АКИКЛОВІР ІКМА 250 MG Інфузійний порошок
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Інструкція із застосування AKIKLOVIR IKMA
Зміст інструкції
Aciclovir Hikma,
250 mg and 500 mg
Powder for solution for infusion
Generic medicine
Read this leaflet carefully before using this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask the nurse.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet
- 1. What Aciclovir Hikma is and what it is used for
- 2. What you need to know before you use Aciclovir Hikma
- 3. How to use Aciclovir Hikma
- 4. Possible side effects
- 5. How to store Aciclovir Hikma
- 6. Contents of the pack and other information
1. What is Aciclovir Hikma and what it is used for
Aciclovir Hikma contains a medicine called aciclovir. This belongs to a group of
medicines called antivirals. It works by killing or stopping the growth of viruses.
Aciclovir Hikma can be used for:
- Treating Varicella Zoster(chickenpox) infections.
- Treating severe cases of genital herpes.
- Preventing and treating Herpes Simplex(cold sores and genital herpes) infections in people whose immune system is not working well, which means their body is less able to fight infections
- Treating Herpes Simplexinfections in children up to 3 months of age. This can rarely be caused by the virus responsible for cold sores and genital herpes infections.
- Treating Herpes encephalitis(inflammation of the brain. This can rarely be caused by the virus responsible for cold sores and genital herpes infections).
2. What you need to know before using Aciclovir Hikma
Do not use Aciclovir Hikma:
- if you are allergic (hypersensitive) to aciclovir or valaciclovir or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or nurse before using Aciclovir Hikma.
Check with your doctor or nurse before taking Aciclovir Hikma if:
- You have kidney problems
- You are over 65 years of age. If you are not sure if the above conditions apply to you, talk to your doctor or nurse before using Aciclovir Hikma.
Other medicines and Aciclovir Hikma
Tell your doctor if you are taking, have recently taken or may take any 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;
- tacrolimus, cyclosporine or mycophenolate mofetil, used to prevent rejection in patients undergoing organ transplantation;
- lithium, used to treat manic-depressive disorders;
- theophylline, used to treat some respiratory disorders.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Aciclovir Hikma contains sodium
Aciclovir Hikma contains 37.8 mg of sodium per dose. This should be taken into consideration in people
who are following a low-sodium diet.
3. How to use Aciclovir Hikma
You should never take this medicine on your own. It will always be administered to you by a
trained person.
Before the medicine is administered to you, it must be diluted.
Aciclovir Hikma will be administered to you as a continuous infusion into a vein, slowly
over a period of 1 hour.
Aciclovir Hikma is generally administered every 8 hours.
You may be given fluids to avoid dehydration.
The dose that will be administered to you, the frequency and the duration of the dose will depend on:
- Type of infection you are suffering from,
- Your weight,
- Your age.
The doctor may adjust the dose of Aciclovir Hikma if:
- You suffer from kidney problems. If you have kidney problems, it is important that you receive an adequate amount of fluids while being treated with Aciclovir Hikma.
- You are overweight.
- You are elderly. Tell your doctor if any of the characteristics listed above apply to you before taking Aciclovir Hikma.
Use in children
The dose of Aciclovir Hikma administered to:
- Children between 3 months and 12 years of age is calculated based on the body surface area.
- Newborns and infants up to 3 months of age is calculated based on body weight. If a child has kidney problems, the dose of the medicine may be reduced.
If you use more Aciclovir Hikma than you should
If you think you have been given too much Aciclovir Hikma, tell
your doctor or nurse immediately.
If you have been given too much Aciclovir Hikma you may:
- Feel confused or agitated,
- Have hallucinations (see or hear things that do not exist),
- Have convulsions,
- Lose consciousness (coma).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Allergic reactions(affect less than 1 in 10,000 people)
If you have an allergic reaction, stop taking Aciclovir Hikma and contact a
doctor immediately. Symptoms may include:
- skin rash, itching or hives on the skin;
- swelling of the face, lips, tongue or other parts of the body;
- shortness of breath, wheezing or breathing problems;
- unexplained fever (high temperature) and feeling faint, especially when getting up.
Other side effects include:
Common(affect less than 1 in 10 people)
- feeling unwell or sick;
- itching, hive-like rash;
- skin reaction after exposure to light (photosensitivity);
- itching;
- swelling, redness and pain at the injection site.
Uncommon(affect less than 1 in 100 people)
- nosebleeds and bruising more easily than usual.
Very rare(affect less than 1 in 10,000 people)
- headache or feeling dizzy;
- diarrhoea or stomach pain;
- feeling tired;
- fever;
- effects on some urine and blood tests;
- feeling weak;
- feeling agitated or confused;
- restlessness or tremors;
- hallucinations (seeing or hearing things that are not there);
- convulsions;
- feeling unusually sleepy or apathetic;
- unsteadiness when walking and lack of coordination;
- difficulty speaking;
- inability to think or judge clearly;
- loss of consciousness (coma);
- paralysis of part or all of the body;
- disturbance of behaviour, speech and eye movements;
- stiff neck and sensitivity to light;
- inflammation of the liver (hepatitis);
- yellowing of the skin and whites of the eyes (jaundice);
- kidney problems where little or no urine is produced;
- pain in the lower back, in the area of the kidneys or just above the hip (kidney pain)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Aciclovir Hikma
Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Prepare immediately before use. Any unused solution must be discarded.
