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About the medicine

How to use PROKAM 50 mg POWDER FOR INJECTABLE SOLUTION

Contents of the leaflet

  1. Introduction
  2. What is Prokam and what is it used for
  3. What you need to know before you are given Prokam
  4. How Prokam is administered
  5. Possible side effects
  6. Storage of Prokam
  7. Contents of the pack and further information

Introduction

Package Leaflet: Information for the Patient

Prokam50 mg powder for solution for injection

Cefuroxime

Read all of this leaflet carefully before this medicine is administered to you because it contains important information for you.

  • Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Prokam and what is it used for
  2. What you need to know before you are given Prokam
  3. How Prokam is administered
  4. Possible side effects
  5. Storage of Prokam
  6. Contents of the pack and further information

1. What is Prokam and what is it used for

  • Prokam contains the active substance cefuroxime (as cefuroxime sodium), which belongs to a group of antibiotics called cephalosporins. Antibiotics are used to kill the bacteria or germs that cause infections.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or the common cold.

It is important to follow the instructions regarding the dose, administration interval, and duration of treatment indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

  • This medicine will be used if you are undergoing cataract surgery (opacity of the lens).
  • In order to prevent eye infection, the ophthalmic surgeon will inject this medicine into your eye at the end of the cataract operation.
Doctor consultation

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

Do not useProkam

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

Warnings and precautions

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

    Staphylococcus aureusresistant to methicillin,

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

Prokam should only be administered under aseptic conditions (meaning cleanliness and absence of germs) typical of cataract surgery.

Each vial of Prokam should be used for a single patient.

Using Prokam with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy andbreast-feeding

  • If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before this medicine is administered to you.
  • Prokam will only be administered if the benefit outweighs the potential risks.

Prokam contains sodium

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

3. How Prokam is administered

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

If you are given too much or too little Prokam

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

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

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

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

  • Severe allergic reaction causing difficulty breathing or fainting.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for human use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Prokam

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 label of the vial and the carton after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C. Keep the vial in the outer packaging to protect it from light.

For single use only.

After reconstitution: the product 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. This will help protect the environment.

6. Contents of the pack and further information

Composition ofProkam

The active substance is cefuroxime (as cefuroxime sodium).

Each vial contains 50 mg of cefuroxime.

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

There are no other ingredients.

Appearance ofProkamand pack contents

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

Each box contains one, ten, or twenty vials, or ten vials along with ten sterile needles with a 5-micron filter. Only certain pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

LABORATOIRES THEA

12 rue Louis Blériot

63017 CLERMONT-FERRAND Cedex 2

France

Local representative:

Laboratorios THEA S.A.

C/ Enric Granados, nº 86-88, 2ª planta

08008 Barcelona

Manufacturer:

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 medicine is authorised in the Member States of the European Economic Area under the following names:

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

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

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

Date of last revision of thisleaflet:August 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

Incompatibilities

There are no references to incompatibilities with products commonly used in cataract surgery in the literature. This medicine should not be mixed with other medicines, except for those mentioned below [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, Prokam should be administered by intraocular injection into the anterior chamber of the eye (intracameral injection), by an ophthalmic surgeon, under the recommended aseptic conditions of cataract surgery.

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

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

The recommended dose for cefuroxime is 1 mg in 0.1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

DO NOT INJECT MORE THAN THE RECOMMENDED DOSE.

The vial is for single use.

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

To prepare Prokamfor intracameral administration, follow these instructions:

Black text that says “Must be disinfected” in large and bold lettersMedicine vial with cap removed and needle connected to a superior administration device

  1. Check the integrity of the "flip-off" cap before removing it.

White medicine vial with rectangular cap and black arrow pointing downwards indicating direction

  1. Before proceeding to step 3, disinfect the rubber stopper surface of the vial.

5 ml syringe extracting liquid from a transparent vial with a needle pointing downwards indicated by black arrows

  1. Insert the needle (sterile) vertically into the center of the vial stopper, keeping the vial in a vertical position. Aseptically inject 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into the vial.

Medicine vial with gray stopper and four transparent vials around it showing curved arrows

  1. Gently shake until no particles are observed in the solution.

Syringe extracting liquid from a transparent vial with a needle inserted and arrows indicating the movement of the plunger

  1. Attach a needle (18G x 1 ½, 1.2 mm x 40 mm) with a sterile 5-micron filter (acrylic copolymer with a non-woven nylon membrane) to a sterile 1 ml syringe (the needle with a 5-micron filter may be found inside the box). Then, insert this sterile syringe vertically into the center of the vial stopper, keeping the vial in a vertical position.
  2. Aseptically, aspirate at least 0.1 ml of the solution.

Syringe with interchangeable needles and tips separated showing how they connect to the applicator

  1. Remove the needle from the syringe and attach a sterile anterior chamber cannula to it.

Pre-filled syringe with 0.1 ml of transparent liquid showing a graduated scale and beveled needle tip

  1. Carefully remove the air from the syringe and adjust the dose to the 0.1 ml mark on the syringe. The syringe is now ready for injection.

After use, discard any remaining reconstituted solution. Do not store it for later use.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations. Dispose of used needles in a puncture-resistant container.

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Frequently Asked Questions

PROKAM 50 mg POWDER FOR INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in PROKAM 50 mg POWDER FOR INJECTABLE SOLUTION is cefuroxime. This information helps identify medicines with the same composition but different brand names.

PROKAM 50 mg POWDER FOR INJECTABLE SOLUTION is manufactured by Laboratoires Thea. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Ophthalmologists, ENT doctors, General medicine doctors may assess whether PROKAM 50 mg POWDER FOR INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, PROKAM 50 mg POWDER FOR INJECTABLE SOLUTION is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (cefuroxime) include AZYDROP 15mg/g, SINGLE-DOSE SOLUTION EYE DROPS, COLIRCUSI GENTAMICINA 3mg/ml EYE DROPS SOLUTION, FUCITHALMIC 10 mg/g OPHTHALMIC GEL. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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