ACICLOVIR 25 MG/ML STERILE CONCENTRATE
Active substance: ACICLOVIR
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Aciclovir 25 mg/ml Sterile Concentrate
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Aciclovir Sterile Concentrate is and what it is used for 2. Before you use Aciclovir Sterile Concentrate 3. How to use Aciclovir Sterile Concentrate 4. Possible side effects 5. How to store Aciclovir Sterile Concentrate 6. Further information
1. WHAT ACICLOVIR STERILE CONCENTRATE IS AND WHAT IT IS USED FOR
Aciclovir Sterile Concentrate is an anti-viral medicine. It is used: to treat severe genital herpes to prevent or treat Herpes simplex infections (may appear as cold sores around the lips or as blisters on any part of the skin including the genitals) in patients whose immune system is not working properly to treat Herpes simplex infections in very young babies or in infants up to 3 months of age to treat Varicella zoster viral infections (e.g. shingles) to treat herpes encephalitis (inflammation of the brain following infection with herpes)
2. BEFORE YOU USE ACICLOVIR STERILE CONCENTRATE Do not use Aciclovir Sterile Concentrate
if you have shown signs of hypersensitivity (severe allergy) to aciclovir or valaciclovir in the past Tell your doctor if the above applies to you before this medicine is used.
Take special care with Aciclovir Sterile Concentrate
if you have any nervous system problems such as convulsions or hallucinations if you had a nervous system side effect after treatment with an anti-cancer medicine in the past if you have serious problems with your liver if you have any problems with your kidneys if tests show that you are hypoxic (have a low amount of oxygen reaching your body tissues) if blood tests have shown that you have abnormal amounts of electrolytes in your blood Tell your doctor if any of the above applies to you before this medicine is used. It is important that while you are being treated with aciclovir you do not become dehydrated. Before you are given this medicine your doctor will check to make sure you are passing urine, are receiving enough fluid and are not dehydrated. The doctor will also check if you are taking any other medicine which could harm your kidneys. These checks are particularly important in patients whose kidneys may not be working properly.
Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with Aciclovir Sterile Concentrate, for example: probenecid (a medicine used in the treatment of gout) cimetidine (a medicine used to reduce stomach acid) theophylline (a medicine used to treat some breathing disorders) mycophenolate mofetil (a medicine used to prevent transplant rejection) lithium (a medicine used for manic-depressive disorder) drugs which may affect the kidneys e.g. ciclosporin, tacrolimus (medicines used to prevent transplant rejection) interferon (used for treating multiple sclerosis) intrathecal methotrexate (methotrexate injected into the spine) for cancer treatment
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may impair your ability to drive; if affected do not drive or operate machinery.
Important information about some of the ingredients of Aciclovir Sterile Concentrate
This medicinal product contains 3.3 mmol sodium (75 mg) per 700 mg dose. To be taken into consideration by patients on a controlled sodium diet.
Aciclovir 25 mg/ml Sterile Concentrate
The following information is intended for medical or healthcare professionals only Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.
Incompatibilities
Aciclovir sodium is reported to be incompatible with solutions of amifostine, amsacrine, aztreonam, diltiazem hydrochloride, dobutamine hydrochloride, dopamine hydrochloride, fludarabine phosphate, foscarnet sodium, idarubicin hydrochloride, meropenem, morphine sulphate, ondansetron hydrochloride, pethidine hydrochloride, piperacillin sodium - tazobactam sodium, sargramostim and vinorelbine tartrate. Do not use bacteriostatic water for injection containing parabens or benzyl alcohol. Biologic or colloidal fluids (e.g. blood products, protein containing solutions) are incompatible with aciclovir sodium.
