%`, `5%` ×2, `5.1%`, `5.6%` ×3, `5.8%` ×3, `6.2%`, `6.6%`, `6.7%` ×2, `61.5%`, `65.6%`, `65.9%`, `7.1%`, `74.7%`, `75.9%`, `79.8%`, `8.9%`, `80%`, `81.5%`, `83.5%`, `86.1%`, `87.9%`, `88.9%` ×2, `9.1%`, `9.5%` ×2, `9.6%`, `90%`, `90.0%`, `92.3%`, `94.6%`, `95%` ×8, `95.31%`, `96.1%`, `97.5%`, `98.6%`, `98.8%`
- **Approval number:** `30600AMX00281`
- **Date:** `2019年1月15日`, `2019年2月8日`, `2021年1月` ×2, `2021年1月22日` ×4, `2021年7月19日` ×2, `2024年4月30日`, `2025年5月`, `2025年8月`, `2025年8月25日`, `2026年6月`

</details>

### ファセンラ皮下注30mgシリンジ・30mgペン・10mgシリンジ (`fsn10_pi`)

- Source: `Package Insert/FSN10_PI.pdf` (6 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 81 | 81 | 80 | **NEEDS REVIEW** |
| Administration schedule | 20 | 20 | 20 | VERIFIED |
| Percentage | 46 | 46 | 46 | VERIFIED |
| Approval number | 3 | 3 | 3 | VERIFIED |
| Date | 14 | 14 | 14 | VERIFIED |

**Per-document diff**

- **Dose / strength**
  - PDF only: `100mg` ×1 (PDF page 3)
  - HTML only: `0mg` ×1 — HTML context: “0mg(6例)”

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.03mg`, `0.06mg`, `0.5mL` ×2, `0.7mg`, `1.2mg`, `1.4mg`, `100mg`, `1098ng/mL`, `10mg` ×13, `10mg/日`, `1303ng/mL`, `1774ng/mL`, `1mL` ×3, `1シリンジ` ×2, `2.3mg`, `200mg` ×2, `25mg`, `267ng/mL`, `300mg`, `30mg` ×33, `324ng/mL`, `326ng/mL`, `330ng/mL`, `35kg` ×4, `47mg`, `4mg/日`, `50mg/日`, `902ng/mL`, `95mg`
- **Administration schedule:** `4週間隔` ×2, `8週間隔` ×2, `Q4W` ×6, `Q8W` ×10
- **Percentage:** `0.1%`, `1%` ×2, `1.2%`, `1.21%`, `1.4%`, `1.5%`, `10%`, `10.6%`, `100%`, `12.0%`, `12.6%`, `13.3%` ×2, `14.9%`, `16.4%`, `25%`, `26%`, `28.6%`, `3%` ×2, `3.0%` ×2, `3.3%`, `4%`, `4.3%`, `4.5%`, `41%`, `50%`, `58.9%`, `65%`, `7.1%`, `74%`, `84%`, `9.0%`, `95%` ×11
- **Approval number:** `23000AMX00016`, `30600AMX00129`, `30600AMX00312`
- **Date:** `2018年1月19日` ×6, `2018年4月`, `2024年12月27日`, `2024年3月26日`, `2024年6月`, `2025年3月`, `2025年4月`, `2026年5月`, `2026年5月18日`

</details>

### フォシーガ錠5mg・10mg (`fxg_pi`)

- Source: `Package Insert/FXG_PI.pdf` (8 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 187 | 188 | 187 | **NEEDS REVIEW** |
| Administration schedule | 21 | 24 | 21 | **NEEDS REVIEW** |
| Percentage | 105 | 105 | 104 | **NEEDS REVIEW** |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 3 | 3 | 3 | VERIFIED |

