Ganciclovir 500 Mg Powder For Solution For Infusion
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Package leaflet: Information for the user
Ganciclovir 500 mg powder for solution for infusion
Ganciclovir
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ganciclovir is and what it is used for
2. What you need to know before you use Ganciclovir
3. How to use Ganciclovir
4. Possible side effects
5. How to store Ganciclovir
6. Contents of the pack and other information
1. What Ganciclovir is and what it is used for
Ganciclovir contains a medicine called ganciclovir. This belongs to a group of medicines called ‘anti-virals’.
Ganciclovir is used to treat infections caused by a virus called cytomegalovirus (CMV).
• The virus can infect any part of the body. This includes the retina of the eye where it causes problems with eye sight.
• The virus can infect anyone. However, in people who have a poor immune system because of other diseases or medicines (people who are ‘immuno-compromised’), it can lead to serious infections.
Ganciclovir is also used to prevent cytomegalovirus (CMV) infection after an organ transplant.
2. What you need to know before you use Ganciclovir
Do not use Ganciclovir:
- if you are allergic to ganciclovir or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to similar medicines, called ‘anti-virals’. These include valganciclovir, aciclovir and valaciclovir.
- if you have granulocytes less than or equal to 500/mm3
- if you have platelet levels less than 25,000/mm3
- if you are a woman of childbearing potential and not using contraception,
- if you are a man and not using contraception during your treatment or 90 days after treatment.
- if you are pregnant or breast-feeding a baby. See the section on ‘Pregnancy, breast-feeding and fertility’.
- if you are cosuming any medicine containing didanosine.
You must not be given Ganciclovir if any of the above apply to you.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ganciclovir if:
• you have low numbers of white blood cells, red blood cells or platelets in your blood.
• you have had blood problems in the past that have been caused by medicines.
• you are having radiotherapy, or have recently had it.
• you have kidney problems.
• you or your partner might become pregnant during treatment. See the section on ‘Pregnancy, breast-feeding and fertility’.
Other medicines and Ganciclovir
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
This includes medicines that you buy without a prescription and herbal medicines. This is beacuse Ganciclovir can affect the way some medicines work. Also some medicines can affect the way this medicine works.
Tell your doctor or nurse if you are taking any of the following medicines:
• Probenecid (used to treat gout).
• Mycophenolate mofetil (used after an organ transplant).
• Zidovudine, didanosine, cidofovir or foscarnet (used to treat HIV).
• Imipenem-cilastatin, trimethprim, pentamidine, flucytosine, amphotericine B or dapsone (antibiotics used to treat infections).
• Doxorubicin, vincristine, vinblastine or hydroxyurea (used to treat cancer).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you must not use Ganciclovir.
• If you are a man and your partner is at an age where she could get pregnant, you must use condoms during your treatment with Ganciclovir and for 90 days after the end of treatment.
• If you are a woman at an age where you could get pregnant, you must use contraception (birth control) during your treatment.
If you are not sure if you are protected (have adequate contraception), talk to your doctor or nurse before you use Ganciclovir.
Driving and using machines
Ganciclovir can make you feel dizzy, sleepy or confused. It can also cause fits and loss of co-ordination. If any of these happen to you, do not drive or used any tools or machines.
This medicinal product contains 1.96 mmol sodium (45.057mg) per vial of the label claim.
3. How to use Ganciclovir
Before ganciclovir powder for concentrate for solution for infusion can be used, it must first be dissolved in infusion liquid. Usually, this is done in a pharmacy or hospital. Ganciclovir will be given to you by a doctor or nurse. It will be given to you through a small tube into one of your veins (called an‘intravenous infusion’). It usually takes one hour for the medicine to be given.
• The dose of Ganciclovir varies from one patient to another. It depends on you age, weight, how well your kidneys are working and what you need the medicine for. The doctor will work out how much to give you.
• How often you have Ganciclovir and how long you keep having it for also varies from one patient to another. You will usually start by having one infusion every 12 hours for up to 21 days. After that you may have one infusion a day.
• Your doctor will see how you respond to this medicine and you may need to have regular blood tests. If necessary, your dose might be changed or your treatment stopped.
