Apulco Acometh 0.3%/0.3%/0.3% medicinal compressed gas

Spain
Brand name Apulco Acometh 0.3%/0.3%/0.3% medicinal compressed gas
Form gas, medicinal compressed
Active substance / Dosage
METHANE · 0,3 % M/M
CARBON MONOXIDE · 0,3 % M/M
ACETYLENE · 0,3 % M/M
Prescription type Hospital Use Only
Registration number 80759

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apulco Acometh 0.3%/0.3%/0.3% medicinal compressed gas

Carbon monoxide (CO), methane (CH4), and acetylene (C2H2).

Read all of this leaflet carefully before you start using this medicine, 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.
  • This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What Apulco Acometh is and what it is used for
  2. What you need to know before using Apulco Acometh
  3. How to use Apulco Acometh
  4. Possible adverse effects
  5. How to store Apulco Acometh
  6. Contents of the pack and other information

1. What Apulco Acometh is and what it is used for

Apulco Acometh is a medicinal gas used solely for diagnostic purposes. It is administered during pulmonary function tests and is primarily used to measure the lungs' capacity to absorb the inhaled gas into the bloodstream. It may also be used to measure lung volume and pulmonary blood flow.

2. What you need to know before using Apulco Acometh

Do not use Apulco Acometh:

  • Unless your doctor has requested that you undergo pulmonary function tests.

Warnings and precautions

Consult your doctor before starting to use Apulco Acometh for pulmonary function testing.

Use of Apulco Acometh with other medicines

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

Use of Apulco Acometh with food, beverages and alcohol

When using Apulco Acometh, you should not be in a condition that would prevent you from properly performing the pulmonary function test as instructed by your doctor or medical personnel.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before inhaling Apulco Acometh.

Driving and using machines

Using Apulco Acometh during pulmonary function tests should not affect your ability to drive or operate machinery.

3. How to use Apulco Acometh

Inhale Apulco Acometh only during pulmonary function diagnostic tests and exactly as directed by your doctor or the medical personnel attending you. If in doubt, consult your doctor again.

Only your doctor or the medical personnel attending you should decide the duration of the pulmonary function diagnostic test and how frequently the test should be repeated.

4. Possible adverse effects

During inhalation of Apulco Acometh in pulmonary function tests, adverse effects such as dizziness, chest pain, and a sensation of disorientation may occur, although these are very rare. If any of these symptoms appear while using the medicinal gas, inhalation of Apulco Acometh must be stopped immediately and appropriate medical treatment administered.

A venous blood sample may need to be drawn for blood gas analysis after inhalation of Apulco Acometh.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may 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. Conservation of Apulco Acometh

Keep out of the sight and reach of children.

Gas cartridges must be stored under cover and protected from adverse weather conditions.

Do not use this medicinal gas after the expiry date stated on the label.

Do not dispose of this medicinal gas in the trash. Return it to your supplier. This will help protect the environment.

6. Contents of the package and other information

What Apulco Acometh contains

The active substances are carbon monoxide and helium.

The other components are nitrogen and oxygen.

What Apulco Acometh looks like and contents of the pack

Apulco Acometh is an odourless, colourless compressed gas in aluminium gas cylinders.

The body of the gas cylinder is white and the top part of the cylinder is bright green.

Pack sizes in litres (200 bar): 5 L, 10 L, 20 L and 40 L.

Capacity in liters

Filling pressure (bar)

Gas liters

m3 of gas at 1 bar and 15°C

5

200

904

0.904

10

200

1808

1.808

20

200

3615

3.615

40

200

7231

7.231

Marketing Authorization Holder

S.E. de Carburos Metálicos S.A.

Avda. de la Fama, 1

08940 Cornella de Llobregat

Spain

Manufacturer

S.E. de Carburos Metálicos S.A.

Pol. Nord-Este C-35, km 59

08470 Sant Celoni

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Netherlands: Apulco Acometh.

Germany: Apulco Acometh.

Spain: Apulco Acometh.

Portugal: Apulco Acometh.

Date of the most recent review of this leaflet: March 2021

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