**Per-document diff**

- **Dose / strength**
  - PDF only: None
  - HTML only: `0.2単位/kg` ×1 — HTML context: “eGFRが45mL/min/1.73m2以上の2型糖尿病患者を対象とし、インスリン製剤〔持効型、中間型、混合型、速効型及び超速効型のいずれか2剤まで、0.2単位/kg/日以上かつ15単位/日以上…”
- **Administration schedule**
  - PDF only: None
  - HTML only: `1日1回` ×3 — HTML context: “通常、成人にはダパグリフロジンとして5mgを1日1回経口投与する。なお、効果不十分な場合には、経過を十分に観察しながら10mg1日1回に増量することができる。”
- **Percentage**
  - PDF only: `95%` ×1 (PDF pages 4, 6)
  - HTML only: `5%` ×1 — HTML context: “5%以上”

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.35kg` ×2, `0.7kg` ×2, `100錠` ×2, `10mg` ×80, `10mg/日`, `10錠` ×3, `11g/日`, `12.3mg`, `12.4mg`, `12.7mg`, `130mg`, `140錠` ×2, `14錠` ×2, `15mL/min`, `15単位/日`, `162ng/mL`, `18g/日`, `191ng/mL`, `1錠` ×2, `2.29kg`, `20mg`, `21.4mg`, `25mL/min` ×8, `260mg`, `30mL/min` ×2, `45mL/min` ×4, `5000mg`, `500錠` ×2, `50mL/min`, `50mg` ×4, `52g/日`, `5mg` ×36, `5μg/mL`, `6.15mg`, `60mL/min` ×5, `670ng・h`, `727ng・h`, `75mL/min`, `80mL/min` ×2, `80μg`, `85g/日`, `90mL/min` ×4
- **Administration schedule:** `1日1回` ×21
- **Percentage:** `0%` ×4, `0.09%` ×2, `0.1%` ×5, `0.10%` ×2, `0.2%` ×4, `0.33%`, `0.36%`, `0.4%`, `0.7%`, `1%` ×2, `1.0%` ×2, `1.1%` ×2, `1.3%` ×2, `1.6%`, `1.7%` ×3, `1.8%`, `1.9%` ×3, `100%`, `15%`, `17.0%`, `19.5%`, `2.3%`, `2.4%`, `2.6%` ×2, `2.8%`, `20%` ×3, `21%`, `23.3%`, `3.2%` ×2, `3.4%`, `3.6%`, `3.7%`, `3.9%`, `32.1%`, `35.0%`, `39%`, `4%`, `4.1%`, `4.4%`, `40%` ×2, `42%`, `5%` ×5, `5.6%`, `50%` ×3, `6.0%` ×2, `6.1%`, `6.5%` ×3, `6.6%`, `6.7%`, `61%`, `7.2%`, `75%`, `78%`, `8.5%`, `8.9%`, `85.2%`, `86.7%`, `87.1%`, `9.2%`, `9.6%`, `90%` ×3, `91%` ×2, `92%`, `95%` ×4, `98.7%`
- **Approval number:** `22600AMX00528`, `22600AMX00529`
- **Date:** `2014年5月`, `2024年12月`, `2025年4月`

</details>

### イジュド点滴静注25mg・300mg (`jd025_pi`)

- Source: `Package Insert/JD025_PI.pdf` (6 pages)
- Critical-token status: **VERIFIED**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 66 | 66 | 66 | VERIFIED |
| Administration schedule | 0 | 0 | 0 | VERIFIED |
| Percentage | 58 | 58 | 58 | VERIFIED |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 8 | 8 | 8 | VERIFIED |

**Per-document diff**

- No differences. Every in-scope token occurrence matches.

