Beruflich Dokumente
Kultur Dokumente
VINBL ASTI NE S ULFA TE Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni ngs, VINBLASTINE SU LFATE Dosage & Rx Info | VINBLASTINE SU LFATE Uses, Side E ffects -: Indications, Side E ffe cts, Warni ngs, VINBL ASTI NE S ULFA TE - Drug I nformation - Taj P harma, VIN BLASTI NE SULFATE dose Taj pharma ceuti cals VINBLASTINE SU LFATE interactions, Taj Phar maceutical VIN BLASTINE S ULFATE contraindi cations, VI NBLASTINE SULFATE pri ce, VIN BLASTINE SU LFATE Taj Phar ma Vinblastine Sulfate 1 mg/ml solution for injectionSMPC- Taj Pharma . Stay conne cted to all updated on VINBLASTINE SU LFATE Taj Pharma ceutical s Taj phar mace uticals Hyderabad.
Information available at present suggests that Since metabolism and excretion are primarily
vinblastine sulfate may be useful, either alone or hepatic, no modification is recommended for
in combination with other oncolytic drugs, for patients with impaired renal function.
the treatment of: Hodgkin's disease; non- Vinblastine should not be given
Hodgkin's lymphoma; carcinoma of the breast; intramuscularly, subcutaneously or
methotrexate-resistant choriocarcinoma; renal intrathecally.
cell carcinoma; testicular teratoma and
seminoma; histiocytosis X. Other neoplasms Method of administration
occasionally show a marked response to The solution may be injected either directly into
vinblastine sulfate, but less frequently than the the vein or into the injection site of a running
more susceptible conditions listed above. intravenous infusion. Injection of vinblastine
sulfate may be completed in about one minute.
Vinblastine Sulfate 1 mg/ ml solution for injection SMPC, Taj Pharma ceutical s
VINBL ASTI NE S ULFA TE Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni ngs, VINBLASTINE SU LFATE Dosage & Rx Info | VINBLASTINE SU LFATE Uses, Side E ffects -: Indications, Side E ffe cts, Warni ngs, VINBL ASTI NE S ULFA TE - Drug I nformation - Taj P harma, VIN BLASTI NE SULFATE dose Taj pharma ceuti cals VINBLASTINE SU LFATE interactions, Taj Phar maceutical VIN BLASTINE S ULFATE contraindi cations, VI NBLASTINE SULFATE pri ce, VIN BLASTINE SU LFATE Taj Phar ma Vinblastine Sulfate 1 mg/ml solution for injectionSMPC- Taj Pharma . Stay conne cted to all updated on VINBLASTINE SU LFATE Taj Pharma ceutical s Taj phar mace uticals Hyderabad.
1. Removal of as much CSF as is safely Liver disease may alter the elimination of
possible. vinblastine in the bile, markedly increasing
toxicity to peripheral nerves and necessitating a
2. Flushing with Lactated Ringer's solution by dosage modification in affected patients.
continuous infusion at 150 ml/h, through a
catheter in a cerebral lateral ventricle and The vial stopper contains dry natural rubber (a
removed through lumbar access, until fresh derivative of latex), which may cause allergic
plasma became available. reactions.
3. Fresh frozen plasma, 25 ml, diluted with 1litre Precautions: Patients should be carefully
of Lactated Ringer's was then infused similarly monitored for infection until the white cell count
at 75 ml/h. The rate of infusion should be has returned to normal levels, if leucopoenia
adjusted to maintain a spinal fluid protein level with less than 2000 white blood cells per
of 150 mg/dl. mm3 occurs following a dose of vinblastine
sulfate.
Vinblastine Sulfate 1 mg/ ml solution for injection SMPC, Taj Pharma ceutical s
VINBL ASTI NE S ULFA TE Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni ngs, VINBLASTINE SU LFATE Dosage & Rx Info | VINBLASTINE SU LFATE Uses, Side E ffects -: Indications, Side E ffe cts, Warni ngs, VINBL ASTI NE S ULFA TE - Drug I nformation - Taj P harma, VIN BLASTI NE SULFATE dose Taj pharma ceuti cals VINBLASTINE SU LFATE interactions, Taj Phar maceutical VIN BLASTINE S ULFATE contraindi cations, VI NBLASTINE SULFATE pri ce, VIN BLASTINE SU LFATE Taj Phar ma Vinblastine Sulfate 1 mg/ml solution for injectionSMPC- Taj Pharma . Stay conne cted to all updated on VINBLASTINE SU LFATE Taj Pharma ceutical s Taj phar mace uticals Hyderabad.
