The information of our products contained in this section is partial and for orientation purposes only. A health care professional or certified physician must always be consulted for an appropriate diagnosis and use of these medications.

 BRAND                                                   DRUG SUBSTANCE                                 PRESENTATION

            BEMUX®                                                             Bendamustine                                                      25 mg / 100 mg lyoph. vial x 1
Made in Argentina
For sale under prescription
Bendamustine
Composition:
 Each vial of Bemux 25 contains Bendamustine Hydrochloride 25 mg. Each vial o Bemux 100 contains Bendamustine Hydrochloride 100 mg.
Therapeutic Action:
 Antineoplastic. ATC code: L01AA09
Indications:
 Chronic Lymphocytic Leukemia (CLL) in patients for whom a combination chemotherapy with Fludarabine is inappropriate. Non-Hodgkin Lymphoma (NHL) indolent B cells that has progressed during or within 6 months of treatment with Rituximab or Rituximab-containing regimen. Multiple Myeloma (MM) in first-line therapy (stage II Durle-Salmon with progression or stage III) in combination with Prednisone. Patients over 65 years who are not suitable for autologous stem cells transplant and who already have clinical neuropathy at diagnosis, which excludes treatment with Thalidomide or Bortezomib.
Dosage and Administration
CLL: 100 mg/m2 administered intravenously over 30 minutes on days 1 and 2 of a 28 day cycle, up to 6 cycles. NHL: 120 mg/m2 administered intravenously over 60 minutes on days 1 and 2 of a 21 day cycle, up to 8 cycles. MM: 120-150 mg/m2 intravenously on days 1 and 2 and Prednisone 60 mg/m2 orally on days 1 and 4, every 4 weeks.
Presentation:
 Packages with 1 vial containing lyophilized powder for injection solution.
            CAPECIT®                                                          Capecitabine                                                         500 mg tabs. x 120
Made in Argentina
For sale under prescriptiontacc-es
Capecitabine
Composition:
 Each CAPECIT coated tablet contains: Capecitabine 500 mg.
Therapeutic Action:
 Antineoplastic.
Indications:
 CAPECIT is indicated for the treatment of paclitaxel or anthracycline chemotherapy resistant locally advanced or metastatic breast cancer.
Dosage and Administration
The recommended CAPECIT dose is 2,500 mg/m2/day, for two weeks followed by one rest week. CAPECIT total daily dose administered orally should be divided in two takes (morning and evening) to be taken within 30 minutes after a meal. . Capecitabine tablets should be swallowed whole with water. The treatment must be interrupted if progressive disease or intolerable toxicity are observed. Dose Adjustment during Treatment: Capecitabine toxicity may be controlled by a symptomatic treatment, capecitabine dose modification (discontinuation of the medication or dosing reduction) or both. Once the dose is reduced, it must not be increased at any time. The recommended dose modifications in the event of toxicity are detailed as follows: Grade 1: Keep the dose. Grade 2: First Onset: The treatment must be interrupted until the toxicity remits to grade 0-1, the following treatment cycle must be continued with 100% of the recommended dose. Second Onset: The treatment must be interrupted until the toxicity remits to grade 0-1, the following treatment cycle must be continued with 75% of the recommended dose. Third Onset: The treatment must be interrupted until the toxicity remits to grade 0-1, the following treatment cycle must be continued with 50% of the recommended dose. Fourth Onset: The treatment must be permanently discontinued. Grade 3: First Onset: The treatment must be interrupted until the toxicity remits to grade 0-1, the following treatment cycle must be continued with 75% of the recommended dose. Second Onset: The treatment must be interrupted until the toxicity remits to grade 0-1, the following treatment cycle must be continued with 50% of the recommended dose. Third Onset: The treatment must be permanently discontinued. Grade 4: The treatment must be permanently discontinued. If it is deemed that it is beneficial for the patient to continue with the treatment, the treatment should be interrupted until toxicity remits to grade 0-1, to be later resumed after the following therapeutic cycle with 50% of the recommended dose. Dose Adjustment in Special Populations. Hepatic Insufficiency: Capecitabine pharmacokinetics was evaluated in patients with mild or moderate hepatic dysfunction caused by hepatic metastasis. In these patients it is not necessary to adjust the dose. Renal Insufficiency: Capecitabine effect was not evaluated in patients with renal insufficiency (defined as a serum creatinine value > 1.5 times the upper limit of normality). Children: No studies were done to evaluate toxicologic safety or efficacy of Capecitabine in children. Elderly Populations: No dose adjustment is needed. However, in elderly patients (> 65 years of age) the risk of toxicity caused by 5-FU is higher than in younger patients. A careful monitoring of elderly patients is advisable.
Presentation:
 Package containing one hundred and twenty 500 mg coated tablets.
 
