Pfizer

Concentrate for solution for infusion 25 mg / ml 
(Clear, colorless, or almost colorless solution)

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, pharmacist, or nurse.

– 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. See section 4.

In this leaflet: 
1. What Aciclovir Pfizer is and what it is used for 
2. What you need to know before you use Aciclovir Pfizer 
3. How to use Aciclovir Pfizer 
4. Possible side effects 
5. How to store Aciclovir Pfizer 6. Contents of the pack 
and other information 

What Aciclovir Pfizer is and what it is used for

Aciclovir Pfizer contains the active substance aciclovir, which belongs to a group of medicines called antiviral medicines. Aciclovir works by inhibiting the proliferation of the herpes virus.

Aciclovir Pfizer can be used to:

  • treat severe genital herpes
  • prevent or treat infection caused by Herpes simplex (cold sores or blisters on the skin including genitals) in patients with a weakened immune system
  • treat varicella-zoster – infection (chickenpox and shingles )
  • treat herpes encephalitis ( meningitis caused by the herpes virus)
  • treat Herpes simplex – an infection in newborns and infants up to 3 months of age)

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

2. What you need to know before using Aciclovir Pfizer

Do not use Aciclovir Pfizer

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

Do not use Aciclovir Pfizer if the above applies to you. Talk to your doctor or pharmacist if you are unsure before using Aciclovir Pfizer.

Warnings and cautions

Tell your doctor, pharmacist, or nurse before using Aciclovir Pfizer if:

  • you have impaired kidney function
  • you are over 65 years old

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before using Aciclovir Pfizer.

When treating with Aciclovir Pfizer, it is important to maintain a good fluid balance.

Other medicines and Aciclovir Pfizer

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

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, ciclosporin, or mycophenolate mofetil, used to prevent the body from repelling transplanted organs)
  • theophylline (a medicine used to treat lung diseases)
  • lithium (a medicine used to treat manic depressive illness)

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.

Aciclovir Pfizer contains sodium

This medicine contains 2.67 mg / ml (0.116 mmol / ml) sodium . This should be considered by patients on a low-salt diet.

3. How to use Aciclovir Pfizer

This medicine will be diluted with a liquid such as sodium chloride 9 mg/ml solution before it is given to you. It will be given by a slow intravenous infusion (drip) into a vein for at least one hour. You may be given fluids so that you do not become dehydrated.

Tell your doctor or nurse immediately if you accidentally get Aciclovir Pfizer in your eyes or on your skin so that it can be rinsed off.

Dosage

The dose you receive and how often it is given will be determined by your doctor and depends on the type of infection you have, your age, your weight, and your kidney function.

Treatment with Aciclovir Pfizer usually lasts 5 days, but depends on how quickly you get better. Treatment of herpes encephalitis usually lasts 10 days. Treatment of herpes infections in newborns usually lasts for 14 days for skin/eye/mouth infections and for 21 days for infections that affect the whole body.

If Aciclovir Pfizer is given to prevent a viral infection, it is given as long as your doctor thinks you are at risk of getting an infection .

If you take more Aciclovir Pfizer than you should

This medicine is given to you in a hospital, under the supervision of a doctor. It is unlikely that you will get too much or too little, however, talk to your doctor or nurse if you feel unsure.

If you take more aciclovir than you should:

  • feel confused or upset
  • get hallucinations (see or hear things that do not exist)
  • have seizures
  • become unconscious ( coma ).

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

4. Possible side effects

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

If you get any of the following symptoms, contact a doctor immediately:

  • severe allergic reaction (usually characterized by a sudden itchy rash ( hives ), swelling of the hands, feet, ankle, face, lips, tongue, or throat (may cause difficulty swallowing or breathing) and it may feel like you are about to faint.
  • altered blood values ​​e.g. anemia and/or decreased white blood cell count and/or decreased platelet count (which makes it easier to get bruises). Your doctor may take blood samples to detect this.
  • yellowing of the skin and whites of the eyes (jaundice)
  • soreness or swelling at the injection site during or immediately after injection
  • confusion or unusual and disordered thoughts ( psychosis )
  • cramps or seizures
  • hallucinations
  • indignation
  • shaking or trembling
  • coma
  • difficulty breathing or shortness of breath
  • impaired movement coordination
  • difficulty speaking
  • kidney problems or kidney failure, including blood in the urine
  • severe skin reaction with itchy pink spots (erythema multiforme), which may cause blisters
  • in immunocompromised patients:
  • a rare disease of the blood clotting system called thrombotic thrombocytopenic purpura, which can cause bruising, headaches, hallucinations but also blood clots in the kidneys
  • a severe form of anemia called a hemolytic uremic syndrome, which can make you look pale and cause a feeling of fatigue due to anemia, and also cause bruising and kidney problems

These side effects are very rare.