Instructions for use and handling
Aciclovir 25 mg/ml Sterile Concentrate contains no preservative. Dilution should therefore be carried out immediately before use under full aseptic conditions and any unused solution should be discarded. Refrigeration is not recommended as precipitation may occur. For adults, it is recommended that infusion bags containing 100 ml of infusion fluid are used, even when this would give an aciclovir concentration substantially below 0.5% w/v. Thus one 100 ml infusion bag may be used for any dose between 250 mg and 500 mg aciclovir but a second bag must be used for doses between 500 and 1000 mg. Aciclovir 25 mg/ml Sterile Concentrate should not be diluted to a concentration greater than 5 mg/ml (0.5% w/v) for administration by infusion. After addition of Aciclovir 25 mg/ml Sterile Concentrate to an infusion solution the mixture should be shaken to ensure thorough mixing. Q62936
4XXXXX
3. HOW TO USE ACICLOVIR STERILE CONCENTRATE
This medicine will be diluted with a solution such as sodium chloride 0.9% before it is given to you. It will be given to you by a slow infusion (drip) into a vein over a period of 1 hour. You may be given fluids to ensure you do not become dehydrated. If Aciclovir Sterile Concentrate accidentally gets into your eyes or onto your skin, tell your doctor or nurse immediately so that it may be washed away.
Dosage
The dose of medicine given to you and how often you are given it will be determined by your doctor and will depend on your medical condition, age, size and how well your kidneys are working. Treatment with aciclovir usually lasts 5 - 7 days depending on how quickly you get better. However, treatment for herpes encephalitis and Herpes simplex in very young babies usually lasts for at least 10 days. If aciclovir is being given to prevent a viral infection, it will be given for the period your doctor thinks you are at risk of getting an infection.
If you are given too much or too little Aciclovir Sterile Concentrate
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
4. POSSIBLE SIDE EFFECTS
Like all medicines Aciclovir Sterile Concentrate can cause side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
severe allergic reaction you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint. pain or swelling at the injection site during or immediately after the injection convulsions or fits confusion or unusual and disordered thoughts (psychosis) hallucinations agitation trembling or shaking feeling unusually sleepy coma
If any of the following happen, tell your doctor as soon as possible:
blood in the urine inflammation (soreness, redness and swelling) of the skin near the infusion site or along the vein used for the infusion sweating or fever thirst low blood pressure (you may feel dizzy when you stand up) headache abdominal pain feeling or being sick rash or hives Aciclovir Sterile Concentrate may lead to changes in your blood cells and liver and kidney function. Your doctor may take blood samples to monitor for these. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE ACICLOVIR STERILE CONCENTRATE
Keep out of the reach and sight of children
Expiry
This medicine must not be used after the expiry date which is stated on the vial label and carton after EXP. Where only a month and year is stated, the expiry date refers to the last day of that month.
Storage
Do not store above 25C. Do not refrigerate.
Visible signs of deterioration 6. FURTHER INFORMATION
This medicine should not be used if it has visible particles in it.
What Aciclovir Sterile Concentrate contains
The active substance is aciclovir. Each millilitre (ml) of sterile concentrate contains 25 milligrams (mg) of aciclovir (as aciclovir sodium). The other ingredients are sodium hydroxide and Water for Injections. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH of the solution.
What Aciclovir Sterile Concentrate looks like and contents of the pack
Aciclovir Sterile Concentrate is a concentrate for solution for infusion (sterile concentrate). This means it is a concentrated solution, which is diluted then given as an infusion (drip). It comes in glass containers called vials. It may be supplied in packs containing: 5 x 250 mg/10 ml vials 5 x 500 mg/20 ml vials 1 x 1 g/40 ml vial Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK
Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia This leaflet was last approved in 09/2009
For children and neonates, where it is advisable to keep the volume of infusion fluid to a minimum, it is recommended that dilution is on the basis of 4 ml of sterile concentrate (100 mg aciclovir) added to 20 ml of infusion fluid. Aciclovir 25 mg/ml Sterile Concentrate when diluted in accordance with the above schedule will give an aciclovir concentration not greater than 0.5% w/v. When diluted as recommended, Aciclovir 25 mg/ml Sterile Concentrate is known to be compatible with the infusion fluids listed below: Sodium Chloride Intravenous Infusion 0.9% w/v Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion Sodium Chloride (0.9% w/v) and Glucose (5% w/v) Intravenous Infusion Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion Compound Sodium Lactate Intravenous Infusion (Hartmanns Solution) After dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25C. 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. When dilution is carried out under validated aseptic conditions, the product may be stored for a maximum of 12 hours at room temperature, below 25C. Should any visible turbidity or crystallisation appear in the solution before or during infusion, the preparation should be discarded.
