CONTRAST MEDIA
HEXOPACK
Non ionic, Water Soluble Low Osmolar iodinated Contrast Media Composition:
HEXOPACK is available in three different Strengths of the following composition:
HEXOPACK-240-Each vials contains iohexol USP 517.85 mg/ml, equivalent to lodine 240 Mg/ml
HEXOPACK-300-Each vial contains local USP 647.10 mg/ml, equivalent to Lodine 300 Mgl/ml
HEXOPACK-350-Each vial contains iohexol USP 755 mg/ml, equivalent to Lodine 350 Mgl/ml
HEXOPACK is available in three different Strengths of the following composition:
HEXOPACK-240-Each vials contains iohexol USP 517.85 mg/ml, equivalent to lodine 240 Mg/ml
HEXOPACK-300-Each vial contains local USP 647.10 mg/ml, equivalent to Lodine 300 Mgl/ml
HEXOPACK-350-Each vial contains iohexol USP 755 mg/ml, equivalent to Lodine 350 Mgl/ml
Low chemotoxicity.
Lesser influence on haemodynamic parameters.
Low serum protein binding. +Little effect on coagulation.
Low erythrocyte deformability
Lesser influence on haemodynamic parameters.
Low serum protein binding. +Little effect on coagulation.
Low erythrocyte deformability
HEXOPACK-350 Injection Not for Intrathecal use.
Low osmolality.
Low systemic toxicity.
Low inhibition of enzyme activity.
Low osmolality.
Low systemic toxicity.
Low inhibition of enzyme activity.
Warning and Precautions:
HEXOPACK does not cross the intact blood brain barrier. HEXOPACK does not lead to vacuolisation in cells of the proximal renal tubule. HEXOPACK has minimal effects on blood pressure & heart rate, Special precautions for use of non-ionic monomeric contrast media in general: A positive history of allergy, asthama, or untoward reactions to iodinated contrast media indicates a need for special caution, Premedication with corticosteroids or histamine H1 and H2 antagonists might be considered in these cases.
General: The dosage varies depending on the types of examination, age, weight, cardiac output and general condition of the patent and the technique used. Usually the same lodine concentration and volume is used as with other iodinated x-ray contrast media current use. Adequate hydration should be assured before and after administration as for other contrast media. For intravenous, Intra-arterial and intrathecal use and use in body cavities. The following dosages may serve as a general guides.
GASTROPACK
GASTROPACK:- Sodium Distrzoste 417 mg/ml lodine Content-250 mg/m Qualitative & Quantitative Composition Each mi GASTROPACK contains 417 mg Sodium Diatrizate It contains excipients viz. solubilizers, preservatives, mixed fruit favour, etc
Indications-This product is for use by oral or rectal administration only: GASTROPACK is a contrast medium for the radiological examination of the gastrointestinal tract. It
is administered orally or as an enema & is indicated in cases where use of barium sulphate is unsatisfactory or contraindicated. These include:
suspicion of a radiologically undetectable perforation or anastomotic delect in the oesophagus &/or gastrointestinal tract
prior resection of the stomach or the intestine (danger of perforation or leak)
small bowel obstruction
acute haemonhage
Megacolon
visualisation of a gastrointestinal fistula.
threatening perforation (peptic ulcer, diverticulum)
visualization of a foreign body or tumour before endoscopy
postoperative ileus
other acute conditions which are likely to require surgery suspected partial or complete stenosis
Treatment of uncomplicated meconiumlleus
Computerised tomography in the abdominal region
- In addition to these situations, GASTROPACK can generally be used for the same purposes as banium sulphate with the exception of the visualization of mucosal diseases Due to the insufficient coating properties of GASTROPACK, barium sulphate should be used for single or double contrast techniques. In combination with barium sulphate, GASTROPACK has improved routine investigation of the gastrointestinal tract both from diagnostic & organisational point of view. It is unsuitable for the diagnosis of enteritis.
- The danger of incorrect diagnoses in computerised tomography in the abdominal regions is significantly reduced if the intestine is opacited with GASTROPACK, especially for differential diagnoses in the minor pelvis. GASTROPACK facilitates delmitation of the intestine from neighbouring organs & permits an assessment of changes in the shape of the pancress.
Hydration: Adequate hydration must be ensured before & after contrast medium administration. This applies especially to patient's with multiple myeloma, diabaties mellitus with nephropathy, polyuria, oliguria, hyperuricemia, as well as to newboms, infants, small children & elderly patients. disturbance of water & electrolyte balance must be corrected before the examination. Newborns (<1 month), Infants(1month-2years)& Children (2-11 years).
