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At least 343 records · Page 19Linked to original sources

Comparison of monthly intramuscular injections of Sandostatin LAR with multiple subcutaneous injections of octreotide in the treatment of acromegaly; effects on growth hormone and other markers of growth hormone secretion.

OBJECTIVE: To compare the effects of monthly intra-muscular injections of a long acting preparation of octreotide, Sandostatin LAR, with multiple daily subcutaneous injections of octreotide and to study the interrelationships between mean 24 h growth hormone profile, serum total and free IGF-1 levels, 24 h urinary growth hormone levels and serum IGFBP-3. DESIGN: Patients were assessed by 24 h GH profile off octreotide or any other GH modifying drug therapy; on subcutaneous octreotide (200-600 micrograms daily in divided doses for six weeks); and 28 days after the second of two injections of Sandostatin LAR (20 mg by intra-muscular injection) administered 28 days apart. Serum total and free IGF-1, serum IGFBP-3 and 24 h urinary GH were also measured on each occasion. RESULTS: Sandostatin LAR was well tolerated. None of the patients reported any adverse effect and all completed the study uneventfully. Mean GH off treatment was 10.1 +/- 3.0 micrograms/l falling equally significantly (P < 0.05) during therapy with subcutaneous octreotide to 3.0 +/- 0.7 micrograms/l and Sandostatin LAR to 2.8 +/- 0.7 micrograms/l. Fasting 0900 h GH was significantly reduced (P < 0.05) on Sandostatin LAR (3.0 +/- 0.7 micrograms/l) compared with subcutaneous octreotide (5.1 +/- 1.2 micrograms/l). Mean total IGF-1 off treatment was 658.6 +/- 56.1 micrograms/l and was reduced to a comparable extent with subcutaneous octreotide and Sandostatin LAR (466.0 +/- 59.7 and 448.6 +/- 59.5 micrograms/l respectively; both P < 0.05). Free IGF-1 off treatment was 3.1 +/- 0.6 micrograms/l and was reduced equally by subcutaneous octreotide and Sandostatin LAR (1.2 +/- 0.2 and 1.2 +/- 0.2 micrograms/l; both P < 0.05). IGFBP-3 was reduced to a greater extent during Sandostatin LAR than during subcutaneous octreotide (4518.2 +/- 247.3 vs 5132.8 +/- 280.7 micrograms/l; P < 0.05). Twenty-four hour urinary GH excretion was reduced to a comparable extent with both therapies. Highly significant positive correlations were found between mean 24 h GH levels and free IGF-1 (r = 0.66, P < 0.0001) and 24 h urinary GH excretion (r = 0.94, P < 0.0001). The relationships between mean 24 h GH levels and total IGF-1 and IGFBP-3 although significant showed less powerful correlations. CONCLUSIONS: These results suggest that Sandostatin LAR is well tolerated and as effective as subcutaneous octreotide. In addition, urinary growth hormone and serum free IGF-1 may prove valuable for outpatient follow-up of acromegalic patients, as both correlate well with mean 24 h serum growth hormone levels.

Acromegaly↗

Anal submucosal injection: methotrexate concentration in rectal tumor tissue and serum after anal compared with parenteral injection.

As the results of adjuvant chemotherapy in the treatment of advanced rectal cancer are unsatisfactory, more effective regimens and routes of administration are being tried. Submucosal anal injection of methotrexate (MXT) has given encouraging results in the treatment of pelvic malignancies. This communication studies the MXT level in serum and rectal cancer tissue after either anal submucosal or parenteral MXT administration. Twenty four patients, mean age 46.4 years (16 men and eight women), with stage C rectal cancer were divided into two equal, age- and sex-matched groups. MXT (50 mg) was administered to each patient intravenously in one group and into the anal submucosa in the other. A blood sample was taken 30, 60 and 120 min after injection, and again after 24 h. A tumor sample was also taken each 30 and 60 min of injection. The serum and tissue MXT levels were determined using a radioimmunoassay kit. The serum MXT concentration was significantly higher after parenteral than after anal injection. Meanwhile, the concentration of MXT in tumor tissue was higher after anal administration. In conclusion, the anal route of administration of MXT, by inducing a high MXT concentration in the tumor tissue associated with a low serum level, might achieve satisfactory therapeutic results in advanced rectal cancer, with minimal side effects.

