Gemcitabine Sun (Gemcitabine)
Gemcitabine Sun 200 mg Powder for Solution for
Infusion Gemcitabine Sun 1000 mg Powder for Solution for Infusion
Gemcitabine
1. WHAT GEMCITABINE SUN IS AND WHAT IT IS USED FOR
Gemcitabine SUN belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells.
Gemcitabine SUN may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.
Gemcitabine SUN is used in the treatment of the following types of cancer:
- non-small cell lung cancer (NSCLC), alone or together with cisplatin
- pancreatic cancer.
- breast cancer, together with paclitaxel.
- ovarian cancer, together with carboplatin.
- bladder cancer, together with cisplatin.
2. BEFORE YOU ARE GIVEN GEMCITABINE SUN
You should not be given Gemcitabine SUN:
- if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine SUN.
- if you are breast-feeding
Take special care with Gemcitabine SUN:
Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemcitabine SUN. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to evaluate your kidney and liver function.
Please tell your doctor if:
- you have, or have previously had liver disease, heart disease or vascular disease.
- you have recently had, or are going to have radiotherapy,
- you have been vaccinated recently
- you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure).
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine SUN. If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.
- Taking other medicines
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription.
- Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine SUN should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine SUN during pregnancy.
- If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine SUN treatment.
- Driving and using machines
Gemcitabine SUN may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Gemcitabine SUN treatment has not made you feel sleepy.
Important information about some of the ingredients of Gemcitabine SUN
Gemcitabine SUN contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial and 17.5 mg (< 1 mmol) sodium in each 1000 mg vial. To be taken into consideration by patients on a controlled sodium diet.
3. HOW GEMCITABINE SUN IS GIVEN
The usual dose of Gemcitabine SUN is 1000-1250 mg for every square metre of your body’s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
How frequently you receive your Gemcitabine SUN infusion depends on the type of cancer that you are being treated for.
A hospital pharmacist or doctor will have dissolved the Gemcitabine SUN powder before it is given to you.
You will always receive Gemcitabine SUN by infusion into one of your veins. The infusion will last approximately 30 minutes.
If you have further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gemcitabine SUN can cause side effects, although not everybody
gets them.
Frequencies of the observed side effects are defined as:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency can’t be estimated from the available data
You must contact your doctor immediately if you notice any of the following:
- Fever or infection (common): if you have a temperature of 38°C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
- Irregular heart rate (arrhythmia) (frequency not known).
- Pain, redness, swelling or sores in your mouth (common).
- Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common).
- Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
- Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
- Difficulty breathing (it is very common to have mild breathing difficulty soon after the Gemcitabine SUN infusion which soon passes, however uncommonly or rarely there can be more severe lung problems)
Side effects with Gemcitabine SUN may include:
Very common side effects
- Low haemoglobin level (anaemia)
- Low white blood cells
- Low platelet count
- Difficulty breathing
- Vomiting
- Nausea
- Skin rash- allergic skin rash, frequently itchy
- Hair loss
- Liver problems: found through abnormal blood test results
- Blood in urine
- Abnormal urine tests: protein in urine
- Flu like symptoms including fever
- Oedema (swelling of ankles, fingers, feet, face)
Common side effects
- Fever accompanied by low white blood cell count (febrile neutropaenia)
- Anorexia (poor appetite)
- Headache
- Insomnia
- Sleepiness
- Cough
- Runny nose
- Constipation
- Diarrhoea
- Pain, redness, swelling or sores in the mouth
- Itching
- Sweating
- Muscle pain
- Back pain
- Fever
- Weakness
- Chills
Uncommon side effects
Interstitial pneumonitis (scarring of the air sacs of the lung)
Spasm of the airways (wheeze)
Abnormal chest X ray/scan (scarring of the lungs)
Rare side effects
Heart attack (myocardial infarction) Low blood pressure
Skin scaling, ulceration or blister formation Injection site reactions
Very rare side effects
- Increased platelet count
- Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
- Sloughing of skin and severe skin blistering
- Side effects with frequency not known
- Irregular heart beat (arrhythmia)
- Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)
- Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.
- Fluid in the lungs
- Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy
- Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)
- Heart failure
- Kidney failure
- Gangrene of fingers or toes
- Serious liver damage, including liver failure
- Stroke
You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.
If you are concerned about any side effects, talk to your doctor.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor.
5. HOW TO STORE GEMCITABINE SUN
Keep out of the reach and sight of children.
Gemcitabine SUN should not be used after the expiry date which is stated on the vial and carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 15-30°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 30°C.
The reconstituted solution should not be refrigerated.
Do not use if you notice a cloudy solution or an insoluble precipitate.
Medicine should not be disposed of via wastewater or household waste
6. FURTHER INFORMATION
What Gemcitabine SUN 200 mg / Gemcitabine SUN 1000 mg Powder for Solution for Infusion contains
The active substance is: gemcitabine (as hydrochloride)
The other ingredients are: mannitol, sodium acetate trihydrate, sodium hydroxide, hydrochloric acid.
[For 200 mg strength]
One vial contains 200 mg gemcitabine (as hydrochloride).
[For1 g strength]
One vial contains 1 g gemcitabine (as hydrochloride).
One ml of the reconstituted solution for infusion contains 38 mg gemcitabine (as hydrochloride).
What Gemcitabine SUN 200 mg /Gemcitabine SUN 1000 mg Powder for Solution for Infusion looks like and contents of the pack
Powderfor solution for infusion
White to off-white lyophilized cake.
For 200 mg strength
1 vial of 10 ml.
For 1 g strength
1 vial of 50 ml.
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