            DOXETAL®                                                         Docetaxel                                                              20 mg / 80 mg vial x 1
Made in Argentina
For sale under prescription
Docetaxel
Composition:
 20 mg/0.5 ml injection: Each vial contains: Docetaxel 20.00 mg. 80 mg/2.0 ml injection: Each vial contains: Docetaxel 80.00 mg.
Therapeutic Action:
 Antineoplastic
Dosage and Administration
The recommended dose is 60/100mg/m2 administered as IV infusion in 1 hour every 3 weeks.
Presentation:
 20 mg/0.5 ml injection: Package containing 1 vial. 80 mg/2.0 ml injection: Package containing 1 vial.
            DRIFEN®                                                             Paclitaxel                                                              30 mg 1 vial x 5 ml.
Made in Argentina
For sale under prescription
Paclitaxel
Composition:
 30 mg Injection: Each vial contains: Paclitaxel 30 mg.
Therapeutic Action:
 Antimicrotubule agent which promotes the binding of microtubules of tubulin dimers stabilizing them and preventing depolymerization.
Indications:
 Treatment of metastatic ovarian and breast carcinoma after failure of standard therapy.
Dosage and Administration
The recommended dose of paclitaxel is 175 mg/m2 administered as a 3-hour IV infusion every 3 weeks.
Presentation:
 30 mg Injection: Packages containing one 5 ml-vial.
            DRIFEN®                                                              Paclitaxel                                                             150 mg 1 vial x 25 ml.
Made in Argentina
For sale under prescription
Paclitaxel
Composition:
150 mg Injection: Each vial contains: Paclitaxel 150 mg.
Therapeutic Action:
 Antimicrotubule agent which promotes the binding of microtubules of tubulin dimers stabilizing them and preventing depolymerization.
Indications:
 Treatment of metastatic ovarian and breast carcinoma after failure of standard therapy.
Dosage and Administration
The recommended dose of paclitaxel is 175 mg/m2 administered as a 3-hour IV infusion every 3 weeks.
Presentation:
150 mg Injection: Packages containing one 25 ml-vial.
            ESPASEVIT®                                                      Ondansetrón                                                         8 mg amps. x 1 y 25
Made in Argentina
For sale under prescription
Ondansetron
Composition:
 Each ampoule contains: Ondansetron Hydrochloride 8 mg.
Therapeutic Action:
 Antiemetic. 5-HT 3 Receptor antagonist.
Dosage and Administration:
Adults
 

Dosing may range between 8 and 32 mg per day.

 
Children:
 

Dosing is the same as for adults, with a minimum of 0.15 to 0.20 mg/kg.

