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Olive Oil And Soybean Oil (Clinolipid)

Trade Name : Clinolipid

Baxter Healthcare Corporation

INJECTION, EMULSION

Strength 164 g/100mLg/100mL

OLIVE OIL; SOYBEAN OIL Lipid Emulsion [EPC],Lipids [CS],Lipid Emulsion [EPC],Lipids [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Olive Oil And Soybean Oil (Clinolipid) which is also known as Clinolipid and Manufactured by Baxter Healthcare Corporation. It is available in strength of 16; 4 g/100mL; g/100mL per ml. Read more

Olive Oil And Soybean Oil (Clinolipid) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Dosage and Administration, (, , )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a007/2016
  • Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.
  • Autopsy findings included intravascular fat accumulation in the lungs.
  • Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
  • [See Warnings and Precautions(n- )and Use in Specific Populations(n- )]
  • WARNING: DEATH IN PRETERM INFANTS
  • See full prescribing information for complete boxed warning
  • Deaths in preterm infants have been reported in literature. (n- , n- )
  • 5.1n- 8.4
  • Autopsy findings included intravascular fat accumulation in the lungs. (n- , n- )
  • 5.1n- 8.4
  • Preterm and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. (n- , n- )
  • 5.1n- 8.4
  • CLINOLIPID is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
  • Limitations of Usen- u00a0
  • CLINOLIPID is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population. [See ]
  • The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. [See ]
  • CLINOLIPID is indicated in adults for parenteral nutrition providing a source of calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated. ()
  • 1n- 8.4
  • No data
  • 2.2n- 2.3
  • CLINOLIPID 20% is a lipid injectable emulsion. The lipid content is 0.2 g/mL in 100 mL, 250 mL, 500 mL, and 1000 mL.
  • CLINOLIPID 20% is a lipid injectable emulsion. The lipid content is 0.2 grams/mL in 100 mL, 250 mL, 500 mL, and 1000 mL. ()
  • The use of CLINOLIPID is contraindicated in patients with the following:
  • No data
  • 5.3n- 5.4n- 5.5
  • The most common (5%) adverse drug reactions from clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests. ()
  • No drug interaction studies have been performed with CLINOLIPID.
  • Olive and soybean oils have a natural content of Vitamin K that may counteract the anticoagulant activity of coumarin derivatives, including warfarin.
  • The anticoagulant activity of coumarin derivatives, including warfarin, may be counteracted. ()
  • Hepatic Impaired: Use with caution in patients with preexisting liver disease or liver insufficiency. ()
  • In the event of overdose, fat overload syndrome may result [see ]. Stop the infusion to allow lipids to clear from serum. The effects are usually reversible after the lipid infusion is stopped. If medically appropriate, further intervention may be indicated. The lipid administered and fatty acids produced are not dialyzable.
  • CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic lipid emulsion for intravenous infusion. CLINOLIPID is a lipid emulsion containing a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The lipid content is 0.2 g/mL. In CLINOLIPID, the mean composition of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and u03b1-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter.n The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L.
  • Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0.
  • The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:
  • The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas:
  • CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion)
  • CLINOLIPID contains no more than 25 mcg/L of aluminum.
  • CLINOLIPID administered intravenously provides biologically utilizable source of calories and essential fatty acids.
  • No data
  • Two clinical trials (Study 1 and Study 2) in adults compared CLINOLIPID to a pure soybean oil based intravenous lipid emulsion. Although Study 1 and Study 2 were not adequately designed to demonstrate noninferiority of CLINOLIPID to the soybean oil comparator, they support CLINOLIPID injection as a source of calories and essential fatty acids in adults. The lipid dosage was variable in Studies 1 and 2 and adjusted to the patientu2019s nutritional requirements.
  • Study 1 was a randomized, open-label, multicenter study. Forty eight (48) patients, aged 17 to 75 years, requiring u226515 days (mean 22 days) exclusive parenteral nutrition (TPN) were enrolled and randomized to either CLINOLIPID or a pure soybean oil based intravenous lipid emulsion. Nutritional efficacy was assessed by anthropometric indices (body weight, arm circumference, skin-fold thickness), biomarkers of protein metabolism (total protein, albumin) and lipid metabolism. Anthropometric criteria (body weight, arm circumference, and skin fold thickness) were comparable for both groups. Mean total serum protein and albumin increased similarly in both groups.
  • Study 2 was a randomized, open label multicenter study that enrolled 22 patients aged 32-81 years who required long-term parenteral nutrition. Twelve patients received CLINOLIPID for a mean of 202 days (range 24 to 408 days) and 10 patients received the comparator lipid for a mean of 145 days (range 29-394 days). The two groups had similar outcomes for weight, weight loss, mid-arm circumference and triceps skinfold thickness.
  • No data
  • CLINOLIPID lipid injectable emulsion, USP is supplied in single-dose CLARITY polyolefin bags as follows:
  • The CLARITY Container is a lipid-compatible plastic container (PL 2401-1). The bag is packaged in an oxygen barrier overpouch, which contains an oxygen absorber / oxygen indicator sachet.
  • CLINOLIPID should be stored at 20 to 25 u00b0C (68 to 77 u00b0F). Excursion permitted between 15 to 30 u00b0C (59 to 86 u00b0F). See USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Store in overpouch until ready to use.
  • To ensure the safe and effective use of CLINOLIPID, this information should be discussed with the patient.
  • Inform patients of the following:
  • Should patients self-administer CLINOLIPID at home, patients should also be instructed to:
  • Baxter Healthcare Corporation
  • Baxter, Clarity, Clinolipid and Exactamix are trademarks of Baxter International Inc., or its subsidiaries.
  • 1000 mL
  • EADB9524 NDC 0338-9540-04
  • Arrayn- Baxter Logo
  • Clinolipid n- (Lipid Injectable Emulsion, USP) 20%200 g/1000 mL (0.2 g/mL)
  • Intravenous use only
  • 1000 mL sterile single dose container
  • Each 100 mL contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, Water for Injection USP and Sodium Hydroxide NF for pH adjustment pH 6.0u20139.0 Osmolarity 260 mOsmol/L (calc)
  • Cautions
  • Do not add supplemental medications Must not be used in series connections
  • Usual Dosage
  • Store at 20 to 25 u00b0C (68 to 77 u00b0F) Excursion permitted between 15 to 30 u00b0C (59 to 86 u00b0F) See USP Controlled Room Temperature Protect from freezing Do not use beyond 24 hours once opened;discard unused portion after 24 hoursn n
  • Baxter Healthcare Corporation
  • BE-35-02-746
  • EXP LOT
  • 1000
  • 750
  • 500
  • 250
  • 100

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