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.1mg`, `0.3mg`, `1,000mg/m2`, `1,250mg/m2`, `1,500mg` ×4, `1.25mL` ×3, `1.5mg`, `100mg/m2`, `105mg`, `10mg`, `10mg/mL`, `1260mg`, `1500mg` ×3, `15mL` ×3, `1mg`, `1バイアル` ×6, `25mg` ×7, `300mg` ×11, `30kg` ×3, `3mg`, `49mg`, `4mg`, `4mg/kg` ×2, `500mg/m2` ×2, `75mg` ×6, `75mg/m2` ×2
- **Administration schedule:** —
- **Percentage:** `0.1%` ×4, `0.3%`, `0.4%`, `0.6%`, `0.7%`, `0.8%`, `1%`, `1.0%`, `1.5%`, `1.7%`, `10%` ×2, `10.1%`, `10.3%`, `10.7%` ×2, `11.9%`, `117.2%`, `12.1%` ×2, `12.4%`, `13.1%`, `14.2%`, `15.9%`, `156.5%`, `17.0%` ×2, `2.1%`, `2.6%`, `21.5%`, `21.6%`, `22.4%`, `22.9%`, `24.5%`, `26.5%`, `28.2%`, `3.2%`, `3.3%`, `30.0%`, `4.7%`, `41.5%`, `49.7%`, `5%`, `50%`, `65.62%`, `75.68%`, `8.4%`, `80.83%`, `84.7%`, `95%` ×4, `97.3%`, `97.4%`
- **Approval number:** `30400AMX00454`, `30400AMX00455`
- **Date:** `2021年3月12日`, `2021年8月27日`, `2022年12月23日` ×3, `2023年3月`, `2024年11月`, `2026年6月`

</details>

### ロケルマ懸濁用散分包5g・10g (`lok05_pi`)

- Source: `Package Insert/LOK05_PI.pdf` (4 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 90 | 90 | 90 | VERIFIED |
| Administration schedule | 11 | 13 | 11 | **NEEDS REVIEW** |
| Percentage | 46 | 46 | 46 | VERIFIED |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 7 | 7 | 7 | VERIFIED |

**Per-document diff**

- **Administration schedule**
  - PDF only: None
  - HTML only: `1日1回` ×2 — HTML context: “通常、成人には、開始用量として1回10gを水で懸濁して1日3回、2日間経口投与する。なお、血清カリウム値や患者の状態に応じて、最長3日間まで経口投与できる。以後は、1回5gを水で懸濁して1日1回…”

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.4g`, `0.8g`, `1.28mmol/L`, `10g` ×24, `10mg`, `15g` ×6, `1包` ×2, `2.5g`, `20mg`, `25mg`, `28包` ×2, `3.0mEq/L`, `3.5mEq/L`, `3.5mmol/L` ×6, `45mL`, `5.0mmol/L` ×5, `5.1mmol/L`, `5.3mmol/L`, `5.5mmol/L`, `50mg/L`, `50μg`, `5g` ×24, `5mg` ×3, `5mg/mL`, `75mg` ×2
- **Administration schedule:** `1日1回` ×7, `1日3回` ×4
- **Percentage:** `0.5%`, `1.0%` ×5, `1.3%` ×3, `10%`, `10.1%`, `11.5%`, `19.3%`, `2.0%` ×2, `2.1%`, `2.9%`, `3.0%`, `4.0%`, `41.2%`, `5.1%`, `5.2%`, `5.6%`, `56%`, `6.1%`, `6.7%`, `63%`, `63.3%`, `65%`, `65.3%`, `71%` ×2, `77%`, `81.3%`, `82.0%`, `89.1%`, `90%` ×3, `93.3%`, `95%` ×6
- **Approval number:** `30200AMX00430`, `30200AMX00431`
- **Date:** `2020年3月25日` ×4, `2020年5月`, `2022年11月`, `2025年10月`

</details>

### リムパーザ錠100mg・150mg (`lyn100_pi`)

- Source: `Package Insert/LYN100_PI.pdf` (8 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 83 | 83 | 81 | **NEEDS REVIEW** |
| Administration schedule | 38 | 41 | 38 | **NEEDS REVIEW** |
| Percentage | 148 | 148 | 147 | **NEEDS REVIEW** |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 41 | 41 | 41 | VERIFIED |

