USES OF GEM RTU 1GM INJECTION

Used in the treatment of:

• Non-small cell lung cancer (alone or with cisplatin)
• Pancreatic cancer
• Breast cancer (with paclitaxel)
• Ovarian cancer (with carboplatin)
• Bladder cancer (with cisplatin)

HOW GEM RTU 1GM INJECTION WORKS

GEM RTU 1GM INJECTION kills the dividing cancer cells by inhibition of their DNA (hereditary material) synthesis.

DIRECTIONS FOR USE

GEM RTU 1GM INJECTION will be given to you only by a doctor or a nurse into a vein as an intravenous infusion. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and surface area and disease condition.

SIDE EFFECTS OF GEM RTU 1GM INJECTION

COMMON

• Vomiting, nausea, constipation, diarrhoea
• Hair loss
• Liver problems
• Blood or protein in urine, abnormal urine test
• Swollen ankles, fingers, feet, face
• Poor appetite
• Headache
• Insomnia, sleepiness
• Cough, runny nose
• Itching, sweating
• Muscle or back pain
• Fever, weakness, chills, infections

UNCOMMON

• Scarring of air sacs of the lungs
• Wheezing
• Scarring of the lungs seen as abnormal chest X ray/scan
• Heart, kidney or liver failure
• Stroke

RARE

• Low blood pressure
• Skin scaling, ulceration or blistering
• Skin sloughing and severe blistering
• Injection site reactions
• Radiation recall (a skin rash like severe sunburn which can occur on skin that has been exposed to radiotherapy in the past)
• Fluid in the lungs
• Radiation toxicity (scarring of the air sacs of the lung related to radiation therapy)
• Gangrene of fingers or toes
• Inflammation of the blood vessels

Stop receiving GEM RTU 1GM INJECTION and contact your doctor immediately if you experience any of the following side effects:

• Allergic reactions (mild to moderate skin rash, fever, itching)
• Low haemoglobin (tiredness, feeling faint, easy breathlessness, paleness)
• Low platelet count (bleeding from the gums, nose or mouth, any bleeding that would not stop, reddish or pinkish urine, unexpected bruising)
• Low white blood cell count with fever, sweating or other signs of infection
• Stomatitis (pain, redness, swelling, mouth ulcers)
• Mild breathing trouble
• Irregular heartbeat
• Capillary leak syndrome (generalised swelling, shortness of breath, weight gain due to fluid leakage from small blood vessels into tissues)
• Posterior reversible encephalopathy syndrome (headache with vision changes, confusion, seizures or fits)
• Thrombotic microangiopathy and haemolytic uraemic syndrome (extreme tiredness and weakness, bruises, low or no urine output, signs of infection)

HOW TO MANAGE SIDE EFFECTS

Nausea:

Take regular sips of a cold drink. Have ginger or peppermint tea. Stick to simple meals. Avoid eating oily or spicy foods. If symptom persists, contact your doctor.

Vomiting:

Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like it – no need to eat or avoid any specific foods. If symptom persists, contact your doctor.

Diarrhea:

Drink fluids such as water or fruit juices so that you are sufficiently hydrated. If symptom persists, contact your doctor.

Constipation:

Have plenty of fiber rich foods like fresh fruits, vegetables, cereals and drink ample amount of water. Exercise more regularly. If symptom persists, contact your doctor.

Poor appetite:

Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Eat a protein-rich or other healthy snack such as dried fruit and nuts. If symptom persists, contact your doctor.

Headache:

Drink plenty of water and get adequate rest. Try to be relaxed and stress free. Take medicine for headache after asking your doctor. If symptom persists, contact your doctor.

Skin rash:

Avoid hot showers to prevent further irritation of skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. If symptom persists, contact your doctor.

WARNING & PRECAUTIONS

PREGNANCY

GEM RTU 1GM INJECTION is not recommended for use in pregnancy. Consult your doctor before receiving it.

BREASTFEEDING

GEM RTU 1GM INJECTION is not recommended for use in breastfeeding women. Consult your doctor before receiving it.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel sleepy after receiving GEM RTU 1GM INJECTION.

ALCOHOL

Do not consume alcohol during the treatment with GEM RTU 1GM INJECTION as it can make you feel sleepy.

KIDNEY

GEM RTU 1GM INJECTION should be used with caution in patients who had or have any kidney diseases. Contact your doctor before receiving it.

LIVER

GEM RTU 1GM INJECTION should be used with caution in patients who had or have any liver diseases. Contact your doctor before receiving it.

ALLERGY

Do not receive GEM RTU 1GM INJECTION if you are allergic to gemcitabine or any of the other ingredients of this medicine.

HEART DISEASE

GEM RTU 1GM INJECTION should be used with caution in patients who had or have any heart or vascular diseases. Contact your doctor before receiving it.

OTHERS

Before receiving GEM RTU 1GM INJECTION, inform your doctor if you:

• Had or are about to have radiotherapy
• Have been vaccinated recently

Use in paediatrics:

GEM RTU 1GM INJECTION is not recommended for use in children and adolescents (under 18 years of age) due to insufficient data on safety and efficacy. Consult your child’s doctor for advice.

Use in geriatrics:

No dose adjustment of GEM RTU 1GM INJECTION is required for elderly patients, however, consult your doctor before receiving it.

INTERACTIONS

A. Drug - Drug interactions:

Before receiving GEM RTU 1GM INJECTION, inform your doctor if you are taking, have taken or might take any other medicine, including prescription, non-prescription or any herbal medicine.

Overdosage:

GEM RTU 1GM INJECTION will be administered to you only by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience anything unusual.

SYNOPSIS

Drug:  GemcitabinePharmacological Category:  Pyrimidine antagonistsTherapeutic Indication:  Cancer treatmentDosage Forms:  Injection

MORE INFORMATION

• Keep GEM RTU 1GM INJECTION out of reach of children
• Store GEM RTU 1GM INJECTION between 25°C