Adult↗

Paraplegia after intracord injection during attempted epidural steroid injection in an awake-patient.

UNLABELLED: Epidural steroid injection is recommended in patients with back ache from spinal and radicular pain or pain suggestive of radiculopathy. During needle placement and injections, clinicians often rely on the patient's complaint of paresthesia or shooting pain along the nerve root, dura, or cord in case a needle pierces these areas. We report the accidental intracord injection of steroid solution during epidural block using fluoroscopy in a conscious patient, which caused paraplegia. This case suggests failure of undue reliance on a patient reporting pain in the vicinity of needle puncturing the spinal cord structures. IMPLICATIONS: Intracord injection of triamcinolone acetate and local anesthetic, resulting in permanent paraplegia, may occur in conscious patients.

Humans↗

Are needle-free injections a useful alternative for growth hormone therapy in children? Safety and pharmacokinetics of growth hormone delivered by a new needle-free injection device compared to a fine gauge needle.

The clinical safety, use and pharmacokinetics of a new needle-free device for delivery of growth hormone (GH) were compared with those of conventional needle injection devices. In an open-label, randomized, 4-period crossover study, 18 healthy adults received single subcutaneous injections of Genotropin administered by the Genotropin ZipTip needle-free device and by conventional injection. Bioequivalence was established between the devices. In a separate open-label, randomized, multicenter, 2-period crossover study, pediatric patients underwent 2-weeks Genotropin treatment administered by the Genotropin ZipTip and by a fine-gauge needle device (>95% used the Genotropin Pen). In total, 128/133 patients who were treated completed the study. Genotropin ZipTip was well tolerated and >50% of patients found no difference between the devices for all parameters assessed. After study completion, >20% patients preferred to continue using Genotropin ZipTip. Although statistical analyses demonstrated superiority of the Genotropin Pen versus Genotropin ZipTip for bleeding, pain, soreness, and bruising, Genotropin ZipTip was considered to provide a safe and bioequivalent alternative to needle injection.

Adolescent↗

The effect of vitamin E supplementation on discoloration of injection-site lesions in retail cuts and the greening reaction observed in injection-site lesions in muscles of the chuck.

Concern has been raised about green discoloration of injection-site lesions in chuck muscles in modified-atmosphere packages. Objectives were: 1) to recreate green lesions, 2) to compare the severity of discoloration of injection-site lesions in chucks from carcasses of control or vitamin E-supplemented steers, and 3) to identify pigment(s) responsible for discoloration via in vitro color reactions. In Exp. 1, 23 steers (BW = 415 kg; 37 d before harvest) were injected with one of 12 pharmaceuticals, following label directions for route and dose, with the exception of a 5-mL maximum dose, to identify a product that could result in discoloration. Two vaccines (Products A and B) resulted in greening. In Exp. 2, 50 steers were injected (i.m.) with Product A and assigned to the control or vitamin E (1,000 IU/steer daily for 60 d) group. After retail display, 80 and 72% of steaks from the control and treatment groups, respectively, were discolored. Although vitamin E did not reduce (P = 0.53) greening, there was a trend (P = 0.10) toward delay discoloration of lesions from the treatment group. In Phase I of Exp. 3, pigments extracted from green lesions obtained from Exp. 2 were compared with solutions, exposed to a high partial pressure of oxygen (ppO), of myoglobin (Mb), copper sulfate, hydrogen peroxide (H2O2), vaccine, and aluminum hydroxide either alone or in combination. In Phase II of Exp. 3, solutions of two or more of Mb, Cu, sodium sulfide, sodium sulfite, sodium sulfate (Na2SO4), and H2O2 were made at pH 7.2 or 5.5 and exposed to low or high ppO. Normal muscle tissue displayed a 3.2 and 56.7% decrease in absorbance/microg of protein as wavelength changed from 654 to 656 nm and 656 to 658 nm, respectively. Pigments from control and treatment group green tissue displayed a 164.5 and 621.3% increase, respectively, in absorbance/microg of protein as wavelength changed from 654 to 656 nm. As wavelength changed from 656 to 658 nm, the absorbance/microg of protein for control and treatment group lesions decreased by 75 and 109%, respectively. The Mb+Cu+Na2SO4 solution, at pH 5.5 and high ppO, exhibited similar absorbance trends as green lesions indicating that greening may result from a Mb, Cu, and Na2SO4 interaction. Results indicated that greening varies with pharmaceuticals and oxidation of tissue cannot be controlled with vitamin E supplementation. Research on the causative agents of green discoloration, with an emphasis on compounds containing sulfate or Cu, is needed.

