INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ASPEN ETOPOSIDE 100 mg/5 mL (SOLUTION FOR INFUSION)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

ASPEN ETOPOSIDE 100 mg/5 mL (SOLUTION FOR INFUSION)

COMPOSITION
Each 5 mL vial contains:
Etoposide 100 mg
Absolute ethanol 20% v/v
Excipients:
Anhydrous citric acid, macrogol 400, polysorbate 80.

PHARMACOLOGICAL CLASSIFICATION
A26 Cytostatic agents

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Etoposide forms a ternary complex with topoisomerase II and DNA and prevents resealing of the break that normally follows topoisomerase binding to DNA. The enzyme remains bound to the free end of the broken DNA strand, leading to an accumulation of DNA breaks and cell death. Cells in the S and G
2phases of the cell cycle are most sensitive to etoposide. Resistant cells demonstrate: 1) amplification of the mdr-1 gene that encodes the P-glycoprotein medication efflux transporter; 2) mutation or decreased expression of topoisomerase II; 3) mutations of the p53 tumour suppressor gene, a required component of the apoptotic pathway.
Pharmacokinetic properties
After intravenous injection of etoposide, peak plasma concentrations of 30 micrograms/mL are achieved. Etoposide concentrations in the CSF average
1-10% of those in plasma. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumours and normal tissues of the myometrium. In vitro, etoposide is highly protein bound (97%) to human plasma proteins. An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children.
Elimination:
There is a biphasic pattern of clearance with a terminal t1/2 of 6–8 hours in patients with normal renal function. 42–67% of an administered dose is excreted intact in the urine and only 6% in the bile. In patients with compromised renal function, dosage should be reduced in proportion to the reduction in creatinine clearance (CrCl). In patients with advanced liver disease, increased toxicity may result from a low serum albumin (decreased etoposide binding) and elevated bilirubin (which displaces etoposide from albumin). However, guidelines for dose reductions in liver disease have not been defined.

INDICATIONS
ASPEN ETOPOSIDE 100 mg/5 mL is indicated for the treatment of:
Testicular tumours
  In combination therapy with other approved chemotherapeutic agents.
Small cell carcinoma of the lung
  In combination therapy with other approved chemotherapeutic agents.
Non-Hodgkin’s lymphomas
  In combination with other approved chemotherapeutic agents.
Acute non-lymphocytic leukaemia
Carcinoma of the breast
Kaposi’s sarcoma associated with acquired immunodeficiency syndrome (AIDS)

CONTRAINDICATIONS
Hypersensitivity to ASPEN ETOPOSIDE 100 mg/5 mL or to any components of the formulation.
Patients with severe hepatic dysfunction.
Severe myelosuppression (especially after extensive radio and/or chemotherapy or as a result of neoplastic infiltration). This condition may be evidenced by mild to marked leucopenia and/or thrombocytopenia.
Pregnancy and lactation (see PREGNANCY AND LACTATION).
Acute infections.
The safety and efficacy in children has not been established.

WARNINGS
ASPEN ETOPOSIDE 100 mg/5 mL should be administered under the supervision of a doctor experienced in the use of cancer chemotherapeutic agents. Severe bone marrow suppression may occur, complicated by bleeding or infection, which may be fatal (see CONTRAINDICATIONS and Special precautions).

Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Patients being treated with ASPEN ETOPOSIDE 100 mg/5 mL must be observed for myelosuppression carefully and frequently both during and after therapy. Dose limiting bone marrow suppression is the most significant toxicity associated with ASPEN ETOPOSIDE 100 mg/5 mL therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent dose of ASPEN ETOPOSIDE 100 mg/5 mL; platelet count, haemoglobin, white blood cell count and differential. The occurrence of a platelet count below 50 000/mm
3or an absolute neutrophil count below 500/mm3is an indication to withhold further therapy until the blood counts have sufficiently recovered.
Medical practitioners should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnoea and hypotension. Acute fatal reactions associated with bronchospasm have been reported, as well as hypertension and flushing or seizures. Blood pressure usually normalises within a few hours after cessation of the infusion. Anaphylactoid reactions can occur with the initial dose of ASPEN ETOPOSIDE 100 mg/5 mL. Apnoea has occurred. Treatment is symptomatic. When an anaphylactic reaction occurs, administration of ASPEN ETOPOSIDE 100 mg/5 mL should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the medical practitioner.
ASPEN ETOPOSIDE 100 mg/5 mL should be given only by slow intravenous infusion (usually over a 30 to 60 minute period) since hypotension has been reported as a possible side-effect of rapid intravenous injection.
ASPEN ETOPOSIDE 100 mg/5 mL can cause stomatitis which can cause considerable discomfort.
Bacterial infections should be brought under control before treatment with ASPEN ETOPOSIDE 100 mg/5 mL commences. Great care should be taken when giving ASPEN ETOPOSIDE 100 mg/5 mL to patients exposed to varicella zoster infection.
Patients with renal function impairment should be given a lower dose of ASPEN ETOPOSIDE 100 mg/5 mL (see DOSAGE AND DIRECTIONS FOR USE).
Liver and kidney function should be periodically monitored.