If you use more Ganciclovir than you should
• You may get changes to your blood, problems with your liver or kidneys, stomach pain, being sick, diarrhoea, fits and shaking.
• If you think you have been given too much Ganciclovir, tell your doctor or nurse.
If you stop using Ganciclovir
Only your doctor can determine how long the treatment will have to continue. Never stop the treatment without consulting your doctor or nurse.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (uncommon, may affect up to 1 in 100 people)
If you have an allergic reaction, tell a doctor straight away.
The signs may include:
• A raised itchy skin rash (hives).
• Difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips and mouth.
This information is intended for healthcare professionals only:
Information for healthcare professionals
Ganciclovir 500 mg powder for solution for infusion
Ganciclovir
Please refer to the Summary of Product Characteristics for full prescribing information.
Posology and method of administration
For intravenous infusion following reconstitution with 10 ml Water for Injections BP. Based on patient weight the appropriate calculated dose volume should be removed from the vial (ganciclovir concentration 50 mg/ml) and added to an acceptable infusion fluid (typically 100 ml) for delivery over the course of 1 hour. Infusion concentrations greater than 10 mg/ml are not recommended. (For further information see Instructions for use/handling and disposal).
Posology
Acquired immunodeficiency syndrome (AIDS):
Treatment is started as soon as the diagnosis is focused on ophthalmologic data in cases of retinitis, and possibly a positive CMV viral marker (viraemia).
At other visceral sites (gastrointestinal, neurological, lung), it must be based on clinical data confirmed by virus isolation and by the presence of intracellular viral inclusions.
For initial treatment, the dosage is 5 mg/kg infused at a constant rate for 1 hour every 12 hours (10 mg/kg/day).
In cases of CMV retinitis, initial treatment lasts for 2-3 weeks or until lesions heal and is followed by maintenance treatment.
For maintenance therapy in patients at risk of recurrent CMV infection, two dosage regimens are used: 6 mg/kg per day administered 5 days a week or 5 mg/kg per day, 7 days a week; i.e. 30 or 35 mg/kg/week.
In transplantation
Treatment of generalised infections or visceral sites:
5 mg/kg infused at a constant rate for 1 hour every 12 hours (10 mg/kg/day) for 14 to 21 days in patients with normal renal function.
Early treatment in patients with allogeneic bone marrow transplants when routine virological monitoring highlights viral excretion (viraemia, BAL), start treatment when the transplant is taken (granulocytes > 500/mm3), at a dose of 5 mg/kg infused at a constant rate for 1 hour every 12 hours (1 mg/kg/day) for 7 days. Continue with maintenance therapy up until day 100 or day 120 post-transplant at a dose of 5 mg/kg/day, 5-7 days per week as a single daily infusion.
Prophylactic treatment after organ transplantation with increased risk of symptomatic CMV infection due to intense immunosuppressive therapy, if the recipient is already immunised against CMV (presence of anti-CMV antibodies in serum before transplantation), especially in heart transplantation: 5 mg/kg infused at a constant rate for 1 hour every 12 hours (10 mg/kg/day) for 14 days, followed by maintenance treatment for 14 days at 6 mg/kg, 5 days out of 7. Patients with renal impairment:
Serum creatinine levels or creatinine clearance should be monitored carefully. Dosage adjustment is required according to creatinine clearance as shown in the table below.
An estimated creatinine clearance (ml/min) can be related to serum creatinine by the following formulae:
(140-age [years]) x (body weight [kg])
1 For males = -------------------------------------------------------------------
I (72) x (0.011 x serum creatinine [micromol/L])
For females = 0.85 x male value
|
CrCl |
Induction dose of ganciclovir |
|
> 70 ml/min |
5.0 mg/kg every 12 hours |
|
50 - 69 ml/min |
2.5 mg/kg every 12 hours |
|
25 - 49 ml/min |
2.5 mg/kg/day |
|
10 - 24 ml/min |
1.25 mg/kg/day |
|
< 10 ml/min |
1.25 mg/kg/day after haemodialysis |
Do not exceed the recommended dosage, dosing frequency or rate of infusion.