**Per-document diff**

- **Dose / strength**
  - PDF only: `1120mg` ×2 (PDF page 7)
  - HTML only: `20mg` ×2 — HTML context: “固形癌患者(76例)を対象に、本剤300mgとタモキシフェン(20mg1日1回)、アナストロゾール(1mg1日1回)又はレトロゾール(2.5mg1日1回)との併用投与を行ったところ(例数はそれぞ…”
- **Administration schedule**
  - PDF only: None
  - HTML only: `1日2回` ×3 — HTML context: “通常、成人にはオラパリブとして1回300mgを1日2回、経口投与する。なお、患者の状態により適宜減量する。”
- **Percentage**
  - PDF only: `95%` ×1 (PDF pages 4, 5, 6, 7)
  - HTML only: `5%` ×1 — HTML context: “対照群ハザード比中央値(カ月)[95%信頼区間]※5%信頼区間]”

**Reviewed representation notes (not defects)**

- `175mg` (PDF) ↔ `175mg/m2` (HTML) ×1: positioned unit denominator

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.41g`, `0.62g`, `1000mg` ×2, `100mg` ×11, `10μg/mL` ×2, `1120mg` ×2, `1500mg` ×2, `150mg` ×6, `175mg`, `1mg`, `1錠` ×2, `2.5mg`, `200mg` ×6, `20mg`, `250mg`, `300mg` ×31, `30mL/min`, `400mg`, `50mL/min`, `56錠` ×2, `5mg`, `600mg`, `6mg・min`, `80mL/min`, `8錠` ×2, `9g`
- **Administration schedule:** `1日1回` ×7, `1日2回` ×22, `Q3W` ×5, `Q4W` ×4
- **Percentage:** `0.1%`, `0.4%` ×2, `0.7%`, `1%` ×3, `1.6%` ×2, `10%` ×3, `12.0%`, `13%` ×2, `13.7%`, `14%` ×2, `15%` ×3, `16%`, `18%`, `20.3%`, `21%`, `22%`, `22.4%`, `22.6%`, `23.6%`, `24%`, `26%`, `27%`, `27.9%`, `28%` ×2, `28.1%`, `29%`, `30.1%`, `30.2%`, `31.3%`, `32.2%`, `32.8%`, `34%`, `34.2%`, `35.3%`, `36.5%`, `36.6%`, `37%`, `37.4%`, `37.9%`, `38.1%`, `39.5%`, `4%`, `40.0%`, `40.2%`, `40.8%`, `40.9%`, `41.1%`, `41.4%`, `42%`, `43.1%`, `44%` ×2, `45.1%` ×2, `45.5%`, `45.8%`, `46.1%`, `47%`, `47.4%`, `48%`, `52.9%`, `53.3%`, `53.7%`, `56%` ×2, `57.0%`, `58.0%`, `6%` ×3, `6.8%`, `67%`, `7.0%`, `70%`, `70.6%`, `71%`, `74%`, `75.9%`, `76%`, `77.3%`, `8%` ×2, `81.5%`, `82%`, `83%`, `84%`, `87%`, `89%` ×2, `89.2%`, `90%` ×11, `91.8%`, `95%` ×26, `95.3%`, `95.6%`, `95.8%`, `97.1%`, `97.2%`, `97.6%`, `98.5%` ×2, `99.3%`
- **Approval number:** `23000AMX00022`, `23000AMX00023`
- **Date:** `2010年6月30日`, `2016年12月9日`, `2016年5月9日`, `2016年9月19日` ×2, `2017年9月25日`, `2018年1月` ×2, `2018年1月19日` ×11, `2018年4月`, `2018年5月17日` ×2, `2018年7月2日`, `2019年1月15日` ×2, `2019年3月22日` ×2, `2019年6月4日` ×2, `2020年12月25日`, `2020年3月27日`, `2021年7月12日`, `2021年7月30日` ×3, `2023年4月12日` ×4, `2024年11月`, `2026年3月`

</details>

### サフネロー皮下注120mgオートインジェクター (`spn120p_pi`)

- Source: `Package Insert/SPN120P_PI.pdf` (4 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 26 | 26 | 26 | VERIFIED |
| Administration schedule | 2 | 4 | 2 | **NEEDS REVIEW** |
| Percentage | 31 | 31 | 31 | VERIFIED |
| Approval number | 1 | 1 | 1 | VERIFIED |
| Date | 4 | 4 | 4 | VERIFIED |

