Aciclovir 25 Mg/Ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aciclovir 25 mg/ml Concentrate for solution for infusion
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The name of your medicine is Aciclovir 25 mg/ml Concentrate for solution for infusion, which will be referred to as Aciclovir throughout this leaflet.
Read all of this leaflet carefully before you start taking 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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In this leaflet
1. What Aciclovir is and what it is used for
2. What you need to know before you are given Aciclovir
3. How to be given Aciclovir
4. Possible side effects
5. How to store Aciclovir
6. Contents of the pack and other information
1. What Aciclovir is and what it is used for
Aciclovir contains the active ingredient aciclovir, which is a guanosine analogue antiviral drug.
Aciclovir is indicated:
• for the treatment of severe cases of genital herpes
• for the treat of chickenpox
• to treat and stop cold sores and genital herpes in people whose immune systems work less well, which means their bodies are less able to fight infections.
• for the treatment of serious virus infections in children up to 3 months of age. This can rarely be caused by the virus responsible for cold sore infection and genital herpes.
• to treat inflammation of brain. This can rarely be caused by tirus responsible for cold sore infection and genital herpes.
2. What you need to know before you are given Aciclovir
Do not be given Aciclovir if:
You are allergic (hypersensitive) to aciclovir and valaciclovir or any of the other ingredients of this medicine (listed in Section 6.)
Warnings and precautions:
• you have kidney problems
• you are over 65 years of age
• you are suffering from dehydration
If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Aciclovir.
Other medicines and Aciclovir
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• probenecid, used to treat gout
• cimetidine, used to treat stomach ulcers
• tracrolimus, ciclosporin or mycophenolate mofetil, used to stop your body rejecting transplanted organs.
Pregnancy and breast-feeding
You will not be given Aciclovir if you are pregnant or breastfeeding unless your doctor thinks it is necessary.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Important information about some of the ingredients of Aciclovir
This medicinal product contains 0.116 mmol (or 2.67 mg) sodium per ml, 1.16 mmol (or 26.7 mg) sodium per 10 ml vial & 2.32 mmol (or 53.4 mg) sodium per 20 ml vial. This has to be taken into consideration for patients on a controlled sodium diet.
3. How to be given Aciclovir
You will be given Aciclovir in hospital by a doctor or nurse. Aciclovir is diluted and given to you as a continuous infusion into your vein. This is where the drug is given to you over a period of time.
The dose you will be given, the frequency and duration of the dose will depend on:
- type of infection
- your weight
- your age.
Your doctor may adjust the dose of Aciclovir if:
- if you have kidney problems. If you have kidney problems, it is important you receive plenty of fluids while you are being treated with Aciclovir.
Talk to your doctor before having Aciclovir if any of the above apply.
If you are given more Aciclovir than you should
If you think you have been given too much Aciclovir, talk to your doctor or nurse straight away.
If you have been given too much Aciclovir you may:
• feel confused or agitated
• have hallucinations (seeing or hearing things that aren’t there)
• have fits
• become unconscious (coma).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Evaluation of the side effects is based on the following frequencies:
very common: more than 1 user in 10 common : 1 to 10 users in 100
uncommon : 1 to 10 users in 1,000
rare : 1 to 10 users in 10,000
very rare : less than 1 user in 10,000
Allergic reactions (affects less than 1 in 10,000 people)
If you have an allergic reaction, stop taking Aciclovir and see a doctor straight away. The signs may include:
- rash, itching or hives on your skin
- swelling of your face, lips, tongue or other parts of your body
- shortness of breath, wheezing or trouble breathing
- unexplained fever (high temperature) and feeling faint, especially when standing up.
Other side effects include:
Common:
- itchy, hive-like rash
- skin reaction after exposure to light (photosensitivity)
- itching
- swelling, redness and tenderness at the site of injection.
- Nausea, vomiting
- Inflammation of vein
- Changes in blood tests that determine the functioning of your liver
- Changes in blood tests that determine the functioning of dneys.
Uncommon:
- reduced number of red blood cell (anemia)
- reduced white blood cell count (leukopenia)
- reduced number of platelets (blood cell important for blood clotting).
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The following information is intended for medical or healthcare professionals only.
Instructions for use and handling
For single use only. Discard unused solution. Reconstitution should be performed under aseptic conditions. Before administration, the solution should be visually inspected for particulate matter, turbidity or crystallisation. The solution should only be used if the solution is clear and free from particles.