When cachexia or ulcerated areas of the skin are administration of vinblastine and bleomycin, and
present, a more profound leucopenic response of other vascular events (such as myocardial
may be produced by vinblastine. Therefore, its infarction and cerebrovascular accident)
use should be avoided in older persons suffering following combined treatment with vinblastine,
from either of these conditions. bleomycin and cisplatin.
Leucocyte and platelet counts have sometimes Erythromycin may increase the toxicity of
fallen precipitously after moderate doses of vinblastine.
vinblastine sulfate in patients with malignant
cell infiltration of the bone marrow. Serum levels of anticonvulsants may be reduced
by cytotoxic drug regimes, which include
Further use of the drug in such patients is vinblastine.
inadvisable. Avoid contamination of the eye
with vinblastine sulfate solution for injection. If Caution should be exercised in patients
accidental contamination occurs, severe concurrently taking drugs known to inhibit drug
irritation or corneal ulceration may result. The metabolism by hepatic cytochrome P450
affected eye should be thoroughly irrigated with isoenzymes in the CYP 3A subfamily, or in
water immediately. patients with hepatic dysfunction. Concurrent
administration of vinblastine sulfate with an
4.5 Interaction with other medicinal inhibitor of this metabolic pathway may cause
products and other forms of interaction an earlier onset and/or an increased severity of
side-effects.
When chemotherapy is being given in
conjunction with radiation therapy through 4.6 Fertility, pregnancy and lactation
portals which include the liver, the use of
Pregnancy
vinblastine should be delayed until radiation
therapy has been completed. Although information on the use of vinblastine
during pregnancy is limited, the drug may cause
Vinblastine used as part of a combination
foetal toxicity when administered to pregnant
regimen with mitomycin may result in acute
women. The drug causes resorption of foetuses
respiratory distress and pulmonary infiltration.
in animals and produces gross foetal
Cases of respiratory distress with interstitial
abnormalities in surviving offspring. There are
pulmonary infiltrates have been reported in
no adequate and controlled studies to date using
patients given a regimen comprising vinblastine,
vinblastine in pregnant women, and the drug
mitomycin, and progesterone (MVP). Acute
should be used during pregnancy only in life-
shortness of breath and severe bronchospasm
threatening situations or severe disease for
have been reported following the administration
which safer drugs cannot be used or are
of the vinca alkaloids. These reactions have been
ineffective. Women of childbearing potential
encountered most frequently when the vinca
should be advised to avoid becoming pregnant
alkaloid was used in combination with
while receiving the drug. When vinblastine is
mitomycin-C and may be serious when there is
administered during pregnancy or the patient
pre-existing pulmonary dysfunction. The onset
becomes pregnant while receiving the drug, the
may be within minutes, or several hours after the
patient should be informed of the potential
vinca is injected, and may occur up to 2 weeks
hazard to the foetus.
following a dose of mitomycin. Progressive
dyspnoea, requiring chronic therapy, may occur. Fertility
Vinblastine should not be re-administered.
The effect of vinblastine on fertility in humans is
Co-administration of cisplatin has been reported not fully known. Aspermia has occurred in some
to cause higher plasma concentrations of individuals during vinblastine therapy.
vinblastine.
Breast-feeding
There have been reports of Raynaud's
phenomenon and gangrene following co-
Vinblastine Sulfate 1 mg/ ml solution for injection SMPC, Taj Pharma ceutical s
VINBL ASTI NE S ULFA TE Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni ngs, VINBLASTINE SU LFATE Dosage & Rx Info | VINBLASTINE SU LFATE Uses, Side E ffects -: Indications, Side E ffe cts, Warni ngs, VINBL ASTI NE S ULFA TE - Drug I nformation - Taj P harma, VIN BLASTI NE SULFATE dose Taj pharma ceuti cals VINBLASTINE SU LFATE interactions, Taj Phar maceutical VIN BLASTINE S ULFATE contraindi cations, VI NBLASTINE SULFATE pri ce, VIN BLASTINE SU LFATE Taj Phar ma Vinblastine Sulfate 1 mg/ml solution for injectionSMPC- Taj Pharma . Stay conne cted to all updated on VINBLASTINE SU LFATE Taj Pharma ceutical s Taj phar mace uticals Hyderabad.