Other side effects are

Common (may affect up to 1 in 10 people):

  • inflammation (tenderness, redness, or swelling) along a vein used for infusion one
  • feeling sick or being sick
  • skin rash, hives, or photosensitivity of the skin
  • altered liver and kidney function (your doctor may take blood samples to detect this)
  • nausea
  • vomiting

Uncommon (may affect up to 1 in 100 people):

  • decreased number of red blood cells ( anemia )
  • decreased white blood cell count ( leukopenia )
  • decreased platelet count ( thrombocytopenia )

Very rare (may affect up to 1 in 10,000 users):

  • sweating or fever
  • headache
  • abdominal pain
  • diarrhea
  • dizziness
  • fatigue
  • the feeling of unusual drowsiness
  • brain disease ( encephalopathy )
  • pain in the lower back, back area at the kidneys, or pain when passing urine (kidney pain)

No known frequency (cannot be calculated from the available data):

  • thirst
  • low blood pressure (feeling dizzy when you get up)
  • degradation of red blood cells ( hemolysis )
  • inflammation of the small blood vessels (leukocytoclastic vasculitis )
  • tingling or numbness

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aciclovir Pfizer

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 carton and label after EXP. The expiration date is the last day of the specified month.

Storage

Store at a maximum of 25 o C. Store in protection against cold. Do not freeze.

Visible signs of deterioration

Do not use this medicine if it contains visible particles.

6. Contents of the packaging and other information

Content declaration

  • The active substance is aciclovir. Each ml of concentrate contains 25 mg of aciclovir as aciclovir sodium.
  • The other ingredients are sodium hydroxide and water for injections. Sodium hydroxide and/or hydrochloric acid are used for pH adjustment of the solution.

What the medicine looks like and the contents of the pack

Aciclovir Pfizer is a concentrate for solution for infusion (sterile concentrate). This means that it is a concentrated solution, which must be diluted before it is given as an infusion (drip). It is available in glass containers called vials.

Aciclovir Pfizer is a clear, colorless, or almost colorless solution.

Aciclovir Pfizer is available in the following pack sizes:

5 x 250 mg / 10 ml vial

5 x 200 mg / 20 ml vial

1 x 1 g / 40 ml vial

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Phone: 08-550 520 00

Email: eumedinfo@pfizer.com

Manufacturer

Hospira UK Limited,

Horizon, Honey Lane, Hurley,

Maidenhead, SL6 6RJ,

UK

or

Hospira Enterprises BV,

Randstad 22-11,

NL-1316 BN Almere,

Netherlands

or

Pfizer Service Company BVBA,

Hoge Wei 10,

B-1930 Zaventem,

Belgium

This leaflet was last modified on 11 May 2019

The following information is intended for healthcare professionals only:

In addition to the information included in section 3, there is practical information on the preparation/handling of the medicine here:

Incompatibilities

Acyclovir sodium is reported to be incompatible with solutions containing amifostine, amsacrine, aztreonam, diltiazem hydrochloride, dobutamine hydrochloride, dopamine hydrochloride, fludarabine phosphate, foscarnet sodium, idarubicin hydrochloride, meropenem, morphine sulfate hydrochloride, tacituracetonate, tranacetonate, tranacetonate, tranacetonate,

Sterile water for injection containing parabens or benzyl alcohol must not be used.

Biological and colloidal fluids (eg blood products and solutions containing proteins ) are incompatible with aciclovir sodium.

Instructions for use

For intravenous infusion only.

Aciclovir Pfizer 25 mg/ml does not contain preservatives. Dilution should therefore be performed aseptically immediately before use and any remaining solution discarded.

Do not store in the refrigerator as precipitation may occur.

For adults, the use of infusion bags with 100 ml of infusion solution is recommended, even if this results in an aciclovir concentration that is significantly below 0.5% w / v. An infusion bag of 100 ml can be used for each aciclovir dosage between 250 mg and 500 mg, but the dose s between 500 and 1000 mg 2 bags must be used. Aciclovir Pfizer 25 mg / ml should never be diluted to concentrations above 5 mg / ml (0.5% w / v) when administered as an infusion . After adding Aciclovir Pfizer 25 mg/ml to an infusion solution, the mixture should be shaken to ensure thorough mixing.

For children and infants, where the infusion volume should be kept to a minimum, it is recommended that the dilution be performed by mixing 4 ml solution (100 mg aciclovir) in 20 ml infusion fluid.

When diluted according to the recommendations, Aciclovir Pfizer 25 mg/ml is compatible with the following infusion fluids:

Sodium chloride for intravenous infusion 0.9% w / v;

Sodium chloride (0.18% w / v) and glucose (4% w / v) for intravenous infusion;

Sodium chloride (0.9% w / v) and glucose (5% w / v) for intravenous infusion;

Sodium chloride (0.45% w / v) and glucose (2.5% w / v) for intravenous infusion;

Sodium lactate mixture for intravenous infusion (Hartmann’s solution).

Aciclovir Pfizer 25 mg/ml does not contain preservatives.

In case of visible signs of turbidity or crystallization of the liquid before or during an infusion, the solution should be discarded.

Muhammad Nadeem

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