cotton linter allergy
cotton linter allergy
PubMed, Diagnostic use of allergenic extracts usually begins with direct skin testing. This dilution can be prepared by diluting 1:20 to 1:50 w/v (2% - 5%) extracts to 5-6 or 1:10 w/v (10%) extracts to 5-7 (five-fold dilutions). 49288-0581-1, However, they may be reacting to allergens introduced into the fabric during its manufacture, such as formaldehyde. Dilute 1:10 w/v (10%) extracts to 10-3 if using ten-fold dilutions. Adverse reactions include, but are not limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing. 14. In some cases, they have a true cotton allergy. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Size of reactions are quantitated based on size of wheal and erythema. A negative control, 50% glycerine diluted with diluent to 5-2 (1:25) or 10-1 (1:10) dilution and a positive control of histamine phosphate, should be tested and included in interpretation of skin reactions.1, 13. 6. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. Reid, Michael J., Lockey, Richard F., Turkeltaub M.D., Paul C., Platts-Mills, Thomas. Refer to container label for actual Antigen E content. Less sensitive individuals can be tested intradermally with an appropriately diluted extract. Proper measurement of dose and caution in making injection will minimize reactions. Therefore, it is imperative that physicians administering allergenic extracts understand and prepare for treatment of severe reactions. Confirmation is determined by skin testing. Hence, the importance of a good patient history. Injections should never be given intravenously. 10. Some people are allergic to cotton plant tissues. Epinephrine 1:1000 should be available. 66, No. 49288-0154-2, Annals of Allergy, Vol. Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction. Do not administer in the presence of diseases characterized by bleeding diathesis. Systemic reactions range from mild exaggeration of patients allergic symptoms to anaphylactic reactions.14 Very sensitive patients may show a rapid response. 5. This schedule is intended only as a guide and must be modified according to the reactivity of the individual patient. 49288-0403-1, : Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery: Instructional Courses, Vol. View NDC Code(s)NEW! These fibers grow on cotton seeds inside the cotton boll, or the fruit of the cotton plant. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=d71013ab-718c-4cb0-ae1a-31fdd6db8851, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Small amounts of erythema and swelling at the site of injection are common. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. 49288-0344-2, Refer to WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections below. Chemicals that are beta-blockers and may be components of other drugs: Acebutolol, Atenolol, Esmolol, Metoprolol, Nadolol, Penbutolol, Pindolol, Propanolol, Timolol, Labetalol, Carteolol.1, Beta-adrenergic agents. Refer to WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections for signs and symptoms of an overdose. The initial dose must be based on skin testing as described in the DOSAGE AND ADMINISTRATION section of this insert. Some people are allergic to cotton fibers. Extracts in 5 ml dropper bottles are available for prick-puncture testing. Intracutaneously inject 0.01 to 0.02 ml of the test allergen to form a 4 mm diameter superficial skin wheal. NIAID Task Force Report, U.S. Dept. A decreased skin test reactivity has been observed in patients undergoing specific immunotherapy with pollen extracts, grass pollen allergoids, mites, hymenoptera venoms, or in professional beekeepers who are spontaneously desensitized. Subcutaneous injection is the recommended route. Oxygen should be given by mask if indicated. Children can receive the same dose as adults. Patient must be instructed to report any adverse reactions that occur within 24 hours after injection. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 49288-0343-3, The initial dilution of allergenic extract, starting dose, and progression of dosage must be carefully determined on the basis of the patients history and results of skin tests. Long-term corticosteroid therapy modifies the skin texture and makes the interpretation of immediate skin tests more difficult.1, Theophylline. After administration of epinephrine, profound shock and vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Ten-fold dilution to 10-6 of a 1:10 w/v (10%) extract would be a safe starting dilution. Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Clinical Trials, Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. 