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DRUGS & SUPPLEMENTS
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GlucaGen HypoKit
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GlucaGen HypoKit uses
- Description
- Clinical pharmacology
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
- References
- Information for the user
DESCRIPTION
GlucaGen HypoKit for Injection (rDNA origin) is a polypeptidehormone identical to human GlucaGen HypoKit that increases blood glucose and relaxessmooth muscle of the gastrointestinal tract. GlucaGen HypoKit is synthesized in aspecial non-pathogenic laboratory strain of Escherichiacoli bacteria that has been genetically altered by the additionof the gene for GlucaGen HypoKit.
GlucaGen HypoKit is a single-chainpolypeptide that contains 29 amino acid residues and has a molecular weightof 3483.
The empirical formula is C153H225N43O49S.The primary sequence of GlucaGen HypoKit is shown below.
Crystalline GlucaGen HypoKit is a white to off-white powder. It isrelatively insoluble in water but is soluble at a pH of less than 3 or morethan 9.5.
GlucaGen HypoKit is available for use intravenously,intramuscularly, or subcutaneously in a kit that contains a vial of sterileglucagon and a syringe of sterile diluent. The vial contains 1 mg (1 unit)of GlucaGen HypoKit and 49 mg of lactose. Hydrochloric acid may have been added duringmanufacture to adjust the pH of the GlucaGen HypoKit. One International Unit of glucagonis equivalent to 1 mg of GlucaGen HypoKit.1 The diluent syringe contains12 mg/mL of glycerin, Water For Injection, and hydrochloric acid.
Primary Sequence of GlucaGen HypoKit
CLINICAL PHARMACOLOGY
GlucaGen HypoKit increases blood glucose concentration andis used in the treatment of hypoglycemia. GlucaGen HypoKit acts only on liver glycogen,converting it to glucose.
GlucaGen HypoKit administeredthrough a parenteral route relaxes smooth muscle of the stomach, duodenum,small bowel, and colon.
Pharmacokinetics
GlucaGen HypoKit has been studied following intramuscular,subcutaneous, and intravenous administration in adult volunteers. Administrationof the intravenous GlucaGen HypoKit showed dose proportionality of the pharmacokineticsbetween 0.25 and 2.0 mg. Calculations from a 1 mg dose showed a small volumeof distribution and a moderate clearance (mean, 13.5 mL/min/kg).The half-life was short, ranging from 8 to 18 minutes.
Maximum plasma concentrations of 7.9 ng/mL were achieved approximately20 minutes after subcutaneous administration (see Figure 1A). Withintramuscular dosing, maximum plasma concentrations of 6.9 ng/mL were attainedapproximately 13 minutes after dosing.
Glucagonis extensively degraded in liver, kidney, and plasma. Urinary excretion ofintact GlucaGen HypoKit has not been measured.
Pharmacodynamics
In a study of 25 volunteers, a subcutaneous doseof 1 mg GlucaGen HypoKit resulted in a mean peak glucose concentration of 136 mg/dL30 minutes after injection (see Figure 1B). Similarly, followingintramuscular injection, the mean peak glucose level was 138 mg/dL, whichoccurred at 26 minutes after injection. No difference in maximum blood glucoseconcentration between animal-sourced and rDNA glucagon was observed aftersubcutaneous and intramuscular injection.
Figure 1 Mean (±SE) serum GlucaGen HypoKit and blood glucose levels after subcutaneous injection of GlucaGen HypoKit (1 mg) in 25 normal volunteers
INDICATIONS AND USAGE
For the treatment of hypoglycemia:
GlucaGen HypoKit is indicated as a treatment for severehypoglycemia.
Because patients with type 1diabetes may have less of an increase in blood glucose levels compared witha stable type 2 patient, supplementary carbohydrate should be given as soonas possible, especially to a pediatric patient.
For use as a diagnostic aid:
GlucaGen HypoKit is indicated as a diagnostic aid in theradiologic examination of the stomach, duodenum, small bowel, and colon whendiminished intestinal motility would be advantageous.
Glucagonis as effective for this examination as are the anticholinergic drugs. However,the addition of the anticholinergic agent may result in increased side effects.