dose related. Therefore, following administration, the drug is rapidly cleared from
administration of more than the recommended the blood and distributed into body tissues.
dose, patients can be expected to experience
these effects in an exaggerated fashion. Vinblastine crosses the blood-brain barrier
poorly and does not appear in the CSF in
In addition, neurotoxicity similar to that seen therapeutic concentrations. Vinblastine is
with vincristine sulfate may be observed. reported to be extensively metabolised,
primarily in the liver, to desacetylvinblastine,
Treatment: Supportive care should include: (1) which is more active than the parent compound
prevention of the side effects that result from the
on a weight basis. The drug is excreted slowly in
syndrome of inappropriate secretion of urine and in faeces via the bile.
antidiuretic hormone. This includes restriction of
fluid intake and perhaps the use of a diuretic 5.3 Preclinical safety data
acting on the loop of Henle and distal tubule None
function; (2) administration of an
anticonvulsant; (3) prevention and treatment of 6. PHARMACEUTICAL
ileus; (4) monitoring the patient's cardiovascular PARTICULARS
system; and (5) daily blood counts for guidance
in transfusion requirement. 6.1 List of excipients
The major effect of excessive doses of
vinblastine will be on granulocytopoeisis, and Sodium chloride
this may be life-threatening. Water for injections
5. PHARMACOLOGICAL 6.2 Incompatibilities
PROPERTIES
Vinblastine sulfate is incompatible with
5.1 Pharmacodynamic properties furosemide, when injected sequentially into Y-
site with no flush between or when mixed in
Pharmacotherapeutic group: Vinca alkaloids and syringe. Immediate precipitation results.
analogues,
6.3 Shelf life
Mechanism of action
Although the mechanism of action has not been 2 years.
definitely established, vinblastine appears to
6.4 Special precautions for storage
bind to or crystallise critical microtubular
proteins of the mitotic spindle, thus preventing
their proper polymerisation and causing Store in a refrigerator (2°C - 8°C). Keep vial in
metaphase arrest. In high concentrations, outer carton in order to protect from light.
vinblastine also exerts complex effects on 6.5 Nature and contents of container
nucleic acid and protein synthesis. Vinblastine
reportedly also interferes with amino acid 10 ml, Type I clear conventional glass vial, West
metabolism by blocking cellular utilisation of Type 1888 rubber closure, aluminium spun cap
glutamic acid and thus inhibits purine synthesis, ring, in packs of 5 vials.
the citric acid cycle, and the formation of urea.
Vinblastine exerts some immunosuppressive 10 ml, Type I clear Onco-Tain® vials, West
activity. Type 1888 rubber closure, aluminium spun cap
ring, in packs of 5 vials.
Not all above presentations and pack sizes may
5.2 Pharmacokinetic properties be marketed.
Vinblastine sulfate is unpredictably absorbed
from the GI tract. Following intravenous
6.6 Special precautions for disposal and
other handling
Vinblastine Sulfate 1 mg/ ml solution for injection SMPC, Taj Pharma ceutical s
VINBL ASTI NE S ULFA TE Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warni ngs, VINBLASTINE SU LFATE Dosage & Rx Info | VINBLASTINE SU LFATE Uses, Side E ffects -: Indications, Side E ffe cts, Warni ngs, VINBL ASTI NE S ULFA TE - Drug I nformation - Taj P harma, VIN BLASTI NE SULFATE dose Taj pharma ceuti cals VINBLASTINE SU LFATE interactions, Taj Phar maceutical VIN BLASTINE S ULFATE contraindi cations, VI NBLASTINE SULFATE pri ce, VIN BLASTINE SU LFATE Taj Phar ma Vinblastine Sulfate 1 mg/ml solution for injectionSMPC- Taj Pharma . Stay conne cted to all updated on VINBLASTINE SU LFATE Taj Pharma ceutical s Taj phar mace uticals Hyderabad.