Product portfolio Oncology & Onco-Hematology CAPECITABINA KHAIRI Composition Each film-coated tablet contains: Capecitabine 500 mg Excipients: q.s. for 1 film-coated tablet Indications Capecitabine is indicated for: • The first-line treatment of advanced gastric cancer in combination with platinum-based chemotherapy. • As monotherapy in the adjuvant treatment of patients suffering from Dukes C (stage III) colon cancer, after the full surgical resection of the primary tumor. • As monotherapy in the first-line treatment of patients suffering colorectal cancer. • In combination with docetaxel, Capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer, after the failure of prior anthracyclines chemotherapy. • Capecitabine is indicated as monotherapy in the treatment of patients with locally advanced or metastatic breast cancer after the failure of a taxane-based chemotherapy system and having also received anthracycline-based chemotherapy, or for those patients for whom these drugs are not indicated. How supplied Capecitabina Khairi 500 mg: Containers with 120 film-coated tablets each. By medical prescription only.. IMATINIB KHAIRI Composition Each film-coated tablet contains: Imatinib Khairi 100 mg: Imatinib (as mesylate), 100 mg Excipients: q.s. for 1 film-coated tablet Imatinib Khairi 400 mg: Imatinib (as mesylate), 400 mg Excipients: q.s. for 1 film-coated tablet Indications Imatinib is indicated for the treatment of: • Adult and pediatric patients with Chronic Myeloid Leukemia (CML), recently diagnosed positive Philadelphia chromosome (Ph+) or BCR/ABL fusion gene, for which bone-marrow replacement has not been considered as a first-line treatment. • Adult and pediatric patients with chronic-stage CML Ph+ after the failure of treatment with alpha- interferon, or in accelerated phase or blast crisis. • Adult patients with recently diagnosed acute lymphoblastic leukemia with positive Philadelphia chromosome (ALL Ph+), combined with chemotherapy. • As monotherapy for adult patients with resistant or relapsing ALL Ph+. • Adult patients with myelodysplastic/myeloproliferative syndromes (MDS/MPN) associated with the receptor-gene rearrangement of the platelet-derived growth factor (PDGF). • Patients with aggressive systemic mastocytosis (ASM) with no c-Kit D816V mutation, or with unknown mutational status of the c-Kit. • Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with rearrangement of the FIP1L1-PDGFRα. • Treatment of adult patients with malignant, unresectable and/or (CD 177) KIT-positive metastatic gastrointestinal stromal tumors (GIST). • The adjuvant treatment of adult patients with a significant risk of relapsing after the resection of a (CD117) KIT-positive GIST. Patients with a low or very low relapse risk should not receive any adjuvant treatment. • The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurring and/or metastatic DFSP not eligible for surgery. How supplied Imatinib Khairi 100 mg film-coated tablets: Containers with 120 and 180 film-coated tablets. Imatinib Khairi 400 mg film-coated tablets: Containers with 30 film-coated tablets. By medical prescription only.
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Product portfolio
Oncology & Onco-Hematology
CAPECITABINA KHAIRI
Composition Each film-coated tablet contains: Capecitabine 500 mg Excipients: q.s. for 1 film-coated tablet
Indications Capecitabine is indicated for: • The first-line treatment of advanced gastric cancer in combination with platinum-based chemotherapy. • As monotherapy in the adjuvant treatment of patients suffering from Dukes C (stage III) colon cancer, after the full surgical resection of the primary tumor. • As monotherapy in the first-line treatment of patients suffering colorectal cancer. • In combination with docetaxel, Capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer, after the failure of prior anthracyclines chemotherapy. • Capecitabine is indicated as monotherapy in the treatment of patients with locally advanced or metastatic breast cancer after the failure of a taxane-based chemotherapy system and having also received anthracycline-based chemotherapy, or for those patients for whom these drugs are not indicated.
How supplied Capecitabina Khairi 500 mg: Containers with 120 film-coated tablets each.
By medical prescription only..
