Hepatitis C
Ledipasvir + Sufosbuvir
This is recommended as a unique option for treating adults with chronic hepatitis C infection.
Sofosbuvir is a nucleotide analogue inhibitor and ledipasvir is an HCV inhibitor; they reduce viral load by inhibiting hepatitis C virus RNA replication.
Indications
of genotype 1 without cirrhosis (treatment naive patients)—8 weeks’ treatment
of genotype 1 or 4 with cirrhosis (treatment naive patients)—12 weeks’ treatment
of genotype 1 or 4 without cirrhosis (or with cirrhosis but only if the person has a low risk of the disease getting worse) that has not responded adequately to previous treatment—12 weeks’ treatment
In addition, ledipasvir with sofosbuvir is only recommended in patients with cirrhosis for the durations mentioned above if the following criteria are met:
Child-Pugh class A
platelet count of 75 000/mm3 or more
no features of portal hypertension
no history of an HCV-associated decompensation episode
not previously treated with an NS5A inhibitor
Biosimilars
Rilast (Rituximab Injection)
Rituximab is a monoclonal antibody that targets CD20, a specific B-cell surface antigen.
Rituximab was the first monoclonal antibody approved for the treatment of non-Hodgkin lymphoma. In 1997, the FDA approved rituximab for the treatment of refractory low-grade lymphoma.
Rituximab has since been used for the treatment of a number of CD20-positive B-cell malignancies.
The selectivity of the drug for B-cells led to further investigations involving autoimmune B-cell driven diseases, including rheumatoid arthritis. Rituximab has since been approved for the treatment of rheumatoid arthritis by the FDA.1
Indications
Rheumatoid arthritis (specialist use only)
By intravenous infusion
For Adult
1 g, then 1 g after 2 weeks, consult product literature for information on retreatment.
Non-Hodgkin’s lymphoma (specialist use only),
Chronic lymphocytic leukaemia (specialist use only),
Granulomatosis with polyangiitis and microscopic polyangiitis (specialist use only)
By intravenous infusion
For Adult
(consult product literature).
Non-Hodgkin’s lymphoma (specialist use only)
By subcutaneous injection
For Adult
(consult product literature).
Pemphigus vulgaris (specialist use only)
By intravenous infusion
For Adult
1 g, then 1 g after 2 weeks; maintenance 0.5 g, at months 12 and 18, and then every 6 months thereafter if needed, consult product literature for the treatment of relapse.
Derise (Darbepoetin Alfa Injection)
Darbepoetin alfa injection is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time).
Indications
Symptomatic anaemia associated with chronic renal failure in patients on dialysis
By subcutaneous injection, or by intravenous injection
For Adult
Initially 450 nanograms/kg once weekly, dose to be adjusted according to response by approximately 25% at intervals of at least 4 weeks, maintenance dose to be given once weekly or once every 2 weeks, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose, when changing route give same dose then adjust according to weekly or fortnightly haemoglobin measurements, adjust doses not more frequently than every 2 weeks during maintenance treatment.
Symptomatic anaemia associated with chronic renal failure in patients not on dialysis
By subcutaneous injection
For Adult
Initially 450 nanograms/kg once weekly, alternatively initially 750 nanograms/kg every 2 weeks, dose to be adjusted according to response by approximately 25% at intervals of at least 4 weeks, maintenance dose can be given once weekly, every 2 weeks, or once a month, subcutaneous route preferred in patients not on haemodialysis, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose, when changing route give same dose then adjust according to weekly or fortnightly haemoglobin measurements, adjust doses not more frequently than every 2 weeks during maintenance treatment.
Symptomatic anaemia associated with chronic renal failure in patients not on dialysis
By intravenous injection
For Adult
Initially 450 nanograms/kg once weekly, dose to be adjusted according to response by approximately 25% at intervals of at least 4 weeks, maintenance dose given once weekly, subcutaneous route preferred in patients not on haemodialysis, reduce dose by approximately 25% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25% lower than the previous dose, when changing route give same dose then adjust according to weekly or fortnightly haemoglobin measurements, adjust doses not more frequently than every 2 weeks during maintenance treatment.