INTERACTIONS
High dose ciclosporin may increase the AUC of ASPEN ETOPOSIDE 100 mg/5 mL with a decrease in total body clearance of ASPEN ETOPOSIDE 100 mg/5 mL.
Concomitant cisplatin therapy is associated with a reduced total body clearance of ASPEN ETOPOSIDE 100 mg/5 mL.
Acute leukaemia, with or without a preleukaemic phase, can occur in patients treated with ASPEN ETOPOSIDE 100 mg/5 mL in association with other antineoplastic medication, e.g. bleomycin, cisplatin, ifosfamide, methotrexate.
Phenylbutazone, salicylic acid and sodium salicylate can affect the protein binding of ASPEN ETOPOSIDE 100 mg/5 mL.
The action of oral anticoagulants can be increased.
ASPEN ETOPOSIDE 100 mg/5 mL can potentiate the cytotoxic and myelosuppressive action of other medication. Dose reduction of ASPEN ETOPOSIDE 100 mg/5 mL may need to be considered depending on blood counts.
Experimentally confirmed cross-resistance between anthracyclines and ASPEN ETOPOSIDE 100 mg/5 mL has been reported.

PREGNANCY AND LACTATION
Pregnancy
ASPEN ETOPOSIDE 100 mg/5 mL can cause foetal harm when administered to pregnant women. There are no adequate and well-controlled studies in pregnant women. If this medication is used during pregnancy, or if the patient becomes pregnant while receiving this medication, the patient should be advised of the potential hazard to the foetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Due to the possibility of carcinogenicity and mutagenicity of ASPEN ETOPOSIDE 100 mg/5 mL , it should only be used in patients of child bearing age or if the expected benefits outweigh the risks of therapy and adequate contraception is used. The patient should be advised of the potential hazard to the foetus if she becomes pregnant.
Males undergoing treatment with ASPEN ETOPOSIDE 100 mg/5 mL should use contraceptive measures because of the mutagenic potential of the medication to induce damage in spermatozoa.
Lactation
ASPEN ETOPOSIDE 100 mg/5 mL is excreted into human breast milk. Breastfeeding is contraindicated during treatment with ASPEN ETOPOSIDE 100 mg/5 mL.
Fertility
ASPEN ETOPOSIDE 100 mg/5 mL may lead to suppression of ovarian and testicular function resulting in amenorrhoea and the inhibition of spermatogenesis. Gynaecomastia has been reported.

DOSAGE AND DIRECTIONS FOR USE
Do not administer the injection undiluted.

Intravenous dosage:
The usual intravenous dose of ASPEN ETOPOSIDE 100 mg/5 mL is 50 to 100 mg/m
2/day, for days 1 to 5 or 100 mg/m2/day on days 1, 3 and 5. These regimens are given every 3 to 4 weeks in combination with other approved relevant medicines.
Dosage should be modified to take into account the myelosuppressive effects of other medication in the combination or the effects of prior X-ray therapy or chemotherapy which may have compromised bone marrow reserve.

Dosage in renal impairment:
Dose adjustment for measured creatinine clearance are recommended as follows:
Measured creatinine clearance Dose of ASPEN ETOPOSIDE 100 mg/5 mL
>50 mL/min 100% of dose
*15-50 mL/min 75% of dose
*data not available for creatinine clearance <15 mL/min and further dose reduction should be considered.

