Avastin 100mg/4ml Vial 100 mg/4ml

āĻĻā§‡āĻļ: āĻœāĻ°ā§āĻĄāĻ¨

āĻ­āĻžāĻˇāĻž: āĻ‡āĻ‚āĻ°ā§‡āĻœāĻŋ

āĻ¸ā§‚āĻ¤ā§āĻ°: JFDA (Jordan Food & Drug Administration - اŲ„Ų…ؤØŗØŗØŠ اŲ„ؚاŲ…ØŠ Ų„Ų„ØēØ°Ø§ØĄ ŲˆØ§Ų„دŲˆØ§ØĄ)

āĻ¸āĻ•ā§āĻ°āĻŋāĻ¯āĻŧ āĻ‰āĻĒāĻžāĻĻāĻžāĻ¨:

Bevacizumab 100 mg/4ml

āĻĨā§‡āĻ•ā§‡ āĻĒāĻžāĻ“āĻ¯āĻŧāĻž:

Ų…ØŗØĒŲˆØ¯Øš ادŲˆŲŠØŠ شاŲˆŲŠ Ųˆ ØąØ´ŲŠØ¯Ø§ØĒ Ųˆ Ų…ØŗŲ†Ø§ØĒ - Shawi & Rushedat Drug Store

āĻāĻŸāĻŋāĻ¸āĻŋ āĻ•ā§‹āĻĄ:

L01XC07

INN (āĻ†āĻ¨ā§āĻ¤āĻ°ā§āĻœāĻžāĻ¤āĻŋāĻ• āĻ¨āĻžāĻŽ):

Bevacizumab 100 mg/4ml

āĻĄā§‹āĻœ:

100 mg/4ml

āĻĒā§āĻ¯āĻžāĻ•ā§‡āĻœ āĻ‡āĻ‰āĻ¨āĻŋāĻŸ:

1 Vial

Manufactured by:

F.Hoffmann La- Roche, kaiseraugst (ØŗŲˆŲŠØŗØąØ§)

āĻ¤āĻĨā§āĻ¯ āĻ˛āĻŋāĻĢāĻ˛ā§‡āĻŸ

                                March 2021 Product Information GCC
Ro 487-6646 Avastin
_ _
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AVASTIN
ÂŽ
Bevacizumab
ANTINEOPLASTIC AGENT
COMPOSITION
_Active substances _
Bevacizumab (manufactured by recombinant DNA technology using CHO
[Chinese hamster ovary]
cells).
_Excipients _
Îą,Îą-Trehalose dihydrate, sodium dihydrogen phosphate monohydrate,
anhydrous disodium phosphate,
polysorbate 20, water for injection.
1 ml of concentrate contains 1.35 mg sodium, i.e. 5.42 mg or 21.67 mg
per vial.
PHARMACEUTICAL FORM AND ACTIVE SUBSTANCE QUANTITY PER UNIT
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless to pale brown sterile fluid
for intravenous infusion.
Each 4 ml vial contains 100 mg bevacizumab.
Each 16 ml vial contains 400 mg bevacizumab.
INDICATIONS/USES
_Metastatic colorectal cancer _
Avastin (bevacizumab) is indicated for first-line treatment of
patients with metastatic carcinoma of the
colon or rectum in combination with the following chemotherapies:
ī€­
5-fluorouracil/folinic acid
ī€­
5-fluorouracil/folinic acid/irinotecan
ī€­
capecitabine/oxaliplatin (XELOX)
Avastin is indicated as second-line therapy in combination with an
irinotecan- or oxaliplatin-based
chemotherapy regimen in patients with metastatic colorectal cancer
with prior oxaliplatin- or irinotecan-
based chemotherapy with or without Avastin.
_Metastatic breast cancer _
Avastin (bevacizumab) is indicated in combination with paclitaxel for
first-line treatment of patients
with HER2-negative, metastatic breast cancer.
_Advanced, metastatic or recurrent non-small cell lung cancer (NSCLC)
_
First-line
therapy
in
combination
with
cisplatin-
and
gemcitabine-containing
chemotherapy
in
unresectable, advanced, metastatic or recurrent, non-squamous
non-small cell lung cancer (NSCLC).
March 2021 Product Information GCC
Ro 487-6646 Avastin
_ _
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_Advanced and/or metastatic renal cell cancer _
Avastin in combination with interferon alfa-2a is indicated for
first-line treatment of nephrectomised
patients with advanced and/or metastatic renal cell cance
                                
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