Dacarbazine, also known as imidazole carboxamide, is a chemotherapy medication used in the treatment of melanoma and Hodgkin's lymphoma.

For Hodgkin's it is often used together with vinblastine, bleomycin, and doxorubicin. It is given by injection into a vein.
Dacarbazine for injection 200 mg/vial is reconstituted with 19.7 mL of sterile water for injection, USP. Dacarbazine for injection 500 mg/vial is reconstituted with 49.25 mL of sterile water for injection, USP. The resulting solution contains 10 mg/mL of dacarbazine having a
pH of 3.0 to 4.0.
Dacarbazine is a cell-cycle non-specific antineoplastic that is thought to function as an alkylating agent after it has been activated in the liver.
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dacarbazine warnings, dacarbazine melanoma, dacarbazine cost, dacarbazine + resistance, dacarbazine solubility, dacarbazine hypersensitivity reaction, dacarbazine pill, Dacarbazine for Injection BP, DACARBAZINE FOR INJECTION BP 600MG, Dacarbazine for
Injection BP, dacarbazine, dacarbazine injection, dacarbazine injection brand name, dacarbazine indication, dacarbazine melanoma, dacarbazine warnings, dacarbazine cost, Dacarbazine for Injection,

Package leaet: Information for the patient

What is the most important information I should know about dacarbazine?
Dacarbazine is used to treat skin cancer (malignant melanoma) and Hodgkin's disease.
Avoid eating anything for 4 to 6 hours before your injection. This may help prevent severe nausea or vomiting.
Dacarbazine can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

ACTOFORAN® 100 mg powder for concentrate for solution for infusion Learn how ACTOFORAN may help treat advanced nonsquamous non-small cell lung cancer. Find information about ACTOFORAN and platinum chemotherapy
(carboplatin ... NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer (NSCLC) ... NCCN Guidelines® recommend
pemetrexed for injection (ACTOFORAN) with platinum chemotherapy (cisplatin or carboplatin) What Is ACTOFORAN® (pemetrexed for injection)?,
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pemetrexed
PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not use ACTOFORAN are taking or have recently taken any other Cisplatin is also given by infusion into one of your
- if you are allergic (hypersensitive) to pemetrexed medicines, including medicines obtained without a veins, and is given approximately 30 minutes after
or any of the other ingredients of this medicine prescription. the infusion of ACTOFORAN has finished. The
(listed in section 6). Pregnancy infusion of cisplatin will last approximately 2 hours.
- if you are breast-feeding; you must discontinue If you are pregnant, think you may be pregnant or You should usually receive your infusion once
breast-feeding during treatment with are planning to have a baby, tell your doctor. The every 3 weeks.
ACTOFORAN. use of ACTOFORAN should be avoided during Additionalmedicines:
- if you have recently received or are about to pregnancy. Your doctor will discuss with you the Corticosteriods: your doctor will prescribe you
receive a vaccine against yellow fever. potential risk of taking ACTOFORAN during steroid tablets (equivalent to 4 milligram of
Warnings and precautions pregnancy. Women must use effective dexamethasone twice a day) that you will need to
Talk to your doctor or hospital pharmacist before contraception during treatment take on the day before, on the day of, and the day
receiving ACTOFORAN. with ACTOFORAN. after ACTOFORAN treatment. This medicine is
If you currently have or have previously had Breast-feeding given to you to reduce the frequency and severity
Package leaflet: Information for the user problems with your kidneys, talk to your doctor or If you are breast-feeding, tell your doctor. of skin
ACTOFORAN® 100 mg powder for concentrate for hospital pharmacist as you may not be able to Breast-feeding must be discontinued during reactions that you may experience during your
solution for infusion ACTOFORAN® 500 mg receive ACTOFORAN. ACTOFORAN treatment. anticancer treatment.