Animals↗

What happens if intradermal injections of rabies vaccine are partially or entirely injected subcutaneously?

Reported are the results of a study with the Thai Red Cross two-site intradermal purified Vero-cell rabies vaccine (PVRV) schedule that was deliberately injected into subcutaneous tissue. The 44 healthy nonimmune Thai adults who were enrolled in the study were randomly assigned to the following groups and given PVRV as shown: group A (two intradermal injections on days 0, 3, and 7); group B (one intradermal and one subcutaneous injection on days 0, 3, and 7); and group C (two subcutaneous injections on days 0, 3, and 7). Neutralizing antirabies antibody titres were determined on day 14 using the rapid fluorescent focus inhibition test. High rabies antibody titres were obtained for all three groups. These results suggest that the economical and safe Thai Red Cross intradermal PVRV regimen could be used in selected general health care facilities.

Adolescent↗

Flow-injection analysis of dopamine in injections with a periodate-selective electrode.

Dopamine determination in pharmaceutical preparations based on its oxidation with periodate (IO(4)(-)) using a new IO(4)(-)-selective electrode under flow conditions is presented. An electrode with a tubular configuration, no internal reference solution, and a PVC (31. 2%) membrane, with metaperiodate bis(triphenylphosphoranylidene)ammonium (1.3%) as ion exchanger and 2-nitrophenyloctylether (67.5%) as mediator solvent, was used. Optimization procedures were directed at potentials versus dopamine readings instead of potential versus the remaining IO(4)(-). This approach was achieved by selecting a 50-cm reactor and an overall flow of 7 mL/min, and injecting 70 microL of dopamine standards in a 3.0 x 10(-4) M IO(4)(-) solution. Under these conditions, a linearity range of 8.0 x 10(-3) to 2.7 x 10(-1) g/L, with a slope of 310.1 +/- 7.4 mV L g(-1) and a reproducibility of +/-0.4 mV, were recorded (n = 8). Interference from common excipients was negligible. Under these conditions, analysis of dopamine injections (n = 12) presenting 200 mg/injection gave average and standard deviation values of 201.0 and 3.3 mg/injection, respectively. A simple and inexpensive flow-injection analysis (FIA) manifold, with a good potentiometric detector, enabled the analysis of 200 samples/h without requiring pretreatment procedures. Comparison with the dopamine injection analysis in the United States Pharmacopoeia monograph showed good accuracy, with a relative deviation of -0.2%.

Dopamine↗

Intramuscular injections and muscle damage: effects of concentration, volume, injection speed and vehicle.

An intramuscular injection was given to rabbits with the needle inserted in the longissimus dorsi muscle. The muscle tissue at the injection site was examined post-mortem 3 days after the injection and areas of necrotic muscle tissue were dissected for weighing. With a fixed dose of the neuroleptic drug cis(Z)-clopenthixol it was shown that a small volume of a concentrated solution caused less muscle damage than a larger volume of a relatively less concentrated solution. Injection speed, on the other hand, was not an important factor. Aqueous solutions of neuroleptic drugs caused local muscle damage which was diminished or prevented by oily vehicles.