Administration precautions
Caution should be exercised with handling and preparation of ASPEN ETOPOSIDE 100 mg/5 mL. Skin reactions with accidental exposure may occur. Use of gloves and masks is recommended. If ASPEN ETOPOSIDE 100 mg/5 mL does come into contact with skin or mucosa, the area should be washed immediately with soap and water.

During intravenous infusion, great care must be taken to ensure the catheter stays in the vein as any leakage into surrounding tissue is highly irritating.

Hypotension following rapid intravenous administration of ASPEN ETOPOSIDE 100 mg/5 mL has been reported. It is recommended that the medicine be given by slow intravenous infusion over 30 to 60 minutes. Hypotension usually responds to cessation of infusion and/or other supportive therapy as appropriate. When restarting the infusion, a slower rate of administration should be used based on patient tolerance.

ASPEN ETOPOSIDE 100 mg/5 mL should not be administered intra-arterially, intra-pleurally or intra-peritoneally. ASPEN ETOPOSIDE 100 mg/5 mL SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS PUSH.

Preparation of intravenous administration
Hard plastic devices made from acrylic or ABS (a polymer of acrylonitrile, butadiene and styrene) can crack or leak when used for undiluted ASPEN ETOPOSIDE 100 mg/5 mL injection. This effect has not been reported with the diluted form of ASPEN ETOPOSIDE 100 mg/5 mL.

ASPEN ETOPOSIDE 100 mg/5 mL can be diluted with 5% dextrose water or 0,9% sodium chloride solution to give a final concentration of 0,2 to 0,4 mg/mL. More concentrated solutions may show crystal formation within 5 minutes and should not be given intravenously. If a 0,4 mg/mL solution of ASPEN ETOPOSIDE 100 mg/5 mL is administered through tubing connected to a peristaltic pump, it may precipitate out of solution. The final mixture of ASPEN ETOPOSIDE 100 mg/5 mL for parenteral use should be visually inspected for particulate matter and discolouration prior to administration.

For detail regarding the stability of the diluted ASPEN ETOPOSIDE 100 mg/5 mL refer to STORAGE INSTRUCTIONS.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects
In all instances where ASPEN ETOPOSIDE 100 mg/5 mL is considered for chemotherapy, the medical practitioner must evaluate the need and benefit of the medicine against the risk of adverse reactions. In cases where severe reactions occur, ASPEN ETOPOSIDE 100 mg/5 mL should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgement of the medical practitioner. Patients with low serum albumin may be at increased risk for etoposide-induced side effects.

Infections and infestations
Frequency unknown: Infections have been reported in patients with bone marrow depression
Neoplasms benign and malignant
Frequent: Leukaemia
Frequency unknown: Acute promyelocytic leukaemia
Blood and the lymphatic system disorders
Frequent: Myelosuppression (see WARNINGS and Special precautions), anaemia, leukopenia, thrombocytopenia
Immune system disorders
Frequent: Anaphylactoid reactions characterised by flushing, chills, fever, tachycardia, bronchospasm, dyspnoea, hypotension (see Special precautions)
Metabolism and nutrition disorders
Frequent: Anorexia
Less frequent: Hyperuricaemia
Psychiatric disorders
Frequent: Drowsiness, somnolence
Nervous system disorders
Less frequent: Peripheral neuropathy
Frequency unknown: Seizures
Eye disorders
Less frequent: Reversible loss of vision, transient cortical blindness, optic neuritis
Cardiac disorders
Less frequent: Dysrhythmia, myocardial infarction, cyanosis
Vascular disorders
Frequent: Hypotension, haemorrhage
Respiratory, thoracic or mediastinal disorders
Less frequent: Bronchospasm, coughing, laryngospasm, apnoea, interstitial pneumonia, pulmonary fibrosis
Gastrointestinal disorders
Frequent: Nausea, vomiting, abdominal pain, diarrhoea, stomatitis
Less frequent: Mucositis, oesophagitis, constipation, dysphagia, taste disturbance
Hepato-biliary disorders
Frequent: Hepatotoxicity/hepatic dysfunction
Skin and subcutaneous tissue disorders
Frequent: Reversible alopecia which may progress to total baldness
Less frequent: Rash, urticaria, pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, radiation recall dermatitis, hand-foot syndrome
Renal and urinary disorders
Frequent: Accumulation in the liver and kidney and potential functional impairment
General disorders and administration site conditions
Frequent: Fatigue
Less frequent: Asthenia, malaise. After extravasation: irritation of soft tissue, thrombophlebitis and inflammation
Frequency unknown: Delayed wound healing, shivering
Investigations
Frequent: Increased bilirubin, increased AST, increased phosphatase