Q62936 4XXXXX
Aciclovir 25 mg/ml Sterile Concentrate
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Aciclovir Sterile Concentrate is and what it is used for 2. Before you use Aciclovir Sterile Concentrate 3. How to use Aciclovir Sterile Concentrate 4. Possible side effects 5. How to store Aciclovir Sterile Concentrate 6. Further information
1. WHAT ACICLOVIR STERILE CONCENTRATE IS AND WHAT IT IS USED FOR
Aciclovir Sterile Concentrate is an anti-viral medicine. It is used: to treat severe genital herpes to prevent or treat Herpes simplex infections (may appear as cold sores around the lips or as blisters on any part of the skin including the genitals) in patients whose immune system is not working properly to treat Herpes simplex infections in very young babies or in infants up to 3 months of age to treat Varicella zoster viral infections (e.g. shingles) to treat herpes encephalitis (inflammation of the brain following infection with herpes)
2. BEFORE YOU USE ACICLOVIR STERILE CONCENTRATE Do not use Aciclovir Sterile Concentrate
if you have shown signs of hypersensitivity (severe allergy) to aciclovir or valaciclovir in the past Tell your doctor if the above applies to you before this medicine is used.
Take special care with Aciclovir Sterile Concentrate
if you have any nervous system problems such as convulsions or hallucinations if you had a nervous system side effect after treatment with an anti-cancer medicine in the past if you have serious problems with your liver if you have any problems with your kidneys if tests show that you are hypoxic (have a low amount of oxygen reaching your body tissues) if blood tests have shown that you have abnormal amounts of electrolytes in your blood Tell your doctor if any of the above applies to you before this medicine is used. It is important that while you are being treated with aciclovir you do not become dehydrated. Before you are given this medicine your doctor will check to make sure you are passing urine, are receiving enough fluid and are not dehydrated. The doctor will also check if you are taking any other medicine which could harm your kidneys. These checks are particularly important in patients whose kidneys may not be working properly.
Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with Aciclovir Sterile Concentrate, for example: probenecid (a medicine used in the treatment of gout) cimetidine (a medicine used to reduce stomach acid) theophylline (a medicine used to treat some breathing disorders) mycophenolate mofetil (a medicine used to prevent transplant rejection) lithium (a medicine used for manic-depressive disorder) drugs which may affect the kidneys e.g. ciclosporin, tacrolimus (medicines used to prevent transplant rejection) interferon (used for treating multiple sclerosis) intrathecal methotrexate (methotrexate injected into the spine) for cancer treatment
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may impair your ability to drive; if affected do not drive or operate machinery.
Important information about some of the ingredients of Aciclovir Sterile Concentrate
This medicinal product contains 3.3 mmol sodium (75 mg) per 700 mg dose. To be taken into consideration by patients on a controlled sodium diet.
Aciclovir 25 mg/ml Sterile Concentrate
The following information is intended for medical or healthcare professionals only Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.
Incompatibilities
Aciclovir sodium is reported to be incompatible with solutions of amifostine, amsacrine, aztreonam, diltiazem hydrochloride, dobutamine hydrochloride, dopamine hydrochloride, fludarabine phosphate, foscarnet sodium, idarubicin hydrochloride, meropenem, morphine sulphate, ondansetron hydrochloride, pethidine hydrochloride, piperacillin sodium - tazobactam sodium, sargramostim and vinorelbine tartrate. Do not use bacteriostatic water for injection containing parabens or benzyl alcohol. Biologic or colloidal fluids (e.g. blood products, protein containing solutions) are incompatible with aciclovir sodium.