Young infants (age<1years)& newborns are susceptiles to electrolyte inbalance & haemodynamic alteration. Particualr attension should be paid to the dose of contrast medium to be given, the technical performance of the radiological procedure and the patient status. Because of its high osmotic pressure & the tendency to absorption from the intestine, GASTROPACK should not be administered to newborn, infants, & young children in doses higher then those recommended, In newborns & infants low osmolar contrast media can often be used more safely than the high osmolar GASTROPACK.
Young infants (age<1years)& newborns are susceptiles to electrolyte inbalance & haemodynamic alteration. Particualr attension should be paid to the dose of contrast medium to be given, the technical performance of the radiological procedure and the patient status. Because of its high osmotic pressure & the tendency to absorption from the intestine, GASTROPACK should not be administered to newborn, infants, & young children in doses higher then those recommended, In newborns & infants low osmolar contrast media can often be used more safely than the high osmolar GASTROPACK.
Dosage for Oral Use: The dosage is dependent on the type of examination & the age of the patient.Adults & Children of 10 Years of Age & Over, Visualization of the stomach, 50 ml, Follow-through examination of the gastrointestinal tract a maximum of 100 mi In adult patients & children of 10 years of age & over 60 mi is sufficient for visualization of the stomach for a follow-through examination of the gastrointestinal tracta maximum of 100 ml may be required. For elderly & cachectic patients dilution with an equal volume of water is recommended. For the early diagnosis of a perforation or anastomosis in the oesophagus &/or gastrointestinal tract, the patient should drink up to 100 ml GASTROPACK. If the suspected lesion cannot be clearly identified on the X-ray film, a chemical reaction can be employed for further clarification. After 30-60 minutes (later, if the defect is suspected of being in the distal gut) a urine specimen should be taken & 5mimixed with 5 drops of concentrated hydrochloric acid. The contrast medium which has undergone renal excretion will appear within 2 hours as a typical crystal formation in the precipitate.
Newboms, infants & young children: 15-30ml (diluted with 3 times its volume of water) Children (up to 10 years of age) 15-30ml (can be diluted with twice its volume of water) in children up to 10 years of age, 15-30 ml is generally sufficient. This dose can be diluted with twice its volume of water. For newborns, infants & young children it is recommended that the contrast medium be diluted with 3 times its volume of water. (CT)-05-1.5 litres of an approximately 3% GASTROPACK solution (30 m GASTROPACK/1 litre of water) (including Therapy of Uncomplicated Meconiumlleus). Up to 500ml GASTROPACK duration (diluted with 3-4 times its volume of water) For adult patients the contrast medium should be diluted with 3-4 times its volume of water, in general, unlike a barium sulphate enema, not more than 500 ml of this GASTROPACK actions required.
Children: Children (up to 5 years of age): up to 500ml GASTROPACK dilution (diluted with 5 Emes its volume of water) Children (over 5 years of age): up to 500ml GASTROPACK dilution (diluted with 4-5 times its volume of water) For children over 5 years of age, the contrast medium should be diluted with 4-5 times its volume of water, for younger patients diution with 5 times its volume of water is recommended. Therapy of Meconium leus GASTROPACK can be given by enema for non-operative treatment of an uncomplicated meconium ileus. Advantage is taken of the high osmotic pressure of the contrast medium: the surrounding tissue is forced to release considerable amounts of fluid, which then flows into the gut & dissolves the inspissated (thickened or hardened) meconium.
Dosage for GASTROPACK In Combination with Barium Sulphate: Adults & Children of 10 Years of Age & Over, In addition to the usual dose of barium sulphate: 30ml GASTROPACK, In adult patienta & children of 10 years of age & over, addition of approximately 30 ml GASTROPACK to the usual dose of banum sulphate has proved most satisfactory Children in addition to the usual dose of barium sulphate, Children (up to 5 years of age): 2-5 ml Gastro-Oral to 100 ml barium sulphate suspension, Children (from 5-10 years of age) 10 ml GASTROPACK to 100 ml berium sulphate suspension, in children from 5-10 years of age, 10 ml GASTROPACK may be added to the required amount of barium sulphate, in patients up to 5 years of age, addition of 2-5ml GASTROPACK to 100 ml barum sulphate suspension has proved of value. If necessary (in cases of pylorospasm or pyloric stenosis), the portion of GASTROPACK in the suspension may be further increased. This does not affect the contrast.