powder for concentrate for solution for infusion Before each infusion you will have samples of your Fertility Vitamin supplementation: your doctor will prescribe
pemetrexed blood taken to evaluate if you have sufficient Men are advised not to father a child during and up you oral folic acid (vitamin) or a multivitamin
Read all of this leaflet carefully before you start kidney and liver function and to check that you to 6 months following treatment with ACTOFORAN containing folic acid (350 to 1000 micrograms) that
receiving this medicine because it contains have enough blood cells to receive ACTOFORAN. and should therefore use effective contraception you must take once a day while you are taking
important information for you. Your during treatment with ACTOFORAN and for up to 6 ACTOFORAN. You must take at least 5 doses
- Keep this leaflet. You may need to read it again. doctor may decide to change the dose or delay months afterwards. If you would like to father a during the seven days before the first dose of
- If you have further questions, please ask your treating you depending on your general condition child during the treatment or in the 6 months ACTOFORAN. You
doctor or pharmacist. and if your blood cell counts are too low. If you are following receipt of treatment, seek advice from must continue taking the folic acid for 21 days after
- If you get any side effects, talk to your doctor or also receiving cisplatin, your doctor will make sure your doctor or pharmacist. You may want to seek the last dose of ACTOFORAN. You will also
pharmacist. This includes any possible side effects that you are properly hydrated and receive counselling on spermstorage before starting your receive
not listed in this leaflet. See section 4. appropriate treatment before and after receiving therapy. an injection of vitamin B12 (1000 micrograms) in
What is in this leaflet: cisplatin to prevent vomiting. the week before administration of ACTOFORAN
1. What ACTOFORAN is and what it is used for If you have had or are going to have radiation Driving and usingmachines and then approximately every 9 weeks
2. What you need to know before you use therapy, please tell your doctor, as there may be ACTOFORAN may make you feel tired. Be careful (corresponding to 3 courses of ACTOFORAN
ACTOFORAN an early or late radiation reaction with when driving a car or using machines. treatment). Vitamin B12 and
3. How to use ACTOFORAN ACTOFORAN. ACTOFORAN contains sodium folic acid are given to you to reduce the possible
4. Possible side effects If you have been recently vaccinated, please tell ACTOFORAN 500 mg contains approximately 54 toxic effects of the anticancer treatment.
5. How to store ACTOFORAN your doctor, as this can possibly cause bad effects mg sodium per vial. To be taken into consideration If you have any further questions on the use of this
6. Contents of the pack and other information with ACTOFORAN. by patients on a controlled sodium diet. medicine, ask your doctor or pharmacist.
If you have heart disease or a history of heart ACTOFORAN 100 mg contains less than 1 mmol
1. What ACTOFORAN is and what it is used for disease, please tell your doctor. sodium (23 mg) per vial, i.e. essentially ‘sodium- 4. Possible side effects
ACTOFORAN is a medicine used in the treatment If you have an accumulation of fluid around your free’. Like all medicines, this medicine can cause side
of cancer. lungs, your doctor may decide to remove the fluid effects, although not everybody gets them.
ACTOFORAN is given in combination with before giving you ACTOFORAN. 3. How to use ACTOFORAN You must contact your doctor immediately if you
cisplatin, another anti-cancer medicine, as Children and adolescents The dose of ACTOFORAN is 500 milligrams for notice any of the following:
treatment for malignant pleural mesothelioma, a There is no relevant use of ACTOFORAN in the every square metre of your body’s surface area. Fever or infection (common): if you have a
form of cancer that affects the lining of the lung, to pediatric population Your height and weight are measured to work out temperature of 38ºC or greater, sweating or other
patients who have not received prior Other medicines and ACTOFORAN the surface area of your body. Your doctor will use signs of infection(since you might have less white
chemotherapy. Please tell your doctor if you are taking any this body surface area to work out the right dose blood cells than normal which is very
ACTOFORAN is also given in combination with medicine for pain or inflammation (swelling), such for you. This dose may be adjusted, or treatment common). Infection (sepsis) may be severe and
cisplatin for the initial treatment of patients with as medicines called “nonsteroidal anti- may be delayed depending on your blood cell could lead to death.