IMATINIB KHAIRI
Composition Each film-coated tablet contains: Imatinib Khairi 100 mg: Imatinib (as mesylate), 100 mg Excipients: q.s. for 1 film-coated tablet
Indications Imatinib is indicated for the treatment of: • Adult and pediatric patients with Chronic Myeloid Leukemia (CML), recently diagnosed positive Philadelphia chromosome (Ph+) or BCR/ABL fusion gene, for which bone-marrow replacement has not been considered as a first-line treatment. • Adult and pediatric patients with chronic-stage CML Ph+ after the failure of treatment with alpha- interferon, or in accelerated phase or blast crisis. • Adult patients with recently diagnosed acute lymphoblastic leukemia with positive Philadelphia chromosome (ALL Ph+), combined with chemotherapy. • As monotherapy for adult patients with resistant or relapsing ALL Ph+. • Adult patients with myelodysplastic/myeloproliferative syndromes (MDS/MPN) associated with the receptor-gene rearrangement of the platelet-derived growth factor (PDGF).• Patients with aggressive systemic mastocytosis (ASM) with no c-Kit D816V mutation, or with unknown mutational status of the c-Kit.• Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with rearrangement of the FIP1L1-PDGFRα. • Treatment of adult patients with malignant, unresectable and/or (CD 177) KIT-positive metastatic gastrointestinal stromal tumors (GIST). • The adjuvant treatment of adult patients with a significant risk of relapsing after the resection of a (CD117) KIT-positive GIST. Patients with a low or very low relapse risk should not receive any adjuvant treatment. • The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurring and/or metastatic DFSP not eligible for surgery.
How supplied Imatinib Khairi 100 mg film-coated tablets: Containers with 120 and 180 film-coated tablets. Imatinib Khairi 400 mg film-coated tablets: Containers with 30 film-coated tablets.
Indications• Pemetrexed in combination with cisplatin is indicated for the treatment of patients with unresectable malignant pleural mesothelioma who had not received chemotherapy before.• Pemetrexed in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, except for those who have a predominantly squamous cell histology.• As monotherapy it is indicated as maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer, except for those who have a predominantly squamous cell histology, in which the disease has not progressed immediately after a platinum-based chemothe rapy regime.• Permetrexed as monotherapy is indicated for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, except for those who have a predominantly squamous cell histology.
How suppliedPemetrexed Khairi 500 mg: Containers with 1 vial.
IndicationsAbiraterone Acetate is indicated, in combination with Prednisone or Prednisolone for the treatment of:• Metastatic castration-resistant prostate cancer of asymptomatic or mildly symptomatic adult men after failure of androgen deprivation therapy in which chemotherapy is not clinically indicated.• Metastatic castration-resistant prostate cancer in adult men in which the disease has progressed during or after the docetaxel-based chemotherapy regime.
How suppliedAbiraterona Khairi 250 mg: Containers with 120 film-coated tablets each.
Indications• Bendamustine is indicated for the first-line treatment of patients with chronic lymphocytic leukemia (Binet Stage B or C) when a combined therapy with fludarabine is not suitable.• Bendamustine is indicated as monotherapy in the treatment of patients with indolent Lym phoma non-Hodgkin that has progressed during or within the six- month treatment with rituximab or with a rituximab containing regime.• Bendamustine is indicated as first-line treatment in patients with multiple myeloma (Durie-Salmon Stage II with progression or Stage III), concomitantly with prednisone, in patients over 65 years who are not eligible for autologous stem cell transplantation and present clinical neuropathy at the moment of diagnosis, preventing treatment with talidomide or bortezomib.
How suppliedBendamustina Khairi 25 mg: Containers with 1, 2, 4 and 10* vials. *Exclusive hospital use.
By medical prescription only.
Oncology & Onco-Hematology
LENALIDOMIDA KHAIRI
CompositionEach hard capsule contains:Lenalidomida Khairi 10 mg: Lenalidomide 10 mgExcipients q.s. for 1 capsule. It contains lactose.
Lenalidomida Khairi 25 mg: Lenalidomide 25 mgExcipients q.s. for 1 capsule. It contains lactose.
IndicationsLenalidomide 10 mg is indicated:• For the treatment of adult patients with multiple myeloma (MM) naïve to treatment that are not eligible for transplant.• Lenalidomide in combination with dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one previous treatment.• For the treatment of patients with transfusion-dependent anemia due to low risk or intermediate-1 myelodysplastic syndromes (MDS) associated to a 5q deletion cytogenetic abnormality when other treatment options are insufficient or inadequate.• Lenalidomide is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Lenalidomide 25 mg is indicated:• For the treatment of adult patients with multiple myeloma (MM) naïve to treatment that are not eligible for a transplant.• Lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one previous treatment.• Lenalidomide is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
How suppliedLenalidomida Khairi: in capsules of 10 mg and 25 mg, packaged in 21-capsule containers.