Animals↗

Comparison of the acute biological action of injectable salmon calcitonin and an injectable and oral calcitonin analogue.

In most countries, calcitonin is available in the form of injections, and less frequently as an intranasal spray. An oral route of administration should improve compliance. In a preliminary feasibility study, we have compared the acute biological action of injectable salmon calcitonin (50 IU), with the injectable calcitonin analogue ASC 710 (0.2 mg) and oral ASC 710 (20 mg) in 6 patients suffering from active Paget's disease of bone. The intensity and duration of the biological response were not significantly different in the 3 modes of therapy. In conclusion, the oral calcitonin analogue ASC 710 possesses an antiresorbing activity in Paget's disease comparable to that of an injection of salmon calcitonin which demonstrates that it can cross the intestinal barrier.

Administration, Intranasal↗

Modification, by a poly I:C injection, of organ distribution of intravenously injected murine lymphoma cells and of blood coagulability.

51Cr-or 111In-labelled murine lymphoma cells were injected IV in control and poly I:C-treated mice. The organ distribution (lung, spleen, liver) of radioactivity was measured 2 h after injection. The results showed that if cell injection was performed 1 day after poly I:C treatment, the modifications of organ distribution did not fit with the expectations from a reinforcement of the NK function in vivo. In NK-suppressed mice, poly I:C affected the distribution of radioactivity in spleen and liver in the same manner as in normal mice, suggesting that the action does not entirely depend on the NK system. Additionally to that, poly I:C injections affected coagulability of the plasma from treated mice, by prolonging the coagulation time. It is concluded that poly I:C exerts a complex action on circulation and fixation of lymphoma cells.

Animals↗

New contributions to the field of bead-injection spectroscopy-flow-injection analysis: determination of cobalt.

A bead-injection spectroscopy-flow-injection analysis (BIS-FIA) system with spectrophotometric detection has been developed for the determination of cobalt. A homogeneous bead suspension of Dowex 50 W resin (600 microL) previously loaded with the chromogenic reagent 1-(2-pyridylazo)-2-naphthol (PAN) was injected to fill the flow-cell. Co is injected into the carrier (pyrophosphate, pH 5) and reacts with the immobilized chromogenic reagent to form a green chelate. The analytical signal corresponds to the formation of the Co-PAN complex on the solid surface. At the end of the analysis, the beads are discarded by reversing the flow and instantaneously transported out of the system. The sensor shows both excellent selectivity, which could also be increased with a simple on-line modification to avoid interferences from Ni(II), Zn(II) and Cu(II), and good sensitivity; the detection limit was 19 ng mL(-1), the linear range 50-2000 ng mL(-1) and the RSD (%) 4.16. The method was satisfactorily applied to the determination of Co in waters, pharmaceuticals and alloy steels.

Calibration↗

Flow-injection manifold for the simultaneous spectrophotometric determination of Fe(II) and Fe(III) using 2,2'-dipyridyl-2-pyridylhydrazone and a single-line double injection approach.