CONTRAINDICATIONS
GlucaGen HypoKit is contraindicated in patients with knownhypersensitivity to it or in patients with known pheochromocytoma.
WARNINGS
GlucaGen HypoKit should be administered cautiously to patientswith a history suggestive of insulinoma, pheochromocytoma, or both. In patientswith insulinoma, intravenous administration of GlucaGen HypoKit may produce an initialincrease in blood glucose; however, because of glucagon's hyperglycemiceffect the insulinoma may release insulin and cause subsequent hypoglycemia. A patient developing symptoms of hypoglycemia after a dose of GlucaGen HypoKit shouldbe given glucose orally, intravenously, or by gavage, whichever is most appropriate.
Exogenous GlucaGen HypoKit also stimulates the release ofcatecholamines. In the presence of pheochromocytoma, GlucaGen HypoKit can cause thetumor to release catecholamines, which may result in a sudden and marked increasein blood pressure. If a patient develops a sudden increase in blood pressure,5 to 10 mg of phentolamine mesylate may be administered intravenously in anattempt to control the blood pressure.
Generalized allergic reactions, including urticaria,respiratory distress, and hypotension, have been reported in patients whoreceived GlucaGen HypoKit by injection.
PRECAUTIONS
General
GlucaGen HypoKit is effective in treating hypoglycemiaonly if sufficient liver glycogen is present. Because GlucaGen HypoKit is of littleor no help in states of starvation, adrenal insufficiency, or chronic hypoglycemia,hypoglycemia in these conditions should be treated with glucose.
Information for Patients
Refer patients and family members to the attachedInformation for the User for instructions describing the method of preparingand injecting GlucaGen HypoKit. Advise the patient and family members to become familiarwith the technique of preparing GlucaGen HypoKit before an emergency arises. Instructpatients to use 1 mg for adults and 1/2 the adult dose (0.5 mg) [0.5 unit]for pediatric patients weighing less than 44 lb (20 kg).
Patients and family members should be informedof the following measures to prevent hypoglycemic reactions due to insulin:
- Reasonable uniformity from day to day with regard to diet, insulin,and exercise.
- Careful adjustment of the insulin program so that the type (or types)of insulin, dose, and time (or times) of administration are suited to theindividual patient.
- Frequent testing of the blood or urine for glucose so that a changein insulin requirements can be foreseen.
- Routine carrying of sugar, candy, or other readily absorbable carbohydrateby the patient so that it may be taken at the first warning of an oncomingreaction.
To prevent severe hypoglycemia, patients andfamily members should be informed of the symptoms of mild hypoglycemia andhow to treat it appropriately.
Family membersshould be informed to arouse the patient as quickly as possible because prolongedhypoglycemia may result in damage to the central nervous system. Glucagonor intravenous glucose should awaken the patient sufficiently so that oralcarbohydrates may be taken.
Patients shouldbe advised to inform their physician when hypoglycemic reactions occur sothat the treatment regimen may be adjusted if necessary.
Laboratory Tests
Blood glucose determinations should be obtainedto follow the patient with hypoglycemia until patient is asymptomatic.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Because GlucaGen HypoKit is usually given in a singledose and has a very short half-life, no studies have been done regarding carcinogenesis. In a series of studies examining effects on the bacterial mutagenesis assay, it was determined that an increase incolony counts was related to technical difficulties in running this assaywith peptides and was not due to mutagenic activities of the GlucaGen HypoKit.
Reproduction studies have been performed in ratsat doses up to 2 mg/kg GlucaGen HypoKit administered two times a day (up to 40 timesthe human dose based on body surface area, mg/m2) and have revealedno evidence of impaired fertility.
Pregnancy
Pregnancy Category B - Reproduction studies have not been performed with recombinantglucagon. However, studies with animal-sourced GlucaGen HypoKit were performed inrats at doses up to 2 mg/kg GlucaGen HypoKit administered two times a day (up to 40 timesthe human dose based on body surface area, mg/m2), and have revealedno evidence of impaired fertility or harm to the fetus due to GlucaGen HypoKit. Thereare, however, no adequate and well-controlled studies in pregnant women. Becauseanimal reproduction studies are not always predictive of human response, thisdrug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excretedin human milk. Because many drugs are excreted in human milk, caution shouldbe exercised when GlucaGen HypoKit is administered to a nursing woman. If the drugis excreted in human milk during its short half-life, it will be hydrolyzedand absorbed like any other polypeptide. GlucaGen HypoKit is not active when takenorally because it is destroyed in the gastrointestinal tract before it canbe absorbed.