Presentation:
 8 mg Injection: Packages containing 1 ampoule and 25 ampoules.
            FONTRAX®                                                         Dasatinib                                                               50 mg coat. tabs. x 60 / 100 mg coat. tabs. x 30
Made in Argentina
For sale under filed prescription
Dasatinib
Composition:
 Each coated tablet of FONTRAX 50 contains: Dasatinib 50 mg. Each coated tablet of FONTRAX 100 contains: Dasatinib 100 mg.
Therapeutic Action:
 It is a kinase protein inhibitor antineoplastic agent.
Indications:
 Dasatinib is indicated for the treatment of adults with chronic myeloid leukemia (CML) in chronic phase, accelerated or blastic, with resistance or intoleracet to prior therapy including imatinib mesylate. Dasatinib is also indicated for the treatment of adults with acute lymphoblastic leukemia (ALL) with Philadelphia-chromosome positive (Ph+) and lymphoid blast crisis of CML with resistance or intolerance to prior therapy.
Dosage and Administration
Treatment should be initiated by a physician experienced in the diagnosis and treatment of patients with leukemia. The recommended starting dose for chronic phase CML is 100 mg of dasatinib once daily, administered orally. The recommended starting dose for CML in accelerated phase, myeloid or lymphoid blast crisis (late stages) or Philadelphia-chromosome positive ALL (Ph +) is 140 mg once daily taken orally. The tablets should not be crushed or split, they should be swallowed whole. Dasatinib may be taken with or without food and should be taken in the morning or evening. Duration of treatment: in clinical trials, treatment with Dasatinib was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment after achieving a complete cytogenetic response has not been investigated. It is recommended to increase or decrease the dose based on patient response and tolerability. Dose escalation: In clinical trials of adult patients with CML and ALLPh + a gradual increase in dose was allowed to 140 mg once daily (chronic phase CML) or 180 mg once daily (CML in advanced phases or ALL Ph +) in patients not achieving a hematologic or cytogenetic response at the recommended starting doses.
Presentation:
FONTRAX 50: package containing 60 coated tablets. FONTRAX 100: package containing 30 coated tablets.
            GEZT®                                                                 Gemcitabine                                                         1 g vial x 1
Made in Argentina
For sale under filed prescription
Gemcitabine
Composition:
 Each vial contains: Gemcitabine (as hydrochloride) 1 g.
Therapeutic Action:
 Antineoplastic
Indications:
 Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, for the treatment of patients with locally advanced or metastatic pancreatic adenocarcinoma, and also for patients with 5-FU refractory pancreas cancer. Gemcitabine in combination with cysplatin is indicated for the treatment of patients with bladder cancer.
Dosage and Administration:
Adults:
 

Gemcitabine recommended dose is 1000 mg/m2, administered as a 30-minute IV infusion.

 
Children:
 

Gemcitabine was not tested in children.

Presentation:
 Packages containing 1 vial.
            MONOFER® (imported)                                     Iron                                                                        100 mg/ml x 1 vials x 5ml / 100 mg/ml x 1 vial x 10 ml
Made in Argentina
For sale under filed prescription
Iron (as Iron III Isomaltoside 1000)
Composition:
 Each ml. of solution contains Iron (as Iron III Isomaltoside 1000) 100 mg, excipients: Sodium Hydroxide or Hydrochloric Acid, Water for injections.
Therapeutic Action:
 Parenteral trivalent iron preparation. ATC Code: B03AC06
Indications:
Monofer is indicated for the treatment of iron deficiency anemia in the following conditions: when oral iron preparations are ineffective or can not be used or when there is clinical need for quickly iron administration. The diagnosis of iron deficiency anemia should be based on appropriate laboratory tests (eg. serum ferritin, serum iron, transferrin saturation or hypochromic red cells)
Dosage
Calculation of the total iron dose:

Iron replacement in patients with iron deficiency anemia:
 

The dose and dosing schedule of Monofer must be individually set for each patient, based on the calculation of the total iron deficit. The optimal hemoglobin target vary in different patients groups. Monofer dose is expressed in mg of elemental iron. The total dose of iron is calculated by the Ganzoni formula where hemoglobin is abbreviated as Hb: Total iron dose (mg iron) = body weight (A) x (Hb target - actual Hb) (B) 2.4 x (C) + iron for iron deposits (D) (mg iron) (A) It is recommended to use the patient's ideal body weight or pre-pregnancy weight. (B) To convert Hb (mM) to Hb (g/dl), Hb (mM) should be multiplied by the factor 1.611145. (C) Factor 2.4 = 0.07 x 10.000 x 0.0034 %((%0.0034: the iron content of hemoglobin is 0.34% - 0.07: blood volume is 70 ml/kg body weight = 7% of body weight - 10.000: the conversion factor 1 g/dl = 10.000 mg / l%))%. (D) For a person weighing more than 35 kg body weight, iron stores are approximately 500 mg. The iron deficiency anemia will not appear until the total iron deposits have been depleted. Iron therapy should therefore replenish both hemoglobin iron and iron stores. After the total iron deficiency is corrected, patients may require continuous Monofer therapy to maintain the hemoglobin target levels and acceptable limits of other iron parameters.