Special precautions
Myelosuppression with fatal outcome has been reported following ASPEN ETOPOSIDE 100 mg/5 mL administration (see WARNINGS).
Myelosuppression is often dose-limiting, with granulocyte nadirs occurring 7 to 14 days, and platelet nadirs occurring 9 to 16 days, after administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Leukopenia and severe leukopenia (less than 1 000 cells/mm
3) were observed in patients treated with a single agent ASPEN ETOPOSIDE 100 mg/5 mL. Thrombocytopenia and severe thrombocytopenia (less than 50 000 platelets/mm3) were seen in this same group of patients.
The occurrence of acute leukaemia with or without a preleukaemic phase has been reported in patients treated with ASPEN ETOPOSIDE 100 mg/5 mL in association with other anti-neoplastic agents.

Laboratory Tests:
Periodic complete blood counts should be done during the course of ASPEN ETOPOSIDE 100 mg/5 mL treatment. They should be performed prior to therapy and at appropriate periods during therapy. At least one determination should be done prior to each dose of ASPEN ETOPOSIDE 100 mg/5 mL.
Re-institution of ASPEN ETOPOSIDE 100 mg/5 mL therapy should be carried out with caution, and with adequate consideration of the further need for the medicine and alertness as to the possible recurrence of toxicity.

Special precautions relating to excipients:
ASPEN ETOPOSIDE 100 mg/5 mL injection contains polysorbate 80. In premature infants a life threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia and ascites has been associated with an injectable vitamin E product containing polysorbate 80.

Effect on ability to drive and operate machines
ASPEN ETOPOSIDE 100 mg/5 mL may cause side effects such as drowsiness. Patients should be advised not to drive or operate machines until it is established that their ability to perform such activities is not affected.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms and signs of overdose
Severe nausea and vomiting, severe myelosuppression, severe mucositis, metabolic acidosis, hepatotoxicity.
Treatment of overdose
There is no antidote for ASPEN ETOPOSIDE 100 mg/5 mL. Treatment of overdose is symptomatic and supportive.

IDENTIFICATION
A clear colourless to pale yellow, slightly viscous solution.

PRESENTATION
One clear colourless glass vial with a dark grey rubber stopper, and aluminium metal cap with a polypropylene disk, packed into a carton.

STORAGE INSTRUCTIONS
Store at or below 25ºC. Store in original package. Do not remove the vial from the carton until required for use. Use immediately after dilution. Protect from light.
Storage Conditions of the diluted solutions: Stability of the solutions diluted in 5% glucose and 0,9% Sodium Chloride Injection without any special protection from light:

Concentration at dilution Diluent Container material Maximum storage period after dilution (25ºC)
0,2 mg/mL 5% Glucose,
0,9% Sodium Chloride
PVC, glass 96 hours
0,4 mg/mL     24 hours

If not used immediately after dilution, in-use storage times and conditions prior to use, as indicated in the table above, are the responsibility of the user.
Solutions of concentration greater than 0,4 mg/mL may show signs of precipitation and are therefore not recommended. Any solution showing signs of precipitation should be discarded. The intravenous solution is suitable for infusion only in glass and PVC containers.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER
42/26/0017

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THE PACKAGE INSERT
19 April 2013

APPROVED PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before ASPEN ETOPOSIDE 100 mg/5 mL is administered to you.
•        Keep this leaflet. You may need to read it again.
•        If you have further questions, please ask your doctor or your pharmacist.
•        ASPEN ETOPOSIDE 100 mg/5 mL has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours

SCHEDULING STATUS
Schedule 4

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ASPEN ETOPOSIDE 100 mg/5 mL (SOLUTION FOR INFUSION)

WHAT ASPEN ETOPOSIDE 100 mg/5 mL CONTAINS
The active substance in ASPEN ETOPOSIDE 100 mg/5 mL is etoposide.
The other ingredients are absolute ethanol, anhydrous citric acid, macrogol, polysorbate.

WHAT ASPEN ETOPOSIDE 100 mg/5 mL IS USED FOR
The active ingredient in ASPEN ETOPOSIDE 100 mg/5 mL belongs to the group of medicines known as antineoplastic agents.