Pediatric Use
For the treatment of hypoglycemia: The use ofglucagon in pediatric patients has been reported to be safe and effective.2-6
For use as a diagnostic aid: Effectiveness hasnot been established in pediatric patients.
Geriatric Use
Clinical studies of GlucaGen HypoKit did not include sufficientnumbers of subjects aged 65 and over to determine whether they respond differentlyfrom younger subjects. Other reported clinical experience has not identifieddifferences in responses between the elderly and younger patients. In general,dose selection for an elderly patient should be cautious, usually startingat the low end of the dosing range, reflecting the greater frequency of decreasedhepatic, renal, or cardiac function, and of concomitant disease or other drugtherapy.
ADVERSE REACTIONS
Severe adverse reactions are very rare, although nauseaand vomiting may occur occasionally. These reactions may also occur with hypoglycemia. Generalized allergic reactions have been reported (see WARNINGS). In athree month controlled study of 75 volunteers comparing animal-sourced glucagonwith GlucaGen HypoKit manufactured through rDNA technology, no glucagon-specific antibodieswere detected in either treatment group.
OVERDOSAGE
Signs andSymptoms - If overdosage occurs, nausea, vomiting, gastric hypotonicity,and diarrhea would be expected without causing consequential toxicity.
Intravenous administration of GlucaGen HypoKit has been shown tohave positive inotropic and chronotropic effects. A transient increase inboth blood pressure and pulse rate may occur following the administrationof GlucaGen HypoKit. Patients taking β-blockers might be expected to have a greaterincrease in both pulse and blood pressure, an increase of which will be transientbecause of glucagon's short half-life. The increase in blood pressureand pulse rate may require therapy in patients with pheochromocytoma or coronaryartery disease.
When GlucaGen HypoKit was given inlarge doses to patients with cardiac disease, investigators reported a positiveinotropic effect. These investigators administered GlucaGen HypoKit in doses of 0.5 to16 mg/hour by continuous infusion for periods of 5 to 166 hours. Total dosesranged from 25 to 996 mg, and a 21-month-old infant received approximately8.25 mg in 165 hours. Side effects included nausea, vomiting, and decreasingserum potassium concentration. Serum potassium concentration could be maintainedwithin normal limits with supplemental potassium.
Theintravenous median lethal dose for GlucaGen HypoKit in mice and rats is approximately300 mg/kg and 38.6 mg/kg, respectively.
Becauseglucagon is a polypeptide, it would be rapidly destroyed in the gastrointestinaltract if it were to be accidentally ingested.
Treatment - To obtain up-to-date information about the treatment of overdose,a good resource is your certified Regional Poison Control Center. Telephonenumbers of certified poison control centers are listed in the Physicians'Desk Reference (PDR). In managing overdosage, consider the possibilityof multiple drug overdoses, interaction among drugs, and unusual drug kineticsin your patient.
In view of the extremely shorthalf-life of GlucaGen HypoKit and its prompt destruction and excretion, the treatmentof overdosage is symptomatic, primarily for nausea, vomiting, and possiblehypokalemia.
If the patient develops a dramaticincrease in blood pressure, 5 to 10 mg of phentolamine mesylate has been shownto be effective in lowering blood pressure for the short time that controlwould be needed.
Forced diuresis, peritonealdialysis, hemodialysis, or charcoal hemoperfusion have not been establishedas beneficial for an overdose of GlucaGen HypoKit; it is extremely unlikely that oneof these procedures would ever be indicated.
DOSAGE AND ADMINISTRATION
General Instructions for Use:
- The diluent is provided for use only in the preparation of GlucaGen HypoKit for parenteral injection and for no other use.
