Gantsiklovir-Pharmex liofit. for solution for inf. 500 mg fl. No. 1

Gantsiklovir-Pharmex it is shown to adults and teenagers ≥ 12 years for:

• treatment of a Cytomegaloviral (CMV) infection at patients with an immunodeficiency;
• prevention of CMV of an infection by preventive therapy at patients with medicamentous immunosuppression (for example, after transplantation of body or chemotherapy of cancer).

Gantsiklovir-Pharmex it is also shown to children from the birth for prevention of CMV of an infection by universal prevention at patients with medicamentous immunosuppression (for example, after transplantation of body or chemotherapy of cancer).

Structure

Active ingredient: gantsiklovir;

1 bottle supports a gantsiklovir of 500 mg (in the form of a gantsiklovir of sodium salt).

Contraindication

Hypersensitivity to a gantsiklovir, a valgantsiklovir or to other component of medicine.

Feeding by a breast.

Route of administration

Attention: gantsiklovir it is necessary to enter by intravenous infusion within 1 hour in the concentration which is not exceeding 10 mg/ml. It is impossible to enter by a fast or bolyusny injection as the toxicity of a gantsiklovir can increase because of its excessive level in blood plasma.

Cannot be entered by an intramuscular or subcutaneous injection as it can lead to heavy irritation of fabrics because of a high rn (~ 11) solution of a gantsiklovir.

Cannot exceed the recommended doses, frequency or speed of infusion.

Gantsiklovir-Pharmex is a lyophilisate (powder) for preparation of solution for infusions. After restoration the medicine Gantsiklovir-Pharmex represents solution from colourless till light yellow color, practically without visible particles.

to a vein with the corresponding stream of blood, it is desirable through a plastic cannula.

Feature of application

Pregnant

Gantsiklovir should not be applied to pregnant women, except cases when clinical need for treatment of the woman exceeds possible teratogenic risk for a fruit.

Children

limited experience of treatment of children up to 12 years Exists.

Drivers

Use of a gantsiklovir can significantly influence control of motor transport and work with other mechanisms.

Overdose

About overdose cases gantsikloviry (some with a lethal outcome) was reported during conduct of clinical trials and at postregistration use of medicine. The majority of messages were not connected with emergence of any side reactions or included one or more side reactions from the list given below:

• hematologic toxicity: myelosuppression, in particular pancytopenia, leukopenia, neutropenia, granulocytopenia, insufficiency of marrow;
• hepatotoxicity: hepatitis, abnormal liver function;
• kidney toxicity: strengthening of a hamaturia at patients with the renal failures which are available before, a sharp renal failure, increase in level of creatinine;
• gastrointestinal toxicity: abdominal pain, diarrhea, vomiting;
• neurotoxicity: generalized tremor, spasms.

during a hemodialysis; thus, in blood plasma of patients to whom the excess amount of the medicament is administered it is possible to apply a hemodialysis to decrease in its level.

Side effects

Note: valgantsiklovir is an inactive form (pro-medicine) of a gantsiklovir, and side reactions, connected with application of a valgantsiklovir, it is possible to expect in case of application of a gantsiklovir. Gantsiklovir is not made for oral administration any more, but side reactions about which reported during its application can be expected at the patients receiving gantsiklovir intravenously. Therefore the list includes side reactions which were observed at intravenous or oral administration of a gantsiklovir or valgantsiklovir.

patients who were treated gantsiklovirom/valgantsikloviry the most serious and frequent side reactions had a neutropenia, anemia and thrombocytopenia.

Interaction

Probenetsid. Use of a probenetsid with an oral gantsiklovir leads to significant decrease in kidney clearance of a gantsiklovir that, in turn, leads to the significant growth of exposure. Similar effects are expected also in case of simultaneous intravenous application of a gantsiklovir and a probenetsid. Thus, the patients accepting probenetsid and gantsiklovir should be observed carefully regarding toxicity of a gantsiklovir.

Didanozin. It is established that at simultaneous application of a didanozin and gantsiklovir of concentration of a didanozin in blood plasma steadily raise. At intravenous administration of a gantsiklovir in doses of 5-10 mg/kg in day of AUC the didanozina increases by 38-67%. Clinically significant changes of concentration of a gantsiklovir at the same time were not. However taking into account increase in plasma concentration of a didanozin in the presence of a gantsiklovir of patients it is necessary to observe carefully concerning toxicity of a didanozin.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Expiration date - 3 years.