A simple and rapid flow-injection (FI) method is reported for the simultaneous spectrophotometric determination of Fe(II) and Fe(III) in pharmaceutical products. The method is based on the reaction of Fe(II) with 2,2'-dipyridyl-2-pyridylhydrazone (DPPH) in acidic medium to form a water-soluble reddish complex (lambdamax=535 nm). Fe(III) reacts with DPPH under flow conditions only after its on-line reduction by ascorbic acid (AsA). Both analytes were determined in the same run via a double-injection valve, which enabled the simultaneous injection of two sample volumes in the same carrier stream (,,single-line double-injection" approach). The two well-defined peaks produced corresponded to total iron [Fe(II)+Fe(III)] and Fe(II). Speciation of the analytes in their mixtures was achieved by multiple regression analysis. The calibration curves obtained were linear over the ranges 0-30 and 0-50 mg L(-1) for Fe(II) and Fe(II), respectively, and the precision [s(r)=1.0% for Fe(II) and 1.5% for Fe(III)] was satisfactory. The method proved to be selective and adequately sensitive (cL=0.25 and 0.17 mg L(-1) for Fe(III) and Fe(II), respectively, in mixtures). Application of the method to the analysis of pharmaceutical samples resulted in excellent accuracy; the percent mean recoveries were in the range 99.0-102.0% for both Fe(II) and Fe(III) and the mean relative error was e(r)=1.0%.

2,2'-Dipyridyl↗

Trigger point injections vs. jet injection in the treatment of myofascial pain.

Trigger point injections using dilute solutions of local anesthetic agents have proved effective for many patients with myofascial pain. The treatment itself, however, can produce severe pain and may occasionally be associated with complications. It was determined in this study that a local anesthetic solution administered by jet injection in the area of myofascial trigger points was capable of providing short-term pain relief equal to conventional trigger point injections using a hypodermic needle and syringe. The jet injector system produced significantly less pain during treatment than conventional trigger point injections and therefore was preferred by most subjects having the opportunity to compare both forms of treatment.

Adult↗

Only controls: effect of handling, sham injection, and intraperitoneal injection of saline on behavior of mice in an elevated plus-maze.

In male NIH-Swiss mice intraperitoneal injection of physiological saline significantly diminished (vs. naive mice) the ratio of the number of entries into open arms over the sum of entries into open and closed arms, and significantly prolonged time spent in closed arms. These two effects are considered to be typical for anxiety-inducing drugs (anxiogens). The time spent in open arms and at the intersection was unaffected. An equal number of entries into closed and also open arms was observed among fast- and slow-moving individuals. This is an argument against using the number of entries into arms as a measure of locomotor activity of mice. Additional measurement of locomotor activity in actometers is needed to check whether drugs used in experiments with elevated plus-maze alter locomotor activity. Injection of saline significantly shortened the latency of reaching one of the closed arms from the free end of an open arm. Handling, sham injection, and injection significantly diminished the shortening of latency in a second experiment (vs the latency in the first one), a parameter used as a criterion of memory and learning. Thus, saline-treated groups taken as controls in pharmacological experiments possess the behavioral profile of stressed and anxious animals in an elevated plus-maze, a device used as a model of anxiety and a model for studying memory and learning in mice and rats.

Analysis of Variance↗

Comparative safety, efficacy, and cycle control of Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) and Ortho-Novum 7/7/7 oral contraceptive (norethindrone/ethinyl estradiol triphasic). Lunelle Study Group.

An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C) (MPA/E2C) (Lunelle Monthly Contraceptive Injection) with that of a norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum 7/7/7). At study enrollment, women chose either the injections or the oral contraceptive. A higher proportion of women in the NET/EE group (65.1%) than in the MPA/E2C group (48.7%) had used hormonal contraception during the month before the study (p < 0.01). Overall, 55.5% (434/782) of MPA/E2C users and 67.6% (217/321) of NET/EE users completed the 60-week trial. One-year contraceptive efficacy (13 cycles of 28 days) for MPA/E2C and NET/EE was based on 8008 and 3434 woman-cycles of use, respectively. During the first year, one pregnancy occurred in an NET/EE user for a life table rate of 0.3; no pregnancies occurred in users of MPA/E2C. One additional pregnancy in the NET/EE group occurred during the 15th treatment cycle. After the first treatment cycle, women in both groups experienced regular menses, with an average cycle length of 28 days in MPA/E2C users and 27 days in NET/EE users. Although MPA/E2C users were more likely to experience bleeding irregularities, only 2.5% (19/775) cited metrorrhagia as a reason for discontinuing treatment. The adverse events reported in both treatment groups are consistent with those expected with the use of combined hormonal contraceptives. Overall, the results of this first Phase III US clinical trial of MPA/E2C confirm this method's high contraceptive efficacy and safety, as shown in previous studies by the World Health Organization. These results suggest that a monthly combination injectable would represent a welcome new contraceptive option for women in the US.