Instructions for use and handling
Aciclovir 25 mg/ml Sterile Concentrate contains no preservative. Dilution should therefore be carried out immediately before use under full aseptic conditions and any unused solution should be discarded. Refrigeration is not recommended as precipitation may occur. For adults, it is recommended that infusion bags containing 100 ml of infusion fluid are used, even when this would give an aciclovir concentration substantially below 0.5% w/v. Thus one 100 ml infusion bag may be used for any dose between 250 mg and 500 mg aciclovir but a second bag must be used for doses between 500 and 1000 mg. Aciclovir 25 mg/ml Sterile Concentrate should not be diluted to a concentration greater than 5 mg/ml (0.5% w/v) for administration by infusion. After addition of Aciclovir 25 mg/ml Sterile Concentrate to an infusion solution the mixture should be shaken to ensure thorough mixing. Q62936
4XXXXX
3. HOW TO USE ACICLOVIR STERILE CONCENTRATE
This medicine will be diluted with a solution such as sodium chloride 0.9% before it is given to you. It will be given to you by a slow infusion (drip) into a vein over a period of 1 hour. You may be given fluids to ensure you do not become dehydrated. If Aciclovir Sterile Concentrate accidentally gets into your eyes or onto your skin, tell your doctor or nurse immediately so that it may be washed away.
Dosage
The dose of medicine given to you and how often you are given it will be determined by your doctor and will depend on your medical condition, age, size and how well your kidneys are working. Treatment with aciclovir usually lasts 5 - 7 days depending on how quickly you get better. However, treatment for herpes encephalitis and Herpes simplex in very young babies usually lasts for at least 10 days. If aciclovir is being given to prevent a viral infection, it will be given for the period your doctor thinks you are at risk of getting an infection.
If you are given too much or too little Aciclovir Sterile Concentrate
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
4. POSSIBLE SIDE EFFECTS
Like all medicines Aciclovir Sterile Concentrate can cause side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
severe allergic reaction you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint. pain or swelling at the injection site during or immediately after the injection convulsions or fits confusion or unusual and disordered thoughts (psychosis) hallucinations agitation trembling or shaking feeling unusually sleepy coma
If any of the following happen, tell your doctor as soon as possible:
blood in the urine inflammation (soreness, redness and swelling) of the skin near the infusion site or along the vein used for the infusion sweating or fever thirst low blood pressure (you may feel dizzy when you stand up) headache abdominal pain feeling or being sick rash or hives Aciclovir Sterile Concentrate may lead to changes in your blood cells and liver and kidney function. Your doctor may take blood samples to monitor for these. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE ACICLOVIR STERILE CONCENTRATE
Keep out of the reach and sight of children
Expiry
This medicine must not be used after the expiry date which is stated on the vial label and carton after EXP. Where only a month and year is stated, the expiry date refers to the last day of that month.
Storage
Do not store above 25C. Do not refrigerate.
Visible signs of deterioration 6. FURTHER INFORMATION
This medicine should not be used if it has visible particles in it.
What Aciclovir Sterile Concentrate contains
The active substance is aciclovir. Each millilitre (ml) of sterile concentrate contains 25 milligrams (mg) of aciclovir (as aciclovir sodium). The other ingredients are sodium hydroxide and Water for Injections. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH of the solution.
What Aciclovir Sterile Concentrate looks like and contents of the pack
Aciclovir Sterile Concentrate is a concentrate for solution for infusion (sterile concentrate). This means it is a concentrated solution, which is diluted then given as an infusion (drip). It comes in glass containers called vials. It may be supplied in packs containing: 5 x 250 mg/10 ml vials 5 x 500 mg/20 ml vials 1 x 1 g/40 ml vial Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK
Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia This leaflet was last approved in 09/2009
For children and neonates, where it is advisable to keep the volume of infusion fluid to a minimum, it is recommended that dilution is on the basis of 4 ml of sterile concentrate (100 mg aciclovir) added to 20 ml of infusion fluid. Aciclovir 25 mg/ml Sterile Concentrate when diluted in accordance with the above schedule will give an aciclovir concentration not greater than 0.5% w/v. When diluted as recommended, Aciclovir 25 mg/ml Sterile Concentrate is known to be compatible with the infusion fluids listed below: Sodium Chloride Intravenous Infusion 0.9% w/v Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion Sodium Chloride (0.9% w/v) and Glucose (5% w/v) Intravenous Infusion Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion Compound Sodium Lactate Intravenous Infusion (Hartmanns Solution) After dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25C. 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. When dilution is carried out under validated aseptic conditions, the product may be stored for a maximum of 12 hours at room temperature, below 25C. Should any visible turbidity or crystallisation appear in the solution before or during infusion, the preparation should be discarded.
Q62936 4XXXXX
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