84-86. Strongly positive skin tests may be risk factors for systemic reactions. (current), tobacco leaf allergenic extract 100 MG/mL Injectable Solution, tobacco leaf allergenic extract 100 MG/ML Injectable Solution, Nicotiana tabacum leaf extract 0.1 GM/ML Injectable Solution, Nicotiana tabacum leaf extract 100 MG/ML Injectable Solution, orris root allergenic extract 100 MG/ML Injectable Solution, Iris germanica var. (See Serial Dilution Titration Test Dilutions chart below.) Updated Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Epinephrine or beta-adrenergic drugs (Alupent) may be ineffective. The route of administration for immunotherapy is subcutaneous. A positive control using histamine phosphate identifies patients whose skin may not react due to medications, metabolic or other reasons. Patients who have been taking beta-blockers may be unresponsive to epinephrine. Careful attention to dosage and administration limit such reactions. Store all stock concentrates and dilutions at 2-8 C. Keep at this temperature during office use. Allergenic extracts have been used routinely in children, and no special safety problems or specific hazards have been found. Some allergenic extracts naturally precipitate. florentina root extract 0.1 GM/ML Injectable Solution, orris root extract 0.1 GM/ML Injectable Solution, orris root extract 100 MG/ML Injectable Solution, tobacco leaf allergenic extract 50 MG/mL Injectable Solution, tobacco leaf allergenic extract 50 MG/ML Injectable Solution, Nicotiana tabacum leaf extract 0.05 GM/ML Injectable Solution, Nicotiana tabacum leaf extract 50 MG/ML Injectable Solution, kapok tree fiber allergenic extract 50 MG/mL Injectable Solution, kapok tree fiber allergenic extract 50 MG/ML Injectable Solution, Ceiba pentandra fiber allergenic extract 0.05 GM/ML Injectable Solution, kapok tree fiber extract 5 MG/ML Injectable Solution, cotton fiber allergenic extract 50 MG/ML Injectable Solution, cotton fiber allergenic extract 0.05 GM/ML Injectable Solution, cotton fiber extract 50 MG/ML Injectable Solution, Pyrethrum cinerariifolium allergenic extract 50 MG/ML Injectable Solution, Pyrethrum cinerariifolium extract 0.05 GM/ML Injectable Solution, Tanacetum cinerariifolium extract 0.05 GM/ML Injectable Solution, Tanacetum cinerariifolium extract 50 MG/ML Injectable Solution, tobacco leaf allergenic extract 20 MG/mL Injectable Solution, tobacco leaf allergenic extract 20 MG/ML Injectable Solution, Nicotiana tabacum leaf extract 0.02 GM/ML Injectable Solution, Nicotiana tabacum leaf extract 20 MG/ML Injectable Solution, jute fiber allergenic extract 50 MG/mL Injectable Solution, jute fiber allergenic extract 50 MG/ML Injectable Solution, Corcorus capsularis fiber extract 0.05 GM/ML Injectable Solution, Corcorus capsularis fiber extract 50 MG/ML Injectable Solution, orris root allergenic extract 50 MG/ML Injectable Solution, Iris germanica var. However, oral terbutaline and parenteral ephedrine were shown to decrease the allergen-induced wheal.1, Cromolyn. The dermatitis may be atopic, which means that it can occur on parts of the body not in direct contact with the allergen. may be prepared either by dilution from a more concentrated stock or by direct extraction. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. 123-222, 1972. 49288-0285-5, 6, p. 511, December 1980. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Cromolyn inhaled or injected prior to skin tests with allergens or degranulating agents does not alter skin whealing response.1, Other drugs. Refer to OVERDOSAGE section for description of treatment for anaphylactic reactions. 49288-0582-1, Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp 9-48. 1:50, 1:33, etc.) If you are a consumer or patient please visit DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088. Patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. 1986, "British Journal of Industrial Medicine"; An Investigation of Allergy in; V. Popa, et al; Apr. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENTS SENSITIVITY AND TOLERANCE. The endpoint dilution is used as a starting dose concentration for immunotherapy. (1) Start testing with the most dilute allergenic extract concentration. 12. Alternatively, some people who think that they are allergic to cotton may actually react to dyes applied to cotton textiles. Is Linen or Cotton Better in Hot Weather. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing. Sterile syringe and needle must be used for each individual patient to prevent transmission of serum hepatitis, Human Immunodeficiency Virus (HIV) and other infectious agents. Willoughby, J.W. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. For patients demonstrating a positive prick-puncture skin test, an initial screening dilution of 1:312,500 w/v is safe. is this? Dosages progressively increase according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief from symptoms, (2) induration at the site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose is reached (the largest dose tolerated by the patient that relieves symptoms without undesirable local or systemic reactions). Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%. Report Adverse Dilutions of the allergenic extracts containing less than 50% glycerine are less stable. 49288-0272-4, Monitor airways for obstruction. Extract should be temporarily withheld or dosage reduced in case of any of the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms; 4) adverse reaction to previous injection until cause of reaction has been evaluated by physician supervising patients immunotherapy program. Other drugs have been shown to decrease skin test reactivity. Antigen Laboratories allergenic extracts are manufactured from source material listed on the vial label. 11. The following are commonly prescribed beta-blockers: Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. 2. Discontinue use of the tourniquet after hour. Wasserman, S.: The Mast Cell and the Inflammatory Response. However, some allergic reactions in cotton factory workers are not caused by the cotton fibers themselves, but by allergens added to the fibers while the cotton is being processed. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v. Citations, Report Adverse Withdraw plunger slightly after inserting needle to determine if a blood vessel has been entered. Symptoms of progressive anaphylaxis include airway obstruction and/or vascular collapse. Events, (What 49288-0285-3, Needless to say, the physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions.6, Some patients may tolerate larger doses of the allergenic extract depending on patient response.7 Because diluted extract tends to lose activity in storage, the first dose from a more concentrated vial should be the same, or less than, the previous dose.8, 12. 4, p. 52, edited by Middleton et al. This maintenance dose may be continued at regular intervals perennially. Imipramines, phenothiazines, and tranquilizers. Copy the URL below and paste it into your RSS Reader application. Rocklin, R.E., Sheffer, A.L., Grainader, D.K. Possible adverse reactions include unusual swelling and/or tenderness at injection site, rhinorrhea, sneezing, coughing, wheezing, shortness of breath, nausea, dizziness, or faintness. Benefit versus risk needs to be evaluated in steroid dependent asthmatics, patients with unstable asthma or patients with underlying cardiovascular disease. Subsequent exposure to the allergen results in a combination of allergen with IgE antibody fixed on mast cells or basophil membranes. For interpretation of skin reactions, refer to chart below. SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. ; 2007, Pak Tribune; Baby Girl Dies of Cotton Allergy; Nov. 2005. and Melmon, K.: Generation of antigen-specific suppressor cells during allergy desensitization, New England Journal of Medicine, 302, May 29, 1980, pp. The Mast Cell-its role in Health and disease. A Web Experience brought to you by LEAFtv, "Environmental Health Perspectives"; Immunologic Responses to; John Salvaggio; Apr. Repeat dose in 5-10 minutes if necessary. Long, W.F., Taylor, R.J., Wagner, C.J., et al. Sterile solutions, vials, syringes, etc. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988. 49288-0583-1, Fresh egg white extract is available at 1:9 v/v extraction ratio. 49288-0403-4, The flowers of the cotton plant rest on a structure called a receptacle. Adrenocorticosteroids may be administered parenterally or intravenously. Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen. 133-138. Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. 49288-0581-5, 1969, "Dermatology Online Journal: Common Misconceptions in; Rajani Katta; 2008, N.C. Department of Labor; A Guide for; Cherie Berry, et al. Long acting antihistamines (e.g., astemizole) may inhibit the wheal and flare for up to forty days.1, 2, Imipramines, phenothiazines, and tranquilizers. Patients extremely sensitive to a common allergen in several components of a mixture may be more likely to experience a systemic reaction than when skin tested individually for each component.9. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label. Loosen tourniquet briefly at 5 minute intervals to prevent circulatory impairment. 49288-0581-2, If a systemic or anaphylactic reaction does occur, apply tourniquet above the site of allergenic extract injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 Epinephrine-hydrochloride into the opposite arm or gluteal area. 49288-0582-5, Antihistamines, H2 antagonist, bronchodilators, steroids and theophylline may be used as indicated after providing adequate epinephrine and circulatory support.4. For patients demonstrating a negative or weakly reactive prick-puncture skin test, an initial screening dilution of 1:12,500 w/v is safe. If after 20 minutes no skin reaction is observed, continue testing using increasing increments of the concentration until a reaction of 5-10 mm wheal and 11-30 mm erythema is obtained, or a concentration of 5-2 or 10-1 has been tested. The rate of increase in dosage in the early stages of treatment with highly diluted extracts is usually more rapid than the rate of increase possible with more concentrated extracts. Patients should be observed for at least 20 minutes following allergenic extract injections. this version. Discomfort is minimized by dividing the dose in half and administering injection at two different sites.16, 17, Antihistamines. Boxed Warnings, When harvested and processed, they make a fine textile called cotton. 16. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies in animals have not been conducted with allergenic extract to determine their potential for carcinogenicity, mutagenicity or impairment of fertility. The epinephrine HCL 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml. Fatalities are rare but can occur.5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria.13, 14. 49288-0344-1, Antibodies protect against diseases, but they may also provoke allergic reactions. Tricyclic antidepressants exert a potent and sustained decrease of skin reactions to histamine. 6-15, 1993. The usual precautions in administering allergenic extracts are necessary, refer to boxed WARNINGS and WARNINGS section. 49288-0403-5, Events, However, it causes discomfort to individuals who are allergic to cotton. Antihistamines inhibit the wheal and flare reaction. View Labeling Archives, This fabric has clothed millions of people and has furnished blankets and pillowcases for the comfort of sleepers. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Precaution is necessary when using extract mixture for skin testing. 