Refrigeration is not recommended, because 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 Concentrate for solution for infusion 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 Concentrate for solution for infusion to an infusion solution, the mixture should be shaken to ensure thorough mixing.
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 solution (100 mg aciclovir) added to 20 ml of infusion fluid.
When diluted in accordance with the recommended schedules, Aciclovir 25 mg/ml Concentrate for solution for infusion 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;
Very rare:
- headache or feeling dizzy
- diarrhoea or stomach pains
- feeling tired
- fever
- feeling weak
- feeling agitated or confused
- shaking or tremors
- hallucinations (seeing or hearing things that aren’t there)
- feeling unusually sleepy or drowsy
- unsteadiness when walking and lack of coordination
- difficulty speaking
- inability to think orjudge clearly
- unconsciousness (coma)
- paralysis of part or all of your body
- disturbances of behaviour, speech and eye movements
- inflammation of the liver (hepatitis)
- yellowing of your skin and whites of your eyes (jaundice)
- kidney problems where you pass little or no urine
- pain in your lower back, the kidney area of your back or just above your hip (renal pain).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Marketing Authorisation Holder and Manufacturer Claris Lifesciences (UK) Limited
Crewe Hall, Crewe, Cheshire, CW1 6UL United Kingdom
Manufacturer
Peckforton Pharmaceuticals Limited
Crewe Hall, Crewe, Cheshire, CW1 6UL United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
UK Aciclovir 25mg/ml Concentrate for solution
for infusion
Estonia Aciclovir Claris
Ireland Aciclovir 25mg/ml Concentrate for solution
for infusion
Lithuania Aciclovir Claris 25mg/ml Koncentratas
Infuziniam tirpalui
Netherlands Aciclovir Claris 25mg/ml Concentraat voor oplossing voor intraveneuze infusie
This Leaflet was last revised in month 03 / 2015
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517 Website:www.hpra.ie, e-mail: medsafety@hpra.ie
5. How to store Aciclovir
Keep this medicine out of the sight and reach of children.
Do not store this medicine above 25°C. Do not refrigerate.
Store in the original carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date (Exp.) refers to the last day of that month.
Discard unused solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Chemical and physical in-use stability has been demonstrated for 12 hours at 25oC. 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.
Do not use Aciclovir if you notice any visible turbidity or crystallisation in the solution before or during infusion.
6. Contents of the pack and other information
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What Aciclovir contains:
The active substance is Aciclovir.
Each 1 ml contains 25 mg of aciclovir as aciclovir sodium.
Each 10 ml vial contains 250 mg of aciclovir (sodium salt formed in situ)
Each 20 ml vial contains 500 mg of aciclovir (sodium salt formed in situ)
A clear, colourless solution, free from visible particles The other ingredients are:
Water for Injections, Sodium hydroxide (for pH adjustment) and Hydrochloric acid (for pH adjustment)
For further information or if you have any questions about the use of this product, please contact on, telephone +44 1270 58 22 550.
What Aciclovir looks like and contents of the pack
Aciclovir comes in 10 ml and 20 clear glass vials.
Each pack contains 5, 10 and 20 vials of 10ml and 5, 10, 20 vials of 20ml.
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 (Hartmann's Solution).
Dilutions of Aciclovir in the above mentioned diluents have been demonstrated to be stable in Non polyvinyl chloride (Non-PVC) infusion bags
Aciclovir 25 mg/ml Concentrate for solution for infusion when diluted in accordance with the above schedule will give an aciclovir concentration not greater than 0.5% w/v. Aciclovir 25 mg/ml Concentrate for solution for infusion contains no preservative.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Aciclovir 25 mg/ml Concentrate for solution for infusion is incompatible with solutions of amifostine, amsacrine, aztreonam, diltiazem hydrochloride, dobutamine hydrochloride, dopamine hydrochloride, fludarabine phosphate, foscarnet sodium, idarubicin hydrochloride, meropenem, morphine sulfate, ondansetron hydrochloride, pethidine hydrochloride, piperacillin sodium - tazobactam sodium, sargramostim, and vinorelbine tartrate.
Do not use bacteriostatic water for injection that contains benzyl alcohol or parabens. Biological or colloidal fluids (eg blood products, protein-containing solutions) are incompatible with aciclovir.