Contraceptive Agents, Female↗

Anal submucosal injection: a new route for drug administration in pelvic malignancies. II. Methotrexate anal injection in the treatment of advanced bladder cancer. Preliminary study.

The clinical efficacy of submucosal anal injections of methotrexate in advanced bladder cancer is investigated. An experimental study on 20 mice has shown that methotrexate injected into the anal submucosa has no clinicopathological effect on the anorectum. The clinical study comprised 18 patients with advanced bladder cancer (13 with stage T3 and 5 with stage T4 disease) as a test group in whom methotrexate was injected into the anal submucosa and 8 (6 with stage T3 and 2 with stage T4 cancer) treated concurrently with intravenous methotrexate. The dose in both groups was 50 mg. every 5 days for 5 consecutive doses. The course was repeated at 3-week intervals. Most patients received methotrexate as outpatients. Methotrexate blood levels were measured 4 and 24 hours after administration in both groups. In the test group 10 of the 18 patients showed complete tumor regression and were alive 21 to 50 months after the start of treatment. Partial regression was observed in 8 patients. Hematological reserve remained unchanged. Mild toxicity occurred in 3 patients. Of the 8 patients treated intravenously the tumor showed partial regression in 1, was stable in 3 and progressed in 4. Side effects were severe in 5 patients. Our results show that methotrexate injection is highly effective in the treatment of advanced bladder cancer. It is safe, well tolerated and can be used on an outpatient basis.

Adult↗

DMSO as a vehicle for central injections: tests with feeding elicited by norepinephrine injected into the paraventricular nucleus.

Dimethyl sulfoxide (DMSO) is becoming increasingly popular as a vehicle in studies employing central injections. The aim of the present study was to determine whether the vehicle required for solubilization of substances for central injection [75% DMSO and 25% artificial CSF (aCSF)] would alter the well-characterized stimulatory response to norepinephrine (NE) injected into the paraventricular nucleus (PVN) on short-term food intake. To evaluate its suitability, we compared the effects of repeated unilateral injections of NE dissolved in two different vehicles (100% aCSF or 75% DMSO, 25% aCSF), in separate groups of animals every 48 h over a 30-day period. NE (40 nmol) stimulated food intake by approximately sevenfold compared to either vehicle alone, and the stimulatory effect was similar whether aCSF or 75% DMSO was used as a vehicle. Furthermore, the NE-induced feeding did not vary in magnitude across a series of 13 tests. These results suggest that 75% DMSO is a suitable vehicle for administering NE (and likely other water-insoluble substances)in small volumes of 0.3 microl into specific brain regions.

Animals↗

Recurrence rates of excised keloids treated with postoperative triamcinolone acetonide injections or interferon alfa-2b injections.

BACKGROUND: Keloids that are surgically removed commonly recur within the excision sites. OBJECTIVE: Our purpose was to determine whether postsurgical adjunctive therapy reduces such recurrences. METHODS: We determined the rate of recurrence after excision alone (n = 43) and postoperative injection with triamcinolone acetonide (TAC; n = 65) or interferon alfa-2b (IFN-alpha 2b; n = 16). RESULTS: Of lesions excised without postoperative injections, 51.1% (22 of 43) recurred; 58.4% of TAC-treated lesions (38 of 65) recurred and 18.7% of IFN-alpha 2b-treated lesions (3 of 16) recurred (p = 0.025). CONCLUSION: Postoperative TAC injections do not reduce the number of keloid recurrences. However, injection of keloid excision sites with IFN-alpha 2b offers a therapeutic advantage over keloid excision.

Adolescent↗