Iron replacement due to bleeding:
 

Iron therapy in patients with bleeding must provide the iron amount equivalent to the amount of iron represented by the loss of iron. If Hb levels are reduced: Use the previous formula considering that the iron deposits need not be recovered: total iron dose (mg of iron) = (A) x (B) x (C). If the volume of bleeding is unknown, administration of 200 mg of Monofer results in increased hemoglobin is equivalent to 1 blood unit: Iron to be replaced (mg iron) = number of blood lost x 200 units.


Administration:
 

Often, a few minutes after administration, anaphylactoid reactions occur due to parenteral iron, therefore, strict observation is necessary. If at any time during the intravenous administration of Monofer any signs of hypersensitivity reaction or intolerance are detected, administration must be stopped immediately. When a dose of parenteral iron is administered, must be available both medication for resuscitation and trained staff to evaluate anaphylactoid reactions. Children and adolescents: Monofer use in children and adolescents under 18 years is not recommended due to insufficient data on safety and efficacy. Adults and elderly: Monofer can be administered either as intravenous bolus injection as total dose infusion and intravenous drip or direct injection into the venous branch of the dialyzer. Monofer has not to be administered concomitantly with oral iron preparations since the absorption of oral iron can be decreased. Intravenous bolus injection: Monofer can be administered as intravenous bolus injection of 100-200 mg up to 3 times a week at a frequency of administration of 50 mg iron / minute. It can be diluted in 10 to 20 ml of 0.9% sodium chloride sterile solution. Total dose infusion: Monofer can be administered as infusion of total dose in which the total iron dose is administered in a single infusion. It is administered as a single dose of up to 20 mg iron/kg body weight as an intravenous drip infusion. Dose of 0-10 mg of iron/kg body weight may be infused for 30 minutes. Dose of 11 to 20 mg iron/kg body weight may be infused over 60 minutes. If the total dose of iron exceeds 20 mg iron/kg body weight, the dose may be divided in 2 administrations at an interval of at least one week. Monofer should be added to 100-500 ml of 0.9% sterile chloride solution. Total dose infusion has been associated with an increased incidence of adverse events, including delayed hypersensitivity reactions. Intravenous administration of Monofer by the method of infusion of total dose should be restricted to hospital use. Intravenous drip infusion: Monofer can be administered at doses of 200-1000 mg once a week until the total iron dose has been administered. Dose of 0-5 mg of iron/kg body weight must be infused for 15 minutes, 6-10 mg for 60 minutes and 11 to 20 mg for 60 minutes. Monofer should be added to 100-500 ml of 0.9% sterile sodium chloride. Injection into the dialyzer: Monofer can be administered during hemodialysis directly into the venous branch of the dialyzer under the same procedures defined for intravenous bolus injection.