1365-1376, 1988. Van Metre, T., Adkinson, N., Amodio, F., Lichtenstein, L., Mardinay, M., Norman, P., Rosenberg, G., Sobotka, A., Valentine, M.: A Comparative Study of the Effectiveness of the Rinkel Method and the Current Standard Method of Immunology for Ragweed Pollen Hay Fever, The Journal of Clinical Allergy and Immunology, Vol. 76-113, 1985. Labels, All Index Patient should remain under observation of a nurse, physician, or personnel trained in emergency measures for at least 20 minutes following immunotherapy injection. 213-217, May 1979. Inhaled beta2 agonists in the usual doses used for the treatment of asthma do not usually inhibit allergen-induced skin tests. Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. & Articles, All A cotton allergy may express itself in dermatitis, an inflammation of the skin characterized by such phenomena as rashes. J. Dis. It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions. Immediate medical attention must be sought for reactions that occur during or after leaving physicians office. These drugs should be administered even though a beta-blocker may have been taken. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. This product should not be injected intravenously. A cotton allergy may also express itself in respiratory problems, such as asthma and rhinitis, or inflammation of the nasal mucous membranes. Injections should never be given intravenously. Nelson, H.S. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Files, All Mapping 63, No. Certain plants of the genus Gossypium have soft fibers that cling to the seeds. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. Immunotherapy must be given under physicians supervision. INTRADERMAL TESTING-SKIN ENDPOINT TITRATION: physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions, SERIAL DILUTION TITRATION TEST DILUTIONS APPROXIMATE ALLERGENIC EXTRACT CONCENTRATION RESULTING FROM 1:5 DILUTION, All Drug The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. Bousquet, Jean: In vivo methods for study of allergy: Skin tests Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing. The usual duration of treatment has not been established. A 5/8 inch, 25 gauge needle on a sterile syringe allows deep subcutaneous injection. PRICK-PUNCTURE TESTING: To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick-puncture test using a drop of the extract concentrate be performed prior to initiating very dilute intradermal testing. INTRADERMAL TESTING-SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patients degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving progressive five-fold dilutions of allergenic extracts. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 49288-0154-4, 49288-0154-5, Less aggressive immunotherapy schedules may be indicated for such patients. 9-20. These detergent allergens may adhere to the cotton fabric, where they may provoke an allergic reaction in a sensitized individual. I and II, pp 135-163, 1988. Larger local reactions are not only uncomfortable, but indicate the possibility of a severe systemic reaction if dosage is increased. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. 4. 49288-0154-3, Refer to STORAGE section for proper storage condition for allergenic extract. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. A systemic reaction to allergenic extract could cause uterine contractions leading to spontaneous abortion or premature labor. Ishizaka, K.: Control of IgE Synthesis, Third Edition, Allergy Principles and Practices, Vol. 49288-0583-4, Ophthalmic beta-blockers: Betaxolol, Levobunolol, Timolol, Timoptic. 49288-0285-1, Allergy Clin. florentina root allergenic extract 0.05 GM/ML Injectable Solution, Iris germanica var. 49288-0581-4, 49288-0582-3, 9. Detergents used to wash cotton fabrics may also contain allergens. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). Holgate, S.T., Robinson, C., Church, Mike: Mediators of Immediate Hypersensitivity, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. florentina root allergenic extract 1 GM per 20 ML Injectable Solution, Iris germanica var. IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENTS SENSITIVITY AND TOLERANCE. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter. 49288-0154-1, This cross-linking results in stimulation of mast cell which leads to release and generation of pharmacologically active substances that produce immediate hypersensitivity reaction.3, The mode of action of immunotherapy with allergenic extracts is still under investigation. Children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Among them, dopamine is the best-documented compound.1, Specific Immunotherapy. Lower concentrations (e.g. Get Label RSS Feed, A period of two or three years on immunotherapy constitutes an average minimum course of treatment. 49288-0285-4, 58, pp. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER: Sodium chloride.0.95%, Sodium bicarbonate..0.24%, Glycerine50% (v/v), Water for Injectionq.s. 49288-0582-4, Refer to OVERDOSAGE section. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen. Extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients who have experienced severe symptoms or anaphylaxis by natural exposure, or during previous skin testing or treatment. 1213-1219. It is not known whether allergenic extracts cause fetal harm during pregnancy or affect reproductive capacity.
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