ASPEN ETOPOSIDE 100 mg/5 mL is used to treat your cancer, either alone or in combination with other medication.

BEFORE YOU RECEIVE ASPEN ETOPOSIDE 100 mg/5 mL
Do not receive ASPEN ETOPOSIDE 100 mg/5 mL if:
You are allergic to etoposide or any of the other ingredients contained in ASPEN ETOPOSIDE 100 mg/5 mL.
You have severe liver problems.
You are pregnant or breastfeeding your baby.
Safety and efficacy of the ASPEN ETOPOSIDE 100 mg/5 mL in children has not been established.

Take special care with ASPEN ETOPOSIDE 100 mg/5 mL
ASPEN ETOPOSIDE 100 mg/5 mL should be administered under the supervision of a doctor experienced in the use of cancer medication. Severe bone marrow suppression may occur, complicated by bleeding or infection, which may be fatal.
Your doctor will treat you in a facility which is adequately equipped to diagnose and treat you.
Your doctor will monitor you carefully during and after therapy for potential myelosuppression. Myelosuppression is a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets.
To doctor will request frequent platelet, red blood cell and white blood cell counts.
Your doctor will also monitor you closely for possible anaphylaxis. Anaphylaxis is a life-threatening type of allergic reaction. Symptoms develop rapidly, often within seconds or minutes. Symptoms include, but are not limited to, chills, fever, increased heart rate, sudden constriction of the walls of the airways, difficulty in breathing and low blood pressure.

ASPEN ETOPOSIDE 100 mg/5 mL can cause inflammation of the mucous lining of the mouth which can cause considerable discomfort, inform you doctor if you experience these effects.
You should be cautious when you receive ASPEN ETOPOSIDE 100 mg/5 mL if you have kidney problems.
Your liver and kidney function should be periodically monitored.
If you have had an infection recently, the infections should be brought under control before treatment with ASPEN ETOPOSIDE 100 mg/5 mL starts.
You should tell your doctor if you have been exposed to chickenpox or shingles.

Pregnancy and breastfeeding
ASPEN ETOPOSIDE 100 mg/5 mL must not be used at any time during pregnancy or whilst breast-feeding.
If you are pregnant, planning to have a baby or breastfeeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.
ASPEN ETOPOSIDE 100 mg/5 mL may cause harm to your unborn baby. You should use contraceptive measures while receiving ASPEN ETOPOSIDE 100 mg/5 mL.

Driving and using machinery
ASPEN ETOPOSIDE 100 mg/5 mL may cause drowsiness. ASPEN ETOPOSIDE 100 mg/5 mL may affect your ability to drive or use machines. Make sure you know what effect ASPEN ETOPOSIDE 100 mg/5 mL has on you before driving or using machinery.

Important information about some of the ingredients of ASPEN ETOPOSIDE 100 mg/5 mL
ASPEN ETOPOSIDE 100 mg/5 mL injection contains polysorbate 80. In premature infants a life threatening syndrome consisting of liver and kidney failure, weakening of the lungs, and bleeding has been associated with an injectable vitamin E product containing polysorbate 80.

Taking other medicines with ASPEN ETOPOSIDE 100 mg/5 mL
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ASPEN ETOPOSIDE 100 mg/5 mL these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.
Please inform your doctor or pharmacist if you are taking or using:
Ciclosporin (an immunosuppressant medication).
Other medication for the treatment of cancer e.g. bleomycin, cisplatin, ifosfamide, methotrexate.
Phenylbutazone, salicylic acid and sodium salicylate, anti-inflammatory medication.
Medication used to treat blood clotting referred to as anticoagulants, such as warfarin.

HOW ASPEN ETOPOSIDE 100 mg/5 mL IS USED
The dose of ASPEN ETOPOSIDE 100 mg/5 mL will be different for different patients.
ASPEN ETOPOSIDE 100 mg/5 mL should be administered only by intravenous injection. Your doctor will decide on the dose and length of treatment you receive depending on your condition and other treatment you may receive.
Your doctor will adapt the dose if you have kidney impairment.

