4 mg / ml solution for injection / infusion 
dexamethasone phosphate

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.
  • 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Dexavit is and what it is used for

Dexavit contains dexamethasone. Dexamethasone belongs to a group of medicines called corticosteroids. It prevents the release of substances that cause inflammation in the body. Dexavit is used in acute conditions when oral treatment with corticosteroids is not possible.

Dexavit is used to treat several different conditions such as:

  • cerebral edema (increased pressure inside the skull) caused by tumors, brain surgeries, wart formation, or meningitis
  • severe skin diseases
  • active phases of collagenosis (a group of connective tissue diseases) including a disease called lupus erythematosus ( SLE )
  • serious infectious diseases in combination with anti-infective agents
  • to prevent and treat nausea and vomiting caused by cancer drugs
  • rheumatic diseases
  • inflammation in tendons or mucous sacs around joints.

You need to talk to a doctor if you do not feel better or if you feel worse.

Dexamethasone contained in Dexavit 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 using Dexavit

You should not be given Dexavit

  • if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6)
  • if you have a widespread infection that is not currently being treated
  • if you are going to get vaccines that contain live viruses.

Dexavit should not be injected directly into the joint or tissue:

  • if you have an infection in or very close to the joint to be treated
  • if you have bacterial arthritis (joint inflammation caused by bacteria)
  • if the joint to be treated is unstable
  • if you are prone to bleeding, either spontaneously or as a result of treatment with blood thinners ( anticoagulants )
  • if you have an accumulation of calcium salts in the soft tissue around the joint (periarticular calcifications)
  • if you have bone tissue death due to insufficient blood supply (avascular necrosis)
  • if you have a tendon rupture
  • if you have a condition called neurogenic arthropathy (loss of sensation in the joint, leading to disorders and damage to the joint).

You should not be given Dexavit if you have an infection at the injection site that is not currently being treated.

Warnings and cautions

  • A severe allergic reaction ( anaphylactic reaction ) may occur during treatment with Dexavit. See section 4.
  • Glucocorticoids can cause adrenal insufficiency, especially when used in high doses or for a long time. This means that the adrenal glands do not produce enough steroid hormones. The most common symptoms are fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, and nausea. Talk to your doctor if you get any of these symptoms.
  • Tell your doctor if you are being treated for infection as corticosteroids may hide some signs of infection.
  • You should avoid exposing yourself to infectious diseases such as chickenpox and measles. Ask your doctor immediately if you think you may have been exposed to these infections. You will need immediate hospitalization if you develop any of these diseases.
  • If you have an accident, become ill, have a baby, or need to have surgery while you are being treated with Dexavit, you should inform your healthcare professional that you are using Dexavit. Dose one may need to be adjusted as the body’s response to stress caused by these events may be reduced.
  • You may experience withdrawal symptoms after stopping corticosteroids such as dexamethasone or when your dose is reduced. These withdrawal symptoms include fever, fatigue, aches, and pains in muscles and joints. Talk to your doctor if you get such symptoms.

You will be closely monitored:

  • if you have a bacterial or viral infection (such as hepatitis, polio, polio), herpes, an eye infection, nor a wound on the surface of the eye)
  • if you have or have had tuberculosis or have recently had a reaction in connection with a tuberculosis vaccination
  • if you have a parasitic infection (machine infection) or a fungal infection inside your body.

Talk to your doctor, pharmacist, or nurse before using Dexavit:

  • if you are being treated for infection, as corticosteroids can hide some signs of infection
  • if you need to be vaccinated. The vaccination may not have the same effect and the risk of infection when using a live vaccine may be greater if you are being treated with Dexavit at the same time.
  • if you have ulcerative colitis ( chronic inflammation and ulceration of the colon)
  • if you have diverticulitis ( inflammation of the bulges of the inner layer of the colon)
  • if a diseased part of your intestine has been removed and you have a surgical connection between two parts of the intestine ( anastomosis of the intestine)
  • if you have or have had stomach ulcers
  • if you have myasthenia gravis (a disease that causes muscle weakness)
  • if you have or have had severe heart failure
  • if you have high blood pressure
  • if you have glaucoma (increased eye pressure)
  • if you have diabetes
  • if you have osteoporosis (osteoporosis)
  • if you have hypothyroidism (underactive thyroid gland )
  • if you have liver cirrhosis (severe scarring of the liver).