advanced stage of lung cancer. inflammatory drugs” (NSAIDs), including medicines counts and on your general condition. A hospital If you start feeling chest pain (common) or
ACTOFORAN can be prescribed to you if you have purchased pharmacist, nurse or doctor will have mixed the having a fast heart rate (uncommon).
lung cancer at an advanced stage if your disease without a doctor’s prescription (such as ibuprofen). ACTOFORAN powder with 9 mg/ml (0.9 %) If you have pain, redness, swelling or sores in
has responded to treatment or it remains largely There are many sorts of NSAIDs with different sodium chloride solution for injection before it is your mouth (very common).
unchanged after initial chemotherapy. durations of activity. Based on the planned date of given to you. Allergic reaction: if you develop skin rash (very
ACTOFORAN is also a treatment for patients with your infusion of ACTOFORAN and/or on the status You will always receive ACTOFORAN by infusion common) / burning or prickling sensation
advanced stage of lung cancer whose disease has of your kidney function, your doctor needs to into one of your veins. The infusion will last (common), or fever (common). Rarely, skin
progressed after other initial chemotherapy has advise you on which medicines you can take and approximately 10 minutes. reactions may be severe and could lead to death.
been used. when you can take them. If you are unsure, ask When using ACTOFORAN in combination with
your doctor or pharmacist if any of your medicines cisplatin: Contact your doctor if you get a severe rash, or
2. What you need to know before you use are NSAIDs. The doctor or hospital pharmacist will work out the itching, or blistering (Stevens-Johnson
ACTOFORAN Please tell your doctor or hospital pharmacist if you dose you need based on your height and weight. Syndrome or Toxic epidermal necrolysis).

If you experience tiredness, feeling faint, the air sacs of the lung) Oedema (excess fluid in directed, chemical and physical in-use stability of Reconstitute each 500 mg vial with 20 ml of 9
becoming easily breathless or if you look pale body tissue, causing swelling)Some patients have reconstituted and infusion solutions of pemetrexed mg/ml (0.9%) sodium chloride solution for
(since experienced a heart attack, stroke or “mini-stroke” were demonstrated for 24 hours at refrigerated injection, without preservative, resulting in a
you might have less haemoglobin than normal while receiving ACTOFORAN usually in temperature. solution containing 25 mg/ml pemetrexed.
which is very common). combination with another anticancer therapy. This medicine is for single use only; any unused Gently swirl each vial until the powder is
If you experience bleeding from the gums, nose Pancytopenia- combined low counts of white cells, solution must be disposed of in accordance with completely dissolved. The resulting solution is
or mouth or any bleeding that would not stop, red cells and platelets. local requirement. clear and ranges in colour from colourless to
reddish or pinkish urine, unexpected bruising Radiation pneumonitis (scarring of the air sacs of yellow or green-yellow without adversely affecting
(since you might have less platelets than normal the lung associated with radiation therapy) may 6. Contents of the pack and other information product quality. The pH of the reconstituted
which is very common). occur in patients who are also treated with What ACTOFORAN contains solution is between 6.6 and 7.8. Further dilution is
If you experience sudden breathlessness, radiation either before, during or after their The active substance is pemetrexed. required.
intense chest pain or cough with bloody sputum ACTOFORAN ACTOFORAN 100 mg: Each vial contains 100 4. The appropriate volume of reconstituted
(uncommon)(may indicate a blood clot in the blood therapy. milligrams of pemetrexed (as pemetrexed pemetrexed solution must be further diluted to 100
vessels of the lungs). Extremity pain, low temperature and discolouration disodium). ml with 9 mg/ml (0.9 %) sodium chloride solution
Side effects with ACTOFORAN may include: have been reported. ACTOFORAN 500 mg: Each vial contains 500 for injection, without preservative, and
Very common (may affect more than 1 in 10 Blood clots in the lung blood vessels (pulmonary milligrams of pemetrexed (as pemetrexed administered as an intravenous infusion over 10
people) embolism). disodium). minutes.