If you receive more ASPEN ETOPOSIDE 100 mg/5 mL than you should
Since a healthcare professional will administer this medicine, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.
Symptoms of overdose include severe nausea, vomiting, painful inflammation and ulceration of the mucous membranes lining the digestive tract, liver toxicity and severe bone marrow suppression.
If you notice any of these symptoms in yourself or anyone else that has possibly received more of ASPEN ETOPOSIDE 100 mg/5 mL than prescribed, please contact your doctor, pharmacist or nearest hospital immediately.

If you forget to receive ASPEN ETOPOSIDE 100 mg/5 mL
Your doctor will administer ASPEN ETOPOSIDE 100 mg/5 mL to you. If you suspect that you have not received ASPEN ETOPOSIDE 100 mg/5 mL correctly, consult with your doctor immediately.

POSSIBLE SIDE EFFECTS
ASPEN ETOPOSIDE 100 mg/5 mL can have side effects.
Tell your doctor or the nurse immediately if:
You have chills, fever, increased heart rate, sudden constriction of the walls of the airways, difficulty in breathing and low blood pressure as these can be signs of a serious, life-threatening allergic condition.
When you are being given ASPEN ETOPOSIDE 100 mg/5 mL, you feel pain, or a burning or stinging sensation at the place where the medicines goes into your vein you must tell your doctor immediately.
Flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed as this can be an indication of Stevens-Johnson syndrome. Stevens-Johnson syndrome is a rare, serious disorder in which your skin and mucous membranes react severely to a medication or infection and presents as a medical emergency.
If your laboratory results indicate abnormal liver enzyme values as ASPEN ETOPOSIDE 100 mg/5 mL can cause liver damage. Other symptoms include, but are not limited to nausea, vomiting, abdominal pain, loss of appetite diarrhoea, feeling weak or tired, yellowing of the skin and nails.
The following side effects have been reported frequently:
Cancer of the blood, bone-marrow suppression resulting in fewer red and white blood cells and platelets, decreased appetite, exhaustion, feeling drowsy, lowered blood pressure, bleeding, nausea, vomiting, stomach pain, diarrhoea, inflammation of the mucous membranes of the mouth, reversible hair loss, increased liver enzymes.
The following side effects have been reported less frequently:
Infections, feeling of ‘needles and pins’ in the extremities, inflammation of the nerves of the eye, taste disturbances, reversible loss of vision, transient blindness, irregular heartbeats, heart attack, appearance of a blue or purple colour of the skin or mucous membranes due to limited oxygen supply, constriction of the respiratory muscles, difficulty in breathing, scarring of the lungs, coughing, inflammation of the mucous membranes in the digestive tract, inflammation of the oesophagus, constipation, difficulty in swallowing, rash, itching of the skin, pigmentation.
The following side effects have been reported but the frequency is unknown:
Delayed wound healing and shivering.
Not all side effects reported for ASPEN ETOPOSIDE 100 mg/5 mL are included in this leaflet. Should your general health worsen while taking ASPEN ETOPOSIDE 100 mg/5 mL, please consult your doctor, pharmacist or other health care professional for advice.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist

STORAGE AND DISPOSING OF ASPEN ETOPOSIDE 100 mg/5 mL
Do not dispose of unused medicine in drains or sewerage systems (eg. toilets).
Store below 25ºC. Store in original package. Do not remove the vial from the carton until required for use. Use immediately after dilution. Protect from light.
ASPEN ETOPOSIDE 100 mg/5 mL when diluted as recommended to a concentration of 0,2 or 0,4 mg/mL, is stable for 96 and 24 hours respectively, at room temperature (25ºC) under normal room fluorescent light in both glass and plastic containers. If not used immediately after dilution, in-use storage times and conditions prior to use, as indicated above, are the responsibility of the user.
KEEP OUT OF THE REACH OF CHILDREN.

PRESENTATION OF ASPEN ETOPOSIDE 100 mg/5 mL
ASPEN ETOPOSIDE 100 mg/5 mL is presented as one clear colourless glass vial with a dark grey rubber stopper, and aluminium metal cap with a polypropylene disk, packed into a carton.

IDENTIFICATION OF ASPEN ETOPOSIDE 100 mg/5 mL
A clear, colourless to pale yellow, slightly viscous solution.

REGISTRATION NUMBER
42/26/0017

NAME AND ADDRESS OF REGISTRATION HOLDER
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION
19 April 2013

New addition to this site: October 2014
Source: Pharmaceutical Industry

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