**Per-document diff**

- **Administration schedule**
  - PDF only: None
  - HTML only: `1週間ごと` ×2 — HTML context: “通常、成人にはアニフロルマブ(遺伝子組換え)として、1回120mgを1週間ごとに皮下注射する。”

**Reviewed representation notes (not defects)**

- `120mg` ×1: outlined product identity validated by source crop

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.4mg`, `0.8mL` ×3, `120mg` ×14, `1mg`, `1シリンジ` ×2, `300mg` ×2, `39mg`, `3mg`, `7mg`
- **Administration schedule:** `1週間ごと`, `Q4W`
- **Percentage:** `0.3%`, `0.6%`, `1%`, `1.7%`, `10%` ×2, `10.8%`, `15.5%`, `2.3%`, `29.6%`, `3.54%`, `4.1%`, `43.9%`, `5.1%`, `5.3%`, `5.6%`, `5.7%`, `59.4%`, `6.5%`, `6.8%`, `7.4%`, `7.6%` ×2, `71.2%`, `74.4%`, `8.0%`, `80%`, `9.1%`, `9.4%`, `90%`, `96.46%`
- **Approval number:** `30800AMX00081`
- **Date:** `2026年2月`, `2026年2月19日` ×3

</details>

### サフネロー点滴静注300mg (`spn300_pi`)

- Source: `Package Insert/SPN300_PI.pdf` (4 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 53 | 53 | 53 | VERIFIED |
| Administration schedule | 2 | 3 | 2 | **NEEDS REVIEW** |
| Percentage | 59 | 59 | 59 | VERIFIED |
| Approval number | 1 | 1 | 1 | VERIFIED |
| Date | 7 | 7 | 7 | VERIFIED |

**Per-document diff**

- **Administration schedule**
  - PDF only: None
  - HTML only: `4週間ごと` ×1 — HTML context: “通常、成人にはアニフロルマブ(遺伝子組換え)として、300mgを4週間ごとに30分以上かけて点滴静注する。”

**Reviewed representation notes (not defects)**

- `300mg` ×1: outlined product identity validated by source crop

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `1000mg` ×6, `100mL`, `100mg` ×2, `150mg`, `18mg`, `1mg`, `1バイアル` ×3, `2.0mL` ×2, `2mL` ×3, `300mg` ×29, `3mg`, `50mL`, `6mg`, `98mg`
- **Administration schedule:** `4週間ごと` ×2
- **Percentage:** `0.3%`, `1%`, `1.7%` ×2, `10%` ×2, `10.1%`, `11.0%`, `12.0%`, `12.2%` ×2, `13.9%`, `14.7%`, `15.6%`, `16.2%`, `16.3%` ×2, `17.0%`, `18.2%`, `19.7%`, `20.0%`, `21.7%`, `26.3%` ×2, `26.8%`, `27.0%`, `28.3%`, `30.2%`, `31.5%` ×2, `36.2%`, `37.1%`, `37.3%`, `4.2%`, `40.4%`, `43.0%`, `47.1%`, `47.8%` ×2, `49.0%`, `5.6%`, `5.8%`, `55.5%`, `6.0%`, `7.7%`, `78.3%`, `80%`, `84.1%`, `88.3%`, `89.4%`, `9.8%`, `9.9%`, `95%` ×7
- **Approval number:** `30300AMX00447`
- **Date:** `2021年11月`, `2021年9月`, `2021年9月27日` ×3, `2025年5月`, `2026年2月`

</details>

### テゼスパイア皮下注210mgシリンジ・210mgペン (`tez210_pi`)

- Source: `Package Insert/TEZ210_PI.pdf` (4 pages)
- Critical-token status: **NEEDS REVIEW**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 37 | 35 | 35 | **NEEDS REVIEW** |
| Administration schedule | 12 | 13 | 12 | **NEEDS REVIEW** |
| Percentage | 20 | 20 | 20 | VERIFIED |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 13 | 13 | 13 | VERIFIED |