Presentation:
 Packages containing 1 vials of 5 ml and 1 vial of 10 ml
            OLIMPIS®                                                            Carboplatin                                                          150 mg lyoph. vial x 1 / 450 mg lyoph. vial x 1
Made in Argentina
For sale under filed prescription
Carboplatin
Composition:
 150 mg Injection: Each vial contains: Carboplatin 150 mg. 450 mg Injection: Each vial contains: Carboplatin 450 mg.
Therapeutic Action:
 Antineoplastic agent
Dosage and Administration
The recommended mean dose as monotherapy for chemotherapy or radiotherapy naïve adults with a normal renal function is 400 mg/m2. This dose must not be repeated before 4 weeks have elapsed and until the blood parameters have been reestablished.
Presentation:
 150 mg Injection: Package containing 1 vial. 450 mg Injection: Package containing 1 vial.
            PIPETECAN®                                                      Irinotecan                                                             100 mg vial x 1
Made in Argentina
For sale under filed prescription
Irinotecan
Composition:
 Each vial contains: Irinotecan Hydrochloride (as trihydrate) 100 mg.
Therapeutic Action:
 Antineoplastic agent
Indications:
 It is indicated in patients with metastatic colon or rectal carcinoma, or whose disease recurred or progressed after 5-fluorouracil based therapy.
Dosage and Administration
Starting dose and dose modifications: The recommended irinotecan injection starting dose is 125 mg/m2. Doses must be administered as a 90-minute IV infusion. The recommended therapeutic regimen (1 treatment course) is 125 mg/m2 administered once a week for 4 weeks, followed by a 2-week rest period. After this, additional treatment courses may be repeated every 6 weeks (4 weeks of therapy followed by 2 weeks free of therapy).
Presentation:
 Packages containing one 5 ml-vial.
            REXINTH®                                                           Abiraterone                                                          250 mg coat. tabs. x 120

Argentina Industry

Sale under filed prescription only

 
Abiraterona Acetate 250 mg
 

Composition

 

Each coated tablet contains Abiraterona Acetate 250 mg

 

Therapeutic Action

 

Pharmacotherapeutic group: endocrine therapy, other hormone antagonists and related agents.

ATC code: L02BX03

 

Dosage and Administration

 

Adults:

The recommended dose is 1,000 mg (four 250 mg tablets) as a single daily dose that must not be taken with food. Taking the tablets with food increases systemic exposure to abiraterone.

Abiraterone Acetate is to be taken with low dose prednisone or prednisolone. The recommended dose of prednisone or prednisolone is 10 mg daily.

Treatment with Abiraterone Acetate should not be reinitiated until symptoms of the toxicity have resolved to Grade 1 or baseline.

Paediatric population:

There is no relevant use of Abiraterone Acetate in the paediatric population.

 

Presentation

 

Cardboard box containing 120 coated tablets.

            ROXORIN®                                                          Doxorubicin                                                         10 mg vial x 1 / 50 mg vial x 1
Made in Argentina
For sale under filed prescription
Doxorubicin
Composition:
 10 mg Injection: Each vial contains: Doxorubicin Hydrochloride 10 mg. Each solvent ampoule contains: Water for injection 5 ml. 50 mg Injection: Each vial contains: Doxorubicin Hydrochloride 50 mg.
Therapeutic Action:
 Antineoplastic agent (antitumoral antibiotic of the anthracycline group).
Dosage and Administration
The median dose is 60 to 75 mg/m2 per treatment cycle in 1 single administration or divided in equal parts in 2 or 3 consecutive days. Each cycle is applied with a 3 to 4 week interval. Cycles are repeated until a total maximum dose of 550 mg/m2.

Children:
 

1 mg/kg/day in 1 single dose or 0.8 mg/kg/day for 2 consecutive days, or 0.6 mg/kg/day during 3 consecutive days.

