PIL — Respimax
PIL labeling artefact for Respiralimab in Italy. Version 3.0. Language: sv.
Artifact ID
LBL-042
Type
PIL
Product
Market
Italy
Version
3.0
Language
sv
Status
Approved
Last Reviewed
2024-05-22
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-124 | Dosing | SmPC Section 4.4 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2024-03-10 |
| STMT-125 | Contraindication | SmPC Section 4.8 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-09-27 |
| STMT-126 | Dosing | Core Data Sheet | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-04-30 |
| STMT-127 | Contraindication | SmPC Section 4.8 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-08-28 |
| STMT-128 | Dosing | SmPC Section 4.1 | Treatment should be initiated under the supervision of a physician experienced i… | 2024-01-27 |
| STMT-129 | Efficacy | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-05-06 |
| STMT-130 | Safety | SmPC Section 4.8 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2024-05-21 |
| STMT-131 | Safety | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2024-02-01 |
| STMT-132 | Contraindication | SmPC Section 4.4 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-10-01 |
| STMT-133 | Contraindication | SmPC Section 5.2 | This product has been designated as an orphan medicine in the European Union.… | 2022-10-30 |
Change History
Posology revision
Section 4.8 ADR update
Section 4.8 ADR update
Section 4.8 ADR update
Harmonisation to core label