Package Insert: Information for the Patient

Prokam50 mg Powder for Injectable Solution

Cefuroxime

Read this package insert carefully before this medicine is administered to you, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Prokam and how is it used

2. What you need to know before Prokam is administered to you

3. How to administer Prokam

4. Possible adverse effects

5. Storage of Prokam

6. Contents of the package and additional information

• Prokamcontains an active substance, cefuroxime (as cefuroxime sodium) that belongs to a group of antibiotics called cephalosporins. Antibiotics are used to eliminate bacteria or germs that cause infections.

• This medication will be used if you are scheduled for cataract surgery (opacity of the crystalline lens).
• To prevent eye infection, the ophthalmic surgeon will inject this medication into your eye at the end of the cataract surgery.

Do not useProkam

• If you are allergic (hypersensitive) to cefuroxime or any of the antibiotics in the cephalosporin group.

Warnings and precautions

Inform your doctor, pharmacist or nurse before starting to use,Prokam:

• If you are allergic to other antibiotics such as penicillin,
• If you are at risk of developing an infection caused by bacteria known asStaphylococcus aureusresistant to methicillin,
• If you are at risk of developing a severe infection,
• If you have been diagnosed with a complicated cataract,
• If you are scheduled to undergo combined eye surgery,
• If you have a severe thyroid disease.

Prokamis only administered as an injection into the eye (intracameral injection).

Prokamshould only be administered in aseptic conditions (meaning cleanliness and absence of germs) typical of cataract surgery.

Each vial of Prokamshould be used for a single patient.

Use of Prokam with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication

Pregnancy andbreastfeeding

• If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor or pharmacist before this medication is administered to you.
• Prokamwill only be administered in cases where the benefits outweigh the potential risks.

Prokam contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.

• Prokam injectionswill be administered by an ophthalmic surgeon at the end of cataract surgery.
• Prokamis presented as a sterile powder, which dissolves in saline solution for injection before administration.

If too much or too little Prokam is administered

This medication will be administered by a healthcare professional. If you think you have missed a dose or received too much medication, inform your doctor or nurse.

If you have any other questions about the use of thismedication, ask your doctor,pharmacistor nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, Prokammay cause adverse effects, although not all people will experience them.

The following adverse effects are very rare (may affect up to 1 in 10,000 people):

• Severe allergic reaction that causes difficulty breathing or fainting.

The following adverse effect has been reported with an unknown frequency (cannot be estimated from available data):

• Macular edema (blurred or distorted vision near or in the center of your field of vision).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use.:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe vial label and cartonafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above25ºC.Keep the vial in the outer packaging to protect it from light.

For single use only.

After reconstitution: the product must be used immediately.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacisthow to disposeofthepackaging and of themedicines that you no longerneed. This will help protect the environment.

Composition ofProkam

The active principle iscefuroxima (in the form of cefuroxima sodium).

Each vial contains 50 mg of cefuroxima.

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

There are no other components.

Appearance ofProkamand contents of the package

Prokam is a white to almost white powder for injectable solution, contained in a glass vial.

Each box contains one, or ten or twenty vials or ten vials together with ten sterile 5-micron filter needles. Some package sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LABORATOIRES THEA

12 rue Louis Blériot

63017 CLERMONT-FERRAND Cedex 2

France

Local representative:

Laboratorios THEA S.A.

C/ Enric Granados, nº 86-88, 2nd floor

08008 Barcelona

Responsible for manufacturing:

BIOPHARMA S.R.L.

Via Delle Gerbere, 22/30 Santa Palomba

00134 ROMA

Italy

or

LABORATOIRES THEA

12 rue Louis Blériot

63017 CLERMONT-FERRAND Cedex 2

France

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Iceland, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, United Kingdom …………………………………………………Aprokam

Cyprus, Greece, Spain…………………………………………………………..Prokam

Ireland…………………………………………………………………………….APROK

Date of the last review of thisleaflet:August 2019

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Incompatibilities

There are no references to incompatibilities with the products used in cataract surgery in the literature. This medicinal product should not be mixed with other products, except for the following [sodium chloride 9 mg/ml (0.9%) solution for injection].

How to prepare and administer Prokam

Single-use vial, for intracameral use only.

After reconstitution, Prokammust be administered by intracameral injection into the anterior chamber of the eye (intracameral injection), by an ophthalmic surgeon, in the recommended aseptic conditions of cataract surgery.

The reconstituted solution must be visually inspected, and only used if it is a colorless to yellowish solution without visible particles.

After reconstitution, the product must be used immediately and should not be reused.

The vial is for single use only.

Only one vial per patient. Attach the detachable label to the patient's documentation.

The disposal of unused medicinal product and all materials that have been in contact with it, will be carried out in accordance with local regulations.Dispose of used needles in a sharp objects container.