Prokam 50 mg powder for injection solution

Spain
Brand name Prokam 50 mg powder for injection solution
Form powder for solution for injection
Active substance / Dosage
CEFUROXIME SODIUM · 52,6 mg
Prescription type Hospital Use Only
ATC code
S01A S01AA S01AA27
Registration number 76098
Manufacturer Laboratoires Thea
Prokam 50 mg powder for injection solution powder for solution for injection

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Prokam 50 mg powder for injectable solution

Cefuroxime

Read the entire leaflet carefully before this medicine is administered to you, because it contains important information for you.

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

Leaflet contents

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

1. What Prokam is and what it is used for

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

  • This medicine will be used if you are undergoing cataract surgery (clouding of the lens).
  • To prevent eye infection, the ophthalmic surgeon will inject this medicine into your eye at the end of the cataract operation.

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

Do not use Prokam

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

Warnings and precautions

Tell 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 called Staphylococcus aureus resistant to methicillin,
  • if you are at risk of developing a severe infection,
  • if you have been diagnosed with complicated cataract,
  • if you are scheduled to undergo combined eye surgery,
  • if you have a severe thyroid disease.

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

Prokam must only be administered under sterile conditions (meaning cleanliness and absence of germs) appropriate for cataract surgery.

Each vial of Prokam must be used for a single patient only.

Use of Prokam with other medicines

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

Pregnancy and breastfeeding

  • If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before receiving this medicine.
  • 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, i.e., 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 supplied as a sterile powder, which is dissolved in sodium chloride solution for injection prior to administration.

If too much or too little Prokam is administered

This medicine will be administered by a healthcare professional. If you think a dose has been missed or that too much medicine has been given, inform your doctor or nurse.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Prokam may produce adverse effects, although not everyone experiences them.

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

  • Severe allergic reaction causing difficulty breathing or fainting.

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

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

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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 outer carton after EXP. The expiry date refers to the last day of the month indicated.

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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prokam

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 components.

Appearance of Prokam and contents of the container

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATOIRES THEA
12 rue Louis Blériot
63017 CLERMONT-FERRAND Cedex 2
France

Local representative:
Laboratorios THEA S.A.
Enric Granados, nº 86-88, 2nd floor
08008 Barcelona
Spain

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 medicinal product is authorized in the European Economic Area member states under 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 most recent review of this package leaflet: August 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Incompatibilities

There are no reported incompatibilities in the literature with products commonly used during cataract surgery. This medicinal product must not be mixed with other medicinal products except 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 must 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 used only if it is a colorless to slightly yellow solution and free from visible particles.

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

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

DO NOT INJECT MORE THAN THE RECOMMENDED DOSE.

The vial is for single use only.

Use only one vial per patient. Attach the detachable label from the vial to the patient's medical record.

To prepare Prokampara for intracameral administration, follow the instructions below:

Black text on white background with the two-line message: Must be disinfectedDiagram showing the removal of the protective cap from a medical vial using a black arrow pointing downwards

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

Schematic drawing of a glass vial with a black curved arrow pointing to the top cap of the container

  1. Prior to proceeding to step 3, disinfect the surface of the vial's rubber stopper.

Diagram showing a syringe labeled 5 ml being pushed downward with an arrow to aspirate liquid from a vial

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

Five medicine vials arranged in a fan shape, the central one in focus and the others slightly blurred and tilted on the sides

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

Syringe with needle inserted into a glass vial for liquid withdrawal, with an arrow pointing downwards

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

Diagram showing the rotational motion to attach different needle tips to a cylindrical syringe body with plunger

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

Technical drawing of a syringe indicating a dose of 0.1 ml with a line pointing to the graduated scale on the cylinder

  1. Carefully remove 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 save it for later use.

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations. Dispose of used needles in a sharps container.