SAIZEN 8mg / ml injectible solution medication leaflet

H01AC01 somatropin • Systemic hormonal preparations, excluding sex hormones and insulins | Anterior pituitary lobe hormones and analogues | Somatropin and somatropin agonists

Somatropin is a recombinant human growth hormone used to treat growth disorders and growth hormone deficiency. It is indicated for conditions such as growth hormone deficiency in children and adults, Turner syndrome, chronic kidney failure in children, Prader-Willi syndrome, and for children born small for gestational age who have not caught up in growth.

It is administered via subcutaneous injection, usually once daily, with the dose adjusted based on body weight and the patient's response.

Common side effects include pain at the injection site, edema, joint or muscle pain, and, in some cases, increased blood sugar levels. Rarely, it may cause intracranial hypertension or allergic reactions.

Somatropin is contraindicated in patients with active tumors, acute critical illnesses, or allergies to the product's components. Regular medical monitoring is required to assess its effectiveness and safety.

General data about SAIZEN 8mg / ml

Substance: somatropin

Date of last drug list: 01-08-2019

Commercial code: W66037004

Concentration: 8mg / ml

Pharmaceutical form: injectible solution

Quantity: 5

Product type: original

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: MERCK SERONO S.P.A. - ITALIA

Holder: MERCK ROMANIA SRL - ROMANIA

Number: 13318/2020/04

Shelf life: 18 months; Dupa prima deschidere a cartusului - 28 days

Concentrations available for somatropin

1.3mg/ml, 10mg/1.5ml, 10mg/2ml, 10mg/ml, 15mg/1.5ml, 16UI/ml(5.3mg/ml), 3.3mg/ml, 4mg, 5.3mg/ml (16ui), 5.83mg/ml, 5mg/1.5ml, 5mg/ml, 6.7mg/ml, 8mg/ml