Presentation:
 10 mg Injection: Package containing 1 vial with one solvent ampoule. 50 mg Injection: Package containing 1 vial.
            TREXAM®                                                            Pemetrexed                                                         500 mg lyoph. vial x 1
Made in Argentina
For sale under filed prescription
Pemetrexed
Composition:
 Each vial contains Pemetrexed (as Pemetrexed Disodium Hemipentahydrate) 500 mg. Excipients: Mannitol.
Therapeutic Action:
 Antineoplastic. Folic acid analogue.
Indications:
 Pemetrexed in combination with a platinum agent is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or in any way are not candidates for curative surgery. Pemetrexed is indicated as monotherapy for the treatment of patients with metastatic non-small cell lung cancer locally advanced or metastatic after prior chemotherapy. The effectiveness of pemetrexed as second-line treatment of NSCLC (lnon-small cell lung cancer) is based on the response rate. There are no controlled trials demonstrating a clinical benefit, such as a favorable survival effect or improvement of disease-related symptoms.
Dosage and Administration
Pemetrexed should be administered only intravenously. Pemetrexed should be administered only under the supervision of a qualified physician experienced in the use of antineoplastic agents. Use in combination with cisplatin: malignant pleural mesothelioma: the recommended dose of pemetrexed is 500 mg/m2 administered as an intravenous infusion over 10 minutes on day 1 of each cycle of 21 days. The recommended dose of cisplatin is 75 mg/m2 infused over 2 hours beginning approximately 30 minutes after pemetrexed administration is terminated. Patients should receive adequate antiemetic treatment and be hydrated according to local clinical practice before and / or after receiving cisplatin. View cisplatin prospectus for more information. Use as a single agent (monotherapy): NSCLC : the recommended dose of pemetrexed is 500 mg/m2 administered as an intravenous infusion over 10 minutes on day 1 of each cycle of 21 days.
Presentation:
 TREXAM is presented in unidose sterile vials containing 500 mg pemetrexed.
            XALIPLAT®                                                          Oxaliplatin                                                           50 mg vial x 1 / 100 mg vial x 1
Made in Argentina
For sale under filed prescription
Oxaliplatin
Composition:
 50 mg Injection: Each vial contains: Oxaliplatin 50 mg. 100 mg Injection: Each vial contains: Oxaliplatin 100 mg.
Therapeutic Action:
 Antineoplastic agent.
Dosage and Administration:
In monochemotherapy or in combination therapy, the recommended dose is 130 mg/m2 repeated every 3 weeks, in the absence of significant phenomena of important toxicity. Oxaliplatin is generally administered as a short perfusion from 2 to 8 hours diluted in a 5% glucose solution with a variable volume from 250 to 500 ml. The administration may be modified based on the patient’s tolerance, especially neurologic tolerance.
Presentation:
 50 mg Injection: Package containing 1 vial. 100 mg Injection: Package containing 1 vial.
            ZIATIR®                                                                Imatinib                                                               100 mg coat. tabs. x 180 / 400 mg coat. tabs. x 30
Made in Argentina
For sale under filed prescription
Imatinib
Composition:
 Each ZIATIR 100 coated tablet contains: imatinib (as imatinib mesylate) 100mg. Each ZIATIR 400 coated tablet contains: imatinib (as imatinib mesylate) 400mg.
Therapeutic Action:
 Inhibitor of the proteine tyrosine kinase.
Indications:
 ZIATIR is indicated for the treatment of adult patients with Chronic Myeloid Leukemia (CML) positive for Philadelphia chromosome (bcr-abl) in its chronic phase after the treatment with interferon alpha failed, or in accelerated phase or blastic crisis. Imatinib efficacy is based on the general indexes of hematologic and citogenetic responses. There are no controlled studies to demonstrate a clinical benefit or increase of survival.
Dosage and Administration:
A physician with experience in the treatment of patients with CML must be in charge of the beginning of the treatment. The prescribed dose must be administered orally, once a day with one meal and a big glass of water. The ZIATIR recommended dose is 400 mg/day for patients with CML in chronic phase, 600 mg/day for patients in the accelerated phase, and 600 mg/day for patients with blastic crisis. Treatment Duration: In clinical studies published, ZIATIR treatment continued until the progression of the disease. The effect of suspending the treatment after achieving a complete cytogenic responce was not investigated. Dose increase from 400 to 600 mg may be considered in patients with the disease in its chronic phase, or from 600 mg. up to a maximum of 800 mg (administered as 400 mg twice a day) in patients in the accelerated phase or blastic crisis, in absence of any serious adverse pharmacologic reaction and serious neutropenia or thrombocytopenia not related with leukemia, under the following circumstances: progression of the disease (any moment); failure to achieve a satisfactory hematologic response after at least three months of treatment, loss of a hematologic response achieved before. Patients must be monitored closely after a dose increase, because of the possibility of an increase in the incidence of adverse phenomena at high doses.
Presentation:
 ZIATIR 100: Packages containing 180 coated tablets. ZIATIR 400: Packages containing 30 coated tablets.

Note: Products which are still under patent are manufactured according to Argentinean requirements. Please note that they are delivered only to countries where the substance and  its use are not protected by patents.