Your Guide to Blafol: Understanding Propofol Injection

This article serves as your comprehensive guide to Blafol, a medication containing Propofol Injection BP 1% w/v. It is important to read this leaflet carefully, especially if you’ve been prescribed this medicine. Here, we provide vital information about its use and potential side effects.

1. What is Blafol, and What is it Used For?

Blafol contains a medication called Propofol, which falls under the category of general anaesthetics. General anaesthetics are administered to induce unconsciousness or a state of sleep. This is crucial for various medical procedures or surgeries. Propofol can also be used to sedate individuals, making them drowsy but not entirely unconscious.

Blafol is used for the following:

In adults and children over 1 month of age:

  • Inducing sleep before a procedure.
  • Maintaining sleep during a procedure.
  • Sedation during diagnostic and surgical processes, either alone or combined with local or regional anaesthesia.

In individuals over 16 years old, it is also used:

  • For sedation during artificial respiration in an Intensive Care Unit (ICU).

2. What to Consider Before Using Blafol

Before using Blafol, be aware of the following:

Do NOT use Blafol if:

  • You are allergic to Propofol or any of the other ingredients listed in section 6.
  • You are allergic to peanuts or soya, as Blafol contains soya oil.
  • You are 16 years of age or younger and require sedation in intensive care.

If any of these conditions apply to you, do not take Blafol, and inform your doctor, anaesthetist, or nurse. If you’re uncertain, consult with one of these professionals before proceeding.

Special Care with Blafol:

  • If you have ever experienced a seizure or convulsion.
  • If you’ve been informed of extremely high fat levels in your blood.
  • If your body has difficulty processing fat.
  • If you are dehydrated (severely lacking water).
  • If you have other health issues such as heart problems, breathing difficulties, kidney or liver problems.
  • If you’ve been generally unwell for an extended period.
  • If you have mitochondrial disease.

If you’re unsure whether any of these conditions apply to you, consult your doctor or nurse before taking Blafol.

Taking Other Medicines:

Inform your healthcare provider about any other medicines you’re taking, including non-prescription and herbal remedies. In particular, let your doctor, anaesthetist, or nurse know if you are taking Rifampicin for tuberculosis (TB).

Pregnancy and Breastfeeding:

Avoid using Blafol during pregnancy unless it is absolutely necessary. If you are pregnant, breastfeeding, planning to have a baby, or suspect pregnancy, consult your doctor before taking this medicine.

Driving and Using Machines:

After taking Blafol, do not drive, operate tools, or machinery until you’re certain the effects have worn off. You may still feel drowsy for a period.

  • If you are discharged shortly after receiving Blafol, refrain from driving or using tools and machinery.
  • Check with your doctor for guidance on when you can resume these activities and return to work.

Important Information about Blafol Ingredients:

Blafol contains sodium. If you are on a sodium-controlled diet, consider this in your dietary choices. Also, if you are allergic to peanuts or soya, do not use this product, as it contains soya oil. During prolonged use of Blafol in intensive care, you may require a zinc supplement due to the presence of disodium edetate.

3. How to Use Blafol

Blafol is administered by a medical professional. It is given as an injection into a vein, often in the back of your hand or forearm. The injection can be delivered through a needle or a fine plastic tube known as a ‘cannula.’ In some cases, an electric pump is used to control the speed of the injection, particularly during extended surgeries or ICU treatment.

The required dose of Blafol varies from one patient to another. It depends on factors like your age, size, physical condition, and the desired level of sleepiness or sleep. Your doctor will determine the initial and maintenance doses by closely monitoring your responses and vital signs, such as pulse, blood pressure, and breathing.

During anaesthesia, you might require several medications to ensure you stay asleep or sleepy, are pain-free, breathe healthily, and maintain steady blood pressure. Your doctor will decide which medications you need and when.

4. Possible Side Effects

Like all medications, Blafol may cause side effects, although not everyone experiences them. Side effects can be categorized into those that occur during anaesthesia and those that occur after.

Side effects that can happen during anaesthesia include:

  • Feeling pain at the injection site (before falling asleep).
  • Low blood pressure.
  • Changes in breathing patterns.
  • Slow heartbeat.
  • Twitching, shaking, or seizures (which may also occur upon waking).
  • Unusual urine color (which may also occur upon waking).
  • Allergic reactions.
  • Cardiac arrest.
  • Fluid buildup in the lungs leading to breathlessness (which may also occur upon waking).
  • Shallow breathing.
  • Prolonged, sometimes painful erection (priapism).

Side effects that can happen after anaesthesia include:

  • Nausea.
  • Vomiting.
  • Headache.
  • Vein swelling, redness, or blood clots.
  • Feeling sexually aroused.
  • Fever.
  • Redness or soreness at the injection site.
  • Unconsciousness after the operation (patients have recovered without complications).
  • Tissue damage.
  • A feeling of pain at the injection site.
  • Injection site swelling.
  • Prolonged, often painful erection (priapism).
  • Withdrawal symptoms (unusual behavior, sweating, shaking, anxiety).
  • Skin flushing.
  • Euphoric mood.
  • Involuntary movements.
  • Drug abuse and dependence on Blafol (mainly by healthcare professionals).
  • Abnormal ECG.
  • Rhabdomyolysis (breakdown of muscle cells).

Remember that not everyone will experience these side effects. If you encounter serious side effects or ones not listed here, notify your healthcare provider.

5. How to Store Blafol

Proper storage of Blafol is vital:

  • Keep it out of children’s reach.
  • The doctor and hospital pharmacist are responsible for storing, using, and disposing of Blafol correctly.
  • Store Blafol below 30ºC and do not freeze it.
  • Do not use Blafol after the expiration date mentioned on the carton.
  • Properly dispose of unused or expired Blafol through your pharmacist to protect the environment.

6. Additional Information

What Blafol Contains:

  • Active substance: Propofol, 10 mg per ml.
  • Other ingredients: Soybean Oil, Egg Phospholipid (Lipoid E 80), Glycerol, Disodium Edetate, Sodium Oleate B, Sodium Hydroxide.

Description and Packaging:

Blafol is a milky white emulsion, packaged in 10 ml 20 mm Flint Tubular USP Type-I Vials, with Rubber Stopper Grey Bromo Butyl RFU & Aluminum Seal Lacq 20mm F/O Top Transparent yellow.

Marketing Authorization Holder and Manufacturer:

Bliss GVS Pharma Ltd. 102, Hyde Park, Saki Vihar Road, Andheri (E), Mumbai – 400 072, INDIA. Tel: +91 – 22 – 4216 0000 / 28505387 Fax: + 91 – 22 – 28563930

This leaflet was last revised in June 2020. Always consult your healthcare provider for personalized advice. Your safety and well-being are of utmost importance.