- GlucaGen HypoKit should not be used at concentrations greater than 1 mg/mL (1 unit/mL).
- Reconstituted GlucaGen HypoKit should be used immediately. Discard any unused portion.
- Reconstituted GlucaGen HypoKit solutions should be used only if they are clear and of a water-like consistency.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Directions for Treatment of Severe Hypoglycemia:
Severe hypoglycemia should be treated initiallywith intravenous glucose, if possible.
- If parenteral glucose can not be used, dissolve the lyophilized glucagonusing the accompanying diluting solution and use immediately.
- For adults and for pediatric patients weighing more than 44 lb (20 kg),give 1 mg (1 unit) by subcutaneous, intramuscular, or intravenous injection.
- For pediatric patients weighing less than 44 lb (20 kg), give 0.5 mg(0.5 unit) or a dose equivalent to 20 to 30 μg/kg.2-6
- Discard any unused portion.
- An unconscious patient will usually awaken within 15 minutes followingthe GlucaGen HypoKit injection. If the response is delayed, there is no contraindicationto the administration of an additional dose of GlucaGen HypoKit; however, in viewof the deleterious effects of cerebral hypoglycemia emergency aid should besought so that parenteral glucose can be given.
- After the patient responds, supplemental carbohydrate should be givento restore liver glycogen and to prevent secondary hypoglycemia.
Directions for Use as a Diagnostic Aid:
Dissolve the lyophilized GlucaGen HypoKit using the accompanyingdiluting solution and use immediately. Discard anyunused portion.
The dosesin the following table may be administered for relaxation of the stomach,duodenum, and small bowel, depending on the onset and duration of effect requiredfor the examination. Since the stomach is less sensitive to the effect ofglucagon, 0.5 mg (0.5 units) IV or 2 mg (2 units) IM are recommended.
| * Administration of 2 mg (2 units) doses produces a higher incidence of nausea and vomiting than do lower doses. | |||
| Dose | Route of Administration | Time of Onset of Action | Approximate Duration of Effect |
| 0.25-0.5 mg (0.25-0.5 units) | IV | 1 minute | 9-17 minutes |
| 1-mg (1 unit) | IM | 8-10 minutes | 12-27 minutes |
| 2 mg* (2 units) | IV | 1 minute | 22-25 minutes |
| 2 mg* (2 units) | IM | 4-7 minutes | 21-32 minutes |
For examination of the colon, it is recommendedthat a 2 mg (2 units) dose be administered intramuscularly approximately 10 minutesprior to the procedure. Colon relaxation and reduction of patient discomfortmay allow the radiologist to perform a more satisfactory examination.
HOW SUPPLIED
GlucaGen HypoKit Emergency Kit for Low Blood Sugar (MS8031):
1 mg (1 unit) - (VL7529), with 1 mL ofdiluting solution (Hyporet®* HY7530) (1s) NDC 0002-8031-01
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* Hyporet® (disposablesyringe, Lilly).
Stability and Storage:
BeforeReconstitution - Vials of GlucaGen HypoKit, as well as the Diluting Solutionfor GlucaGen HypoKit, may be stored at controlled room temperature 20° to 25°C (68° to 77°F)[seeUSP].
The USP defines controlled room temperatureby the following: A temperature maintained thermostatically that encompassesthe usual and customary working environment of 20° to 25°C (68° to 77°F);that results in a mean kinetic temperature calculated to be not more than 25°C;and that allows for excursions between 15° and 30°C (59° and 86°F) that areexperienced in pharmacies, hospitals, and warehouses.
AfterReconstitution - GlucaGen HypoKit for Injection (rDNA origin) should beused immediately. Discard any unused portion.
REFERENCES
- Drug Information for the HealthCare Professional. 18th ed. Rockville, Maryland: The United StatesPharmacopeial Convention, Inc; 1998; I:1512.
- Gibbs et al: Use of GlucaGen HypoKit to terminate insulin reactions in diabeticchildren. Nebr Med J 1958;43:56-57.
- Cornblath M, et al: Studies of carbohydrate metabolism in the newborn:Effect of GlucaGen HypoKit on concentration of sugar in capillary blood of newborninfant. Pediatrics 1958;21:885-892.