Do not use this medicine after the expiry date which is stated on the vial and the outer packaging
after EXP. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Aciclovir Hikma contains
- The active ingredient is aciclovir.
- Each vial contains 250mg of aciclovir as sodium salt.
- Each vial contains 500mg of aciclovir as sodium salt
- The other ingredient is sodium hydroxide.
Description of the appearance of Aciclovir Hikma and contents of the pack
Aciclovir Hikma is supplied in glass vials containing a white powder, closed with
a rubber stopper and sealed with a flip-off cap.
The 250 mg dosage is available in vials of 10 ml, in a carton containing 5 and 10
vials.
The 500 mg dosage is available in vials of 20 ml, in a carton containing 5 and 10
vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença
2705-906 Terrugem SNT
Portugal
This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Italy: Aciclovir Hikma 250 mg e 500 mg Powder for solution for infusion
Germany: Aciclovir Hikma 250 mg und 500 mg, Pulver zur Herstellung einer
Infusionslösung
Portugal : Aciclovir Hikma, 250 mg e 500 mg, Pó para solução para perfusão
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The following information is intended for healthcare professionals only:
Chemical and physical stability of the product after reconstitution and dilution
Chemical and physical stability during use has been demonstrated for 12 hours at 15°C – 25°C.
From a microbiological point of view the medicinal product must be used immediately. If not
used immediately, the storage times during use and conditions prior to use are the responsibility of the user.
Special precautions for disposal and handling
Reconstitution:
Aciclovir Hikma must be reconstituted using the following volumes of both water for injections and Sodium Chloride for intravenous administration (0.9% w/v) to obtain a
solution containing 25 mg of aciclovir per ml:
Formulation Volume of fluid for reconstitution
250 mg vial 10 ml
500 mg vial 20 ml
From the calculated dose, determine the correct number and exact concentration of vials to
use. To reconstitute each vial add the recommended volume of infusion fluid and
gently shake until the contents of the vial have completely dissolved.
Administration:
The required dose of Aciclovir Hikma must be administered via slow intravenous infusion over a period of 1 hour.
After reconstitution Aciclovir Hikma can be administered via an infusion pump at a controlled rate.
Alternatively, the reconstituted solution can be further diluted to obtain an aciclovir concentration of no more than 5 mg/ml (0.5% w/v) for administration via
infusion.
Add the required volume of reconstituted solution to the chosen infusion solution, as
recommended below, and shake well to ensure adequate mixing.
For children and neonates, if it is advisable to keep the volume of infusion fluid to a
minimum, it is recommended that the dilution is based on 4ml of reconstituted solution (100mg
of aciclovir) added to 20ml of infusion fluid.
For adults, it is recommended to use infusion bags containing 100ml of infusion
fluid, even if this leads to an aciclovir concentration practically below 0.5% w/v. In this way an infusion bag of 100ml can be
used for each dose between 250mg and 500mg of aciclovir (10 and 20 ml of reconstituted
solution) but a second bag must be used for doses between 500 mg and 1000 mg.
When diluted in accordance with the recommended plans, Aciclovir Hikma is known to be
compatible with the following infusion fluids and stable for up to 12 hours at room temperature
(from 15°C to 25°C):
- Sodium Chloride intravenous infusion (0.45% and 0.9% w/v)
- Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion
- Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion
- Sodium Lactate mixture Intravenous Infusion (Hartmann's Solution).
Aciclovir Hikma when diluted according to the scheme above will give an aciclovir concentration of
no more than 0.5% w/v.
As there is no antimicrobial preservative present, reconstitution and dilution must be
carried out under aseptic conditions, immediately before use, and any unused solution must then be discarded.
Reconstituted or diluted solutions must not be frozen.
If any turbidity or crystallization is visible in the solution before or during
infusion, the preparation must be discarded.
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- Країна реєстрації
- Лікарська формаPowder for intravenous infusion solution, 250 MG
- Код АТХJ05AB01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до AKIKLOVIR IKMAЛікарська форма: Coated tablet, 400 MGДіюча речовина: ацикловирВиробник: FIDIA FARMACEUTICI S.P.A.Потрібен рецептЛікарська форма: Oral suspension, 400 MG/5 MLДіюча речовина: ацикловирВиробник: ABC FARMACEUTICI S.P.A.Рецепт не потрібенЛікарська форма: Coated tablet, 400 MGДіюча речовина: ацикловирВиробник: ALFASIGMA S.P.A.Потрібен рецепт
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Часті запитання
AKIKLOVIR IKMA потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у AKIKLOVIR IKMA — ацикловир. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
AKIKLOVIR IKMA виробляється компанією HIKMA FARMACEUTICA (PORTUGAL) S.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування AKIKLOVIR IKMA з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати AKIKLOVIR IKMA у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (ацикловир) включають AKIKLIN, AKIKLOVIR ABK, AKIKLOVIR ALFASIGMA. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
