Diabetes

Authorized indications:

Galvus® is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type-2 diabetes mellitus (T2DM):

• In monotherapy
• In dual combination therapy
• In triple combination therapy

Authorized indications:

Galvus Met® is indicated as a complement to diet and exercise for improving blood sugar control in patients who have not been able to sufficiently control their diabetes with the maximum tolerated dosage of metformin or vildagliptin taken orally in monotherapy, or who are already being treated with a combination of vildagliptin and metformin in individual tablets.

Instructions for Use:

1. Remove the adhesive seal. Attach the needle by screwing it onto the insulin pen.
2. Set the dose as prescribed by your healthcare provider.
3. Remove both the outer and inner needle caps. Inject subcutaneously following your healthcare provider’s guidance.

Note: Insulin pens may vary; consult the device’s manual before use.

Recommended Injection Technique

• BD Ultra-Fine 4mm: Inject at a 90-degree angle without pinching the skin. For children aged 2–6 years or very thin adults, a skin pinch may be required.

Precautions and Warnings

• Always remove the needle from the insulin pen after each use to prevent air entry or insulin leakage.
• Do not inject through clothing.
• Dispose of the needle in a rigid, puncture-proof container. Seal and label the container as biohazardous.
• Use only if the adhesive seal and packaging are intact.
• The sterility of the fluid path is guaranteed as long as the packaging remains unopened and undamaged.
• Keep out of reach of unsupervised children.

For further information, consult a healthcare professional.

Instructions for Use (Multi-Pack):

1. Remove the white cap by twisting it to break the safety seal, exposing the plunger.
2. Twist and remove the orange needle cap, taking care to avoid needle damage.
3. Push the plunger to the tip of the syringe, then slowly pull it back to the prescribed dose. Align the thin black line with the desired dosage mark.
4. Use the syringe once only. Dispose of the syringe and needle immediately after injection.

Attention: Follow instructions to avoid dosing errors.

Precautions

• Patients mixing two types of insulin must:
  • Follow the mixing order prescribed by their physician.
  • Avoid switching syringe brands or models without consulting a healthcare professional.
• Use only with U-100 insulin.
• Sterile as long as the protective caps remain intact (multi-pack) or if the blister pack is sealed (individual blister).
• Single-use product. Discard after use.

Instructions for Use:

1. Open the individual wrapper along the perforated edge.
2. Gently rub the target skin area for 1 minute to ensure thorough disinfection.

Warnings:

• For external use only. Flammable: Keep away from fire or flames.
• Discontinue use if irritation or redness occurs. Seek medical advice if symptoms persist for more than 72 hours.
• Avoid contact with eyes, mucous membranes, or sensitive skin areas. In case of eye contact, rinse thoroughly with water.
• Keep out of reach of children and away from food and beverages.
• Do not inhale fumes; they may cause dizziness or drowsiness.
• Do not use on individuals sensitive to the ingredients or for prolonged periods.
• Do not mix with other products.

In case of accidental exposure or adverse reactions, consult a healthcare professional and provide the product label or packaging.