Hypersensitivity: Particularly careful risk-benefit assessment is required in patients with known hypersensitivity to Diatrizoate sodium solution USP or any of its ingredients due to an increased risk for anaphylactoid/ hypersensitivity reactions Patients with hypersensitivity or a previous reaction to iodinated contrast media are at Increased risk of experiencing a severe reaction. However, such reactions are reguler & unpredictable in nature. In patients with an allergic disposition, known hypersensitivity to iodinated contrast media or a history of asthma, premedication with antihistamines &/or glucocorticoide may be considered Patents with bronchial asthma are at particular risk of experiencing bronchospasms or hypersensitivity reactions, Nausea, vomiting, mild angioedema, conjunctivitis, coughing.pruritus, rhinitis, sneezing & urticaria have been reported. These reactions, which can occurspective of the amount administered & the mode of administration
Exposures: Exposures of the stomach are taken in the usual way whether GASTROPACK is used alone or in combination with barium sulphate. The time taken for emptying of the stomach is the same as for barlum sulphate whereas that for filling of the intestine is shorter. When GASTROPACK is used alone, the contrast medium has generally reached the rectum after 2 hours, while the GASTROPACK may take up to 3 hours, or longer in individual cases. The most favourable time for taking exposures of the colon is indicated by the urge to defaecate which all patients experience.
Contraindications Manifest hyperthyroidism. GASTROPACK must not be administered undiluted in patients with low plasma volume, as in newboms, infants, children & in dehydrated patients, since hypovolaemic complications can be particularly serious in these patients. GASTROPACK must not be administered undiluted in patients with suspected possibility of aspiration or broncho-oesophageal fistula, since hyperosmolarity may cause acute pulmonary oedema, chemical pneumonia, respiratory collapse
& death Special Warnings & Precautions for Use The following risks are higher in the case of intravascular administration of iodinated contrast media but are also relevant for the enteral use of GASTROPACK.
& death Special Warnings & Precautions for Use The following risks are higher in the case of intravascular administration of iodinated contrast media but are also relevant for the enteral use of GASTROPACK.
-any history of allergic disorders -history of bronchial asthma
-a previous anaphylactoidhypersensitivity reaction to lodinated contrast media
Particularly care risk-benefit assessment is required in patients with a previous anaphylactid/hypersenstivity reaction to any other iodinated contrast medium because of an increased risk of anaphylactoid hypersensitivity reactions in these patients. Patients taking beta blockers who experience such reactions may be resistant to treatment with beta agonists. Patients with cardiovascular disorders are more susceptible to serious or even fatal outcomes of severe anaphylactoid hypersensitivity reactions. Thyroid Dysfunction Particularly careful risk-benefit assessment is required in patients with known or suspected hyperthyroidism or goitre as iodinated contrast media may interfere with thyroid function, aggravate or induce hyperthyroidism & thyreotoxic crisis. Testing of thyroid function prior to Distrizate sodium solution USP administration &for preventive thyreostatic medication may be considered in patients with known or suspected hyperthyroidism
- System Organ Class
- Immune system disorders
- Endocrine disorders
- Metabolism & nutrition disorders
- Nervous system disorders
- Cardiac disorders
- Vascular disorders
- Respiratory thoracic &mediastinal disorders
- Gastrointestinal disorders
- Skin & subcutaneous tissue disorders
- General disorders & administration site conditions.
Vomiting Nausea Diarrhoea
Common (≥21/100)
- Rare
(<1/1000) - Anaphylactold shock Anaphylactoid / hypersensitivity reaction
- Hyperthyroidism
- Fluid & electrolyte imbalance
- Disturbances in consciousness, Headache, Dizziness
- Cardiac arrest, Tachycardia
- Shock, Hypotension
- Bronchospasm, Dyspnoea, Medication aspiration, Pulmonary
- oedema following, aspiration, Aspiration pneumonia
- Intestinal perforation, Abdominal pain Oral mucosal blistering
- Toxic epidermal necrolysis, Urticaria, Rash, Pruntus, Erythema, Oedema face
- Pyrexia, Sweating
Vividol
Approve as an oil-based radiopaque Diagnosis and therapeutic agent:
Approve as an oil-based radiopaque Diagnosis and therapeutic agent:
Liver Lesion Diagnosis
Vascular embolization with surgical glue
Conventional Trans-Arterial Chemo-Embolization(cTACE)
Lymphography (Chylous syndromes, obstruction & collateral flow)
Better arterial enhancement of tumous
Early venous enhancement
complete visualization of arterioportal vascular bed
Quick to find leak site
Better real time imagine
Vascular embolization with surgical glue
Conventional Trans-Arterial Chemo-Embolization(cTACE)
Lymphography (Chylous syndromes, obstruction & collateral flow)
Better arterial enhancement of tumous
Early venous enhancement
complete visualization of arterioportal vascular bed
Quick to find leak site
Better real time imagine
Discription
Macrocycle 0.5 Molar - Ensures high safely by resucing possibility of gadolinium deposition in the body
Approve for use in adults and paediatric population including zero age
Available in vials of 10ml , 15ml & 20ml
Active Ingredient ''Gadoterate Meglumine' filed with US FDA (US DMF #36148)
Approve for use in adults and paediatric population including zero age
Available in vials of 10ml , 15ml & 20ml
Active Ingredient ''Gadoterate Meglumine' filed with US FDA (US DMF #36148)
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