250 mg, 500 mg, and 1 g powder for solution for injection; Fortum 2 g powder for solution for injection/infusion
ceftazidime

1. What Fortum is and what it is used for

Fortum is an antibiotic used in adults and children (including newborn babies). It works by killing bacteria that cause you an infection. It belongs to a group of medicines called cephalosporins.

Fortum is used to treat serious bacterial infections in:

  • the lungs or chest
  • the lungs and trachea of ​​patients suffering from cystic fibrosis
  • the brain meningitis )
  • the ear
  • the urinary tract
  • the skin and the soft parts
  • abdomen and abdominal wall ( peritonitis )
  • skeleton and joints.

Fortum can also be used:

  • to prevent infection during prostate surgery in men
  • to treat patients with low white blood cell count ( neutropenia ) who have a fever due to a bacterial infection.

Ceftazidime contained in Fortum may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you are given Fortum

You must not be given Fortum:

  • if you are allergic to ceftazidime or any of the other ingredients of this medicine (listed in section 6).
  • if you have had a severe allergic reaction to any other antibiotics ( penicillin, monobactam, and carbapenem) as you may also be allergic to Fortum.
  • Tell your doctor before starting Fortum if you think this is true for you. You must not be given Fortum.

Take special care with Fortum

You need to be aware of certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal diseases such as diarrhea when you are given Fortum. This reduces the risk of possible problems. See (“Conditions you need to be aware of”) in section 4. If you have had an allergic reaction to another antibiotic, you may also be allergic to Fortum.

If you need a blood or urine sample

Fortum can affect the results of urine tests for sugar and a blood test called the Coombs test. If you are going to do a test:

  • Tell the person taking the test that you have received Fortum.

Other drugs and Fortum

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

You should not be given Fortum without talking to your doctor if you are also taking:

  • an antibiotic called chloramphenicol
  • a type of antibiotic called aminoglycoside is, e.g. gentamicin, tobramycin
  • diuretic tablets called furosemide .
  • Tell your doctor if this is true for you.

Pregnancy, breastfeeding, and fertility

Consult your doctor before giving Fortum:

  • If you are pregnant, think you may be pregnant or planning to become pregnant
  • if you are breast-feeding.

Your doctor will consider the benefit of treating you with Fortum against the risk to your baby.

Driving and using machines

Fortum can cause side effects, such as dizziness that can affect your ability to drive.

Do not drive or use machines unless you are sure you have not been affected.

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.

Fortum contains sodium

You need to take this into account if you have been prescribed a low-salt diet.

Strength of Fortum Quantity per bottle
Fortum 250 mg 13 mg
Fortum 500 mg 26 mg
Fortum 1 g 52 mg
Fortum 2 g 104 mg
Fortum 2 g Monrovia 104 mg

3. How Fortum is given

Fortum is usually given by a doctor or nurse. It can be given as a drip ( intravenous infusion ) or as an injection directly into a vein or muscle.

Fortum is prepared by a doctor, pharmacist, or nurse using water for injections or a suitable infusion solution.

Recommended dose

The correct dose of Fortum for you is determined by your doctor and depends on: the severity and type of infection, if you are taking any other type of antibiotic, your weight, and age, how well your kidneys are working.

Newborns (0–2 months)

For every 1 kg the child weighs, 25 to 60 mg of Fortum is given per day divided into two doses.

Infants (over 2 months) and children weighing less than 40 kg

For every 1 kg the infant or baby weighs, 100 to 150 mg of Fortum is given per day divided into three doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more

1 to 2 g Fortum 3 times daily. Maximum 9 g per day.

Patients over 65

The daily dose should not normally exceed 3 g per day, especially if you are over 80 years old.

Patients with kidney problems

You may be given a different dose than the regular dose. Your doctor or nurse will determine how much Fortum you need, depending on the severity of your kidney disease. Your doctor will monitor you closely and you may need to have more regular kidney function tests.

If you have received too much Fortum

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 accidentally take more than your prescribed dose, contact your doctor or nearest hospital immediately.

If you forget to use Fortum

If you miss an injection, you should take it as soon as possible. Do not take a double dose (two injections at the same time) to make up for a forgotten dose, but take your next dose at the usual time.

Do not stop taking Fortum

Do not stop taking Fortum unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

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

Conditions that you need to be aware of

The following serious side effects have affected a small number of people but it is not known how often they occur:

  • severe allergic reaction. Signs include raised and itchy rashes, swelling, sometimes on the face or mouth that make it difficult to breathe.
  • skin rash that can form blisters and look like small targets (dark dot in the middle surrounded by a lighter area with a dark ring around the edge).
  • a widespread rash with blisters and scaly skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis ).
  • disorders of the nervous system tremors, seizures, and in some cases coma. These have affected people when the dose they have been given has been too high, especially for people with kidney disease.
  • In rare cases, there have been reports of severe hypersensitivity reactions with severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increase in a type of white blood cell ( eosinophilia ), effect on liver, kidneys or lungs (a reaction called DRESS syndrome).
  • Contact a doctor or nurse immediately if you get any of these symptoms.

