Vivanat Rompharm solution/in type 1 mg/ml 3 ml syringe 1 pc.

An inhibitor of bone resorption, a nitrogen-containing bisphosphonate. It has a selective action on bone tissue, which is caused by a high affinity for hydroxyapatite, the mineral component of bone matrix. Ibandronic acid inhibits bone resorption and has no direct effect on bone formation.

Ibandronic acid prevents bone destruction caused by cessation of gonadal function, retinoids, extracts of tumors and tumors in vivo.

In postmenopausal women reduces the increased rate of bone turnover to the level of reproductive age, which leads to a progressive increase in bone mass.

Ibandronic acid prevents the development of new and reduces the growth of existing bone metastases. It has a dose-dependent inhibitory effect on tumor osteolysis.

Active substance:
Ibandronic acid

Manufacturer

K.O.Romfarm Company SRL Romania

Composition

ml of 1:

ibandronate sodium monohydrate – 1,125 mg, which corresponds to the content of 1 mg of ibandronic acid.

Excipients:

sodium acetate trihydrate – 0.2 mg,

glacial acetic acid – 0.5 mg

sodium chloride – 8.6 mg,

acetic acid 1% solution – to pH 3.7-4.0,

water d / and – up to 1 ml.

Indications

Postmenopausal osteoporosis to prevent fractures.

Metastatic bone disease to reduce the risk of hypercalcemia, pathologic fractures, decrease pain, reduce the need for radiation therapy of pain and the threat of fractures.

Hypercalcemia of malignancy.

Contraindications

For oral administration, and on / in the: hypocalcemia, severe renal impairment (creatinine clearance < 30 ml / min), lesions of the esophagus, leading to delay emptying, such as stricture or achalasia (oral), pregnancy, lactation (breast feeding), children and adolescents under 18 years of age, hypersensitivity to ibandronic acid.

For oral administration: lesions of the esophagus, leading to delay emptying, such as stricture or achalasia; inability to be sitting or standing for 60 minutes.

Side effects

From the digestive system: often – dyspepsia (nausea, abdominal pain), bloating, diarrhea, constipation, gastritis, gastroenteritis, ingestion – esophagitis, gastroesophageal reflux disease; infrequently ingestion – oesophagitis, including ulceration or stricture of the esophagus, dysphagia, vomiting; rarely – duodenitis.
From the nervous system and psyche: often – headache, dizziness, and insomnia.

Skin and subcutaneous tissue disorders: often – a rash.

Allergic reactions: seldom – angioedema, face edema, urticaria.

On the part of the musculoskeletal system: often – arthralgia, myalgia, pain in limb, osteoarthritis, back pain, musculoskeletal pain; infrequently – bone pain; rarely – atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class characteristic of); very rarely – osteonecrosis of the jaw.

From a sight organ: seldom – inflammatory diseases of the eye.

On the part of the body as a whole: often – flu-like symptoms, weakness; infrequently – asthenia.

Other: often – nasopharyngitis, cystitis, urinary tract infection, bronchitis, upper respiratory tract infection, hypertension, hypercholesterolemia; infrequently – the reaction at the injection site, phlebitis, thrombophlebitis; rarely – hypersensitivity reactions; at / in a possible short-term lowering calcium levels in serum.

How to accept, acceptance rate and dosage

Applied inside or / in.

The dose and the scheme of application depend on the indication and the clinical situation.

Active substance

Ibandronic acid

Interaction

While the use of aminoglycosides may develop hypocalcemia (since these active substances reduce the calcium level in the serum for a long time); possible hypomagnesemia.

Special conditions

To use caution in patients with hypersensitivity to other bisphosphonates.

The treatment should monitor renal function, levels of calcium, phosphorus and magnesium in the blood plasma. It is recommended to avoid excessive hydration in patients with circulatory failure.

It will be appreciated that the use of bisphosphonates can cause bronchospasm in patients with asthma and hypersensitivity to aspirin.

Avoid intra-arterial injection.

Products containing calcium and other polyvalent cations (e.g., aluminum, magnesium, iron), including: milk and solid food, can interfere with the absorption of ibandronic acid (they should consume no earlier than 30 minutes after oral administration of the drug).

Pregnancy and lactation

Contraindicated during pregnancy and lactation.

Weight	0.030 kg
Dosage form	injection