**Per-document diff**

- **Dose / strength**
  - PDF only: `1.91mL` ×2 (PDF pages 1, 4)
  - HTML only: None
- **Administration schedule**
  - PDF only: None
  - HTML only: `4週間隔` ×1 — HTML context: “通常、成人及び12歳以上の小児にはテゼペルマブ(遺伝子組換え)として1回210mgを4週間隔で皮下に注射する。”

**Reviewed representation notes (not defects)**

- `210mg` ×1: outlined product identity validated by source crop

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.19mg`, `1.91mL` ×4, `105mg`, `1シリンジ` ×2, `210mg` ×23, `280mg` ×3, `35mg`, `48mg`, `70kg`
- **Administration schedule:** `4週間隔`, `Q4W` ×11
- **Percentage:** `0.2%`, `0.6%`, `1%` ×2, `1.5%` ×3, `1.9%`, `13.8%`, `3.0%` ×3, `4.9%`, `5.2%`, `8.7%`, `81%`, `95%` ×3, `99%`
- **Approval number:** `30400AMX00402`, `30500AMX00236`
- **Date:** `2022年11月`, `2022年9月` ×2, `2022年9月26日` ×5, `2023年12月` ×2, `2026年2月` ×3

</details>

### トルカプ錠160mg・200mg (`trq160_pi`)

- Source: `Package Insert/TRQ160_PI.pdf` (6 pages)
- Critical-token status: **VERIFIED**

| Check category | Source PDF occurrences | Searchable HTML occurrences | Verified matches* | Category status |
|---|---:|---:|---:|---|
| Dose / strength | 44 | 44 | 44 | VERIFIED |
| Administration schedule | 11 | 11 | 11 | VERIFIED |
| Percentage | 39 | 39 | 39 | VERIFIED |
| Approval number | 2 | 2 | 2 | VERIFIED |
| Date | 20 | 20 | 20 | VERIFIED |

**Per-document diff**

- No differences. Every in-scope token occurrence matches.

<details>
<summary>Complete PDF token inventory used for this document</summary>

- **Dose / strength:** `0.42g`, `0.52g`, `100μg` ×2, `160mg` ×5, `1mg`, `1錠` ×2, `200mg` ×7, `20mg`, `320mg` ×2, `32錠` ×2, `400mg` ×15, `500mg`, `800mg`, `80mg`, `8錠` ×2
- **Administration schedule:** `1日1回`, `1日2回` ×10
- **Percentage:** `0.3%` ×2, `0.6%`, `1%` ×4, `1.7%`, `10%` ×4, `14.1%`, `15%`, `16%`, `20.6%`, `20.8%`, `21%`, `22%`, `22.0%`, `27.3%`, `28%`, `29%`, `34.1%`, `34.6%`, `44%`, `45%`, `50%`, `57%`, `67.3%`, `7.4%`, `72.4%`, `78.9%`, `8.0%`, `83%`, `9.3%`, `95%` ×2, `96.6%`
- **Approval number:** `30600AMX00119`, `30600AMX00120`
- **Date:** `2024年3月` ×3, `2024年3月26日` ×14, `2024年5月`, `2025年3月`, `2026年3月`

</details>

## Traceability and limitations

- Machine-readable evidence: `build/_qc/business-token-audit.json`
- Standard conversion QC: `QC_REPORT.md`
- The source and HTML SHA-256 hashes above identify the exact files checked.
- Outlined product names, graphs, logos, and visible table typography are images and therefore outside a text-token comparison; their source-pixel identity is covered by the existing asset/table/figure QC.
- “PDF only” means the searchable HTML layer has fewer occurrences; the visible source crop can still contain the exact printed token. “HTML only” means the generated HTML text layer has additional occurrences and should be reviewed for duplication or cell splitting.
- An HTML context shown beside a surplus token is an example occurrence, not a claim that this exact sentence is the surplus copy when other occurrences of the same token match.
- This report is a deterministic verification record, not regulatory approval or a substitute for business-owner sign-off.

**Checked by:** Codex