Aciclovir TedeC 25 mg/ml solution for infusion EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aciclovir TEDEC 25 mg/ml solution for infusion EFG
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Aciclovir Tedec is and what it is used for
- What you need to know before using Aciclovir Tedec
- How to use Aciclovir Tedec
- Possible side effects
- How to store Aciclovir Tedec
- Contents of the pack and other information
1. What Aciclovir Tedec is and what it is used for
Aciclovir belongs to the antiviral medicinal group active against herpes viruses.
This medicine is indicated for:
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Treatment of infections caused by herpes simplex virus.
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Prevention of herpes simplex virus infections in immunocompromised patients.
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Treatment of immunocompromised patients with herpes zoster, particularly in progressive or disseminated skin infections.
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Treatment of herpes simplex virus infections in neonates.
2. What you need to know before starting to use Aciclovir Tedec
Do not use Aciclovir Tedec:
- If you are allergic to aciclovir, valaciclovir, ganciclovir, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use aciclovir:
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If you have any kidney disease or are elderly, your doctor may use a lower dose. In addition, you should drink sufficient amounts of liquid during treatment to maintain adequate hydration.
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If used in patients who have undergone kidney transplantation, your doctor should monitor kidney function, as a slight increase in serum creatinine or urea may occur, which could be mistaken for a rejection reaction.
Consult your doctor, even if any of the above circumstances have occurred to you in the past.
Other medicines and Aciclovir Tedec
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The safety of this medicine in pregnant women has not been demonstrated; it will only be used in cases where the benefit/risk assessment by your doctor justifies its use.
Aciclovir is excreted in breast milk.
Driving and using machines
There are no data indicating limitations for this activity.
Aciclovir Tedec contains sodium and sodium metabisulfite
This medicine contains 39.3 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 1.965% of the maximum daily recommended sodium intake for an adult.
This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite.
3. How to use Aciclovir Tedec
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to use your medicine.
This medicine and its route of administration have been prescribed exclusively for you. You must never give it to other people, nor should it be used for other types of disorders.
Your doctor will indicate the dose and duration of your treatment with intravenous aciclovir. In acute herpes simplex virus infections, 5 days of treatment is usually appropriate; however, the duration of treatment will depend on the severity of the infection, the patient's condition, and response to treatment. Treatment of herpes encephalitis and neonatal herpes simplex is usually 10 days in duration. The duration of prophylactic intravenous aciclovir administration will be determined by the length of the risk period.
The recommended dose is:
Adults
Normal renal function
Patients with herpes simplex virus infections (except herpes encephalitis) or varicella zoster virus: 5 mg/kg dose every 8 hours.
Immunocompromised patients with infections caused by varicella zoster virus or with herpes encephalitis: 10 mg/kg dose every 8 hours.
Impaired renal function
Administration of intravenous aciclovir in patients with impaired renal function must be performed with caution.
The following dose adjustments are recommended in case of renal dysfunction:
Creatinine clearance (ml/min) | Original dose | Adjusted dose |
25 – 50 | 5 mg/kg every 8 hours 10 mg/kg every 8 hours | 5 mg/kg every 12 hours 10 mg/kg every 12 hours |
10 – 25 | 5 mg/kg every 8 hours 10 mg/kg every 8 hours | 5 mg/kg every 24 hours 10 mg/kg every 24 hours |
0 – 10 | 5 mg/kg every 8 hours 10 mg/kg every 8 hours | 2.5 mg/kg every 24 hours 5 mg/kg every 24 hours after dialysis |
Use in children and adolescents
The intravenous aciclovir dose for children between 3 months and 12 years of age is calculated based on body surface area.
Children with infections caused by herpes simplex virus or varicella zoster: 250 mg/m² body surface area, every 8 hours.
Immunocompromised children with varicella zoster or children with herpetic encephalitis: 500 mg/m² body surface area, every 8 hours.
Children with impaired renal function require appropriate dose adjustments according to the degree of impairment.
The dose of aciclovir in neonates (herpes simplex): 10 mg/kg every 8 hours.
Use in elderly patients
The dose should be reduced in patients who have renal impairment.
If you think that the effect of aciclovir is too strong or too weak, inform your doctor.
If you use more Aciclovir Tedec than you should
If you have used a higher dose than recommended, consult your doctor or pharmacist immediately. No adverse effects have been observed following single doses of up to 80 mg/kg. Intravenous aciclovir is dialyzable.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. Take this leaflet with you.
If you forget to use Aciclovir Tedec
Do not administer a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Some patients treated with intravenous aciclovir have experienced the following symptoms: increased liver enzymes, decreased hematological indices, rashes and fever, nausea and vomiting.
Nervous system disorders: agitation, confusion, tremor, difficulty with movement, difficulty speaking, confusion or perceiving things that are not real (hallucinations), seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are generally reversible and usually occurred in patients with renal impairment or predisposing factors.
In some patients, a rapid and reversible increase in blood levels of urea or creatinine was observed, believed to be due to high plasma levels of the drug and the patient's hydration status. Therefore, it is essential that the patient's hydration level is adequate.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aciclovir Tedec
Keep this medicine out of the sight and reach of children.
Before dilution: No special storage conditions are required.
After dilution: The shelf life of this medicine after dilution is 8 hours at 25°C and 24 hours at 2-8°C.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.
6. Package contents and other information
Composition of Aciclovir Tedec
The active substance is aciclovir. Each vial contains 250 mg of aciclovir.
The other components (excipients) are: sodium metabisulfite (E-223), sodium hydroxide, sodium citrate (E-331), hydrochloric acid, water for injections, and nitrogen.
Presentation of the product and contents of the pack
Aciclovir Tedec 25 mg/ml is a solution for infusion. It is supplied in clear glass vials. The solution is a colourless or pale yellow transparent liquid. Each pack contains 5 vials. It is also available in a clinical pack containing 50 vials.
Marketing Authorization Holder and Manufacturer
Meiji Pharma Spain, S.A.
Avda. de Madrid, 94
28802 Alcalá de Henares, Madrid (Spain)
Date of the most recent revision of this leaflet: May 2021
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es
This information is intended exclusively for healthcare professionals
The solution must be administered intravenously only, continuously and very slowly, over a period of not less than one hour.
If required, dilution should be performed immediately before use. Any unused solution must be discarded. If visible turbidity or crystallization occurs before or during infusion, the solution must be rejected.
Instructions for administration
Intravenous infusion without dilution:
The solution is administered using a controlled-rate infusion pump over a period of not less than one hour.
Infusion with dilution:
The solution may be diluted for administration by infusion. Dilution, either total or partial depending on the required dose, is achieved by adding and mixing the solution with at least 50 ml of infusion fluid to obtain a final concentration not exceeding 0.5% (250 mg/50 ml). The contents of 2 vials (500 mg of aciclovir) may be added to 100 ml of infusion fluid; if the required dose exceeds 500 mg, a second volume of infusion fluid may be used.
This medicinal product is compatible with the following infusion solutions:
- Sodium chloride (0.45%, 0.9% w/v).
- Sodium chloride (0.18% w/v) and glucose (4% w/v).
- Sodium chloride (0.45% w/v) and glucose (2.5% w/v).
- Sodium lactate (Hartmann's solution).
The solution must be shaken vigorously to ensure thorough mixing.
Following accidental intravenous injection of aciclovir, severe extravascular tissue inflammation may occur, sometimes followed by ulceration. Infusion using mechanical pumps carries higher risks than gravity-driven infusion. Phlebitis and inflammation at the infusion site may occur.