IndicationsPazopanib is indicated for:• The first line treatment of adult patients with advanced Renal Cell Carcinoma (RCC) and in patients with advanced disease who have received prior treatment with cytokines.• The treatment of adult patients with certain types of advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease, or progressed after 12 months of adjuvant/neoadjuvant treatment. The efficacy and safety has been established just in certain histological subtypes of STS.
How suppliedPazopanib Khairi 400 mg: Containers with 30 or 60 film-coated tablets each.
By medical prescription only.
Oncology & Onco-Hematology
BORTEZOMIB KHAIRI
Composition Each vial with lyophilized powder contains: Bortezomib 3,5 mg Excipients: mannitol.
Indications Bortezomib is indicated:• In monotherapy, or in combination with pegylated liposomal doxorubicin or dexamethasone, for the treatment of adult patients with multiple myeloma in progression who have previously received at least one treatment and who have undergone or are not candidates for hematopoietic stem cell transplantation.• In combination with melphalan and prednisone, in the treatment of adult patients with Multiple Myeloma who have not been previously treated and are not candidates for treatment with high doses of chemotherapy prior to a transplant of hematopoietic progenitors.• In combination with dexamethasone or dexamethasone and thalidomide, in the induction treatment of adult patients with multiple myeloma who have not been previously treated and who are candidates for treatment with high doses of chemotherapy prior to a transplant of hematopoietic progenitors.• In combination with rituximab, cyclophosphamide, doxorubicin and prednisone, it is indicated for the treatment of adult patients with mantle cell lymphoma who have not been previously treated and who are not candidates for transplantation of hematopoietic progenitors.
How Supplied Bortezomib Khairi 3,5 mg: Containers with 1 vial.
By medical prescription only.
Product portfolio
Hematology
WILFACTIN
Composition
Each vial with lyophilized powder contains:Human von Willebrand factor: 100 UI*/mL in reconstituted solution.*Expressed in UI activity of the ristocetin cofactor (VWF: RCo).Excipients: human albumin, arginine hydrochloride, glycine, trisodium citrate, calcium chloride.
IndicationsWilfactin is indicated:• In the treatment and prevention of hemorrhagic episodes and during surgery in von Willebrand’s disease. WILFACTIN is used when treatment with desmopressin alone, another medication, is ineffective or contraindicated.
How suppliedWilfactin 1000 UI/10 mL: containers containing a vial with lyophilized powder, a vial with solvent for 10 mL, an accessory for reconstitution.
By medical prescription only.
Rare diseases
GLASSIA KAMADA
COMPOSITIONEach vial contains: Glassia: 1 g of functional Alpha1-PI in 50 mL of ready-to-use solution.
IndicacionesGlassia is indicated for:• Chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency alpha1-PI, also known as alpha-1-antitrypsin (AAT) deficiency.
How Supplied GLASSIA: Single use vial containing 50 mL of ready to use solution. A needle with a sterile single-use filter.
Indications Pirfenidone is indicated for: • The treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adults.
How suppliedPirfenidona Tuteur 200 mg: Containers with 200 film-coated tablets.
By medical prescription only.
FINGOLIMOD TUTEUR 0,5 mg
CompositionEach hard capsule contains:Fingolimod 0,5 mg (as chlorhydrate).Excipientes: q.s. for 1 hard capsule.
Indications Fingolimod is indicated in adults patients with Relapsing-Remitting Multiple Sclerosis (MS), which occurs with outbreaks, particularly in: • Patients who do not respond to treatment despite a treatment for MS. • Patients who rapidly develop severe MS.
How suppliedFingolimod Tuteur 0,5 mg: Containers with 28 hard capsules.
IndicationsCinacalcet is indicated in the treatment of:• Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis. It can be used as part of a therapeutic regimen, which includes phosphate binders and/or vitamin D analogues, as appropriate.• Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but it is not clinically adequate or contraindicated.
How suppliedTenalcet 30 mg: Containers with 30 film-coated tablets.Tenalcet 60 mg: Containers with 30 film-coated tablets.