Symptomatic anaemia in adults with non-myeloid malignancies receiving chemotherapy
By subcutaneous injection
For Adult
Initially 6.75 micrograms/kg every 3 weeks, alternatively initially 2.25 micrograms/kg once weekly, if response inadequate after 9 weeks further treatment may not be effective; if adequate response obtained then reduce dose by 25–50%, reduce dose by approximately 25–50% if rise in haemoglobin concentration exceeds 2 g/100 mL over 4 weeks or if haemoglobin concentration exceeds 12 g/100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and restart at a dose approximately 25% lower than the previous dose. Discontinue approximately 4 weeks after ending chemotherapy.
Bevaas (Bevazizumab Injection)
Bevacizumab injection (Avastin) is used to treat certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), and peritoneal (layer of tissue that lines the abdomen) cancer that has not improved or has come back after treatment with other medications.
Bevacizumab injection products are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.
Indications
Bevacizumab injection products come as a solution (liquid) to administer slowly into a vein. Bevacizumab injection products are administered by a doctor or nurse in a medical office, infusion center, or hospital. Bevacizumab injection products are usually given once every 2 or 3 weeks.
Your dosing schedule will depend on the condition that you have, the other medications you are using, and how well your body responds to treatment.
It should take 90 minutes for you to receive your first dose of a bevacizumab injection product. A doctor or nurse will watch you closely to see how your body reacts to bevacizumab. If you do not have any serious problems when you receive your first dose of a bevacizumab injection product, it will usually take 30 to 60 minutes for you to receive each of your remaining doses of the medication.
Bevacizumab injection products may cause serious reactions during infusion of the medication. If you experience any of the following symptoms, tell your doctor immediately: difficulty breathing or shortness of breath, chills, shaking, sweating, headaches, chest pain, dizziness, feeling faint, flushing, itching, rash, or hives. Your doctor may need to slow down your infusion, or delay or stop your treatment if you experience these or other side effects.
Pamera (Adalidumab Injection)
Adalimumab injection is used alone or with other medications to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage)
Indications
Juvenile idiopathic arthritis (JIA; a condition that affects children in which the body attacks its own joints, causing pain, swelling, loss of function, and delays in growth and development) in children 2 years of age and older,
Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications in adults and children 6 years of age and older,
Ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) when other medications and treatments did not help or could not be tolerated in adults,
Ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults,
psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults,
Hidradenitis suppurativa (a skin disease that causes pimple-like bumps in the armpits, groin, and anal area) in adults and children 12 years of age and older,
Uveitis (swelling and inflammation of different areas of the eye) in adults and children 2 years of age and older,
Chronic plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults.
Sezuma (Traztuzumab Injection)
Treatment of early breast cancer which overexpresses human epidermal growth factor receptor-2 (HER2) (initiated by a specialist)
Treatment of metastatic breast cancer in patients with HER2-positive tumours who have not received chemotherapy for metastatic breast cancer and in whom anthracycline treatment is inappropriate (in combination with paclitaxel or docetaxel) (initiated by a specialist)
Treatment of metastatic breast cancer in postmenopausal patients with hormone-receptor positive HER2-positive tumours not previously treated with trastuzumab (in combination with an aromatase inhibitor) (initiated by a specialist)
Indications
By intravenous infusion, or by subcutaneous injection
For Adult
(consult product literature or local protocols).
Monotherapy for metastatic breast cancer in patients with tumours that overexpress HER2 who have received at least 2 chemotherapy regimens including, where appropriate, an anthracycline and a taxane (initiated by a specialist)
By intravenous infusion, or by subcutaneous injection
For Adult
Women with oestrogen-receptor-positive breast cancer should also have received hormonal therapy (consult product literature or local protocols).