Tell your doctor if you (or anyone else who is taking this medicine) have any of the following:

  • signs of mental problems, as serious mental problems can occur during treatment with drugs such as dexamethasone. You must talk to a doctor if you (or anyone else using this medicine) feel depressed or have suicidal thoughts.
  • if you have blood cancer and have symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or visual disturbances, and shortness of breath.

If you are being treated with high doses of Dexavit, your doctor may monitor the level of potassium in your blood. Your doctor may also want you to reduce your salt intake and may advise you to take a potassium supplement while you are being treated with this medicine.

If you are receiving Dexavit as a local injection (eg injection in a joint), your doctor will take special care to reduce the risk of bacterial infection. This medicine must not be injected directly into an infected area. Tell your doctor if after local injection of this medicine you get complications such as a marked increase in pain accompanied by local swelling, further restriction of joint mobility, fever, or malaise.

Children

Your doctor will monitor growth and development at regular intervals during treatment as this medicine may cause growth retardation.

Other medicines and Dexavit

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

You must tell your doctor or pharmacist if you are taking:

  • anti- HIV drugs (cobicistat and ritonavir)
  • drugs against tuberculosis (rifampicin and isoniazid )
  • antiepileptic drugs ( phenytoin and carbamazepine)
  • nasal congestion medicine ( ephedrine )
  • anti-cancer drugs (aminoglutethimide)
  • drugs for sleep disorders and epilepsy ( barbiturates and primidone)
  • medicines for fungal infections ( ketoconazole and itraconazole)
  • medicines for pain and inflammation ( acetylsalicylic acid and other anti-inflammatory drugs)
  • anticoagulants ( anticoagulant coumarin)
  • diuretics ( diuretics )
  • drugs for diabetes ( insulin and diabetes medicines taken by mouth)
  • cardiac drugs (cardiac glycosides)
  • birth control pills or hormone replacement therapy ( estrogens ).

If you need to have a blood, urine, or skin sample, always tell your doctor that you are being treated with Dexavit, as Dexavit may affect test results.

Pregnancy and breastfeeding

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.

Pregnancy

Your doctor will only give you this medicine if the benefits to you and your baby outweigh the risks. Treatment will take place under close supervision. Your baby may need close monitoring after birth.

Breast-feeding

Dexavit should only be used according to the doctor’s instructions and under close supervision.

Driving and using machines

Dexavit does not affect the ability to drive and use 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.

Dexavit contains sodium

Dexavit contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.

3. How to use Dexavit

The injection is given by a doctor or nurse. The doctor will decide the right dose for you and how and when an injection should be given.

Dexavit can be given:

  • intravenously ( injection into a vein)
  • intramuscular ( injection into a muscle)
  • directly in a joint or tissue
  • as a slow injection by a drip into a vein ( infusion )

Dose one depends on your illness and how you respond to treatment.

The recommended dose is 

Intravenous and intramuscular use

Starting dose: The starting dose depends on your illness and is 0.8-60 mg per day. For milder conditions, a dose lower than 0.8 mg may suffice.

The starting dose is maintained or adjusted until a satisfactory response is achieved.

Injection of the joints or tissue s

Dosage one and how often you need to be given the medicine depends on your condition and the area in which the medicine is injected. The usual dose is 0.4-6 mg.

Use for children

Maximum 16 mg per day divided into three or four doses. In more severe conditions, a higher dose may be required.

Hepatic impairment

Dose one may need to be adjusted in patients with severe liver disease.

Impaired renal function

Dose one does not need to be adjusted.

If you take more Dexavit then you should

The medicine is given to you by a doctor or nurse. It is unlikely that you will get too much or too little.

Signs of acute overdose are sudden skin rash, difficulty breathing, and fainting as a result of an allergic reaction ( anaphylaxis ). Prolonged overdose may lead to the development of Cushing’s syndrome or impaired adrenal function. The symptoms are:

  • Cushing’s syndrome: increased appetite, weight gain, fat accumulation especially on the abdomen, between the shoulders and in the upper part of the neck and the face (moon face), skin changes, fatigue, irritability, depression, and increased thirst.
  • Impaired adrenal function: fatigue, weight loss, and decreased appetite, skin changes, nausea, diarrhea or vomiting, muscle or joint pain, irritability, and depression.

