250mg, 500mg powder for infusion solution
acyclovir

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about:
1. What Geavir is and what it is used for
2. What you need to know before you use Geavir
3. How to use Geavir
4. Possible side effects
5. How to store Geavir
6. Contents of the packaging and other information

1. What Geavir is and what it is used for

Geavir is intended for the treatment or prevention of various infections caused by the Herpes simplex virus and against chickenpox and shingles, as well as for the prevention of infection with cytomegalovirus (which belongs to the herpes group virus ) in patients undergoing bone marrow transplantation.

This preparation is intended for use in hospitals only.

Aciclovir contained in Geavir may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Geavir

Do not use Geavir

  • if you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Geavir.

  • Adequate fluid intake is important when using Geavir. For elderly patients, adequate fluid intake is especially important.

Talk to your doctor if you have impaired kidney function. Because aciclovir is excreted from the body through the kidneys, your doctor will reduce the dose of aciclovir if you have kidney failure. Elderly people often have impaired kidney function and therefore the doctor may reduce the dose even for elderly patients.

The risk of neurological and psychological side effects in people with kidney failure or dehydration and in the elderly is increased. If this applies to you, your doctor will monitor your neurological and mental function. Any side effects of this type are in most cases transient.

Long-term treatment of immunocompromised patients (eg patients who have undergone bone marrow transplantation or who have HIV ) may increase the risk of virus strains becoming resistant to aciclovir.

Other medicines and Geavir

Tell your doctor or pharmacist if you have recently taken or might take any other medicines.

The use of the following medicines with Geavir may require a dose adjustment.

  • Lithium (used in bipolar disorder also known as manic depressive illness).
  • Theophylline (used in certain lung diseases, including asthma ).
  • Cimetidine (used to inhibit acid secretion in the stomach).
  • Mycophenolate mofetil (used to inhibit the activity of the immune system in organ transplants and connective tissue diseases, among other things).
  • Probenecid (used for gout ).

Your doctor will check your kidney function if you are given Geavir together with medicines that affect kidney function, such as cyclosporine and tacrolimus (used to inhibit the activity of the immune system in organ transplants, for example).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of Geavir should only be considered when the expected benefit outweighs any unknown risks. No increase in the incidence of malformations in relation to the population on average has been observed.

Aciclovir is known to be excreted in human milk to a small extent. Caution is therefore advised if breastfeeding women use Geavir, even though the baby is unlikely to be affected.

Driving and using machines

Geavir infusion solution is used in hospitals, and therefore the question of its effect on the ability to drive and the ability to use machines is not generally relevant. Geavir can in very rare cases give e.g. drowsiness and dizziness, which should be taken into account.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Geavir contains sodium

This medicine contains 1.13 mmol (or 26 mg) or 2.2 mmol (or 51 mg) sodium per vial . This should be considered by patients on a low-salt diet.

3. How to use Geavir

Geavir is given as a slow intravenous infusion into a blood vessel, either as a drip or by means of an infusion pump. Geavir should only be given intravenously (in a vein).

Your doctor will adjust the dose individually for you.

For patients with healthy kidneys, the doses are given at 8-hour intervals (3 times a day), but if renal function is impaired, the time interval between doses is increased. For patients receiving dialysis, dose one is also reduced. The infusion is usually given over the course of 1 hour. Depending on the disease being treated and how Geavir is affected, it is common for treatment to last for 7 to 10 days, but it can be shorter or longer.

Your doctor will make sure that you have enough fluid in your body and can therefore also prescribe infusion of fluid solutions that do not contain drugs.

Use for children and adolescents

The doctor prescribes dose one and the duration of treatment according to the child’s age, weight and illness.

If you take more Geavir than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Because treatment is done in a hospital, overdose is unlikely. Possible overdose may cause stomach symptoms (nausea, vomiting), impaired renal or hepatic function, and central nervous system symptoms (dizziness, drowsiness, tremors, and agitation, as well as in case of major overdose confusion, hallucinations, sleep disturbances, seizures, and coma ). Severe overdose can be treated with dialysis, which removes aciclovir from the body.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor or healthcare professional immediately if you experience any of the following symptoms ( angioedema ):

  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and difficulty breathing

Possible side effect s

Common (may affect up to 1 in 10 people ): Skin rash (including sensitivity to sunlight), itching, nausea, vomiting, venous inflammation, transient increase in liver values, hives, increased urea and creatinine levels in the blood.

Very rare (may affect up to 1 in 10,000 people):  Shortness of breath, renal impairment, acute kidney failure, kidney pain (kidney pain may be associated with kidney failure ), inflammation of the liver, jaundice, abdominal pain, diarrhea, fatigue, fever, local inflammation ( at the site of administration).

Aciclovir, which by intravenous injection has occurred outside the vein and into the tissue outside the blood vessel, has caused severe local inflammation and skin damage.

The following side effects are common and have usually been reported in patients with renal impairment, dehydration, or concomitant use of certain medicines (see “Other medicines and Geavir” above).

Uncommon (may affect up to 1 in 100 people):  Altered blood levels ( anemia, decreased platelet count, and white blood cells ( thrombocytopenia, leukopenia )).

Very rare (may affect up to 1 in 10,000 people ): Immediate severe hypersensitivity reactions, confusion, hallucinations, psychotic symptoms, agitation, headache, dizziness, tremors, impaired motor coordination, speech difficulties, seizures, sleep disorders, brain disease, coma.

Nausea and vomiting are seen especially at higher doses. Side effects in the nervous system are seen especially at higher doses and in medically complicated cases.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Geavir

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label/carton after EXP. or EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is aciclovir. One vial contains aciclovir sodium equivalent to 250 mg and 500 mg aciclovir, respectively.
  • The other ingredients are sodium hydroxide.

What the medicine looks like and contents of the pack

Geavir 250 mg and 500 mg powder for solution for infusion: white powder in a clear glass bottle.

Pack sizes:

5 x 250 mg

5 x 500 mg

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Hexal A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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