País: Armènia
Idioma: anglès
Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pertuzumab
Roche Diagnostics GmbH
L01XC13
pertuzumab
30mg/ml
concentrate for solution for infusion
(1) glass vial 14ml
Prescription
Registered
2019-12-20
PERJETA ® 10223257 PERJETA ® 10223257 10223257 FE Artwork Creator Date Version Signature Proofreader Date Signature Perigord / MAH 31 Jan 2020 1 Genisys-No. 10223257 make-up code: FE Type size: 9 pt Printing colour: Pantone Black Format: 450x500 mm folded: 47x60 mm Drawing Norm: NP9357 17.08.10 10.114 PERJETA ® Pertuzumab 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Antineoplastic agent, recombinant humanised IgG1 monoclonal antibody HER2 dimerisation inhibitor ATC code: L01XC13 pertuzumab 1.2 TYPE OF DOSAGE FORM Concentrate for solution for infusion. 1.3 ROUTE OF ADMINISTRATION Intravenous (IV) infusion. 1.4 STERILE / RADIOACTIVE STATEMENT Sterile product. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _ Pertuzumab. _Dosage preparations:_ Perjeta is supplied as a single-use vial containing 14 ml preservative-free liquid concentrate, at a concentration of 30 mg/ml. Each vial of Perjeta drug product contains a total of 420 mg pertuzumab. _Excipients:_ As registered locally. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION Perjeta is indicated in combination with Herceptin and docetaxel for patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. 2.2 DOSAGE AND ADMINISTRATION GENERAL Patients treated with Perjeta should have HER2-positive tumour status, defined as a score of 3+ by IHC or a ratio of ≥ 2.0 by ISH assessed by a validated test. To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures. For full instructions on assay performance and interpretation please refer to the package inserts of validated HER2 testing assays. Substitution by any other biological medicinal product requires the consent of the prescribing physician. In order to prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml. After dilution, one ml of solution contains approximately 3.02 mg of pertuzumab for the initial dose and approximately 1.59 mg of pertuzumab for the maintenance dose (see section 6.6). Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale yellow, liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy in: • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1) • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1) Metastatic breast cancer Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, _ _ who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Perjeta should only be initiated under the supervision of a physician experienced in the administration of anti-cancer agents. Perjeta should be administered by a healthcare professional prepared to manage anaphylaxis and in an environment where full resuscitation facilities are immediately available. Posology Patients treated with Perjeta must have HER2-positive tumour status, defined as a score of 3+ by immunohistochemistry (IHC) and/or a ratio of ≥ 2.0 by in situ hybridisati Llegiu el document complet