Seek medical attention immediately if you get any of these symptoms.

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

If you stop using Dexavit

If Dexavit has been used for several days, treatment should be stopped gradually.

4. Possible side effects

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

Serious side effects are

Seek medical attention immediately if you get any of the following serious side effects.

Less common side effects are ( may affect up to 1 in 100 ):

  • severe abdominal pain and fever caused by a sudden inflammation of the pancreas
  • increased pressure inside the skull (headache, nausea, vomiting, pain behind the eyes, visual disturbances)
  • heart failure (shortness of breath, fatigue, weakness, swelling of the legs, rapid or irregular heartbeat, cough, loss of appetite, and nausea)
  • severe allergic reaction (rash, difficulty breathing, and fainting)
  • seizures.

Common side effects are (may affect up to 1 in 10):

  • impaired adrenal function. You may experience symptoms such as fever, joint or muscle pain, and malaise.

Less common side effects are ( may affect up to 1 in 100 ):

  • acute mental illness (delusions, paranoia, hallucinations, confusion).

Has been reported (occurs in an unknown number of users):

  • visual disturbances, vision loss.

Contact a doctor if you get any of the following serious side effects.

Common side effects are ( may affect up to 1 in 10) :

At high doses or long-term treatment:

  • red, round “moon face”, thirst due to high blood sugar, headache due to high blood pressure, decreased muscle mass, abnormal fat accumulation in the face, neck, and body, and skin changes reminiscent of acne (Cushing’s syndrome).

Other side effects are

Common side effects are ( may affect up to 1 in 10) :

  • diseases of the nervous system caused by changes in the function of the nerves
  • swelling (fluid accumulation) in fingers, hands, feet, or legs
  • increased risk of infection due to the weakened immune system
  • fungal infection in the mouth
  • frequent urination, thirst, and fatigue due to high blood sugar
  • increased appetite
  • cataract
  • delayed wound healing
  • pain, redness, and swelling at the injection site.

At high doses:

  • pain in the upper abdomen, heartburn, and possibly vomiting due to stomach ulcers
  • hot flashes
  • increased / abnormal hair growth
  • the skin becomes darker (increased pigmentation )
  • skin and connective tissue become harder and denser.

For long-term treatment:

  • increased risk of bone fractures due to osteoporosis
  • muscle wasting.

Less common side effects are ( may affect up to 1 in 100 ):

  • general malaise, increased susceptibility to infection, especially sore throat and fever due to blood cell changes (lack of white blood cells ).
  • weakness and decreased muscle strength due to lack of potassium in the blood. Too low a potassium level can in very rare cases become serious and cause paralysis and heart rhythm disturbances (risk of heart failure ).
  • irregular heartbeat or palpitations
  • muscle weakness
  • missed menstruation
  • sweating
  • hiccup
  • thrombotic diseases
  • high blood pressure.

5. How to store Dexavit

  • Keep this medicine out of the sight and reach of children.
  • Do not store above 30 ° C.
  • Store in the original package. Sensitive to light.
  • Do not use this medicine after the expiry date which is stated on the vial after EXP. The expiration date is the last day of the specified month.
  • Do not use this medicine if the solution is cloudy or contains particles.
  • For single use only. Dispose of unused contents immediately after use.

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 dexamethasone phosphate.
  • 1 ml contains 4 mg dexamethasone phosphate (as 4.37 mg dexamethasone sodium phosphate) – equivalent to 3.33 mg dexamethasone.
  • 5 ml contains 20 mg dexamethasone phosphate (as 21.85 mg dexamethasone sodium phosphate) corresponds to 16.65 mg dexamethasone.

The other ingredients are Disodium edetate, sodium citrate (E 331), sodium hydroxide (E 524) (for pH adjustment ), and water for injections.

What the medicine looks like and the contents of the pack

Dexavit is a clear, colorless solution in a glass ampoule containing 1 ml or 5 ml.

Pack sizes:

1 ml ampoule: 3 x 1 mL vial s and 100 x 1 ml ampoule s

5 ml ampoule: 5 x 5 ml ampoule is

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Vital Pharma Nordic ApS

Tuborgvej 5

2900 Hellerup

Denmark

Manufacturer

HB -Medical ApS

Dr. Neergaardsvej 17

2970 Hørsholm

Denmark

Muhammad Nadeem

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