Elderly patients
No studies on the efficacy or safety of Ganciclovir in elderly patients have been conducted. Since elderly individuals often have reduced renal function, Ganciclovir should be administered to elderly patients with special consideration for their renal status (see above).
Paediatric patients
There has been limited clinical experience in treating patients under the age of 12 years. Reported adverse events were similar to those seen in adults.
However, the use of Ganciclovir in children warrants extreme caution due to the potential for long-term carcinogenicity and reproductive toxicity. The benefits of treatment should outweigh the risks.
Dimension: 320 x 320 mm
Front Side
Ganciclovir is not indicated for the treatment of congenital or neonatal CMV infections.
Dosage reductions
For less severe neutropenia or other cytopenias a reduction in the total daily dose should be considered. Cell
counts usually normalise within 3 to 7 days after discontinuing the medicine or decreasing the dose. As evidence of marrow recovery becomes apparent gradual increases in dose, with careful monitoring of white blood cell counts, may be appropriate.
Patients with severe leucopenia, neutropenia, anaemia, thrombocytopenia and pancytopenia
Severe leucopenia, neutropenia, anaemia, thrombocytopenia, pancytopenia, bone marrow depression and aplastic anaemia have been observed in patients treated with Ganciclovir. Therapy should not be initiated if the absolute neutrophil count is less than 500 cells/pL, or the platelet count is less than 25000/pL, or the haemoglobin level is less than 8 g/dL.
Ganciclovir should be used with caution in patients with pre-existing haematological cytopenia or a history of drug-related haematological cytopenia and in patients receiving radiotherapy.
If there is a significant deterioration of blood cell counts during therapy with Ganciclovir, treatment with haematopoetic growth factors and/or dose interruption should be considered.
Method of administration
Ganciclovir is a powder for solution for intravenous infusion. For directions on the preparation of the infusion solution, see Instructions for use/handling, and disposal.
Ganciclovir must only be given by intravenous infusion, preferably via a plastic cannula, into a vein with adequate blood flow.
Caution - do not administer by rapid or bolus i.v. injection! The toxicity of Ganciclovir may be increased as a result of excessive plasma levels.
Caution - i.m. or s.c. injection may result in severe tissue irritation due to the high pH (~11) of ganciclovir solutions.
The recommended dosage, frequency, or infusion rates should not be exceeded.
Instructions for use/handling and disposal
Caution should be exercised in the handling of Ganciclovir.
Since Ganciclovir is considered a potential teratogen and carcinogen in humans, caution should be exercised in its handling. Avoid inhalation or direct contact of the powder contained in the vials or direct contact of the reconstituted solution with the skin or mucous membranes. Ganciclovir solutions are alkaline (pH approximately 11). If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with sterile water, or plain water if sterile water is unavailable.
Method of Preparation of Ganciclovir solution
Each 10 mL clear glass vial contains the equivalent of 500 mg ganciclovir.
1. Lyophilized Ganciclovir should be reconstituted by injecting 10 ml of sterile Water for Injections into the vial. Do not use bacteriostatic water for injection containing parabens (para-hydroxybenzoates), since these are incompatible with Ganciclovir sterile powder and may cause precipitation.
2. The vial should be shaken to dissolve the drug.
3. Reconstituted solution should be inspected for particulate matter prior to proceeding with the admixture
Preparation for infusion.
4. Reconstituted solution in the vial is stable at 25°C for 12 hours.
It should not be refrigerated.
Preparation and administration of infusion solution
Based on patient weight and therapeutic indications the appropriate calculated dose volume should be removed from the Ganciclovir vial (concentration 50 mg/ml) and added to an acceptable infusion fluid (typically 100 mL) for a one-hour infusion. Normal saline, dextrose 5% in water, Ringer’s or lactated Ringer’s solution are determined chemically or physically compatible with Ganciclovir.
Infusion concentrations greater than 10 mg/ml are not recommended. Ganciclovir should not be mixed with other i.v. products.
Do not administer as a rapid iv or bolus injection, as the toxicity of the product can be increased by excessive plasma concentrations.