- Carson MJ, Koch R: Clinical studies with GlucaGen HypoKit in children. J Pediatr 1955;47:161-170.
- Shipp JC, et al: Treatment of insulin hypoglycemia in diabetic campers. Diabetes 1964;13:645-648.
- Aman J, Wranne L: Hypoglycemia in childhood diabetes II: Effect of subcutaneousor intramuscular injection of different doses of GlucaGen HypoKit. ActaPediatr Scand 1988;77:548-553.
Literature revised September 19, 2012
Marketed by: Lilly USA, LLC
Indianapolis,IN 46285, USA
PA 2286 AMP
Copyright © 1999, 2012, Eli Lilly and Company. All rights reserved.
INFORMATION FOR THE USER
GlucaGen HypoKit
FOR INJECTION
(rDNA ORIGIN)
BECOMEFAMILIAR WITH THE FOLLOWING INSTRUCTIONS BEFORE AN EMERGENCY ARISES. DO NOTUSE THIS KIT AFTER DATE STAMPED ON THE BOTTLE LABEL. IF YOU HAVE QUESTIONSCONCERNING THE USE OF THIS PRODUCT, CONSULT A DOCTOR, NURSE OR PHARMACIST.
Make sure that your relatives or close friends know thatif you become unconscious, medical assistance must always be sought. Glucagonmay have been prescribed so that members of your household can give the injectionif you become hypoglycemic and are unable to take sugar by mouth. If you areunconscious, GlucaGen HypoKit can be given while awaiting medical assistance.
Show your family members and others where you keep thiskit and how to use it. They need to know how to use it before you need it. They can practice giving a shot by giving you your normal insulin shots. Itis important that they practice. A person who has never given a shot probablywill not be able to do it in an emergency.
IMPORTANT
- Act quickly. Prolonged unconsciousness may be harmful.
- These simple instructions will help you give GlucaGen HypoKit successfully.
- Turn patient on his/her side to prevent patient from choking.
- The contents of the syringe are inactive. You must mix the contentsof the syringe with the GlucaGen HypoKit in the accompanying bottle before givinginjection. (See DIRECTIONS FOR USEbelow.)
- Do not prepare GlucaGen HypoKit for Injection until you are ready to use it.
WARNING: THEPATIENT MAY BE IN A COMA FROM SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) RATHERTHAN HYPOGLYCEMIA. IN SUCH A CASE, THE PATIENT WILL NOT RESPOND TO GlucaGen HypoKit AND REQUIRES IMMEDIATE MEDICAL ATTENTION.
INDICATIONS FOR USE
Use GlucaGen HypoKit to treat insulincoma or insulin reaction resulting from severe hypoglycemia (low blood sugar).Symptoms of severe hypoglycemia include disorientation, unconsciousness, andseizures or convulsions. Give GlucaGen HypoKit if (1) the patient is unconscious (2) thepatient is unable to eat sugar or a sugar-sweetened product (3) the patientis having a seizure, or (4) repeated administration of sugar or a sugar-sweetenedproduct such as a regular soft drink or fruit juice does not improve the patient'scondition. Milder cases of hypoglycemia should be treated promptly by eatingsugar or a sugar-sweetened product. (See INFORMATIONON HYPOGLYCEMIA below for more information on the symptoms of hypoglycemia.)Glucagon is not active when taken orally.
DIRECTIONS FOR USE
TO PREPARE GLUCAGONFOR INJECTION
- Remove the flip-off seal from the bottle of GlucaGen HypoKit. Wipe rubber stopperon bottle with alcohol swab.
- Remove the needle protector from the syringe, and inject the entirecontents of the syringe into the bottle of GlucaGen HypoKit. DO NOT REMOVE THE PLASTICCLIP FROM THE SYRINGE. Remove syringe from the bottle.
- Swirl bottle gently until GlucaGen HypoKit dissolves completely. GlucaGen HypoKit SHOULDNOT BE USED UNLESS THE SOLUTION IS CLEAR AND OF A WATER-LIKE CONSISTENCY.