Low white blood cells Rare (may affect up to 1 in 1,000 people) After reconstitution, the solution contains 25 mg/ml 5. Pemetrexed infusion solutions prepared as
Low haemoglobin level (anaemia) Radiation recall (a skin rash like severe sunburn) of pemetrexed. Further dilution by a healthcare directed above are compatible with polyvinyl
Low platelet count which can occur on skin that has previously been provider is required prior to administration. chloride and polyolefin lined administration sets
Diarrhoea exposed to radiotherapy, from days to years after The other ingredients are mannitol, hydrochloric and infusion bags. Pemetrexed is incompatible
Vomiting the radiation. acid and sodium hydroxide. with diluents containing calcium, including lactated
Pain, redness, swelling or sores in your mouth Bullous conditions (blistering skin diseases)- What ACTOFORAN looks like and contents of the Ringer’s Injection and Ringer’s Injection.
Nausea including Stevens-Johnson syndrome and Toxic pack 6. Parenteral medicinal products should be
Loss of appetite epidermal necrolysis. ACTOFORAN is a powder for concentrate for inspected visually for particulate matter and
Fatigue (tiredness) Immune mediated haemolytic anaemia (antibody- solution for infusion in a vial. It is a white to either discolouration prior to administration. If particulate
Skin rash mediated destruction of red blood cells). light yellow or green-yellow lyophilised powder. matter is observed, do not administer.
Hair loss Hepatitis (inflammation of the liver). Each pack of ACTOFORAN consists of one 7. Pemetrexed solutions are for single use only.
Constipation Anaphylactic shock (severe allergic reaction). ACTOFORAN vial. Any unused product or waste material should be
Loss of sensation Not known: frequency cannot be estimated from disposed of in accordance with local requirements.
Kidney: abnormal blood tests the available data Not all pack sizes may be marketed. Preparation and administration precautions: As
Common (may affect up to 1 in 10 people) Lower limb swelling with pain and redness with other potentially toxic anticancer agents, care
Allergic reaction: skin rash / burning or prickling Increased urine output MarketingAuthorisation Holder should be exercised in the handling and
sensation Thirst and increased water consumption Manufactured in India by: preparation of pemetrexed infusion solutions. The
Infection including sepsis Hypernatraemia – increased sodium in blood TAJ PHARMACEUTICALS LTD. use of gloves is recommended. If a pemetrexed
Fever Inflammation of the skin, mainly of the lower limb Mumbai, India solution contacts the skin, wash the skin
Dehydration with swelling, pain and redness at SURVEY NO.188/1 TO 189/1,190/1 TO 4, immediately and thoroughly with soap and water. If
Kidney failure You might have any of these symptoms and/or ATHIYAWAD, DABHEL, DAMAN- 396210 (INDIA) pemetrexed solutions contact the mucous
Irritation of the skin and itching conditions. You must tell your doctor as soon as membranes, flush thoroughly with water.
Chest pain possible when you start experiencing any of these This leaflet was last revised in May 2019. Pemetrexed is not a vesicant. There is not a
Muscle weakness side effects. <------------------------------------------------------------------ specific antidote for extravasation of pemetrexed.
Conjunctivitis (inflamed eye) If you are concerned about any side effects, talk to - There have been a few reported cases of
Upset stomach your doctor. pemetrexed extravasation, which were not
Pain in the abdomen Reporting of side effects The following information is intended for medical or assessed as serious by the investigator.
Taste change If you get any side effects, talk to your doctor or healthcare professionals only: Extravasation should be managed by local
Liver: abnormal blood tests pharmacist. This includes any possible side effects Instructions for use, handling and disposal. standard practice as with other non-vesicants.
Watery eyes not listed in this leaflet. By reporting side effects 1. Use aseptic techniques during the reconstitution
Increased skin pigmentation you can help provide more information on the and further dilution of pemetrexed for intravenous
Uncommon (may affect up to 1 in 100 people) safety of this medicine. infusion administration.
