Leaflet ONSWIK 500 unitati/ml 500U / ml solution for injection in pre-filled pen

Product code:
W72198001
Indicated for:
type 2 diabetes mellitus in adults
Route of administration:
injectable
Substance:
insulin efsitora alfa (once-weekly basal insulin analogue)
Insulin efsitora alfa is a long-acting basal insulin given once weekly for type 2 diabetes in adults. It helps cells use glucose and reduces glucose production by the liver. It complements diet and exercise; it is not intended for type 1 diabetes or emergency treatment of severe hyperglycaemia.

After training, inject it under the skin on the same day each week. The clinician chooses the dose and manages any switch from another insulin; do not convert a daily dose into a weekly one yourself. Check the pen label and strength, rotate injection sites and never share pens. Do not inject it daily, into a vein or through an insulin pump.

The main risk is low blood glucose, with sweating, shaking, hunger, palpitations or confusion. Weight gain, injection-site reactions, skin thickening and allergic reactions can also occur. Monitor glucose regularly: illness, missed meals, exercise and other medicines can change insulin requirements.

Follow your hypoglycaemia plan and keep fast-acting sugar available. If someone is unconscious or cannot swallow, give nothing by mouth and call emergency services. Contact the diabetes team about a missed dose, an extra injection or repeated low readings; the long action may require prolonged observation. Discuss pregnancy and kidney problems with the clinician.

General data about ONSWIK 500 unitati/ml 500U / ml

Substance:
insulin efsitora alfa
Product code:
W72198001
Concentration:
500U / ml
Pharmaceutical form:
solution for injection in pre-filled pen
Product type:
Generic medicine
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
LILLY FRANCE S.A.S. - FRANTA
Holder:
ELI LILLY NEDERLAND B.V. - TARILE DE JOS
Number:
2049/2026/01
Shelf life:
2 years

Concentrations available for insulin efsitora alfa

  • 1000U/ml
  • 500U/ml

Precautions:

Driving impairment

This medicine may affect your ability to drive or use machines.

General warning

Read the package leaflet before use.

Avoid alcohol

Avoid alcohol during treatment.

Hypoglycemia

This medicine may lower blood sugar.

Major drug interactions

This medicine may have important interactions with other medicines.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Pediatric warning

Use in children only as recommended in the leaflet or by a doctor.

Electrolyte disturbances

This medicine may change blood electrolyte levels.