the package insert of the medicine Cymevene. Therapeutic class of Antiviróticos. Active principles ganciclovir sodium.
Cymevene is used for maintenance treatment of retinitis caused by cytomegalovirus in patients carriers of the AIDS virus, provided that the retinitis is stable after induction therapy, for the prevention of disease by CMV in patients carriers of the AIDS virus, with a risk of developing this disease, and in patients who received a transplant of solid organs. Cymevene injection is restricted to use in hospitals.
When should I not use?
Cymevene should not be used by people with a known allergy to ganciclovir or any of the components of the formula of the product.
How to use?
Cymevene is constituted by powder liófilo white to almost white, and, after reconstitution, the solution-clear to slightly yellowish. Organoleptic characteristics Cymevene does not have organoleptic characteristics striking. Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment. Do not stop treatment without the knowledge of your doctor.
What are the evils that can cause me?
Tell your doctor about the onset of reactions, which are unpleasant. In addition to the beneficial effects of Cymevene , it is possible to occur undesirable effects during the treatment, even when administered as prescribed. Doctors may stop your treatment temporarily or permanently, depending on your conditions. You should check all the possible adverse effects of the use of Cymevene with your doctor. Cymevene may cause a decrease in the count of white blood cells, a condition known as neutropenia. This makes the body more prone to infections and less able to deal with them satisfactorily. This is important if you have had
dysfunction of the bone marrow, is the result of exposure to radiation, or after ingestion of drugs that cause damage to the bone marrow, or as a reaction to other medications. You should ask your doctor what are the signs that may indicate that this type of
problem is happening with you. Initial signs the most common include infections of the gums, throat and upper airway.
Cymevene may also suppress the production of platelets, which are important factors for clotting. A decrease in platelets would increase the risk of bruising and bleeding. If it occurs, you should seek your doctor immediately. Some people may experience anemia, or a decrease in the number of red blood cells, which can cause a feeling of loss of strength and shortness of breath after exertion. Been found tumors in laboratory animals who were given ganciclovir, although to date there is no information from human studies. The drug also has effects on the reproductive system. When used in men, it can decrease the number of
sperm in the semen, which may be total and irreversible. In women, not only can cause infertility, such as the use during pregnancy may cause malformations of the fetus. The adverse effects described below have occasionally been reported with the use of Cymevene: diarrhea, vomiting, loss of appetite, loss of energy, fever, chills, sore throat and flu-like symptoms, abdominal pain, headache, changes in testing blood in the laboratory, mental confusion. Adverse effects are less frequent: pain, infection, cellulitis, abdominal distension, chest pain, breast pain, malaise, photosensitivity, flatulence, eructation, oral ulcers, constipation, difficulty swallowing, fecal incontinence, bleeding, difficulty breathing, tingling of the fingers, rash, itching, hair loss, sweating, acne, blisters, loss of sleep, vertigo, dreams and thoughts abnormal, anxiety, euphoria, changes in gait, confusion, hyperactivity, seizures, tremors, agitation, forgetfulness, visual changes, pain in the eyes or ears, loss of vision, ringing in the ears, conjunctivitis, retinal detachment, decreased hearing, change of taste, urinary tract infection, increased urinary frequency, migraine, abnormal blood pressure, change in heartbeat, weakness, and muscle aches. If you present symptoms such as fever, tremors, pain, difficulty in
breathing or other unwanted effects, you should contact your doctor immediately. If you are concerned about these or other adverse effects, talk with your doctor.
Warnings and Precautions
what should I know before using?
Cymevene should always be used as prescribed by your doctor. Larger Doses than recommended may lead to a severe reduction in the count of white blood cells, which can cause his hospitalization. In the event of an overdose, contact your doctor immediately. Tell your doctor about any medicine you are using, before the beginning or during the treatment.
Before you start the treatment, make sure that your doctor knows if you:
− has some kidney problem;
− you have other diseases or allergies.
Your doctor will request blood tests to determine certain types of blood cells. If you have low number of white blood cells and platelets, should be especially careful. It is very important that both men and women that could have children use
effective methods of contraception during treatment with Cymevene ; men should continue using condoms for 90 days after treatment. The use in children should be carefully evaluated by the pediatrician. You should not be given Cymevene if you are allergic to ganciclovir or to acyclovir.
Caution when driving vehicles and operate machinery
During the treatment, the patient should not drive vehicles or operate machinery, as your skill and attention may be harmed.
Use in pregnancy and during breastfeeding
This medicine should not be used by pregnant women without medical or dental surgeon. Tell your doctor the occurrence of pregnancy during treatment or after its termination. Inform the doctor if you are breast-feeding. During pregnancy or during the period of
breastfeeding Cymevene should only be used after careful evaluation of risks/ benefits by your doctor. Were not conducted clinical studies in children in the age group of 0 to 12 years. Tell the doctor or dentist the appearance of undesirable reactions.
Tell your doctor or dentist if you are taking any other medicine. Do not use this medicine without the knowledge of your doctor. It can be dangerous to your health.
what to do if someone use a larger amount than is recommended?
Overdosage with Cymevene injectable has been reported in clinical studies and during post-marketing experience of the product. In some cases, no adverse event has been reported. The majority of the patients presented toxicity demonstrated in blood tests, changes in the examinations for the evaluation of the function of the liver and kidneys, abdominal pain, diarrhea, vomiting, seizures and tremors widespread. In addition, an adult patient received an excessive volume of ganciclovir injectable by injection in the eye, and presented a temporary loss of vision, secondary to an increase in pressure
intra-ocular due to the volume of fluid injected. In the case of a superdose look for a center of poisoning or medical relief.