Common side effects are

These can occur in up to 1 in 10 people:

  • diarrhea
  • swelling and redness along a vein
  • red raised rash that may be itchy
  • pain, burning sensation, swelling, or inflammation at the injection site.
  • Tell your doctor if any of these bother you.

Common side effects that can be detected in blood tests:

  • an increase in a type of white blood cell ( eosinophilia )
  • an increase in the number of cells that help the blood to clot
  • an increase in liver enzymes.

Uncommon side effects are

These can occur in up to 1 in 100 people:

  • inflammation of the intestine which may cause pain or diarrhea which may contain blood
  • cod – a fungal infection of the mouth or vagina
  • headache
  • dizziness
  • magont
  • nausea or vomiting
  • fever and chills.
  • Tell your doctor if you experience any of these side effects.

Uncommon side effects that can be detected in blood tests:

  • a decrease in the number of white blood cells
  • a decrease in the number of platelets (cells that help the blood to clot)
  • an increase in the levels of urea, urea nitrogen, or serum creatinine in the blood.

Very rare side effect s

These can occur in up to 1 in 10,000 people:

  • inflammation of the kidneys or renal failure.

Other side effects are

Other side effects have been reported in a small number of people but it is not known how often they occur:

  • numbness
  • taste change
  • yellowing of the whites of the eyes or the skin.

Other side effects that can be detected in blood tests:

  • red blood cells that are destroyed too quickly
  • an increase in a certain type of white blood cell
  • severe decrease in white blood cell count.

5. How to store Fortum

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. The expiration date (Expiration Date) is the last day of the specified month.

Do not store above 25 ° C.

Store the bottle in the outer carton. Sensitive to light.

250 mg, 500 mg, 1 g powder for solution for injection, 2 g powder for solution for injection or infusion

Ready-made and diluted solution

Your doctor, pharmacist, or nurse will prepare your medicine in water for injections or other compatible liquid. The reconstituted solution should be used within 6 days when stored in a refrigerator (at 4 ° C) and 9 hours when stored at room temperature (maximum 25 ° C).

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will discard any leftover medicine. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ceftazidime pentahydrate corresponding to ceftazidime 250 mg, 500 mg, 1 g, and 2 g respectively.
  • The only other ingredient is sodium carbonate (anhydrous, sterile).
  • See section 2 for further important information on sodium, which is an ingredient in Fortum.

What the medicine looks like and the contents of the pack

Fortum 250 mg powder for solution for injection is a sterile, white to cream powder, supplied in 17 ml glass bottles with bromobutyl rubber stoppers and an aluminum closure with a flip-off cap.

Pack of 5 bottles.

Fortum 500 mg powder for solution for injection is a sterile, white to cream-colored powder supplied in 17 ml glass bottles with bromobutyl rubber stoppers and an aluminum closure with a flip-off cap.

Pack of 5 bottles.

Fortum 1 g powder for solution for injection is a sterile, white to cream-colored powder supplied in 26 ml glass bottles with bromobutyl rubber stoppers and an aluminum closure with a flip-off cap.

Pack of 5 bottles.

Fortum 2 g powder for solution for injection/infusion is a sterile, white to cream-colored powder supplied in 77 ml glass bottles with bromobutyl rubber stoppers and an aluminum closure with a flip-off cap.

Pack of 5 bottles.

Not all pack sizes may be marketed.

Your doctor, pharmacist, or nurse will prepare your medicine in water for injections or other compatible liquid. After preparation, the solution may vary in color from light yellow to amber. This is completely normal.

Marketing Authorisation Holder

GlaxoSmithKline AB, Box 516, 169 29 Solna

Tel: 08-638 93 00

Email: info.produkt@gsk.com

Manufacturer

ACS Dobfar SpA

Via Alessandro Fleming 2

37135 Verona

Italy

This medicinal product is authorized under the European Economic Area under the names:

250 mg powder for solution for injection :

France – Fortum enfants et nourrisons

Italy – Glazidim

Poland, Great Britain – Fortum

500 mg powder for solution for injection :

Czech Republic, Denmark, Ireland, Lithuania, Netherlands, Norway, Poland, Romania, Slovakia, UK – Fortum

Belgium, Finland, Italy, Luxembourg – Glazidim

France – Fortum enfants et nourrisons

Portugal – Cefortam

1 g powder for solution for injection :

Finland, Italy – Glazidim

The Netherlands, Iceland – Fortum

2 g powder for injection/infusion solution, solution:

Austria, Czech Republic, Denmark, France, Hungary, Iceland, Lithuania, Netherlands, Norway, Poland, Romania, Slovakia, UK – Fortum

Belgium, Italy, Luxembourg – Glazidim

Finland – Glazidim

France – Fortumset

Greece – Solve

Portugal – Cefortam

Spain – Fortum IV

2 g powder for solution for infusion (Monovial packaging):

Ireland, the UK – Fortum

Italy – Glazidim

Muhammad Nadeem

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