Aprokam contains an active substance, cefuroxime (like cefuroxime sodium), an antibiotic belonging to the group cephalosporins. Antibiotics are used to kill the bacteria that cause infection.
This medicine will be used if you have eye surgery for cataracts.
Your eye surgeon will give this medicine with an injection in the eye at the end of cataract surgery to prevent an eye infection.

2. What you need to know before you are given Aprokam

Do not use Aprokam

if you are allergic to cefuroxime or any other antibiotic belonging to the group cephalosporins.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before giving Aprokam:

If you are allergic to other antibiotics such as penicillin.
If you are at risk for an infection caused by a bacterium called methicillin-resistant Staphylococcus aureus ( MRSA ).
If you are at risk for a serious infection.
If you have been diagnosed with complicated cataracts.
If a combined eye operation is planned.
If you have severe thyroid disease.

Aprokam is given only as an injection into the eye (intracameral use).

Aprokam should be given under aseptic conditions (clean and germ-free) during cataract surgery.

One vial should only be used for a single patient.

Other medicines and Aprokam

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

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.
You will only be treated with Aprokam if your doctor deems it necessary.

Aprokam contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.

3. How Aprokam is given

Injection with Aprokam is given by an eye surgeon at the end of cataract surgery.
Aprokam is supplied as a sterile powder and is dissolved in saline solution for injection before administration.

If you take too much, or too little, Aprokam

Your treatment is usually given by healthcare professionals. If you have the impression that a dose has been missed or that you have received too much of the medicine, talk to your doctor or nurse.

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.

The following side effects are very rare (affects less than 1 user in 10,000):

The severe allergic reaction causes difficulty breathing or dizziness.

The following side effects have been reported:

Macular edema (blurred or wavy vision near or in the middle of your field of vision ).

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 Aprokam

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 on the vial after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Keep the vial in the outer carton. Sensitive to light.

For single use only.

After reconstitution, the drug should be used immediately.

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 cefuroxime (as cefuroxime sodium).

One vial contains 50 mg of cefuroxime.

After reconstitution, 0.1 ml of solution contains 1 mg of cefuroxime.

No other ingredients are included.

What the medicine looks like and the contents of the pack

Aprokam is a white to off-white powder for solution for injection in vials.

The pack contains 1, 10, or 20 vials or 10 vials together with 10 sterile filter needles. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Thea Laboratories

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

Manufacturer:

Biopharma SRL

Via Delle Gerber, 22/30 (loc. S. Palomba)

00134 Rom (RM)

Italy