TO INJECT GlucaGen HypoKit
Use Same Technique as for Injecting Insulin
- Using the same syringe, hold bottle upside down and, making sure theneedle tip remains in solution, gently withdraw all of the solution (1 mgmark on syringe) from bottle. The plastic clip on the syringe will preventthe rubber stopper from being pulled out of the syringe; however, if the plasticplunger rod separates from the rubber stopper, simply reinsert the rod byturning it clockwise. The usual adult dose is 1 mg (1 unit). For childrenweighing less than 44 lb (20 kg), give 1/2 adult dose (0.5 mg). For children,withdraw 1/2 of the solution from the bottle (0.5 mg mark on syringe). DISCARDUNUSED PORTION.
USING THE FOLLOWING DIRECTIONS, INJECT GlucaGen HypoKit IMMEDIATELY AFTER MIXING.
- Cleanse injection site on buttock, arm, or thigh with alcohol swab.
- Insert the needle into the loose tissue under the cleansed injectionsite, and inject all (or 1/2 for children weighing less than 44 lb) of theglucagon solution. THERE IS NO DANGER OF OVERDOSE. Apply light pressure atthe injection site, and withdraw the needle. Press an alcohol swab againstthe injection site.
- Turn the patient on his/her side. When an unconscious person awakens,he/she may vomit. Turning the patient on his/her side will prevent him/herfrom choking.
- FEED THE PATIENT AS SOON AS HE/SHE AWAKENS AND IS ABLE TO SWALLOW. Givethe patient a fast-acting source of sugar (such as a regular soft drink orfruit juice) and a long-acting source of sugar (such as crackers and cheeseor a meat sandwich). If the patient does not awaken within 15 minutes, giveanother dose of GlucaGen HypoKit and INFORM A DOCTOR OR EMERGENCY SERVICES IMMEDIATELY.
- Even if the GlucaGen HypoKit revives the patient, his/her doctor should be promptlynotified. A doctor should be notified whenever severe hypoglycemic reactionsoccur.
INFORMATIONON HYPOGLYCEMIA
Early symptomsof hypoglycemia (low blood glucose) include:
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If not treated, the patient may progress to severehypoglycemia that can include:
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The occurrence of early symptoms calls for promptand, if necessary, repeated administration of some form of carbohydrate. Patientsshould always carry a quick source of sugar, such as candy mints or glucosetablets. The prompt treatment of mild hypoglycemic symptoms can prevent severehypoglycemic reactions. If the patient does not improve or if administrationof carbohydrate is impossible, GlucaGen HypoKit should be given or the patient shouldbe treated with intravenous glucose at a medical facility. GlucaGen HypoKit, a naturallyoccurring substance produced by the pancreas, is helpful because it enablesthe patient to produce his/her own blood glucose to correct the hypoglycemia.
POSSIBLE PROBLEMS WITHGLUCAGON TREATMENT
Severeside effects are very rare, although nausea and vomiting may occur occasionally.
A few people may be allergic to GlucaGen HypoKit or to one of theinactive ingredients in GlucaGen HypoKit, or may experience rapid heart beat for ashort while.
If you experience any other reactionswhich are likely to have been caused by GlucaGen HypoKit, please contact your doctor.
STORAGE
Before dissolving GlucaGen HypoKit with dilutingsolution - Store the kit at controlled room temperature between 20° to 25°C(68° to 77°F).
After dissolving GlucaGen HypoKit withdiluting solution - Should be used immediately. Discardany unused portion. Solutions should be clear and of a water-likeconsistency at time of use.
Literature revised September 19, 2012
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
PA 2286 AMP
Copyright © 1999, 2012, Eli Lilly and Company. All rights reserved.
Step 1 Figure Step 2 Figure Step 3 Figure Step 4 Figure
Lilly
Rx only
GlucaGen HypoKit Emergency Kit for Low Blood Sugar
GlucaGen HypoKit for Injection (rDNA origin) 1 mg (1 unit)
NDC 0002-8031-01
MS8031
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
GlucaGen HypoKit: Product of Austria
Diluting Syringe: Product of Germany
GlucaGen HypoKit pharmaceutical active ingredients containing related brand and generic drugs:
GlucaGen HypoKit available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.