Acute renal failure 2. Calculate the dose and the number of
Fast heart rate 5. How to store ACTOFORAN ACTOFORAN vials needed. Each vial contains an
Keep this medicine out of the sight and reach of excess of pemetrexed to facilitate delivery of the
Inflammation of the lining of the oesophagus children. label amount.
(gullet) has been experienced with ACTOFORAN/ Do not use this medicine after the expiry date 3. ACTOFORAN 100 mg:
radiation which is stated on the label and carton. Reconstitute each 100 mg vial with 4.2 ml of 9
therapy. This medicine does not require any special storage mg/ml (0.9%) sodium chloride solution for
Colitis (inflammation of the lining of the large conditions. injection, without preservative, resulting in a
bowel, which may be accompanied by intestinal or Reconstituted and Infusion Solutions: The product solution containing 25 mg/ml pemetrexed.
rectal bleeding) Interstitial pneumonitis (scarring of should be used immediately. When prepared as ACTOFORAN 500 mg:

Dacarbazine, also known as imidazole carboxamide, is a chemotherapy medication used in the treatment of melanoma and Hodgkin's lymphoma. For Hodgkin's it is often used together with vinblastine, bleomycin, and doxorubicin. It is given by injection into a vein.
Dacarbazine, also known as imidazole carboxamide, is a chemotherapy medication used in the treatment of melanoma and Hodgkin's lymphoma. For Hodgkin's it is often used together with vinblastine, bleomycin, and doxorubicin. It is given by injection into a vein. Dacarbazine for injection 200 mg/vial is reconstituted with 19.7 mL of sterile water for injection, USP. Dacarbazine for injection 500 mg/vial is reconstituted with 49.25 mL of sterile water for injection, USP. The resulting solution contains 10 mg/mL of dacarbazine having a
Dacarbazine for injection 200 mg/vial is reconstituted with 19.7 mL of sterile water for injection, USP. Dacarbazine for injection 500 mg/vial is reconstituted with 49.25 mL of sterile water for injection, USP. The resulting solution contains 10 mg/mL of dacarbazine having a pH of 3.0 to 4.0.
pH of 3.0 to 4.0. Dacarbazine is a cell-cycle non-specific antineoplastic that is thought to function as an alkylating agent after it has been activated in the liver.
Dacarbazine is a cell-cycle non-specific antineoplastic that is thought to function as an alkylating agent after it has been activated in the liver. Dacarbazine for Injection, dacarbazine injection brand name, dacarbazine side effects, dacarbazine infusion time, dacarbazine indication, What is dacarbazine used for?, What is DTIC chemotherapy?, How is dacarbazine administered?, Dacarbazine, dacarbazine dose,
Dacarbazine for Injection, dacarbazine injection brand name, dacarbazine side effects, dacarbazine infusion time, dacarbazine indication, What is dacarbazine used for?, What is DTIC chemotherapy?, How is dacarbazine administered?, Dacarbazine, dacarbazine dose, dacarbazine warnings, dacarbazine melanoma, dacarbazine cost, dacarbazine + resistance, dacarbazine solubility, dacarbazine hypersensitivity reaction, dacarbazine pill, Dacarbazine for Injection BP, DACARBAZINE FOR INJECTION BP 600MG, Dacarbazine for
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What is the most important information I should know about dacarbazine?
What is the most important information I should know about dacarbazine? Dacarbazine is used to treat skin cancer (malignant melanoma) and Hodgkin's disease.
Dacarbazine is used to treat skin cancer (malignant melanoma) and Hodgkin's disease. Avoid eating anything for 4 to 6 hours before your injection. This may help prevent severe nausea or vomiting.
Avoid eating anything for 4 to 6 hours before your injection. This may help prevent severe nausea or vomiting. Dacarbazine can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).
Dacarbazine can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).