Do not inject intramuscularly or subcutaneously, as severe tissue lesions may occur due to the high pH of ganciclovir solutions (approximately 11). Because Ganciclovir is reconstituted with nonbacteriostatic sterile water, the infusion solution should be used within maximum of 24 hours of dilution when stored at 2 - 8°C in order to reduce the risk of bacterial contamination. The infusion solution should be refrigerated. Freezing is not recommended. Any unused product or waste material should be disposed of in accordance with local requirements.
• Sudden swelling of the hands, feet and ankles.
Other possible side effects:
Very common (may affect more than 1 in 10 people)
• Low numbers of one type of white blood cell (called neutrophils).
The signs include infections of the mouth, gums, throat and lungs. Your doctor may want you to have blood tests.
• Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, palpitations (a fluttering sensation in the heart) and being short of breath.
• Difficulty breathing.
• Diarrhoea.
Common (may affect up to 1 in 10 people)
• Infections of the blood, skin, urinary tract and mouth. The signs include high temperature (fever), chills, feeling tired, redness and swelling of the skin, pain on passing water and creamy white spots in the mouth.
• Low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat and lungs.
• Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds.
• Low numbers of all the types of cells in your blood. The signs include feeling tired, bruising easily, being short of breath and nose bleeds.
• Loss of appetite.
• Depression, anxiety, feelings of confusion and abnormal thinking.
• Headache.
• Difficulty in sleeping.
• Changes to the way things taste.
• Dizziness.
• Fits (‘convulsions’).
• Changes in your skin sensitivity (such as numbness, pins and needles, burning sensations).
• Changes to your eye-sight (vision), loss of vision or eye pain.
• Pain in your ears.
• A cough.
• Feeling or being sick, pain in your stomach, constipation, wind and difficulty swallowing.
• Problems with your liver, shown in a blood test.
• Skin rashes (including inflammation, redness and blistering), itchiness and sweating at night.
• Pain in your back, joints, muscles or chest or muscle cramps.
• Problems with your kidneys. This may affect the amount of water (urine) that you pass.
• Feeling tired, unwell or weak, high temperature (fever), shivering, weight loss.
• A reaction where this medicine was given into your vein.
Uncommon (may affect up to 1 in 100 people)
• Changes to your bone marrow (which may affect how your body produces some blood cells).
• Disturbances of the mind, including feeling agitated and losing contact with reality.
• Shaking or trembling that you cannot control.
• Infection of the eye (conjunctivitis).
• Deafness.
• Uneven heart beat.
• Low blood pressure. The signs include feeling dizzy or light-headed.
• Mouth ulcers, swelling of the abdomen (tummy) and pancreatitis. The signs of pancreatitis include severe pain in the stomach which spreads to your back.
• Loss of hair and dry skin.
• Serious kidney disease.
• Blood in your urine (water).
• Infertility in men. Ganciclovir may stop men from producing sperm. This can be temporary or permanent.
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www. mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Ganciclovir
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Undiluted vials: This medicinal product does not require any special storage condition.
Shelf-life after reconstitution:
Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C.
Shelf-life after dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and 2 - 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
6. Contents of the pack and other information
What Ganciclovir contains
- The active substance(s) is ganciclovir. Each glass vial contains ganciclovir sodium equivalent to ganciclovir 500 mg.
- The other ingredients are: sodium hydroxide and water for injections. What Ganciclovir looks like and contents of the pack Ganciclovir is a white to off white lyophilized cake or powder, supplied in a 10 ml multidose glass vial (type I, clear glass) with dark grey Bromobutyl rubber closure and flip off aluminium seals.
Before it is given, Ganciclovir is made into a solution by adding sterile water to the vial.
The correct dose is then taken out of the vial and added to the bag of infusion solution to be given to the patient.
Vials of Ganciclovir are supplied in packs of 1, 5 or 25.
Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Agila Specialties UK Limited New Bridge Street House,
30, 34 New Bridge street,
London, EC4V6BJ,
United Kingdom Manufacturer
Agila Specialities Polska Sp. z. o. o.
10, Daniszewska Str., 03-230 Warsaw Poland.
This leaflet was last revised in 08/2014
Dimension: 320 x 320 mm
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