Treatment of metastatic gastric cancer in patients with HER2-positive tumours who have not received treatment for metastatic gastric cancer (in combination with capecitabine or fluorouracil and cisplatin) (initiated by a specialist)
By intravenous infusion
For Adult
(consult product literature or local protocols).
Anti – Alcoholism
Meedzo
Alcoholism is a serious illness, which carries grave socioeconomic consequences to individuals and their families.
Meedzo is a powerful inhibitor of dehydrogenase aldehyde which, constitutes a valuable adjuvant to the psychotherapy treatment of alcoholism, as it induces a reaction of intolerance towards the consumption of alcohol.
Indications
Commercial Name: MEEDZO
Name of active substance: Cyanamide
Anatomic therapeutic Chemical (ATC): N07A1, treatment of chronic alcoholism
Form of dosage: oral drops
Composition:
Active ingredient: Cyanamide – 60 mg/ml (3 mg per drop)
Excipients: Sorbic acid, acetic acid, sodium acetate, purified water.
Description: Transparent and colourless solution with a light scent of acetic acid.
Indications
Treatment for alcohol – dependency (chronic alcoholism), as an adjuvant to psychotherapy.
Dosage
12 – 25 drops to be administered orally (37 – 75mg of cyanamide) twice a day with a 12 hour interval.
Instructions for handling correctly
MEEDZO can be applied to any drink, except for alcoholic drinks, or food. However, it should be taken into account that higher temperatures can destroy the drug.
Pharmacodynamics
The effect of the drug MEEDZO is based in blocking dehydrogenase aldehyde, which takes part in the metabolism of alcohol. This leads to an increase in the concentration of the metabolite for alcohol – acetaldehyde, which causes negative effects (redness, nausea, tachycardia, shortness of breath, etc.) which make the consumption of alcohol unpleasant after taking the drug. This leads to an adverse reaction conditioned by smell and taste of alcoholic beverages.
Contraindications
Serious cardiac illness, Hyper-sensitivity to the drug, Pregnancy, Insufficient respiratory or renal function, hepatic encephalopathy.
Precautions
Meedzo should be used only under the supervision of a doctor and with the patient’s knowledge. May experience a reaction to alcohol contained in other drugs or food products.
Treatment with MEEDZO can begin only 12 hours after the last time alcohol was consumed. MEEDZO must be used with caution in the event of ingesting simultaneously with alcohol as it can lead to a risk to the patient’s health: in case of hyperthyroidism, diabetes, epilepsy, cardiovascular and renal illnesses. In case of prolonged use, it is recommended to check thyroid glandular function at least once every six months.
Use while pregnant and/or lactating.
This medicine should not be taken during pregnancy or lactation.
Interaction with other drugs.
MEEDZO is not prescribed with metronidazole, isoniazid, phenytoin and other inhibitors of dehydrogenase aldehyde, which can increase the reaction with alcohol. After taking disulfiram, before taking MEEDZO, there must be a period of at least 10 days.
Secondary effects
As a general rule of thumb, the drug is well tolerated if not consumed with alcohol. It is possible from time to time to experience some fatigue, drowsiness, spots, tinnitus and transient leukocytosis.
Reaction to alcohol
If alcohol is taken with this product, the following symptoms can surge:
Intense redness of the skin, palpitations in the head and neck, nausea, tachycardia, difficulty breathing, weakness, blurred vision, sweat, chest pain. In the most serious cases: vomit, hypertension, respiratory pressure loss or circulatory collapse
The nature and severity of these symptoms depend on the quantities consumed. In serious cases, it is necessary to perform symptomatic therapy directed towards maintaining the respiratory and cardiovascular systems. It has also been recommended the intravenous infusion of antihistamenics.
Storage
Store in a dark place with a temperature not surpassing 25 ºC.
Keep out of reach of children.
Expiration: 2 years. Do not use this medication past the expiry date printed on the packet.
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